Fate Therapeutics, Inc. · NASDAQ:FATE
Fate Therapeutics — Investor Presentation (February 2022)
50 slides from Fate Therapeutics's investor presentation, February 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 February 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 Cellular Immunotherapies
Fate Therapeutics The Leading Developer of Off-the-shelf, iPSC-derived Cellular Immunotherapies Disruptive Technology Platform: industry-leading iPSC product platform supported by 10+ years of internal R&D and dominant IP estate with 350+ issued patents Leading Off-the-shelf NK & T-cell Product Pipe
Slide 4: Changing the Game in Cell Therapy
Changing the Game in Cell Therapy Established Leadership Position in Off-the-shelf, Cell-based Cancer Immunotherapy Multiplexed Engineering Incorporate multiple mechanisms of action to eradicate cancer Treatment Paradigm Mass Production Out-patient treatment strategies Scalable manufacturing with to
Slide 5: Creating Master Multiplexed-engineered iPSC Lines
Creating Master Multiplexed-engineered iPSC Lines Isolation, Characterization & Selection of Single Multiplexed-engineered iPSC 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 Ex
Slide 6: Mass Production of Off-the-shelf, Cell-based Cancer Immunotherapies
Mass Production of Off-the-shelf, Cell-based Cancer Immunotherapies Use of Master Multiplexed-engineered iPSC Bank as Starting Material Off-the-shelf, On-demand Treatment in Outpatient Setting ✓ Multiplexed engineering Multiple tumor-fighting mechanisms ✓ Homogeneous product High quality; consistent
Slide 7: Transforming the Treatment of Cancer
Transforming the Treatment of Cancer Leveraging Unique Advantages of Off-the-shelf, iPSC-derived Cellular Immunotherapy • Differentiated safety profile that enables early intervention Earlier Treatment Settings • Off-the-shelf convenience that supports community reach • Reliable administration witho
Slide 8: Off-the-Shelf, iPSC-derived NK Cell Cancer Immunotherapy Franchise
Off-the-Shelf, iPSC-derived NK Cell Cancer Immunotherapy Franchise Systematic Build of Industry-Leading iPSC-derived NK Cell Product Pipeline Universal, Off-the-Shelf NK Cell Cancer Immunotherapy Pipeline Clonal Master iPSC Line Synthetic Biology FT500 FT516 FT596 FT538 FT576 FT536 FT573 Multi-facet
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: B-cell Malignancy Franchise
B-cell Malignancy Franchise - 10 -
Slide 11: iPSC-derived NK Cell Franchise for B-cell Malignancies: FT516 and FT596
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 12: FT516: Novel High-Affinity, Non-Cleavable CD16a Fc Receptor
FT516: Novel High-Affinity, Non-Cleavable CD16a Fc Receptor Optimizing Antibody-Dependent Cellular Cytotoxicity for Use with mAb Therapy Novel High-affinity, Non-cleavable CD16 (hnCD16) NK Cell Fc Receptor for Enhanced ADCC High Affinity Non-Cleavable Only 15% of the population TME causes shedding o
Slide 13: FT516-101: Phase 1 Study in R/R B-cell Lymphoma
FT516-101: Phase 1 Study in R/R B-cell Lymphoma • 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/maximum assessed dose – Additional objectives: safety,
Slide 14: FT516-101: Interim Phase 1 Clinical Data in R/R B-cell Lymphoma
FT516-101: Interim Phase 1 Clinical Data in R/R B-cell Lymphoma 80% ORR in CAR T Naïve Population; 38% CR in Prior CAR T Population Interim Phase 1 Data at ≥90M Cells / Dose 1 CAR T Naïve Prior CAR T Aggressive BCL Indolent BCL Aggressive BCL n 5 5 8 Response 2 Objective Response (%) 4 (80%) 4 (80%)
Slide 15: FT516-101: Median Duration of Response Not Reached
FT516-101: Interim Phase 1 Clinical Data in R/R B-cell Lymphoma Median Duration of Response Not Reached at ≥90M Cells / Dose 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, inclu
Slide 16: FT516-101: Ongoing Dose Expansion
FT516-101: Ongoing Dose Expansion Dose Expansion at 900M Cells / Dose; Favorable Safety Profile Enables Exploration of Higher Cell Doses • Signal observed in both FT516 and FT596 Phase 1 studies R/R DLBCL post-aCD19 • Potential fast-to-market pathway / pivotal study launch in 2H22 CAR T-cell therapy
Slide 17: FT596: hnCD16 + CAR19 + IL15-RF iPSC-derived NK Cell Product Candidate
FT596: hnCD16 + CAR19 + IL15-RF iPSC-derived NK Cell Product Candidate Novel Dual-antigen Targeting Strategy to Overcome Tumor Heterogeneity and Antigen Escape CAR-mediated Cytotoxicity hnCD16-mediated Cytotoxicity Leukemia xenograft NSG immunodeficient mouse model Lymphoma xenograft NSG immunodefic
Slide 18: FT596-101: Phase 1 Study in R/R B-cell Lymphoma
FT596-101: Phase 1 Study in R/R B-cell Lymphoma Monotherapy and in Combination with CD20-targeted Monoclonal Antibody Therapy • Single-dose treatment cycle • Option for second single-dose treatment cycle – Initially required FDA consent – Requirement lifted based on acceptable safety and maintenance
Slide 19: FT596-101: Interim Phase 1 Clinical Data in R/R B-cell Lymphoma
FT596-101: Interim Phase 1 Clinical Data in R/R B-cell Lymphoma 75% ORR and 58% CR in Single-dose Combination Arm at ≥300M Cells Interim Phase 1 Data – Single Dose 1 Monotherapy Combination 1 Dose x 1 Cycle (n=13) (n=19) Single-dose Level Cohorts (Cells) OR CR OR CR 30M 1/3 (33%) 0 0/3 (0%) 0 90M 3/
Slide 20: FT596-101: Median Duration of Response Not Reached
FT596-101: Interim Phase 1 Clinical Data in R/R B-cell Lymphoma Median Duration of Response Not Reached at 90M and 300M Cell Dose 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 1
Slide 21: FT596-101: Ongoing Dose Escalation
FT596-101: Ongoing Dose Escalation 2-dose x 2-cycle Escalation Cohorts in Combination with Rituximab FT596 2-dose schedule Day 1 & 15; up to 2 cycles Potential to dose escalate • Multiple disease-specific FT596 1-dose schedule FT596 2-dose schedule expansion cohorts Up to 2 cycles Day 1 & 15; up to
Slide 22: 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 23: 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 - 23 -
Slide 24: 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; Enrolling DL2 (90M Cells) for BCL, CLL and pre-B ALL Regimen A1 Regimen A Regimen B + IL-2 Day 1 Day 1 Day 1 Day 3 Day 5 MPAD or MAD Max+IL2 MAD Max DL
Slide 25: Multiple Myeloma Franchise
Multiple Myeloma Franchise - 25 -
Slide 26: iPSC-derived NK Cell Franchise for Multiple Myeloma: FT538 and FT576
Off-the-Shelf, iPSC-derived NK Cell Franchise for Multiple Myeloma FT538 and FT576 Product Candidates hnCD16: High-affinity 158V, non- hnCD16 cleavable CD16 Fc receptor to hnCD16 augment ADCC IL-15RF: Interleukin-15 receptor CAR-BCMA fusion to promote survival, proliferation and trans-activation of
Slide 27: 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 ✓ The deletion of the CD38 gene (CD38KO) enhances metabolic fitness, promotes persistence, and enables cytotoxic function in high oxidative stress envir
Slide 28: FT538: Enhanced Persistence Without Cytokine Support
FT538: hnCD16 + IL-15RF + CD38KO NK Cell Product Candidate Enhanced Persistence Without Cytokine Support Primary NK vs. FT538 in NSG Mouse FT516 vs. FT538 in NSG Mouse Primary NK Cells Day 16 Day 16 - 28 -
Slide 29: 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 First Patients Treated at 100M Cells / Dose in Combination with daratumumab - 29 -
Slide 30: 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 31: FT576: Phase 1 Dose Escalation Schema
FT576: Phase 1 Dose Escalation Schema Single- and Multi-dose Schedule as Monotherapy and in Combination with CD38-targeted mAb Enrolling DL1 (100M Cells) Single-dose Monotherapy 600M Cells 600M Cells 1.5B Cells 1.5B Cells x 2 doses x 2 doses 300M Cells 300M Cells 600M Cells 600M Cells x 2 doses x 2
Slide 32: AML Franchise
AML Franchise - 32 -
Slide 33: iPSC-derived NK Cell Franchise for AML: FT516 and FT538
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 34: 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 35: 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 36: Solid Tumor Franchise
Solid Tumor Franchise - 36 -
Slide 37: 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 38: Emerging Product Pipeline for Solid Tumors
Emerging Product Pipeline for Solid Tumors Multiplexed-engineered, iPSC-derived NK and T-cell Product Candidates Orthogonal Mechanisms of Attack for Solid Tumors Cooperation between Innate and Adaptive Immunity | Augmenting ADCC Overcoming Tumor Escape | Targeting Metabolic Profile of Cancer - 38 -
Slide 39: 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 • Multiple cycles each comprising Cy / Flu conditioning, 3 doses of FT538, and mAb therapy – 2 cycles; potential to administer additional cycles with clinical benefit and
Slide 40: 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 Engineered with Four Anti-tumor Modalities for Solid Tumors hnCD16: High-affinity 158V, non-cleavable CD16 Fc receptor that has been modified to augment antibody-dependent cellula
Slide 41: FT536: Pan-tumor Targeting Strategy to Overcome Tumor Escape
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 42: 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 - 42 -
Slide 43: FT573: Multi-antigen Targeted CAR-B7H3 NK Cell Product Candidate
FT573: Multi-antigen Targeted CAR-B7H3 NK Cell 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, with limited ex
Slide 44: FT573: Identification of Novel anti-camB7H3 scFv
FT573: Multi-antigen Targeted CAR-B7H3 NK Cell Product Candidate Identification of Novel anti-camB7H3 scFv Robust Recognition and Activity CAR Design Against Multiple Solid Tumor Lines • Based on camelid antibodies • Maintain high target affinity and specificity associated with conventional antibodi
Slide 45: FT573: Pan-tumor Targeting Approach Aimed at the Metabolic Profile of Cancer
FT573: Multi-antigen Targeted CAR-B7H3 NK Cell Product Candidate Pan-tumor Targeting Approach Aimed at the Metabolic Profile of Cancer Uniform Expression of Antigen-specific Cytokine Release & B7H3 CAR Cytotoxicity Degranulation - 45 -
Slide 46: Collaborations & Financials
Collaborations & Financials - 46 -
Slide 47: Janssen Cancer Immunotherapy Collaboration (April 2020)
Janssen Cancer Immunotherapy Collaboration (April 2020) Off-the-shelf, iPSC-derived CAR NK Cell and CAR T-Cell Collaboration Oncology Innovation • Proprietary antigen domains contributed by Janssen • Up to 4 targets including hematologic malignancies and solid tumors • Substantial investment in next
Slide 48: ONO Cancer Immunotherapy Collaboration (September 2018)
ONO Cancer Immunotherapy Collaboration (September 2018) Off-the-shelf, iPSC-derived CAR T-Cell Collaboration Oncology Innovation • Proprietary antigen domain contributed by Ono • Targeting solid tumors • Potential to include additional antigen binding domains Strategic Collaboration • FATE leads pre
Slide 49: Financial Summary
Financial Summary As reported in Company’s Consolidated Financial Statements Three Months Ended September 30, 2021 Revenue $14.2M Operating Expense1 $68.9M Cash & Cash Equivalents $804M Employees ~400 Total Shares Outstanding2 109.4M 1 Includes $13.5m in stock-based compensation 2 Includes 14.0M sha
Slide 50: Better Cells For Better Therapies
Better Cells For Better Therapies™ - 50 -
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