On August 9, 2022 PMV Pharmaceuticals, Inc. ("PMV Pharma" Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported financial results for the second quarter ended June 30, 2022, and provided a corporate update (Press release, PMV Pharma, AUG 9, 2022, View Source [SID1234617942]).

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"The highlight of the second quarter was the oral presentation at ASCO (Free ASCO Whitepaper) of positive initial data from the ongoing PYNNACLE study of PC14586, our investigational first-in-class p53 Y220C reactivator, in patients with solid tumors," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "The data provide clinical proof of concept for PC14586 as monotherapy, with meaningful clinical activity observed across multiple tumor types."

Corporate Highlights:

Initial data from the dose-escalation portion of the Phase 1/2 PYNNACLE study were featured in an oral presentation at the 2022 ASCO (Free ASCO Whitepaper) annual meeting. Enrollment is ongoing to support the determination of a recommended Phase 2 dose.
PMV Pharma announced a clinical trial collaboration and supply agreement with Merck (known as MSD outside the U.S. and Canada) to evaluate the combination of PC14586 with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy. The combination trial is anticipated to begin in Q4 2022.
Appointed Marc Fellous, M.D. as Vice President, Clinical Development and Medical Affairs. Prior to joining PMV Pharma, Dr. Fellous was Global Medical Affairs Head on larotrectinib, the first tumor-agnostic drug approved in the U.S. and Europe, and selitrectinib programs at Bayer. He held leadership roles at Bayer and Roche for more than 13 years, contributing to the strategy and launch of multiple successful oncology products. Dr. Fellous completed his doctorate in general medicine at the University Paris V along with a specialized master’s degree in medical management from ESCP-Europe Business School.
Continued progress on the Company’s research pipeline of its Wild-Type p53-Induced Phosphatase 1 (WIP1) inhibitor and p53 mutant programs.
Second Quarter 2022 Financial Results

As of June 30, 2022, PMV Pharma had $277.4 million in cash, cash equivalents, and marketable securities, compared to $339.0 million as of June 30, 2021. Net cash used in operations was $31.7 million for the six months ended June 30, 2022, compared to $22.1 million for the six months ended June 30, 2021.
Net loss for the six months ended June 30, 2022, was $35.7 million compared to $24.5 million for the quarter ended June 30, 2021.
Research and development (R&D) expenses were $23.3 million for the six months ended June 30, 2022 compared to $15.2 million for the six months ended June 30, 2021. The increase in R&D expenses was primarily due to increased headcount and clinical trial expenses associated with advancing our lead product candidate, PC14586, through the Phase 1/2 clinical trial.
General and administrative (G&A) expenses were $13.2 million for the six months ended June 30, 2022, compared to $9.6 million for the six months ended June 30, 2021. The increase in G&A expenses was primarily due to costs relating to operating as a public company.
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 (FDA) 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).