Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38905 NextCure, Inc. (Exact name of registrant as specified in its charter) | Title of each class | Trading ...

Exhibit 99.1 NextCure Provides Business Update and Reports Second Quarter 2025 Financial Results BELTSVILLE, Md. – August 7, 2025 – NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today provided a business update and reported second quarter 2025 financial results. "Our recent strategic acquisition of the global rights, excluding greater China, for SIM0505 targeting CDH6 (cadh ...

Announced strategic partnership with Simcere Zaiming for Phase 1 program SIM0505 (CDH6 ADC) with plans to dose the first SIM0505 patient in the United States this quarter Currently in cohort 4 of the Phase 1 trial of LNCB74 (B7-H4 ADC) in multiple cancersPlan to provide SIM0505 and LNCB74 program updates by the fourth quarter of 2025, along with proof of concept data readouts in the first half of 2026 BELTSVILLE, Md., Aug. 07, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharm ...

BELTSVILLE, Md., July 24, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, today announced the presentation of new preclinical data in a well-established model of osteogenesis imperfecta (OI) demonstrating that treatment with NC605, a novel anti-Siglec-15 antibody, achieved improved bone microarchitecture and reduced fracture incidence compared to anti- ...

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)

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]