Cabaletta Bio, Inc. · NASDAQ:CABA
Cabaletta Bio — Investor Presentation (May 2023)
23 slides from Cabaletta Bio's investor presentation, May 1, 2023
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 clinical site experience to initiate Phase 1/2 trial of CABA-201 in SLE & LN
Leveraging years of experience with clinical sites to initiate Phase 1/2 trial of CABA-201 in SLE & LN 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 – Investigational
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 may be possible 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 Being evaluated in a single clinical trial for CABA-201. Additional CAART disease targets in discovery stage include two undisclosed indications. CABA™ Platform Indication Program Discovery Preclinical Phase 1 Phase 2/3 CARTA Chimeric Ant
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 & 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: SLE & 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 12: Planned Phase 1/2 study of CABA-201 in patients with 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 13: 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 14: Chimeric AutoAntibody Receptor T Cells DSG3-CAART & MuSK-CAART
Chimeric AutoAntibody Receptor T Cells DSG3-CAART & MuSK-CAART
Slide 15: Current treatments require broad immunosuppression with safety risks and transient efficacy
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 16: 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 FDA has requested, and the Company has agreed, that we will share data from part A to inform a discussion on the optimal design of part C. According to FDA advic
Slide 17: Combination strategy to enhance CAART activity
Combination strategy designed to enhance cytokine and/or diminish autoantibody effects on CAART activity Combination sub-study prioritized to increase CAART exposure Amagai, Masayuki, et al. "A randomized double-blind trial of intravenous immunoglobulin for pemphigus." Journal of the American Academ
Slide 18: Strategy for first-in-human MuSK-CAART trial informed by DesCAARTes study
Strategy for first-in-human trial informed by learnings 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 Escal
Slide 19: Corporate Summary
Corporate Summary Cabaletta Bio’
Slide 20: Three-stage manufacturing strategy
Three-stage approach allows for efficient allocation of capital while leveraging experienced partners Manufacturing strategy CDMOs shown are currently contracted for select CAART product candidates. Stage 3: Commercialization & Scale-Up Data-gated, staged investment Stage 1: Penn Stage 2: CDMOs & CA
Slide 21: 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 22: 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 CABA-201 4-1BB CD19-CAR T Expected Timing Expected Milestone 1H 2023 1H 2024 Initial clinica
Slide 23: Corporate Presentation MAY 2023
Corporate Presentation MAY 2023