Fate Therapeutics, Inc. · NASDAQ:FATE
Fate Therapeutics — Investor Presentation (February 2025)
44 slides from Fate Therapeutics's investor presentation, February 2025
Slide 1: Making a Living Drug Readily Accessible to Patients in Need
Making a Living Drug Readily Accessible to Patients in Need Transforming the Treatment of Cancer and Autoimmune Diseases with Off-the-shelf, Multiplexed-engineered, iPSC-derived Cellular Immunotherapy February 2025 -1-
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the safety and therapeutic potential of the Company’s product candidates, the advancement of and plans and tim
Slide 3: Fate Therapeutics: Pioneering the Vision of Drug Development for Cell Therapies
Fate Therapeutics Pioneering the Vision of Drug Development for Cell Therapies A “living drug” uniquely capable of A novel paradigm where cell A renewable manufacturing process targeting a broad array of diseases therapies are administered routinely that can deliver cell therapies in an outpatient s
Slide 4: A Living Drug Designed for Complete Disease Elimination
A “Living Drug” Designed for Complete Disease Elimination In vivo expansion tilts the balance toward drug product efficacy in difficult to treat diseases Untreated Disease CAR iT cells demonstrate the unique ability to proliferate upon exposure to targeted disease and tilt the balance towards high e
Slide 5: Novel Sword and Shield Strategy to Avoid Conditioning Chemotherapy
Novel Sword and Shield Strategy to Avoid the Need for Conditioning Chemotherapy Alloimmune defense receptor (ADR) & CD58 disruption FT836 + -5-
Slide 6: A Renewable Manufacturing Process Delivering Cell Therapies On-demand
A Renewable Manufacturing Process that can Uniquely Deliver Cell Therapies On-demand to Patients in Need -6-
Slide 7: iPSC Product Platform
iPSC Product Platform Creating Multiplexed-engineered Clonal Master iPSC Banks Single iPSC Clone Unprecedented Resolution in Clonal iPSC Characterization and Selection ➢ Multiplexed Engineering ➢ Extensive Characterization ➢ Uniform Composition TRAC = T-cell receptor α constant locus ➢ Unlimited Clo
Slide 8: Mass Production of Drug-like Cell Products
Mass Production of Drug-like Cell Products Routine cGMP production of iPSC-derived cell products to meet clinical demand One iPSC MCB vial has the potential to yield trillions of uniformly-engineered cells Inventory generated through Stage 1: iCD34 Cell Production Stage 2: iNK/iT Cell Production rou
Slide 9: Mass Production of Drug-like Cell Products: GMP Facility
Mass Production of Drug-like Cell Products Advanced Manufacturing Capabilities to Provide Clinical and Early Commercial Supply State of the Art GMP facility (San Diego, CA) • 40,000 ft2 Fate cGMP manufacturing facility co-located with corporate headquarters • Launched in 2022 with end-to-end capabil
Slide 10: Pioneering Off-the-Shelf iPSC-derived Cell Therapies
Fate Therapeutics Pioneering Off-the-Shelf iPSC-derived Cell Therapies Induced Pluripotent Highly differentiated approach to cell therapy with unmatched engineering capability, Stem Cell Platform manufacturing scale, and product quality and consistency Eliminate Conditioning Proprietary ADR technolo
Slide 11: Product Pipeline
Product Pipeline - 11 -
Slide 12: First-in-class Product Pipeline
First-in-class Product Pipeline Multiplexed-engineered, iPSC-derived CAR NK Cell and CAR T-cell Product Candidates Program Indication CAR Targets Research Preclinical Phase 1 Partner CAR T-cell Product Candidates FT819 Systemic Lupus Erythematosus CD19 FT825 Solid Tumors HER2/EGFR Undisclosed Solid
Slide 13: FT819 Program
FT819 Program Off-the-shelf, CD19-targeted CAR T-cell Product Candidate - 13 -
Slide 14: Off-the-Shelf CAR T cells for Targeting CD19+ B cells
Off-the-Shelf CAR T cells for Safe and Effective Targeting of CD19+ B cells with Broad Patient Accessibility FT819: First-of-kind off-the-shelf CAR T cell • Derived from a clonal master engineered iPSC line State of the art CAR Complete TCR knock out to prevent incorporating unique functional elemen
Slide 15: FT819-101 Phase 1 Study: First iPSC-derived CAR T-cell Clinical Trial
FT819-101 Phase 1 Study: First iPSC-derived CAR T-cell Clinical Trial Initial Clinical Experience in Relapsed / Refractory B-cell Lymphoma Heavily Pre-treated Patient Population • Median of 4 prior lines of therapy (range 2-12) • >71% of patients with aggressive large B-cell lymphoma (LBCL) had prev
Slide 16: FT819 Pharmacokinetics
FT819 Pharmacokinetics Phase 1 translational data illustrates measurable PK FT819 demonstrates dose-dependent CAR T-cell expansion and exposure* * FT819 PK (mean ± SEM) at 90 and 360 million cells in patients with r/r B-cell lymphoma (BCL) (n=11). In vivo CAR T-cell expansion and persistence were me
Slide 17: FT819 Exhibits Durable and Specific Elimination of B cells
FT819 Exhibits Durable and Specific Elimination of B cells in Lymphoma Patients As a monotherapy in a lymphoma clinical trial, FT819 Where Cy / Flu conditioning did not result in B-cell depletion in the demonstrated the ability to support rapid, deep and periphery, a single dose of FT819 achieved ra
Slide 18: FT819 in SLE (FT819-102)
FT819 in SLE (FT819-102) First-of-kind Treatment of SLE with Off-the-Shelf anti-CD19 CAR T cell Therapy (NCT06308978) or or Highly-differentiated therapeutic approach Regimen Description ✓ Does not require patient apheresis Single FT819 dose following CCT with one of the following auxiliary medicina
Slide 19: First Patients Treated in FT819-102
First 3 Patients Treated in FT819-102 Lupus Nephritis patients with multiple prior therapies, all given fludarabine-free conditioning FT819 in SLE: Baseline Characteristics Patient # 1 2 3 Age / Gender 28 F 21 F 29 F Disease Type Active Lupus Nephritis Active Lupus Nephritis Active Lupus Nephritis D
Slide 20: FT819 Persistence and B cell Depletion with Fludarabine-free Conditioning
FT819 Exhibits Persistence and B cell Depletion in the Presence of Fludarabine-free Conditioning FT819 is detected in the peripheral blood for approximately In the presence of light conditioning and in dose level 1, two weeks in SLE patients after treatment with either FT819 demonstrates durable B c
Slide 21: FT819-102 Patient Case Study
FT819-102 Patient 1 Case Study 6-month Evaluation Reveals Complete Clinical Response and Suggests Durable Immunological Reset FT819 Patient 1 Case Study: DORIS Clinical Remission and LLDAS at 6-month Follow-up Safety & Tolerability 6-month Clinical Assessment • No apheresis, and no tapering of thera
Slide 22: FT819-102 Patient 1: 6-month Evaluation Suggests Immune Reset
FT819-102 Patient 1: 6-month Evaluation Suggests Immune Reset Has Been Achieved Patient 1: Reconstituting B cells are predominantly naïve with limited activated and switched memory phenotypes Patient 1: Pathogenic double-negative Naive B Cells Immature B Cells Memory B Cells (DN) B cell subset is lo
Slide 23: FT825 Program
FT825 Program Off-the-shelf, HER2-targeted CAR T-cell Product Candidate - 23 -
Slide 24: FT825/ONO-8250: Off-the-Shelf Seven-Point Edited HER2 CAR T-Cell Therapy
FT825/ONO-8250: First-in-Class, Off-the-Shelf, Seven-Point Edited HER2-directed CAR T-Cell Therapy, Engineered for Enhanced Solid Tumor Efficacy Overcoming the Challenges in Solid Tumors TRAC KO: Complete elimination of TCR prevents GvHD in allo-setting Novel HER2-Directed CAR: Potent and preferenti
Slide 25: FT825 Novel Cancer-specific Antigen Binder Targets HER2
FT825 iPSC-derived, HER2-targeted CAR T-Cell Product Candidate Novel Cancer-specific Antigen Binder Preferentially Targets HER2 on Tumor Cells Novel cancer-specific antigen binder preferentially targets HER2 on tumor cells with limited recognition of HER2 on healthy cells Hosking et al. 2023 SITC An
Slide 26: FT825 Activity Across HER2 Expression Density
FT825 iPSC-derived, HER2-targeted CAR T-Cell Product Candidate Novel Cancer-specific Antigen Binder Exhibits Activity Across HER2 Expression Density Robust antigen-dependent targeting across HER2 expression levels, including HER2-low tumor cell lines FT825 Target cells Hosking et al. 2023 SITC Annua
Slide 27: FT825/ONO-8250: High-affinity Non-cleavable CD16 (hnCD16)
FT825/ONO-8250: high-affinity, non-cleavable CD16 (hnCD16) Uniquely enabling innate ADCC function in a T cell for potent anti-tumor activity CD16a/FcγRIIIa ADCC-enabled therapeutic hnCD16: antibodies ✓ Flexible multi-antigen High affinity (176 V/V) targeting Non-cleavable (ADAM17) ✓ Complementary CA
Slide 28: FT825/ONO-8250 in Advanced Solid Tumors (NCT06241456)
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, with or without Monoclonal Antibodies in Advanced Solid Tumors (NCT06241456) Monotherapy • HER2+ Breast, Gastric, GEJ FT825 Treatment Cycle PTFU/LTFU (Regimen A) cancer • HER2Mut NSCLC Cetuximab (Regimen B only) • HER2+ salivary, endometrial, and other
Slide 29: T-cell Platform Innovation
T-cell Platform Innovation - 29 -
Slide 30: Developing a Portfolio of Engineered Features
Developing a Portfolio of Engineered Features Proprietary Functional Elements for Enhanced Cell Functionality & Synergizing with IO mAbs Direct Multi-Antigen Targeting CARs directed to CD19, BCMA, Combinations with mAbs / Engagers MICA/B, B7H3, others hnCD16 and synthetic CD3 receptors to uniquely I
Slide 31: Next-generation iPSC-derived CD8αβ CAR T cells
Next-generation iPSC-derived CD8αβ CAR T cells Creating Differentiated iPSC-derived CAR T Cells 1250 1250 1250 Tumor only Primary CAR T cell CAR iT cell Subcutaneous model 1000 1000 1000 Tumor Volume (mm ) Tumor Volume (mm ) Tumor Volume (mm ) 3 3 3 of prostate cancer 750 750 750 500 500 500 250 250
Slide 32: Novel Sword & Shield Approach to Eliminate Conditioning Chemotherapy
Novel “Sword & Shield” Approach to Eliminate Conditioning Chemotherapy Superior Compared to Other Immune Evasion Methods Fate’s Comprehensive Approach to Promote Functional Persistence of Allogeneic Cell Therapies without Conditioning Chemotherapy Various Strategies to Overcome the Need for Conditio
Slide 33: Sword & Shield CAR T cells Eliminate Need for Intense Conditioning
Sword & Shield CAR T cells Eliminate the Need for pre-Treatment with Intense Conditioning Chemotherapy Through Selective Targeting and Passive Evasion of Alloreactive Immune cells (-) Allo T cells (+) Allo T cells No tumor CAR iT + CAR iT + control Vehicle Allo T CAR iT ADR/CD58KO CAR iT ADR/CD58KO
Slide 34: MICA/B-targeted CAR T Cells
MICA/B-targeted CAR T Cells α3 Domain Targeting Uniquely Eliminates Broad Array of Tumors in Preclinical Studies MICA and MICB are stress ligands expressed on many cancers CAR targeting the alpha 3 domain is uniquely resistant to shedding and interference by soluble MICA/B Cytotoxicity post MICA/B c
Slide 35: Next Generation Dual-CAR T Targeting Multiple Aberrant Cells
Next Generation Dual-CAR T Capable of Targeting Multiple Aberrant Cells Simultaneously Next Generation Dual-CAR T cells designed to eliminate conditioning chemotherapy Dual-CAR for complete disease elimination Complete TCR knock out to prevent GvHD in allogeneic setting Anti-CD19 CAR Anti-BCMA or An
Slide 36: Dual CAR T Cells Extend Breadth of B Cell Targeting
Dual CAR T Cells Extend Breadth of B Cell Targeting and Drive Deeper and More Durable Elimination of Aberrant cells Baseline Tumor BCMA/CD19 Control Alone No CAR BCMA CAR CD19 CAR Dual CAR + D1 Anti-CD19 Anti-BCMA CAR CAR D7 CAR iT cells (i.v.) Radiance (p/sec/cm2/sr) NALM6 WT +BCMA OE (i.v.) D14 D2
Slide 37: FT522 Program
FT522 Program Off-the-shelf, CD19-targeted CAR NK Cell Product Candidate - 37 -
Slide 38: FT522: Next Generation Multi-antigen Targeting CAR NK cell with ADR
FT522: Next Generation Off-the-Shelf Multi-antigen Targeting CAR NK cell armed with ADR to Avoid the Need for Conditioning Chemotherapy CD19+ B Cells CAR-mediated IL-15RF cytotoxicity Cell potentiation without 4-1BB+ CD19-CAR cytokine support Alloreactive Potent CAR- Immune Cell mediated activity FT
Slide 39: ADR-armed NK Cells Uniquely Proliferate and Persist
ADR-armed NK Cells Uniquely Proliferate and Persist Preclinical Data in Ex Vivo Allogeneic System Williams et al. 2022 ASH Annual Conference - 39 -
Slide 40: FT522 In Vivo Trafficking and Tissue Residency
FT522 In Vivo Trafficking and Tissue Residency Preclinical Data Show Broad Distribution across Primary, Secondary, and Tertiary Tissues Dose-dependent trafficking, infiltration, & residency in primary, secondary & tertiary tissues without cytokine support at human dose equivalency levels of 250 mill
Slide 41: FT522 Unique Functional Profile in Unmatched Donor SLE System
FT522 Unique Functional Profile in Unmatched Donor SLE System Preclinical Data Show B-cell Depletion, Alloreactive T Cell Elimination, and Functional Persistence In vitro activity in unmatched donor SLE PBMCs suggest unique functional profile in the presence of an unmatched host immune system* Witty
Slide 42: FT522 Eliminates both B cells and Plasma Cells
FT522 has the Unique Ability to Eliminate both B cells and Plasma Cells Without the Need for Conditioning Chemotherapy FT522 uniquely synergizes with anti-CD38 Unlike primary anti-CD19 CAR T cells, FT522 has the ability mAb to effectively eliminate both CD19+ and to support durable elimination of B
Slide 43: FT522 Phase 1 Basket Study in Autoimmunity
FT522 Phase 1 Basket Study in Autoimmunity IND cleared and patient enrollment to commence mid-2025 No Conditioning; Multiple Indications; Induction and Maintenance Regimens Basket Trial Design AAV = Antineutrophilic cytoplasmic antibody-associated vasculitides IIM = Idiopathic inflammatory myositis
Slide 44: Better Cells For Better Therapies
Better Cells For Better Therapies® - 44 -
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