NextCure, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>NextCure, Inc. has filed its 2023 10-K report detailing its financial performance and business operations for the fiscal year ending December 31, 2023.</b>

AI Summary

NextCure, Inc. (NXTC) filed a Annual Report (10-K) with the SEC on March 21, 2024. NextCure, Inc. filed its 2023 Form 10-K on March 21, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal business address is 9000 Virginia Manor Road, Suite 200, Beltsville, MD 20705. NextCure, Inc. is classified under Pharmaceutical Preparations (SIC 2834). The filing includes financial data for the fiscal years ending December 31, 2023, 2022, and 2021.

Why It Matters

For investors and stakeholders tracking NextCure, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of NextCure's financial health, operational activities, and strategic direction for the past fiscal year, which is crucial for investors to assess the company's performance and future prospects. As a pharmaceutical preparations company, the detailed financial statements and risk factors disclosed in this filing are essential for understanding the company's position within the highly regulated and competitive healthcare industry.

Risk Assessment

Risk Level: medium — NextCure, Inc. shows moderate risk based on this filing. The company operates in the pharmaceutical sector, which is subject to significant regulatory oversight, clinical trial risks, and market competition, as indicated by its SIC code and the nature of its business.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess NextCure's financial stability and its ability to navigate the challenges in the pharmaceutical industry.

Key Numbers

• 2023-12-31 — Fiscal Year End (The report covers the period ending on this date.)
• 2024-03-21 — Filing Date (The date the 10-K was filed with the SEC.)
• 0001558370-24-003672 — Accession Number (Unique identifier for the filing.)
• 001-38905 — SEC File Number (The SEC's file number for NextCure, Inc.)

Key Players & Entities

• NextCure, Inc. (company) — Filer of the 10-K report.
• 2023 (date) — Fiscal year end for the report.
• 2024-03-21 (date) — Filing date of the report.
• Beltsville, MD (location) — Location of the company's business address.
• 2834 (industry_code) — Standard Industrial Classification for Pharmaceutical Preparations.

FAQ

Risk Factors

• Regulatory Risks [medium — regulatory]: The company is subject to extensive regulation by government authorities, which can impact its operations and product development.
• Market Competition [medium — market]: The pharmaceutical market is highly competitive, with potential for new entrants and existing competitors to develop superior products.
• Clinical Trial Risks [high — operational]: The success of drug development is uncertain and depends on the outcome of clinical trials, which can be costly and time-consuming.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-03-21: Filing Date — Date the 10-K was officially submitted to the SEC.

Key Financial Figures

• $0.001 — nge on which registered: Common Stock, $0.001 par value per share NXTC Nasdaq Glo

Filing Documents

• nxtc-20231231x10k.htm (10-K) — 1814KB
• nxtc-20231231xex10d30.htm (EX-10.30) — 403KB
• nxtc-20231231xex23d1.htm (EX-23.1) — 11KB
• nxtc-20231231xex31d1.htm (EX-31.1) — 15KB
• nxtc-20231231xex31d2.htm (EX-31.2) — 14KB
• nxtc-20231231xex32d1.htm (EX-32.1) — 12KB
• nxtc-20231231xex97.htm (EX-97) — 19KB
• nxtc-20231231x10k005.jpg (GRAPHIC) — 45KB
• nxtc-20231231x10k006.jpg (GRAPHIC) — 56KB
• 0001558370-24-003672.txt (&nbsp;) — 7520KB
• nxtc-20231231.xsd (EX-101.SCH) — 40KB
• nxtc-20231231_cal.xml (EX-101.CAL) — 53KB
• nxtc-20231231_def.xml (EX-101.DEF) — 119KB
• nxtc-20231231_lab.xml (EX-101.LAB) — 414KB
• nxtc-20231231_pre.xml (EX-101.PRE) — 283KB
• nxtc-20231231x10k_htm.xml (XML) — 1037KB

Business

Business 6 Item 1A

Risk Factors

Risk Factors 29 Item 1B Unresolved Staff Comments 73 Item 1C Cybersecurity 73 Item 2

Properties

Properties 74 Item 3

Legal Proceedings

Legal Proceedings 74 Item 4 Mine Safety Disclosures 74 PART II Item 5 Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities 74 Item 6

Selected Financial Data

Selected Financial Data 74 Item 7

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 75 Item 7A

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 82 Item 8

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 83 Item 9 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 105 Item 9A

Controls and Procedures

Controls and Procedures 105 Item 9B Other Information 105 Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 105 PART III Item 10 Directors, Executive Officers, and Corporate Governance 105 Item 11

Executive Compensation

Executive Compensation 105 Item 12

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 106 Item 13 Certain Relationships and Related Transactions and Director Independence 106 Item 14 Principal Accounting Fees and Services 106 PART IV Item 15 Exhibits, Financial Statement Schedules 106 Item 16 Form 10-K Summary 109

SIGNATURES

SIGNATURES 110 2 Table of Contents SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report contains forward-looking statements, including with respect to our plans, objectives and expectations for our business, operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. The forward-looking statements are contained principally in the sections entitled "Business," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations," but are also contained elsewhere in this Annual Report. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "continue," "could," "due," "estimate," "expect," "intend," "may," "objective," "plan," "predict," "project," "potential," "positioned," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. Forward-looking statements include, but are not limited to, statements about: our expectations regarding the timing, progress and results of preclinical studies and clinical trials for NC410, LNCB74 and any other product candidates we develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; the timing or likelihood of regulatory filings for NC410, LCNB74 and any other product candidates we develop and our ability to obtain and maintain regulatory approvals for such product candidates for any indication; the identification, analysis and use of biomarkers and biomarker data; the anticipated benefits of our recently announced prioritization and restructuring plan; our drug produc

Business

Item 1. Business Overview We are a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including Antibody-Drug Conjugates (ADCs), antibodies and proteins. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. We are focusing on our highest-value opportunities: i) NC410, a LAIR-2 fusion protein that, in combination with pembrolizumab, demonstrated early evidence of clinical activity in colorectal (CRC) and ovarian cancers. We expect several potential catalysts in 2024. ii) LNCB74, an ADC that is directed to B7-H4, a clinically validated cancer target. Given our internal expertise of B7-H4 coupled with LegoChem Biosciences, Inc's (LegoChem) ADC technology, we plan for an Investigational New Drug application (IND) in 2024. In March 2024, we announced a prioritization and restructuring of our operations to align with our focused pipeline. We are pausing our internal manufacturing operations and reducing our workforce. In addition, we are seeking to partner our clinical programs NC525 and NC318 and our preclinical non-oncology programs NC605, for chronic bone diseases, and NC181, for Alzheimer's disease. We project these actions will extend our cash runway into the second half of 2026. Our Strategy The crucial elements of our business strategy include the following: Advancing development of NC410 in combination with pembrolizumab (NC410 Combo) based on early evidence of clinical activity . Based on emerging Phase 1b results in ovarian cancer, where NC410 Combo demonstrated an overall response rate (ORR) of 42.8% at the 9-week scan based on 7 evaluable patients, we are in the p

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View this 10-K filing on SEC EDGAR