Mineralys Therapeutics Q4 2024: Unraveling Key Contradictions in Blood Pressure Measurement and Drug Efficacy

These are the key contradictions discussed in Mineralys Therapeutics' latest 2024Q4 earnings call, specifically including: Blood Pressure Measurement Techniques, Hyperkalemia Thresholds, Primary Endpoint Changes, and Blood Pressure Reduction Thresholds:



Clinical Trial Advancements:
- Mineralys Therapeutics is expecting top-line data for two pivotal trials, Advance-HTN and Launch-HTN, in March and mid-first half of 2025, respectively.
- The trials are designed to evaluate the efficacy and safety of lorundrostat as an add-on therapy for controlled and resistant hypertension.
- The trials are anticipated to provide definitive evidence for the potential benefits of lorundrostat in treating hypertension, which could impact the treatment paradigm and access to market.

Financial Performance and Cash Position:
- The company ended 2024 with cash, cash equivalents, and investments of $198.2 million, a decrease from $239 million in 2023.
- R&D expenses increased to $168.6 million for 2024 from $70.4 million in 2023, primarily due to the initiation of the lorundrostat pivotal program and increased headcount.
- The decrease in cash was attributed to increased R&D and G&A expenses, and the company believes its current cash position will be sufficient to fund planned clinical studies and corporate operations through the first quarter of 2026.

Exploratory Programs and Potential Market Impact:
- The company is conducting exploratory programs for lorundrostat in chronic kidney disease and obstructive sleep apnea, with top-line data expected in the second quarter of 2025.
- These programs aim to augment the anti-hypertensive profile of lorundrostat and demonstrate its potential to reduce cardiovascular risk.
- Successful outcomes could expand the addressable market and position lorundrostat as a unique therapy for specific conditions.

Publication and Presentation of Clinical Data:
- Top-line data from pivotal trials will be presented at conferences such as the American College of Cardiology (ACC) meeting.
- The company plans to publish data to establish lorundrostat's efficacy and safety in treating hypertension and other conditions.
- These presentations aim to position the drug as a new therapy and potentially change the current treatment paradigm for hypertension.