Cabaletta Bio, Inc. · NASDAQ:CABA
Cabaletta Bio — Investor Presentation (January 2025)
26 slides from Cabaletta Bio's investor presentation, Jan 13, 2025
Slide 1: Corporate Presentation January 2025
Corporate Presentation JANUARY 2025 © 2025 Cabaletta Bio. All rights reserved.
Slide 2: Disclaimer
Disclaimer The following presentation, including any printed or electronic copy of these slides, the talks given by the presenters, the information communicated during any delivery of the presentation and any question and answer session and any document or material distributed at or in connection wi
Slide 3: Develop and launch the first curative targeted cellular therapies for autoimmune diseases
Develop and launch the first curative targeted cellular therapies for patients with autoimmune diseases
Slide 4: 2025: Realizing our vision by defining an efficient path to approval
3 2025: Realizing our vision by defining an efficient path to approval Planning to leverage increasing clinical data and unique development program for rese-cel (resecabtagene autoleucel; CABA-201) Compelling clinical efficacy Unique development strategy Multiple near-term catalysts with favorable s
Slide 5: Innovative clinical strategy with potential for accelerated regulatory path
Innovative clinical strategy with potential for accelerated regulatory path RESET clinical program has disease-specific cohorts designed to evolve directly into registrational studies Program1 Trial Preclinical Phase 1/2 Pivotal Dermatomyositis Rheumatology Antisynthetase syndrome RESET-Myosit Neuro
Slide 6: Chimeric Antigen Receptor T Cells for Autoimmunity (rese-cel)
Chimeric Antigen Receptor T Cells for Autoimmunity (rese-cel) 6
Slide 7: Rese-cel: CD19-CAR T specifically designed for autoimmunity
Rese-cel: CD19-CAR T specifically designed for autoimmunity Cabaletta rese-cel binder with similar in vitro & in vivo activity to construct used in academic studies1,3 Rese-cel product design & clinical / translational data Fully human anti-CD19 binder 4-1BB costimulatory domain with fully human bin
Slide 8: RESET program addressing several autoimmune markets
RESET program addressing several autoimmune markets Broad por ith six RESET trials designed to address high unmet need and realize the potential of rese-cel Phase 1/2 TrialsNo Flu/Cy Myositis SLE SSc gMG MS PV Typical onset middle age Affects young women & Middle age onset Bimodal age of onset Chron
Slide 9: Industry-leading clinical site footprint across RESET program
Industry-leading clinical site footprint across RESE program1 +1 SLE site in Europe SLE sites Myositis sites Juvenile myositis sites SSc sites MG sites PV sites 21 patients enrolled2 across the RESETTM studies, with 44 actively recruiting clinical sites in the US & Europe 1. Data per clinicaltrials.
Slide 10: Rese-cel Clinical & Translational Data
Rese-cel Clinical & Translational Data (Based on Presentation at ACR Convergence 2024) 10
Slide 11: Key inclusion and exclusion criteria in RESET clinical program
Key inclusion and exclusion criteria in RESETTM clinical program Designed to evaluate the safety and tolerability of rese-cel in subjects with active, refractory disease Key inclusion criteria1–3 Evidence of active disease despite prior or current treatment with standard of care RESET-Myosit RESET-S
Slide 12: Baseline characteristics of first patients in the RESET program
Baseline characteristics of first 8 patients in the RESE program All patients had active, refractory disease and most had failed B cell-targeting therapi RESET-Myositi RESET-SLE RESET-SSc SLE-1† SSc-Skin-1 Patient / Cohort IMNM-1 IMNM-2 DM-1 SLE-2 SLE-3 LN-1 Class V LN (severe skin cohort) Age, sex
Slide 13: Consistent and deep B cell depletion
Consistent and deep B cell depletion by Day 221 In patients with >3-month follow-up, B cell repopulation with naïve cells started as early as 8 weeks 1st 150 days: B cell depletion / repopulation & 1st 30 days: B cell depletion & rese-cel expansion rese-cel expansion Rese-cel exhibited a PK/PD profi
Slide 14: Incidence and severity of adverse events in the first patients
Incidence and severity of adverse events in the first 8 patients* RESET-Myositi RESET-SLE RESET-SSc Cohort IMNM DM Non-renal SLE LN SSc – Severe Skin Patient IMNM-1 IMNM-2 DM-1 SLE-1 SLE-2 SLE-3 LN-1** SSc-Skin-1 CRS† None None None None Grade 1 None Grade 1 Grade 2 ICANS† None None None None None N
Slide 15: RESET-Myositis: Efficacy data following rese-cel infusion
RESET-Myositis : Efficacy data following rese-cel infusion 1st known adult DM pati ed with CAR T demonstrated compelling early response off immunosuppressants‡ DM patient demonstrated a major TIS response at Day 29 & Disease activity & improvement measures st 1 IMNM patient showed a moderate TIS res
Slide 16: RESET-SLE: Efficacy data in SLE following rese-cel infusion
RESET-SL : Efficacy data in SLE following Rese-cel infusion All 3 SLE patients onstrated clinical responses off immunosuppressants; first patient completed steroid taper‡ SLE-1 (Class V LN) SLE-2 SLE-3 30 30 30 26 25 25 25 20 20 20 Discontinued Discontinued Discontinued 2K GC, MMF, HCQ 2K AZA, HCQ 2
Slide 17: RESET-SLE: Outcomes in first LN patient following rese-cel infusion
RESET-SL : Outcomes in first LN following rese-cel infusion LN-1 demonstrat ed improvement of proteinuria off all immunosuppressants, continuing steroid taper‡ UPCR decreased from 7.22 to 0.63 mg/mg at Week 16 1st LN patient SLEDAI reduced by 14 points at Week 16 Discontinued all Proteinuria SLEDAI-
Slide 18: Emerging efficacy data in first SSc patient
Emerging efficacy data 42 days post infusion in first SSc patient Early disease improvements in face and hands after discontinuation of disease-specific medication Baseline mRSS score by body area1 Overall mRSS score1 Day 42 mRSS score by body area1 Baseline Day 22 Day 42 mRSS 42 38 36 • Modified Ro
Slide 19: Achieving immune system reset may predict long-term durability
Achieving ‘immune system reset’ may predict long-term durability Autologous CAR T is the only modality to date that has facilitated an immune system reset in autoimmune patients CAR T & B cell levels1 CD19-CAR T Cells Following treatment with autologous CD19-CAR T, 6 pts with 12+ mo. of drug-free re
Slide 20: Rese-cel Product/Process Innovations & Indication Expansion
Rese-cel Product/Process Innovations & Indication Expansion
Slide 21: Securing & expanding our leadership in autoimmune cell therapy
Securing & expanding our leadership in autoimmune cell therapy Several innovations to prioritize patient experience, expand access and address scale in autoimmune disease Product/Process Innovations in development Evaluating rese-cel in PV without preconditioning Both published data and experience w
Slide 22: Manufacturing strategy – securing reliable supply then innovating
Manufacturing strategy – securing reliable supply then innovating Staged approach allows for efficient allocation of capital while leveraging experienced partners Clinical & Commercial Supply: Innovative Manufacturing: Penn, CDMOs & CABA Process Scale-Up & Reduced COGs • Penn has reliably provided t
Slide 23: Corporate Summary
Corporate Summary Cabaletta Bio’
Slide 24: Cabaletta Bio leadership
Cabaletta Bio leadership Track record of operational success evaluating & developing novel cell therapy candidates in autoimmunity LEADERSHIP TEAM Steven Nichtberger, M.D. Samik Basu, M.D. Gwendolyn Binder, Ph.D. David J. Chang, M.D., M.P.H., FACR Arun Das, M.D. Michael Gerard President, CEO & Chair
Slide 25: Cabaletta's Anticipated Key Milestones for 2025
Cabaletta’s Anticipated Key Milestones for 2025 1H25 2025 2025 2025 Plan to meet with Present clinical data Enroll and complete Present additional FDA to align on evaluating rese-cel dosing in multiple clinical & translational registrational trial without preconditioning disease-specific data on res
Slide 26: © 2025 Cabaletta Bio. All rights reserved.
Corporate Presentation JANUARY 2025 © 2025 Cabaletta Bio. All rights reserved.