Cabaletta Bio, Inc. posted an updated corporate presentation on its website detailing rese-cel clinical progress, no preconditioning data, automated manufacturing, and planned 2026 data readouts across autoimmune trials.
Key takeaways
Posted updated Corporate Presentation (Exhibit 99.1) on April 20, 2026, to Investors & Media website section.
Pivotal myositis study enrolling with planned 2027 BLA submission; complete Phase 1/2 data expected in SSc and SLE/LN in 1H26.
No preconditioning rese-cel data shows early near-complete symptom resolution in 2/3 PV and SLE patients at threshold dose.
Initial patients dosed with Cellares automated manufacturing; initial data presentation planned.
Safety profile supports outpatient use: 95% no CRS or Grade 1 CRS, 95% no ICANS in first 40 preconditioned patients.
FDA Fast Track and RMAT designations received for rese-cel in multiple indications including myositis, SLE, SSc, MG, MS.