On November 5, 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, reported a business update and announced third quarter 2025 financial results.

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"We have made significant progress advancing our promising ADC programs," said Michael Richman, NextCure’s president and CEO. "We recently began U.S. enrollment in the Phase 1 trial for SIM0505, our CDH6 ADC, initiating at a mid-tier dose range where multiple clinical responses were observed in China by our partner Simcere Zaiming. We expect to advance into higher-dose cohorts in the US shortly, as is currently occurring in China. We believe the ability to dose at levels that match or exceed competitor CDH6-targeting ADCs should demonstrate the promise of this program. We also received FDA clearance for our LNCB74 protocol amendment, giving us the ability to add higher dose escalation cohorts. We plan to provide proof of concept data readouts on SIM0505 and LNCB74 in the first half of 2026."

Business Highlights and Near-Term Milestones

SIM0505 (CDH6 ADC)

● A novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window.
● Acquired global rights in June 2025, excluding greater China where Simcere Zaiming retained rights.
● First U.S. patient dosed in October 2025 at a mid-tier dose level where multiple responses have been observed along with good tolerability in the ongoing Chinese trial.
● Proof of concept data readout, including data from Simcere Zaiming’s ongoing Phase 1 trial, in the first half of 2026.

LNCB74 (B7-H4 ADC)

● A novel ADC directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload.
● Co-developed with LigaChem Biosciences Inc. in a 50-50 cost share arrangement.
● Received Food and Drug Administration (FDA) acceptance of a protocol amendment giving us the ability to add higher dose escalation cohorts.
● Proof of concept data readout in the first half of 2026.

Financial Results for Quarter Ended September 30, 2025

● Cash, cash equivalents, and marketable securities as of September 30, 2025 were $29.1 million as compared to $68.6 million as of December 31, 2024. The decrease of $39.5 million was primarily due to cash used to fund operations, including the $12.0 million upfront license fee to Simcere Zaiming. We expect current financial resources to be sufficient to fund operating expenses and capital expenditures into mid-2026.
● Research and development expenses were $6.1 million for the three months ended September 30, 2025, as compared to $8.8 million for the three months ended September 30, 2024. The decrease of $2.6 million was due to lower costs related to deprioritized programs, lower preclinical development costs and lower personnel-related costs.
● General and administrative expenses were $2.8 million for the three months ended September 30, 2025, as compared to $3.7 million for the three months ended September 30, 2024. The decrease of $0.9 million was primarily related to lower personnel costs.
● Net loss was $8.6 million for the three months ended September 30, 2025, as compared to a net loss of $11.5 million for the three months ended September 30, 2024 due to the lower research and development costs and lower general and administrative costs as described above, partially offset by lower other income.

(Press release, NextCure, NOV 5, 2025, View Source [SID1234659467])