Rezatapopt Clinical Development - PMV Pharma's lead candidate, rezatapopt (PC14586), is a first-in-class p53 Y220C reactivator targeting the previously undruggable p53 Y220C mutation, found in approximately 1% of solid tumors[4,9] - Rezatapopt has shown clinical proof of concept with favorable safety and preliminary efficacy across multiple tumor types[4] - A single-arm, registrational, tumor-agnostic Phase 2 trial was initiated in Q1 2024, with an interim analysis planned for mid-2025 and NDA submission planned for the end of 2026[4] - In the Phase 1 study, tumor shrinkage was observed in 87% of patients with measurable disease at baseline, KRAS wild type, and at least one post-baseline assessment in the efficacious dose range[22] - Confirmed responses at the Recommended Phase 2 Dose (RP2D) of 2000 mg QD showed an Overall Response Rate (ORR) of 38% in TP53 Y220C/KRAS WT patients[24] - The median time to response in the efficacious dose range for TP53 Y220C/KRAS WT patients was 15 months[27] Safety and Tolerability - Rezatapopt demonstrated a favorable safety profile, with most Treatment-Related Adverse Events (TRAEs) being Grade 1 or 2[29] - The most frequent TRAEs were nausea (507%) and vomiting (433%), which improved when rezatapopt was given with food[29] - The rate of drug discontinuation due to a TRAE was low at 3%[29] Financial Position and Future Plans - PMV Pharma had $198 million in cash as of September 30, 2024, providing a cash runway to year-end 2026[4] - The Phase 2 trial includes defined registration paths in ovarian and tumor-agnostic patient populations, with approximately 90% of TP53 Y220C patients being KRAS wild type[39,42]