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Mar 31, 2025
Mineralys Therapeutics Q1 2025 Earnings Report
Mineralys Therapeutics reported financial results for the first quarter ended March 31, 2025, and provided a corporate update.
Key Takeaways
Mineralys Therapeutics reported a net loss of $42.2 million for the first quarter of 2025, an increase from $31.5 million in the same period last year, primarily due to increased research and development and general and administrative expenses. The company ended the quarter with a strong cash position of $343.0 million following a public equity financing.
Net loss for Q1 2025 was $42.2 million, compared to $31.5 million for Q1 2024.
Cash, cash equivalents and investments totaled $343.0 million as of March 31, 2025, up from $198.2 million at the end of 2024.
Research and development expenses increased to $37.9 million in Q1 2025 from $30.8 million in Q1 2024.
General and administrative expenses rose to $6.6 million in Q1 2025 from $4.6 million in Q1 2024.
Forward Guidance
Mineralys Therapeutics anticipates its current cash, cash equivalents, and investments will fund operations into 2027. They are working towards submitting a new drug application for lorundrostat, with a pre-NDA meeting with the FDA expected in Q4 2025. Topline data from the Explore-CKD Phase 2 trial is expected in Q2 2025.
Positive Outlook
- Current cash position is expected to fund operations into 2027.
- Pre-NDA meeting with FDA for lorundrostat anticipated in Q4 2025.
- Topline data from Explore-CKD Phase 2 trial expected in Q2 2025.
- Explore-OSA Phase 2 trial initiated in Q1 2025.
- Pivotal Advance-HTN and Launch-HTN trials successfully achieved primary endpoints.
Challenges Ahead
- Future performance is entirely dependent on the success of lorundrostat.
- Potential for delays in clinical trial commencement, enrollment, and completion.
- FDA review upon NDA submission may be inconsistent with prior feedback.
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