Slide 1: Corporate Presentation May 2023
Corporate Presentation MAY 2023 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: Leveraging cellular therapy experience in autoimmunity to initiate CABA-201 clinical trials
Leveraging years of experience with cellular therapy in autoimmunity to initiate CABA-201 clinical trials Cabaletta®: Pursuing cures for a broad range of autoimmune diseases CAART – Chimeric AutoAntibody Receptor T cells; CARTA – Chimeric Antigen Receptor T cells for Autoimmunity; IND – Investigatio
Slide 5: One CABA platform, two strategies to address autoimmune diseases
One CABA™ platform, two strategies to address autoimmune diseases Complementary strategies to optimize clinical outcomes using cellular therapies in autoimmune diseases Mackensen, Andreas, et al. "Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus." Nature Medicine (2022): 1-9.
Slide 6: Biologic opportunity for cure or treatment in dozens of autoimmune diseases
Biologic opportunity for cure or treatment may be possible in dozens of autoimmune diseases* CABA™ platform may apply across a range of autoimmune diseases Pemphigus Vulgaris1,2,3 Pemphigus Foliaceus1,2,3 Epidermolysis Bullosa Acquisita3 Bullous Pemphigoid1,2,3 Lupus Nephritis3,4 Membranous Nephropa
Slide 7: Pipeline targeting autoimmune diseases where cure is possible
Pipeline targeting autoimmune diseases where cure is possible CABA-201 is being evaluated in separate clinical trials for myositis and SLE. Additional CAART pipeline candidates include PLA2R-CAART in preclinical stage for PLA2R membranous nephropathy, DSG3/1-CAART in discovery stage for mucocutaneou
Slide 8: Chimeric Antigen Receptor T Cells for Autoimmunity CABA-201
Chimeric Antigen Receptor T Cells for Autoimmunity CABA-201
Slide 9: Academic data: Immune system reset in SLE and myositis patients
SLE – Systemic lupus erythematosus; ASyS – Anti-synthetase syndrome; scFv – Single chain variable fragment; SLEDAI-2K – Systemic Lupus Erythematosus Disease Activity Index 2000; CRS – Cytokine release syndrome; ICANS – Immune effector cell-associated neurotoxicity syndrome; Anti-dsDNA Abs – Anti-dou
Slide 10: CABA-201: CD19-targeting CAR T therapy for autoimmune diseases
Cabaletta’s CD19 binder with similar in vitro & in vivo activity to FMC631 (binder used in academic studies2,3) CABA-201: CD19-targeting CAR T therapy for autoimmune diseases SLE – Systemic lupus erythematosus; IIT – Investigator-initiated trial; Flu/Cy – Fludarabine/Cyclophosphamide; CRS – Cytokine
Slide 11: Myositis: Strong scientific rationale and significant disease burden
~66K U.S. patients with IIM subtypes with B cell involvement; frequently severe, with limited treatment options Myositis: Strong scientific rationale & significant disease burden Lundberg, Ingrid E., et al. "Idiopathic inflammatory myopathies." Nature Reviews Disease Primers 7.1 (2021): 86. Adapted
Slide 12: CABA-201 to be evaluated in patients with active myositis
CABA-201 to be evaluated in patients with active myositis, including DM, ASyS & IMNM Planned Phase 1/2 study of CABA-201 in patients with myositis DM – Dermatomyositis; ASyS – Anti-synthetase syndrome; IMNM – Immune-mediated necrotizing myopathy Subjects will be treated with a standard preconditioni
Slide 13: SLE and Lupus Nephritis: High unmet clinical need
Up to 320,000 SLE patients in the U.S., ~40% with LN, who face increased risk of kidney failure & death SLE & Lupus Nephritis: High unmet clinical need Helmick CG, Felson DT, Lawrence RC, Gabriel S, Hirsch R, Kwoh CK, Liang MH, Kremers HM, Mayes MD, Merkel PA, Pillemer SR, Reveille JD, Stone JH; Nat
Slide 14: CABA-201 to be evaluated in patients with active SLE
CABA-201 to be evaluated in patients with active SLE with or without renal involvement Planned Phase 1/2 study of CABA-201 in patients with SLE SLE – Systemic lupus erythematosus; EULAR – European League Against Rheumatism; ACR – American College of Rheumatology Subjects will be treated with a stand
Slide 15: Accelerating development of CABA-201 for autoimmune diseases
Our product candidate, people and partnership enable accelerated progress while integrating unique insights Accelerating development of CABA-201 for autoimmune diseases SLE – Systemic lupus erythematosus Dai, Zhenyu, et al. "Development and functional characterization of novel fully human anti‐CD19
Slide 16: Chimeric AutoAntibody Receptor T Cells DSG3-CAART & MuSK-CAART
Chimeric AutoAntibody Receptor T Cells DSG3-CAART & MuSK-CAART
Slide 17: Current pemphigus vulgaris treatments require broad immunosuppression
Current treatments require broad immunosuppression associated with safety risks and transient efficacy Overview of pemphigus vulgaris & current treatment landscape Image credit: D@nderm. http://www.vgrd.org/archive/cases/2004/pv/DSCN4996%20copy.JPG Joly, Pascal, et al. "First-line rituximab combined
Slide 18: Monotherapy DSG3-CAART with favorable tolerability, but persistence plateaus
Monotherapy DSG3-CAART with favorable tolerability to date, but persistence plateaus Ongoing DesCAARTes™ study in patients with mucosal PV Cohort A6m reflects a two-dose regimen of 5.0 to 7.5 billion cells, 3 weeks apart, for a total of 10 to 15 billion cells, which is designed to prolong exposure t
Slide 19: MusCAARTes study of MuSK-CAART
Study timelines being evaluated based on emerging data from DesCAARTes™ study High unmet need in MuSK myasthenia gravis MusCAARTes™ study of MuSK-CAART Ongoing open-label study to determine the maximum tolerated dose & to evaluate safety of MuSK-CAART Part Cohort Subjects A – Monotherapy Dose Escala
Slide 20: Corporate Summary
Corporate Summary Cabaletta Bio’
Slide 21: Three-stage manufacturing approach for efficient capital allocation
Three-stage approach allows for efficient allocation of capital while leveraging experienced partners Manufacturing strategy Currently contracted for MuSK-CAART product candidate. Stage 3: Commercialization & Scale-Up Data-gated, staged investment Stage 1: Penn Stage 2: CDMOs & CABA Process Cell pro
Slide 22: Cabaletta Bio leadership
BOARD OF DIRECTORS Cabaletta Bio leadership LEADERSHIP TEAM Anup Marda Chief Financial Officer Arun Das, M.D. Chief Business Officer David J. Chang, M.D., M.P.H., FACR Chief Medical Officer Martha O’Connor Chief HR Officer Michael Gerard General Counsel Steven Nichtberger, M.D. President, CEO & Chai
Slide 23: Multiple potential clinical catalysts anticipated in next 18 months
Multiple potential clinical catalysts anticipated in next 12-18 months1 Assumes no dose-limiting toxicities are observed in any cohort and uninterrupted enrollment occurs in the trials. Cash runway into 1Q25 Expected Timing Expected Milestone CABA-201 4-1BB CD19-CAR T 1H 2023 1H 2023 DSG3-CAART Muco
Slide 24: Corporate Presentation MAY 2023
Corporate Presentation MAY 2023