Cabaletta Bio (CABA) Earnings Call Presentation

Rese-cel Development and Regulatory Strategy - Cabaletta Bio plans to submit a Biologics License Application (BLA) for Rese-cel in 2027 following recent alignment with the FDA [7] - The company is rapidly accelerating enrollment across a broad portfolio of indications at 67 active clinical sites [7, 14] - The initial BLA submission is planned in myositis, which affects approximately 80,000 US patients, followed by rapid expansion to SLE/LN and SSc [7] - The FDA has aligned with Cabaletta Bio on an open-label, single-arm evaluation of two registrational cohorts in the RESET-Myositis trial, with approximately 15 patients in each subtype-specific cohort [8] - Over 40% of the safety database is already enrolled across the RESET clinical development program [18] Clinical Data and Efficacy - Clinically meaningful responses have been observed with most patients off all immunomodulatory medications and steroids [8] - Deep transient systemic B cell depletion in blood and tissues has been confirmed by lymph node biopsy in an SSc patient [8] - In non-renal SLE, 3 out of 4 patients achieved DORIS (Definition of Remission in SLE) at the latest follow-up [84] - In the LN cohort, the first patient achieved CRR (Complete Renal Response) at week 44 [89] Manufacturing and Innovation - Cabaletta Bio is evaluating a whole blood process to eliminate apheresis [112] - The company has an expanded partnership for automated manufacturing with Cellares and completed the Technology Adoption Program [110]