---
schema_version: "secwatch.filing_event.v1"
accession: "0001933414-25-000139"
form_type: "8-K"
ticker: "MLYS"
cik: "0001933414"
company_name: "Mineralys Therapeutics, Inc."
filed_at: "2025-11-10T23:59:59+00:00"
generated_at: "2026-05-16T22:40:56.614576+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Mineralys Therapeutics Q3 net loss $36.9M; NDA planned late-2025/Q1 2026; cash $593.6M

## Summary
- Net loss $36.9M for Q3 2025 vs $56.3M YoY; R&D expenses fell to $31.5M from $54.0M.
- Cash, cash equivalents and investments $593.6M at Sep 30, 2025 (Dec 31, 2024: $198.2M) after $287.5M equity financing.
- NDA submission for lorundrostat planned late 2025 or Q1 2026 following pre-NDA FDA feedback.
- Enrollment complete in Explore-OSA Phase 2 trial; topline data anticipated Q1 2026.
- Company expects current cash to fund planned clinical and regulatory activities into 2028.

## SEC filing metadata
- accession: 0001933414-25-000139
- form_type: 8-K
- ticker: MLYS
- cik: 0001933414
- company_name: Mineralys Therapeutics, Inc.
- filed_at: 2025-11-10T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1933414/000193341425000139/0001933414-25-000139-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1933414/000193341425000139/mlys-20251110.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001933414-25-000139
- JSON: https://secwatch.observer/filing/0001933414-25-000139.json
- Plain text: https://secwatch.observer/filing/0001933414-25-000139.txt

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