Cabaletta Bio, Inc. · NASDAQ:CABA
Cabaletta Bio — Investor Presentation (January 2026)
48 slides from Cabaletta Bio's investor presentation, Jan 12, 2026
Slide 1: Corporate Presentation January 2026
Corporate Presentation January 2026 Exhibit 99.2
Slide 2: Disclaimer
Disclaimer This 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 distributed at or in connection with the presentation (
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: Rese-cel: Delivering on the promise of CD19-CAR T in autoimmunity
Pivotal myositis study enrolling; automated manufacturing & new clinical data with no preconditioning in 2026 Rese-cel1: Delivering on the promise of CD19-CAR T in autoimmunity ASyS – antisynthetase syndrome; BLA – biologics license application; CRR – complete renal response; DM – dermatomyositis; f
Slide 5: FDA aligned on myositis and SLE registrational designs
FDA aligned on myositis and SLE registrational designs; SSc and MG alignment anticipated in 1H26 Innovative clinical strategy to support accelerated regulatory path Program Trial Preclinical Phase 1/2 Registrational Rese-cel (CABA-201) 4-1BB CD19-CAR T RESET-Myositis® CARTA Chimeric Antigen Receptor
Slide 6: Multiple catalysts anticipated in next 12 months
Innovations to enhance scalability and eliminate preconditioning can expand current opportunity Multiple catalysts anticipated in next 12 months Myositis BLA submission on track for 2027 Expected Timing Expected Milestone Rese-cel Resecabtagene autoleucel 1H26 1H26 Clinical manufacturing experience
Slide 7: Rese-cel: Clinical Profile and Commercial Opportunity
Rese-cel: Clinical Profile and Commercial Opportunity
Slide 8: Broad portfolio with six RESET trials addressing high unmet need
Broad portfolio with six RESET trials designed to address high unmet need and realize the potential of rese-cel RESET™ program advancing trials in a broad portfolio of diseases SLE – Systemic lupus erythematosus; DM – Dermatomyositis; SSc – Systemic sclerosis; gMG – Generalized myasthenia gravis; PC
Slide 9: Rese-cel: CD19-CAR T specifically designed for autoimmunity
Rese-cel binder with similar in vitro & in vivo activity to construct used in academic studies in autoimmunity1,3 Rese-cel: CD19-CAR T specifically designed for autoimmunity Peng BJ, et al. Mol Ther Methods Clin Dev. 2024;32(2):101267. Dai, Zhenyu, et al. "Development and functional characterization
Slide 10: RESET trials have consistent design principles
Many of the RESET trials share common elements of preconditioning, dose, and study design RESETTM clinical trials have consistent design principles1 †Follow up period encompasses at least 15 years in total, aligned to regulatory guidance for CAR T cell therapies. AE, adverse event; CABA, Cabaletta A
Slide 11: Rese-cel expansion and B cell kinetics across indications
Peak rese-cel expansion and transient peripheral B cell depletion occurred within ~2 weeks post infusion Rese-cel expansion & B cell kinetics across indications* *All data is as of 11 Sep, 2025, except DM-3 which includes Week 24 data as of 08 Oct 2025. **LN-1 had prolonged rese-cel detection due
Slide 12: 95% of patients with no CRS or Grade 1 CRS and no ICANS
Across 4 RESET™ studies, 95% of patients with no CRS or Grade 1 CRS (fever) and 95% with no ICANS1 Demographics & CRS/ICANS in 1st 40 patients dosed with rese-cel RESET-Myositis RESET-SLE RESET-SSc RESET-MG Number of patients 15 10 9 6 Age, years, mean (SD) 51.7 (14.6) 30.4 (7.6) 53.1 (12.3) 57.5 (9
Slide 13: Safety profile permits outpatient administration
Rese-cel safety profile permits outpatient administration which can facilitate favorable reimbursement CAR T may eliminate active disease & use of expensive medications Cancer patients experience early and frequent CRS/ICANS CAR T therapy, which increases inpatient admissions and shifts Medicare rei
Slide 14: Outpatient administration reduces burden and improves accessibility
Outpatient administration reduces administrative burden and improves patient and provider accessibility RESET™ program designed for outpatient administration at launch INPATIENT MODEL OUTPATIENT MODEL Limited patient beds and resource infrastructure Increases inpatient resource pressure: ↑ total cos
Slide 15: Rese-cel commercial model: manufacturing and COGM
Health status of patient population and slower disease progression improve manufacturing cost efficiency Rese-cel commercial model – manufacturing and COGM Late-stage oncology patients have high drop-off rate due to rapid disease progression and compromised T cell fitness, leading to higher manufact
Slide 16: Myositis: Unmet Need & Clinical Data
Myositis: Unmet Need & Clinical Data
Slide 17: Myositis: High rates of disability and increased mortality risk
Highly concentrated treatment network in the US; dermatomyositis represents ~75% of this market Myositis: High rates of disability & increased risk of mortality High disease burden: disability & mortality Typical patient is a middle-aged female who experiences muscle weakness, fatigue, pain, shortne
Slide 18: Myositis: Limited treatment options for ~80k U.S. patients
IVIg is the only approved therapy (only for patients with the adult dermatomyositis subtype) Myositis: Limited treatment options for ~80k U.S. patients Lundberg, Ingrid E., et al. "Idiopathic inflammatory myopathies." Nature Reviews Disease Primers 7.1 (2021): 86. Analysis from quantitative survey
Slide 19: FDA alignment on myositis registrational cohort
FDA alignment achieved in Type C meeting; single-arm evaluation of DM/ASyS sub-types at 16 weeks in a 17-patient cohort FDA aligned on key design elements of myositis registrational cohort Registrational Cohort2 ASyS DM & ASyS (n=17) Initial Phase 1/2 Cohorts1 DM (combined n ~6) TIS, total improveme
Slide 20: Baseline characteristics: First 13 patients in RESET-Myositis
All patients had active, refractory disease despite multiple immunomodulatory agents, including IVIg Baseline characteristics: First 13 patients in RESET-Myositis* *As of 11 Sep, 2025. †Baseline disease activity = activity before preconditioning. ‡Reflects any exposure to RTX and IVIg prior or at ti
Slide 21: DM: Efficacy data following rese-cel infusion
3 of 3 patients with DM with sufficient follow-up achieved major TIS responses at Week 16 DM: Efficacy data following rese-cel infusion* *As of 11 Sep, 2025. † Historical NXP-2 autoantibody, but none detected at Pre-preconditioning (Baseline) visit). ‡ At latest follow-up (Day 29). § Insufficient fo
Slide 22: ASyS: Efficacy data following rese-cel infusion
Patient who would meet key inclusion criteria in registrational cohort achieved a major TIS response at Week 16 ASyS: Efficacy data following rese-cel infusion* *As of 11 Sep, 2025. †Reflects trend from baseline to latest timepoint antibody results are available (Week 24 for both patients). In ASyS-
Slide 23: Rese-cel Manufacturing Strategy & Innovation
Rese-cel Manufacturing Strategy & Innovation
Slide 24: Rese-cel commercial process preliminary comparability established
Rese-cel commercial process preliminary comparability established T cell collection Rese-cel manufacture (9 day) Rese-cel administration apheresis cell selection and activation cell expansion cell harvest preconditioning infusion Product release QC testing and QA release Reliable process with >90% m
Slide 25: Advancing breakthrough innovations to improve scalability and costs
Automation and elimination of preconditioning and apheresis could enhance patient experience Advancing breakthrough innovations to improve scalability and costs Stratton et al, ESGCT 2024. Poster available at https://www.cabalettabio.com/technology/posters-publications (https://d1io3yog0oux5.cloudfr
Slide 26: Three successful engineering runs led to IND amendment clearance
Three successful engineering runs3 completed in 2025 led to IND amendment (INDa) clearance Rese-cel engineering runs with Cellares supported INDa clearance Note: Shaded areas represent historical ranges defined by tolerance intervals that covers 90% of the population with 95% confidence. Cellares us
Slide 27: Rese-cel – Initial Dose Data without Preconditioning
Rese-cel – Initial Dose Data without Preconditioning
Slide 28: Biologic and clinical activity in all three PV patients
Clear evidence of biologic and clinical activity in all three PV patients in the initial dose cohort PDAI improvements were present in all three and were compelling in two of the three patients All patients remain off all immunomodulators while GCs are being tapered from low doses Peripheral B cell
Slide 29: Similar rese-cel expansion and B cell depletion with and without PC
Similar magnitude of rese-cel expansion & B cell depletion kinetics in patients treated with and without PC Similar PK & B cell depletion in rese-cel treated patients without PC* *As of 11 September 2025. Gray vertical dotted line indicates day of rese-cel infusion (study visit Day 1). Gray shading
Slide 30: Near complete resolution of symptoms in 2 of 3 patients
Near complete resolution of clinical symptoms and rapid reduction in autoantibodies in 2 of 3 patients Early clinical activity of rese-cel without preconditioning* *As of 11 September 2025. Cabaletta Bio: Data on file. Disease severity intervals as defined Krain RL, et al. Br J Dermatol. 2021;184(5)
Slide 31: Lupus: Unmet Need & Clinical Data
Lupus: Unmet Need & Clinical Data
Slide 32: SLE & LN: High unmet clinical need
Increased mortality risk & negative impact on quality of life for patients with SLE & LN SLE & LN: Represent a high unmet clinical need ESRD, end-stage renal disease; LN, lupus nephritis; SLE, systemic lupus erythematosus. 1. Zen M, et al. Eur J Intern Med. 2023;112:45–51. 2. Rahman P, et al. Lupus.
Slide 33: Baseline characteristics: First 9 patients in RESET-SLE
All patients had active, refractory disease and had failed multiple B cell-targeted therapies Baseline characteristics: First 9 patients in RESET-SLE* *As of 11 Sep, 2025. †Baseline disease activity = activity before preconditioning. ‡SLE medications may include biologics, anti-malarials, and immuno
Slide 34: Improvements in SLEDAI-2K and reduction in anti-dsDNA antibodies
Improvements in SLEDAI-2K over time and significant reduction in anti-dsDNA antibodies after discontinuing immunomodulators Efficacy data following rese-cel infusion* *As of 11 Sep, 2025. †Week 20 urinalysis components of the SLEDAI-2K (WBC, RBC and casts) imputed from Week 16 for total SLEDAI-2K sc
Slide 35: Systemic Sclerosis: Unmet Need & Clinical Data
Systemic Sclerosis: Unmet Need & Clinical Data
Slide 36: Systemic sclerosis: Profound unmet need & limited options
Associated with progressive morbidity and high mortality1,2 Systemic sclerosis: Profound unmet need & limited options AHSCT, autologous hematopoietic stem cell transplantation; ILD, interstitial lung disease; SSc, systemic sclerosis. 1. Allanore Y, et al. Nat Rev Dis Primers. 2015;1:15002. 2. Denton
Slide 37: Baseline characteristics: First 6 patients in RESET-SSc
All patients had active, refractory disease and were on 1 to 3 disease-specific therapies at screening Baseline characteristics: First 6 Patients in RESET-SSc* *As of 11 Sep, 2025; primary endpoint is incidence and severity of adverse events through Day 29 †Baseline disease activity = activity befor
Slide 38: SSc: Efficacy data following rese-cel infusion
As of the data cut-off, 4 of 4 SSc patients with ≥12 weeks follow-up had FVC stabilization or improvement SSc: Efficacy data following rese-cel infusion* *As of 11 Sep, 2025; primary endpoint is incidence and severity of adverse events through Day 29. †Reflects trend from baseline to latest availabl
Slide 39: Myasthenia Gravis: Unmet Need & Clinical Data
Myasthenia Gravis: Unmet Need & Clinical Data
Slide 40: Myasthenia gravis: Significant disease & treatment burden
High impact of disease due to patient symptoms & cost burden, particularly for refractory patients Myasthenia gravis: Significant disease & treatment burden Gilhus NE, et al. Eur J Neurol. 2024 2. Dresser L, et al. J Clin Med. May 2021. 3. Results from quantitative survey of U.S. MG-treating physici
Slide 41: Baseline characteristics: First patients in RESET-MG
Baseline characteristics: First 4 patients in RESET-MG* *As of 11 Sep, 2025. †Baseline disease activity = activity before preconditioning. ‡ Serognegative = no anti-AChR, anti-MuSK and anti-LRP4 antibodies AChR, acetylcholine receptor; AZA, azathioprine; ECU, eculizumab; EFG, efgartigimod; GC, gluco
Slide 42: MG: Efficacy data following rese-cel infusion
As of latest follow-up, both evaluable patients showed improvement off immunomodulators and steroids MG: Efficacy data following rese-cel infusion* *As of 11 Sep. 2025. †AChR-pos-1, Day 29 visit data unavailable. In AChR-pos-1, azathioprine, a prohibited medication, was continued until the day of in
Slide 43: Corporate Summary
Corporate Summary Cabaletta Bio’
Slide 44: Cabaletta Bio leadership
Track record of operational success evaluating & developing novel cell therapy candidates in autoimmunity Cabaletta Bio leadership LEADERSHIP TEAM Anup Marda Chief Financial Officer Nicolette Sherman Chief HR Officer Michael Gerard General Counsel Steven Nichtberger, M.D. President, CEO & Chairman H
Slide 45: Multiple catalysts anticipated in next 12 months
Innovations to enhance scalability and eliminate preconditioning can expand current opportunity Multiple catalysts anticipated in next 12 months Myositis BLA submission on track for 2027 Expected Timing Expected Milestone Rese-cel Resecabtagene autoleucel 1H26 1H26 Clinical manufacturing experience
Slide 46: Appendix
Appendix Cabaletta Bio’
Slide 47: Total Improvement Score (TIS) composite tool
TIS is a composite tool measuring a patient’s relative improvement from their baseline Myositis outcomes captured through validated composite endpoint Major Total Improvement Score 100 80 0 Minimal Moderate 60 40 20 Week 24 Baseline Week 12 None Extramuscular Activity 20 max achievable score Manual
Slide 48: Corporate Presentation January 2026
Corporate Presentation January 2026