On May 2, 2023, Mineralys Therapeutics, Inc. announced the first patient dosed in the ADVANCE-HTN pivotal trial to evaluate the safety and efficacy of lorundrostat for the treatment of uncontrolled hypertension (uHTN) and resistant hypertension (rHTN) when used as an add-on therapy to standardized background treatment of two or three antihypertensive medications. The topline data from this trial are expected in the first half of 2024. The randomized, double-blind, placebo-controlled ADVANCE-HTN trial will enroll up to approximately 300 eligible adult participants who will be randomized to three arms placebo, lorundrostat 50 mg once daily (QD), and lorundrostat 50 uHTN 50 mg QD and then titrated to 100 mg QD, as needed, at week four.

The primary endpoint of the trial is change in systolic blood pressure versus placebo after 12 weeks of treatment, as measured by 24-hour ambulatory blood pressure monitoring. This is the first of two clinical trials under the planned pivotal program to evaluate the safety and efficacyof lorundrostat for The treatment of uHTN and rHTN subjects, is expected to begin enrolling in the second half of 2023, with data anticipated in mid-2025. Patients from both studies will be offered the opportunity to participate in an open label extension trial after completion of these trials.

In addition, the Company plans to initiate a randomized, double-blind, randomized, double-blind, trial to evaluate the safety and effectiveness of lorundroStat for the treatment of uHTN and RHTN in a chronic kidney disease (CKD) population in mid-2023. Topline data from the CKD trial is expected in the first half of 2022. In November 2022, the Company presented results of its Target-HTN Phase 2 trial demonstrating that lorundrostat lowered the systolic blood pressure of patients with uHTN and rHT N at a clinically meaningful and statistically significant level, with a mean placebo-adjusted reduction in systolic blood pressure of 9.6 mmHg and 7.8 mmHg with a 50 mg or 100 mg QD dose, respectively.

Additionally, treatment with lorundrostat demonstrated a robust effect in obese patients, who, studies show, tend to have abnormal aldosterone biology. The Company believes the approach of reducing aldosterone production can provide an effective, targeted approach for the control of hypertension, especially in the rapidly growing subset of hypertensive individuals with obesity.