Slide 1: The Next Evolution in Cellular Medicine
Exhibit 99.1 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 One Placenta à Many Patients Cryopreserved - On Demand T-Cell Isolation + Genetic Modification • 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: Our Experienced Leadership Team
OUR EXPERIENCED LEADERSHIP TEAM With Deep Expertise in Cell Therapy Executive Leadership Team David Bradley Glover, Anne Jones, Robert J. Hariri, Andrew Pecora, John Dr. Stephen Keary Beth MD, PhD MD, FACP, CPE Haines Beers PhD PhD Brigido Dunn, Esq. Steinbrenner President Chief Financial Chief Tech
Slide 9: Clinical Pipeline Overview
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 10: Cell Characterization
Cell Characterization
Slide 11: The Placenta Is Enriched for Naïve/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 Placenta T Stem Cell Central Effe
Slide 12: 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 T population following manufacturing SCM PBMC CD19 CAR-T CYCART-19 PBMC CD19 CAR-T CYCART-19 CYCART-19
Slide 13: 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 14: CYNK-001 AML and GBM
CYNK-001 AML and GBM
Slide 15: 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 DONOR CYNK-001 & – Key mediators of antibody-dependent cellular cytotoxicity (ADCC) Technology Scorecar
Slide 16: 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 17: CYNK-001 AML
CYNK-001 AML
Slide 18: CYNK-001-AML-001 Phase 1 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 19: 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 20: 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 Intermediate / 75 1656 mg / 138 mg 1.8 Billion 0.87% 0.54% 0.42% 0.18% 1.6% 1.9% 102-00
Slide 21: CYNK-001 GBM
CYNK-001 GBM
Slide 22: 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 Resection recurrent resection eligible GBM 9 6 (2.4 x10 cells – D1,D8,D15) (100x10 cells – (3 out of 4 wks) Cohort 2 Lymphodepletion Intraveno
Slide 23: CYNK-101 HER2+ Advanced Esophageal / Gastric Adenocarcinoma
CYNK-101 HER2+ Advanced Esophageal / Gastric Adenocarcinoma
Slide 24: CYNK-101 in HER2+ Gastric Cancer Overview
CYNK-101 (modified NK cellular therapy) IN HER2+ GASTRIC CANCER Overview RATIONALE § Engineering CYNK cells with high affinity and cleavage resistant (CD16VS) Antibody-Dependent Cellular Cytotoxicity expected to improve affinity for IgG1 therapeutic antibodies, resist Target Recognition activation i
Slide 25: 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 gastric cancer cell lines was shown at E:T rati
Slide 26: 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 E:T Ratio (Against Daudi) CYNK-101 + mAb CYNK + mAb CYNK-101 + IgG CYNK + IgG • Improved ADC
Slide 27: 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 Maintenance Induction NK Cell Re- Induction (every 21 days) (5 cycles every 21 days) Pembrolizumab Lymphodepletion 200 mg (Day 1 of cycle) Pembrolizumab CR, PR, Pembrolizumab (3 days)
Slide 28: CyCART-19 B-Cell Malignancies
CyCART-19 B-Cell Malignancies
Slide 29: 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 OTHER CELULARITY TECHNOLOGY AUTOLOGOUS ALLOGENEIC CYCART-19 SCORECARD • Potenti
Slide 30: 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) 6 40 x10 cells • DLBCL N=3 • High Grade B-Cell lymphoma • Primary mediastinal B-Cell lym
Slide 31: Appendix Additional Detail
Appendix Additional Detail
Slide 32: Celularity IMPACT Platform: Broad IP Protection
CELULARITY IMPACT™ PLATFORM Broad IP Protection Across All Lead Programs PNK Broad Background Patent Process Patents 15 PATENT PLACENTAL NK Genetically Modified PNK Patents Treatment of AML & MM FAMILIES Cryopreserved PNK (CYNK-001) Patents Treatment of GBM Process Patents Cryopreserved Genetically
Slide 33: Celularity IMPACT Platform: Placenta as Renewable Allogeneic Source
CELULARITY IMPACT™ PLATFORM The Placenta as a Renewable Allogeneic Source, with Purpose-Built Commercial Scale Manufacturing PROCESSES PRODUCTS INDICATION Acute Myeloid Leukemia Lymphocytic Progenitors CYNK-001 Glioblastoma Multiforme CD34+ Cells Placental NK Gastric Cancer Lymphocytic Progenitors G
Slide 34: 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