Mineralys Therapeutics, Inc. Q3 FY2025 earnings call

• Jon Congleton provided an overview of the business, including clinical programs and recent milestones: received pre-NDA feedback from FDA, moving ahead with NDA filing, data from Launch-HTN and Advance-HTN pivotal trials demonstrating lorundrostat's efficacy in reducing systolic blood pressure, details on diverse patient populations in trials, and ongoing development activities like Explore-CKD and Explore-OSA. - Adam Levy reviewed financial results: ended Q3 2025 with $593.6M in cash, cash equivalents, and investments; R&D expenses decreased due to conclusion of lorundrostat pivotal program but offset by other increases; G&A expenses increased; net loss decreased compared to Q3 2024.

No distinct product segments with financial performance and revenue contribution % discussed as the focus is on the company's clinical and financial overview rather than product segments.

• Expect to submit NDA either late this quarter or in Q1 2026. - Results from Explore-OSA trial expected in Q1 2026. - Progressing well with open-label extension trial, with DSMB reviewing data and plans to publish results when last subject completes relevant aspects.

• Potential differences in results due to imputations in data analysis. - FDA requirements regarding handling of missing data and imputation in primary analysis. - General business risks associated with clinical trial outcomes and regulatory approvals affecting the NDA process.

Q: On resistant hypertension population and imputations, what would the result be without imputations?

A: Jon Congleton and David Rodman discussed that they haven't done that analysis, it's complicated to estimate imputation without raw data and can vary by 3-5 mmHg.

Q: On FDA requirements regarding missing data and imputation in primary analysis, thoughts?

A: Jon Congleton and David Rodman explained that in Advance-HTN, it was pre-discussed with FDA and set in SAP, and handling missing data needs to be in statistical analysis plan, with different methods like jump to reference possible.

Q: On open-label extension trial expectations and data update?

A: Jon Congleton said they're progressing well with open-label extension, no surprises, DSMB reviewing data, and will publish results when last subject completes relevant aspect.

Q: On leveraging data from Explore-OSA trial?

A: Jon Congleton said Explore-OSA data will help round out lorundrostat's profile by showing benefit beyond blood pressure reduction for patients with related comorbidities.

Q: On differences between lorundrostat and Bax and partnering?

A: Jon Congleton discussed lorundrostat's best-in-class profile, ASIs as a differential class, and ongoing partnering dialogues for ex U.S. commercialization and co-development.

Q: On African-American patients in trials and efficacy difference, percentage to goal?

A: Jon Congleton and others discussed that Advance-HTN had over 50% black/African-American patients, race not a determinant of response, 44% of Launch-HTN patients got to goal at week 6, 42% of Advance patients got to goal at week 4, odds ratio over 3 in each study.