Mineralys Therapeutics (MLYS) Guggenheim Securities Inaugural Healthcare Innovation Conference summary

Strategic focus and clinical rationale

• Targeting dysregulated aldosterone to address cardiorenal metabolic conditions, especially hypertension, with lorundrostat as a targeted therapy for patients not reaching blood pressure goals.

• Emphasis on identifying patient subgroups, such as those with obesity or resistant hypertension, who may benefit most from aldosterone inhibition.

• Clinical approach aims for third-line use, not first-line, to complement existing therapies and address unmet needs.

• Payer strategy built around generating data that demonstrates value in difficult-to-treat populations, aligning with payer interests.

Clinical trial design and learnings

• Target-HTN proof-of-concept study revealed lorundrostat efficacy across renin levels and highlighted BMI as a predictor of response.

• Advance-HTN and Launch-HTN pivotal trials incorporate diuretic use and broad BMI inclusion to confirm and expand on Target-HTN findings.

• Both pivotal studies use rigorous compliance tracking and standardized blood pressure measurement techniques.

• Advance-HTN is designed for specialists with high rigor, while Launch-HTN reflects real-world primary care settings.

Advance-HTN and Launch-HTN specifics

• Advance-HTN uses a run-in period with standardized background meds and compliance monitoring before randomization.

• 24-hour ambulatory blood pressure monitoring is the primary endpoint, with 90% power to detect a 7 mm Hg placebo-adjusted change.

• Two-thirds of Advance-HTN participants have BMI above 30, and over 50% are Black or African American, supporting robust subgroup analyses.

• Launch-HTN is larger, designed to augment safety data, and uses in-office BP measurements with a 12-week duration.