---
schema_version: "secwatch.filing_event.v1"
accession: "0001933414-25-000088"
form_type: "8-K"
ticker: "MLYS"
cik: "0001933414"
company_name: "Mineralys Therapeutics, Inc."
filed_at: "2025-08-12T23:59:59+00:00"
generated_at: "2026-05-17T14:54:24.900746+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Mineralys Therapeutics Q2 net loss $43.3M; cash $324.9M; pre-NDA meeting set for Q4 2025

## Summary
- Net loss $43.3M vs $41.0M in Q2 2024; R&D expenses $38.3M, G&A $8.5M.
- Cash, equivalents and investments $324.9M, sufficient to fund operations into 2027.
- Explore-CKD Phase 2 met primary endpoints: 9.25 mmHg systolic BP reduction, 30.51% UACR reduction.
- Pre-NDA meeting with FDA scheduled for Q4 2025; Explore-OSA top-line data expected in 1H 2026.
- Pivotal Launch-HTN and Advance-HTN results published in JAMA and NEJM.

## SEC filing metadata
- accession: 0001933414-25-000088
- form_type: 8-K
- ticker: MLYS
- cik: 0001933414
- company_name: Mineralys Therapeutics, Inc.
- filed_at: 2025-08-12T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1933414/000193341425000088/0001933414-25-000088-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1933414/000193341425000088/mlys-20250812.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001933414-25-000088
- JSON: https://secwatch.observer/filing/0001933414-25-000088.json
- Plain text: https://secwatch.observer/filing/0001933414-25-000088.txt

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