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PMV Pharmaceuticals Reports First Quarter 2025 Financial Results and Corporate Highlights
Globenewswire· 2025-05-09 12:00
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]
PMV Pharmaceuticals Reports Full Year 2024 Financial Results and Corporate Highlights
Newsfilter· 2025-03-03 13:00
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].