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Mar 31, 2022
Verve Therapeutics Q1 2022 Earnings Report
Verve Therapeutics reported financial results for the first quarter of 2022 and outlined its global development strategy for VERVE-101.
Key Takeaways
Verve Therapeutics announced the clearance of its first VERVE-101 clinical trial application and outlined its global clinical development strategy. The company's cash, cash equivalents, and marketable securities totaled $323.3 million, providing a cash runway into 2024. Net loss for the quarter was $30.2 million, or $0.62 per share.
Received clearance for first VERVE-101 clinical trial application in New Zealand.
Plans to initiate a Phase 1 clinical trial in HeFH patients in New Zealand in mid-2022, with initial clinical data expected in 2023.
Preparing to submit regulatory filings for VERVE-101 in the United Kingdom and United States in the second half of 2022.
Cash, cash equivalents, and marketable securities of $323.3 million provide cash runway into 2024.
Verve Therapeutics
Verve Therapeutics
Forward Guidance
Verve Therapeutics is focused on advancing its VERVE-101 program and expanding its pipeline. The company anticipates initiating clinical trial sites and patient enrollment in the respective regions shortly following clearance of its applications, should they be accepted.
Positive Outlook
- Initiate a first-in-human Phase 1 clinical trial in patients with HeFH in mid-2022.
- Submit both a CTA in the United Kingdom and an investigational new drug (IND) application in the United States in the second half of 2022.
- Complete IND-enabling studies in the third quarter.
- Advance its product-focused pipeline.
- Identify new targets to address.
Challenges Ahead
- Risks associated with the company’s limited operating history
- The timing of and the company’s ability to submit applications for, its product candidates
- Advance its product candidates in clinical trials
- Correctly estimate the potential patient population and/or market for the company’s product candidates
- Replicate in clinical trials positive results found in preclinical studies and/or earlier-stage clinical trials of VERVE-101 and its other product candidates