Cabaletta Bio(CABA) - 2025 Q3 - Quarterly Results

Clinical Development - Rese-cel demonstrated potentially transformative, drug-free clinical responses with a favorable safety profile for autoimmune patients, supporting outpatient use[1] - All myositis patients in the Phase 1/2 DM/ASyS cohort met the registrational primary endpoint of moderate or major total improvement score response[6] - Planned BLA submission for rese-cel in myositis is expected in 2027, based on a 14-patient registrational cohort[1] - FDA alignment on additional registrational cohort designs for RESET-SSc and RESET-SLE is anticipated by year-end 2025[1] - Initial data from the RESET-PV trial showed complete B cell depletion in 2 of 3 patients treated with a low dose of rese-cel without preconditioning[6] - The planned size of the registrational DM/ASyS cohort is 14 patients, based on the assumed treatment effect of rese-cel[6] - New regulatory designations granted by EMA and FDA include PRIME and RMAT for rese-cel in myositis and systemic lupus erythematosus[10] - Cabaletta expects to present additional clinical data from RESET trials throughout 2026[6] Financial Performance - Research and development expenses were $39.8 million for Q3 2025, up from $26.3 million in Q3 2024, reflecting a 51% increase[11] - Research and development expenses increased to $39.824 million in Q3 2025 from $26.290 million in Q3 2024, representing a 51.7% increase[16] - Total operating expenses rose to $46.588 million in Q3 2025 compared to $33.046 million in Q3 2024, marking a 41.2% increase[16] - Net loss for Q3 2025 was $44.866 million, up from a net loss of $30.629 million in Q3 2024, reflecting a 46.5% increase in losses[16] - Net loss per share for Q3 2025 was $0.44, compared to $0.62 in Q3 2024, indicating a decrease in loss per share[16] Cash and Assets - As of September 30, 2025, Cabaletta had cash, cash equivalents, and short-term investments of $159.9 million, down from $164.0 million as of December 31, 2024[11] - Cash, cash equivalents, and investments totaled $159.931 million as of September 30, 2025, slightly down from $163.962 million at the end of 2024[18] - Total assets increased to $189.759 million as of September 30, 2025, compared to $185.046 million at the end of 2024, showing a growth of 2.3%[18] Liabilities and Equity - Total liabilities rose to $50.293 million as of September 30, 2025, up from $32.711 million at the end of 2024, indicating a significant increase of 53.7%[18] - Total stockholders' equity decreased to $139.466 million as of September 30, 2025, down from $152.335 million at the end of 2024, reflecting an 8.4% decline[18]