Mineralys Therapeutics (MLYS) investor relations material

Industry landscape and innovation

• Aldosterone synthase inhibitors (ASIs) represent the first new hypertension drug class in 20 years, with strong early adoption and market interest following the launch of baxdrostat.

• Over half of treated hypertension patients remain uncontrolled, highlighting significant unmet need and demand for innovative therapies targeting aldosterone.

• Early market research and real-world data support payer willingness to provide access for new ASIs, with a pragmatic approach to step therapy based on medication failure.

Clinical development and data highlights

• Lorundrostat's comprehensive phase III program focused on third-line and later patients, including those with multiple comorbidities and diverse backgrounds.

• LAUNCH-HTN trial showed a nearly 19 mmHg absolute drop in systolic BP and low hyperkalemia rates, with robust representation of Black and female patients.

• ADVANCE-HTN and EXPLORE-CKD trials demonstrated meaningful BP reductions in difficult-to-treat populations, with additional benefits such as reduced albuminuria and improved heart failure biomarkers.

• Explore-OSA trial confirmed efficacy in patients with obesity and sleep apnea, though this data will be used for scientific communication rather than labeling.

Commercial strategy and market access

• Pre-launch commercial plans are on track, with a seasoned leadership team and sales force expected to be in place by the PDUFA date.

• Initial market entry is expected in the fourth-line setting due to payer access dynamics, but data supports expansion into third-line use as physician experience grows.

• Access will be managed through step-edit requirements, leveraging EMR data to identify eligible patients who have failed two or more antihypertensive medications.

• Pricing strategy aims to avoid specialty tier placement, informed by competitor benchmarks and market research.