Exhibit 99.1
Cabaletta Bio Reports First Quarter 2026 Financial Results and Provides Business Update
Preconditioning-free (PC-free) 6-to-9-month clinical data with a single infusion of the lowest dose of rese-cel in the RESET-PV® study presented today at ASGCT 2026 Annual Meeting along with initial rese-cel translational data using Cellares’ industrialized, automated manufacturing
PC-free rese-cel initial data from the lowest dose RESET-SLE cohort expected in 1H26
Pivotal RESET-Myositis® cohort with outpatient dosing option progressing to support first planned BLA submission for rese-cel next year
Second pivotal indication for advancement to be announced after presentation of complete Phase 1/2 lupus and scleroderma data during June 2026 EULAR Congress
PHILADELPHIA, May 14, 2026 -- Cabaletta Bio, Inc. (Nasdaq: CABA), a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases, today reported financial results for the first quarter ended March 31, 2026, and provided a business update.
“Since January, while advancing our myositis pivotal trial and planning to initiate a second pivotal indication, we announced that we have signed a long-term commercial supply agreement with Cellares which provides the potential to produce rese-cel for thousands of patients per year at among the lowest cost of goods in the industry with minimal capital investment. In addition, today we are presenting data at ASGCT demonstrating that without preconditioning, even the lowest dose of rese-cel demonstrated compelling drug-free clinical responses in half of the pemphigus vulgaris patients through 6-months of follow-up,” said Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta. “Later this quarter, we expect to announce initial data from the lowest dose cohort of lupus patients dosed without preconditioning. In the second half of 2026, we expect to report longer-term, PC-free rese-cel data from the lowest dose RESET-PV and RESET-SLE cohorts as well as data from patients treated with a higher PC-free dose of rese-cel. Bolstered by our recent oversubscribed financing, we believe we are well-positioned to advance rese-cel to BLA submission and potential commercial launch while continuing to differentiate and deliver rese-cel to autoimmune disease patients at scale.”
Recent Operational Highlights and Upcoming Anticipated Milestones
Rese-cel: Rese-cel (resecabtagene autoleucel) is an investigational, autologous CAR T cell therapy engineered with a fully human CD19 binder and a 4-1BB co-stimulatory domain, designed specifically for the treatment of autoimmune diseases. Administered as a single, weight-based infusion after discontinuation of all immunomodulators, rese-cel has demonstrated the ability to transiently, reliably and deeply deplete CD19-positive cells, with the goal of resetting the immune system and achieving durable clinical responses without the need for