Celularity Inc. · NASDAQ:CELU
Celularity — Investor Presentation (May 2022)
28 slides from Celularity's investor presentation, May 2022
Slide 1: The Next Evolution in Cellular Medicine
THE NEXT EVOLUTION IN CELLULAR MEDICINE May 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 Corp. Announced Merger CYNK-101 in FIH cryopreserved Agreement to Create a Company Ticker Advanced HER2/neu allogeneic placental- Publicly Li
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 à 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: Our Experienced Leadership Team
OUR EXPERIENCED LEADERSHIP TEAM With Deep Expertise in Cell Therapy Executive Leadership Team Robert J. Hariri, Andrew Pecora, John David Bradley Glover, Anne Jones, Dr. Stephen Keary Beth MD, PhD MD, FACP, CPE Haines Beers PhD PhD Brigido Dunn, Esq. Steinbrenner Founder, Chairman President Chief Op
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: 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 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 TSCM population following manufacturing 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 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 CYCART-19 secre
Slide 14: CYNK-001 AML
CYNK-001 AML
Slide 15: CYNK-001 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 16: AML Patient Outcomes - 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 17: AML Patient Outcomes - 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 18: CYNK-001 GBM
CYNK-001 GBM
Slide 19: CYNK001-GBM-002 Glioblastoma Program
CYNK001-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 20: CYNK-101 HER2+ Esophageal / Gastric Adenocarcinoma
CYNK-101 HER2+ Advanced Esophageal / Gastric Adenocarcinoma
Slide 21: CYNK-101 in HER2+ Gastric Cancer Overview
CYNK-101 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 activation induced cleavage Antibody-Dependent Cellular Cytotoxicity and improve overall ADCC potential
Slide 22: 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 23: CyCART-19 B-Cell Malignancies
CyCART-19 B-Cell Malignancies
Slide 24: CyCART-19 Overview
CYCART-19 OVERVIEW Celularity Approach and Advantages CAR-T THERAPIES CELL THERAPY RATIONALE TECHNOLOGY AUTOLOGOUS OTHER CELULARITY ALLOGENEIC CYCART-19 • Rationale for greater stemness, expandability, persistence SCORECARD • Abundant renewable starting cell source for allogeneic therapies Source Pr
Slide 25: Appendix
Appendix Additional Detail
Slide 26: 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 27: Placenta as a 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 28: 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