On March 3, 2021 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, reported financial results for the fourth quarter and full year ended December 31, 2020 and provided corporate highlights (Press release, PMV Pharma, MAR 3, 2021, View Source [SID1234576006]).
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"2020 was a transformative year for PMV Pharma, marked by our entry into the clinic, a strengthened management team and successful completion of our Nasdaq initial public offering," said David Mack, Ph.D., President and Chief Executive Officer. "The treatment of the first patient with PC14586, our tumor agnostic small molecule targeting the p53 Y220C mutant, was an important step forward in precision oncology. Our strong leadership and balance sheet position us to further advance our discovery pipeline of small molecule, tumor-agnostic precision medicine products that specifically target p53 mutants."
Corporate Highlights:
Initiated Phase 1/2 study of PC14586 in patients with advanced solid tumors that have a p53 Y220C mutation. The Phase 1/2 study will enroll up to 130 patients with a p53 Y220C mutation as determined by next generation sequencing. Phase 1 dose escalation will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of PC14586. Phase 2 will assess the overall response rate and duration of response at the PC14586 dose identified in Phase 1.
For information on the Phase 1/2 trial, please visit www.clinicaltrials.gov (NCT study identifier NCT04585750).
In October, the FDA granted PMV Pharma Fast Track designation to PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.
Appointment of Deepika Jalota, Pharm. D. to Chief Regulatory and Quality Officer, who joined PMV Pharma in June 2019 as Senior Vice President, Head of Regulatory Affairs and Quality Assurance. Dr. Jalota will continue to lead global regulatory strategy and execution as well as the quality assurance function. Dr. Jalota is a strategic regulatory leader with more than 20 years of regulatory affairs and drug development experience in oncology and other therapeutic areas. Prior to joining PMV Pharma, she served as Vice President, Global Regulatory Strategy, Oncology at Bayer HealthCare Pharmaceuticals where she was responsible for driving the development of global regulatory strategies for multiple early and late-stage oncology projects, including Xofigo, Vitrakvii and Nubeqa.
Expanded Scientific Advisory Board with the appointment of p53 pioneer Dr. Guillermina (Gigi) Lozano, Professor and Chair, Department of Genetics, MD Anderson Cancer Center.
Fourth Quarter 2020 Financial Results
PMV Pharma ended the fourth quarter with $361.4 million in cash, cash equivalents, and marketable securities, compared to $101.5 million as of December 31, 2019. Net cash used in operations was $32.7 million for the twelve months ended December 31, 2020 compared to $22.1 million for the twelve months ended December 31, 2019.
Net loss for the year ended December 31, 2020 was $34.4 million compared to $25.4 million for the year ended December 31, 2019.
Research and development (R&D) expenses were $23.9 million for the year ended December 31, 2020 compared to $20.8 million for the year ended December 31, 2019. The increase in R&D expenses was primarily related to increased headcount and clinical expenses related to advancing research on PC14586, the Company’s lead drug candidate.
General and administrative (G&A) expenses were $11.0 million for the year ended December 31, 2020, compared to $5.9 million for the year ended December 31, 2019. The increase in G&A expenses was primarily due to expanding the infrastructure necessary for operating as a public company.
About p53
p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.
About PC14586
PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice created by the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.