Mineralys Therapeutics (MLYS) 7th Annual Evercore ISI HealthCONx Conference summary

Program overview and trial design

• Focus on aldosterone's role in cardiorenal metabolic syndrome, with robust phase 2 efficacy on blood pressure and manageable hyperkalemia risk guiding pivotal development.

• Two pivotal hypertension studies: Advance-HTN (specialist-focused, standardized regimen) and Launch-HTN (real-world, global, background treatment not standardized).

• Both studies require diuretic use and are designed to support an NDA package, with key data readouts expected in the first half of 2025.

• Advance-HTN is 90% powered for a 7 mmHg placebo-adjusted SBP reduction on 24-hour ABPM; Launch-HTN is 98% powered at six weeks for the same endpoint.

• Dose response in phase 2 showed similar effects for 50 mg and 100 mg, with titration in pivotal studies aimed at optimizing individual patient response.

Key findings from prior studies and sensitivity analyses

• Target-HTN phase 2 data informed dose selection, with sensitivity analyses revealing a 10.5 mmHg SBP reduction in a refined patient subset.

• Nighttime BP reduction was 8 mmHg for 100 mg and 4 mmHg for 50 mg, with nighttime BP being a critical cardiovascular risk metric.

• BMI and diuretic use were independent predictors of response; synergy with diuretics led to their inclusion in all pivotal study backgrounds.

Safety and risk management

• Hyperkalemia risk is managed by lowering potassium entry criteria and ensuring 100% diuretic use, which may reduce incidence compared to prior studies.

• Titration to 100 mg only occurs if patients do not reach BP goals and have normal electrolytes, aiming to minimize unnecessary exposure.