Cabaletta reports Q2 2026 results, reaffirms mid-2027 myositis data and 2H27 BLA plan

Cabaletta Bio reported financial results for the quarter ended June 30, 2026, alongside a pipeline update for its CAR T cell therapy rese-cel in autoimmune diseases.

The company said it continues to expect data from a registrational cohort of 17 dermatomyositis and antisynthetase syndrome patients (14 adult DM, 3 adult ASyS) in mid-2027¹. If that data is positive, Cabaletta plans to file its first Biologics License Application with the FDA in the second half of 2027, incorporating both the registrational cohort and a juvenile cohort that could support eligibility for a Priority Review Voucher.¹

At the EULAR 2026 Congress, Cabaletta presented Phase 1/2 data showing that 80% (8 of 10) of evaluable adult DM and ASyS patients would have met the registrational cohort's primary endpoint, with all DM responders sustaining their responses for up to 1.5 years of follow-up¹. Across all 17 Phase 1/2 patients in the myositis trial, every patient had no or only Grade 1 cytokine release syndrome, and none developed neurotoxicity, a profile the company said supports outpatient dosing already used in the trial.¹

For systemic sclerosis, Cabaletta is preparing a single-arm registrational study in about 25 patients with SSc-associated interstitial lung disease, using a forced vital capacity endpoint at 52 weeks, with initiation anticipated in the fourth quarter of 2026.¹

On manufacturing, Cabaletta added ElevateBio as a second contract manufacturing partner alongside Lonza to expand capacity for rese-cel.¹

Financially, R&D expenses were $44.4 million for the quarter versus $37.6 million a year earlier, while G&A expenses were $7.6 million versus $8.3 million.¹ Cash, equivalents and short-term investments totaled about $225.1 million as of June 30, 2026, up from $133.6 million at year-end 2025, which the company said should fund operations into mid-2027.¹