secwatch.observer — SEC 8-K summary
======================================

Issuer:     Cabaletta Bio, Inc. (CABA)
CIK:        0001759138
Form:       8-K
Filed at:   2025-10-27T23:59:59+00:00
Accession:  0001193125-25-250676
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cabaletta Bio: all DM/ASyS myositis patients meet registrational endpoint; SSc and lupus data positive
--------------------------------------------------------------------------------

- All 4 DM/ASyS patients with sufficient follow-up achieved immunomodulatory-free moderate or major TIS response at week 16.
- Initiating DM/ASyS registrational cohort this quarter; plans 14 patients with 16-week primary endpoint of moderate or major TIS.
- All 4 SSc patients with at least 3 months follow-up achieved rCRISS-25 response off all immunomodulators and steroids.
- 7 of 8 lupus patients with sufficient follow-up achieved DORIS remission or renal response; all 9 patients off immunomodulators.
- Expanding RESET-SLE to include no preconditioning cohort; initial data expected 2026; 76 patients enrolled at 77 sites globally.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1759138/000119312525250676/0001193125-25-250676-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1759138/000119312525250676/caba-20251027.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-250676

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