NextCure(NXTC)
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NextCure(NXTC) - 2020 Q1 - Quarterly Report
2020-05-07 21:30
PART I. FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed financial statements for Q1 2020 show a net income of $9.7 million, a significant improvement from a $6.2 million net loss in the prior year, primarily due to $22.4 million revenue from the terminated Eli Lilly agreement [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Condensed Balance Sheets (in thousands) | Financial Metric | March 31, 2020 (in thousands) | December 31, 2019 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $28,907 | $34,091 | | Marketable securities | $293,191 | $300,514 | | Total current assets | $326,664 | $339,995 | | Total assets | $343,472 | $356,168 | | **Liabilities & Equity** | | | | Total current liabilities | $8,152 | $15,042 | | Total liabilities | $11,715 | $34,684 | | Total stockholders' equity | $331,757 | $321,484 | - Total assets decreased from **$356.2 million** at the end of 2019 to **$343.5 million** as of March 31, 2020, while total liabilities significantly reduced from **$34.7 million** to **$11.7 million**, primarily due to deferred revenue recognition[9](index=9&type=chunk) [Condensed Statements of Operations and Comprehensive Income (Loss)](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) Condensed Statements of Operations and Comprehensive Income (Loss) (in thousands) | Metric | Three Months Ended March 31, 2020 (in thousands) | Three Months Ended March 31, 2019 (in thousands) | | :--- | :--- | :--- | | Revenue | $22,378 | $1,357 | | Research and development | $10,578 | $6,513 | | General and administrative | $3,588 | $1,659 | | **Income (loss) from operations** | **$8,212** | **($6,815)** | | **Net income (loss)** | **$9,733** | **($6,155)** | | **Diluted EPS** | **$0.33** | **($4.46)** | - The company reported a **net income of $9.7 million** for Q1 2020, a significant turnaround from a **net loss of $6.2 million** in Q1 2019, driven by a substantial increase in revenue from a research and development arrangement[11](index=11&type=chunk) [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Condensed Statements of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2020 (in thousands) | Three Months Ended March 31, 2019 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($10,594) | ($7,080) | | Net cash provided by (used in) investing activities | $5,373 | ($935) | | Net cash used in (provided by) financing activities | ($240) | $2,970 | | **Net decrease in cash, cash equivalents and restricted cash** | **($5,461)** | **($5,045)** | - Net cash used in operating activities increased to **$10.6 million** in Q1 2020 from **$7.1 million** in Q1 2019, resulting in a **net decrease of $5.5 million** in total cash, cash equivalents, and restricted cash for the quarter[16](index=16&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) - The company is a clinical-stage biopharmaceutical entity focused on discovering and developing immunomedicines for cancer and other immune-related diseases utilizing its proprietary FIND-IO platform[17](index=17&type=chunk) - The research and development collaboration agreement with Eli Lilly and Company was terminated without cause, leading to the recognition of all remaining deferred revenue, totaling **$22.4 million**, in Q1 2020[36](index=36&type=chunk)[37](index=37&type=chunk) - The COVID-19 pandemic has slowed enrollment in the Phase 2 portion of the NC318 clinical trial and temporarily delayed the initiation of a Phase 2 combination trial for NC318 and a Phase 1/2 trial for NC410[53](index=53&type=chunk) - Stock-based compensation expense for Q1 2020 was **$1.008 million**, an increase from **$0.383 million** in Q1 2019[44](index=44&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical-stage operations, highlighting COVID-19's impact on trial delays, a Q1 2020 net income of $9.7 million due to the Lilly Agreement termination, increased operating expenses, and a belief that **$322.1 million** in cash is sufficient for the next 12 months [Overview](index=18&type=section&id=Overview) - NextCure is a clinical-stage biopharmaceutical company developing first-in-class immunomedicines for cancer and other immune-related diseases utilizing its proprietary FIND-IO platform[58](index=58&type=chunk) - The COVID-19 pandemic has caused significant disruptions, slowing patient enrollment for the Phase 2 trial of NC318 and temporarily delaying other planned trials for NC318 and NC410[59](index=59&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk) - The company's lead product candidate, NC318, targeting Siglec-15 (S15), is in a Phase 1/2 clinical trial, and its second candidate, NC410, received IND acceptance from the FDA in Q1 2020[62](index=62&type=chunk)[63](index=63&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Results of Operations (in thousands) | Metric (in thousands) | Q1 2020 | Q1 2019 | Change | | :--- | :--- | :--- | :--- | | Revenue | $22,378 | $1,357 | $21,021 | | Research and development | $10,578 | $6,513 | $4,065 | | General and administrative | $3,588 | $1,659 | $1,929 | | **Net income (loss)** | **$9,733** | **($6,155)** | **$15,888** | - Revenue increased by **$21.0 million** due to the recognition of all deferred revenue from the terminated Lilly Agreement[90](index=90&type=chunk) - R&D expenses rose by **$4.1 million**, primarily due to a **$1.7 million** increase in lab supplies and services for NC318, NC410, and other programs, and a **$1.4 million** increase in personnel costs[91](index=91&type=chunk) - G&A expenses increased by **$1.9 million**, driven by higher professional fees, insurance, and personnel costs associated with operating as a public company[92](index=92&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) - As of March 31, 2020, the company held **$322.1 million** in cash, cash equivalents, and marketable securities (excluding restricted cash)[72](index=72&type=chunk) - Management believes that existing cash, cash equivalents, and marketable securities are sufficient to fund planned operations for at least the next 12 months[72](index=72&type=chunk)[95](index=95&type=chunk) - The company has primarily financed operations through public offerings, private placements of preferred stock, and the upfront payment from the Lilly Agreement[94](index=94&type=chunk) Cash Flow Activity (in thousands) | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($10,594) | ($7,080) | | Net cash provided by (used in) investing activities | $5,373 | ($935) | | Net cash used in (provided by) financing activities | ($240) | $2,970 | [Quantitative and Qualitative Disclosures about Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is not required to provide this information as it qualifies as a smaller reporting company - As a smaller reporting company, NextCure is not required to provide the information requested by this item[111](index=111&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated disclosure controls as of March 31, 2020, concluding their effectiveness, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2020, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[112](index=112&type=chunk) - No changes in internal control over financial reporting occurred during Q1 2020 that materially affected, or are reasonably likely to materially affect, internal controls[113](index=113&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business - The company is not currently involved in any litigation or legal proceedings that management believes would have a material adverse effect on the business[114](index=114&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) This section highlights significant business risks, emphasizing the ongoing and potential future impacts of the COVID-19 pandemic, including clinical trial delays, supply chain disruptions, and overall economic uncertainty - The COVID-19 pandemic has caused a slowdown in patient enrollment for the Phase 2 trial of NC318 and has delayed the initiation of other planned clinical trials for NC318 and NC410[116](index=116&type=chunk) - The pandemic could continue to adversely affect business operations, including interruptions to the supply chain, site closures, and difficulties in adhering to trial protocols, potentially impacting financial position and results[116](index=116&type=chunk)[117](index=117&type=chunk) - The company depends on third-party suppliers for key materials, and any supply interruption, potentially exacerbated by COVID-19, could materially harm its ability to manufacture product candidates and delay development[119](index=119&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[120](index=120&type=chunk) [Defaults Upon Senior Securities](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None[121](index=121&type=chunk) [Mine Safety Disclosures](index=32&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[122](index=122&type=chunk) [Other Information](index=32&type=section&id=Item%205.%20Other%20Information) There is no other information to report for the period - None[123](index=123&type=chunk) [Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section provides an index of the exhibits filed as part of the Quarterly Report, including officer certifications and XBRL data files - The report includes an exhibit index listing certifications pursuant to the Sarbanes-Oxley Act and XBRL-related documents[124](index=124&type=chunk)[126](index=126&type=chunk)
NextCure(NXTC) - 2019 Q4 - Annual Report
2020-03-12 21:07
Part I [Business Overview](index=5&type=section&id=Item%201.%20Business) NextCure is a clinical-stage biopharmaceutical company developing first-in-class immunomedicines for cancer and immune-related diseases, leveraging its FIND-IO platform and in-house manufacturing [Company and Strategy](index=5&type=section&id=Overview) NextCure is a clinical-stage biopharmaceutical company focused on developing novel immunomedicines for cancer and other diseases, advancing lead candidates and leveraging its FIND-IO platform - The company primarily focuses on developing first-in-class immunomedicines for cancer patients unresponsive to existing therapies[18](index=18&type=chunk) - Key strategic elements include advancing lead candidates NC318 and NC410, leveraging the FIND-IO platform, utilizing in-house cGMP manufacturing, and exploring non-oncology opportunities[33](index=33&type=chunk)[38](index=38&type=chunk) [Product Pipeline](index=9&type=section&id=Our%20Pipeline) NextCure's pipeline features lead candidates NC318 (S15) and NC410 (LAIR-1) in clinical development, alongside preclinical programs from its FIND-IO platform Clinical Pipeline Status | Product Candidate | Target | Indication | Development Phase | | :--- | :--- | :--- | :--- | | **NC318** | S15 | Advanced/Metastatic Solid Tumors | Phase 1/2 (Phase 2 enrolling) | | **NC410** | LAIR-1 | Advanced/Metastatic Solid Tumors | Phase 1/2 (Planned Q2 2020) | - NC318 Phase 1 preliminary data demonstrated a **complete response** and a **partial response** in NSCLC patients, advancing to Phase 2 in October 2019[19](index=19&type=chunk)[62](index=62&type=chunk) - The FDA accepted the IND for NC410 in Q1 2020, with a Phase 1/2 trial planned for Q2 2020 in advanced or metastatic solid tumors[20](index=20&type=chunk)[76](index=76&type=chunk) - The company is pursuing preclinical antibodies targeting a novel B7-family member, another immune modulator, and additional LAIR-1 monoclonal antibodies[96](index=96&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) [FIND-IO Discovery Platform](index=28&type=section&id=Our%20FIND-IO%20Discovery%20Engine) The FIND-IO platform is NextCure's proprietary function-based screening engine for identifying novel immune-modulating targets, expanding into non-oncology areas like autoimmunity - FIND-IO is a function-based screening platform identifying novel cell surface molecular interactions that drive functional immune responses[42](index=42&type=chunk)[99](index=99&type=chunk) - The platform integrates gene libraries, various immune and non-immune cell types, and functional outputs to identify new immune modulators[100](index=100&type=chunk) - The company is expanding the platform beyond oncology to discover targets in autoimmunity and inflammation via the new FIND-AI platform[108](index=108&type=chunk) [Collaboration Agreements](index=30&type=section&id=Our%20Collaboration%20Agreements) NextCure holds an exclusive license and sponsored research agreement with Yale University, while its collaboration with Eli Lilly was terminated in March 2020 - The company holds an exclusive, worldwide license from Yale University for S15 patents, requiring milestone payments up to **$2.975 million** per product and low single-digit royalties[109](index=109&type=chunk)[110](index=110&type=chunk) - A Sponsored Research Agreement with Yale provides up to **$12.4 million** in funding for new immunomedicine target discovery, expiring December 31, 2020[111](index=111&type=chunk) - The collaboration agreement with Eli Lilly, including a **$25.0 million** upfront payment and **$15.0 million** equity investment, was terminated by Lilly effective March 3, 2020[112](index=112&type=chunk) [Manufacturing](index=32&type=section&id=Manufacturing) NextCure operates its own cGMP-compliant manufacturing facility with 1,000-liter capacity, producing drug supply for preclinical and clinical trials, including NC318 - The company operates a dedicated, state-of-the-art cGMP manufacturing facility with an initial capacity of **1,000 liters**[113](index=113&type=chunk) - This facility manufactures drug supply for all preclinical studies and the NC318 Phase 1/2 clinical trial[113](index=113&type=chunk) [Intellectual Property](index=34&type=section&id=Intellectual%20Property) NextCure protects its intellectual property through patent applications for NC318/NC410, an exclusive license from Yale for S15, and trade secret protection for FIND-IO - As of year-end 2019, the company has **18 pending foreign** and **2 pending U.S. patent applications** for NC318 and NC410, expected to expire starting in 2037 if issued[119](index=119&type=chunk) - The company holds an exclusive license from Yale for S15 patents, expected to expire no earlier than 2036 if issued[120](index=120&type=chunk) - The FIND-IO platform is protected as a trade secret via confidentiality and invention assignment agreements[122](index=122&type=chunk) [Government Regulation](index=36&type=section&id=Government%20Regulation) NextCure's product candidates are regulated as biologics by the FDA and international authorities, requiring extensive preclinical and clinical development, ongoing post-approval compliance, and adherence to healthcare laws - Product candidates are regulated as biologics in the U.S., requiring extensive preclinical and clinical testing before BLA submission to the FDA[126](index=126&type=chunk)[128](index=128&type=chunk) - Post-approval, the company must comply with ongoing FDA regulations, including cGMP, adverse event reporting, and potential REMS requirements[165](index=165&type=chunk)[303](index=303&type=chunk) - The business is subject to healthcare laws including the federal Anti-Kickback Statute, False Claims Act, and HIPAA, regulating relationships with providers and payors[196](index=196&type=chunk)[335](index=335&type=chunk) - Commercial success depends on coverage and reimbursement from third-party payors like Medicare, Medicaid, and private insurers, subject to pricing pressures and healthcare reform[193](index=193&type=chunk)[317](index=317&type=chunk)[325](index=325&type=chunk) [Risk Factors](index=60&type=page&id=Item%201A.%20Risk%20Factors) The company faces significant financial, development, regulatory, commercial, operational, and global health risks, including a history of losses and reliance on unproven candidates - **Financial Risks:** The company has a history of significant net losses, including **$33.7 million in 2019**, and will require substantial additional financing to continue operations[211](index=211&type=chunk) - **Development & Regulatory Risks:** Clinical development is lengthy and uncertain, with the FIND-IO platform unproven and product candidates like NC318 and NC410 facing trial failure or non-approval risks[228](index=228&type=chunk)[241](index=241&type=chunk)[258](index=258&type=chunk) - **Commercial & Competition Risks:** Approved products may not achieve market acceptance, and the company faces intense competition from large, well-funded pharmaceutical companies[292](index=292&type=chunk)[416](index=416&type=chunk) - **Operational Risks:** The company has limited manufacturing experience, relies on third parties for key services and collaborations, and is highly dependent on key personnel[344](index=344&type=chunk)[396](index=396&type=chunk)[412](index=412&type=chunk) - **Global Health Risks:** The novel coronavirus outbreak could disrupt business operations, including clinical trial recruitment and supply chains[437](index=437&type=chunk) [Properties](index=82&type=section&id=Item%202.%20Properties) The company's headquarters, lab, and manufacturing facilities are located in Beltsville, Maryland, under leases expiring in 2025 and 2030 - The company's headquarters, lab, and manufacturing facilities are located in Beltsville, Maryland, under leases expiring in **2025** and **2030**[464](index=464&type=chunk) [Legal Proceedings](index=83&type=section&id=Item%203.%20Legal%20Proceedings) As of the report date, NextCure is not a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[466](index=466&type=chunk) Part II [Market for Common Equity and Related Matters](index=83&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 Nasdaq under "NXTC", the company has never paid dividends, and its May 2019 IPO raised approximately $76.9 million - Common stock is traded on the Nasdaq Global Select Market under the symbol **"NXTC"**[468](index=468&type=chunk) - The company has never declared dividends and does not plan to in the foreseeable future[469](index=469&type=chunk) - The May 2019 IPO generated net proceeds of approximately **$76.9 million**[470](index=470&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=83&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For 2019, NextCure reported a net loss of $33.7 million, with increased R&D and G&A expenses, holding $334.6 million in cash expected to fund operations into mid-2023, following the Lilly agreement termination [Results of Operations](index=87&type=section&id=Results%20of%20Operations) In 2019, revenue was $6.3 million from the Lilly Agreement, while R&D expenses increased by $14.4 million and G&A expenses by $6.2 million, leading to a higher net loss Results of Operations (in thousands) | | Year Ended Dec 31, 2019 | Year Ended Dec 31, 2018 | Change | | :--- | :--- | :--- | :--- | | Revenue from research and development arrangement | $6,347 | $0 | $6,347 | | Research and development | $34,216 | $19,787 | $14,429 | | General and administrative | $9,613 | $3,409 | $6,204 | | **Loss from operations** | **($37,482)** | **($23,196)** | **($14,286)** | | Other income, net | $3,745 | $397 | $3,348 | | **Net loss** | **($33,737)** | **($22,799)** | **($10,938)** | - The **$14.4 million** increase in R&D expenses was driven by a **$4.4 million** increase in lab supplies, a **$4.1 million** increase in personnel costs, and a **$3.0 million** increase in NC318 clinical research costs[505](index=505&type=chunk) - The **$6.2 million** increase in G&A expenses was primarily due to a **$2.8 million** increase in professional fees and a **$1.2 million** increase in insurance expenses as a public company[507](index=507&type=chunk) [Liquidity and Capital Resources](index=88&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2019, NextCure held $334.6 million in cash and marketable securities, bolstered by 2019 offerings, expected to fund operations into mid-2023, with net cash used in operations at $35.6 million - As of December 31, 2019, the company held **$334.6 million** in cash, cash equivalents, and marketable securities[486](index=486&type=chunk)[510](index=510&type=chunk) - The company raised approximately **$237.8 million** in net proceeds from its IPO and a follow-on public offering in 2019[509](index=509&type=chunk) - Management expects the current cash position to fund planned operations into the first half of **2023**[486](index=486&type=chunk)[510](index=510&type=chunk) Cash Flow Summary (in thousands) | | Year Ended Dec 31, 2019 | Year Ended Dec 31, 2018 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | $(35,623) | $7,992 | | Net cash used in investing activities | $(303,923) | $(3,063) | | Net cash provided by financing activities | $243,043 | $121,417 | [Financial Statements and Supplementary Data](index=94&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The audited financial statements for 2019 and 2018 are presented, showing a 2019 net loss of $33.7 million, total assets of $356.2 million, and notes detailing key accounting policies and events Balance Sheet Highlights (in thousands) | | Dec 31, 2019 | Dec 31, 2018 | | :--- | :--- | :--- | | Cash and cash equivalents | $34,091 | $135,173 | | Marketable securities | $300,514 | $0 | | **Total Assets** | **$356,168** | **$147,628** | | Total current liabilities | $15,042 | $10,298 | | Deferred revenue, non-current | $15,950 | $21,736 | | **Total Liabilities** | **$34,684** | **$32,349** | | **Total Stockholders' Equity (Deficit)** | **$321,484** | **($46,944)** | - Upon the IPO closing in May 2019, all outstanding convertible preferred stock automatically converted into **15,560,569 shares** of common stock[563](index=563&type=chunk) - Subsequent Event: Lilly terminated the Lilly Agreement effective March 3, 2020, with the remaining **$22.4 million** in deferred revenue to be recognized in Q1 2020[695](index=695&type=chunk)[696](index=696&type=chunk) Part III [Directors, Executive Compensation, and Corporate Governance](index=119&type=section&id=Item%2010%2C%2011%2C%2012%2C%2013%2C%2014) Information on directors, executive compensation, security ownership, and corporate governance is incorporated by reference from the forthcoming 2020 Proxy Statement - Information regarding directors, executive compensation, security ownership, and other governance matters is incorporated by reference from the forthcoming **2020 Proxy Statement**[703](index=703&type=chunk)[704](index=704&type=chunk)[705](index=705&type=chunk)[706](index=706&type=chunk)[707](index=707&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=120&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section provides an index of all exhibits filed with the 10-K, including financial statements, corporate governance documents, and material agreements - This section contains the index of all exhibits filed with the **10-K**, including corporate governance documents, material agreements, and required certifications[711](index=711&type=chunk)[713](index=713&type=chunk)
NextCure (NXTC) Presents At Cowen Health Care Conference - Slideshow
2020-03-06 14:36
MARCH 2020 Next@ure Next-Generation Immunomedicines 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, conditions, or circumstances, are intend ...
NextCure(NXTC) - 2019 Q3 - Quarterly Report
2019-11-12 13:11
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, 2019 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 ...
NextCure (NXTC) Investor Presentation - Slideshow
2019-09-13 15:59
Pipeline and Programs - NC318 (targeting Siglec-15) Phase 1/2 topline data is expected in Q4 2019[6], with Phase 1 initiated in October 2018[23] - NC410 (LAIR-1) IND filing is expected in Q1 2020[6], designed to promote T cell function and dendritic cell activity[58] - Multiple discovery and research programs are underway, with the first IND filing anticipated in early 2021[20] - The FIND-IO platform aims for its first IND filing in late 2022[20] Financial and Partnerships - An oncology partnership with Eli Lilly includes $40 million upfront and equity[7] - NextCure has a strong balance sheet to deliver on objectives[7] NC318 Details - NC318 targets tumors and macrophages by blocking S15-induced immunosuppression[23] - Phase 1 trial of NC318 had 21 subjects dosed as of March 31, 2019, with the 4th dose cohort open[54] - In the NC318 Phase 1 trial, there was 1 confirmed partial response, 6 stable diseases, and 6 progressive diseases[55] - S15 and PD-L1 expression generally do not overlap in NSCLC tumors, suggesting NC318 as a potential treatment for PD-1/PD-L1 non-responders[34] NC410 Details - NC410 is a decoy human fusion protein targeting the TME, specifically Leukocyte Associated Immunoglobulin-like Receptor-1 (LAIR-1)[58] - NC410 is designed to prevent immune suppression caused by LAIR-1, promoting T cell function and dendritic cell activation[62, 63] FIND-IO Platform - The FIND-IO platform is a functional, integrated discovery engine for immuno-oncology[76] - Lilly–NextCure partnership to validate platform and approach includes $25 million upfront and $15 million equity investment[86]
NextCure(NXTC) - 2019 Q2 - Quarterly Report
2019-08-12 20:06
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Unaudited financial statements for June 30, 2019, show increased cash and assets from the May 2019 IPO, higher Eli Lilly revenue, and a larger net loss due to rising R&D and G&A expenses [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2019 (Unaudited) | December 31, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $192,689 | $135,173 | | Total current assets | $196,521 | $135,785 | | Total assets | $213,050 | $147,628 | | **Liabilities & Equity** | | | | Total liabilities | $34,455 | $32,349 | | Total redeemable preferred stock | $0 | $162,223 | | Total stockholders' equity (deficit) | $178,595 | $(46,944) | - The **significant increase** in **cash and cash equivalents** and the shift from a **stockholders' deficit** to a **positive equity position** were primarily driven by the **net proceeds** from the company's **IPO** in May 2019[23](index=23&type=chunk)[16](index=16&type=chunk) - **All redeemable preferred stock** was **converted into common stock** upon the closing of the IPO, resulting in a **zero balance** for preferred stock as of June 30, 2019[25](index=25&type=chunk)[16](index=16&type=chunk) [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) Condensed Statements of Operations Highlights (in thousands) | Account | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | Revenue from research and development arrangement | $1,402 | $0 | $2,759 | $0 | | Research and development expense | $7,643 | $4,434 | $14,156 | $8,644 | | General and administrative expense | $2,714 | $866 | $4,373 | $1,665 | | Loss from operations | $(8,955) | $(5,300) | $(15,770) | $(10,309) | | Net loss | $(8,221) | $(5,231) | $(14,376) | $(10,227) | | Net loss per share | $(0.61) | $(3.82) | $(1.92) | $(7.47) | - **Revenue** in 2019 was generated from the research and development arrangement with **Eli Lilly**, which commenced in January 2019[63](index=63&type=chunk) - **Operating expenses increased significantly** year-over-year, driven by **higher R&D costs** for advancing product candidates and **increased G&A expenses** related to operating as a public company[12](index=12&type=chunk)[112](index=112&type=chunk)[115](index=115&type=chunk) [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Condensed Statements of Cash Flows Highlights (in thousands) | Activity | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | $(17,685) | $(9,760) | | Net cash used in investing activities | $(2,067) | $(853) | | Net cash provided by financing activities | $81,847 | $30,800 | | Net increase in cash, cash equivalents and restricted cash | $62,095 | $20,187 | - The **primary source of cash** in the first six months of 2019 was **$77.3 million** in **net proceeds** from the **IPO**[20](index=20&type=chunk) - **Cash used in operating activities increased** due to a **higher net loss**, reflecting **expanded research and development activities**[20](index=20&type=chunk)[123](index=123&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) - The company is a **clinical-stage biopharmaceutical firm** focused on discovering and developing **immunomedicines** for cancer and other immune-related diseases using its proprietary **FIND-IO platform**[22](index=22&type=chunk) - On **May 13, 2019**, the company closed its **IPO**, selling **5,750,000 shares** of common stock at **$15.00 per share** for **net proceeds of approximately $77.0 million**[23](index=23&type=chunk) - The company **recognizes revenue** from its **collaboration agreement with Eli Lilly** using an **input method** based on R&D costs incurred. For the six months ended June 30, 2019, **$2.8 million in revenue** was recognized under this agreement[62](index=62&type=chunk)[63](index=63&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage status, lead product candidates, historical losses, and funding sources, noting increased revenue and expenses, with current cash sufficient to fund operations into the second half of 2022 [Overview](index=23&type=section&id=Overview) - NextCure is a **clinical-stage biopharmaceutical company** developing **first-in-class immunomedicines** for cancer and other immune-related diseases using its proprietary **FIND-IO discovery platform**[86](index=86&type=chunk) - The lead product candidate, **NC318**, is in a **Phase 1/2 clinical trial** for advanced or metastatic solid tumors, with Phase 1 completion expected in **Q4 2019**[87](index=87&type=chunk) - The second product candidate, **NC410**, is designed to block immune suppression mediated by LAIR-1, with an **IND submission planned for Q1 2020**[87](index=87&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Comparison of Results of Operations (in thousands) | Account | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $1,402 | $0 | $2,759 | $0 | | R&D Expenses | $7,643 | $4,434 | $14,156 | $8,644 | | G&A Expenses | $2,714 | $866 | $4,373 | $1,665 | | Net Loss | $(8,221) | $(5,231) | $(14,376) | $(10,227) | - **Revenue for 2019** is attributed to the recognition of upfront consideration from the **Lilly Agreement**[111](index=111&type=chunk) - The **increase in R&D expenses** for the six months ended June 30, 2019 was driven by a **$1.6 million increase in personnel costs**, **$1.5 million in clinical research costs for NC318**, and **$1.3 million in lab supplies**[114](index=114&type=chunk) - The **increase in G&A expenses** for the six months ended June 30, 2019 was primarily due to a **$1.3 million rise in professional fees** (legal, finance, audit) related to the **IPO**[116](index=116&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) - As of **June 30, 2019**, the company had **cash and cash equivalents of $192.7 million**[120](index=120&type=chunk) - The company believes its existing cash, including net proceeds from the IPO, will be **sufficient to fund planned operations into the second half of 2022**[120](index=120&type=chunk) - In **January 2019**, the company amended its **Term Loan** to **increase borrowing capacity from $1.0 million to $5.0 million**, with the **full amount outstanding** as of June 30, 2019[120](index=120&type=chunk)[121](index=121&type=chunk) Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | | Net cash used in Operating activities | $(17,685) | $(9,760) | | Net cash used in Investing activities | $(2,067) | $(853) | | Net cash provided by Financing activities | $81,847 | $30,800 | [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, NextCure is not required to provide the information requested by this item - The company is **not required** to provide quantitative and qualitative disclosures about market risk because it qualifies as a **smaller reporting company**[132](index=132&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures as of June 30, 2019, and concluded they were effective at a reasonable assurance level. There were no material changes in internal control over financial reporting during the quarter - Management concluded that as of June 30, 2019, the company's disclosure controls and procedures were **effective at the reasonable assurance level**[133](index=133&type=chunk) - **No changes in internal control over financial reporting** occurred during the quarter ended June 30, 2019, that materially affected, or are reasonably likely to materially affect, internal controls[134](index=134&type=chunk) [Part II. OTHER INFORMATION](index=35&type=section&id=Part%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any litigation or legal proceedings that are likely to have a material adverse effect on its business - As of the report date, the company is **not involved in any legal proceedings** that management believes would have a **material adverse effect** on the business[135](index=135&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) This section outlines key investment risks, including limited operating history, significant losses, dependence on early-stage product candidates and an unproven platform, regulatory uncertainties, manufacturing complexities, and reliance on third parties - The company has a history of **significant losses** (**$14.4 million** for the six months ended June 30, 2019) and expects to incur **substantial losses for the foreseeable future**, with **no products approved for commercial sale**[137](index=137&type=chunk)[138](index=138&type=chunk) - The business is **highly dependent** on advancing its lead product candidates, **NC318 and NC410**, through clinical trials and obtaining regulatory approval, which is a **lengthy, expensive, and uncertain process**[153](index=153&type=chunk)[158](index=158&type=chunk) - The company's **FIND-IO platform** for discovering and developing product candidates is **unproven** and **may not result in marketable products**[175](index=175&type=chunk) - The company has **limited manufacturing experience** and **relies on third-party CMOs** for certain elements, posing risks related to **cGMP compliance, supply chain disruptions, and scalability**[260](index=260&type=chunk)[265](index=265&type=chunk) - The company **relies on third parties like CROs** to conduct clinical trials and on **collaborators like Eli Lilly** for the development and commercialization of certain candidates, which **limits control and introduces dependency risks**[303](index=303&type=chunk)[306](index=306&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=110&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the use of proceeds from the company's Initial Public Offering (IPO) on May 13, 2019. The IPO generated net proceeds of approximately $77.0 million. As of June 30, 2019, $0.5 million was used for a payment to Yale University, with the remainder held in temporary investments pending other uses. There has been no material change in the planned use of proceeds - On **May 13, 2019**, the company closed its **IPO**, raising **net proceeds of approximately $77.0 million** after deducting underwriting discounts and offering expenses[363](index=363&type=chunk) - As of **June 30, 2019**, **$0.5 million** of the IPO proceeds were used for a payment to **Yale University**, with the rest invested temporarily. The planned use of proceeds has **not materially changed**[363](index=363&type=chunk)[364](index=364&type=chunk) [Item 3. Defaults Upon Senior Securities](index=110&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None - There were **no defaults upon senior securities** during the period[365](index=365&type=chunk) [Item 4. Mine Safety Disclosures](index=110&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - This item is **not applicable** to the company[366](index=366&type=chunk) [Item 5. Other Information](index=110&type=section&id=Item%205.%20Other%20Information) None - There is **no other information** to report for this item[367](index=367&type=chunk) [Item 6. Exhibits](index=110&type=section&id=Item%206.%20Exhibits) This section provides an index of the exhibits filed as part of the Quarterly Report, including corporate governance documents, incentive plans, and required certifications - The report includes an **index of exhibits**, such as the **Amended and Restated Certificate of Incorporation, Bylaws, 2019 Omnibus Incentive Plan, and CEO/CFO certifications**[371](index=371&type=chunk) [Signatures](index=114&type=section&id=SIGNATURES) - The report was duly signed on **August 12, 2019**, by **Michael Richman, President and Chief Executive Officer**, and **Steven P. Cobourn, Chief Financial Officer**[376](index=376&type=chunk)[378](index=378&type=chunk)
NextCure(NXTC) - 2019 Q1 - Quarterly Report
2019-06-10 20:11
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, 2019 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 ...