secwatch.observer — SEC 8-K summary
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Issuer:     Mineralys Therapeutics, Inc. (MLYS)
CIK:        0001933414
Form:       8-K
Filed at:   2026-08-11T20:08:44+00:00
Accession:  0001933414-26-000112
Event type: earnings
Sentiment:  neutral
Materiality: 0.75
Item codes: 2.02, 5.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Mineralys Q2 net loss $241M; lorundrostat PDUFA Dec 22, 2026; new CMO appointed
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- Q2 2026 net loss $241.1M vs $43.3M in Q2 2025; R&D $221.4M incl $200M Tanabe upfront payment.
- Cash $661.4M at June 30; raised ~$150M offering and drew $100M tranche of $500M Pharmakon loan.
- FDA PDUFA target date Dec 22, 2026 for lorundrostat NDA; commercial launch preparations on track.
- Amended Tanabe license: $200M paid to eliminate royalties; remaining milestones up to $255M.
- Appointed Dr. Terry Ferguson CMO effective Aug 10; David Rodman stays as Strategic Advisor.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1933414/000193341426000112/0001933414-26-000112-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1933414/000193341426000112/mlys-20260805.htm
  HTML page:      https://secwatch.observer/filing/0001933414-26-000112

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer