Clinical Read2026-06-30

Rese-cel (formerly CABA-201)

Cabaletta BioCABA

Indication
Systemic sclerosis
Stage
Phase 1/2
Event
Phase 1/2 Data readout
Details

May 14, 2026 — Cabaletta Bio, Inc. (Nasdaq: CABA) reported Q1 2026 financial results and highlighted progress for rese-cel (resecabtagene autoleucel), its investigational autologous CD19 CAR T therapy for autoimmune diseases. At the ASGCT 2026 Annual Meeting, Cabaletta presented preconditioning-free (PC-free) 6–9 month clinical and translational data from RESET-PV (pemphigus vulgaris): in four patients treated with the lowest dose, “drug-free” clinical responses were reported in 2/4 through 6 months; initial experience with Cellares-manufactured rese-cel (two evaluable patients) showed CAR T expansion and B-cell depletion comparable to current manufacturing partners. Cabaletta expects initial PC-free data from the lowest-dose RESET-SLE cohort in 1H26 and longer-term PC-free data from RESET-PV/RESET-SLE plus higher-dose PC-free data in 2H26. The registrational, 17-patient RESET-Myositis cohort is enrolling to support a planned first BLA in 2027, and a second pivotal indication is expected to be announced after June 2026 EULAR presentations. Business updates include a 10-year commercial supply agreement with Cellares and a $150M registered direct offering. Q1 2026: R&D $37.4M; G&A $6.9M; net loss $43.5M; cash/investments $116.6M (expects funding into mid-2027 with May financing).

Financial Snapshot

Market Cap

$616.3M

Price

$3.67