Mineralys Therapeutics (MLYS) Corporate presentation summary

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).

• Dysregulated aldosterone is implicated in 30% of u/rHTN cases and is linked to comorbidities such as chronic kidney disease (CKD) and obstructive sleep apnea (OSA).

• Lorundrostat has shown meaningful 24-hour blood pressure reduction and safety in u/rHTN, CKD, and OSA populations.

• NDA for lorundrostat has been accepted, with a target PDUFA date of December 22, 2026.

Clinical efficacy and safety

• Lorundrostat demonstrated robust reductions in systolic blood pressure across multiple clinical trials, including LAUNCH-HTN, ADVANCE-HTN, EXPLORE-CKD, and EXPLORE-OSA.

• Up to 44% of lorundrostat-treated patients achieved BP goals versus 24% on placebo in real-world settings.

• In CKD patients, lorundrostat reduced urinary albumin-to-creatinine ratio by 31% at 4 weeks.

• Safety profile is favorable, with very low rates of serious adverse events and treatment discontinuations across diverse patient groups.

• Potassium elevations were mild and comparable to ACE inhibitors and ARBs, typically resolving within two weeks.

Market opportunity and commercial strategy

• Approximately 20 million people in the U.S. have u/rHTN, with significant overlap in CKD and OSA populations.

• Each year, 8.8 million u/rHTN patients try new treatments, representing a large eligible pool for lorundrostat, especially in third-line and fourth-line therapy.

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

• Launch strategy targets both generalists and specialists, leveraging clinical data to drive adoption in high-need populations.