On May 10, 2023 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 first quarter ended March 31, 2023, and provided a corporate update (Press release, PMV Pharma, MAY 10, 2023, View Source [SID1234631398]).

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"We are pleased with the ongoing progress in the PYNNACLE study of PC14586, a first-in-class p53 Y220C reactivator, in patients with advanced solid tumors. We look forward to providing the next clinical and regulatory update in the second half of 2023," said David Mack, Ph.D., President and Chief Executive Officer. "Additionally, we are actively enrolling patients in the combination arm of PYNNACLE to explore the potential synergistic effects between PC14586 and KEYTRUDA."

Corporate Highlights:

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The ongoing Phase 1/2 PYNNACLE study is evaluating PC14586 in patients with advanced solid tumors harboring a p53 Y220C mutation. The next clinical and regulatory update is expected in 2H 2023.
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Commenced enrollment in the combination arm of PYNNACLE evaluating PC14586 with KEYTRUDA (pembrolizumab). PMV Pharma and Merck entered into a collaboration in 2022 under the terms of which Merck will supply KEYTRUDA for this study.

First Quarter 2023 Financial Results

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PMV Pharma ended the first quarter with $229.4 million in cash, cash equivalents, and marketable securities, compared to $243.5 million as of December 31, 2022. Net cash used in operations was $15.0 million for the three months ended March 31, 2023, compared to $18.0 million for the three months ended March 31, 2022.
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Net loss for the quarter ended March 31, 2023, was $19.1 million compared to $18.4 million for the quarter ended March 31, 2022.
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Research and development (R&D) expenses were $15.1 million for the quarter ended March 31, 2023, compared to $11.8 million for the quarter ended March 31, 2022. The increase in R&D expenses was primarily related to increased clinical expenses to advance research on PC14586, the Company’s lead drug candidate.
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General and administrative (G&A) expenses were $6.4 million for the quarter ended March 31, 2023, compared to $6.8 million for the quarter ended March 31, 2022. The decrease in G&A expenses was primarily due to reduced spend for insurance and outside services.

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

About PC14586

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

Y220C mutation. For more information about the Phase 1/2 PYNNACLE trial (PMV-586-101), refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).