Cabaletta Bio, Inc. · NASDAQ:CABA
Cabaletta Bio — Investor Presentation (October 2024)
23 slides from Cabaletta Bio's investor presentation, Oct 7, 2024
Slide 1: Corporate Presentation October 2024
Corporate Presentation OCTOBER 2024 Exhibit 99.1
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: Realizing the vision to transform autoimmune disease treatment
Realizing the vision to transform autoimmune disease treatment 1H24: Reported initial myositis & SLE clinical data Securing efficient & scalable commercial manufacturing Advancing whole blood program to replace apheresis Enrolling PV trial of CABA-201 without preconditioning Cash runway into 1H26 En
Slide 5: Innovative and scalable clinical strategy with potential for accelerated development path
Innovative and scalable clinical strategy with potential for accelerated development path Pipeline targeting autoimmune diseases with high unmet need Program Trial Preclinical Phase 1/2 Pivotal CABA-201 4-1BB CD19-CAR T RESET-Myositis™ CARTA Chimeric Antigen Receptor T cells for Autoimmunity RESET-S
Slide 6: Chimeric Antigen Receptor T Cells for Autoimmunity CABA-201
Chimeric Antigen Receptor T Cells for Autoimmunity CABA-201
Slide 7: CABA-201: CD19-CAR T specifically designed for autoimmunity
Cabaletta’s CD19 binder with similar in vitro & in vivo activity to construct used in academic studies1,3 CABA-201: CD19-CAR T specifically designed for autoimmunity IIT – Investigator-initiated trial; Flu/Cy – Fludarabine/Cyclophosphamide Peng, Binghao J, et al. “Preclinical specificity and activit
Slide 8: RESET Clinical Program for CABA-201
Below RESET trials are currently enrolling, with a broadening portfolio to realize the potential of CABA-201 REstoring SElf-Tolerance (RESET™) Clinical Program for CABA-201 SLE – Systemic lupus erythematosus; DM – Dermatomyositis; SSc – Systemic sclerosis; gMG – Generalized myasthenia gravis; ESRD –
Slide 9: Industry-leading U.S. clinical site footprint across RESET program
Industry-leading U.S. clinical site footprint across RESET™ program1 Data per clinicaltrials.gov as of October 4, 2024, as compared to companies with actively recruiting U.S. clinical sites for autoimmune cell therapy trials under company-sponsored INDs. 30+ actively recruiting clinical sites in the
Slide 10: Broad investigation of CABA-201 in well-defined patient populations
Broad investigation of CABA-201 in well-defined patient populations with the same dose & similar design Clinical strategy to reduce risk, maximize reach & accelerate timelines SLE – Systemic lupus erythematosus; SSc – Systemic sclerosis; gMG – Generalized myasthenia gravis; ASyS – Anti-synthetase sy
Slide 11: RESET-Myositis Phase 1/2 study design for CABA-201
Clinical data to be presented at ACR 2024; enrolling patients with active myositis with DM, ASyS and IMNM RESET-Myositis™: Phase 1/2 study design for CABA-201 IIM – Idiopathic inflammatory myopathy; DM – Dermatomyositis; ASyS – Anti-synthetase syndrome; IMNM – Immune-mediated necrotizing myopathy; C
Slide 12: RESET-SLE Phase 1/2 study design for CABA-201
Clinical data to be presented at ACR 2024; enrolling patients with active SLE with or without renal disease RESET-SLE™: Phase 1/2 study design for CABA-201 SLE – Systemic lupus erythematosus; SSc – Systemic sclerosis; gMG – Generalized myasthenia gravis Subjects will be treated with a standard preco
Slide 13: Initial CABA-201 clinical and translational data
Initial CABA-201 clinical & translational data IMNM Patient #1 Non-renal SLE Patient #11,2 LN Patient #1 No CRS, ICANS, or infections observed within 28 days of infusion CAR T cell expansion & B cell depletion kinetics consistent with academic experience Remains off all disease-specific therapies at
Slide 14: Autologous CAR T facilitates an immune system reset in autoimmune patients
Autologous CAR T is the only modality to date that has facilitated an immune system reset in autoimmune patients Achieving ‘immune system reset’ may predict long-term durability Illustrative graphic, adapted from Taubmann, J., et al. "OP0141 Long Term Safety and Efficacy Of CAR-T Cell Treatment in R
Slide 15: Initial patient phenotyping data consistent with potential immune system reset
Initial patient phenotyping data consistent with potential immune system reset; confirmatory analyses ongoing Naïve B cell repopulation occurred at 2 months in first IMNM patient Note: Flow plot gating reflects CD19+ CD20+ live lymphocytes. Data cut-off as of May 28, 2024. B Cell, % B cell phenotypi
Slide 16: CABA-201 Product Candidate & Process Innovations
CABA-201 Product Candidate & Process Innovations
Slide 17: Enrolling trial of CABA-201 without preconditioning in pemphigus
Enrolling trial of CABA-201 without preconditioning in pemphigus DSG – Desmoglein; PV – Pemphigus vulgaris Cohen, Adam D., et al. "B cell maturation antigen–specific CAR T cells are clinically active in multiple myeloma." The Journal of Clinical Investigation 129.6 (2019). Schmidt, Enno, et al. "Nov
Slide 18: Staged manufacturing strategy leveraging experienced partners
Staged approach allows for efficient allocation of capital while leveraging experienced partners Manufacturing strategy – secure reliable supply then innovate Innovative Manufacturing: Scale-Up & Reduced COGs Clinical & Commercial Supply: Penn, CDMOs & CABA Process Penn has reliably provided timely
Slide 19: Securing & expanding our leadership in autoimmune cell therapy
Securing & expanding our leadership in autoimmune cell therapy Myositis Systemic lupus erythematosus Systemic sclerosis Generalized myasthenia gravis Pemphigus vulgaris Minimizing the requirement for inpatient stay Innovating to address scale in autoimmune disease Seeking to remove the burden of aph
Slide 20: Corporate Summary
Corporate Summary Cabaletta Bio”
Slide 21: Track record of operational success evaluating novel cell therapy candidates
Track record of operational success evaluating novel cell therapy candidates in autoimmunity Cabaletta Bio leadership LEADERSHIP TEAM Anup Marda Chief Financial Officer Martha O’Connor Chief HR Officer Michael Gerard General Counsel Steven Nichtberger, M.D. President, CEO & Chairman Heather Harte-Ha
Slide 22: Realizing the vision to transform autoimmune disease treatment
Realizing the vision to transform autoimmune disease treatment 1H24: Reported initial myositis & SLE clinical data Securing efficient & scalable commercial manufacturing Advancing whole blood program to replace apheresis Enrolling PV trial of CABA-201 without preconditioning Cash runway into 1H26 En
Slide 23: Corporate Presentation OCTOBER 2024
Corporate Presentation OCTOBER 2024