NextCure (NXTC) investor relations material

Pipeline overview

• Advancing two differentiated antibody-drug conjugates (ADCs): SIM0505 (CDH6, TOPO1 inhibitor) and LNCB74 (B7-H4, tubulin inhibitor), both in Phase 1 trials targeting multiple solid tumors.

• SIM0505 is being developed globally (ex-China) via a strategic partnership and is in clinical trials for ovarian, lung, and renal cancers, with initial data expected in 2Q 2026.

• LNCB74 is co-developed with LigaChem Biosciences, targeting breast, ovarian, and endometrial cancers, with a unique glucuronidase linker for improved safety and efficacy.

• Both ADCs are designed for multi-pronged approaches to overcome resistance and improve durability, with options for concurrent or sequenced administration.

• Additional programs in discovery and preclinical stages target leukemia, osteogenesis imperfecta, and Alzheimer's disease.

SIM0505 clinical and preclinical data

• SIM0505 demonstrates strong binding affinity, high internalization, and favorable pharmacokinetics, with a hydrophilic payload for reduced toxicity.

• Preclinical models show potent anti-tumor activity in ovarian and renal cancer models, outperforming comparators.

• Initial Phase 1 data (April 2025): 5 patients enrolled, no dose-limiting toxicities, and a partial response at the lowest dose in serous endometrial carcinoma.

• Differentiated from competitors by unique epitope binding, high systemic clearance, and anticipated safety improvements.

• Ongoing global Phase 1 trial with joint data from China and US; readout expected 2Q 2026.

LNCB74 clinical and preclinical data

• LNCB74 features a glucuronidase-cleavable linker for targeted payload release, higher potency, and reduced toxicity compared to traditional linkers.

• Demonstrated potent anti-tumor activity in breast, ovarian, and triple-negative breast cancer models, achieving complete responses in preclinical studies.

• Phase 1 dose escalation study initiated in January 2025, with expansion cohorts planned for breast and ovarian cancers.

• Differentiated from competitors by site-specific conjugation, improved therapeutic index, and lower toxicity profile.

• Addresses unmet needs in breast and gynecological cancers with a patient selection strategy.