Allogene Therapeutics, Inc. · NASDAQ:ALLO
Allogene Therapeutics — J.P. Morgan Healthcare Conference 2024
30 slides from Allogene Therapeutics's conference presentation, 2024
Slide 1: Redefining the Future of CAR T
Redefining the Future of CAR T Doing What No Autologous Treatment Has Done Before David Chang, M.D., Ph.D., President, CEO & Co-Founder J.P. Morgan 2024
Slide 2: Legal Disclaimers
Legal Disclaimers This presentation contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. To the extent statements contained in this Presentation are not descriptions of historical facts regarding Allogene Therap
Slide 3: 2024 Platform Vision: Paradigm Shifting Approach to CAR T
2024 Platform Vision: Paradigm Shifting Approach to CAR T Cema-cel in r/r CLL ALLO-329 in Autoimmune • Capture the growing unmet medical need in • Next-generation AlloCAR TTM product to address both CLL post-BTKi/BCL2i B cell and T cell dysfunction in autoimmune diseases • Address T cell dysfunction
Slide 4: ALPHA3 in 1L Consolidation
AlloCAR T Product Competitive Edge: ALPHA3 Pivotal Trial in 1L Consolidation for LBCL The Allogeneic Advantage: The Only Competition is Cancer Itself Right Time • On demand product with potential to safely and powerfully consolidate remission • Sensitive and specific MRD assay to identify the right
Slide 5: Ph1 Cema-cel Data Are Foundational for the ALPHA3 Trial
Ph1 Cema-cel Data Are Foundational for the ALPHA3 Trial Median Time From Enrollment to Treatment ≤ 3 days KYMRIAH®1 YESCARTA®2 BREYANZI®3 All Alloy (n=33) FCA90 Alloy (n=12) Phase 2 Pivotal Phase 2 Pivotal Phase 2 Pivotal ORR 58% 67% 50% (label) 72% (label) 73% (label) CR in LBCL (mITT) 42% 58% 32%
Slide 6: Sensitivity at End of Therapy
Breakthrough: Foresight’s End of 1L Therapy Landmark MRD Assay Allows Identification of LBLC Patients Whose Disease Will Recur 90% in DLBCL Patients who Relapse clinical sensitivity Sensitivity at End of Therapy 17-40% clinical sensitivity Roschewski et al. Hematological Oncology 41(S2):177-179, ICM
Slide 7: Standard 1L End of Therapy Evaluation
Current Standard of Care Leaves Patients with a “Watch and Wait” Approach 40% of Patients Will Progress After 1L Treatment1 1L Treatment Observation ”Watch and Wait” 2L Treatment Remission Standard 1L End of Therapy Evaluation ? ~60% “Watch and Cured Responding wait” until 1L Therapy Relapse occurs
Slide 8: PhasED-Seq MRD Test
Potential Future: Changing the Standard of Care 40% of Patients Will Progress After 1L Treatment1 1L Treatment Observation ”Watch and Wait” 2L Treatment MRD Negative Remission Standard 1L End of Therapy Evaluation PhasED-Seq MRD Test ~60% Future State Cured Responding 1L Therapy LBCL Complete Diagno
Slide 9: ALPHA3 Pivotal Design is Seamless and Efficient
ALPHA3 Pivotal Design is Seamless and Efficient 2024 2025 MRD by PhasED-Seq Screening Including Observation MRD Conversion Interim Analysis: 1° EFS by BICR4 Randomization Randomization 1L Observation 2° PFS, OS and Safety Therapy FCA1 CR or PR Lymphodepletion Cema-cel3 by Treatment Selected LD Cema-
Slide 10: ALPHA3: $3B+ US Market Opportunity to Transform LBCL Treatment
ALPHA3: $3B+ US Market Opportunity to Transform LBCL Treatment 1L Consolidation Potential US Market Opportunity Sizing 1 1L US Drug-Treated Patients ~34,000 % CR/PR Who Will ~30% Later Relapse % MRD+ ~100% % MRD Tested ~75% Potentially Addressable ~7,700 Patients/Year US Market Opportunity 2 >$3B Re
Slide 11: ALPHA3: Potential to Dramatically Transform the LBCL Market
ALPHA3: Potential to Dramatically Transform the LBCL Market Projected US CAR T-Treated Patients in LBCL by Line of Therapy ~10,700 Total Patients Estimated US CAR T-Treated LBCL Patients >$4B Revenue 10,000 Allogeneic CAR T in 1L consolidation could disrupt the current CAR T 7,500 ~5,600 Patients 1L
Slide 12: AlloCAR T Product Competitive Edge: ALPHA2 Trial in r/r CLL
AlloCAR T Product Competitive Edge: ALPHA2 Trial in r/r CLL The Allogeneic Advantage: The Only Competition is Cancer Itself Right Time • Growing need for effective treatment post-Bruton tyrosine kinase inhibitors (BTKi) and B-cell lymphoma 2 inhibitor (BCL2i) therapies • Potential to get closer to t
Slide 13: ALPHA2 CLL Cohort Enables Rapid Start and Enrollment
ALPHA2 CLL Cohort Enables Rapid Start and Enrollment Lymphodepletion (Day -5 to Day -3) Cema-cel Phase 1b EP: Enrollment Screening Treatment Safety, Prelim Efficacy Fludarabine 30 mg/m2/day (Day 0) Cyclophosphamide 300 mg/m2/day Cema-cel: 120 x 10 6 Phase 2 EP: ALLO-647 30 mg/day CR rate CAR+ T cell
Slide 14: Potential to Meet the Needs of a Large Patient Population in Need
Potential to Meet the Needs of a Large Patient Population in Need CLL/SLL Potential US Market Opportunity Sizing1 US Drug-Treated Incidence 1L Potentially Addressable Target Populations ~22,400 2L Prior-BTKi w/high-risk genetic features R/R 2L ~12,800 ~2,500 patients/year R/R 3L+ 3L + Prior-BTKi/BCL
Slide 15: AlloCAR T Product Competitive Edge: ALLO-329 & Readying the Next Leapfrog
AlloCAR T Product Competitive Edge: ALLO-329 & Readying the Next Leapfrog The Allogeneic Advantage: The Optimal Approach for Autoimmune Disease Right Time • Emerging clinical validation that supports immune resetting is feasible with a deep and transient depletion of lymphocytes with CAR T • Opportu
Slide 16: Dagger Biology: Depletes Activated CD70+ Host T Cells
Dagger Biology: Depletes Activated CD70+ Host T Cells, Preventing Rejection and Supporting CAR T Expansion and Persistence Day 4 Host T CD8+ CD70+ ALLO-316 FC ALLO-316 FCA30 CD4+ CD8 CD70+ CD3 CAR T ALLO-501A FCA90 ALLO-316 CAR CD70 Day 10 Host T CD8+ CD70+ ~2 Log increase in peak expansion over ALL
Slide 17: Emerging Clinical PoC for CAR T Suggests an Expansive Market Opportunity
Emerging Clinical PoC for CAR T Suggests an Expansive Market Opportunity Estimated US Diagnosed Prevalence for Select Autoimmune Diseases IgG4 Vasculitis <10,000 15,000 Lupus (SLE) 330,000 Systemic SPMS Myasthenia RRMS RA Myositis Encephalitis NMOSD 70,000 Sclerosis 120,000 Gravis LN 450,000 725,000
Slide 18: AlloCAR T Product Profile is Commensurate with Broad Autoimmune Opportunity
AlloCAR T Product Profile is Commensurate with Broad Autoimmune Opportunity Single Autologous & Allogeneic Infusion Prolonged Remissions Off-the-Shelf, On-Demand Scalability & Economics cema-cel Ph2 protocol Allogeneic Only Multiplex Gene Engineering allows outpatient dosing Outpatient Treatment & C
Slide 19: ALLO-329 Phase 1: Design Underway to Be Immediately Competitive
ALLO-329 Phase 1: Design Underway to Be Immediately Competitive Autoimmune Disease Trial Next Steps 1 2 3 IND enabling manufacturing Potential clinical POC in IND submission and Ph1 process and analytic assay autoimmune indications by trial projected in 1H 2025 development underway YE 2025 19
Slide 20: AlloCAR T Product Competitive Edge: TRAVERSE Trial in RCC
AlloCAR T Product Competitive Edge: TRAVERSE Trial in RCC The Allogeneic Advantage Right Time • Growing clinical validation from Ph1 trial that different targets can be safely deployed to treat solid tumors with CAR T • Advances in gene editing and engineering allows opportunity to design CAR T to a
Slide 21: ALLO-316: A Potentially Best-In-Class Candidate for RCC
ALLO-316: A Potentially Best-In-Class Candidate for RCC Post-ICI/TKI RCC Represents An Open Field of Unmet Need • Belzutifan approved in post-ICI/TKI setting with ORR 22% and mPFS <6mo1 TRAVERSE Phase 1 Shows Encouraging Activity in CD70+ RCC • 30% ORR, 100% DCR in patients with established CD70+ ex
Slide 22: ALLO-316 Clinical Efficacy Correlated to CD70 Expression Status
ALLO-316 Clinical Efficacy Correlated to CD70 Expression Status Response Rates Correlate with CD70 Expression • All Patients Evaluable for Efficacy: 17% ORR and 89% disease control rate (DCR) • CD70+ Patients: 30% ORR and 100% DCR A Significant Tumor Reduction Observed in Primary Tumor • 70-year-old
Slide 23: TRAVERSE Trial Next Steps
TRAVERSE Trial Next Steps • Continue advancing scientific innovation underlying Dagger technology – Optimize CAR T cell expansion and persistence – Maximize the potential of allogeneic CAR T in solid tumors – Mitigate treatment-associate inflammatory response • Q2 2024: Algorithm update relating to
Slide 24: Delivering on Scalability to Keep Pace with Expanding Opportunities
Delivering on Scalability to Keep Pace with Expanding Opportunities • Key personnel across Process Development, Supply Chain, Quality & Mfg • 140K ft2 Modular Facility designed to US and International Commercial cGMP Standards • Qualified Suppliers Across all Input Materials • End-to-end capabilitie
Slide 25: 2024 Platform Vision: Paradigm Shifting Approach to CAR T
2024 Platform Vision: Paradigm Shifting Approach to CAR T 1Q: Cema-cel in 1L LBCL (Pivotal) 1H: ALLO-329 in Autoimmune • ALPHA3 start-up activities initiated • Phase 1 planned 1Q: Cema-cel in r/r CLL (Ph1) 1H: Cema-cel in r/r CLL • Ph1 cohort in ALPHA2 initiation • Pivotal P2 trial initiation Q1 Q2
Slide 26: The Only Competition Is Cancer: Redefining the Future of CAR T
26 THE ONLY COMPETITION IS), e | A « | "5 FF € o > FE : > L > L Redefining the Future of CAR T DOING WHAT NO AUTOLOGOUS TREATMENT HAS DONE BEFORE
Slide 27: TALEN gene-editing technology licensed from Cellectis
Allogene’s investigational oncology products utilize TALEN® gene-editing technology pioneered and owned by Cellectis. ALLO-501 and cemacabtagene ansegedleucel (previously k nown as ALLO-501A) are anti-CD19 AlloCAR T products that were jointly developed under a collaboration agreement between Servier
Slide 28: Pipeline Designed to Maximize Greatest Opportunity
Pipeline Designed to Maximize Greatest Opportunity 1 Phase 2 designed to be registrational; 2ALLO-647 (anti-CD52 mAb) is intended to enable expansion and persistence of certain allogeneic CAR T product candidates; 3TurboCAR 28
Slide 29: Resetting the Immune System by Depleting Autoreactive Lymphocytes
Resetting the Immune System by Depleting Autoreactive Lymphocytes Several mechanisms contribute to the pathogenesis of autoimmune disorders including: • Production of autoantibodies • B-cell dependent antigen presentation • Activation of autoreactive T cells CAR T may enable the safe and effective r
Slide 30: Delivering on Access to Improve Patient Experience and Expand Market
Delivering on Access to Improve Patient Experience and Expand Market Transforming a complex procedure… … Into an “off-the-shelf” product 3 Weeks to 6+ M onths Available immediately Autologous CAR T Procedure AlloCAR T Products AlloCAR T Products Can Expand CAR T Sites of Care and Commercial Opportun
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