Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38905 NextCure, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of ...

PART I [Item 1. Business](index=9&type=section&id=Item%201.%20Business) NextCure, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing first-in-class immunomedicines for cancer and immune-related diseases using its proprietary FIND-IO platform [Overview](index=9&type=section&id=Overview) NextCure is a clinical-stage biopharmaceutical company developing novel immunomedicines for cancer and immune-related diseases, leveraging its FIND-IO platform - NC318, a first-in-class immunomedicine targeting Siglec-15 (S15), is in **Phase 1/2 clinical trials** for advanced/metastatic solid tumors, with a **Phase 2 combination trial** with pembrolizumab initiated by Yale University[33](index=33&type=chunk)[35](index=35&type=chunk)[36](index=36&type=chunk) - NC410, designed to block LAIR-1 mediated immune suppression, is in **Phase 1/2 clinical trials** for advanced/metastatic solid tumors, showing safety, tolerability, and immune modulation[37](index=37&type=chunk) - NC762, an immunomedicine targeting B7-H4, initiated a **Phase 1/2 clinical trial** in July 2021 for lung, breast, ovarian, and other tumor types[38](index=38&type=chunk)[39](index=39&type=chunk) - NC525, a novel LAIR-1 antibody, is in preclinical development for Acute Myeloid Leukemia (AML), demonstrating inhibition of AML blast and leukemic stem cells, with an IND submission planned for **Q4 2022**[40](index=40&type=chunk)[41](index=41&type=chunk) [Our Strategy](index=11&type=section&id=Our%20Strategy) NextCure's strategy focuses on building a sustainable pipeline of immunomedicines for cancer patients underserved by current therapies - The company aims to advance clinical development of NC318, NC410, and NC762, including a **Phase 2 combination trial** for NC318 with pembrolizumab[44](index=44&type=chunk)[46](index=46&type=chunk) - NextCure is building an oncology pipeline of novel targets for non-responders by leveraging its FIND-IO platform and immunological expertise[49](index=49&type=chunk) - The company utilizes its fully integrated development, quality systems, and cGMP manufacturing facility (**2,000 liters capacity**) to support its pipeline, offering better quality assurance, control, and capital efficiency compared to third-party manufacturers[49](index=49&type=chunk) - Beyond oncology, NextCure plans to expand its FIND-IO platform to discover novel targets in other inflammatory and neuro-inflammatory diseases[49](index=49&type=chunk) - The strategy includes extending the reach of product candidates through strategic partnerships and collaborations for global development and commercialization, particularly in key markets and regions like Asia[49](index=49&type=chunk) [Immuno-Oncology Background](index=13&type=section&id=Immuno-Oncology%20Background) Immuno-oncology focuses on leveraging the immune system to fight cancer, particularly by overcoming tumor-induced immunosuppression in the tumor microenvironment (TME) - The immune system provides surveillance against cancers, but complex interactions in the tumor microenvironment (TME) can lead to immunosuppression and immune evasion, allowing tumors to grow[47](index=47&type=chunk) - Despite the success of checkpoint inhibitors (e.g., PD-L1, PD-1, CTLA-4), an estimated **60% to 70% of cancer patients** do not respond to single-agent therapy, underscoring the need for novel targets and molecular pathways[48](index=48&type=chunk)[50](index=50&type=chunk) [Our Approach to Developing Immunomedicines for Cancer](index=15&type=section&id=Our%20Approach%20to%20Developing%20Immunomedicines%20for%20Cancer) NextCure's approach combines its FIND-IO platform with immunological expertise to identify novel immune modulators that restore normal immune function in the tumor microenvironment (TME) - NextCure's FIND-IO platform uses a function-based screening approach to identify novel cell surface and secretory molecules that drive functional immune responses, aiming to restore normal immune function in the TME[52](index=52&type=chunk)[53](index=53&type=chunk) - The platform broadly and quantitatively evaluates interactions between protein components and different T-cellular types, expanding beyond its predecessor (TCAA) with different gene libraries, biological pathways, reporters, and immune cell types[52](index=52&type=chunk)[53](index=53&type=chunk) - Product candidates like NC318 and NC410 target various immune cells (macrophages, tumor cells, dendritic cells, T-cells) to prevent suppression and promote anti-tumor immunity[55](index=55&type=chunk) [Our Programs](index=16&type=section&id=Our%20Programs) NextCure's pipeline includes NC318 (anti-S15 monoclonal antibody in Phase 1/2 for solid tumors, with a combination trial), NC410 (LAIR-2 fusion protein in Phase 1/2 for solid tumors), NC762 (anti-B7-H4 monoclonal antibody in Phase 1/2 for various cancers), and NC525 (LAIR-1 antibody in preclinical development for AML) [NC318](index=16&type=section&id=NC318) NC318 is a first-in-class monoclonal antibody targeting Siglec-15 (S15), an immunosuppressive protein, with early clinical benefit in HNSCC, lung, and breast cancers, and a Phase 2 combination trial with pembrolizumab underway - NC318 is a monoclonal antibody that binds to human S15, a highly immunosuppressive protein expressed on tumor cells and M2 macrophages, to promote anti-tumor immune response[58](index=58&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk)[65](index=65&type=chunk) - The Phase 1 portion of the NC318 trial (**49 patients across 7 dose cohorts**) showed NC318 was well-tolerated, with primarily mild/moderate TRAEs, and evidence of immune modulation (e.g., vitiligo, pneumonitis)[68](index=68&type=chunk)[69](index=69&type=chunk) - Preliminary Phase 1 data indicated activity in multiple tumor types, including durable stable disease and complete/partial responses in NSCLC patients[70](index=70&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk) - The Phase 2 portion of the trial was modified for S15-positive patient selection via CLIA-certified screening biopsies and a revised dosing regimen of **800 mg weekly** to increase drug exposure[75](index=75&type=chunk) - Yale University initiated a **Phase 2 investigator-initiated clinical trial** of NC318 in combination with pembrolizumab for NSCLC in April 2021, with initial data expected in **H2 2022**[76](index=76&type=chunk) [NC410](index=21&type=section&id=NC410) NC410 is a LAIR-2 fusion protein designed to block LAIR-1 mediated immune suppression, with ongoing Phase 1/2 clinical trials showing safety and immune modulation - NC410 is a LAIR-2 fusion protein designed to block immune suppression mediated by LAIR-1, a co-inhibitory receptor expressed on immune cells, which binds to collagen and C1q overexpressed in the TME[77](index=77&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk) - Preclinical data indicate NC410 promotes T-cell mediated anti-tumor immunity, enhances infiltration, and increases localized T-cell activity in the TME[87](index=87&type=chunk) - A **Phase 1/2 clinical trial** for NC410 in advanced/metastatic solid tumors is ongoing, with interim data showing safety, tolerability, and evidence of immune modulation[87](index=87&type=chunk) - Genomic and protein analyses suggest LAIR-1 expression negatively correlates with survival in several cancers, guiding potential primary indications for NC410, and a CLIA-certified assay is planned for **Phase 2 patient selection**[84](index=84&type=chunk)[85](index=85&type=chunk)[86](index=86&type=chunk) [NC762](index=25&type=section&id=NC762) NC762 is a monoclonal antibody targeting B7-H4, with a Phase 1/2 clinical trial initiated in July 2021 for various cancers, and initial data expected in H2 2022 - NC762 is a monoclonal antibody targeting B7-H4, a cell surface protein expressed on multiple tumor types (e.g., NSCLC, ovarian, breast, hepatocellular carcinoma) and tumor-associated macrophages, with limited expression in normal tissues[88](index=88&type=chunk)[89](index=89&type=chunk)[95](index=95&type=chunk) - Preclinical data indicate NC762 inhibits tumor cell growth, potentially by enhancing immune response through NK cells, and has an anti-tumor impact even without peripheral blood mononuclear cells, suggesting an ADCC-independent primary mechanism[88](index=88&type=chunk)[90](index=90&type=chunk) - Preclinical safety studies showed no significant concerns, with no adverse effects in cynomolgus monkeys and no off-target binding in human tissue cross-reactivity studies[93](index=93&type=chunk) - A **Phase 1/2 clinical trial** for NC762 was initiated in July 2021, and an IHC assay has been developed and validated to select B7-H4 positive patients for treatment[88](index=88&type=chunk)[94](index=94&type=chunk)[96](index=96&type=chunk) [NC525](index=27&type=section&id=NC525) NC525 is a novel LAIR-1 antibody designed to selectively target and kill Acute Myeloid Leukemia (AML) blast cells and leukemic stem cells (LSCs), with an IND submission planned for Q4 2022 - NC525 is a novel LAIR-1 antibody that selectively targets and kills Acute Myeloid Leukemia (AML) blast cells and leukemic stem cells (LSCs) while sparing hematopoietic stem and progenitor cells (HSPCs)[97](index=97&type=chunk) - Preclinical data showed NC525 inhibits colony formation of AML LSCs in vitro, inhibits AML growth in MV4-11 derived xenografts (CDX) in vivo, and restricts AML progression in patient-derived xenografts (PDX) in vivo[41](index=41&type=chunk)[97](index=97&type=chunk) - An Investigational New Drug (IND) submission for NC525 is planned for the **fourth quarter of 2022**[41](index=41&type=chunk) [Our Research Programs](index=27&type=section&id=Our%20Research%20Programs) In addition to its lead product candidates, NextCure is actively pursuing preclinical evaluation of other potential novel immunomodulatory molecules, leveraging its FIND-IO platform for ongoing discovery efforts - NextCure is pursuing preclinical evaluation of other potential novel immunomodulatory molecules in addition to its lead product candidates[98](index=98&type=chunk) [Our FIND-IO Platform](index=29&type=section&id=Our%20FIND-IO%20Platform) NextCure's proprietary FIND-IO platform uses functional screening to assess immune pathways in various primary immune cells and cell lines, identifying proteins for novel immunomedicines - The FIND-IO platform uses proprietary approaches to functionally assess immune pathways in primary immune cells and established cell lines, enabling the identification of proteins for novel immunomedicines to repair and maintain anti-tumor immunity[100](index=100&type=chunk) - The platform aims to sustain a pipeline of novel immunomedicines for cancer and other immune-related diseases, with plans to expand functional screening to identify targets in autoimmunity, inflammation, and neuro-inflammatory diseases[101](index=101&type=chunk) [Our Collaboration Agreements](index=29&type=section&id=Our%20Collaboration%20Agreements) NextCure has a license agreement with Yale University for intellectual property related to certain product candidates, including NC318, involving low single-digit royalties and milestone payments - NextCure holds an exclusive, royalty-bearing, sublicensable worldwide license from Yale University for intellectual property related to certain product candidates, including S15 (NC318's target), with aggregate milestone payments up to **$2,975,000**[102](index=102&type=chunk) - A corporate sponsored research agreement with Yale, which funded research for new immunomedicine targets, expired on **December 31, 2021**, and will not be renewed[103](index=103&type=chunk) - Eli Lilly and Company terminated its multi-year research and development collaboration agreement with NextCure, focused on the FIND-IO platform, effective **March 3, 2020**, without cause[104](index=104&type=chunk) [Manufacturing](index=31&type=section&id=Manufacturing) NextCure operates a purpose-built, state-of-the-art cGMP manufacturing facility with 2,000 liters production capacity, utilizing single-use technology - NextCure has a purpose-built, state-of-the-art cGMP manufacturing facility with **2,000 liters production capacity**, utilizing single-use technology to support its pipeline[106](index=106&type=chunk) - The company manufactures all drug supply for its preclinical studies and Phase 1/2 clinical trials of NC318, NC410, and NC762 internally, and intends to do so for future trials of NC525[106](index=106&type=chunk) - Internal manufacturing provides better quality assurance, greater control in scheduling and prioritizing activities, and enhanced capital efficiency compared to third-party manufacturers[106](index=106&type=chunk) [Competition](index=31&type=section&id=Competition) NextCure operates in a highly competitive biotechnology and pharmaceutical industry, facing competition from large, well-funded companies and smaller entities - NextCure faces significant competition from larger, better-funded biopharmaceutical companies (e.g., Amgen, AstraZeneca, Bristol-Myers Squibb, Merck, Pfizer, Roche) and smaller entities in the immuno-oncology sector[107](index=107&type=chunk) - Competition factors include product efficacy, safety, convenience, speed of regulatory approval, and the availability of reimbursement from third-party payors[108](index=108&type=chunk)[109](index=109&type=chunk) - Currently marketed oncology drugs include traditional therapies, antibody-drug conjugates, immune checkpoint inhibitors (CTLA-4, PD-1/PD-L1), and T-cell-engager immunotherapies[108](index=108&type=chunk) [Intellectual Property](index=31&type=section&id=Intellectual%20Property) NextCure relies on patent applications, trade secrets, and contractual protections to safeguard its intellectual property - NextCure's intellectual property strategy relies on patent applications, trade secrets, and contractual protections for its products, methods, and manufacturing processes[110](index=110&type=chunk)[114](index=114&type=chunk) - As of **December 31, 2021**, the company had **20 pending foreign** and **6 pending U.S. patent applications** for NC318, NC410, NC762, and NC525, with potential expiration dates between **2037 and 2039**[110](index=110&type=chunk)[111](index=111&type=chunk) - NextCure holds an exclusive, royalty-bearing, sublicensable worldwide license from Yale University for intellectual property, including patent applications related to S15 methods of use and one allowed patent for FIND-IO, expected to expire no earlier than **2036**[112](index=112&type=chunk) [Government Regulation](index=33&type=section&id=Government%20Regulation) The development, approval, and commercialization of NextCure's biological products are extensively regulated by the FDA and other authorities - NextCure's biological products are extensively regulated by the FDA and other authorities, covering research, development, testing, manufacturing, quality control, approval, and post-approval monitoring[115](index=115&type=chunk)[117](index=117&type=chunk) - The approval process involves preclinical studies (GLP), IND application, human clinical trials (cGCP) across Phase 1, 2, and 3, followed by a Biologics License Application (BLA) submission and review[121](index=121&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk)[127](index=127&type=chunk)[132](index=132&type=chunk)[136](index=136&type=chunk)[138](index=138&type=chunk) - Post-approval, products are subject to ongoing regulation, including cGMP compliance, adverse event reporting, and potential Risk Evaluation and Mitigation Strategies (REMS), with strict rules on marketing and promotion[148](index=148&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk)[156](index=156&type=chunk) - The Biologics Price Competition and Innovation Act (BPCIA) provides an abbreviated approval pathway for biosimilars and grants **12 years of exclusivity** for reference biologics, with additional exclusivities for orphan indications and pediatric studies[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk) - Companion diagnostics are regulated as medical devices (often Class III requiring PMA approval) and typically need contemporaneous approval with their therapeutic products, while laboratory developed tests (LDTs) are regulated by CMS under CLIA, with FDA historically exercising enforcement discretion[170](index=170&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk)[174](index=174&type=chunk)[176](index=176&type=chunk) [Healthcare Regulation](index=51&type=section&id=Healthcare%20Regulation) Healthcare regulation significantly impacts NextCure's commercialization prospects, particularly regarding coverage and reimbursement from third-party payors - Commercial success depends on obtaining coverage and adequate reimbursement from third-party payors (governmental and private), which is a time-consuming and costly process with no uniform policy[179](index=179&type=chunk)[180](index=180&type=chunk)[181](index=181&type=chunk) - NextCure's business is subject to federal and state healthcare fraud and abuse laws, including the Anti-Kickback Statute, False Claims Act (FCA), and HIPAA, which prohibit various forms of improper remuneration, false claims, and privacy violations[182](index=182&type=chunk)[183](index=183&type=chunk)[184](index=184&type=chunk)[185](index=185&type=chunk) - Violations of healthcare laws can lead to significant civil, criminal, and administrative penalties, including fines, imprisonment, exclusion from federal healthcare programs, and reputational harm[157](index=157&type=chunk)[189](index=189&type=chunk)[336](index=336&type=chunk) - Healthcare reform initiatives, such as the ACA and subsequent amendments (e.g., American Rescue Plan Act of 2021), have significantly impacted the pharmaceutical industry, including biosimilar competition, Medicaid rebate calculations, and drug pricing pressures[190](index=190&type=chunk)[192](index=192&type=chunk)[193](index=193&type=chunk)[195](index=195&type=chunk)[196](index=196&type=chunk) [Human Capital Resources](index=61&type=section&id=Human%20Capital%20Resources) NextCure's success relies on attracting and retaining highly qualified management and technical personnel - As of **December 31, 2021**, NextCure had **87 full-time employees**, with a diverse workforce (**61% male, 39% female; 46% White, 25% Asian, 20% Black/African American, 9% Hispanic/Latino**)[199](index=199&type=chunk) - The company's success is highly dependent on attracting, motivating, and retaining qualified personnel, facing intense competition in the industry[200](index=200&type=chunk) - NextCure addresses turnover and growth by monitoring compensation programs and providing a competitive mix of compensation, benefits, and equity participation[200](index=200&type=chunk) [Corporate Information and Access to SEC Reports](index=61&type=section&id=Corporate%20Information%20and%20Access%20to%20SEC%20Reports) NextCure, Inc. was incorporated in Delaware in September 2015, with its executive offices in Beltsville, Maryland, and makes its SEC filings available free of charge on its website - NextCure, Inc. was incorporated in Delaware in **September 2015** and provides its SEC filings (10-K, 10-Q, 8-K) on its website[201](index=201&type=chunk) [Item 1A. Risk Factors](index=61&type=section&id=Item%201A.%20Risk%20Factors) Investing in NextCure's common stock is highly speculative due to significant risks across its financial position, product development, regulatory approval, manufacturing, intellectual property, reliance on third parties, business operations, and common stock volatility - NextCure has a limited operating history, a history of significant losses (**$69.4 million in 2021**, **$36.6 million in 2020**), and expects to incur substantial losses for the foreseeable future, with no guarantee of profitability or product sales revenue[204](index=204&type=chunk)[208](index=208&type=chunk) - The company will require substantial additional financing to pursue its business objectives, which may not be available on acceptable terms, potentially forcing delays or termination of product development and commercialization efforts[210](index=210&type=chunk)[218](index=218&type=chunk) - Clinical development is lengthy, expensive, and uncertain, with high failure rates. Delays or failures in trials (e.g., due to patient enrollment, design flaws, or adverse side effects) could prevent regulatory approval and commercialization[236](index=236&type=chunk)[250](index=250&type=chunk)[257](index=257&type=chunk)[260](index=260&type=chunk) - The regulatory approval process is lengthy and unpredictable, and NextCure's product candidates may fail to receive approval due to insufficient safety/efficacy data, disagreements with regulatory authorities, or changes in policies[228](index=228&type=chunk)[229](index=229&type=chunk)[233](index=233&type=chunk)[235](index=235&type=chunk) - Manufacturing risks include limited experience, challenges in scaling up production, dependence on third-party CMOs and suppliers, and the complexity of biologic manufacturing, all of which could increase costs and limit supply[343](index=343&type=chunk)[344](index=344&type=chunk)[346](index=346&type=chunk)[347](index=347&type=chunk)[348](index=348&type=chunk)[349](index=349&type=chunk)[353](index=353&type=chunk)[354](index=354&type=chunk) - The company's success depends on obtaining and maintaining robust patent protection, which is uncertain due to complex legal questions, potential challenges to validity/enforceability, and the high cost of prosecution and enforcement globally[359](index=359&type=chunk)[361](index=361&type=chunk)[362](index=362&type=chunk)[363](index=363&type=chunk)[368](index=368&type=chunk)[370](index=370&type=chunk)[371](index=371&type=chunk)[375](index=375&type=chunk) - Reliance on third parties (CROs, collaborators) for preclinical studies, clinical trials, and potential commercialization exposes NextCure to risks if these parties fail to perform, comply with regulations, or meet deadlines, potentially delaying or terminating development[392](index=392&type=chunk)[393](index=393&type=chunk)[394](index=394&type=chunk)[396](index=396&type=chunk)[399](index=399&type=chunk) - The price of NextCure's common stock is volatile and influenced by clinical trial results, regulatory decisions, competition, financing efforts, and general market conditions, potentially leading to significant fluctuations[434](index=434&type=chunk)[437](index=437&type=chunk) [Item 1B. Unresolved Staff Comments](index=151&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) NextCure, Inc. has no unresolved comments from the SEC staff regarding its filed reports - There are no unresolved staff comments[460](index=460&type=chunk) [Item 2. Properties](index=153&type=section&id=Item%202.%20Properties) NextCure's corporate headquarters in Beltsville, Maryland, comprise approximately 28,500 sq ft of office, 20,600 sq ft of laboratory and manufacturing, and 4,400 sq ft of warehouse space - NextCure's corporate headquarters in Beltsville, Maryland, include **28,500 sq ft of office**, **20,600 sq ft of laboratory and manufacturing**, and **4,400 sq ft of warehouse space**[462](index=462&type=chunk) - An additional **15,800 sq ft** is available for future office and laboratory space, with lease terms expiring in **March 2030**[462](index=462&type=chunk) [Item 3. Legal Proceedings](index=153&type=section&id=Item%203.%20Legal%20Proceedings) NextCure is involved in several legal proceedings, including a putative stockholder class action, a shareholder derivative lawsuit, and a trade secrets misappropriation lawsuit - NextCure is a defendant in a putative stockholder class action (Ye Zhou v. NextCure, Inc., et. al.) alleging violations of the Exchange Act and Securities Act related to statements about NC318 and the FIND-IO platform[445](index=445&type=chunk)[651](index=651&type=chunk) - A shareholder derivative lawsuit (Zach Liu v. Richman et. al.) was filed, alleging breaches of fiduciary duty, unjust enrichment, and other claims against officers and directors, currently stayed pending the Ye Zhou action[446](index=446&type=chunk)[652](index=652&type=chunk)[655](index=655&type=chunk) - Immunaccel, LLC filed a lawsuit alleging misappropriation of trade secrets related to a drug discovery platform named IMMUNE 3D[447](index=447&type=chunk)[656](index=656&type=chunk) - The company intends to vigorously defend these actions but cannot estimate the reasonably possible loss or range of loss due to the preliminary stage and uncertainties of litigation[448](index=448&type=chunk)[657](index=657&type=chunk) [Item 4. Mine Safety Disclosures](index=153&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) NextCure, Inc. has no disclosures to report regarding mine safety - Not Applicable[464](index=464&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities](index=153&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) NextCure's common stock trades on the Nasdaq Global Select Market under the symbol "NXTC", with 27,724,303 shares outstanding as of March 2, 2022 - NextCure's common stock trades on the Nasdaq Global Select Market under the symbol "**NXTC**"[466](index=466&type=chunk) - As of **March 2, 2022**, the company had **27,724,303 shares** of common stock issued and outstanding[5](index=5&type=chunk)[466](index=466&type=chunk) - The company has never declared or paid cash dividends and does not anticipate doing so in the foreseeable future, intending to retain earnings for business development[456](index=456&type=chunk)[467](index=467&type=chunk) - The 2019 IPO generated **$86.3 million in gross proceeds** (**$76.9 million net**), with **$0.5 million** used for a payment to Yale University and the remainder invested in temporary investments[468](index=468&type=chunk) [Item 6. Selected Financial Data](index=154&type=section&id=Item%206.%20Selected%20Financial%20Data) This item is reserved and no selected financial data is provided - Item 6 is reserved, and no selected financial data is provided[469](index=469&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=155&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion highlights NextCure's significant net losses, reliance on R&D, and need for additional capital to fund its clinical-stage immunomedicine pipeline [Overview](index=155&type=section&id=Overview_MD%26A) NextCure is a clinical-stage biopharmaceutical company developing first-in-class immunomedicines for cancer and immune-related diseases, with data updates and IND submissions anticipated in 2022 - NextCure is a clinical-stage biopharmaceutical company focused on discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases[472](index=472&type=chunk) - NC318 is in **Phase 1/2 clinical trials** for advanced/metastatic solid tumors, with a revised dosing regimen (**800 mg weekly**) and a **Phase 2 combination trial** with pembrolizumab initiated by Yale University[473](index=473&type=chunk)[475](index=475&type=chunk)[476](index=476&type=chunk) - NC410 is in **Phase 1/2 clinical trials** for advanced/metastatic solid tumors, showing safety, tolerability, and immune modulation, with further data expected in **H2 2022**[477](index=477&type=chunk) - NC762 initiated a **Phase 1/2 clinical trial** in July 2021 for lung, breast, ovarian, and other tumor types, with initial data expected in **H2 2022**[478](index=478&type=chunk) - NC525 is in preclinical development for Acute Myeloid Leukemia (AML), demonstrating efficacy in killing AML blast and leukemic stem cells, with an IND submission planned for **Q4 2022**[479](index=479&type=chunk) [Financial Overview](index=157&type=section&id=Financial%20Overview) NextCure has incurred significant net losses since its 2015 inception, with an accumulated deficit of $187.0 million as of December 31, 2021, primarily due to R&D and G&A expenses - NextCure has incurred net losses since inception, with an accumulated deficit of **$187.0 million** as of **December 31, 2021**, primarily from R&D and G&A expenses[481](index=481&type=chunk) Net Losses | Year Ended December 31, | Net Loss (in millions) | | :---------------------- | :--------------------- | | 2021 | $(69.4) | | 2020 | $(36.6) | - Funding sources include **$164.4 million** from private placements of preferred stock, **$86.3 million gross** from a May 2019 IPO, **$172.2 million gross** from a November 2019 public offering, and a **$25.0 million upfront payment** from the terminated Lilly Agreement[482](index=482&type=chunk)[483](index=483&type=chunk)[484](index=484&type=chunk)[485](index=485&type=chunk) - As of **December 31, 2021**, cash, cash equivalents, and marketable securities (excluding restricted cash) totaled **$219.6 million**, projected to fund operations into **Q1 2024**[486](index=486&type=chunk)[487](index=487&type=chunk)[510](index=510&type=chunk) - The company expects substantial future expenditures for clinical development, regulatory approval, commercialization, and pipeline expansion, necessitating additional funding[488](index=488&type=chunk)[489](index=489&type=chunk) [Components of Our Results of Operations](index=159&type=section&id=Components%20of%20Our%20Results%20of%20Operations) NextCure's revenue for 2020 was solely from the terminated Lilly Agreement, with no product sales, and operating expenses are primarily driven by R&D - Revenue for 2020 was **$22.4 million**, exclusively from the recognition of deferred revenue related to the terminated Lilly Agreement; no product sales revenue has been generated[490](index=490&type=chunk)[502](index=502&type=chunk) - Research and development expenses are expensed as incurred and include salaries, third-party agreements (e.g., Yale license), consultants, laboratory supplies, manufacturing materials, and facility-related costs[491](index=491&type=chunk)[492](index=492&type=chunk) - General and administrative expenses cover personnel, professional fees (legal, IP, accounting), rent, and other operating costs, including patent-related costs[497](index=497&type=chunk) - Other income, net, primarily comprises interest income from marketable securities[500](index=500&type=chunk) [Results of Operations](index=163&type=section&id=Results%20of%20Operations) NextCure reported a net loss of $69.4 million in 2021, an increase from $36.6 million in 2020, driven by a lack of revenue and increased R&D and G&A expenses Summary of Results of Operations (in thousands) | Item | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | Change | | :--------------------------------------- | :---------------------- | :---------------------- | :---------- | | Revenue from former R&D arrangement | $0 | $22,378 | $(22,378) | | Research and development | $50,192 | $46,554 | $3,638 | | General and administrative | $20,573 | $17,049 | $3,524 | | Loss from operations | $(70,765) | $(41,225) | $(29,540) | | Other income, net | $1,376 | $4,622 | $(3,246) | | Net loss | $(69,389) | $(36,603) | $(32,786) | - Revenue from the former Lilly Agreement was **$0 in 2021**, down from **$22.4 million in 2020** due to the agreement's termination[502](index=502&type=chunk) - Research and development expenses increased by **$3.6 million** to **$50.2 million in 2021**, driven by clinical-related (**$2.3 million**) and personnel-related (**$2.1 million**) expenses, partially offset by a decrease in contract manufacturing (**$1.6 million**)[503](index=503&type=chunk)[504](index=504&type=chunk) - General and administrative expenses increased by **$3.5 million** to **$20.5 million in 2021**, primarily due to **$2.7 million** in personnel-related costs[506](index=506&type=chunk) - Other income, net, decreased by **$3.2 million** to **$1.4 million in 2021**, attributed to lower investment balances and reduced interest rates[507](index=507&type=chunk) [Liquidity and Capital Resources](index=165&type=section&id=Liquidity%20and%20Capital%20Resources) NextCure's operations are financed through public equity offerings, private placements, and past collaboration fees, with existing capital projected to fund operations into Q1 2024 - NextCure's operations are financed by public offerings (**$77.0 million net** from 2019 IPO, **$160.9 million net** from 2019 public offering), private placements (**$164.4 million gross**), and a **$25.0 million upfront payment** from the former Lilly Agreement[508](index=508&type=chunk) - As of **December 31, 2021**, cash, cash equivalents, and marketable securities (excluding restricted cash) totaled **$219.6 million**, expected to fund operations into **Q1 2024**[510](index=510&type=chunk) - The company has an 'at the market offering' sales agreement to sell up to **$75 million** of common stock, but no shares have been sold yet[509](index=509&type=chunk) - Additional capital will be required for product development and commercialization, with funding potentially sought through equity, debt, or strategic alliances, but availability on acceptable terms is not assured[512](index=512&type=chunk)[515](index=515&type=chunk) [Cash Flows](index=167&type=section&id=Cash%20Flows) NextCure's net cash used in operating activities increased to $57.2 million in 2021 from $45.0 million in 2020, primarily due to increased net losses and the absence of deferred revenue recognition Cash Flow Summary (in thousands) | Cash Flows From | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--------------------------- | :---------------------- | :---------------------- | | Operating activities | $(57,244) | $(44,954) | | Investing activities | $36,601 | $43,523 | | Financing activities | $(3,265) | $(1,415) | | Net decrease in cash | $(23,908) | $(2,846) | - Net cash used in operating activities increased to **$57.2 million in 2021** from **$45.0 million in 2020**, driven by a higher net loss and the absence of deferred revenue recognition from the Lilly Agreement[517](index=517&type=chunk)[518](index=518&type=chunk) - Cash provided by investing activities was **$36.6 million in 2021** (vs. **$43.5 million in 2020**), primarily from net proceeds of marketable securities (**$39.0 million**) offset by property and equipment purchases (**$2.4 million**)[519](index=519&type=chunk) - Cash used in financing activities was **$3.3 million in 2021** (vs. **$1.4 million in 2020**), mainly due to payments for the Term Loan, which was fully paid in **August 2021**[520](index=520&type=chunk)[523](index=523&type=chunk) [Contractual Obligations and Commitments](index=169&type=section&id=Contractual%20Obligations%20and%20Commitments) NextCure's primary contractual obligations include operating leases for its headquarters, expiring in March 2030, with total future minimum payments of $11.4 million as of December 31, 2021 Operating Lease Minimum Obligations (in thousands) | Year Ending December 31, | Amount | | :----------------------- | :----- | | 2022 | $1,172 | | 2023 | $1,171 | | 2024 | $1,231 | | 2025 | $1,316 | | Thereafter | $6,537 | | Total future minimum payments | $11,427 | - The Term Loan, which had a borrowing capacity of **$5.0 million**, was fully paid off in **August 2021**, with no outstanding payments due[523](index=523&type=chunk)[658](index=658&type=chunk) - NextCure has potential contingent payment obligations (milestones, royalties) under license agreements, such as with Yale, but the timing and amount are not reasonably estimable[524](index=524&type=chunk) [Critical Accounting Policies, Significant Judgments and Use of Estimates](index=169&type=section&id=Critical%20Accounting%20Policies%2C%20Significant%20Judgments%20and%20Use%20of%20Estimates) NextCure's financial statements rely on significant estimates and assumptions, particularly for valuing share-based compensation and common stock before its IPO - The preparation of financial statements requires significant estimates and assumptions, especially for valuing share-based compensation and common stock prior to the IPO[526](index=526&type=chunk)[527](index=527&type=chunk)[532](index=532&type=chunk) - Research and development expenses, including clinical trial costs, are expensed as incurred, with accruals based on contracted work and progress of studies[529](index=529&type=chunk)[598](index=598&type=chunk) - Revenue recognition follows ASC Topic 606, involving a five-step model to identify performance obligations, measure transaction price (including variable consideration constraints), allocate price, and recognize revenue upon transfer of control[530](index=530&type=chunk)[612](index=612&type=chunk)[615](index=615&type=chunk)[620](index=620&type=chunk)[621](index=621&type=chunk) - Stock-based compensation is expensed based on grant date fair value (Black-Scholes model for options), recognized over the vesting period, with forfeitures recognized as they occur[531](index=531&type=chunk)[604](index=604&type=chunk)[605](index=605&type=chunk)[607](index=607&type=chunk) - Income taxes are accounted for using the asset and liability method, with a full valuation allowance recorded against deferred tax assets due to the company's history of losses and uncertainty of realization[608](index=608&type=chunk)[610](index=610&type=chunk) [Off-Balance Sheet Arrangements](index=173&type=section&id=Off-Balance%20Sheet%20Arrangements) NextCure, Inc. has not engaged in any off-balance sheet arrangements since its inception - NextCure has not engaged in any off-balance sheet arrangements since its inception[536](index=536&type=chunk) [JOBS Act Accounting Election](index=173&type=section&id=JOBS%20Act%20Accounting%20Election) As an 'emerging growth company' (EGC) under the JOBS Act, NextCure has elected to use the extended transition period for complying with new or revised accounting standards - As an 'emerging growth company' (EGC), NextCure has elected to use the extended transition period for complying with new or revised accounting standards, which may result in non-comparable financial statements with non-EGCs[537](index=537&type=chunk) - The company will remain an EGC until the earliest of **December 31, 2024**, achieving **$1.07 billion** in annual gross revenues, having a non-affiliate market value exceeding **$700.0 million**, or issuing over **$1.0 billion** in non-convertible debt[538](index=538&type=chunk) [Recent Accounting Pronouncements](index=173&type=section&id=Recent%20Accounting%20Pronouncements) NextCure adopted ASU 2016-13 (Credit Losses) early, effective January 1, 2021, with no material impact, and plans to adopt ASC 842 (Leases) on January 1, 2022 - NextCure adopted ASU 2016-13 (Credit Losses) early, effective **January 1, 2021**, which did not have a material impact on its financial statements[629](index=629&type=chunk) - The company will adopt ASC 842 (Leases) on **January 1, 2022**, which is estimated to result in approximately **$5.8 million** of right-of-use assets and **$7.2 million** of lease liabilities for operating leases, with no material impact on its statements of operations[628](index=628&type=chunk) [Item 7A. Quantitative and Qualitative Disclosure About Market Risk](index=173&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) As a smaller reporting company, NextCure, Inc. is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, NextCure, Inc. is not required to provide quantitative and qualitative disclosures about market risk[540](index=540&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=174&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents NextCure's audited financial statements for the years ended December 31, 2021 and 2020, including the Balance Sheets, Statements of Operations and Comprehensive Loss, Statements of Stockholders' Equity, and Statements of Cash Flows, accompanied by detailed notes [Report of Independent Registered Public Accounting Firm](index=175&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Ernst & Young LLP issued an unqualified opinion on NextCure's financial statements for 2021 and 2020, affirming fair presentation in conformity with U.S. GAAP - Ernst & Young LLP provided an **unqualified opinion** on NextCure's financial statements for **2021 and 2020**, stating they present fairly the financial position, operations, and cash flows in accordance with U.S. GAAP[544](index=544&type=chunk) - The audit assessed risks of material misstatement and evaluated accounting principles and estimates, but did not include an audit of internal control over financial reporting[546](index=546&type=chunk)[547](index=547&type=chunk) [Balance Sheets](index=176&type=section&id=Balance%20Sheets) NextCure's balance sheets show total assets decreased from $306.6 million in 2020 to $242.4 million in 2021, primarily due to a reduction in marketable securities and cash Balance Sheet Summary (in thousands) | Asset/Liability/Equity | December 31, 2021 | December 31, 2020 | | :--------------------- | :---------------- | :---------------- | | Cash and cash equivalents | $12,337 | $32,772 | | Marketable securities | $207,254 | $250,676 | | Total current assets | $227,817 | $287,978 | | Total assets | $242,386 | $306,644 | | Total current liabilities | $6,608 | $10,325 | | Total liabilities | $9,000 | $12,923 | | Total stockholders' equity | $233,386 | $293,721 | - The decrease in total assets was primarily driven by a reduction in marketable securities and cash and cash equivalents[550](index=550&type=chunk) - The decrease in total liabilities was mainly due to the full payment of the Term Loan[550](index=550&type=chunk) [Statements of Operations and Comprehensive Loss](index=177&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) NextCure reported a net loss of $69.4 million in 2021, significantly higher than the $36.6 million loss in 2020, primarily due to the absence of revenue and increased operating expenses Statements of Operations and Comprehensive Loss (in thousands) | Item | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--------------------------------------- | :---------------------- | :---------------------- | | Revenue from former R&D arrangement | $0 | $22,378 | | Research and development | $50,192 | $46,554 | | General and administrative | $20,573 | $17,049 | | Total operating expenses | $70,765 | $63,603 | | Loss from operations | $(70,765) | $(41,225) | | Other income, net | $1,376 | $4,622 | | Net loss | $(69,389) | $(36,603) | | Net loss per common share - basic and diluted | $(2.51) | $(1.33) | | Unrealized (loss) gain on marketable securities | $(1,442) | $779 | | Total comprehensive loss | $(70,831) | $(35,824) | - The increase in net loss was primarily due to the absence of revenue from the former Lilly Agreement in 2021 and increased operating expenses[552](index=552&type=chunk) - Total comprehensive loss for 2021 included an unrealized loss of **$1.4 million** on marketable securities, compared to an unrealized gain of **$0.8 million** in 2020[552](index=552&type=chunk) [Statements of Stockholders' Equity](index=178&type=section&id=Statements%20of%20Stockholders%27%20Equity) NextCure's total stockholders' equity decreased from $293.7 million in 2020 to $233.4 million in 2021, driven by the net loss and unrealized losses on marketable securities Stockholders' Equity Summary (in thousands, except share data) | Item | December 31, 2021 | December 31, 2020 | | :--------------------------------------- | :---------------- | :---------------- | | Common Stock (shares) | 27,680,997 | 27,568,802 | | Common Stock (amount) | $28 | $28 | | Additional Paid-in Capital | $421,047 | $410,551 | | Accumulated Other Comprehensive (Loss) Income | $(663) | $779 | | Accumulated Deficit | $(187,026) | $(117,637) | | Total Stockholders' Equity | $233,386 | $293,721 | - The decrease in total stockholders' equity was primarily due to the net loss of **$69.4 million** and an unrealized loss on marketable securities of **$1.4 million**[555](index=555&type=chunk) - Increases in additional paid-in capital were due to **$10.3 million** in stock-based compensation and **$0.2 million** from stock option exercises[555](index=555&type=chunk) [Statements of Cash Flows](index=179&type=section&id=Statements%20of%20Cash%20Flows) NextCure's cash flows from operating activities resulted in a net use of $57.2 million in 2021, an increase from $45.0 million in 2020, driven by the net loss and absence of deferred revenue Cash Flow Summary (in thousands) | Cash Flows From | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--------------------------- | :---------------------- | :---------------------- | | Operating activities | $(57,244) | $(44,954) | | Investing activities | $36,601 | $43,523 | | Financing activities | $(3,265) | $(1,415) | | Net decrease in cash | $(23,908) | $(2,846) | - Net cash used in operating activities increased due to the net loss and the absence of deferred revenue recognition from the Lilly Agreement[517](index=517&type=chunk)[518](index=518&type=chunk) - Cash provided by investing activities was primarily from maturities of marketable securities (**$195.4 million in 2021**) offset by purchases (**$156.5 million in 2021**) and property/equipment purchases (**$2.4 million in 2021**)[519](index=519&type=chunk)[558](index=558&type=chunk) - Cash used in financing activities mainly consisted of payments on the Term Loan (**$3.5 million in 2021**)[520](index=520&type=chunk)[558](index=558&type=chunk) [Notes to Financial Statements](index=180&type=section&id=Notes%20to%20Financial%20Statements) The Notes to Financial Statements provide detailed disclosures on NextCure's business, accounting policies, financial instruments, property, liabilities, collaboration agreements, legal proceedings, and equity - NextCure is a clinical-stage biopharmaceutical company with a limited operating history, no product sales revenue, and a history of significant losses, relying on public offerings and private placements for funding[561](index=561&type=chunk)[566](index=566&type=chunk) - The company's financial statements are prepared in accordance with U.S. GAAP, requiring significant estimates and assumptions, particularly for stock-based compensation and fair value measurements[576](index=576&type=chunk)[579](index=579&type=chunk) - Key accounting policies include classifying highly liquid investments with original maturities of **three months or less** as cash equivalents, marketable securities as available-for-sale, and expensing R&D costs as incurred[580](index=580&type=chunk)[583](index=583&type=chunk)[598](index=598&type=chunk) - NextCure has recorded a full valuation allowance against its deferred tax assets due to its history of losses and uncertainty of realization, with federal and state net operating loss carryforwards of **$160.9 million** and **$163.4 million**, respectively, as of **December 31, 2021**[610](index=610&type=chunk)[681](index=681&type=chunk) - The company is subject to risks common to early-stage biotechnology companies, including the need for additional financing, uncertainties in clinical development, and intense competition[572](index=572&type=chunk) - The impact of the COVID-19 pandemic on clinical trials (e.g., patient enrollment, safety monitoring) and overall business is uncertain[573](index=573&type=chunk) [Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=212&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) NextCure, Inc. reports no changes in or disagreements with its accountants on accounting and financial disclosure matters - There are no changes in or disagreements with accountants on accounting and financial disclosure[692](index=692&type=chunk) [Item 9A. Controls and Procedures](index=212&type=section&id=Item%209A.%20Controls%20and%20Procedures) NextCure's management concluded that its disclosure controls and internal control over financial reporting were effective as of December 31, 2021 - Management, with CEO and CFO participation, concluded that disclosure controls and procedures were effective at the reasonable assurance level as of **December 31, 2021**[693](index=693&type=chunk) - Management assessed and concluded that internal control over financial reporting was effective as of **December 31, 2021**, based on the COSO framework[695](index=695&type=chunk) - As an emerging growth company, NextCure is exempt from the requirement for its independent registered public accounting firm to provide an attestation report on internal control over financial reporting[696](index=696&type=chunk) [Item 9B. Other Information](index=212&type=section&id=Item%209B.%20Other%20Information) NextCure, Inc. has no other information to report under this item - No other information is reported under this item[696](index=696&type=chunk) [Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=212&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) NextCure, Inc. has no disclosures regarding foreign jurisdictions that prevent inspections - No disclosures regarding foreign jurisdictions that prevent inspections[697](index=697&type=chunk) PART III [Item 10. Directors, Executive Officers and Corporate Governance](index=212&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item, covering directors, executive officers, and corporate governance, is incorporated by reference from NextCure's definitive Proxy Statement for its 2022 Annual Meeting of Stockholders - Information regarding directors, executive officers, and corporate governance is incorporated by reference from the **2022 Proxy Statement**[699](index=699&type=chunk) [Item 11. Executive Compensation](index=213&type=section&id=Item%2011.%20Executive%20Compensation) Information for this item, pertaining to executive compensation, is incorporated by reference from NextCure's definitive Proxy Statement for its 2022 Annual Meeting of Stockholders - Information regarding executive compensation is incorporated by reference from the **2022 Proxy Statement**[701](index=701&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=214&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information for this item, concerning security ownership of certain beneficial owners and management, and related stockholder matters, is incorporated by reference from NextCure's definitive Proxy Statement for its 2022 Annual Meeting of Stockholders - Information regarding security ownership of certain beneficial owners and management and related stockholder matters is incorporated by reference from the **2022 Proxy Statement**[702](index=702&type=chunk) [Item 13. Certain Relationships and Related Transactions and Director Independence](index=214&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%20and%20Director%20Independence) Information for this item, covering certain relationships and related transactions, and director independence, is incorporated by reference from NextCure's definitive Proxy Statement for its 2022 Annual Meeting of Stockholders - Information regarding certain relationships and related transactions and director independence is incorporated by reference from the **2022 Proxy Statement**[703](index=703&type=chunk) [Item 14. Principal Accounting Fees and Services](index=214&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information for this item, detailing principal accounting fees and services, is incorporated by reference from NextCure's definitive Proxy Statement for its 2022 Annual Meeting of Stockholders - Information regarding principal accounting fees and services is incorporated by reference from the **2022 Proxy Statement**[704](index=704&type=chunk) PART IV [Item 15. Exhibits, Financial Statement Schedules](index=214&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the financial statements and exhibits filed as part of the 10-K report, with all financial statement schedules omitted as they are not applicable or the information is presented in the financial statements or notes - The financial statements are included as part of this report, and all financial statement schedules are omitted because they are not applicable or the required information is shown in the financial statements or notes[706](index=706&type=chunk) - The exhibit index lists various corporate documents, including the Amended and Restated Certificate of Incorporation and Bylaws, license agreements with Yale University, incentive plans, employment agreements, and certifications[708](index=708&type=chunk)[709](index=709&type=chunk)[710](index=710&type=chunk)[713](index=713&type=chunk)[715](index=715&type=chunk) - Portions of certain exhibits, such as the license agreement with Yale and employment agreements, have been omitted in compliance with **Item 601 of Regulation S-K**[713](index=713&type=chunk)[716](index=716&type=chunk) [Item 16. Form 10-K Summary](index=220&type=section&id=Item%2016.%20Form%2010-K%20Summary) NextCure, Inc. has not included a Form 10-K Summary in this report - No Form 10-K Summary is included[717](index=717&type=chunk) [SIGNATURES](index=221&type=section&id=SIGNATURES) This section contains the required signatures for the Annual Report on Form 10-K, affirming compliance with the Securities Exchange Act of 1934 - The report is signed by Michael Richman (President and CEO, Principal Executive Officer) and Steven P. Cobourn (CFO, Principal Financial and Accounting Officer) on **March 3, 2022**[722](index=722&type=chunk)[724](index=724&type=chunk) - Signatures from the Chair of the Board and other Directors are also included, affirming compliance with the Securities Exchange Act of 1934[723](index=723&type=chunk)[724](index=724&type=chunk)

Next@ure Next Generation Immunomedicines 11th Annual SVB Leerink Global Healthcare Conference February 16, 2022 Forward-Looking Statements To the extent that statements contained in this presentation are not descriptions of historical facts, they may be deemed to be forward- looking statements under the Private Securities Litigation Reform Act of 1995. Words such as "may, ""will,""expect," "anticipate," "estimate," "intend," "next," "near-term," "future" and similar expressions, as well as other words and e ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38905 NextCure, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdictio ...

SEPTEMBER 13, 2021 Next@ure Next-Generation Immunomedicines H .C. Wainwright 23rd Annual Global Investment Conference To the extent that statements contained in this presentation are not descriptions of historical facts, they may be deemed to be forward-looking statements under the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "next," "near-term," "future" and similar expressions, as well as other words and expressions referencin ...

Pipeline Progress - NC318 (S15) monotherapy is in Phase 2 with a data update expected in Q4 2021[13] - NC318 (S15) in combination with anti-PD-1 is in an investigator-initiated trial (IIT) with initial data anticipated in 1H 2022[13] - NC410 (LAIR-1) is in Phase 1 with initial data expected in 2H 2021[13] - NC762 (B7-H4) is in Phase 1 with initial data expected in mid-2022[13] Clinical Trial Updates - NC318 Phase 1 included 49 patients across 15 tumor types, showing 1 confirmed CR in NSCLC (118+ weeks) and 1 confirmed PR in NSCLC (92+ weeks)[20] - NC318 Phase 2 resumed enrollment of NSCLC adenocarcinoma cohort at 800 mg weekly, showing 1 confirmed PR in H&N (40 weeks) and 1 confirmed PR in TNBC (21 weeks)[21] - Yale initiated a Phase 2 trial of NC318 with pembrolizumab in S15+ patients with PD-1 refractory NSCLC in April 2021[26] - NC410 Phase 1 is a dose-escalation study from 3 mg to 400 mg in advanced or metastatic solid tumors, with initial data expected in 4Q 2021[49] - NC762 Phase 1 is a dose-escalation study in advanced or metastatic solid tumors, with initial data expected in mid-2022[55] Financial Position - The company's cash position was $249.5 million as of Q2 2021, providing a runway into 2H 2023[66]

Washington, D.C. 20549 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38905 NextCure, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of ...

MAY 5, 2021 Next@ure Next-Generation Immunomedicines 7th Annual Truist Securities Life Sciences Summit Forward-Looking Statements To the extent that statements contained in this presentation are not descriptions of historical facts, they may be deemed to be forward-looking statements under the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "intend," " "near-term," "future" and similar expressions, as well as other words and expressions referencing futu ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This item provides the unaudited condensed financial statements, including the balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with detailed notes explaining the company's accounting policies and specific financial line items [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets%20as%20of%20March%2031,%202021%20(unaudited)%20and%20December%2031,%202020) This section presents the unaudited condensed balance sheets, detailing assets, liabilities, and stockholders' equity Condensed Balance Sheet Highlights (in thousands) | Metric | March 31, 2021 | December 31, 2020 | | :-------------------------------- | :------------- | :---------------- | | Total Assets | $290,959 | $306,644 | | Total Liabilities | $11,800 | $12,923 | | Total Stockholders' Equity | $279,159 | $293,721 | [Unaudited Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Unaudited%20Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20Three%20Months%20Ended%20March%2031,%202021%20and%202020) This section provides the unaudited condensed statements of operations and comprehensive loss, outlining revenue, expenses, and net income or loss Statements of Operations Highlights (in thousands) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Revenue from former R&D arrangement | $0 | $22,378 | | Research and development expenses | $12,386 | $10,578 | | General and administrative expenses | $4,848 | $3,588 | | Net (loss) income | $(16,533) | $9,733 | | Basic EPS | $(0.60) | $0.35 | | Diluted EPS | $(0.60) | $0.33 | [Unaudited Condensed Statements of Stockholders' Equity](index=5&type=section&id=Unaudited%20Condensed%20Statements%20of%20Stockholders'%20Equity%20for%20the%20Three%20Months%20Ended%20March%2031,%202021%20and%202020) This section details changes in stockholders' equity, including stock-based compensation, common stock issuance, and net loss Stockholders' Equity Changes (in thousands) | Item | Three Months Ended March 31, 2021 | | :-------------------------------------- | :-------------------------------- | | Balance as of December 31, 2020 | $293,721 | | Stock-based compensation | $2,508 | | Issuance of common stock | $63 | | Unrealized loss on marketable securities | $(600) | | Net loss | $(16,533) | | Balance as of March 31, 2021 | $279,159 | [Unaudited Condensed Statements of Cash Flows](index=6&type=section&id=Unaudited%20Condensed%20Statements%20of%20Cash%20Flows%20for%20the%20Three%20Months%20Ended%20March%2031,%202021%20and%202020) This section presents the unaudited condensed statements of cash flows, categorizing cash movements into operating, investing, and financing activities Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(13,911) | $(10,594) | | Net cash provided by investing activities | $17,600 | $5,373 | | Net cash used in financing activities | $(354) | $(240) | | Net increase (decrease) in cash, cash equivalents and restricted cash | $3,335 | $(5,461) | | Cash, cash equivalents and restricted cash — end of period | $39,619 | $33,669 | [Notes to Unaudited Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) This section provides detailed explanatory notes integral to understanding the unaudited condensed financial statements - The accompanying notes are an integral part of these unaudited condensed financial statements[15](index=15&type=chunk)[18](index=18&type=chunk)[21](index=21&type=chunk) [1. Nature of the Business](index=7&type=section&id=1.%20Nature%20of%20the%20Business) This note describes NextCure's business as a clinical-stage biopharmaceutical company and its financial outlook regarding product sales and operating losses - NextCure is a clinical-stage biopharmaceutical company developing immunomedicines for cancer and immune-related diseases using its proprietary FIND-IO platform[22](index=22&type=chunk) - The company has not generated product sales revenue and expects to incur additional operating losses and negative operating cash flows for the foreseeable future[23](index=23&type=chunk) - COVID-19 has caused enrollment to slow in the Phase 2 portion of the NC318 clinical trial[25](index=25&type=chunk) [2. Summary of Significant Accounting Policies](index=8&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the company's significant accounting policies, including its status as an Emerging Growth Company and the adoption of new accounting standards - No material changes to significant accounting policies from the 2020 Annual Report[26](index=26&type=chunk) - The company is an Emerging Growth Company (EGC) and has elected to defer compliance with new accounting standards[30](index=30&type=chunk) - ASC 842 (Leases) will be effective for the company on January 1, 2022, and is expected to increase total assets and liabilities[31](index=31&type=chunk)[33](index=33&type=chunk) - ASU 2016-13 (Credit Losses) was adopted early, effective January 1, 2021, with no material impact on financial statements[34](index=34&type=chunk) [3. Restricted Cash](index=10&type=section&id=3.%20Restricted%20Cash) This note details the company's restricted cash balances, primarily held as collateral for its term loan - The company is required to maintain cash collateral for its **$5.0 million** term loan[36](index=36&type=chunk) Restricted Cash Balances (in thousands) | Metric | March 31, 2021 | December 31, 2020 | | :-------------------------------- | :------------- | :---------------- | | Restricted cash | $3,092 | $3,512 | [4. Marketable Securities](index=10&type=section&id=4.%20Marketable%20Securities) This note provides information on the company's marketable securities, including their fair value and realized gains Marketable Securities (in thousands) | Metric | March 31, 2021 | December 31, 2020 | | :-------------------- | :------------- | :---------------- | | Estimated Fair Value | $231,709 | $250,676 | - Realized gains on available-for-sale securities were approximately **$54,000** for Q1 2021 and **$64,000** for Q1 2020[39](index=39&type=chunk) - The company does not intend to sell securities with unrealized losses and believes market conditions are the primary factor for these changes[40](index=40&type=chunk) [5. Fair Value Measurements](index=11&type=section&id=5.%20Fair%20Value%20Measurements) This note presents the fair value measurements of the company's financial assets, categorized by valuation input levels Fair Value of Financial Assets (in thousands) as of March 31, 2021 | Asset Type | Total | Level 1 | Level 2 | Level 3 | | :------------------ | :------ | :------ | :------ | :------ | | Money market funds | $19,185 | $19,185 | $0 | $0 | | Corporate bonds | $231,709 | $0 | $231,709 | $0 | | **Total** | **$250,894** | **$19,185** | **$231,709** | **$0** | - No transfers between fair value levels occurred during the three months ended March 31, 2021 and 2020[45](index=45&type=chunk) [6. Former Agreement with Eli Lilly and Company](index=13&type=section&id=6.%20Former%20Agreement%20with%20Eli%20Lilly%20and%20Company) This note discusses the termination of the research and development collaboration agreement with Eli Lilly and Company and its impact on revenue - The research and development collaboration agreement with Eli Lilly and Company was terminated by Lilly effective March 3, 2020[46](index=46&type=chunk) - Revenue recognized from the Lilly Agreement was **$22.4 million** for the three months ended March 31, 2020, with no revenue in the comparable 2021 period[47](index=47&type=chunk) - No further quarterly research and development support payments are payable to the Company[47](index=47&type=chunk) [7. Stock-Based Compensation](index=13&type=section&id=7.%20Stock-Based%20Compensation) This note details the company's stock-based compensation plans and the associated expenses recognized for the periods - The 2019 Omnibus Incentive Plan became effective May 8, 2019, reserving **2,900,000 shares** plus certain shares from the 2015 Plan[49](index=49&type=chunk)[50](index=50&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $958 | $452 | | General and administrative | $1,550 | $556 | | **Total** | **$2,508** | **$1,008** | - As of March 31, 2021, **$31.1 million** of total unrecognized compensation expense related to unvested options remains, to be recognized over approximately **2.7 years**[53](index=53&type=chunk) [8. Net (Loss) Income Per Share Attributable to Common Stockholders](index=17&type=section&id=8.%20Net%20(Loss)%20Income%20Per%20Share%20Attributable%20to%20Common%20Stockholders) This note provides the basic and diluted net loss or income per share attributable to common stockholders for the reported periods EPS Summary | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :---------- | :-------------------------------- | :-------------------------------- | | Basic EPS | $(0.60) | $0.35 | | Diluted EPS | $(0.60) | $0.33 | - For Q1 2021, all options were excluded from diluted EPS calculation as their effect would have been anti-dilutive due to the net loss[58](index=58&type=chunk) [9. Income Taxes](index=19&type=section&id=9.%20Income%20Taxes) This note explains the company's income tax position, including the absence of a provision or benefit and the maintenance of a full valuation allowance - No provision or benefit for income taxes was recorded for Q1 2021 or Q1 2020[61](index=61&type=chunk) - A full valuation allowance is maintained against deferred tax assets due to cumulative net losses[61](index=61&type=chunk)[62](index=62&type=chunk) - The CARES Act and ARPA 2021 had no significant financial impact on the company's condensed financial statements[64](index=64&type=chunk) [10. Commitments and Contingencies](index=19&type=section&id=10.%20Commitments%20and%20Contingencies) This note outlines the company's commitments and contingencies, including ongoing stockholder class action and shareholder derivative lawsuits - A stockholder class action (Ye Zhou v. NextCure, Inc., et. al.) was filed in September 2020, alleging securities law violations regarding NC318 and the FIND-IO platform[65](index=65&type=chunk) - A shareholder derivative lawsuit (Zach Liu v. Richman et. al.) was filed in March 2021, alleging breaches of fiduciary duty, unjust enrichment, and gross mismanagement[66](index=66&type=chunk) - The company intends to vigorously defend both actions and believes they are without merit, but cannot estimate the reasonably possible loss[68](index=68&type=chunk) - The financial statements are unaudited and prepared in conformity with GAAP for interim reporting[27](index=27&type=chunk) - No material changes to significant accounting policies from the 2020 Annual Report[26](index=26&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations for the three months ended March 31, 2021, compared to the same period in 2020. It covers the business overview, impact of COVID-19, financial performance, components of expenses, and liquidity, highlighting the transition from net income to net loss due to the termination of the Lilly Agreement and increased R&D - The company is a clinical-stage biopharmaceutical company developing immunomedicines for cancer and immune-related diseases[74](index=74&type=chunk) - The COVID-19 pandemic has caused delays and slowdowns in clinical trials, particularly for NC318[71](index=71&type=chunk)[83](index=83&type=chunk) - The company reported a net loss of **$16.5 million** for Q1 2021, compared to a net income of **$9.7 million** for Q1 2020, primarily due to the absence of revenue from the terminated Lilly Agreement[86](index=86&type=chunk) - Existing cash, cash equivalents, and marketable securities of **$268.2 million** are expected to fund operations into the second half of 2023[91](index=91&type=chunk)[110](index=110&type=chunk) [Overview](index=23&type=section&id=Overview) This section provides a business overview, detailing NextCure's clinical-stage product candidates and their development status - NextCure is a clinical-stage biopharmaceutical company developing first-in-class immunomedicines using its FIND-IO platform[74](index=74&type=chunk) - NC318, a lead product candidate targeting Siglec-15 (S15), is in a Phase 1/2 clinical trial for advanced solid tumors, with modifications planned for S15 patient pre-selection[75](index=75&type=chunk)[79](index=79&type=chunk) - NC410, targeting LAIR-1, is in a Phase 1/2 clinical trial for advanced solid tumors, with data expected in H2 2021[80](index=80&type=chunk) - NC762, targeting B7-H4, has an IND cleared and a Phase 1/2 clinical trial is planned for Q2 2021[81](index=81&type=chunk) [COVID-19](index=25&type=section&id=COVID-19) This section discusses the impact of the COVID-19 pandemic on clinical trials and uncertainties regarding its future effects - The COVID-19 pandemic has caused enrollment to slow in the Phase 2 portion of the NC318 clinical trial[83](index=83&type=chunk) - The full scope, duration, and severity of COVID-19 disruptions and their impact on the company's business and financial performance remain uncertain[83](index=83&type=chunk) [Financial Overview](index=25&type=section&id=Financial%20Overview) This section summarizes the company's financial position, including accumulated deficits, net loss, funding sources, and cash runway projections - The company has incurred net losses since inception, with an accumulated deficit of **$134.2 million** as of March 31, 2021[86](index=86&type=chunk) - Net loss for Q1 2021 was **$16.5 million**, compared to net income of **$9.7 million** for Q1 2020[86](index=86&type=chunk) - Operations are funded by public offerings (**$77.0 million** from IPO, **$160.9 million** from follow-on), private placements (**$164.4 million**), and a **$25.0 million** upfront payment from the former Lilly Agreement[87](index=87&type=chunk)[89](index=89&type=chunk)[90](index=90&type=chunk) - Cash, cash equivalents, and marketable securities totaled **$268.2 million** as of March 31, 2021, expected to fund operations into the second half of 2023[91](index=91&type=chunk) - Substantial additional funding will be required for continued operations and development[93](index=93&type=chunk) [Components of Our Results of Operations](index=29&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section breaks down the key components influencing the company's financial results, including revenue and operating expenses - The company has not generated any revenue from product sales through March 31, 2021[95](index=95&type=chunk) - Research and development expenses are expensed as incurred and are expected to increase substantially as product candidates advance[96](index=96&type=chunk)[97](index=97&type=chunk) - General and administrative expenses are also expected to increase due to staff expansion, occupancy costs, and public company operating expenses[101](index=101&type=chunk) [Revenue](index=29&type=section&id=Revenue) This section details the company's revenue streams, primarily from R&D arrangements, and notes the absence of product sales - No revenue from product sales has been generated to date[95](index=95&type=chunk) [Operating Expenses](index=29&type=section&id=Operating%20Expenses) This section outlines the company's operating expenses, including R&D and G&A costs, and their expected future trends - Operating expenses include research and development and general and administrative costs[96](index=96&type=chunk)[100](index=100&type=chunk) - Both R&D and G&A expenses are expected to increase substantially in the foreseeable future[97](index=97&type=chunk)[101](index=101&type=chunk) [Research and Development Expenses](index=29&type=section&id=Research%20and%20Development%20Expenses) This section details R&D expense components and anticipates their substantial increase due to advancing product candidates - R&D expenses include salaries, benefits, stock-based compensation, third-party agreements, consultant fees, laboratory supplies, and manufacturing costs[97](index=97&type=chunk) - R&D expenses are expected to increase substantially due to advancing product candidates, expanding trials, cGMP manufacturing, and discovery programs[97](index=97&type=chunk) - The duration and costs of future clinical trials are uncertain and depend on various factors, including regulatory requirements and patient enrollment[98](index=98&type=chunk)[99](index=99&type=chunk) [General and Administrative Expenses](index=30&type=section&id=General%20and%20Administrative%20Expenses) This section describes G&A expense elements and projects their substantial increase due to staff expansion and public company operations - G&A expenses include personnel costs, professional fees (legal, IP, accounting), rent, and other facility-related costs[100](index=100&type=chunk) - G&A expenses are expected to increase substantially due to staff expansion, higher legal/accounting fees, investor relations, and insurance premiums[101](index=101&type=chunk) [Other Income, Net](index=30&type=section&id=Other%20Income,%20Net) This section explains the nature of other income, net, primarily comprising interest income and term loan interest payments - Other income, net, primarily comprises interest income from marketable securities and interest payments on the term loan[102](index=102&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) This section provides a comparative analysis of financial performance for Q1 2021 and 2020, highlighting changes in revenue and expenses Results of Operations Summary (in thousands) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | Change | | :------------------------------------ | :-------------------------------- | :-------------------------------- | :------- | | Revenue from former R&D arrangement | $0 | $22,378 | $(22,378) | | Research and development | $12,386 | $10,578 | $1,808 | | General and administrative | $4,848 | $3,588 | $1,260 | | (Loss) income from operations | $(17,234) | $8,212 | $(25,446) | | Other income, net | $701 | $1,521 | $(820) | | Net (loss) income | $(16,533) | $9,733 | $(26,266) | [Comparison of the Three Months Ended March 31, 2021 and 2020](index=31&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20March%2031,%202021%20and%202020) This section offers a direct comparison of key financial metrics for the three months ended March 31, 2021, and 2020 Financial Performance Comparison (in thousands) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | Change | | :------------------------------------ | :-------------------------------- | :-------------------------------- | :------- | | Revenue from former R&D arrangement | $0 | $22,378 | $(22,378) | | Operating expenses | $17,234 | $14,166 | $3,068 | | Net (loss) income | $(16,533) | $9,733 | $(26,266) | [Revenue from Research and Development Arrangement](index=31&type=section&id=Revenue%20from%20Research%20and%20Development%20Arrangement) This section explains the significant decrease in revenue due to the termination of the Eli Lilly and Company R&D agreement - Revenue decreased by **$22.4 million** to **$0** in Q1 2021 due to the termination of the Lilly Agreement[104](index=104&type=chunk) - No further quarterly research and development support payments are payable to the Company[104](index=104&type=chunk) [Research and Development Expenses](index=31&type=section&id=Research%20and%20Development%20Expenses) This section analyzes the increase in R&D expenses, attributing it to personnel costs and advancing development programs R&D Expenses (in thousands) | Category | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | Change | | :------------------------------------ | :-------------------------------- | :-------------------------------- | :------- | | External R&D expenses | $6,545 | $6,410 | $135 | | Internal R&D expenses | $5,841 | $4,168 | $1,673 | | **Total R&D expenses** | **$12,386** | **$10,578** | **$1,808** | - The increase was primarily driven by **$1.3 million** in personnel-related costs and costs for NC410 and other development programs[106](index=106&type=chunk) [General and Administrative Expenses](index=33&type=section&id=General%20and%20Administrative%20Expenses) This section details the increase in G&A expenses, primarily driven by higher personnel-related costs - G&A expenses increased by **$1.3 million** to **$4.9 million** in Q1 2021[107](index=107&type=chunk) - The increase was primarily driven by **$1.0 million** in personnel-related costs[107](index=107&type=chunk) [Other Income, Net](index=33&type=section&id=Other%20Income,%20Net) This section explains the decrease in other income, net, due to lower investment balances and reduced interest rates - Other income, net, decreased by **$0.8 million** to **$0.7 million** in Q1 2021[108](index=108&type=chunk) - The decrease was due to lower investment balances and reduced interest rates[108](index=108&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's financial liquidity, capital resources, cash flow activities, and future funding requirements - As of March 31, 2021, cash, cash equivalents, and marketable securities (excluding restricted cash) totaled **$268.2 million**[110](index=110&type=chunk) - Existing capital is expected to fund planned operations into the second half of 2023[110](index=110&type=chunk) - The company has a **$5.0 million** term loan, with **$3.1 million** outstanding as of March 31, 2021[111](index=111&type=chunk) - Substantial additional funding will be required, and failure to raise capital could lead to delays or termination of development programs[112](index=112&type=chunk) [Cash Flows](index=34&type=section&id=Cash%20Flows) This section provides a summary of cash flows from operating, investing, and financing activities for the reported periods Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(13,911) | $(10,594) | | Net cash provided by investing activities | $17,600 | $5,373 | | Net cash used in financing activities | $(354) | $(240) | | Net increase (decrease) in cash, cash equivalents and restricted cash | $3,335 | $(5,461) | [Cash Used in Operating Activities](index=34&type=section&id=Cash%20Used%20in%20Operating%20Activities) This section details net cash used in operating activities, primarily influenced by net loss and deferred revenue recognition - Net cash used in operating activities was **$13.9 million** for Q1 2021, primarily due to a net loss of **$16.5 million**[114](index=114&type=chunk) - Net cash used in operating activities was **$10.6 million** for Q1 2020, mainly due to **$22.4 million** in deferred revenue recognition[114](index=114&type=chunk) [Cash Used in Investing Activities](index=34&type=section&id=Cash%20Used%20in%20Investing%20Activities) This section outlines net cash provided by investing activities, mainly from proceeds from marketable securities - Cash provided by investing activities was **$17.6 million** for Q1 2021, primarily from **$18.4 million** in net proceeds from marketable securities[115](index=115&type=chunk) - Cash provided by investing activities for Q1 2020 was **$5.4 million**, primarily from **$6.8 million** in net proceeds from marketable securities[115](index=115&type=chunk) [Cash Provided by Financing Activities](index=34&type=section&id=Cash%20Provided%20by%20Financing%20Activities) This section describes net cash used in financing activities, primarily related to term loan payments - Cash used in financing activities was **$0.4 million** for Q1 2021 and **$0.2 million** for Q1 2020, both primarily consisting of payments related to the term loan[116](index=116&type=chunk) [Contractual Obligations and Commitments](index=34&type=section&id=Contractual%20Obligations%20and%20Commitments) This section notes no material changes to the company's contractual obligations during the first quarter of 2021 - No material changes to contractual obligations during Q1 2021[117](index=117&type=chunk) [Critical Accounting Policies, Significant Judgments and Use of Estimates](index=34&type=section&id=Critical%20Accounting%20Policies,%20Significant%20Judgments%20and%20Use%20of%20Estimates) This section highlights critical accounting policies, significant judgments, and estimates, noting no material changes - Financial statements require estimates and assumptions, especially for revenue recognition and share-based compensation[118](index=118&type=chunk) - No material changes to critical accounting policies were reported in Q1 2021[120](index=120&type=chunk) [Off-Balance Sheet Arrangements](index=36&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the company has not engaged in any off-balance sheet arrangements since its inception - The company has not engaged in any off-balance sheet arrangements since inception[121](index=121&type=chunk) [Recent Accounting Pronouncements](index=36&type=section&id=Recent%20Accounting%20Pronouncements) This section directs readers to Note 2 for a discussion of recent accounting pronouncements and their impact - Refer to Note 2 for discussion of recent accounting pronouncements[122](index=122&type=chunk) [Emerging Growth Company Status](index=36&type=section&id=Emerging%20Growth%20Company%20Status) This section clarifies the company's status as an Emerging Growth Company and its election for an extended transition period - NextCure is an Emerging Growth Company (EGC) under the JOBS Act[123](index=123&type=chunk) - The company has elected the extended transition period for adopting new accounting standards[123](index=123&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, NextCure is not required to provide quantitative and qualitative disclosures about market risk - Not required to provide market risk disclosures as a smaller reporting company[124](index=124&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, with the participation of the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of March 31, 2021, and concluded they were effective at a reasonable assurance level. No material changes in internal control over financial reporting occurred during the quarter - Disclosure controls and procedures were evaluated and deemed effective as of March 31, 2021[125](index=125&type=chunk) - No material changes in internal control over financial reporting occurred during Q1 2021[126](index=126&type=chunk) [Changes in Internal Control over Financial Reporting](index=36&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section confirms no material changes in internal control over financial reporting occurred during Q1 2021 - There were no changes in the company's internal control over financial reporting during the quarter ended March 31, 2021, that materially affected, or are reasonably likely to materially affect, its internal control over financial reporting[126](index=126&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information beyond the financial statements, including legal proceedings, risk factors, and other required disclosures [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) This item incorporates by reference the legal proceedings information from Note 10 of the condensed financial statements, which details two ongoing lawsuits: a stockholder class action and a shareholder derivative lawsuit. Management believes the ultimate disposition of these and other ordinary course legal proceedings will not have a material adverse effect on the business - Refers to Note 10 for details on legal proceedings[127](index=127&type=chunk) - Management believes the ultimate disposition of legal proceedings will not materially adversely affect the business[127](index=127&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.Risk%20Factors) This section highlights significant risks associated with investing in NextCure's common stock, including the ongoing adverse impacts of the COVID-19 pandemic on clinical trials and operations, potential negative effects from interim results of the NC318 clinical trial, and the costs and distractions associated with current and future securities litigation - Investing in common stock involves a high degree of risk[128](index=128&type=chunk) - Updated risk factors include the impacts of the COVID-19 pandemic, potential adverse effects from NC318 clinical trial results, and securities litigation[128](index=128&type=chunk) [The impacts of the COVID-19 pandemic could continue to adversely affect our business.](index=37&type=section&id=The%20impacts%20of%20the%20COVID-19%20pandemic%20could%20continue%20to%20adversely%20af%20ect%20our%20business.) This section details how the COVID-19 pandemic has slowed clinical trial enrollment and poses ongoing risks to the company's operations and financial performance - COVID-19 has slowed enrollment in the NC318 trial and delayed the NC410 trial[129](index=129&type=chunk) - Potential adverse effects include patient/staff inability to participate, supply chain interruptions, site closures, and difficulties meeting protocol procedures[129](index=129&type=chunk) - The full scope, duration, and severity of COVID-19 disruptions and their impacts are highly uncertain[130](index=130&type=chunk)[132](index=132&type=chunk) [Recently announced interim results regarding our NC318 monotherapy Phase 1/2 clinical trial may adversely impact our product development efforts.](index=39&type=section&id=Recently%20announced%20interim%20results%20regarding%20our%20NC318%20monotherapy%20Phase%201/2%20clinical%20trial%20may%20adversely%20impact%20our%20product%20development%20ef%20orts.) This section discusses the interim results of the NC318 trial, the planned modifications for patient pre-selection, and the potential adverse impacts on development timelines and costs - Interim results for NC318 Phase 1/2 trial showed insufficient S15-positive patients for effective evaluation[133](index=133&type=chunk) - The company is modifying the Phase 2 portion of the trial to pre-select patients based on S15 expression, expected to begin in Q2 2021[133](index=133&type=chunk) - These developments could increase costs, lengthen timelines, and adversely impact regulatory approval and commercialization of NC318[133](index=133&type=chunk) [We are now and may in the future be subject to securities litigation, which can be expensive and could divert management's attention.](index=39&type=section&id=We%20are%20now%20and%20may%20in%20the%20future%20be%20subject%20to%20securities%20litigation,%20which%20can%20be%20expensive%20and%20could%20divert%20management's%20attention.) This section addresses the ongoing stockholder class action and shareholder derivative lawsuits, emphasizing their potential financial and operational burdens - The company is subject to a stockholder class action (Ye Zhou) and a shareholder derivative lawsuit (Zach Liu)[134](index=134&type=chunk)[135](index=135&type=chunk) - Litigation is expensive, can divert management's attention, and could adversely affect the business[136](index=136&type=chunk) - If costs exceed insurance coverage, the company may bear substantial direct expenses[137](index=137&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item states that there were no unregistered sales of equity securities or use of proceeds to report for the period - None to report[139](index=139&type=chunk) [Item 3. Defaults Upon Senior Securities](index=41&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item states that there were no defaults upon senior securities to report for the period - None to report[140](index=140&type=chunk) [Item 4. Mine Safety Disclosures](index=41&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[141](index=141&type=chunk) [Item 5. Other Information](index=41&type=section&id=Item%205.%20Other%20Information) This item states that there is no other information to report for the period - None to report[142](index=142&type=chunk) [Item 6. Exhibits](index=42&type=section&id=Item%206.%20Exhibits) This item lists the exhibits filed or furnished as part of the Quarterly Report, including certifications (Rule 13a-14(a), 18 U.S.C. Section 1350) and XBRL documents - Includes certifications by Michael Richman and Steven P. Cobourn[145](index=145&type=chunk) - XBRL Instance Document and Taxonomy Extension Documents are filed[145](index=145&type=chunk) [SIGNATURES](index=43&type=section&id=SIGNATURES) This section contains the required signatures from the company's principal executive and financial officers, certifying the accuracy of the report - Report signed by Michael Richman, President and CEO, and Steven P. Cobourn, CFO[149](index=149&type=chunk) - Date of signing: May 6, 2021[149](index=149&type=chunk)

APRIL 13, 2021 Next@ure Next-Generation Immunomedicines Needham Investor Conference Forward-Looking Statements To the extent that statements contained in this presentation are not descriptions of historical facts, they may be deemed to be forward-looking statements under the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "intend," " "near-term," "future" and similar expressions, as well as other words and expressions referencing future events, conditio ...