- Cabaletta Bio expanded its manufacturing network by adding ElevateBio as a CDMO partner alongside Lonza to support future commercial supply of its investigational CAR T therapy, rese-cel.
- The company remains on track to report registrational data for RESET-Myositis in mid-2027 and plans a potential Biologics License Application submission in the second half of 2027.
Cabaletta Bio reported second-quarter 2026 financial results and provided a business update highlighting progress across its resecabtagene autoleucel (rese-cel) development program and manufacturing strategy. The company announced that it has added ElevateBio as a contract development and manufacturing organization (CDMO) partner alongside Lonza to increase manufacturing capacity and strengthen supply chain resilience as rese-cel advances toward potential commercialization. Cabaletta also reiterated that registrational data from the RESET-Myositis study remain on track for mid-2027, with a potential Biologics License Application (BLA) submission planned for the second half of 2027.
Rese-cel is an investigational CAR T-cell therapy designed to reset the immune system in patients with autoimmune diseases. According to the company, Phase 1/2 data have demonstrated durable clinical responses following a single infusion across multiple autoimmune indications. Cabaletta is also preparing to initiate a registrational study in systemic sclerosis-associated interstitial lung disease during the fourth quarter of 2026 and is expanding evaluation of a preconditioning-free approach across additional clinical programs.
“A single infusion of rese-cel has demonstrated the potential to deliver deep, clinical responses after discontinuation of all immunomodulators with up to 1.5 years of follow-up as reported in the most recent Phase 1/2 clinical experience.”
Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta Bio
The company also highlighted its automated manufacturing strategy, including a previously announced 10-year commercial supply agreement with Cellares. Cabaletta said ElevateBio, Lonza, and Cellares will support the transition from clinical to commercial manufacturing using an automated process designed to increase production capacity for autologous cell therapies.
For the second quarter ended June 30, 2026, Cabaletta reported research and development expenses of $44.4 million, compared with $37.6 million in the same period of 2025. The company ended the quarter with approximately $225.1 million in cash, cash equivalents, and short-term investments and said it expects its current cash position to fund operations into mid-2027.
