Allogene Therapeutics, Inc. · NASDAQ:ALLO
Allogene Therapeutics — Q1 2025 Earnings Presentation
31 slides from Allogene Therapeutics's earnings presentation, May 13, 2025
Slide 1: Redefining the Future of CAR T
Redefining the Future of CAR T Doing What No CAR T Has Done Before Allogene Corporate Overview June 2025
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: Unlocking the Future: Developing Single Products into Transformative Platforms
Unlocking the Future: Developing Single Products into Transformative Platforms The Platform Opportunities The AlloCAR TTM Difference Maximizing curative potential of CD19 CAR T by targeting MRD+ Highly Scalable, LBCL in 1L consolidation Off-the-Shelf Product cema-cel Heme Malignancies Next generatio
Slide 4: Dedicated and Scalable CAR T Manufacturing
Dedicated and Scalable CAR T Manufacturing The Process is the Product ~20K to 60K+ doses per year capacity Process & Analytical Quality & Product Supply Chain (dependent on cell dose) Development Characterization Management 4
Slide 5: A Groundbreaking Trial: The Right Product, The Right Patient, The Right Time
A Groundbreaking Trial: The Right Product, The Right Patient, The Right Time CURRENT 1L Treatment “Watch and Wait” for Relapse 2L Treatment STANDARD OF CARE The ALPHA3 TRIAL: Designed to Predict & Intervene BEFORE Relapse The Right Product The Right Patient The Right Time cema-cel + + Immediately av
Slide 6: The Right Product: Foundational Ph1 Cema-cel Data Paves the Way for ALPHA3
The Right Product: Foundational Ph1 Cema-cel Data Paves the Way for ALPHA3 Highlights of ALPHA/ALPHA2 Ph1 Data Published in Journal of Clinical Oncology Achieved ORR and CR Rates of 58% and Efficacy Comparable to 42% Across Study and 67% and 58% Autologous CD19 CAR Ts w/ALPHA3 Pivotal Study Regimen
Slide 7: Subgroup Analyses and Durability Show Proof of Concept for Cema-cel in ALPHA3
Subgroup Analyses and Durability Show Proof of Concept for Cema-cel in ALPHA3 ALPHA/ALPHA2 Ph1 Data Published in Journal of Clinical Oncology High CR Rates In Subgroups Most Similar to Expected Ongoing Responses >4 Years in Complete Responders ALPHA3 Population • Patients w/normal LDH: 82% (9/11) •
Slide 8: The Right Product: Foundational Ph1 Cema-cel Data Paves the Way for ALPHA3
The Right Product: Foundational Ph1 Cema-cel Data Paves the Way for ALPHA3 Median Time From Enrollment to Treatment = 2 days Patients Who Received KYMRIAH®1 YESCARTA®2 BREYANZI®3 3L Relapsed/Refractory LBCL All Patients (n=33) Selected Ph2 Dose* (n=12) Phase 2 Pivotal Phase 2 Pivotal Phase 2 Pivotal
Slide 9: The Right Patient: Investigational MRD Assay Identifies MRD+ LBCL Patients
The Right Patient: Investigational MRD Assay Identifies MRD+ LBCL Patients Foresight CLARITY • Detection of Minimal Residual Disease (MRD) after treatment predicts relapse • >350 patients assessed across multiple studies • Data supports the investigational Foresight CLARITY MRD test delivers exquisi
Slide 10: The Right Time: CAR T Works More Safely & Effectively with Low Disease Burden
The Right Time: CAR T Works More Safely & Effectively with Low Disease Burden Disease Burden and Outcome MRD Allows for Earlier Intervention Patients with lower tumor volume are more likely Median disease burden is >200-fold lower in to respond while experiencing less neurotoxicity patients who are
Slide 11: Potential Future: Changing the Standard of Care
Potential Future: Changing the Standard of Care 1L Treatment Observation ”Watch and Wait” 2L Treatment MRD Negative Remission Standard 1L End of Therapy Evaluation ~60% PhasED-Seq MRD Test Future State Cured Responding 1L Therapy LBCL Complete Diagnosis (e.g. Rituxan- Response or Partial Response Id
Slide 12: ALPHA3 Pivotal Design is Seamless and Efficient
ALPHA3 Pivotal Design is Seamless and Efficient 1:1:1 1:1 Next Key Milestones Randomizationa Randomization FCA90 + cema-cel + cema-cel Selected LD Randomization Futility Analysis Regimen 1H 2026: Following MRD screening FC + and LD Regimen Interim EFS Primary EFS Lymphodepletion cema-cel Selectionb
Slide 13: The Future of CAR T Growth in LBCL is in Community Cancer Centers
The Future of CAR T Growth in LBCL is in Community Cancer Centers Where Patients Receive Care 20% 80% Current Auto CAR T-Affiliated High Volume with Other Large Independent ATCs Centers Infrastructure Centers Sites ~200+ US Sites Patient Referral Required Current: CAR T access Autologous Access Barr
Slide 14: ALPHA3: Potential to Dramatically Transform the LBCL Market
ALPHA3: Potential to Dramatically Transform the LBCL Market Projected US+EU5 CAR T Market Size in LBCL by Line of Therapy Market Split: US ~ 2/3, EU5 ~ 1/3 ~$7B Estimated US+EU5 CAR T Net Sales ($B) 1L Consolidation ~14,700 ~$3.5B Potential Patients/Year* Opportunity ~$5B* ~$2B 2L ~$1B 2L 2L 3L+ 3L+
Slide 15: Redefining the Future: Position Cema-cel in Earlier Line MRD+ Settings
Redefining the Future: Position Cema-cel in Earlier Line MRD+ Settings Anchor 1L LBCL Expand B-Cell Malignancies 1L Consolidation 1L Consolidation LBCL Acute Lymphoblastic Leukemia (ALL) 1L Consolidation Follicular Lymphoma (FL) 1L Consolidation Mantle Cell Lymphoma (MCL) Earlier Line Chronic Lympho
Slide 16: ALLO-329: Differentiated Profile in a Crowded Autoimmune Disease Field
ALLO-329: Differentiated Profile in a Crowded Autoimmune Disease Field Dual CD19/CD70 CAR Construct Key Milestones Jan 2025: Phase 1 Rheumatology Basket Overcome Rejection Trial IND Cleared • Dual CD19/CD70 allogeneic CAR T with Dagger® technology, designed to maximize CAR T expansion Mid-2025: Phas
Slide 17: Dual Targeting Protects ALLO-329 From Rejection and Potentially Broadens Effect
Dual Targeting Protects ALLO-329 From Rejection and Potentially Broadens Effect Across Diverse Autoimmune Pathogenesis Alloreactive CD70+ T Cells Dagger® Effect mitigates rejection and has potential to reduce or eliminate lymphodepletion Autoreactive CD19+ B Cells Autoreactive CD70+ T Cells Potentia
Slide 18: ALLO-329 Depletes Autoreactive B Cells & Autoantibodies from SLE Donors
ALLO-329 Depletes Autoreactive B Cells & Autoantibodies from SLE Donors and Shows Resistance to Rejection In Vivo D-8 D-7 D0 D7 D14 Transient expansion in peripheral blood NSG PBMC CAR T Bleed Blood and tissue (5x106) harvesting ALLO-329 ALLO-329 B cell depletion B cell Only ALLO-329 shows persisten
Slide 19: ALLO-329 RESOLUTION Basket Will Study Parallel Reduced Lymphodepletion Regimens
ALLO-329 RESOLUTION Basket Will Study Parallel Reduced Lymphodepletion Regimens RESOLUTION Basket Study RESOLUTION Illustrative Protocol Schema of Parallel Addressing Four Large Diseases Dose Escalation Paths Estimated US Diagnosed Prevalence Lupus (SLE) 330,000 DL1 DL2 DL3 w/Cyclophosphamide w/Cycl
Slide 20: ALLO-316: A Potentially First- and Best-In-Class Candidate for RCC
ALLO-316: A Potentially First- and Best-In-Class Candidate for RCC Encouraging Activity In Solid Tumor Global Market Opportunity TRAVERSE Ph1b Trial Supports Potential in CD70+ RCC • 31% confirmed Overall Response in heavily pre-treated patients with CD70+ (TPS >50%) expression1 • Four of Five Confi
Slide 21: Tumor Responses Occur Early and Are Sustained Following a Single Infusion of ALLO-316
Tumor Responses Occur Early and Are Sustained Following a Single Infusion of ALLO-316 Phase 1b TRAVERSE Trial 60 60 Change in Tumor Size From Baseline, % 40 40 Best Change from Baseline, % 20 20 0 -20 0 -40 -60 -20 -80 -100 -40 -60 TPS ≥50% -80 TPS <50% -100 Baseline Day 21 Day 28 Day 35 Day 49 Day
Slide 22: ALLO-316: High Response Rate and Ongoing Remissions in Heavily Pre-Treated Patients
ALLO-316: High Response Rate and Ongoing Remissions in Heavily Pre-Treated Patients Phase 1b TRAVERSE Trial Prior Therapies Day 28 Month 2 Month 4 Month 6 Month 8 Month 10 Month 12 HIF2α CTLA-4 PD-(L)1/TKI TPS ≥50% TPS <50% PR SD PD Death due to disease progression Death due to unknown reason or unr
Slide 23: ALLO-316 Demonstrated Robust CAR T Tumor Homing and Cell Expansion
ALLO-316 Demonstrated Robust CAR T Tumor Homing and Cell Expansion Phase 1b TRAVERSE Trial ALLO-316 CAR T cells Efficiently Traffick to Tumor Dagger® Effect: ALLO-316 Removing Alloreactive Host CD70+ Cells to Support Expansion and Persistence Magnitude of Expansion Exceeds Autologous CAR T Pivotal T
Slide 24: ALLO-316 Adverse Event Profile Consistent With Lymphodepletion and an Active CAR T Therapy
ALLO-316 Adverse Event Profile Consistent With Lymphodepletion and an Active CAR T Therapy Phase 1 TRAVERSE Trial Phase 1b All patients Phase 1b All patients TEAEs ≥20% n = 22a N = 50 AEs of Special n = 22a N = 50 incidence in Phase Interest, n (%) 1b, n (%) Grade All Grade All Grades Grade ≥3 All G
Slide 25: Allogene: Redefining the Future of CAR T
Allogene: Redefining the Future of CAR T Active Programs Across Heme, Solid Tumors and Autoimmune Indications Strong Financial Next Key Program Catalysts Position • cema-cel futility analysis and LD $335.5 selection (1H’26) • ALLO-329 clinical PoC (1H’26) Million in Cash, Cash Equivalents and Invest
Slide 26: Allogene's investigational AlloCAR T oncology products utilize Cellectis technologies
Allogene’s investigational AlloCAR T oncology products utilize Cellectis technologies. The anti-CD19 oncology products are developed based on an exclusive license granted by Cellectis to Servier. Servier, which has an exclusive license to the anti-CD19 AlloCAR T investigational products from Cellect
Slide 27: Pipeline Designed to Maximize Greatest Opportunity
Pipeline Designed to Maximize Greatest Opportunity 1Phase 2 designed to be registrational 27
Slide 28: Speed and 1x Dose Has Potential to Uniquely Embed Cema-cel into 1L Regimen
Speed and 1x Dose Has Potential to Uniquely Embed Cema-cel into 1L Regimen No research yet conducted to contemplate potential dosing regimen * 1. Tilly H., et al: Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. New England Journal of Medicine. 2021 28
Slide 29: ALPHA3 Addressable Population Creates a ~$5B Opportunity
ALPHA3 Addressable Population Creates a ~$5B Opportunity 1L Consolidation Potential Market Opportunity Sizing1 US EU5 1L Drug-Treated Patients ~34,000 ~31,000 % CR/PR Who Will Later Relapse w/MRD-Positivity ~30%* % MRD Tested ~75% Potentially US+EU5 Addressable >14,700 Patients/Year Market Opportuni
Slide 30: AID Market Opportunity Has Potential to Greatly Exceed CAR T in Heme Malignancies
AID Market Opportunity Has Potential to Greatly Exceed CAR T in Heme Malignancies Estimated US Diagnosed Prevalence for Select Autoimmune Diseases Rheumatology Neurology Nephrology Hematology GI Inflammation Warm Autoimmune Lupus (SLE) SPMS / PPMS Lupus Nephritis Ulcerative Colitis Hemolytic Anemia*
Slide 31: TRAVERSE Addressable Population Creates a >$3.5B Opportunity
TRAVERSE Addressable Population Creates a >$3.5B Opportunity 3L+ ccRCC Potential Market Opportunity Sizing US EU5 3L+ Drug-Treated Patients1 ~7,500 ~7,600 % Prior-ICI/TKI ~100% % CD70+2 ~80% % CD70 ~75% TPS ≥ 50%2 Potentially Addressable WW ~9,000 Patients/Year Market Opportunity3 >$3.5B Revenue Pot
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