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Jun 30, 2023
PMV Pharma Q2 2023 Earnings Report
PMV Pharmaceuticals reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.
Key Takeaways
PMV Pharmaceuticals reported its Q2 2023 financial results, highlighting continued progress in the PYNNACLE study of PC14586 and a successful End-of-Phase 1 FDA meeting. The company ended the quarter with $218.8 million in cash, cash equivalents, and marketable securities.
Continued progress in ongoing Phase 1/2 PYNNACLE study of PC14586.
Concluded successful End-of-Phase 1 FDA meeting with alignment on recommended Phase 2 dose.
Ongoing enrollment in combination arm of PYNNACLE study with PC14586 and KEYTRUDA® (pembrolizumab).
Appointed Dr. Masha Poyurovsky as Vice President of Biology.
PMV Pharma
PMV Pharma
Forward Guidance
The company anticipates initiating the single arm, Phase 2 portion of the PYNNACLE study in early 2024 and sharing updated Phase 1 data in the second half of the year.
Positive Outlook
- Alignment with the FDA was obtained on the recommended Phase 2 dose.
- Key elements of the Phase 2 registrational portion of the PYNNACLE trial were aligned.
- Plans to initiate the single arm, Phase 2 portion of the PYNNACLE study in early 2024.
- Ongoing enrollment in the combination arm of PYNNACLE evaluating PC14586 with KEYTRUDA.
- Company will share updated Phase 1 data in the second half of the year.
Challenges Ahead
- Success of clinical trials are subject to risks and uncertainties.
- Ability to execute on its strategy and operate as an early clinical stage company is uncertain.
- Clinical trials of PC14586 or any future clinical trials of other product candidates may differ from preclinical, preliminary or expected results.
- Company's ability to fund operations is uncertain.
- The impact that the current COVID-19 pandemic will have on the Company’s clinical trials, supply chain, and operations is uncertain.