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PMV Pharmaceuticals Reports Second Quarter 2025 Financial Results and Corporate Highlights
GlobeNewswire News Roomยท 2025-08-07 12:42
Core Viewpoint - PMV Pharmaceuticals reported its financial results for Q2 2025, highlighting a significant increase in net loss and ongoing clinical trials for its lead product, rezatapopt, which targets p53 mutations in various cancers [3][7]. Financial Results - As of June 30, 2025, PMV Pharma had $148.3 million in cash, cash equivalents, and marketable securities, down from $165.8 million as of March 31, 2025 [3][6]. - The net loss for Q2 2025 was $21.2 million, a substantial increase from $1.2 million in Q2 2024, primarily due to the previous year's tax benefit from the sale of accumulated net operating losses [7]. - Research and development (R&D) expenses rose to $18.4 million in Q2 2025 from $14.6 million in Q2 2024, attributed to increased costs associated with the rezatapopt program [7]. - General and administrative (G&A) expenses decreased to $4.5 million in Q2 2025 from $5.5 million in Q2 2024, mainly due to reduced stock-based compensation and operational costs [7]. Clinical Development - PMV Pharma is advancing the Phase 2 PYNNACLE clinical trial for rezatapopt, with an investor webinar scheduled for September 10, 2025, to present interim analysis data from approximately 65 patients [2][6]. - The PYNNACLE trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation, with a focus on efficacy and safety [5][6]. Product Information - Rezatapopt (PC14586) is a first-in-class small molecule designed to reactivate the p53 tumor suppressor function in patients with specific mutations [4]. - The U.S. FDA has granted Fast Track designation to rezatapopt for treating locally advanced or metastatic solid tumors with a p53 Y220C mutation [4]. Company Overview - PMV Pharmaceuticals specializes in precision oncology, focusing on small molecule therapies targeting p53 mutations, which are present in approximately half of all cancers [8]. - The company was co-founded by Dr. Arnold Levine, a pioneer in p53 biology, and is headquartered in Princeton, New Jersey [8].
PMV Pharmaceuticals (PMVP) Earnings Call Presentation
2025-07-01 06:43
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]