On November 8, 2022 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 third quarter ended September 30, 2022 and provided a corporate update (Press release, PMV Pharma, NOV 8, 2022, View Source [SID1234623372]).

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"PMV continues to advance its ongoing PYNNACLE study evaluating PC14586, a first-in-class p53 Y220C reactivator, in patients with advanced solid tumors and plans the next update in the first half of 2023," said David Mack, Ph.D., President, and Chief Executive Officer. "In addition, we look forward to the initiation of our clinical trial of PC14586 in combination with KEYTRUDA. This study builds upon the promising, preliminary tumor-agnostic clinical efficacy observed with PC14586 monotherapy and allows us to explore the potential synergy between the two agents to improve patient outcomes."

Corporate Highlights:

Continued enrollment in the ongoing Phase 1/2 PYNNACLE trial of PC14586 in patients with advanced solid tumors. Initial Phase 1 data presented at the 2022 ASCO (Free ASCO Whitepaper) annual meeting demonstrated responses in patients across multiple solid tumor types with a p53 Y220C mutation.

On track to initiate Phase 1b trial evaluating PC14586 in combination with KEYTRUDA in Q4 2022.

Appointed Carol Gallagher, Pharm.D. to the Board of Directors. Dr. Gallagher brings 30 years of biotech leadership and expertise in drug development and commercialization.
Third Quarter 2022 Financial Results

As of September 30, 2022, PMV Pharma had $258.9 million in cash, cash equivalents, and marketable securities, compared to $314.1 million at December 31, 2021. Net cash used in operations was $48.4 million for the nine months ended September 30, 2022, compared to $34.5 million for the nine months ended September 30, 2021.

Net loss for the nine months ended September 30, 2022, was $54.0 million compared to $39.5 million for the nine months ended September 30, 2021.

Research and development (R&D) expenses were $37.0 million for the nine months ended September 30, 2022, compared to $24.3 million for the nine months ended September 30, 2021. The increase in R&D expenses was primarily due to clinical expenses related to development of PC14586, the Company’s lead drug candidate.

General and administrative (G&A) expenses were $18.9 million for the nine months ended September 30, 2022, compared to $15.5 million for the nine months ended September 30, 2021. The increase in G&A expenses was primarily due to increased headcount expenses including stock-based compensation.

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).