---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-003872"
form_type: "8-K"
ticker: "CABA"
cik: "0001759138"
company_name: "Cabaletta Bio, Inc."
filed_at: "2024-01-08T23:59:59+00:00"
generated_at: "2026-06-07T02:25:52.929488+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA grants Fast Track to CABA-201 for dermatomyositis and systemic sclerosis; cash $241M

## Summary
- FDA Fast Track Designations for CABA-201 in dermatomyositis (improve disease activity) and systemic sclerosis (improve organ dysfunction).
- Unaudited cash, cash equivalents and short-term investments of $241M as of Dec 31, 2023; cash runway into first half of 2026.
- Raised ~$94.1M in Q4 2023 via ATM program at avg $19.76/share (4.76M shares).
- Anticipates initial Phase 1/2 data for SLE and myositis in H1 2024; for SSc and gMG in H2 2024.
- Plans to file INDs for CABA-201 in additional autoimmune indications in 2024; combined US prevalence >1M patients.

## SEC filing metadata
- accession: 0001193125-24-003872
- form_type: 8-K
- ticker: CABA
- cik: 0001759138
- company_name: Cabaletta Bio, Inc.
- filed_at: 2024-01-08T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1759138/000119312524003872/0001193125-24-003872-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1759138/000119312524003872/d265299d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-003872
- JSON: https://secwatch.observer/filing/0001193125-24-003872.json
- Plain text: https://secwatch.observer/filing/0001193125-24-003872.txt

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