PMV Pharma Q4 2024 Earnings Report
Key Takeaways
PMV Pharma reported cash, cash equivalents, and marketable securities of $183.3 million as of December 31, 2024. Net loss for the year ended December 31, 2024, was $58.7 million. Enrollment is on track in Phase 2 pivotal portion of PYNNACLE clinical trial.
Enrollment on track in Phase 2 pivotal portion of PYNNACLE clinical trial evaluating rezatapopt as monotherapy.
Enrollment commenced in the MD Anderson Cancer Center investigator-initiated Phase 1b study evaluating rezatapopt monotherapy and in combination with azacitidine.
Cash, cash equivalents, and marketable securities of $183.3 million as of December 31, 2024, providing expected cash runway to end of 2026.
PMV Pharma plans to provide data from the interim analysis of the Phase 2 monotherapy portion of PYNNACLE in the middle of 2025 and anticipates a New Drug Application submission by the end of 2026.
PMV Pharma
PMV Pharma
Forward Guidance
PMV Pharma's future plans and expectations for rezatapopt, including our ability to obtain approval as a treatment option on a tumor-agnostic basis and as a monotherapy or in combination with other agents, including with azacitidine, expectations regarding timing for interim data readouts and ongoing status of the Phase 2 portion of the PYNNACLE trial, our expectation, anticipation and timing of New Drug Application filing(s) with the U.S. Food and Drug Administration for the current clinical trial for rezatapopt, the current and future enrollment of patients in our clinical trials, including the expected number of patients to be enrolled in our clinical trials, the timing, progress and activation of sites for our clinical trials, collaboration with and plans for the MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center investigator-initiated Phase 1b study evaluating the combination of rezatapopt and azacitidine, and the timing and expectations with respect to our projected cash runway.
Positive Outlook
- ability to obtain approval as a treatment option on a tumor-agnostic basis
- ability to obtain approval as a monotherapy or in combination with other agents, including with azacitidine
- expectations regarding timing for interim data readouts and ongoing status of the Phase 2 portion of the PYNNACLE trial
- expectation, anticipation and timing of New Drug Application filing(s) with the U.S. Food and Drug Administration for the current clinical trial for rezatapopt
- collaboration with and plans for the MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center investigator-initiated Phase 1b study evaluating the combination of rezatapopt and azacitidine
Challenges Ahead
- success, cost, and timing of the Company’s product candidate development activities and planned clinical trials
- the Company’s ability to execute on its strategy and operate as a clinical stage company
- the potential for clinical trials of rezatapopt or any future clinical trials of other product candidates to differ from preclinical, preliminary, interim or expected results
- the Company’s ability to fund operations
- the impact that a global pandemic, other public health emergencies or geopolitical tensions or conflicts may have on the Company’s clinical trials, supply chain, and operations