Mineralys Therapeutics (MLYS) Goldman Sachs 45th Annual Global Healthcare Conference summary

Strategic focus and market opportunity

• Targeting cardiorenal metabolic disorders, with hypertension as the initial indication, especially in patients with dysregulated aldosterone.

• Lorundrostat is positioned as a highly selective, effective, and well-tolerated aldosterone synthase inhibitor.

• Hypertension remains a major unmet need, with current generic therapies not addressing aldosterone-driven cases, which are increasing due to obesity.

• The company aims to identify and treat patients most likely to benefit from lorundrostat, focusing on those with aldosterone-dependent hypertension.

• Significant market potential exists, with 118-120 million hypertensive patients in the U.S. alone.

Clinical development and study design

• Two pivotal studies, ADVANCE-HTN (rigorous, standardized background therapy) and LAUNCH-HTN (real-world, larger scale), form the NDA package.

• Recent changes to the primary endpoint: LAUNCH-HTN now measures at week 6 (from week 12), and ADVANCE-HTN at week 4, to avoid confounding from dose titration and improve statistical power.

• Both studies will still collect 12-week data as key secondary endpoints, ensuring a comprehensive efficacy profile.

• The design changes were made collaboratively with the FDA and do not alter operational aspects or the overall study design.

• ADVANCE-HTN uses ambulatory BP as the primary endpoint, while LAUNCH-HTN uses in-office BP, reflecting their different real-world and controlled settings.

Efficacy expectations and competitive landscape

• Physicians and payers expect an 8-10 mmHg reduction in systolic BP, similar to or better than spironolactone, but without its side effects.

• The targeted approach, especially in obese patients, is resonating with prescribers and payers.

• The company is confident that the earlier time points will capture maximal drug effect, with 12-week data providing additional validation.

• Inclusion of patients previously treated with MRAs in ADVANCE-HTN is not seen as a risk, as lorundrostat's mechanism and safety profile differ.

• LAUNCH-HTN is expected to replicate results from earlier studies, despite a more diverse, global population.