Cabaletta Bio, Inc. · NASDAQ:CABA

Cabaletta Bio — Investor Presentation (June 2025)

40 slides from Cabaletta Bio's investor presentation, Jun 11, 2025

  1. Slide 1: Corporate Presentation June 2025

    Corporate Presentation JUNE 2025 Exhibit 99.2

  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 (

  3. 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

  4. Slide 4: Rapidly accelerating enrollment across a broad portfolio of indications at 67 active clinical sites

    Rapidly accelerating enrollment across a broad portfolio of indications at 67 active clinical sites2 Rese-cel1: 2027 BLA submission planned following recent FDA alignment SLE – systemic lupus erythematosus; LN – lupus nephritis; SSc – systemic sclerosis; BLA – biologics license application. resecabt

  5. Slide 5: Disease-specific cohorts in RESET clinical program designed to evolve into registrational studies

    Disease-specific cohorts in RESET clinical program are designed to evolve directly into registrational studies Innovative clinical strategy to support accelerated regulatory path Program1 Trial Preclinical Phase 1/2 Registrational Rese-cel (CABA-201) 4-1BB CD19-CAR T RESET-Myositis™ CARTA Chimeric A

  6. Slide 6: Rapidly completing enrollment in Phase 1/2 RESET trial cohorts

    Rapidly completing enrollment in Phase 1/2 RESET™ trial cohorts Data per clinicaltrials.gov as of May 30, 2025, as compared to companies with actively recruiting U.S. clinical sites for autoimmune cell therapy trials under company-sponsored INDs. As of May 30, 2025. SLE sites Myositis sites MG sites

  7. Slide 7: FDA alignment achieved in Type C meeting for rese-cel; two single-arm cohorts

    7 FDA alignment recently achieved in Type C meeting for rese-cel; two open-label, single-arm cohorts to evaluate outcomes FDA aligned on key design elements of myositis registrational cohorts Registrational Cohorts2 ASyS DM & ASyS (n ~15) Initial Phase 1/2 Cohorts1 DM IMNM (n ~6) IMNM (n ~15) (combi

  8. Slide 8: Planning to leverage myositis FDA alignment across the portfolio of indications

    Planning to leverage recent myositis FDA alignment and execution across the portfolio of indications Anticipated Rese-cel Milestones with 2027 BLA Submission Planned 1H25 2H25 1H26 2H26 Align with FDA on registrational cohort designs Present complete Phase 1/2 data Initiate enrollment in registratio

  9. Slide 9: Chimeric Antigen Receptor T Cells for Autoimmunity (rese-cel)

    Chimeric Antigen Receptor T Cells for Autoimmunity (rese-cel)

  10. Slide 10: ~150 autoimmune patients dosed with a range of autologous CAR T constructs

    ~150 autoimmune patients have been dosed with a range of autologous CAR T constructs (industry & academia)1 Autologous CAR T is potentially transformational for autoimmunity IIM – idiopathic inflammatory myopathy; MG – Myasthenia gravis; MS – Multiple sclerosis; SPS – Stiff person syndrome; SSc – Sy

  11. Slide 11: 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, Binghao J, et al. “Preclinical specificity and activity of CABA-201, a fully human 4-1BB containing CD19 CAR T therapy f

  12. Slide 12: Broad portfolio with six RESET trials designed to address 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; MS

  13. Slide 13: Myositis: Unmet Need

    Myositis: Unmet Need Cabaletta Bio”

  14. Slide 14: Myositis: A disease of significant unmet need

    High rates of disability; increased mortality risk Myositis: A disease of significant unmet need High disease burden: disability & mortality Typical patient is a middle-aged female who experiences muscle weakness, fatigue, pain, shortness of breath and difficulty swallowing Moderate to severe disabi

  15. Slide 15: 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 option​s 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

  16. Slide 16: Rese-cel Clinical & Translational Data

    Rese-cel Clinical & Translational Data

  17. Slide 17: RESET clinical trials have consistent design principles

    Individual trials in myositis, SLE, and SSc share common elements of preconditioning, dose, and study design RESETTM clinical trials have consistent design principles1 †Follow up period encompasses 15 years in total, aligned to regulatory guidance for CAR T cell therapies. AE, adverse event; CABA, C

  18. Slide 18: Designed to evaluate safety and tolerability of rese-cel in active, refractory disease

    Designed to evaluate the safety and tolerability of rese-cel in subjects with active, refractory disease​ Key inclusion and exclusion criteria in RESETTM clinical program ASyS, antisynthetase syndrome; CAR, chimeric antigen receptor; DM, dermatomyositis; HSCT, hematopoietic stem cell transplantation

  19. Slide 19: Peak rese-cel expansion and transient B cell depletion within ~2 weeks post infusion

    Peak rese-cel expansion and transient peripheral B cell depletion occurred within ~2 weeks post infusion​​ Rese-cel expansion & B cell kinetics across indications *LN-1 had prolonged rese-cel detection due to TCR activation that corresponded to longer time to B cell repopulation. LN-4: follow up ong

  20. Slide 20: Tissue resident depletion observed via lymph node biopsy

    Tissue resident depletion, consistent with the deep B cell depletion in circulation, observed via lymph node biopsy Lymph node B cell depletion in SSc-Skin-11 *Lymph node biopsies were from the left inguinal area using USG at U. Mich. by Dr. Khanna. CAR, chimeric antigen receptor; rese-cel, resecabt

  21. Slide 21: Baseline characteristics: first 8 patients in RESET-Myositis

    All patients had active, refractory disease and most had failed IVIg and B cell-targeting therapies Baseline Characteristics: First 8 Patients in RESET-Myositis* *As of May 6, 2025. ^Patient(s) who had clinical data presented in February 2025 scientific meetings. †Baseline disease activity = activit

  22. Slide 22: Incidence of relevant and related serious adverse events (myositis)

    Fever (Grade 1 CRS) in 4 of 8 patients and no ICANS in any patients Incidence of relevant and related serious adverse events* *As of May 6, 2025; primary endpoint is incidence and severity of adverse events through Day 29. ^Patient(s) who had clinical data presented in February 2025 scientific meeti

  23. Slide 23: DM & ASyS: Efficacy data following rese-cel infusion

    Clinical responses have been observed off immunomodulators and glucocorticoids in all patients DM & ASyS: Efficacy data following rese-cel infusion* *As of May 6, 2025. †DM-1 Week 32 CK value not available; Week 28 CK value used for TIS calculation. ^Patient(s) who had clinical data presented in Feb

  24. Slide 24: IMNM: Efficacy data following rese-cel infusion

    Clinical responses have been observed off immunomodulators in 3 of 4 patients IMNM: Efficacy data following rese-cel infusion1* *As of May 6, 2025. ^Patient(s) who had clinical data presented in February 2025 scientific meetings. †Minimal to moderate improvement at all time points from Week 20, exce

  25. Slide 25: Baseline characteristics: first 8 patients in RESET-SLE

    All patients had active, refractory disease and had failed B cell-targeting therapies Baseline characteristics: First 8 patients in RESET-SLE* *As of June 2, 2025. ^Patient(s) who had clinical data presented in February 2025 scientific meetings. †Baseline disease activity = activity before precondit

  26. Slide 26: Incidence of relevant and related serious adverse events (SLE)

    Fever (Grade 1 CRS) reported in 2 of 8 patients & ICANS reported in 1 of 8 patients Incidence of relevant and related serious adverse events* *As of June 2, 2025; Primary endpoint is incidence and severity of adverse events through Day 29. ^Patient(s) who had clinical data presented in February 2025

  27. Slide 27: Non-renal SLE: Efficacy data following rese-cel infusion

    As of the latest follow up, 3 of 4 SLE patients§ achieved DORIS Non-renal SLE: Efficacy data following rese-cel infusion* *As of June 2, 2025. ^Patient(s) who had clinical data presented in February 2025 scientific meetings. †Enrollment in the LN cohort requires class III/IV +/- V LN. SLE-1 had pure

  28. Slide 28: LN: Efficacy data following rese-cel infusion

    As of the latest follow up 1st LN patient achieved CRR LN: Efficacy data following rese-cel infusion* *As of June 2, 2025. ^Patient(s) who had clinical data presented in February 2025 scientific meetings. ‡SLEDAI-2K components present at latest follow up (SLEDAI-2K contribution score in parenthesis)

  29. Slide 29: Baseline characteristics & serious adverse events in first SSc patients

    Baseline characteristics & serious adverse events in first 2 SSc patients* *As of May 6, 2025; primary endpoint is incidence and severity of adverse events through Day 29. ^Patient(s) who had clinical data presented in February 2025 scientific meetings. **Baseline disease activity = activity before

  30. Slide 30: RESET-SSc: Efficacy data following rese-cel infusion

    Improvements in both SSc patients after discontinuing immunomodulatory drugs and steroids RESET-SSc™: Efficacy data following rese-cel infusion1 *As of May 6, 2025. †RNA Pol III IgG level performed locally at U Mich. ‡ Pulmonary evaluations not available for SSc-Skin-2 at Week 4. CRISS, Composite Re

  31. Slide 31: Preliminary evidence of vascular recovery or stabilization in majority of fingers

    Preliminary evidence of vascular recovery or stabilization in the majority of fingers Nailfold capillaroscopy for SSc-Skin-1 after rese-cel rese-cel, resecabtagene autoleucel; RESET, REstoring SElf-Tolerance; SSc, systemic sclerosis. Cabaletta Bio: Data on File. Baseline Week 24

  32. Slide 32: Rese-cel Product/Process Innovations & Indication Expansion

    Rese-cel Product/Process Innovations & Indication Expansion

  33. Slide 33: Manufacturing strategy to BLA submission

    Manufacturing strategy to BLA submission LVV – lentiviral vector Oxford is a commercial supplier for lentiviral vector utilized in approved CAR T products. Lonza has extensive experience manufacturing commercial cell and gene therapies. Innovative Manufacturing: Clinical Supply: Penn has reliably pr

  34. Slide 34: Removing preconditioning, automating process & eliminating apheresis are potential near-term advances

    Removing preconditioning, automating process & eliminating apheresis are potential near-term advances Lowering COGS, increasing scale & optimizing patient experience T cell collection Rese-cel manufacture and harvest Improve patient & provider experience Rese-cel administration Apheresis Cell select

  35. Slide 35: Corporate Summary

    Corporate Summary Cabaletta Bio”

  36. Slide 36: Track record of operational success in autoimmunity cell therapy

    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

  37. Slide 37: Planning to leverage myositis FDA alignment across the portfolio of indications

    Planning to leverage recent myositis FDA alignment and execution across the portfolio of indications Anticipated Rese-cel Milestones with 2027 BLA Submission Planned 1H25 2H25 1H26 2H26 Align with FDA on registrational cohort designs Present complete Phase 1/2 data Initiate enrollment in registratio

  38. Slide 38: Appendix

    Appendix Cabaletta Bio”

  39. Slide 39: TIS is a composite tool measuring relative improvement from baseline

    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

  40. Slide 40: Corporate Presentation JUNE 2025

    Corporate Presentation JUNE 2025

Cabaletta Bio — Investor Presentation (June 2025) on 6ix