NextCure(NXTC) - 2025 Q2 - Quarterly Results

Business Highlights and Near-Term Milestones 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] - Program updates for SIM0505 and LNCB74 are planned by Q4 2025, with proof-of-concept data expected in H1 2026[3][6] LNCB74 (B7-H4 ADC) 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][7] - NextCure plans to initiate backfill cohorts in H2 2025 for further drug evaluation[7] SIM0505 (CDH6 ADC) 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][7] - The IND application transferred to NextCure in June 2025, with the first US patient expected in Q3 2025[7] - Initial Phase 1 data in China showed early clinical activity, with a partial response in cohort 1 as of April 16, 2025[7] Assets For Which We Are Seeking Partners 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] - Partners are also sought for preclinical assets NC181 (Alzheimer's disease) and NC605 (Osteogenesis Imperfecta)[11] Other Business Updates 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] - Regained compliance with the Nasdaq minimum bid price requirement for continued listing[11] Financial Results for Quarter Ended June 30, 2025 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] - Current cash, cash equivalents, and marketable securities of $35.3 million are projected to fund operations into mid-2026[11] Selected Statement of Operations 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 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. 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] Forward-Looking Statements 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]