NextCure(NXTC)
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NextCure(NXTC) - 2025 Q3 - Quarterly Report
2025-11-05 21:25
Financial Performance - The company reported a net loss of $8.6 million for the three months ended September 30, 2025, compared to a net loss of $11.5 million for the same period in 2024, indicating a 25.2% improvement in quarterly losses [92]. - For the nine months ended September 30, 2025, the net loss was $46.4 million, slightly higher than the $44.1 million loss for the same period in 2024, reflecting a 5.2% increase in losses year-over-year [92]. - As of September 30, 2025, the company had an accumulated deficit of $426.5 million, primarily due to research and development and general administrative expenses [92]. - Net loss for the three months ended September 30, 2025 was $8.6 million, a decrease of $2.9 million from the net loss of $11.5 million in the same period in 2024 [106]. - General and administrative expenses for the nine months ended September 30, 2025 decreased by $2.4 million to $9.7 million compared to the same period in 2024 [112]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $42.0 million, compared to $33.8 million for the same period in 2024 [123]. - Total external research and development expenses for the nine months ended September 30, 2025 increased by $7.6 million to $27.6 million compared to the same period in 2024 [107]. - Net cash provided by investing activities for the nine months ended September 30, 2025 was $19.6 million, down from $48.3 million in the same period in 2024 [124]. - There were no restructuring and asset impairment charges for the three and nine months ended September 30, 2025, compared to $2.5 million in the same periods in 2024 [113]. Funding and Cash Position - The company raised approximately $425 million in gross proceeds from equity instruments since inception through September 30, 2025, with an additional $25 million received from a former collaboration partner [92]. - The company has cash, cash equivalents, and marketable securities totaling $29.1 million as of September 30, 2025, which is insufficient to fund planned operations for the next year [93][94]. - As of September 30, 2025, the company had cash and cash equivalents of $29.1 million, which may not be sufficient to fund operations for the next year [117]. - The company entered into a sales agreement to sell up to $75 million of common stock, but no shares were sold in the three months ended September 30, 2025 [116]. Research and Development - The company is advancing its product candidate SIM0505, which is currently in Phase 1 dose escalation studies in China for treating solid tumors, with proof of concept data expected in the first half of 2026 [87]. - The FDA accepted an IND application for the company's product candidate LNCB74 in December 2024, with the first patient dosed in January 2025 and proof of concept data also expected in the first half of 2026 [89]. - The company plans to incur substantial expenditures in the foreseeable future to advance SIM0505 and LNCB74 through clinical development and regulatory approval processes [95]. - Research and development expenses for the three months ended September 30, 2025 decreased by $2.6 million to $6.1 million compared to the same period in 2024 [106]. Operational Changes - The company has paused internal manufacturing operations and reduced its workforce as part of a restructuring effort to align with its focused pipeline [90]. - The company does not expect to generate product revenue until it obtains marketing approval for its product candidates, with significant doubt about its ability to continue as a going concern [94][96]. Accounting and Reporting - Recent accounting pronouncements may impact the company's financial position and results of operations [134]. - As a "smaller reporting company," the company is not required to provide certain market risk disclosures [135].
NextCure(NXTC) - 2025 Q3 - Quarterly Results
2025-11-05 21:16
Financial Performance - NextCure reported a net loss of $8.6 million for Q3 2025, a decrease from a net loss of $11.5 million in Q3 2024, reflecting lower research and development and general administrative costs[9]. - Research and development expenses were $6.1 million for Q3 2025, down from $8.8 million in Q3 2024, primarily due to reduced costs related to deprioritized programs[9]. - General and administrative expenses were $2.8 million for Q3 2025, down from $3.7 million in Q3 2024, mainly due to lower personnel costs[9]. Cash and Assets - Cash, cash equivalents, and marketable securities decreased to $29.1 million as of September 30, 2025, from $68.6 million as of December 31, 2024, a decline of $39.5 million[9]. - Total assets decreased to $39.6 million as of September 30, 2025, from $80.9 million as of December 31, 2024[14]. - Total stockholders' equity fell to $23.6 million as of September 30, 2025, compared to $65.5 million as of December 31, 2024[14]. Future Outlook - The company expects its current financial resources to be sufficient to fund operations into mid-2026[9]. - Proof of concept data readouts for SIM0505 and LNCB74 are expected in the first half of 2026[2]. Clinical Development - NextCure initiated U.S. enrollment in the Phase 1 trial for SIM0505 in October 2025, with plans to advance into higher-dose cohorts shortly[2]. - The FDA accepted a protocol amendment for LNCB74, allowing the addition of higher dose escalation cohorts[9].
NextCure Provides Business Update and Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-11-05 21:05
Core Insights - NextCure, Inc. is advancing its antibody-drug conjugate (ADC) programs, particularly SIM0505 and LNCB74, with significant progress in clinical trials and FDA approvals [2][3][4]. Business Highlights and Near-Term Milestones - The company has initiated U.S. enrollment in the Phase 1 trial for SIM0505, a CDH6-targeting ADC, at a mid-tier dose range where multiple clinical responses were previously observed in China [2][3]. - FDA clearance was received for a protocol amendment for LNCB74, allowing for higher dose escalation cohorts [2][4]. - Proof of concept data readouts for both SIM0505 and LNCB74 are expected in the first half of 2026 [2][4]. Financial Results for Quarter Ended September 30, 2025 - Cash, cash equivalents, and marketable securities decreased to $29.1 million from $68.6 million as of December 31, 2024, primarily due to operational funding and a $12.0 million upfront license fee to Simcere Zaiming [5][10]. - Research and development expenses were $6.1 million, down from $8.8 million in the same quarter of 2024, attributed to lower costs from deprioritized programs and reduced personnel-related costs [5][10]. - General and administrative expenses decreased to $2.8 million from $3.7 million year-over-year, mainly due to lower personnel costs [5][10]. - The net loss for the quarter was $8.6 million, an improvement from a net loss of $11.5 million in the same quarter of 2024 [5][10]. Selected Financial Information - Total assets as of September 30, 2025, were $39.6 million, down from $80.9 million as of December 31, 2024 [11]. - Total stockholders' equity decreased to $23.6 million from $65.5 million [11].
NextCure and Simcere Zaiming Announce Expansion of Ongoing Phase 1 Trial of SIM0505 (CDH6 ADC) into the United States
Globenewswire· 2025-10-16 12:05
Core Insights - NextCure, Inc. and Simcere Zaiming have initiated the dosing of the first patient in the U.S. for the Phase 1 trial of SIM0505, an antibody drug conjugate targeting advanced solid tumors [1][3] Company Overview - NextCure is a clinical-stage biopharmaceutical company focused on developing innovative cancer therapies, particularly for patients who do not respond to existing treatments [4] - Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group, is dedicated to creating groundbreaking therapies for cancer patients globally, with a strong R&D pipeline [5] Product Development - SIM0505 is designed as a novel antibody drug conjugate targeting cadherin-6 (CDH6) and includes a proprietary topoisomerase 1 inhibitor payload, aiming for broad anti-tumor activity and improved therapeutic potential [2] - The ongoing Phase 1 trial has expanded to include U.S. patients, with dose escalation currently progressing in China [2] Clinical Trial Progress - The first patient in the U.S. has been dosed at a mid-tier level where clinical responses have been observed, marking a significant milestone in the global development of SIM0505 [3][7] - The trial aims to accelerate the timeline for proof-of-concept data, expected in the first half of 2026 [7]
NextCure (NasdaqGS:NXTC) FY Conference Transcript
2025-09-08 21:02
Summary of NextCure Conference Call Company Overview - NextCure is a biotechnology company focused on oncology, particularly women's health and other tumor indications, with two key pipeline assets: B7H4 and CDH6 antibody-drug conjugates (ADCs) [1][2] Key Pipeline Assets - **B7H4 ADC**: - In collaboration with LigaChemBio, currently in phase one clinical development with initial proof-of-concept readouts expected in the first half of next year [1][2] - Targets overexpressed B7H4 in ovarian, endometrial, and breast cancers [3][4] - Utilizes a unique beta-glucuronidase linker system for greater specificity and reduced off-target toxicity [4][6] - **CDH6 ADC**: - Recently licensed from Simcere Zaiming, also in phase one clinical development with readouts expected in the first half of next year [2][14] - Targets CDH6, which is overexpressed in ovarian and endometrial cancers, providing potential synergies with the B7H4 program [14][15] Competitive Landscape - The B7H4 ADC space is competitive, with notable players including AstraZeneca and Pfizer [5][6] - AstraZeneca's recent positive data and Pfizer's discontinuation of their B7H4 ADC were discussed [5][6] - NextCure aims to differentiate through a high-affinity antibody, unique linker system, and distinct payloads [7][8] Clinical Development Strategy - The company employs immunohistochemistry to select patients with high B7H4 expression for clinical trials, aiming to maximize response rates [8][9] - Currently in the fourth dose cohort of the phase one trial, with no dose-limiting toxicities (DLTs) reported [10][11] - Plans to lock in a dose based on pharmacokinetic data and backfill patient populations for further trials [10][11] Expected Outcomes and Milestones - Aiming for a minimum overall response rate of 25% for the B7H4 ADC, with hopes for higher efficacy [12][13] - Initial phase one data updates expected before year-end, with more detailed data anticipated in the first half of 2026 [11][12] - Two significant catalysts are anticipated in the first half of next year, focusing on proof-of-concept outcomes for both ADCs [29] Collaboration and Licensing - The licensing agreement with Simcere Zaiming includes a $12 million upfront payment and shared clinical development responsibilities [17][19] - Simcere is also providing drugs free of charge for the U.S. phase one trial and has made a $2 million equity investment in NextCure [19] Future Directions - NextCure is exploring the potential for combination therapies and sequencing strategies for ADCs to combat tumor resistance [26][27] - The company has multiple prioritized targets for future development, leveraging its expertise in immuno-oncology [27][28] Conclusion - NextCure is positioned to advance its innovative ADC programs in a competitive oncology landscape, with a focus on safety and efficacy, while leveraging strategic partnerships for growth and development [29][30]
NextCure to Present at the H.C. Wainwright 27th Annual Global Investment Conference
Globenewswire· 2025-09-04 11:00
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 [3]. Company Participation - NextCure will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference in New York City on September 8 at 4:00 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 targeted therapies, including antibody-drug conjugates, and aims to advance treatments by leveraging its expertise in biological pathways and biomarkers [3].
NextCure (NXTC) Q2 Loss Widens 71%
The Motley Fool· 2025-08-08 03:32
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]
NextCure(NXTC) - 2025 Q2 - Quarterly Report
2025-08-07 20:27
[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)
NextCure(NXTC) - 2025 Q2 - Quarterly Results
2025-08-07 20:18
[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)
NextCure Provides Business Update and Reports Second Quarter 2025 Financial Results
Globenewswire· 2025-08-07 20:05
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]