Q2 2024 Mineralys Therapeutics Inc Earnings Call Transcript
Key Points
- Mineralys Therapeutics Inc (MLYS) has made significant progress in advancing the development of lorundrostat, their lead asset, particularly in their hypertension registration program.
- Enrollment in the Advance-HTN trial is approximately 90% complete, with top-line data expected in the first quarter of 2025.
- The company has aligned with the FDA to maintain the original primary endpoint for the Advance-HTN trial, ensuring consistency and robustness in data collection.
- Enrollment in the Launch-HTN trial is ahead of schedule, with top-line data expected in the second half of 2025.
- Mineralys Therapeutics Inc (MLYS) ended the quarter with $311.1 million in cash, cash equivalents, and investments, providing sufficient funding for planned clinical trials and corporate operations into 2026.
- The timeline for the Advance-HTN trial's top-line data readout has been extended to the first quarter of 2025, which may disappoint some stakeholders.
- R&D expenses increased significantly to $39.3 million for the quarter, up from $11.9 million in the same quarter of 2023, primarily due to higher preclinical and clinical costs.
- G&A expenses also rose to $5.9 million for the quarter, compared to $3.9 million in the same quarter of the prior year, driven by higher compensation expenses and professional fees.
- Net loss for the quarter was $41 million, a substantial increase from $12.1 million in the same quarter of 2023.
- The Explore-CKD trial's top-line data readout has been adjusted from Q4 2024 to Q1-Q2 2025, indicating potential delays in the trial's progress.
Welcome to the Mineralys Therapeutics second quarter 2024 conference call. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Dan Ferry of LifeSci Advisors. Please go ahead.
Thank you, operator. Good afternoon, everyone, and welcome to our second quarter 2024 conference call. After the close of market trading today, we issued a press release providing our second quarter 2024 financial results and business updates. A replay of today's call will be available on the Investors section of our website approximately one hour after its completion. After our prepared remarks, we will open up the call for Q&A.
Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the company. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.
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