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, Inc. released 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] Efficacy - Confirmed responses were observed in patients with TP53 Y220C mutated and KRAS wild-type tumors across eight tumor types, with an overall response rate (ORR) of 33% [2] - Specific ORRs included: - Ovarian cancer: 43% ORR (19/44 patients, including one confirmed complete response and 17 confirmed partial responses) [3] - Breast cancer: 18% ORR (2/11 patients) [3] - Endometrial cancer: 60% ORR (3/5 patients, including one unconfirmed partial response) [3] - Lung cancer: 22% ORR (4/18 patients, including three unconfirmed partial responses) [3] - Other solid tumors: 21% ORR (4/19 patients) [3] - The median time to response across all cohorts was 1.4 months, with a median duration of response of 6.2 months [3] - In the ovarian cancer cohort, the median time to response was 1.3 months, and the median duration of response was 7.6 months [3] Safety - Treatment-related adverse events (TRAEs) were primarily grade 1-2, with the most frequent TRAEs (>15%) being nausea, fatigue, increased blood creatinine, and increased alanine aminotransferase [4] Regulatory Update - PMV Pharma received feedback from the U.S. Food and Drug Administration (FDA) regarding the initial New Drug Application (NDA) submission strategy for platinum-resistant/refractory ovarian cancer [5] - The company plans to enroll an additional 20-25 platinum-resistant/refractory ovarian cancer patients by the end of Q1 2026 [5] - An NDA submission for platinum-resistant/refractory ovarian cancer is planned by the end of Q1 2027 [6] Price Action - PMVP stock is down 23.30% at $1.23 as of the last check on Wednesday [6]

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 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]

Core Viewpoint - PMV Pharmaceuticals, Inc. reported strong progress in its clinical trials and financial results for the year ended December 31, 2024, highlighting the advancement of its lead drug candidate, rezatapopt, in treating cancers with TP53 mutations [1][4]. Clinical Development - The pivotal Phase 2 portion of the PYNNACLE trial is advancing well, with enrollment on track and more than 90% of sites activated across multiple regions [3][5]. - An interim analysis of the Phase 2 monotherapy data is expected in mid-2025, with a New Drug Application submission anticipated by the end of 2026 [3][5]. - Enrollment has begun in a Phase 1b study at MD Anderson Cancer Center, evaluating rezatapopt in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome with a TP53 Y220C mutation [2][6]. Financial Performance - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities totaling $183.3 million, providing a cash runway expected to last until the end of 2026 [5][12]. - The net loss for the year ended December 31, 2024, was $58.7 million, a decrease from a net loss of $69.0 million in 2023 [12][17]. - Research and development expenses increased to $58.5 million in 2024 from $55.9 million in 2023, primarily due to clinical expenses related to rezatapopt [12][17]. Research Highlights - The Phase 1 data of rezatapopt in advanced ovarian cancer showed a confirmed partial response in 7 out of 15 patients, with a median duration of response of seven months [6]. - In advanced breast cancer, 3 out of 8 patients achieved a confirmed partial response, indicating a favorable safety profile [6]. - A paper detailing the discovery of rezatapopt was published, emphasizing its role as a first-in-class small-molecule reactivator of the p53 Y220C mutant [6][9].