Celularity Inc. · NASDAQ:CELU
Celularity — Investor Presentation (June 2022)
33 slides from Celularity's investor presentation, June 2022
Slide 1: The Next Evolution in Cellular Medicine
THE NEXT EVOLUTION IN CELLULAR MEDICINE June 2022 Page 1
Slide 2: Disclaimers
DISCLAIMERS Forward-Looking Statements This presentation contains certain “forward-looking statements” within the meaning of the federal securities laws. Forward-looking statements may include, but are not limited to, statements regarding Celularity’s expectations, hopes, beliefs, intentions or stra
Slide 3: Celularity's Vision
CELULARITY’S VISION To deliver innovative off-the-shelf allogeneic cellular medicines for patients with high unmet need at unparalleled scale, quality and cost. Lead the evolution in placental-derived therapeutics: advance the discovery of the placenta as a limitless, renewable source of neonatal ce
Slide 4: Celularity: Company History
CELULARITY: COMPANY HISTORY Celgene Spin-out (2017) Leveraging 20+ Years of Cellular Therapeutics Innovation Celularity and GX Acquisition IND Safe to Proceed Orphan Drug Designation Corp. Announced Merger CYNK-101 in for CYNK-101 in the FIH cryopreserved Agreement to Create a Publicly Company Ticke
Slide 5: Celularity Placental-Derived Product Platform
CELULARITY PLACENTAL-DERIVED PRODUCT PLATFORM Capitalizing on the Benefits of Placental-Derived Cells to Target Multiple Diseases T-Cell Isolation + Genetic Modification One Placenta Many Patients Cryopreserved - On Demand • Universal donor material & Off-The-Shelf • No requirement for matching •
Slide 6: Single-Source, Placenta-Based Platform Driving Broad Pipeline
SINGLE-SOURCE, PLACENTA-BASED PLATFORM DRIVING BROAD PIPELINE 4 Key Cell Types Driving 6 Clinical Indications and Potential for Broad Expansion SINGLE SOURCE 4 ALLOGENEIC 4 KEY PROGRAMS 6 INITIAL INDICATIONS MATERIAL CELL TYPES Placental CyCART-19 B-Cell Malignancies CAR-T AML CYNK-001 Unmodified NK
Slide 7: Manufacturing Overview
MANUFACTURING OVERVIEW Fully Integrated, Purpose-Built Commercial Scale Manufacturing Site Including Translational Research & Biorepository PURPOSE BUILT FACILITY FOR STAFFED BY OVER 100 HIGHLY COMMERCIAL SCALE, GMP-READY COMMERCIAL-SCALE CELLULAR SPECIALIZED SCIENTISTS, ENGINEERS THERAPEUTIC MANUFA
Slide 8: Clinical Pipeline
CLINICAL PIPELINE Overview Placental Derived Program Indication Preclinical IND Submission Phase I Phase II Cell Type Acute Myeloid Leukemia (AML) Unmodified CYNK-001 Natural Killer Cell Glioblastoma Multiforme (GBM) ONCOLOGY Genetically CYNK-101 HER2+ Modified + mAb Gastric Cancer Natural Killer Ce
Slide 9: Cell Characterization
Cell Characterization
Slide 10: Placenta Enriched for Naive/SCM T Cells
THE PLACENTA IS ENRICHED FOR NAÏVE/SCM T CELLS COMPARED TO HEALTHY DONOR PERIHPERAL BLOOD ENABLING PRODUCTION OF CAR-T CELLS WITH GREATER ACTIVITY IN ANIMAL MODELS Placenta T cell starting material contains similar CD4/CD8 ratio as healthy adult blood T cells PBMC T Stem Cell Central Effector Placen
Slide 11: CyCART-19 Retained Stemness vs PBMC CD19 CAR-T
CYCART-19 (PLACENTAL CAR-T) RETAINED STEMNESS VS PBMC CD19 CAR-T POST MANUFACTURING Our process uses CRISPR to knockout CYCART-19 cells had better retention of the TRAC and transduction of CD19-CAR TSCM population following manufacturing PBMC CD19 CAR-T CYCART-19 PBMC CD19 CAR-T CYCART-19 CYCART-19
Slide 12: CyCART-19 Secreted High Levels of IL-2
CYCART-19 SECRETED HIGH LEVELS OF IL-2 AS COMPARED TO PBMC DERIVED CAR-T, CONFERRING A POTENTIAL CAR-T CELL SURVIVAL AND PROLIFERATION BENEFIT CYCART-19 and PBMC CD19-CART were similarly cytotoxic CD4 and CD8 CYCART-19 cells strongly expressed IL-2 PBMC CD19 CAR-T CYCART-19 NT PBMC T NT CYCART CYCAR
Slide 13: CYNK-001: AML and GBM
CYNK-001 AML and GBM
Slide 14: CYNK-001 Unmodified NK Cellular Therapy Overview
CYNK-001(unmodified NK cellular therapy) Overview RATIONALE NK CELL THERAPIES NK cells are natural immune cells that eradicate both cancer and virus- infected cells ADULT CELULARITY Cell Therapy – Key mediators of antibody-dependent cellular cytotoxicity (ADCC) Technology Scorecard DONOR DERIVED C
Slide 15: Persistence, Maturation and Proliferation with Absence of Allo-HLA Antibodies
PERSISTENCE, MATURATION AND PROLIFERATION WITH ABSENCE OF ALLO-HLA ANTIBODIES PNK-007 demonstrated persistence Persistent PNK-007 cells up to 28 days (mean=11days) matured and proliferated No detectable exhaustion PNK-007 demonstrated Absence of allo-HLA on PNK-007 cells effector function post infus
Slide 16: CYNK-001: AML
CYNK-001 AML
Slide 17: CYNK-001-AML-001 Study Schema
CYNK-001-AML-001 (MRD+ AND RELAPSED REFRACTORY AML) Phase 1 Study Schema – Trial in progress Enrolling Cohort 4a: Cohort 5a: Cohort 6a: Cohort 7a: EXPANSION COHORT AML MRD+ AML MRD+ AML MRD+ AML MRD+ AML MRD+ (N=4) Lymphodepletion Regimen #1 1.8B x3 1.8B x3 1.8B x 4 3B x 4 (12B) MTD/MPD of CYNK (5.4
Slide 18: AML Patient Outcomes Data Summary – Relapsed Refractory AML
AML PATIENT OUTCOMES DATA SUMMARY – RELAPSED REFRACTORY AML Evidence of a dose effect of CYNK-001 LD Doses: Risk Group / Cell Dose Blast Patient ID Cytoxan/ Day 28 Day 60 Day 120 Day 180 Day 300 Age (yrs) / IL2 Pre-LD Fludarabine 002-1001 Poor/adverse / 70 8400 mg / 230 mg 70 Million 82.2% > 82.2% D
Slide 19: AML Patient Outcomes Data Summary – MRD AML
AML PATIENT OUTCOMES DATA SUMMARY – MRD AML Evidence of a dose effect of CYNK-001 LD Doses: Risk Group/ Cell Dose Blast Patient ID Cytoxan/ Day 28 Day 60 Day 120 Day 180 Day 300 Age (yrs) / IL2 Pre-LD Fludarabine 102-0001 Intermediate / 75 1656 mg / 138 mg 1.8 Billion 0.87% 0.54% 0.42% 0.18% 1.6% 1.
Slide 20: CYNK-001: GBM
CYNK-001 GBM
Slide 21: CYNK-001-GBM-002 Glioblastoma Program
CYNK-001-GBM-002 (GLIOBLASTOMA PROGRAM) Planned Phase 1 Dose Escalation / Phase 2 Proof of Concept Screening Cohort 1 Up to 28 days Intravenous Intracavitary recurrent resection eligible GBM Resection (2.4 x109 cells – D1,D8,D15) (100x106 cells – (3 out of 4 wks) Lymphodepletion Cohort 2 Intravenous
Slide 22: CYNK-101: HER2+ Advanced Esophageal / Gastric Adenocarcinoma
CYNK-101 HER2+ Advanced Esophageal / Gastric Adenocarcinoma
Slide 23: CYNK-101 in HER2+ Gastric Cancer
CYNK-101 (modified NK cellular therapy) IN HER2+ GASTRIC CANCER Overview RATIONALE Engineering CYNK cells with high affinity and cleavage resistant (CD16VS) expected to improve affinity for IgG1 therapeutic antibodies, resist Antibody-Dependent Cellular Cytotoxicity activation induced cleavage and
Slide 24: CYNK-101 Demonstrated Antitumor Activity
CYNK-101 DEMONSTRATED ANTITUMOR ACTIVITY Against Gastric Cancer Cell Lines in Conjunction with Anti-HER2 Monoclonal Antibody NCI-N87 E/T 2:1 RESULTS Target cells alone • Significant ADCC activity of CYNK-101 in combination with Trastuzumab against both Killing Index gastric cancer cell lines was sho
Slide 25: CYNK-101 Provides a Backbone for Combination Therapies
CYNK-101 PROVIDES A BACKBONE FOR COMBINATION THERAPIES Enhanced ADCC with Multiple Antibodies Forms the Basis of Potential Combination Therapies ADCC WITH RITUXIMAB ADCC WITH ELOTUZUMAB ADCC WITH DARATUMUMAB % Specific Lysis % Specific Lysis % Specific Lysis E:T Ratio (Against Daudi) CYNK-101 + mAb
Slide 26: CYNK-101-HER2-001 HER2+ Gastric/GEJ Cancer
CYNK-101-HER2-001 (HER2+ GASTRIC/GEJ CANCER) Planned Phase 1 - Dose Escalation / Phase 2a Expansion/Proof of Concept Induction NK Cell Re- Induction Maintenance (5 cycles every 21 days) Pembrolizumab (every 21 days) Lymphodepletion 200 mg (Day 1 of cycle) CR, PR, Pembrolizumab (UP TO 28 DAYS) Pembro
Slide 27: CyCART-19: B-Cell Malignancies
CyCART-19 B-Cell Malignancies
Slide 28: CyCART-19 Overview
CYCART-19 OVERVIEW Celularity Approach and Advantages RATIONALE CAR-T THERAPIES • Rationale for greater stemness, expandability, persistence CELL THERAPY • Abundant renewable starting cell source for allogeneic therapies TECHNOLOGY AUTOLOGOUS OTHER CELULARITY ALLOGENEIC CYCART-19 • Potential for imp
Slide 29: CyCART-19-BCM-001 Relapsed/Refractory B-Cell Malignancies
CYCART-19-BCM-001 (RELAPSED/REFRACTORY B-CELL MALIGNANCIES) Planned Phase 1 / Phase 2 Phase 1 Phase 2: Safety and Dose Finding Cohorts Cohort A: High Grade NHL Dose Level 1: CD-19 targeted therapy naïve (n= ~66) 40 x106 cells • DLBCL N=3 • High Grade B-Cell lymphoma • Primary mediastinal B-Cell lymp
Slide 30: Appendix
Appendix Additional Detail
Slide 31: Celularity IMPACT Platform: Broad IP Protection
CELULARITY IMPACT™ PLATFORM Broad IP Protection Across All Lead Programs PNK Broad Background Patent Process Patents PLACENTAL-DERIVED CELLULAR PLATFORMS 15 PATENT PLACENTAL NK FAMILIES Genetically Modified PNK Patents Treatment of AML & MM Cryopreserved PNK (CYNK-001) Patents Treatment of GBM Proce
Slide 32: Celularity IMPACT Platform: Renewable Allogeneic Source
CELULARITY IMPACT™ PLATFORM The Placenta as a Renewable Allogeneic Source, with Purpose-Built Commercial Scale Manufacturing PROCESSES PRODUCTS INDICATION PLACENTAL-DERIVED CELLULAR PLATFORMS Acute Myeloid Leukemia Lymphocytic Progenitors CYNK-001 Glioblastoma Multiforme Placental NK CD34+ Cells Gas
Slide 33: Manufacturing Process
MANUFACTURING PROCESS Celularity Purpose-built Commercial Scale 150,000 sq. ft. Manufacturing Facility Network of Longstanding Cell Isolation and Partnerships Selection Product Cryopreservation • Birthing Centers • Proprietary perfusion • In-process cooling/cryopreservation • Obstetricians methodolo