Mineralys Therapeutics, Inc. Q2 FY2025 earnings call

Jon Congleton began by highlighting the company's leading role in developing aldosterone synthase inhibitors (ASIs) for hypertension and comorbid conditions like chronic kidney disease (CKD) and obstructive sleep apnea (OSA). Key clinical milestones included pivotal data from Launch-HTN and Advance-HTN trials, with survey results showing 95% of clinicians likely to prescribe lorundrostat if approved. Adam Levy reviewed financial results: cash, cash equivalents, and investments were $324.9M as of June 30, 2025; R&D expenses decreased due to conclusion of the lorundrostat pivotal program but were offset by higher compensation and other costs; G&A expenses increased; net loss was $43.3M. Congleton also discussed ongoing pre-commercial efforts, clinical trials like Explore-CKD and EXPLORE-OSA, and a pre-NDA meeting with the FDA scheduled for Q4 2025.

Anticipates top line data from EXPLORE-OSA in the first [Technical Difficulty]. Scheduled a pre-NDA meeting with the FDA in the fourth quarter of 2025.

Uncertainty regarding competitor data (e.g., AstraZeneca's BAX-HTM data) and how it may impact lorundrostat's positioning. Potential challenges in commercialization and payer negotiations.

Q: On AstraZeneca's full Phase III BAX-HTM data and thoughts on hyperkalemia rates and partnership discussions A: Jon Congleton stated it's hard to opine on BAX-HTM data specifics but emphasized lorundrostat's favorable safety profile and 95% clinician intent to prescribe if approved. On partnerships, they're interested in partnering ex U.S. and in the U.S. to extend reach.

Q: Thoughts on lorundrostat combination strategies outside hypertension and SGLT2 inhibitors in CKD A: Jon Congleton mentioned aldosterone's role in related comorbidities like CKD, heart failure, and OSA, and lorundrostat's robust response in trials, indicating potential in these areas Q: Drug-drug interactions with PPI and 24-hour profile of lorundrostat A: Jon Congleton noted PPI use is common, with lorundrostat allowing PPI use three times per week and monitoring blood pressure. Confident in 24-hour blood pressure control from clinical studies Q: Commercial launch targeting and pre-NDA meeting preparation A: Jon Congleton stated it's too early for detailed commercial strategy but focused on payer strategy and medical affairs dissemination. Confident in the comprehensive data package for the pre-NDA meeting Q: Baxdrostat data comparison and open-label extension trial A: Jon Congleton discussed trial design differences but hard to opine on Baxdrostat data. Mentioned plans to release data from the open-label extension trial in due course