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

Cabaletta Bio, Inc.

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.

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