Cabaletta Bio, Inc. 8-K

What Happened
Cabaletta Bio (CABA) filed an 8‑K on January 12, 2026 to furnish a press release and updated corporate presentation outlining 2026 strategic priorities for its investigational CAR T therapy rese-cel (resecabtagene autoleucel). Key clinical/regulatory moves: it initiated an FDA‑aligned dermatomyositis (DM) and antisynthetase syndrome (ASyS) registrational cohort (started Dec 2025) expected to evaluate 17 patients with a 16‑week primary endpoint; the company expanded the registrational trial by 3 patients to allow enrollment of ~14 DM patients. Cabaletta said positive Phase 1/2 RESET‑Myositis data support a projected Biologics License Application (BLA) submission for myositis in 2027. The company also reported FDA alignment on registrational cohort designs for SLE and lupus nephritis (two ~25‑patient single‑arm cohorts) and noted an RMAT designation for rese-cel in systemic sclerosis.

On manufacturing, Cabaletta obtained IND amendment clearance to use Cellares’ Cell Shuttle (first clearance for an autologous CAR T program) after three engineering runs showed product consistency; clinical manufacturing data from the automated platform are expected in 1H26. Clinical strategy updates include adding dose‑escalation/no‑preconditioning cohorts in RESET‑PV and RESET‑SLE, and complete Phase 1/2 readouts for RESET‑SLE, RESET‑SSc and RESET‑MG are expected in 1H26.

Key Details

• Filing date: Form 8‑K furnished Jan 12, 2026; press release and corporate presentation attached as Exhibits 99.1 and 99.2.
• Myositis registrational cohort: initiated Dec 2025; planned to evaluate 17 patients with a 16‑week primary endpoint; trial expanded by 3 patients to enroll ~14 DM patients.
• Regulatory/design updates: FDA‑aligned SLE and LN registrational cohorts (~25 patients each); RMAT designation granted for systemic sclerosis; RESET‑SSc and RESET‑MG alignment/updates targeted in 1H26/mid‑2026.
• Manufacturing: IND amendment cleared to use Cellares Cell Shuttle; three engineering runs showed consistency; clinical manufacturing data expected in 1H26.

Why It Matters
These updates move rese-cel closer to potential registrational milestones and commercialization readiness. Initiation and expansion of the myositis registrational cohort, plus prior positive Phase 1/2 myositis data, support Cabaletta’s plan to target a BLA submission in 2027. IND clearance to automate manufacturing with Cellares could enable larger-scale, lower‑cost production if clinical and GMP readiness data are confirmed in 1H26. For investors, the filing highlights regulatory progress, upcoming clinical readouts in 1H26, and steps to scale manufacturing — all material developments that could influence the program’s regulatory timeline and commercial potential if trials succeed.