secwatch.observer — SEC 8-K summary
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Issuer:     Cabaletta Bio, Inc. (CABA)
CIK:        0001759138
Form:       8-K
Filed at:   2025-01-13T23:59:59+00:00
Accession:  0001193125-25-005016
Event type: other_material
Sentiment:  neutral
Materiality: 0.60
Item codes: 2.02, 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cabaletta Bio reports $164M cash, expands rese-cel trials into MS, MG, PV; FDA meeting planned 1H25
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- Unaudited cash $164M as of Dec 31, 2024; funds operations into H1 2026.
- 21 patients enrolled across 44 RESET sites in US/Europe; safety data: 90% no CRS/grade 1, 90% no ICANS.
- First patients enrolled in RESET-PV (no preconditioning) and RESET-MG; RESET-MS IND cleared with Fast Track.
- Expanded CDMO agreement with Lonza for clinical supply from H2 2025.
- Plans to meet FDA in 1H 2025 to align on registrational trial designs.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1759138/000119312525005016/0001193125-25-005016-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1759138/000119312525005016/d781872d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-005016

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