On May 7, 2026 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies to treat cancer, reported a business update and announced first quarter 2026 financial results.
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"Our SIM0505 program reached critical milestones this quarter, headlined by the U.S. Food and Drug Administration (FDA) granting Fast Track designation for platinum-resistant ovarian cancer (PROC) and the upcoming presentation of initial Phase 1 data at the American Society for Clinical Oncology (ASCO 2026)," said Michael Richman, President and CEO of NextCure. "We believe Fast Track designation validates the potential of this CDH6 antibody drug conjugate (ADC) and the urgent need for new therapies. As we prepare to present our data at ASCO (Free ASCO Whitepaper) 2026, we are also focusing on accelerating development, with plans to increase our U.S. trial sites and expand our footprint into Canada and Europe. With the recent initiation of the dose optimization this month, we are fully committed to bringing this transformative treatment to patients."
Business Highlights and Near-Term Milestones
SIM0505 (CDH6 ADC): Phase 1 dose escalation data expected in Q2 2026
SIM0505 is a novel ADC directed to cadherin-6 (CDH6 ADC), overexpressed in several cancers including ovarian cancer, with limited expression in healthy tissues. SIM0505 features a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window.
● Received Fast Track designation for the treatment of women with PROC from the FDA.
● Data from the Phase 1 open-label dose escalation study in patients with advanced solid tumors with a focus on gynecological cancers and an emphasis on PROC (NCT06792552) are expected to be presented at ASCO (Free ASCO Whitepaper) 2026 on June 1, 2026, including results from patients in the U.S. and China.
● Announced in May 2026 the initiation of the Phase 1 dose optimization study in gynecologic cancers by dosing patients with PROC. NextCure anticipates increasing the number of trial sites in the second half of 2026, including the activation of sites in Canada and Europe, with continued study site additions in 2027.
LNCB74 (B7-H4 ADC): Ongoing enrollment in Phase 1 dose escalation
LNCB74 is a novel ADC directed to B7-H4, overexpressed in several cancers, with limited expression in healthy tissues. LNCB74 features a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload.
● Ongoing open-label Phase 1 dose escalation study (NCT06774963) continues to prioritize patients with high B7-H4 expression in breast and gynecological cancers, as well as the inclusion of patients with adenoid cystic carcinoma type 1. NextCure intends to backfill patients to investigate particular dose levels and schedules in the expected therapeutic window.
● Trial progress update planned in the second half of 2026.
Financial Results for the Quarter Ended March 31, 2026
● Cash, cash equivalents, and marketable securities as of March 31, 2026 were $29.7 million as compared to $41.8 million as of December 31, 2025. The decrease of $12.1 million was primarily due to cash used to fund operations of $13.4 million, partially offset by proceeds of $1.2 million from equity sales under our existing ATM program. NextCure expects current financial resources to be sufficient to fund operating expenses and capital expenditures into the first half of 2027 through proof-of-concept for SIM0505.
● Research and development expenses were $6.8 million for the three months ended March 31, 2026, as compared to $7.9 million for the three months ended March 31, 2025. The decrease of $1.1 million was due to lower costs related to deprioritized programs which were largely offset by costs for the SIM0505 program, and lower personnel costs, primarily non-cash stock compensation costs and lower depreciation.
● General and administrative expenses were $3.3 million for the three months ended March 31, 2026, as compared to $3.7 million for the three months ended March, 2025. The decrease of $0.4 million was primarily related to lower non-cash stock compensation costs.
● Net loss was $9.8 million for the three months ended March 31, 2026, as compared to a net loss of $11.0 million for the three months ended March 31, 2025. The lower net loss for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was driven by the lower research and development and general and administrative expenses mentioned above, partially offset by lower other income of $0.3 million.
About SIM0505
SIM0505 is a novel ADC directed to CDH6 ADC, featuring a proprietary TOPOi payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd.
About LNCB74
LNCB74 is a novel ADC directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and a tubulin inhibitor MMAE payload. LNCB74 is being evaluated in an open-label, Phase 1 dose escalation study for the potential treatment of advanced solid tumors. NextCure shares global co-development rights with LigaChem Biosciences, Inc. through a 50-50 cost share arrangement.
(Press release, NextCure, MAY 7, 2026, View Source [SID1234665337])