Core Viewpoint - NextCure, Inc. is advancing its clinical-stage biopharmaceutical efforts with the presentation of a Phase 1 study poster for LNCB74, a B7-H4 targeted antibody-drug conjugate, at the ASCO Annual Meeting, highlighting its potential in treating various advanced solid tumors [1][3]. Company Overview - NextCure, Inc. is focused on developing innovative cancer therapies for patients who do not respond to existing treatments, utilizing differentiated mechanisms such as antibody-drug conjugates, antibodies, and proteins [4]. Study Details - The Phase 1 study is evaluating LNCB74 as a monotherapy for advanced solid tumors, including platinum-resistant ovarian cancer, treatment-refractory breast cancer, endometrial cancer, biliary tract cancer, and squamous non-small cell lung cancer, with ongoing dose escalation [2][7]. - The study includes phases for dose escalation, dose expansion, and optimization, currently enrolling participants in the dose escalation phase [2][7]. Target and Efficacy - B7-H4 is identified as an attractive target for ADC therapy due to its high expression in multiple tumor types and limited expression in normal tissues, with LNCB74 showing a superior safety profile and potent anti-tumor activity in preclinical studies [3].

PART I. FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed financial statements for Q1 2025 show decreased assets and a reduced net loss of **$11.0 million** compared to Q1 2024 [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to **$67.1 million** as of March 31, 2025, driven by reduced cash and marketable securities, impacting equity Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $21,827 | $27,727 | | Marketable securities | $34,033 | $40,894 | | Total current assets | $58,897 | $71,807 | | Total assets | $67,137 | $80,860 | | **Liabilities & Equity** | | | | Total current liabilities | $5,740 | $9,574 | | Total liabilities | $11,282 | $15,388 | | Total stockholders' equity | $55,855 | $65,472 | | Total liabilities and stockholders' equity | $67,137 | $80,860 | [Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a reduced net loss of **$11.0 million** for Q1 2025, primarily due to lower operating expenses and no restructuring charges Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $7,896 | $11,398 | | General and administrative | $3,726 | $4,364 | | Restructuring and asset impairment charges | $0 | $2,542 | | **Total operating expenses** | **$11,622** | **$18,304** | | Loss from operations | ($11,622) | ($18,304) | | **Net loss** | **($10,976)** | **($17,107)** | | Net loss per common share | ($0.39) | ($0.61) | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$13.0 million** in Q1 2025, with cash and cash equivalents decreasing to **$21.8 million** by quarter-end Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($12,994) | ($12,606) | | Net cash provided by investing activities | $7,094 | $17,881 | | Net cash provided by financing activities | $0 | $1 | | **Net (decrease) increase in cash** | **($5,900)** | **$5,276** | | Cash and cash equivalents – end of period | $21,827 | $18,358 | [Notes to Unaudited Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Notes detail the company's clinical-stage biopharmaceutical focus, liquidity, and the impact of the 2024 restructuring plan - The company is a **clinical-stage biopharmaceutical firm** focused on innovative cancer medicines, particularly antibody-drug conjugates[21](index=21&type=chunk) - As of March 31, 2025, the company had **$55.9 million** in cash, cash equivalents, and marketable securities, which it believes is sufficient to fund planned operations for at least the next twelve months[23](index=23&type=chunk) - In March 2024, the company implemented a restructuring plan to focus on its NC410 and LNCB74 programs, which included a **37% workforce reduction** and pausing internal manufacturing. This resulted in **$2.5 million** in restructuring and impairment charges in Q1 2024[58](index=58&type=chunk)[104](index=104&type=chunk) - The company has a **50-50 cost and profit-sharing collaboration agreement** with LigaChem Biosciences for the development of up to three antibody-drug conjugates, with LNCB74 being the first co-development product[53](index=53&type=chunk)[54](index=54&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses advancing the LNCB74 trial, attributing reduced net loss to lower R&D and restructuring, with cash sufficient into H2 2026 - The company is focused on advancing **LNCB74**, a B7-H4 targeted ADC, with the **Phase 1 clinical trial** currently in cohort 3 of dose escalation[82](index=82&type=chunk)[83](index=83&type=chunk) - The company plans to initiate backfill cohorts for the LNCB74 trial in the second half of 2025 and provide a **proof of concept data readout in the first half of 2026**[83](index=83&type=chunk) - Existing cash, cash equivalents, and marketable securities of **$55.9 million** as of March 31, 2025, are expected to fund operations **into the second half of 2026**[85](index=85&type=chunk)[88](index=88&type=chunk)[108](index=108&type=chunk) - The company is **seeking partners** for its other clinical programs, NC410 and NC525, and **third-party financing** for its preclinical non-oncology programs[84](index=84&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Operating expenses significantly decreased to **$11.6 million** in Q1 2025, driven by reduced R&D costs and the absence of restructuring charges Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $7,896 | $11,398 | ($3,502) | | General and administrative | $3,726 | $4,364 | ($638) | | Restructuring and asset impairment charges | $0 | $2,542 | ($2,542) | | **Loss from operations** | **($11,622)** | **($18,304)** | **($6,682)** | - R&D expenses decreased by **$3.5 million**, mainly due to lower costs on programs other than LNCB74, particularly the reduction in spending on NC410 after patient enrollment was stopped[102](index=102&type=chunk) - G&A expenses decreased by **$0.6 million**, driven by **$0.4 million** in lower personnel-related costs from the 2024 restructuring and reduced insurance costs[103](index=103&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds **$55.9 million** in cash, sufficient into H2 2026, but requires substantial additional capital for future development - The company has an active **"at the market" (ATM) sales agreement** to sell up to **$75 million** of common stock, but no shares were sold during the three months ended March 31, 2025[107](index=107&type=chunk) Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($12,994) | ($12,606) | | Net cash provided by investing activities | $7,094 | $17,881 | | Net cash provided by financing activities | $0 | $1 | - Net cash used in operating activities in Q1 2025 was **$13.0 million**, primarily due to the **$11.0 million** net loss and changes in operating assets and liabilities[113](index=113&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a **"smaller reporting company,"** the company is exempt from providing 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[124](index=124&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2025, with no material changes to internal control over financial reporting - The CEO and CFO concluded that as of March 31, 2025, the company's disclosure controls and procedures were **effective at the reasonable assurance level**[127](index=127&type=chunk) - **No changes occurred** during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[128](index=128&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business or financials - The company is **not currently party to any material legal proceedings**[75](index=75&type=chunk)[129](index=129&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.Risk%20Factors) **No material updates** to the risk factors previously disclosed in the company's 2024 Annual Report on Form 10-K - There have been **no material updates** to the risk factors disclosed in the 2024 Annual Report[130](index=130&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports **no unregistered sales of equity securities** or use of proceeds during the period - The company reports **no unregistered sales of equity securities** during the period[131](index=131&type=chunk) [Other Information](index=37&type=section&id=Item%205.%20Other%20Information) **No directors or executive officers adopted or terminated** Rule 10b5-1 trading plans or other arrangements during Q1 2025 - **No directors or executive officers adopted or terminated** a Rule 10b5-1 trading plan or other trading arrangement during the quarter[134](index=134&type=chunk)

[NextCure First Quarter 2025 Business Update and Financial Results](index=1&type=section&id=NextCure%20First%20Quarter%202025%20Business%20Update%20and%20Financial%20Results) [Business Highlights and Near-Term Milestones](index=1&type=section&id=Business%20Highlights%20and%20Near-Term%20Milestones) The company is advancing its LNCB74 program and has cash reserves of $55.9 million to fund operations into H2 2026 - Cash, cash equivalents, and marketable securities of approximately **$55.9 million** are expected to fund operations into the **second half of 2026**[5](index=5&type=chunk)[9](index=9&type=chunk) [LNCB74 (B7-H4 ADC) Program Update](index=1&type=section&id=LNCB74%20(B7-H4%20ADC)) The LNCB74 Phase 1 trial is progressing with key data readouts and cohort initiations planned for 2025 and 2026 - The Phase 1 trial is currently dosing **cohort 3**, having cleared cohort 2 in April 2025[3](index=3&type=chunk)[6](index=6&type=chunk) - The company has expanded its clinical footprint to **10 active trial sites**, with an additional 3 projected to be onboard in May 2025[3](index=3&type=chunk)[6](index=6&type=chunk) - The company plans to initiate **backfill cohorts in the second half of 2025**[5](index=5&type=chunk)[6](index=6&type=chunk) - A **proof of concept data readout** is planned for the **first half of 2026**[3](index=3&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) [Preclinical Non-Oncology Programs Seeking Partnering](index=2&type=section&id=Preclinical%20Non-Oncology%20Programs%20Seeking%20Partnering) The company seeks partners for two preclinical non-oncology programs, NC181 and NC605, which could be IND-ready in 12-18 months - The company is seeking partners or third-party financial support for two preclinical programs: **NC181 for Alzheimer's disease** and **NC605 for Osteogenesis Imperfecta (OI)**[7](index=7&type=chunk)[9](index=9&type=chunk) - Preclinical data for NC181 (ApoE4) demonstrated **amyloid clearance**, prevention of amyloid deposition, and reduced neuroinflammation[9](index=9&type=chunk) - Preclinical data for NC605 (Siglec-15) showed **reduced bone loss** and enhanced bone quality in mice with OI[9](index=9&type=chunk) - With financial support, both programs could lead to **Investigational New Drug (IND) filings within 12 to 18 months**[9](index=9&type=chunk) [Financial Results for Quarter Ended March 31, 2025](index=2&type=section&id=Financial%20Results%20for%20Quarter%20Ended%20March%2031%2C%202025) The company reported a reduced net loss of $11.0 million for Q1 2025, driven by lower operating expenses post-restructuring Selected Statement of Operations (Q1 2025 vs Q1 2024) | (in thousands, except per share data) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $7,896 | $11,398 | | General and administrative | $3,726 | $4,364 | | Restructuring and asset impairment | $0 | $2,542 | | **Loss from operations** | **$(11,622)** | **$(18,304)** | | **Net loss** | **$(10,976)** | **$(17,107)** | | **Net loss per common share** | **$(0.39)** | **$(0.61)** | Selected Balance Sheet Items | (in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and marketable securities | $55,860 | $68,621 | | Total assets | $67,137 | $80,860 | | Total stockholders' equity | $55,855 | $65,472 | - Cash, cash equivalents, and marketable securities were **$55.9 million** as of March 31, 2025, a decrease of $12.8 million from December 31, 2024, primarily due to cash used to fund operations[9](index=9&type=chunk) - The year-over-year decrease in R&D and G&A expenses was primarily due to lower costs related to programs other than LNCB74, reduced preclinical development costs, and lower personnel-related costs following a **restructuring in Q1 2024**[9](index=9&type=chunk)

Core Insights - NextCure, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer treatment, particularly for patients who do not respond to existing therapies [8] Business Highlights and Near-Term Milestones - The LNCB74 antibody-drug conjugate (ADC) program has completed cohort 2 in April 2025 and is progressing through the dose escalation phase of the Phase 1 study, with plans to initiate backfill cohorts in the second half of 2025 [2][6] - A proof of concept data readout for LNCB74 is expected in the first half of 2026 [2][6] - The company has expanded its clinical trial footprint to include 10 active investigator sites, with an additional 3 sites projected to be onboard in May 2025 [2][6] Financial Results for Quarter Ended March 31, 2025 - Cash, cash equivalents, and marketable securities as of March 31, 2025, were approximately $55.9 million, down from $68.6 million as of December 31, 2024, primarily due to operational funding [6][13] - Research and development expenses decreased to $7.9 million for the three months ended March 31, 2025, compared to $11.4 million for the same period in 2024, reflecting lower costs related to non-LNCB74 programs and personnel-related costs due to restructuring [7][12] - General and administrative expenses were $3.7 million for the three months ended March 31, 2025, down from $4.4 million in the same period in 2024, attributed to lower personnel and insurance costs [7][12] - The net loss for the quarter was $11.0 million, an improvement from a net loss of $17.1 million for the same period in 2024 [7][12] Selected Financial Information - Loss from operations for the three months ended March 31, 2025, was $11.6 million, compared to $18.3 million for the same period in 2024 [12] - Total assets as of March 31, 2025, were $67.1 million, down from $80.9 million as of December 31, 2024 [13]

Core Insights - NextCure, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer patients who do not respond to existing treatments [3] - The company will present at the 24th Annual Needham Virtual Healthcare Conference on April 10, 2025, at 8:45 am ET [1] Company Overview - NextCure specializes in creating first-in-class and best-in-class therapies using differentiated mechanisms of action, including antibody-drug conjugates [3] - The company aims to advance treatments by leveraging its expertise in biological pathways, biomarkers, and cell interactions within the tumor microenvironment [3] Event Details - A live audio webcast of the conference presentation will be available on the company's website, with a replay accessible for 30 days post-event [2]

Financial Position - The company reported significant losses and has never generated revenue from product sales, indicating a challenging financial position [23] - The company anticipates requiring substantial additional financing to pursue its business objectives, which may not be available on acceptable terms [23] - The company has a history of significant losses and has never generated revenue from product sales, indicating a need for substantial additional financing to pursue business objectives [23] - The company has limited operating history and may never achieve or maintain profitability, which poses a risk to investors [23] Regulatory Risks - The regulatory approval processes for product candidates are lengthy and inherently unpredictable, posing risks to commercialization [23] - The company is studying product candidates in combination with other therapies, exposing it to additional regulatory risks [23] - Clinical development involves a lengthy and expensive process with uncertain outcomes, and the company has limited experience in designing and implementing clinical trials [23] Compliance and Listing Standards - The company is currently not in compliance with the continued listing standards of the Nasdaq Global Select Market, risking delisting [30] - The company is currently not in compliance with the continued listing standards of the Nasdaq Global Select Market, which could lead to delisting if compliance is not regained [30] Competitive Position - The company has filed patent applications but has obtained only a small number of patents, which may affect its competitive position [30] - The company faces significant competition from other biotechnology and pharmaceutical companies, which may impact its market position [30] - The company has filed patent applications for its product candidates but has obtained only a small number of patents to date, which may affect its ability to compete [30] Operational Challenges - The company relies on third-party suppliers for key materials, and any disruption could harm its business operations [25] - The company relies on third-party suppliers for key materials in its manufacturing process, and any loss of these suppliers could harm its business [25] - The company may encounter difficulties in enrolling patients for clinical trials due to external factors, affecting its development timelines [23] - The company may face difficulties in enrolling patients in clinical trials due to external factors such as pandemics [23] - The company is dependent on its ability to advance product candidates through preclinical studies and clinical trials, which is uncertain [23]

Financial Performance - Full year 2024 net loss was $55.7 million, a decrease from a net loss of $62.7 million in 2023, representing a reduction of approximately 11%[10] - Loss from operations for 2024 was $59.7 million, compared to $67.6 million in 2023, indicating an improvement of approximately 11%[13] - General and administrative expenses decreased to $15.7 million in 2024 from $19.7 million in 2023, a reduction of about 20%[10] - Research and development expenses for 2024 were $41.5 million, down from $47.9 million in 2023, reflecting a decrease of about 13%[10] Cash and Assets - Cash, cash equivalents, and marketable securities as of December 31, 2024, were $68.6 million, down from $108.3 million as of December 31, 2023, a decrease of approximately 36.7%[10] - Total assets as of December 31, 2024, were $80.9 million, down from $128.0 million as of December 31, 2023[15] Clinical Development - The company completed cohort 1 of the Phase 1 trial of LNCB74 (B7-H4 ADC) in February 2025 and plans to initiate backfill cohorts in the second half of 2025[6] - The U.S. FDA accepted an Investigational New Drug (IND) application for LNCB74 in December 2024, with the first patient dosed in January 2025[7] Future Plans - The company aims to secure financial support for preclinical programs NC181 and NC605, potentially leading to IND filings within 12 to 18 months[10] - The company expects current financial resources to fund operations into the second half of 2026[6]

Core Insights - NextCure, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer treatment, reporting a business update and full-year financial results for 2024 [1][6]. Business Highlights and Near-Term Milestones - The company has reprioritized resources to advance its antibody-drug conjugate (ADC) program, specifically LNCB74, and completed cohort 1 of the Phase 1 study for multiple cancers [2][3]. - Plans to initiate backfill cohorts for LNCB74 in the second half of 2025 [2][8]. - Preclinical data for LNCB74 was presented at the Society of Immunotherapy of Cancer annual meeting in November 2024, showcasing its potential for multiple solid tumor indications [8]. Financial Results for Full Year Ended December 31, 2024 - Cash, cash equivalents, and marketable securities decreased to approximately $68.6 million from $108.3 million in 2023, primarily due to operational funding [7][13]. - Research and development expenses were $41.5 million, down from $47.9 million in 2023, while general and administrative expenses decreased to $15.7 million from $19.7 million [8][11]. - The net loss for 2024 was $55.7 million, an improvement from a net loss of $62.7 million in 2023, with a net loss per share of $1.99 compared to $2.25 in the previous year [11][12].

Core Insights - NextCure, Inc. has initiated the first patient dosing in its Phase 1 study of LNCB74, a B7-H4-targeting antibody-drug conjugate aimed at treating multiple cancers [1][2] - The company views this milestone as significant for advancing its B7-H4 ADC program and aims to establish the safety, tolerability, and preliminary anti-tumor activity of LNCB74 [2] - The U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug application for LNCB74 in December 2024, facilitating the commencement of this clinical trial [2] Company Overview - NextCure is a clinical-stage biopharmaceutical company focused on developing innovative cancer therapies for patients who do not respond to existing treatments [3] - The company employs differentiated mechanisms of action, including antibody-drug conjugates, antibodies, and proteins, to advance its therapeutic offerings [3] - NextCure collaborates with LigaChem Biosciences, Inc. for the development of LNCB74 under a co-development agreement [3]

Core Insights - NextCure, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer patients who do not respond to existing treatments or experience disease progression [3] Company Participation - NextCure will participate in a fireside chat at the 36th Annual Piper Sandler Healthcare Conference in New York City on December 5 at 12:00 pm ET [1] Webcast Information - A live audio webcast of the event will be available on the company's website, with a replay accessible for 30 days post-event [2] Company Overview - NextCure specializes in advancing therapies using differentiated mechanisms, including antibody-drug conjugates, antibodies, and proteins, targeting biological pathways and biomarkers relevant to cancer treatment [3]