Mineralys Therapeutics (MLYS) Corporate presentation summary

Strategic focus and market opportunity

• Lorundrostat, a selective aldosterone synthase inhibitor, targets dysregulated aldosterone, a key driver in uncontrolled and resistant hypertension (u/rHTN) and cardiorenal diseases.

• Approximately 20 million u/rHTN patients in the U.S. represent a significant addressable market, with increased opportunity in comorbid CKD and OSA.

• More than half of new-to-line u/rHTN patients annually are eligible for lorundrostat as a third-line or higher therapy, totaling 8.8 million potential new patients per year.

• Majority of primary care physicians, cardiologists, and nephrologists are likely to prescribe lorundrostat based on efficacy and safety data.

• Commercial launch preparations are underway, with NDA accepted and a PDUFA target date of December 22, 2026.

Clinical efficacy and safety

• Lorundrostat demonstrated meaningful 24-hour blood pressure reduction and safety in u/rHTN, CKD, and OSA patient subgroups.

• Clinical trials showed robust systolic BP reductions, with up to 44% of lorundrostat patients achieving BP goals versus 24% on placebo.

• Favorable safety and tolerability profile observed, with very low rates of serious adverse events and treatment discontinuations across studies.

• Potassium profile is mild and predictable, similar to ACE inhibitors and ARBs, with increases typically resolving within two weeks.

• No evidence of cortisol inhibition or adrenal insufficiency, supporting suitability for fixed-dose combinations.

Disease landscape and unmet need

• Dysregulated aldosterone is implicated in 30% of u/rHTN cases and is linked to obesity, CKD, OSA, and increased cardiovascular risk.

• Uncontrolled and resistant hypertension is the leading global modifiable risk factor for cardiovascular death, accounting for over 10 million deaths in 2021.

• Half of treated hypertension patients in the U.S. fail to achieve BP goals, with aldosterone breakthrough common even on ACEI or ARB therapy.

• Cardiorenal-metabolic syndrome (CRMS) conditions present high cardiovascular risk and large unmet therapeutic need.

• Lorundrostat addresses overlapping CRMS conditions, including hypertension, CKD, OSA, and heart failure.