NextCure(NXTC) - 2021 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION 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 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 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 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 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 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 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][18][21] 1. Nature of the Business 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] - 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] - COVID-19 has caused enrollment to slow in the Phase 2 portion of the NC318 clinical trial[25] 2. Summary of Significant Accounting Policies 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] - The company is an Emerging Growth Company (EGC) and has elected to defer compliance with new accounting standards[30] - ASC 842 (Leases) will be effective for the company on January 1, 2022, and is expected to increase total assets and liabilities[31][33] - ASU 2016-13 (Credit Losses) was adopted early, effective January 1, 2021, with no material impact on financial statements[34] 3. Restricted Cash 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] Restricted Cash Balances (in thousands) | Metric | March 31, 2021 | December 31, 2020 | | :-------------------------------- | :------------- | :---------------- | | Restricted cash | $3,092 | $3,512 | 4. Marketable Securities 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] - The company does not intend to sell securities with unrealized losses and believes market conditions are the primary factor for these changes[40] 5. Fair Value Measurements 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] 6. Former Agreement with Eli Lilly and Company 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] - 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] - No further quarterly research and development support payments are payable to the Company[47] 7. Stock-Based Compensation 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][50] 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] 8. Net (Loss) Income Per Share Attributable to Common Stockholders 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] 9. Income Taxes 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] - A full valuation allowance is maintained against deferred tax assets due to cumulative net losses[61][62] - The CARES Act and ARPA 2021 had no significant financial impact on the company's condensed financial statements[64] 10. Commitments and Contingencies 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] - 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] - The company intends to vigorously defend both actions and believes they are without merit, but cannot estimate the reasonably possible loss[68] - The financial statements are unaudited and prepared in conformity with GAAP for interim reporting[27] - No material changes to significant accounting policies from the 2020 Annual Report[26] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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] - The COVID-19 pandemic has caused delays and slowdowns in clinical trials, particularly for NC318[71][83] - 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] - Existing cash, cash equivalents, and marketable securities of $268.2 million are expected to fund operations into the second half of 2023[91][110] 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] - 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][79] - NC410, targeting LAIR-1, is in a Phase 1/2 clinical trial for advanced solid tumors, with data expected in H2 2021[80] - NC762, targeting B7-H4, has an IND cleared and a Phase 1/2 clinical trial is planned for Q2 2021[81] 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] - The full scope, duration, and severity of COVID-19 disruptions and their impact on the company's business and financial performance remain uncertain[83] Financial Overview 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] - Net loss for Q1 2021 was $16.5 million, compared to net income of $9.7 million for Q1 2020[86] - 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][89][90] - 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] - Substantial additional funding will be required for continued operations and development[93] Components of Our Results of Operations 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] - Research and development expenses are expensed as incurred and are expected to increase substantially as product candidates advance[96][97] - General and administrative expenses are also expected to increase due to staff expansion, occupancy costs, and public company operating expenses[101] 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] Operating Expenses 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][100] - Both R&D and G&A expenses are expected to increase substantially in the foreseeable future[97][101] Research and Development Expenses 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] - R&D expenses are expected to increase substantially due to advancing product candidates, expanding trials, cGMP manufacturing, and discovery programs[97] - The duration and costs of future clinical trials are uncertain and depend on various factors, including regulatory requirements and patient enrollment[98][99] General and Administrative Expenses 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] - G&A expenses are expected to increase substantially due to staff expansion, higher legal/accounting fees, investor relations, and insurance premiums[101] Other Income, Net 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] Results of Operations 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 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 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] - No further quarterly research and development support payments are payable to the Company[104] Research and Development Expenses 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] General and Administrative Expenses 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] - The increase was primarily driven by $1.0 million in personnel-related costs[107] Other Income, Net 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] - The decrease was due to lower investment balances and reduced interest rates[108] Liquidity and Capital Resources 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] - Existing capital is expected to fund planned operations into the second half of 2023[110] - The company has a $5.0 million term loan, with $3.1 million outstanding as of March 31, 2021[111] - Substantial additional funding will be required, and failure to raise capital could lead to delays or termination of development programs[112] Cash Flows 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 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] - Net cash used in operating activities was $10.6 million for Q1 2020, mainly due to $22.4 million in deferred revenue recognition[114] Cash Used in Investing Activities 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] - Cash provided by investing activities for Q1 2020 was $5.4 million, primarily from $6.8 million in net proceeds from marketable securities[115] Cash Provided by Financing Activities 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] Contractual Obligations and Commitments 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] Critical Accounting Policies, Significant Judgments and Use of Estimates 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] - No material changes to critical accounting policies were reported in Q1 2021[120] Off-Balance Sheet Arrangements 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] Recent Accounting Pronouncements 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] Emerging Growth Company Status 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] - The company has elected the extended transition period for adopting new accounting standards[123] Item 3. Quantitative and Qualitative Disclosures about Market Risk 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] Item 4. Controls and Procedures 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] - No material changes in internal control over financial reporting occurred during Q1 2021[126] Changes in Internal Control over Financial Reporting 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] PART II. OTHER INFORMATION This section provides additional information beyond the financial statements, including legal proceedings, risk factors, and other required disclosures Item 1. Legal Proceedings 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] - Management believes the ultimate disposition of legal proceedings will not materially adversely affect the business[127] Item 1A. Risk Factors 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] - Updated risk factors include the impacts of the COVID-19 pandemic, potential adverse effects from NC318 clinical trial results, and securities litigation[128] The impacts of the COVID-19 pandemic could continue to adversely affect our business. 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] - Potential adverse effects include patient/staff inability to participate, supply chain interruptions, site closures, and difficulties meeting protocol procedures[129] - The full scope, duration, and severity of COVID-19 disruptions and their impacts are highly uncertain[130][132] Recently announced interim results regarding our NC318 monotherapy Phase 1/2 clinical trial may adversely impact our product development efforts. 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] - 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] - These developments could increase costs, lengthen timelines, and adversely impact regulatory approval and commercialization of NC318[133] We are now and may in the future be subject to securities litigation, which can be expensive and could divert management's attention. 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][135] - Litigation is expensive, can divert management's attention, and could adversely affect the business[136] - If costs exceed insurance coverage, the company may bear substantial direct expenses[137] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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] Item 3. Defaults Upon Senior Securities This item states that there were no defaults upon senior securities to report for the period - None to report[140] Item 4. Mine Safety Disclosures This item is not applicable to the company - Not applicable[141] Item 5. Other Information This item states that there is no other information to report for the period - None to report[142] Item 6. Exhibits 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] - XBRL Instance Document and Taxonomy Extension Documents are filed[145] 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] - Date of signing: May 6, 2021[149]