- Cabaletta Bio, Inc. reported new clinical and translational data for **rese-cel** from the **RESET-PV™ trial** without preconditioning at the **2025 European Society of Gene & Cell Therapy (ESGCT) Annual Congress** on **October 9, 2025**.  **[1759138_0001193125-25-235533_caba-20251009.htm:0]** **[1759138_0001193125-25-235533_caba-ex99_1.htm:1]** 
- The data from three evaluable patients, as of **September 11, 2025**, showed **meaningful early clinical responses** with Pemphigus Disease Area Index (PDAI) scores improving significantly, such as from **83 to 3** for one patient over 3 months.  **[1759138_0001193125-25-235533_caba-20251009.htm:1]** **[1759138_0001193125-25-235533_caba-ex99_1.htm:3]** 
- Rese-cel was **generally well tolerated with no immune effector cell-associated neurotoxicity syndrome (ICANS) reported**, and all three patients remained off immunomodulators.  **[1759138_0001193125-25-235533_caba-20251009.htm:1]** **[1759138_0001193125-25-235533_caba-ex99_1.htm:3]** 
- The company plans to **expand patient enrollment** in the RESET-PV trial and incorporate no preconditioning regimens in other RESET clinical trial programs.  **[1759138_0001193125-25-235533_caba-ex99_1.htm:1]** 
- All adult Phase 1/2 cohorts in the myositis, lupus, scleroderma, and myasthenia gravis RESET trials were **fully enrolled as of September 30, 2025**.  **[1759138_0001193125-25-235533_caba-ex99_1.htm:1]**

Cabaletta Bio Presents Positive Rese-cel Data Without Preconditioning at 2025 ESGCT Annual Congress

- Cabaletta Bio, Inc. posted an updated corporate presentation on **September 3, 2025**, detailing the progress of its lead candidate, **rese-cel (CABA-201)**, a CD19-CAR T cell therapy for autoimmune diseases.  **[1759138_0001759138-25-000007_caba-20250903.htm:0]** **[1759138_0001759138-25-000007_caba-ex99_1.htm:5]** **[1759138_0001759138-25-000007_caba-ex99_1.htm:7]** 
- The company plans a **Biologics License Application (BLA) submission for myositis in 2027**, with **registrational cohorts anticipated to begin enrolling in 2025** following **FDA alignment on key design elements**.  **[1759138_0001759138-25-000007_caba-ex99_1.htm:5]** **[1759138_0001759138-25-000007_caba-ex99_1.htm:6]** 
- Cabaletta Bio expects **FDA alignment on pivotal trial design for SLE/LN and scleroderma in 2H25, and MG in 1H26**.  **[1759138_0001759138-25-000007_caba-ex99_1.htm:5]** 
- Clinical data for rese-cel demonstrates **transformative clinical responses off medications** in most dosed patients, with a favorable safety profile showing **~90% of patients with no CRS or only transient fever (Grade 1 CRS) and ~90% with no ICANS**.  **[1759138_0001759138-25-000007_caba-ex99_1.htm:5]**

Cabaletta Bio (CABA)