On February 29, 2024 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update (Press release, PMV Pharma, FEB 29, 2024, View Source [SID1234640659]).

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"PMV continues to make significant progress with rezatapopt, a first-in-class precision oncology investigational therapy in patients with advanced solid tumors with a p53 Y220C mutation," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "Our registrational, tumor-agnostic Phase 2 clinical trial remains on track to initiate in the first quarter of this year."

Dr. Mack added, "We have extended our cash runway to the end of 2026 by prioritizing the development of rezatapopt and refocusing our discovery research efforts. We look forward to advancing the rezatapopt clinical program to bring a much-needed new treatment option to patients."

Full Year 2023 and Recent Corporate Highlights:

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Charles Baum, M.D., Ph.D., former Mirati Chief Executive Officer, appointed to serve as senior clinical advisor.

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Phase 1 analysis from the PYNNACLE Phase 1/2 study of rezatapopt in a subgroup of patients with advanced ovarian cancer harboring a TP53 Y220C mutation selected as a late-breaking oral presentation at the 2024 SGO Annual Meeting on Women’s Cancer. The data will be presented on March 18, 2024 during the Scientific Plenary V Late-Breaking Abstract Session 2, from 2:30 PM – 3:45 PM PT.

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Prioritization of rezatapopt development and focused discovery research efforts resulted in a workforce reduction; cost savings expected to extend cash runway to end of 2026.

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Updated data from Phase 1 PYNNACLE clinical trial presented at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) demonstrated responses across multiple tumor types with a median duration of response of seven months and a confirmed overall response rate of 38% at the Recommended Phase 2 dose (RP2D) of
2000 mg daily for the intended Phase 2 population of TP53 Y220C and KRAS wild-type patients.

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Concluded successful End-of-Phase 1 U.S. Food and Drug Administration (FDA) meeting with alignment on RP2D and key elements of single arm, tumor agnostic Phase 2 registrational portion of PYNNACLE study.

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Deepika Jalota, Pharm.D., Chief Development Officer, and Marc Fellous, M.D., Senior Vice President, Head of Clinical Development and Medical Affairs appointed to lead the rezatapopt clinical program.

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Promoted Michael Carulli to Chief Financial Officer and appointed Masha Poyurovsky, Ph.D., as Vice President of Biology.

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Initiated enrollment in the combination arm of the PYNNACLE study with rezatapopt and KEYTRUDA (pembrolizumab).

Fiscal Year 2023 Financial Results

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As of December 31, 2023, PMV Pharma had $228.6 million in cash, cash equivalents, and marketable securities, compared to $243.5 million at December 31, 2022. Net cash used in operations was $55.7 million for the year ended December 31, 2023, compared to $63.8 million for the year ended December 31, 2022.

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Net loss for the year ended December 31, 2023, was $69.0 million compared to $73.3 million for the year ended December 31, 2022.

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Research and development (R&D) expenses were $55.9 million for the year ended December 31, 2023, compared to $52.0 million for the year ended December 31, 2022. The increase in R&D expenses was primarily related to increased headcount and clinical expenses for advancing rezatapopt, the Company’s lead drug candidate.

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General and administrative (G&A) expenses were $24.2 million for the year ended December 31, 2023, compared to $25.1 million for the year ended December 31, 2022. The decrease in G&A expenses was primarily due to facility-related costs now allocated to research as our new laboratory building in Princeton, NJ began operations.

KEYTRUDA (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Rezatapopt

Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation.