Cabaletta Bio, Inc.

Cabaletta Bio Reports Second Quarter 2026 Financial Results and Provides Business Update

Cabaletta ended the second quarter with $225.1 million in cash and equivalents, sufficient to fund operations into mid-2027, following a registered direct offering in May. The company reported a net loss of $51.0 million, or $0.34 per share, with R&D expenses increasing to $44.4 million to support ongoing trials. The company confirmed that registrational data from the RESET-Myositis cohort is on track for mid-2027, supporting a planned Biologics License Application (BLA) submission in the second half of next year. Cabaletta also announced plans to initiate a registrational study for systemic sclerosis-associated ILD in the fourth quarter of 2026. Manufacturing capacity is being expanded with the selection of ElevateBio as a second CDMO alongside Lonza, building on a previously announced 10-year supply agreement with Cellares for automated production.

•2mo ago

Cabaletta Bio Announces New Rese-cel Data and Development Updates Across Autoimmune Portfolio, Including Encouraging Early PC-Free Lupus Findings, at EULAR 2026 Congress

Cabaletta Bio presented new Phase 1/2 data for rese-cel at EULAR 2026, showing 83% of dermatomyositis patients achieved durable, immunomodulator-free responses lasting up to 1.5 years. In systemic sclerosis, 83% of patients achieved significant skin/lung improvement off immunomodulators, supporting a planned registrational study initiation in 4Q26. Early preconditioning-free (PC-free) lupus data showed deep B-cell depletion at the lowest dose, suggesting a potential pathway to simplify treatment and expand market access.

•4mo ago

Cabaletta Bio Reports First Quarter 2026 Financial Results and Provides Business Update

Cabaletta Bio presented 6-to-9-month clinical data from the lowest dose cohort of rese-cel in the RESET-PV study, showing compelling drug-free clinical responses in half of pemphigus vulgaris patients without preconditioning. The company also announced a 10-year commercial supply agreement with Cellares, which aims to produce rese-cel for thousands of patients per year at a low cost of goods with minimal capital investment. Cabaletta raised $150 million in gross proceeds from a registered direct offering, including participation from major investors such as Eli Lilly and Company, Bain Capital Life Sciences, Adage Capital Management, and Cormorant Asset Management. The company expects to present complete Phase 1/2 data from the RESET-SLE and RESET-SSc trials at the EULAR 2026 Congress in June, further advancing its clinical development program.

•5mo ago

Cabaletta Bio Presents Preconditioning-free Clinical Data and Automated Manufacturing Translational Data for Rese-cel at ASGCT 2026 Annual Meeting

Cabaletta Bio presented clinical data from the first four patients treated with rese-cel in a preconditioning-free setting, showing 50% of patients maintained drug-free responses for 6 months. The company also shared initial manufacturing and translational data from the first two patients treated with rese-cel using the automated Cell Shuttle platform, demonstrating process consistency and similar clinical outcomes. These findings support Cabaletta's goal of expanding patient access and improving the commercial scalability of rese-cel, if approved.

•5mo ago

Cabaletta Bio and Cellares Announce 10-Year Commercial Supply Agreement for Rese-cel

Cabaletta Bio entered a 10-year commercial supply agreement with Cellares to manufacture its lead drug candidate rese-cel using Cellares’ automated Cell Shuttle and Cell Q platforms. The partnership is designed to enable low-cost, scalable production for thousands of patients annually with minimal capital investment, supporting a planned BLA submission next year. Initial translational data from the first two patients dosed with Cellares-manufactured rese-cel is scheduled for presentation at the ASGCT conference in May.

•6mo ago

Cellares and Cabaletta Bio Sign 10-Year Commercial Supply Agreement to Scale Rese-cel

Cabaletta Bio entered a 10-year commercial supply agreement with Cellares to manufacture its lead investigational therapy, rese-cel, leveraging automated platforms for scale. The partnership aims to produce thousands of batches annually at a low cost, addressing the significant manufacturing demands of treating autoimmune diseases with CAR T cell therapy. This agreement follows the first patient dosing using the automated platform, validating the manufacturing process and supply chain logistics.

•6mo ago