Mineralys Therapeutics, Inc. Q3 FY2024 earnings call

Clinical Progress

• Completed enrollment in Advance-HTN trial for lorundrostat in hypertension, with key demographics: >66% BMI ≥30, >40% women, >50% Black/African-American. Utilizing 24-hour ABPM and AiCure for compliance.
• Upcoming milestones: Advance-HTN top line data expected in March 2025, Launch-HTN top line data moved to mid-first half 2025, Explore-CKD top line data in Q2 2025.
• Hosted KOL event with insights on unmet need in hypertension and potential of lorundrostat.

Financials

• R&D expenses increased due to preclinical/clinical costs, clinical supply, and headcount additions.
• G&A expenses increased due to higher compensation and professional fees.
• Net loss widened compared to prior year.

Mineralys Therapeutics does not have traditional product segments with revenue contributions as it is focused on a single clinical program for lorundrostat. Financials for the quarter: Cash, cash equivalents, and investments were $263.6M as of September 30, 2024. R&D expenses were $54M, G&A expenses were $6.1M, net loss was $56.3M.

Forward-Looking Statements

• Advance-HTN top line data expected in March 2025.
• Launch-HTN top line data moved to mid-first half 2025.
• Explore-CKD top line data expected in Q2 2025.
• Current cash reserves expected to fund clinical trials into 2026.

Risks

• Uncertainties in clinical trial outcomes, including placebo response variability.
• Adherence issues and potential impact on trial results.
• Safety concerns like sinus tachycardia at high doses and rare adverse events like dysgeusia.
• Variability in placebo response across different study populations and measurement techniques.

Q: Michael DiFiore asked about night-time blood pressure in Target-HTN and safety margins of 360 mg dose A: David Rodman responded that sinus tachycardia at 360 mg is a pharmacodynamic effect of volume depletion, not a safety concern, and no explanation for dysgeusia provided Q: Richard Law asked about adherence in Target-HTN and power assumptions for subgroups in Advance-HTN A: David Rodman discussed adherence challenges, and Jon Congleton stated Advance-HTN has 90% power overall, Launch-HTN >95% power Q: Annabel Samimy asked about trial timelines and subset analysis in Launch-HTN A: Jon Congleton explained Launch-HTN's design is confirmatory to Target-HTN, with 6-week primary endpoint and prespecified subset analysis Q: Unidentified Analyst asked about demographics in Launch vs Target-HTN A: Jon Congleton noted Launch-HTN is global, similar obesity correlation, and Target-HTN had ~31 BMI mean and ~39% Black/African-American Q: Rami Katkhuda asked about eGFR impact on hyperkalemia and compliance analysis in Launch-HTN A: Jon Congleton discussed eGFR considerations and prespecified compliance analysis in Launch-HTN Q: Matthew Caufield asked about clinical meaningfulness in Explore-CKD A: Jon Congleton stated clinical meaningfulness applies to Explore-CKD, focusing on BP benefit and renal function