NextCure (NXTC) Corporate presentation summary

ADC pipeline and clinical progress

• SIM0505, a CDH6-targeted ADC with a proprietary TOPO payload, is in advanced clinical development for ovarian, uterine serous carcinoma (USC), and other cancers.

• SIM0505 features a unique binding epitope, high systemic clearance, and is designed for improved safety and potent cytotoxicity.

• Dose escalation and optimization studies have enrolled 59 patients across the US and China, with pivotal trials planned for PROC.

Patient demographics and safety profile

• Patient population is heavily pretreated, with ~73% ECOG 1 and ~75% of ovarian/USC patients at FIGO Stage IV.

• SIM0505 demonstrated a manageable safety profile, with most adverse events being hematological and grades 3/4 events considered manageable.

• No primary prophylaxis was required for neutropenia or thrombocytopenia, and the maximum tolerated dose was not reached.

Efficacy outcomes

• In ovarian cancer patients at therapeutic doses (4.8–8.0 mg/kg), 52.9% achieved partial response, with up to 70% tumor shrinkage observed.

• Most patients (15/17) experienced tumor shrinkage, with the greatest and most durable responses at 6.4 mg/kg.

• In USC, 66.7% of evaluable patients achieved partial response, highlighting activity in this aggressive cancer subtype.