Core Insights - NextCure reported significant advancements in its research and development activities, particularly with the licensing deal for SIM0505 and progress in clinical trials for LNCB74, despite a substantial miss in profitability for Q2 2025 [1][5][11] Financial Performance - GAAP net loss per share was $(11.29), significantly higher than the analyst expectation of $(4.62), marking a 70.8% increase year-over-year from $(6.61) [2][7] - GAAP net loss totaled $26.8 million, up from $15.4 million a year earlier, primarily due to a one-time $17.0 million license fee [1][7] - Research and development expenses reached $24.1 million, a 94.4% increase compared to $12.4 million in Q2 2024 [2][7] - General and administrative expenses decreased to $3.2 million from $4.1 million year-over-year, a reduction of 22.0% [2][7] - Cash, cash equivalents, and marketable securities stood at $35.3 million as of June 30, 2025, down 48.5% from $68.6 million at the end of 2024 [2][11] Product Pipeline and Development - LNCB74, the lead program, is a B7-H4 antibody-drug conjugate currently in early-stage clinical trials, with proof-of-concept results expected in the first half of 2026 [3][10] - SIM0505, another ADC targeting cadherin-6, has entered early-stage clinical testing in the U.S., with plans to treat the first patient in the next quarter [4][6] - The company is also developing other oncology candidates, including NC410 and NC525, as well as preclinical assets for Alzheimer's and bone diseases [9][10] Strategic Initiatives - NextCure's strategy focuses on advancing its pipeline through clinical development and forming targeted partnerships, including acquiring global rights to SIM0505 [4][6] - The company aims to align resources with high-impact programs and is seeking collaboration partners for its clinical candidates [4][10] Future Outlook - Management indicated that the available financial resources should sustain operations into mid-2026, with no new formal financial guidance provided for future quarters [11][12] - Investors are expected to monitor clinical enrollment pace, data release timing, and partnership developments to extend NextCure's cash runway [12]

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company's Q2 2025 financial statements reveal a significant net loss, reduced liquidity, and substantial doubt about its ability to continue as a going concern Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $4,892 | $27,727 | | Marketable securities | $30,416 | $40,894 | | **Total current assets** | **$40,015** | **$71,807** | | Total assets | $47,689 | $80,860 | | Total liabilities | $16,043 | $15,388 | | **Total stockholders' equity** | **$29,646** | **$65,472** | Condensed Statements of Operations Highlights (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $24,091 | $12,418 | $31,987 | $23,816 | | General and administrative | $3,201 | $4,076 | $6,927 | $8,440 | | **Loss from operations** | **($27,292)** | **($16,494)** | **($38,914)** | **($34,798)** | | **Net loss** | **($26,808)** | **($15,404)** | **($37,784)** | **($32,511)** | | Net loss per share | ($11.29) | ($6.61) | ($16.05) | ($13.96) | Condensed Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($35,707) | ($22,382) | | Net cash provided by investing activities | $10,853 | $30,041 | | Net cash provided by financing activities | $2,019 | $107 | | **Net (decrease) increase in cash** | **($22,835)** | **$7,766** | - The company has concluded there is **substantial doubt** about its ability to continue as a going concern within one year, given its history of net losses, negative cash flows, and an accumulated deficit of **$417.9 million** as of June 30, 2025[23](index=23&type=chunk) - On July 14, 2025, the company effectuated a **1-for-12 reverse stock split** to regain compliance with Nasdaq's minimum bid price requirement[16](index=16&type=chunk)[81](index=81&type=chunk)[83](index=83&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strategic pipeline advancements, notably the SIM0505 license, which significantly increased R&D expenses, further weakening the company's financial position and raising going concern doubts - The company is focused on advancing its ADC product candidates, **LNCB74** and **SIM0505**; **Phase 1 dose escalation** for LNCB74 is in cohort 4 with an update expected by **Q4 2025**, while the first patient for SIM0505 is expected to be dosed in **Q3 2025**[91](index=91&type=chunk)[95](index=95&type=chunk) - In June 2025, the company entered into a **license agreement with Zaiming** to develop **SIM0505**, involving an **upfront payment of $12 million** and an **additional $5 million** due by year-end 2025, both expensed as R&D in Q2 2025[53](index=53&type=chunk)[55](index=55&type=chunk)[56](index=56&type=chunk) Comparison of Operating Expenses (in thousands) | Expense Category | Q2 2025 | Q2 2024 | Change | Six Months 2025 | Six Months 2024 | Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Research and development | $24,091 | $12,418 | $11,673 | $31,987 | $23,816 | $8,171 | | General and administrative | $3,201 | $4,076 | ($875) | $6,927 | $8,440 | ($1,513) | - The **increase in R&D expenses** for the three and six months ended June 30, 2025, was primarily due to **$17.0 million in fees for the Zaiming license agreement**, partially offset by lower costs on other deprioritized programs[114](index=114&type=chunk)[115](index=115&type=chunk) - With **$35.3 million** in cash, cash equivalents, and marketable securities as of June 30, 2025, the company believes it can **fund operations into mid-2026** but has concluded there is **substantial doubt about its ability to continue as a going concern**[99](index=99&type=chunk)[123](index=123&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a "smaller reporting company," NextCure, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is **exempt** from providing information on market risk as it qualifies as a "**smaller reporting company**" under SEC rules[141](index=141&type=chunk) [Item 4. Controls and Procedures](index=45&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, 2025, and concluded they were effective at a reasonable assurance level - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective** as of the end of the quarter[142](index=142&type=chunk) - **No changes** occurred during the quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[143](index=143&type=chunk)[144](index=144&type=chunk) [Part II. OTHER INFORMATION](index=47&type=section&id=Part%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material litigation or legal proceedings and is not aware of any pending or threatened litigation that would materially affect its business or financial results - The company reports **no material legal proceedings** that are likely to have a significant impact on its business[79](index=79&type=chunk)[145](index=145&type=chunk) [Item 1A. Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) A primary risk factor is the substantial doubt about the company's ability to continue as a going concern, potentially hindering future financing and operations - A key risk factor is the **substantial doubt about the company's ability to continue as a going concern**, which could negatively impact its ability to raise additional capital[146](index=146&type=chunk)[147](index=147&type=chunk) - The company's cash and marketable securities of **$35.3 million** are expected to **fund operations into mid-2026**, but **failure to secure additional financing** could force it to delay, reduce, or terminate product development[146](index=146&type=chunk)[147](index=147&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=47&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no sales of unregistered equity securities during the period that were not previously disclosed in a Form 8-K - There were **no unregistered sales of equity securities** during the quarter that have not been previously reported[149](index=149&type=chunk) [Item 3. Defaults Upon Senior Securities](index=47&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[150](index=150&type=chunk) [Item 4. Mine Safety Disclosures](index=49&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[151](index=151&type=chunk) [Item 5. Other Information](index=49&type=section&id=Item%205.%20Other%20Information) During the quarter, no directors or executive officers adopted or terminated any Rule 10b5-1 trading plans or any non-Rule 10b5-1 trading arrangements - **No directors or executive officers adopted or terminated any Rule 10b5-1 trading plans** during the fiscal quarter[152](index=152&type=chunk) [Item 6. Exhibits](index=50&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report, including amendments to the Certificate of Incorporation, the License Agreement with Hainan Simcere, the Subscription Agreement, and officer certifications - Exhibits filed include the **License Agreement with Hainan Simcere Zaiming Pharmaceutical Co., Ltd.** and the associated **Subscription and Registration Rights Agreements**[155](index=155&type=chunk)

[Business Highlights and Near-Term Milestones](index=1&type=section&id=Business%20Highlights%20and%20Near-Term%20Milestones) NextCure advanced its ADC pipeline, acquiring SIM0505 global rights and progressing two ADCs in Phase 1 trials, with key data expected in H1 2026 - NextCure is developing ADCs against two clinically validated targets: **SIM0505** (CDH6 target, Topoisomerase 1 Inhibitor payload) and **LNCB74** (B7-H4 target, Tubulin Inhibitor payload)[3](index=3&type=chunk) - Program updates for **SIM0505** and **LNCB74** are planned by **Q4 2025**, with proof-of-concept data expected in **H1 2026**[3](index=3&type=chunk)[6](index=6&type=chunk) [LNCB74 (B7-H4 ADC)](index=1&type=section&id=LNCB74%20(B7-H4%20ADC)) The Phase 1 trial for LNCB74 is progressing, with patients in cohort 4 and plans for backfill cohorts in H2 2025 - The Phase 1 trial for **LNCB74** in multiple cancers is treating patients in **cohort 4**, having cleared **cohort 3** in **June 2025**[6](index=6&type=chunk)[7](index=7&type=chunk) - NextCure plans to initiate backfill cohorts in **H2 2025** for further drug evaluation[7](index=7&type=chunk) [SIM0505 (CDH6 ADC)](index=1&type=section&id=SIM0505%20(CDH6%20ADC)) NextCure acquired global rights for SIM0505, with first US patient expected in Q3 2025 and early clinical activity observed - Global rights (excluding greater China) for **SIM0505** were acquired from Simcere Zaiming[3](index=3&type=chunk)[7](index=7&type=chunk) - The **IND** application transferred to NextCure in **June 2025**, with the first US patient expected in **Q3 2025**[7](index=7&type=chunk) - Initial Phase 1 data in China showed early clinical activity, with a **partial response** in **cohort 1** as of **April 16, 2025**[7](index=7&type=chunk) [Assets For Which We Are Seeking Partners](index=3&type=section&id=Assets%20For%20Which%20We%20Are%20Seeking%20Partners) NextCure seeks partners for clinical programs NC410 and NC525, and preclinical assets for Alzheimer's and OI - NextCure is seeking partners for clinical programs **NC410** (LAIR-2 fusion) and **NC525** (LAIR-1 antibody)[11](index=11&type=chunk) - Partners are also sought for preclinical assets **NC181** (Alzheimer's disease) and **NC605** (Osteogenesis Imperfecta)[11](index=11&type=chunk) [Other Business Updates](index=3&type=section&id=Other%20Business%20Updates) NextCure received a $2.0 million equity investment from Simcere Zaiming and regained Nasdaq compliance - Received a **$2.0 million** equity investment from a Simcere Zaiming US affiliate in **June 2025**[11](index=11&type=chunk) - Regained compliance with the Nasdaq minimum bid price requirement for continued listing[11](index=11&type=chunk) [Financial Results for Quarter Ended June 30, 2025](index=3&type=section&id=Financial%20Results%20for%20Quarter%20Ended%20June%2030%2C%202025) NextCure reported a **$26.8 million net loss** in Q2 2025, primarily due to a **$17.0 million SIM0505 license fee**, with **$35.3 million cash** expected to fund operations into mid-2026 Financial Highlights | Financial Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Cash, Cash Equivalents, and Marketable Securities | $35.3M (as of Jun 30) | $68.6M (as of Dec 31, 2024) | -$33.3M | | Research & Development Expenses | $24.1M | $12.4M | +$11.7M | | General & Administrative Expenses | $3.2M | $4.1M | -$0.9M | | Net Loss | $26.8M | $15.4M | +$11.4M | | Net Loss Per Share (USD) | $11.29 | $6.61 | +$4.68 | - The increase in R&D expenses was primarily due to a **$17.0 million** upfront license fee for the **SIM0505** agreement[11](index=11&type=chunk) - Current cash, cash equivalents, and marketable securities of **$35.3 million** are projected to fund operations into **mid-2026**[11](index=11&type=chunk) [Selected Statement of Operations](index=5&type=section&id=Selected%20Statement%20of%20Operations%20Items) NextCure's Q2 2025 statement of operations shows increased R&D expenses and net loss compared to Q2 2024 Statement of Operations (in thousands, except per share amounts) | | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $24,091 | $12,418 | $31,987 | $23,816 | | General and administrative | $3,201 | $4,076 | $6,927 | $8,440 | | Loss from operations | $(27,292) | $(16,494) | $(38,914) | $(34,798) | | Net loss | $(26,808) | $(15,404) | $(37,784) | $(32,511) | | Net loss per common share | $(11.29) | $(6.61) | $(16.05) | $(13.96) | [Selected Balance Sheet Items](index=5&type=section&id=Selected%20Balance%20Sheet%20Items) The balance sheet reflects decreased cash, total assets, and stockholders' equity from December 2024 to June 2025 Balance Sheet Items (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and marketable securities | $35,308 | $68,621 | | Total assets | $47,689 | $80,860 | | Total stockholders' equity | $29,646 | $65,472 | [About NextCure, Inc.](index=4&type=section&id=About%20NextCure%2C%20Inc.) NextCure is a clinical-stage biopharmaceutical company developing innovative targeted therapies for cancer patients - The company primarily focuses on advancing innovative medicines for cancer patients unresponsive to or progressing on current therapies[12](index=12&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section outlines forward-looking statements, cautioning on inherent business risks and uncertainties - Key risks include unpredictable clinical trial results, limited operating history, significant losses, need for additional financing, and dependence on key personnel[14](index=14&type=chunk)

Core Insights - NextCure, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer treatment, reporting a business update and second quarter 2025 financial results [1][8] Business Highlights and Near-Term Milestones - The strategic acquisition of global rights for SIM0505, targeting CDH6, positions NextCure uniquely in the antibody-drug conjugate (ADC) field, with plans to dose the first patient in the U.S. this quarter [2][6] - NextCure is currently in cohort 4 of the Phase 1 trial for LNCB74 (B7-H4 ADC) and plans to provide updates on both SIM0505 and LNCB74 by Q4 2025, along with proof of concept data in the first half of 2026 [6][7] Financial Results - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled $35.3 million, down from $68.6 million as of December 31, 2024, primarily due to operational funding [5][15] - Research and development expenses for Q2 2025 were $24.1 million, an increase from $12.4 million in Q2 2024, largely due to $17.0 million in up-front license fees [13] - The net loss for Q2 2025 was $26.8 million, compared to a net loss of $15.4 million in Q2 2024, reflecting the impact of the license fee [13][14]

Core Insights - NextCure, Inc. presented new preclinical data showing that NC605, an anti-Siglec-15 antibody, improves bone microarchitecture and reduces fracture incidence in a model of osteogenesis imperfecta (OI) compared to anti-sclerostin treatment [1][4] - OI is characterized by high bone turnover and fragility, with no current cure available; existing treatments increase bone density but compromise bone quality [2] - The study demonstrated that NP159, a surrogate for NC605, significantly enhanced bone mineral density and reduced fracture rates in OI mice [3] Company Overview - NextCure is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer patients who do not respond to existing treatments, utilizing differentiated mechanisms such as antibody-drug conjugates [6] - The company is seeking financial support to advance NC605 towards an Investigational New Drug submission within the next 12 to 18 months [5]

Core Insights - The article discusses a licensing agreement between Sihuan Pharmaceutical (先声药业) and NextCure, Inc. for the innovative antibody-drug conjugate SIM0505, marking the first international recognition of Sihuan's ADC technology platform [1][2] - The agreement allows NextCure to develop SIM0505 outside Greater China, while Sihuan retains rights for a new ADC product targeting CDH6 in Greater China, indicating a strategic expansion in oncology [1][2] - Sihuan is expected to receive up to $745 million in total payments, including upfront and milestone payments, along with tiered royalties based on net sales outside Greater China [1] Company Developments - Sihuan has established a global innovation research network with centers in Boston, Shanghai, Nanjing, and Beijing, collaborating with top research institutions like Harvard Medical School [2] - The company has made significant investments in R&D, exceeding 8 billion yuan over the past five years, focusing on core technology platforms such as ADC and AI drug discovery [3] - Sihuan's innovative drug for stroke, Xianbixin injection, has been launched in China, and its sublingual tablet is undergoing clinical research in the U.S. with breakthrough therapy designation from the FDA [3] Market Position - CDH6 is identified as a promising new target for anti-tumor drugs, with no existing drugs targeting it globally, highlighting the competitive advantage of Sihuan's ADC technology [2] - The recent licensing agreement with NextCure is the second overseas licensing deal for Sihuan in 2023, following a collaboration with AbbVie for another antibody targeting GPRC5D/BCMA/CD3, which has a potential transaction value of $1.055 billion [2]

Core Viewpoint - NextCure, Inc. and Simcere Zaiming have formed a strategic partnership to develop SIM0505, a novel antibody-drug conjugate targeting CDH6 for solid tumors, with clinical testing expected to begin in the U.S. in Q3 2025 [1][3]. Group 1: Partnership Details - The partnership allows NextCure to access Simcere Zaiming's proprietary linker and TOPOi payload for a preclinical-stage ADC developed by NextCure, while Simcere Zaiming retains Greater China rights to this ADC [4][7]. - Simcere Zaiming is eligible for payments up to $745 million throughout the development phases, including upfront payments and tiered royalties on net sales outside Greater China [5][7]. Group 2: Product Development - SIM0505 is currently undergoing Phase 1 dose escalation studies in China, with a global dose expansion study planned to include multiple tumor types [3][7]. - Preclinical studies of SIM0505 have shown robust anti-tumor activity and a promising safety profile [2][5]. Group 3: Company Background - NextCure is focused on developing innovative therapies for cancer patients who do not respond to existing treatments, utilizing differentiated mechanisms such as antibody-drug conjugates [6]. - Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group, aims to develop groundbreaking therapies for cancer patients globally, leveraging its R&D and commercialization capabilities [8].

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)