Mineralys Therapeutics, Inc. Q1 FY2025 earnings call

• Jon Congleton opened by highlighting clinical milestones, including positive top-line data from pivotal Launch-HTN and Advance-HTN trials in uncontrolled and resistant hypertension, with results published in NEJM and presented at ACC. • Dave Rodman discussed details of Launch-HTN and Advance-HTN trials, including significant systolic BP reductions and favorable safety profiles. • Adam Levy reviewed first quarter financials: cash, cash equivalents, and investments at $343M; R&D expenses at $37.9M; G&A expenses at $6.6M; net loss at $42.2M. • Appointment of Eric Warren as Chief Commercial Officer; completion of public equity financing raising ~$201.2M.

No distinct product segments reported; focus is on the clinical and financial performance of lorundrostat and related programs.

• Anticipate discussing results from Launch, Advance, Target-HTN, Transform-HTN, and Explore-CKD trials with FDA in Q4 2025 for NDA submission planning. • Expect top-line data from Explore-CKD trial later in the quarter. • Plan to leverage lorundrostat's clinical profile for potential commercialization and partnering.

• Actual results may differ materially from forward-looking statements due to risks and uncertainties associated with the business, including those in SEC filings. • Uncertainties related to clinical trial outcomes, regulatory approvals, and market acceptance of lorundrostat.

Q: Regarding the CKD trial, will a certain level of hyperkalemia be acceptable if lorundrostat yields a high single-digit placebo-adjusted SBP reduction?

A: Jon Congleton stated specialists treating advanced kidney disease patients are focused on BP benefit and overall kidney function improvement, with tools to manage hyperkalemia and modulate background treatments.

Q: Will data from Explore-OSA be included in the NDA package?

A: Jon Congleton said it's too early to opine; no guidance on top-line data yet, but excited about the study addressing unmet need in OSA-resistant hypertension.

Q: What are gating factors for finalizing and filing the NDA?

A: Jon Congleton mentioned key factors include benefit-risk profile, completion of pivotal programs, unlabeled extension data, and dialogue with FDA in Q4 2025 for pre-NDA meeting guidance.

Q: Plans for subgroup analysis in hypertension readout?

A: Jon Congleton noted prespecified analysis of unique responders, with data showing profound reductions across subsets like gender, age, race, and number of background medications, with ongoing exploration of ideal populations.