Company: PMVP
Filing Date: 2025-11-12
Form Type: 10-Q
Source: 0001193125-25-276003
Chunk: 4

Company: PMV Pharmaceuticals, Inc.
Filing Date: 2025-11-12
Form: 10-Q
Item: Item 2
Chunk 4
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 target p53 mutations and other p53-related cancers.

Since our formation in March 2013, we have devoted substantially all of our time and efforts to performing research and development activities and raising capital. We are not profitable and have incurred losses in each year since our inception. During the three and nine months ended September 30, 2025, the Company incurred net losses of $21.1 million and $59.7 million, respectively. As of September 30, 2025, we had an accumulated deficit of $428.4 million. We do not currently have any product candidates approved for sale, and we continue to incur significant research and development and general administrative expenses related to our operations. We initiated a Phase 1/2 clinical trial, PYNNACLE, in October 2020 for our lead product candidate, rezatapopt. Our strategy is to seek approval under an accelerated pathway, and we believe our PYNNACLE clinical trial has the potential to serve as a pivotal study. In October 2020, we were granted FDA Fast Track designation of rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. In July 2023, we met with the FDA at an End of Phase 1 meeting where alignment was obtained on the recommended Phase 2 dose and key elements of the single arm, Phase 2 registrational portion of the PYNNACLE study. In October 2023, we presented our updated Phase 1 clinical data for rezatapopt at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Annual Meeting. We dosed our first patient in the pivotal Phase 2 monotherapy portion of the PYNNACLE study in the first quarter of 2024. In September 2025, we announced interim data from the Phase 2 pivotal portion of the PYNNACLE clinical trial, which was updated in October 2025 in a late-breaking oral presentation and poster presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. We expect to complete enrollment in the ovarian cohort for our primary analysis from the Phase 2 portion of the PYNNACLE study by the first quarter of 2026, and plan to submit a New Drug Application (NDA) for platinum-resistant/refractory ovarian cancer to the FDA for rezatapopt in the first quarter of 2027. 

We expect that our