secwatch.observer — SEC 8-K summary
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Issuer:     Cabaletta Bio, Inc. (CABA)
CIK:        0001759138
Form:       8-K
Filed at:   2025-10-09T23:59:59+00:00
Accession:  0001193125-25-235533
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud

Cabaletta Bio presents first rese-cel data without preconditioning at ESGCT 2025
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- Rese-cel without preconditioning achieved complete B cell depletion in two of three PV patients, with rapid autoantibody reduction and near-complete symptom resolution.
- PDAI activity scores improved from baseline to latest follow-up: Patient 1 (24 to 10 at 4 mo), Patient 2 (83 to 3 at 3 mo), Patient 3 (22 to 2 at 1 mo).
- All three patients remained off immunomodulators since infusion and are off or tapering steroids as of the September 11, 2025 data cut-off.
- CAR T cell expansion kinetics without preconditioning were similar to those observed across 30+ patients dosed with preconditioning in other RESET trials.
- No ICANS was reported; one patient had transient grade 1 CRS, and another required steroids for a disease flare that later tapered below baseline.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1759138/000119312525235533/0001193125-25-235533-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1759138/000119312525235533/caba-20251009.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-235533

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