Mineralys Therapeutics (MLYS) investor relations material

Targeting aldosterone in cardiorenal diseases

• Lorundrostat is a selective aldosterone synthase inhibitor (ASI) aimed at treating hypertension and cardiorenal diseases, with a focus on uncontrolled and resistant hypertension (u/rHTN), chronic kidney disease (CKD), and obstructive sleep apnea (OSA).

• Dysregulated aldosterone is a key driver in 30% of u/rHTN cases, and lorundrostat is positioned as a potential best-in-class ASI with meaningful 24-hour blood pressure reduction and safety in once-daily dosing.

• The drug has shown benefits in trials for hypertension, CKD, and OSA, with a pre-NDA meeting expected in Q4 and an anticipated NDA filing in late 2025 or early 2026.

Clinical efficacy and safety of lorundrostat

• LAUNCH-HTN trial showed a 16.9mmHg reduction in systolic BP at week 6, increasing to 19mmHg at week 12, with 44.1% of patients reaching BP goals versus 24.1% on placebo.

• ADVANCE-HTN trial in high-risk patients showed 41% of lorundrostat patients achieved BP goals by week 4 versus 18% on placebo.

• EXPLORE-CKD trial demonstrated significant reductions in systolic BP and urinary albumin-to-creatinine ratio (UACR), indicating renal benefit.

• Safety profile is favorable, with low rates of serious adverse events and mild, predictable potassium increases similar to ACE inhibitors and ARBs.

Market opportunity and commercial strategy

• Approximately 20 million people in the U.S. have uncontrolled or resistant hypertension, with significant overlap in CKD and OSA comorbidities.

• 8.8 million u/rHTN patients per year try new treatments, highlighting dissatisfaction with current options and opportunity for lorundrostat.

• Surveys indicate high likelihood of prescribing lorundrostat among primary care physicians, cardiologists, and nephrologists based on efficacy and safety.

• Commercial strategy targets initial launch in resistant hypertension, with expansion into comorbid CKD and OSA populations.