Mineralys Therapeutics, Inc. Q4 FY2024 earnings call

Key Points

• Jon Congleton provided an overview of the business, mentioning upcoming trial data for Advance-HTN (expected March) and Launch-HTN (mid-first half 2024).
• David Rodman discussed clinical programs, including KOL event highlights, ongoing trials like Explore-CKD (enrollment completed, data Q2 2025) and Explore-OSA (initiated).
• Adam Levy reviewed financial results: Cash, cash equivalents, and investments decreased; R&D and G&A expenses increased; net loss widened.

No specific product segment financial performance or revenue contribution % provided as the transcript focuses on clinical programs and overall financials.

Forward-Looking Statements

• Advance-HTN top-line data expected in March 2025.
• Launch-HTN top-line data anticipated in mid-first half of 2025.
• Explore-CKD Phase II trial data expected in Q2 2025.

No detailed discussion of specific risks and operational failures provided in the transcript.

Q: Concerns about extrapolating SBP reduction from small Phase II group to Phase III in Advance-HTN A: Jon Congleton stated confidence in totality of evidence for 50mg QD dose based on individual exposure response and benefit-risk assessment Q: Mechanism of OSA trial improvement and CKD trial SGLT2 confounders A: David Rodman explained OSA trial improvement may be due to fluid volume reduction and non-genomic effects; for CKD trial, SGLT2 naïve patients' effects are accounted for via study design with crossover and sensitivity analysis Q: Guidance on Advance and Launch readout timelines and communication plans A: Jon Congleton confirmed Advance-HTN in March and Launch-HTN mid-first half, with potential corporate announcements or ACC meeting presentations Q: Compliance and device use in Advance-HTN trial A: Jon Congleton and David Rodman discussed experience with ABPM device, training of sites/subjects, and QC requirements for 24-hour ambulatory data Q: Safety and tolerability vs MRAs for lorundrostat A: Jon Congleton and David Rodman highlighted aldosterone synthase inhibitor's distinction from MRAs by reducing plasma aldosterone, avoiding androgenic effects, and modest impact on potassium vs MRAs' hyperkalemia trade-off Q: Payer positioning and addressable market for lorundrostat A: Jon Congleton and David Rodman discussed payer research showing favorable response in resistant and third-line hypertension populations, with addressable market estimated at ~$15-20 million Q: ABPM vs AOBP in Advance-HTN and nighttime coverage of lorundrostat A: Jon Congleton and David Rodman noted concordance between in-office and 24-hour ambulatory measurements in prior trials and confidence in 24-hour coverage due to 10-12 hour half-life Q: Differences in pivotal study responses and aldosterone synthase inhibitor half-life impact A: Jon Congleton discussed different study designs and target populations, and favorable half-life of lorundrostat for CKD and hypertension treatment Q: Mechanism and read through for OSA benefit A: Jon Congleton explained OSA benefit via targeting hypoxia-driven aldosterone increase, with potential fluid shift and inflammation reduction mechanisms