Fate Therapeutics, Inc. · NASDAQ:FATE
Fate Therapeutics — Investor Presentation (November 2022)
44 slides from Fate Therapeutics's investor presentation, November 2022
Slide 1: Programmed Cellular Immunotherapies
Better Cells For Better Therapies™ Programmed Cellular Immunotherapies Transforming the Treatment of Cancer with Off-the-shelf, Multiplexed-engineered, iPSC-derived Cellular Immunotherapy November 2022 -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: The Leading Developer of Off-the-shelf, iPSC-derived Cancer Immunotherapies
Fate Therapeutics The Leading Developer of Off-the-shelf, iPSC-derived Cancer Immunotherapies Disruptive Platform: industry-leading iPSC product platform supported by 10+ years of internal R&D and dominant IP estate with 350+ issued patents Deep Product Pipeline: robust pipeline of multiplexed-engin
Slide 4: Changing the Game in Cell Therapy
Changing the Game in Cell Therapy Transforming the Cell Therapy Field with a Drug-like Cell Product Paradigm Multiplexed Engineering Multiple mechanisms of attack against cancer incorporated into cell product Drug-like Treatment Mass Production Multi-dose schedules administered Scalable GMP operatio
Slide 5: Disruptive iPSC Product Platform
Disruptive iPSC Product Platform Creating Multiplexed-engineered iPSC-Derived Cell Products A Single Human Induced Pluripotent Stem Cell (iPSC) A renewable source for mass production of cell products Unlimited Clonal Single iPSC Clone Potential to Differentiate Expansion into 200+ Cell Types Multipl
Slide 6: Disruptive iPSC Product Platform: Mass Production of Multiplexed-engineered Cell Products
Disruptive iPSC Product Platform Mass Production of Multiplexed-engineered Cell Products for Off-the-shelf Patient Treatment Off-the-shelf, On-demand Treatment in Outpatient Setting ✓ Multiplexed engineering Designed with multiple tumor-fighting mechanisms ✓ Homogeneous product High quality; consist
Slide 7: Novel Functional Armament Deployed in Attack Against Cancer
Disruptive iPSC Product Platform Novel Functional Armament Deployed in Attack Against Cancer Direct Antigen Targeting CARs directed to CD19, BCMA, MICA/B, B7H3 Combinations with mAbs / Engagers hnCD16 and Synthetic CD3 receptors to synergize TCR KO / TRAC with mAbs and NK cell / T-cell engagers inte
Slide 8: A Transformative Cell Product Approach for the Treatment of Cancer
A Transformative Cell Product Approach for the Treatment of Cancer Unique Advantages of Off-the-shelf, Multiplexed-engineered, iPSC-derived Cell Products • On-demand treatment Flexible Administration • Reliable and convenient without the need for hospitalization • Lower administrative burden • Syner
Slide 9: Projected 2022 Corporate Milestones
Off-the-Shelf, iPSC-derived, Cell-based Cancer Immunotherapy Franchise Projected 2022 Corporate Milestones • Launch registration study under RMAT for relapsed / refractory aggressive BCL Hematologic Malignancies • Initiate early-line aggressive BCL study for FT596 + R-CHOP • Generate clinical datase
Slide 10: Hematologic Malignancies
Hematologic Malignancies - 10 -
Slide 11: Hematologic Malignancy Product Pipeline
Hematologic Malignancy Product Pipeline Multiplexed-engineered, iPSC-derived NK and T-cell Product Candidates Program Functionality & Cell Type Target(s) Indication(s) Preclin Phase 1 CD20 BCM + mAb FT516 hnCD16 iNK n/a AML FT596 hnCD16 + IL15RF + CAR-CD19 iNK CD19 ± CD20 BCM ± mAb FT819 CAR-CD19 iT
Slide 12: Non-Hodgkin Lymphoma
Non-Hodgkin Lymphoma - 12 -
Slide 13: Off-the-Shelf, iPSC-derived NK Cell Franchise for B-cell Malignancies
Off-the-Shelf, iPSC-derived NK Cell Franchise for B-cell Malignancies FT516 and FT596 Product Candidates hnCD16: High-affinity 158V, non- cleavable CD16 Fc receptor to augment ADCC CAR19: Chimeric antigen receptor that targets B-cell antigen CD19; optimized for NK cell biology IL-15RF: Interleukin-1
Slide 14: FT516-101: Phase 1 Study in R/R B-cell Lymphoma
FT516-101: Phase 1 Study in R/R B-cell Lymphoma Three-dose Treatment Schedule; Up to 2 Cycles • First-in-human study assessing the safety and activity of FT516 combined with rituximab in patients with r/r B-cell lymphoma – Primary objective: identify DLT and determine maximum tolerated dose / maximu
Slide 15: FT516-101: Interim Phase 1 Clinical Data
FT516-101: Phase 1 Study in R/R B-cell Lymphoma Interim Phase 1 Clinical Data Safety & Tolerability • No CRS, ICANS, GvHD • No treatment discontinuations due to AEs Response Rates • 11 of 18 patients (61%) treated at ≥90M cells / dose achieved OR, including 8 of 10 patients (80%) naïve to treatment
Slide 16: FT596-101: Phase 1 Study in R/R B-cell Lymphoma
FT596-101: Phase 1 Study in R/R B-cell Lymphoma Single-dose Treatment Schedule; Up to 2 Cycles • First-in-human study assessing the safety and activity of FT596 as monotherapy and in combination with rituximab in patients with r/r B-cell lymphoma – Primary objective: identify DLT and determine maxim
Slide 17: FT596-101: Interim Phase 1 Clinical Data
FT596-101: Phase 1 Study in R/R B-cell Lymphoma Interim Phase 1 Clinical Data Safety & Tolerability • No DLTs, ICANS, or GvHD • Observed CRS (n=3) was infrequent, low-grade, and of limited duration Response Rates at 90M and 300M Cell Dose • 13 of 19 patients (68%) achieve OR (n=7/9 in Monotherapy Ar
Slide 18: FT516 and FT596 NK Cell Programs: Ongoing Development Initiatives
FT516 and FT596 NK Cell Programs for B-cell Malignancies Ongoing Development Initiatives FT516 Program FT596 Program • Ongoing FDA interactions under RMAT Designation • Ongoing P1 dose expansion with single-dose treatment covering iPSC-derived product platform and late-stage schedule at 900M cells i
Slide 19: FT819: Off-the-Shelf CAR19 T-Cell Product Candidate
FT819: Off-the-Shelf CAR19 T-Cell Product Candidate Collaboration with Memorial Sloan Kettering Cancer Center First-of-Kind Off-the-Shelf CAR T-cell Therapy Derived from Renewable Master iPSC Line Engineered to Uniformly Express Novel 1XX CAR19 and Knock-out TCR 1XX CAR19: Novel chimeric antigen rec
Slide 20: FT819: Enhanced Tumor Control vs. Primary CAR T Cells
FT819: Enhanced Tumor Control vs. Primary CAR T Cells Disseminated Xenograft Model of Lymphoblastic Leukemia FT819 Consists of Memory Phenotype and Outcompetes Primary CAR T Cells In Vivo - 20 -
Slide 21: FT819-101: Phase I Dose Escalation Schema
FT819-101: Phase I Dose Escalation Schema Concurrent and Independent Dose Escalation in BCL, CLL and pre-B ALL 3 Indications x 3 Treatment Regimens Regimen A1 Regimen A Regimen B + IL-2 Day 1 Day 1 Day 1 Day 3 Day 5 Max + IL2 Max DL Max DL Max DL Max DL DL1 = 30M cells DL3 + DL3 1/3rd 1/3rd 1/3rd IL
Slide 22: Multiple Myeloma Franchise
Multiple Myeloma Franchise - 22 -
Slide 23: FT538: hnCD16 + IL-15RF + CD38KO NK Cell Product Candidate
FT538: hnCD16 + IL-15RF + CD38KO NK Cell Product Candidate Uniformly engineered with three functional elements designed to optimize innate immunity Enhanced persistence without cytokine support FT516 vs. FT538 in NSG Mouse ✓ The deletion of the CD38 gene (CD38KO) enhances metabolic fitness, promotes
Slide 24: FT538: Enhanced ADCC in Combination with anti-CD38 mAb In Vivo
FT538: hnCD16 + IL-15RF + CD38KO NK Cell Product Candidate Enhanced ADCC in Combination with anti-CD38 mAb In Vivo Phase 1 Dose Escalation Ongoing in Combination with daratumumab - 24 -
Slide 25: FT576: Multi-antigen Targeted CAR-BCMA NK Cell Product Candidate
FT576: Multi-antigen Targeted CAR-BCMA NK Cell Product Candidate BCMA Binding Domain with Differentiated Activation Threshold No Exogenous Cytokine No FT576 FT576 Tumor Untreated Batch #1 Batch #2 BCMA-CART ✓ Novel BCMA binding domain triggers target cell lysis at low levels of BCMA expression (~100
Slide 26: FT576-101: Phase 1 Dose Escalation Schema
FT576-101: Phase 1 Dose Escalation Schema Single- and Multi-dose Schedule as Monotherapy and in Combination with CD38-targeted mAb Phase 1 Dose Escalation Ongoing in Single-dose Monotherapy and Single-dose Combination Cohorts 600M Cells 600M Cells 1.5B Cells 1.5B Cells x >1 dose x >1 dose 300M Cells
Slide 27: AML Franchise
AML Franchise - 27 -
Slide 28: Off-the-Shelf, iPSC-derived NK Cell Franchise for AML
Off-the-Shelf, iPSC-derived NK Cell Franchise for AML FT516 and FT538 Product Candidates • 300+ AML/MDS patients treated with allogeneic NK cellsa • Numerous clinical studies in relapsed / refractory AML have showna: – CR rates = 20-35% – No GvHD Jeffrey S. Miller, MD – Minimal CRS / neurotoxicity S
Slide 29: FT516 / FT538: Interim Phase 1 Data in Relapsed / Refractory AML
FT516 / FT538: Ongoing Phase 1 Studies as Monotherapy Interim Phase 1 Data in Relapsed / Refractory AML • Ongoing P1 studies of FT516 and FT538 as monotherapy have enrolled patients with poor prognosis (n=12) – Median of 3 prior lines, with 11 patients refractory to their last prior therapy – 9 pati
Slide 30: FT538: Ongoing Phase 1 Study in Combination with CD38-targeted mAb
FT538: Ongoing Phase 1 Study in Combination with CD38-targeted mAb FT538 + daratumumab for Targeting of CD38 on Leukemic Blasts CD38 expression from bone marrow NK cells in combination with CD38-targeted FT538 uniquely elicits an anti-tumor response against samples was found in 239 of 241 mAb signif
Slide 31: Solid Tumor Franchise
Solid Tumor Franchise - 31 -
Slide 32: Developing Synthetic Killer Cells for Solid Tumors
Off-the-shelf, iPSC-derived Cell-based Cancer Immunotherapies Developing Synthetic Killer Cells for Solid Tumors • Developing next-generation cancer immunotherapies must address numerous challenges that limit the effectiveness of today’s agents in treating solid tumors. – Depleted / dysfunctional im
Slide 33: Solid Tumor Product Pipeline
Solid Tumor Product Pipeline Multiplexed-engineered, iPSC-derived NK and T-cell Product Candidates Program Functionality & Cell Type Target(s) Indication(s) Preclin Phase 1 FT538 hnCD16 + IL15RF + CD38-KO iNK EGFR, HER2, PD1/PD-L1 ST + mAb FT536 hnCD16 + IL15RF + CD38-KO + CAR-MICA/B iNK MICA/B ST ±
Slide 34: FT538-102: Multi-arm, Dose-escalating Phase 1 Study
FT538-102: Multi-arm, Dose-escalating Phase 1 Study Designed to Assess Cooperation with Adaptive Immune System and Enhanced ADCC • hnCD16 Multiple cycles each comprising Cy / Flu conditioning, 3 doses of FT538, and mAb therapy – Up to 2 cycles; potential to administer additional cycles with clinical
Slide 35: FT536: Multi-antigen Targeted CAR-MICA/B NK Cell Product Candidate
FT536: Multi-antigen Targeted CAR-MICA/B NK Cell Product Candidate Pan-tumor Targeting Strategy to Overcome Tumor Escape • MICA/B are cell-surface proteins induced by cellular stress and transformation, and their expression has been reported for many cancer types. • NKG2D, an activating receptor exp
Slide 36: FT536: Durable Tumor Reduction of B16 MICA+ Metastatic Lung Lesions
FT536: Multi-antigen Targeted CAR-MICA/B NK Cell Product Candidate Durable Tumor Reduction of B16 MICA+ Metastatic Lung Lesions 1x104 cells 1x107 cells B16 MICA+ (iv) MICA/B CAR iNK + 3 Days + 11 Days Manual NSG Mice Metastases Count - 36 -
Slide 37: FT536-101: Multi-arm, Dose-escalating Phase 1 Study
FT536-101: Multi-arm, Dose-escalating Phase 1 Study Designed to Assess Cooperation with Adaptive Immune System and Enhanced ADCC • Multiple cycles each comprising Cy / Flu conditioning, 3 doses of FT536, ± mAb – Up to 2 cycles; potential to administer additional cycles with clinical benefit and upon
Slide 38: B7H3-targeted, Multiplexed-engineered CAR Product Candidate
B7H3-targeted, Multiplexed-engineered CAR Product Candidate Pan-tumor Targeting Approach Aimed at the Metabolic Profile of Cancer • B7H3 (CD276) belongs to the B7 superfamily of immune checkpoint molecules. • B7H3 protein is aberrantly overexpressed in a wide variety of cancers – Limited expression
Slide 39: Identification of Novel anti-camB7H3 scFv
B7H3-targeted, Multiplexed-engineered CAR Product Candidate Identification of Novel anti-camB7H3 scFv CAR Design camB7-H3 CAR-T cells Show Durable Control • Based on camelid antibodies and Prevent Disease Progression in vivo • Maintain high target affinity and specificity associated with conventiona
Slide 40: Collaborations & Financials
Collaborations & Financials - 40 -
Slide 41: Janssen Cancer Immunotherapy Collaboration
Janssen Cancer Immunotherapy Collaboration Off-the-shelf, iPSC-derived CAR NK Cell and CAR T-Cell Collaboration Oncology Innovation for Heme Malignancies & Solid Tumors • Proprietary antigen binding domains contributed by Janssen • Four targets selected; 2 for heme malignancies and 2 for solid tumor
Slide 42: ONO Cancer Immunotherapy Collaboration
ONO Cancer Immunotherapy Collaboration Off-the-shelf, iPSC-derived CAR NK Cell and CAR T-Cell Collaboration Oncology Innovation for Solid Tumors • Proprietary antigen binding domains contributed by Ono • Multiplexed-engineered, CAR-targeted product candidates • Incorporating multiple MOAs to address
Slide 43: Financial Summary
Financial Summary As reported in Company’s Consolidated Financial Statements Three Months Ended September 30, 2022 As reported in Company’s Consolidated Financial Statements Revenue $15.0M Operating Expense1 $101.4M Cash & Cash Equivalents $519M Total Shares Outstanding2 111.1M 2022 Cash, Cash Equiv
Slide 44: Better Cells For Better Therapies
Better Cells For Better Therapies™ - 44 -
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