Core Insights - NextCure, Inc. reports promising preclinical data for LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC), and plans to file an Investigational New Drug (IND) application by year-end [1][2] - The company also presents biomarker data from the NC410 combination study with pembrolizumab for colorectal cancer patients [1] Preclinical Data on LNCB74 - LNCB74 is designed with a drug-to-antibody ratio of 4 (DAR4) and utilizes LigaChem Biosciences' ConjuAllTM technology for improved stability and selective payload release in tumor cells [2] - The ADC shows specific binding to B7-H4 expressing tumor cells, mediates potent cytotoxicity with sub-nanomolar to low nanomolar EC50 values, and demonstrates strong anti-tumor activity in various tumor models [3] - A single dose of 3 mg/kg resulted in durable tumor regression, indicating comparable or superior activity to existing B7-H4 targeting ADCs [3] - LNCB74 has favorable pharmacokinetics and stability in rodents and was well tolerated in cynomolgus monkeys at doses up to 10 mg/kg [3] Phase 1b Study of NC410 - The Phase 1b study evaluates NC410, a LAIR-2 fusion protein, in combination with pembrolizumab for ovarian cancer and ICI-naïve MSS/MSI-L colorectal cancer [4] - The combination shows clinical activity against MSS/MSI-L CRC, with subjects achieving partial responses or stable disease demonstrating meaningful durability [4] - Among 43 evaluable ICI-naïve MSS/MSI-L CRC patients, there were 3 partial responses, with disease control rates of 86% and 47% for 200 mg and 100 mg NC410 doses, respectively [5] Biomarker Data for NC410 - Biomarker data supports the proposed mechanism of action for NC410, indicating tumor microenvironment remodeling and enhanced immune infiltration [6] - Treatment with NC410 was well tolerated [6] Presentation Details - NextCure will present findings on LNCB74 and NC410 at the Society for Immunotherapy of Cancer (SITC) annual meeting on November 8 and 9, 2024 [7] Company Overview - NextCure is a clinical-stage biopharmaceutical company focused on developing innovative cancer therapies that target patients unresponsive to current treatments, utilizing differentiated mechanisms including ADCs and proteins [8]

BELTSVILLE, Md., Oct. 04, 2024 (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 two presentations at the Society for Immunotherapy of Cancer (SITC) annual meeting, to be held in Houston, TX from November 6-10, 2024. NextCure will share pre-clinical data from LNCB74 (B7-H4 ADC) and biomarker data from NC410 combination study with pembrolizumab ...

Of the 20 evaluable ovarian cancer patients, there were 5 PRs Of the 43 evaluable ICI-naïve MSS/MSI-L CRC patients without liver metastasis, there were 3 PRs Biomarker data support proposed mechanism of action of NC410 BELTSVILLE, Md., Sept. 16, 2024 (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 that clinical data from the Phase 1b portion ...

About NextCure, Inc. Investor Inquiries Timothy Mayer, Ph.D. NextCure, Inc. Chief Operating Officer (240) 762-6486 IR@nextcure.com A recording of the webcast will be available on the conference day starting at 7 AM ET through the Investors section of the company's website at www.nextcure.com. The webcast will be available on the website for 30 days. Cautionary Statement Regarding Forward-Looking Statements BELTSVILLE, Md., June 20, 2024 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage bio ...

A recording of the webcast will be available on the conference day starting at 7 AM ET through the Investors section of the company's website at www.nextcure.com. The webcast will be available on the website for 30 days. NextCure, Inc. is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies in cancer, including NC410, a LAIR-2 fusion protein, and LNCB74, a novel ADC targeting B7-H4. The Company also has a non-oncology preclinica ...

Of the evaluable ICI-naïve MSS/MSI-L CRC patients without liver metastasis, there were 2 confirmed ongoing PRs and a disease control rate of 51% Of the 7 evaluable ovarian cancer patients, there were 3 PRs and a disease control rate of 43% Data to be presented June 1, 2024, 9:00 am-12:00 pm CT BELTSVILLE, Md., May 30, 2024 (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 ...

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 March 31, 2024 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) Delaware 47-5231247 (State or o ...

[Business Highlights and Near-Term Milestones](index=1&type=section&id=Business%20Highlights%20and%20Near-Term%20Milestones) NextCure updated on NC410 and LNCB74 clinical programs, with NC410 Phase 1b data at ASCO and LNCB74 IND submission planned by year-end, supported by **$96.0 million** cash into H2 2026 - The company's cash reserves of approximately **$96.0 million** are projected to fund operations into the second half of 2026[5](index=5&type=chunk) [NC410 (LAIR-2 fusion)](index=1&type=section&id=NC410%20%28LAIR-2%20fusion%29) - Clinical data from the Phase 1b study of NC410 in combination with pembrolizumab for colorectal (CRC) and ovarian cancer will be presented at the ASCO Annual Meeting on June 1, 2024[5](index=5&type=chunk)[6](index=6&type=chunk) - The ASCO presentation will include data from an additional **20 CRC patients** enrolled in the **100 mg cohort** in January 2024[6](index=6&type=chunk) - Enrollment of additional ovarian cancer patients began in March 2024, with data anticipated in the second half of 2024[6](index=6&type=chunk) [LNCB74 (B7-H4 ADC)](index=1&type=section&id=LNCB74%20%28B7-H4%20ADC%29) - An Investigational New Drug (IND) application for LNCB74 is planned for submission by the end of 2024[3](index=3&type=chunk)[6](index=6&type=chunk) - Preclinical data presented at the 2024 AACR Annual Meeting highlighted strong safety and pharmacokinetic profiles for LNCB74[6](index=6&type=chunk) - GLP toxicology studies have been initiated, and production of clinical material has commenced with collaborator LigaChem Biosciences[3](index=3&type=chunk)[6](index=6&type=chunk) [Financial Results for Quarter Ended March 31, 2024](index=2&type=section&id=Financial%20Results%20for%20Quarter%20Ended%20March%2031%2C%202024) NextCure reported a **net loss of $17.1 million** for Q1 2024, with cash at **$96.0 million**, stable R&D, reduced G&A, and **$2.5 million** in restructuring costs [Financial Performance Summary](index=2&type=section&id=Financial%20Performance%20Summary) Financial Performance Summary (in millions) | Financial Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | **Cash, Cash Equivalents, and Marketable Securities** | $96.0 | - | | **Research and Development Expenses** | $11.4 | $11.6 | | **General and Administrative Expenses** | $4.4 | $5.4 | | **Restructuring and Asset Impairment Costs** | $2.5 | $0 | | **Net Loss** | $17.1 | $16.1 | - The decrease in cash of **$12.3 million** from year-end 2023 was primarily due to cash used to fund operations[10](index=10&type=chunk) - The decrease in G&A expenses was primarily related to lower personnel-related costs and lower insurance costs[10](index=10&type=chunk) [Selected Financial Information](index=4&type=section&id=Selected%20Financial%20Information) Selected Statement of Operations Items (in thousands) | Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $11,398 | $11,647 | | General and administrative | $4,364 | $5,424 | | Restructuring and asset impairment | $2,542 | - | | **Loss from operations** | **($18,304)** | **($17,071)** | | Other income, net | $1,197 | $975 | | **Net loss** | **($17,107)** | **($16,096)** | | **Net loss per common share** | **($0.61)** | **($0.58)** | Selected Balance Sheet Items (in thousands) | Item | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents, and marketable securities | $96,001 | $108,299 | | Total assets | $115,159 | $128,038 | | Total stockholders' equity | $99,048 | $114,421 | [Corporate Information](index=2&type=section&id=Corporate%20Information) This section outlines NextCure's mission for cancer therapies and includes a safe harbor statement on forward-looking statements and risks [About NextCure, Inc.](index=2&type=section&id=About%20NextCure%2C%20Inc.) - NextCure is a clinical-stage biopharmaceutical company focused on advancing innovative medicines for cancer patients who do not respond to, or have disease progression on, current therapies[8](index=8&type=chunk) - The company utilizes differentiated mechanisms of action, including antibody-drug conjugates and antibodies, leveraging its expertise in biological pathways and the tumor microenvironment[8](index=8&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) - The press release contains forward-looking statements concerning the company's financial runway, clinical trial progress, development plans, and upcoming milestones[9](index=9&type=chunk) - Identified risks and uncertainties include the unpredictability of preclinical results in clinical trials, limited operating history, history of significant losses, and the need to obtain additional financing[11](index=11&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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) Delaware 47-5231247 (State or other ...

Mr. Richman continued, "We are excited to focus on NC410 combo, which is demonstrating clinical responses in ovarian and colorectal cancers. We are advancing LNCB74 in collaboration with LegoChem Biosciences, a differentiated ADC directed to B7-H4, a clinically validated cancer target. Given our current cash position and revised runway to the second half of 2026, we believe we can advance our two programs through important near-term clinical milestones." Business Highlights and Near-Term Milestones Prioriti ...