---
schema_version: "secwatch.filing_event.v1"
accession: "0001933414-25-000057"
form_type: "8-K"
ticker: "MLYS"
cik: "0001933414"
company_name: "Mineralys Therapeutics, Inc."
filed_at: "2025-05-12T23:59:59+00:00"
generated_at: "2026-05-22T00:39:51.675730+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.88
calibrated_materiality_score: 0.88
confidence: "high"
source: SEC EDGAR
---

# Mineralys reports positive pivotal trial results; Q1 net loss $42.2M; cash $343M

## Summary
- Launch-HTN: 50 mg lorundrostat achieved 9.1 mmHg placebo-adjusted SBP reduction at week 6 (p<0.0001).
- Advance-HTN: 50 mg cohort met primary endpoint; 7.9 mmHg placebo-adjusted SBP reduction (p=0.001).
- Cash, equivalents and investments $343.0M as of March 31, 2025, vs $198.2M at Dec 31, 2024.
- Net loss for Q1 2025 was $42.2M, up from $31.5M in Q1 2024; R&D expenses rose to $37.9M.
- Appointed Eric Warren as Chief Commercial Officer; pre-NDA meeting with FDA expected Q4 2025.

## SEC filing metadata
- accession: 0001933414-25-000057
- form_type: 8-K
- ticker: MLYS
- cik: 0001933414
- company_name: Mineralys Therapeutics, Inc.
- filed_at: 2025-05-12T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.88
- calibrated_materiality_score: 0.88
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1933414/000193341425000057/0001933414-25-000057-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1933414/000193341425000057/mlys-20250512.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001933414-25-000057
- JSON: https://secwatch.observer/filing/0001933414-25-000057.json
- Plain text: https://secwatch.observer/filing/0001933414-25-000057.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.