Core Insights - PMV Pharmaceuticals reported financial results for Q3 2025, highlighting advancements in their clinical study and financial position [1][2] Financial Performance - As of September 30, 2025, PMV Pharma had $129.3 million in cash, cash equivalents, and marketable securities, down from $148.3 million as of June 30, 2025 [3][4] - The net loss for Q3 2025 was $21.1 million, an increase from $19.2 million in Q3 2024, primarily due to higher research and development costs [10][14] - Research and development expenses for Q3 2025 were $18.2 million, compared to $16.9 million in Q3 2024 [10][14] - General and administrative expenses decreased to $4.3 million in Q3 2025 from $4.9 million in Q3 2024 [10] Clinical Developments - The PYNNACLE study, evaluating rezatapopt, showed a 34% overall response rate among 103 evaluable patients, with a median duration of response of 7.6 months [4][5] - In the ovarian cancer cohort, the overall response rate was 46% among 48 evaluable patients, with a median duration of response of 8.0 months [4][5] - The company plans to submit a New Drug Application (NDA) for rezatapopt in the first quarter of 2027 for the treatment of platinum-resistant/refractory ovarian cancer [2][4] Company Overview - PMV Pharmaceuticals focuses on precision oncology, specifically 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 [8]

Core Insights - PMV Pharmaceuticals announced updated data from the Phase 2 pivotal portion of the ongoing PYNNACLE clinical trial, focusing on rezatapopt for patients with advanced solid tumors harboring a TP53 Y220C mutation [1][4][6] Efficacy Data - The Phase 2 clinical trial data showed a 34% overall response rate (ORR) among 103 evaluable patients, with a median duration of response of 7.6 months [4][5] - In the ovarian cancer cohort, the ORR was 46% among 48 evaluable patients, with a median duration of response of 8.0 months [4][5] - Confirmed responses were observed across eight tumor types, including ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary carcinoma [4][5] Safety Profile - The safety population included 112 patients treated with rezatapopt at a dose of 2000mg daily, with a median of three prior lines of systemic therapy [5][11] - Treatment-related adverse events (TRAEs) were mostly Grade 1-2, with the most frequent being nausea, fatigue, and increased blood creatinine [11] - The rate of drug discontinuations due to TRAEs was 3.6%, indicating manageable safety [11] Regulatory Plans - The company plans to submit a New Drug Application (NDA) for rezatapopt in the first quarter of 2027 for the treatment of platinum-resistant/refractory ovarian cancer [4][6] About Rezatapopt - Rezatapopt is a first-in-class small molecule designed to reactivate p53 by selectively binding to the p53 Y220C mutant protein, restoring its tumor-suppressor function [7][9] About the PYNNACLE Clinical Trial - The PYNNACLE trial is a Phase 1/2 study evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation, with a focus on safety, tolerability, and efficacy [8][9]

Core Insights - PMV Pharmaceuticals announced interim data from the Phase 2 pivotal portion of the PYNNACLE clinical trial evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation [1][5][10] Efficacy - The Phase 2 clinical trial data as of August 4, 2025, showed an overall response rate (ORR) of 33% among 97 evaluable patients across all cohorts, with a median duration of response of 6.2 months [5][6] - In the ovarian cancer cohort, the ORR was 43% among 44 evaluable patients, with a median duration of response of 7.6 months [5][6] - Confirmed responses were observed in eight tumor types, including ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary carcinoma [5][6] Safety - The safety population consisted of 109 patients treated with rezatapopt 2000 mg daily as monotherapy, with a median of three prior lines of systemic therapy [6] - Treatment-related adverse events (TRAEs) were mostly Grade 1-2, with the most frequent being nausea, fatigue, increased blood creatinine, and increased alanine aminotransferase [6] - The rate of drug discontinuations due to TRAEs was 3.7%, and all Grade 3 TRAEs resolved on treatment [6] Regulatory Update - PMV Pharma plans to submit a New Drug Application (NDA) for rezatapopt in platinum-resistant/refractory ovarian cancer by the end of the first quarter of 2027 [5][7] - The company aims to enroll an additional 20-25 patients with platinum-resistant/refractory ovarian cancer by the end of the first quarter of 2026 [7] About Rezatapopt - Rezatapopt (PC14586) is a first-in-class small molecule designed to selectively bind to the p53 Y220C mutant protein, restoring its tumor-suppressor function [9] - The FDA has granted Fast Track designation to rezatapopt for treating patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation [9] About the PYNNACLE Clinical Trial - The ongoing Phase 1/2 PYNNACLE clinical trial evaluates rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation, with the primary objective of assessing efficacy at the recommended Phase 2 dose [10]

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].

Core Insights - PMV Pharmaceuticals reported financial results for Q1 2025, highlighting a net loss of $17.5 million, an increase from $15.3 million in Q1 2024 [4][8][15] - The company has $165.8 million in cash and marketable securities as of March 31, 2025, down from $183.3 million at the end of 2024, providing a cash runway expected to last until the end of 2026 [4][7] - PMV Pharma is advancing its Phase 2 PYNNACLE trial for rezatapopt, with interim analysis data expected in mid-2025, involving approximately 50 patients [2][3][7] Financial Performance - The net cash used in operations for Q1 2025 was $18.3 million, compared to $16.2 million in Q1 2024 [4] - Research and development (R&D) expenses increased to $17.4 million in Q1 2025 from $13.2 million in Q1 2024, primarily due to external expenses related to product candidates [8][15] - General and administrative (G&A) expenses decreased to $4.1 million in Q1 2025 from $5.0 million in Q1 2024, attributed to reduced headcount and operational costs [8][15] Clinical Development - The ongoing Phase 1/2 PYNNACLE trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation, with a focus on safety, tolerability, and pharmacokinetics [6][9] - The primary objective of the Phase 2 portion of the trial is to evaluate the efficacy of rezatapopt at the recommended Phase 2 dose in various cancer cohorts [9] - Rezatapopt has received Fast Track designation from the FDA for treating patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation [5]