Cabaletta Bio (CABA) investor relations material

Executive summary

• Focused on late-stage clinical development of engineered T cell therapies for autoimmune diseases, with rese-cel as the lead candidate in multiple ongoing trials across rheumatology, neurology, and dermatology indications.

• Rese-cel, an investigational CAR T cell therapy, continues to show durable clinical responses in autoimmune diseases, with up to 1.5 years of follow-up after a single infusion and discontinuation of immunomodulators.

• Presented positive clinical data at EULAR 2026, showing significant improvement in disease activity and safety across myositis, lupus, and systemic sclerosis cohorts.

• Expanded manufacturing partnerships and commercial readiness, including agreements with Lonza, Oxford Biomedica, Cellares, and ElevateBio for scalable production and a 10-year supply agreement.

• Ended the quarter with $225.1 million in cash and cash equivalents, expected to fund operations into mid-2027.

Financial highlights

• Net loss for Q2 2026 was $51.0 million, compared to $45.1 million in Q2 2025; net loss for the first half of 2026 was $94.5 million, up from $81.1 million year-over-year.

• Research and development expenses rose to $44.4 million in Q2 2026 (from $37.6 million), driven by increased clinical trial activity, manufacturing, and milestone payments.

• General and administrative expenses decreased to $7.6 million in Q2 2026 (from $8.3 million), reflecting lower personnel costs.

• Cash, cash equivalents, and short-term investments totaled $225.1 million as of June 30, 2026, up from $133.6 million at year-end 2025.

• Cash provided by financing activities in the first half of 2026 totaled $175.3 million, including $140.2 million from a May 2026 equity offering.

Outlook and guidance

• Current cash runway is expected to fund operations into mid-2027, but substantial additional financing will be required to complete clinical development and commercialization.

• Anticipates reporting BLA-enabling topline data for the myositis registrational cohort in mid-2027, with a potential BLA submission in the second half of 2027.

• Plans to initiate a registrational study in systemic sclerosis in Q4 2026 and provide updates on lupus and myasthenia gravis programs as dose-ranging data mature.

• Plans to expand outpatient dosing options and advance PC-free approaches across the RESET program.

• Manufacturing scale-up expected to support transition to commercial supply with minimal capital investment.