Celularity Inc. · NASDAQ:CELU
Celularity — GX Acquisition — SPAC Merger (February 2021)
55 slides from Celularity's SPAC merger presentation, Feb 11, 2021
Slide 1: The Next Evolution in Cellular Medicine
The Next Evolution in Cellular Medicine
Slide 2: Disclaimer
CONFIDENTIAL Page 1 Disclaimer This presentation has been prepared for use by GX Acquisition Corp. (“ GX ”) and Celularity, Inc. (“ Celularity ”) in connection with their proposed business combination (the “ Business Combination ”). This presentation, and any information disclosed, whether in writin
Slide 3: Our Vision
OUR VISION Next Evolution in Off - the - shelf Allogeneic Cellular Therapies, at Greater Scale & Quality with Attractive Economics CONFIDENTIAL Page 3 To harness the placenta’s unique biology and ready availability to develop therapeutic solutions Lead the evolution in placental - derived therapeuti
Slide 4: Key Investment Highlights
Strong intellectual property portfolio with over 1,500 issued and pending patents worldwide KEY INVESTMENT Highlights CONFIDENTIAL Page 4 Proprietary placenta - based platform developed over a 20 - year history Broad pipeline of novel, investigational product candidates across therapeutic areas and
Slide 5: Celularity A Leader In Cellular Therapeutics
Celularity A Leader In Cellular Therapeutics
Slide 6: Corporate, Clinical and Financial Milestones
CORPORATE MILESTONE CLINICAL MILESTONE FINANCIAL MILESTONE KEY: Anthrogenesis acquired by Celgene, becomes Celgene Cellular Therapeutics Placental Exosome program launched ( pExo ) IND Safe to Proceed CYNK - 001 in COVID - 19 Celgene & bluebird bio autologous CAR - T collaboration FIH allogeneic Pla
Slide 7: Celularity IMPACT Platform
Page 7 CELULARITY IMPACT Œ PLATFORM Capitalizing on the Benefits of Placenta Derived Cells to Target Multiple Diseases Celularity IMPACT Œ ( I mmuno - M odulatory P lacenta - derived A llogeneic C ell T herapy) INHERENT ADVANTAGES OF PLACENTAL BASED CELLS ▪ Preclinical and early clinical data demons
Slide 8: Single-Source, Placenta-Based Platform Driving Broad Pipeline
CELULARITY’S SINGLE - SOURCE, PLACENTA - BASED PLATFORM DRIVING BROAD PIPELINE Four Key Cell Types Driving Six Initial Indications and Potential for Further Expansion MANUFACTURING >> Purpose - built, fully integrated manufacturing facility; rapidly scalable, end - to - end supply chain SINGLE SOURC
Slide 9: Pipeline Overview
CONFIDENTIAL Page 9 Pipeline Overview Broad Pipeline Across Oncology and Degenerative Diseases; Catalyst Rich 24 Months Ahead CELL TYPE PROGRAM INDICATION 2021 2022 HEMATOLOGIC MALIGNANCIES Placental CAR - T CyCART - 19 B - Cell Malignancies Placental NK Cell Unmodified NK Cell CYNK - 001 (cryoprese
Slide 10: Multiple Near-Term Clinical & Regulatory Milestones - 2021
MULTIPLE NEAR - TERM CLINICAL & REGULATORY MILESTONES - 2021 CONFIDENTIAL Page 10 Program Milestones CYNK - 001 ▪ 1H21: Phase II Study Start (AML) ▪ 2H21: Pivotal Phase II Trial (GBM) CYNK - 101 ▪ 1H21: IND Submission ▪ 2H21: Phase I/ IIa Trial Start CyCART - 19 ▪ 2H21: IND Submission Expected ▪ 2H2
Slide 11: Purpose-Built Manufacturing Facility
Celularity benefits from Celgene’s 20 year+ investment in developing the technologies and capabilities required to manufacture cellular products at scale with consistent and reliable quality PURPOSE BUILT FACILITY FOR COMMERCIAL - SCALE CELLULAR THERAPEUTIC MANUFACTURING ▪ $80M investment in cGMP /
Slide 12: Experienced Management Team
EXPERIENCED MANAGEMENT TEAM With Deep Expertise in Cell Therapy CONFIDENTIAL Page 12 S olveig Ericson, MD, PhD VP Medical Affairs Krzysztof Grzegorzewk , MD VP Medical Affairs Selected Approvals by Medical Team Sharmila Koppisetti , MD VP Drug Safety Pharmacovigilance Senior Medical Team Chi Li, PhD
Slide 13: Celularity Pipeline Overview
Celularity Pipeline Overview
Slide 14: CyCART-19 B-Cell Malignancies
CyCART - 19 B - Cell Malignancies
Slide 15: CyCART-19 Overview: Celularity Approach and Advantages
C yCART - 19 OVERVIEW Celularity Approach and Advantages CONFIDENTIAL Page 15 CAR - T approach Allogeneic approaches have important advantages ▪ Off - the - shelf for on - demand use ▪ Eliminates lengthy wait time for patient ▪ Scalable manufacturing and simplified logistics instead of “one batch, o
Slide 16: CyCART-19 Superior T Stem Cell Memory Characteristics
Marker Naïve Stem Cell Memory Central Memory Effector Memory Phenotype CD45RA + + - +/ - CD27 +++ +++ ++ +/ - CCR7 +++ +++ ++ - CD28 ++ +++ +++ +/ - Function Telomere +++ +++ ++ + Self - renewal + +++ ++ + IFN - g - + ++ +++ IL - 2 - ++ +++ +/ - Cytotoxicity - +/ - + +++ Adopted from Gattinoni et al
Slide 17: CyCART-19 Superior Anti-Lymphoma Activities & Survival
▪ CyCART - 19 demonstrates significantly reduced tumor burden and survival benefit compared to adult blood - derived CD19 CAR - T cells ▪ CyCART - 19 eliminated tumor and resulted in 100% survival out to 120 days ▪ CyCART - 19 ” memory” characteristics demonstrated via: – Extended survival out to 21
Slide 18: CyCART-19 Cells Do Not Induce Xenogeneic GvHD In Vivo
▪ Placental T (P - T) cells do not induce xenogeneic GvHD in vivo – Evidenced by 100% survival , no weight loss , no increase in detection of any human CD3+ T cells in P - T treated mice – PBMC - treated mice exhibited significant weight loss, death of all mice, and increase of detection of human CD
Slide 19: CyCART-19 Summary
KEY TAKEAWAYS ▪ Celularity has established a robust process to obtain placental T naive/ scm population as source materials to produce off - the - shelf, highly scalable CyCART - 19 cells ▪ CyCART - 19 demonstrates stem cell memory characteristics as evidenced by superior in vivo persistence and dur
Slide 20: CYNK-001 AML
CYNK - 001 AML
Slide 21: NK Cell Overview: Celularity Approach and Advantages
NK CELL OVERVIEW Celularity Approach and Advantages CONFIDENTIAL Page 21 Advantages NK CELL THERAPIES Cell Therapy Technology Scorecard ADULT DONOR DERIVED CELULARITY CYNK - 001 & CYNK - 101 Source Procurement Non - invasive Collection / Reliable Procurement P P Lower COGs Standardized, Scalable Man
Slide 22: First Allogeneic Placental HSC-Derived NK Cell Immunotherapy
▪ CYNK - 001 investigated in two Phase I studies for refractory and relapsed Acute Myeloid Leukemia (r/r AML) and Multiple Myeloma (MM) post autologous stem cell transplant – CYNK - 001 was well tolerated in 25 participants treated FIRST ALLOGENEIC PLACENTAL HSCS - DERIVED NK CELL IMMUNOTHERAPY Biol
Slide 23: AML: Pre-Clinical Data
CML, AML, MM IN VITRO KILLING IFN - G PRODUCTION PRIMARY AML KILLING CYNK - 001 activation releases high concentration of IFN - g, favoring Th1 responses CYNK - 001 exerted up to 60% specific lysis against primary AML samples at an Effector: Target (E:T) ratio of 3:1 AML: PRE - CLINICAL DATA Shows E
Slide 24: CYNK-001-AML-001 Phase I Results
DESIGN ▪ Dose escalation study ▪ Conditioning with cyclophosphamide and fludarabine – Fludarabine 25 mg/m2 x 5 days start day - 6 – Cyclophosphamide 60 mg/kg x 2 days on day - 5 and - 4 (omit Day - 4 if within 4 months of prior transplant) ▪ CYNK - 001 administered IV followed by up to 6 rhIL - 2 in
Slide 25: CYNK-001 Persisted, Matured and Proliferated in AML
CYNK - 001 Persisted, Matured and Proliferated in AML Source: AACR 2019 poster: Immune monitoring of CYNK - 001, an allogeneic, off the shelf NK cell in a Phase I study of acute myeloi d leukemia”, Celularity data CONFIDENTIAL Page 25 CYNK - 001 demonstrated persistence up to 28 days (mean=11days) P
Slide 26: Pivotal Randomized Phase 2 Trial in MRD+ AML
▪ CYNK - 001 + SOC ASCT vs SOC ASCT ▪ Two - arm randomized (1:1) SOC ASCT with or without CYNK - 001 ▪ CYNK - 001 dose from Phase 1 CYNK - 001 - AML - 001 study ▪ N=120 ▪ Primary Endpoints : Leukemia free survival at 12 months ▪ Secondary Endpoints : OS at 12 months, MRD conversion rate PIVOTAL RAND
Slide 27: CYNK-001 in AML Summary
KEY TAKEAWAYS ▪ NK cells are n atural immune cells that eradicate both cancer and virus - infected cells – Key mediators of antibody - dependent cellular cytotoxicity ▪ Placental derived NK cells exhibit distinct characteristics: – Different maturation and activation state – Immature phenotype ▪ CYN
Slide 28: CYNK-101 HER2+ Advanced Esophageal / Gastric Adenocarcinoma
CYNK - 101 HER2+ Advanced Esophageal / Gastric Adenocarcinoma
Slide 29: Genetically Modified NK Program
RATIONALE ▪ Engineering CYNK cells with high affinity and cleavage resistant (CD16VP) expected to improve affinity for IgG1 therapeutic antibodies, resist activation induced cleavage and improve overall ADCC potential – CD16 polymorphism impacts IgG affinity and thus ADCC – CD16 158 V/V – highest af
Slide 30: CYNK-101 Demonstrates Effective Antitumor Activity Against Gastric Cancer
CYNK - 101 DEMONSTRATES EFFECTIVE ANTITUMOR ACTIVITY Against Gastric Cancer Cell Lines in Conjunction with Anti - HER2 Monoclonal Antibody CONFIDENTIAL Page 30 Source: Celularity Data ▪ Significant ADCC activity of CYNK - 101 in combination with Herceptin against both gastric cancer cell lines was s
Slide 31: CYNK-101 Provides a Backbone for Combination Therapies
% Specific Lysis ADCC WITH RITUXIMAB ADCC WITH ELOTUZUMAB ADCC WITH DARATUMUMAB % Specific Lysis % Specific Lysis CY NK - 101 + mAb CYNK + mAb CYNK - 101 + IgG CYNK + IgG E:T Ratio (Against Daudi) ▪ Improved ADCC response observed from CYNK - 101 compared to unmodified CYNK cells against lymphoma ce
Slide 32: CYNK-101 in HER2+ Gastric Cancer Summary
KEY TAKEAWAYS ▪ CYNK - 101 adds “punching power” to the CYNK - 001 platform via genetic modification ▪ When combined with Herceptin demonstrates ADCC activity against HER2+ Gastric Cancer cells – Joint impact of modified NK cells + mAb shows improved immunologic response with added NK cell killing C
Slide 33: Degenerative Diseases
Degenerative Diseases
Slide 34: Allogeneic Placental Pluripotent Cells: Scalable & Off-the-Shelf
One Placenta > 100,000 Doses Master Cell Stock Working Cell Stock Target Product Profile ▪ Culture expanded, undifferentiated Mesenchymal - like Stromal Cells (MSCs) ▪ Composition: CD34 - , CD10+, CD105+, and CD200+ ▪ MOA: Immune - modulatory, anti - inflammatory, pro - angiogenic, cytoprotective, p
Slide 35: Newly Developed APPL Program: Legacy Studies
NEWLY DEVELOPED APPL PROGRAM Leveraging Legacy Placental Mesenchymal - like Stromal Cell Studies to Expand to Degenerative Diseases 50+ patients dosed in multiple Crohn’s Disease studies ▪ Clinical response rates were significantly higher in IV Formulation treatment groups compared with the placebo
Slide 36: Newly Developed APPL Program: APPL-TFKO
NEWLY DEVELOPED APPL PROGRAM Leveraging PDA Cells and Develop New APPL Candidate Genetically Modified APPL with Greater Safety Profile ▪ Tissue factor (TF) Knockout (KO) in APPL using CRISPR/Cas9 to reduce potential safety risk associated with TF ▪ Identified two of four CRISPR guide RNAs showing >9
Slide 37: APPL in Crohn's Disease Summary
KEY TAKEAWAYS ▪ Culture - expanded, undifferentiated mesenchymal - like stromal cells – Genetically modified with tissue factor (TF) knockout (KO) ▪ Mechanism of Action: – Immune - modulatory, anti - inflammatory, pro - angiogenic, cytoprotective and pro - regenerative CLINICAL PLAN ▪ 2H21: IND Subm
Slide 38: Transaction Summary
Transaction Summary
Slide 39: Terms of Transaction: Overview
TERMS OF TRANSACTION Overview Transaction Summary ▪ Celularity Inc. (“Celularity”) intends to combine with GX Acquisition Corp. (“GX”, NASDAQ: GXGX) pursuant to a merger agreeme nt and plan of reorganization (the “Merger Agreement”) − Celularity is a clinical - stage biopharmaceutical company that i
Slide 40: Terms of Transaction: Pro Forma Valuation and Ownership
TERMS OF TRANSACTION Pro Forma Valuation and Ownership Assumes estimated Celularity cash and debt at 12/31/20, an ~$80 million PIPE issuance at $10 / share, that there are no stock hol der redemptions and that the Celularity Shareholder Equity Rollover is issued at the GX stockholder redemption pric
Slide 41: Use of Proceeds
CONFIDENTIAL Page 41 USE OF PROCEEDS Transaction Overview ▪ Approximately $375 million 1 of cash as of 12/31/20, pro forma for the business combination, projected on the combined company balance sheet to pursue Celularity’s research and development programs − Expected to provide cash runway into 202
Slide 42: Near-Term Milestones
NEAR - TERM MILESTONES To Achieve the Next Advance in Placenta - based Cell Therapy CONFIDENTIAL Page 42 June 2019: December 2019: January 2020: March 2020: April 2020: September 2020: Submitted IND for CYNK - 001 in AML Completion of Phase 1/2 (manufacturing) at Florham Park Received FDA Safe to pr
Slide 43: Appendix: Clinical Programs Additional Detail
Appendix Clinical Programs Additional Detail
Slide 44: Celularity IMPACT Platform: Broad IP Protection
CONFIDENTIAL Page 44 PLATFORM CELULARITY IMPACT ΠPLATFORM Broad IP Protection Across All Lead Programs PLACENTAL NK PLACENTAL CAR - T PLACENTAL - DERIVED MESENCHYMAL - LIKE STROMAL CELLS 2 PATENT FAMILIES 15 PATENT FAMILIES 25 PATENT FAMILIES PNK Broad Background Patent Genetically Modified PNK Pat
Slide 45: The Placenta as a Renewable Allogeneic Source
CELULARITY IMPACT ΠPLATFORM The Placenta as a Renewable Allogeneic Source, with Purpose - Built Commercial Scale Manufacturing CONFIDENTIAL Page 45 PLATFORM APPL - 001 Genetic Modification Lymphocytic Progenitors Lymphocytic Progenitors CYNK - 101 CYNK - 001 CyCART - 19 CAR Transduction Gene Editin
Slide 46: Placental CAR-T: Solving the Downside of Autologous CAR-T
CELULARITY PLACENTAL CAR - T ( CyCART ) Solving the Downside of Autologous CAR - T Therapies ALLOGENEIC PLACENTAL CAR - T x No apheresis capacity constraints x High volume manufacturing x On - demand, off - the - shelf cryopreserved packaged product » All CAR T - cell therapies on the market and mos
Slide 47: Placental CAR-T: Upside to Adult-Donor Allogeneic CAR-T
CELULARITY PLACENTAL CAR - T ( CyCART ) Providing Upside to Adult - donor Allogeneic CAR - T Therapies ALLOGENEIC PLACENTAL CAR - T x No apheresis capacity constraints x High volume manufacturing x On - demand, off - the - shelf cryopreserved packaged product » Requires selection, screening & testin
Slide 48: Placental NK Cells: Upside to Adult-Donor NK Cells
CELULARITY PLACENTAL NK CELLS Providing Upside to both Adult - donor NK Cells ALLOGENEIC PLACENTAL NK x No apheresis capacity constraints x High volume manufacturing x On - demand, off - the - shelf cryopreserved packaged product » Apheresis of peripheral blood from healthy donor / patient » Require
Slide 49: CyCART-19 Phase 1 and Phase 2 Study Design
▪ Three dose cohorts (40, 120 and 360 x10 6 transduced, viable CAR - T cells) ▪ 3+3 design ▪ N=up to 18 ▪ Primary Endpoints : Determine safety and maximum tolerated dose ▪ Secondary Endpoints : ORR (CR+PR), DOR, PFS, OS ▪ Exploratory Endpoints: Persistence of CyCART - 19 PHASE 1 STUDY (SAFETY AND DO
Slide 50: NK Cell Therapy for Cancer Immunotherapy
NK CELL THERAPY FOR CANCER IMMUNOTHERAPY Preclinical & Clinical Data Supporting Role of NK cells in the Treatment of Cancer NK CELLS ARE A MAJOR COMPONENT OF THE INNATE IMMUNE SYSTEM ▪ Natural immune cells that eradicate both cancer and virus - infected cells – Directly via cytolytic granule mediate
Slide 51: CYNK-101 Phase 1/2a Trial Treatment Schedule
INDUCTION Biopsies (2) - at the screening, after completing induction (before starting chemotherapy), PET Scans (3) - at screening, after induction phase and before starting maintenance, Planned interim efficacy analyses: ▪ After induction ▪ After 3 cycles ▪ After 6 cycles Planned primary efficacy a
Slide 52: CYNK-101 Phase 1/2a Safety and Feasibility Design
Dose Level 1 CYNK - 101 + SOC* at 1.8x10 9 cells ▪ CYNK - 101 + SOC (Trastuzumab + mFOLFOX - 6) ▪ Dose escalation (3+3) with DLT period of 42 days followed by expansion up to 8 subjects per dose ▪ N=24 ▪ HER2+ GEJ/Gastric adenocarcinoma ▪ Trastuzumab naïve ▪ General objective: to establish MTD and r
Slide 53: CYNK-101 Phase 1/2a Trial Timeline
Phase 1/2a Label Indication Previously untreated HER2+ metastatic GEJ/Gastric Adenocarcinoma Target Patient Population Previously untreated subjects with metastatic or advanced unresectable gastroesophageal junction (GEJ) or gastric adenocarcinoma over - expressing HER - 2 Patient Enrollment ▪ 3 coh
Slide 54: APPL Crohn's Disease Study Design
Study Design : Randomized, double - blind, Placebo - controlled study in adults with 5 doses of 1/4 th unit APPL (~ 37 million cells) over 8 weeks vs. Humira treatment. Study Population: Moderate - to - Severe CD (CDAI score: 220 - 450) who are refractory to Corticosteroids Primary objective: T o as
Slide 55: Additional Information and Non-Solicitation
CONFIDENTIAL Page 55 GX and its directors and officers may be deemed participants in the solicitation of proxies of GX’s stockholders in connection with the Business Combination. GX’s stockholders and other interested persons may obtain, without charge, more detailed information regarding the direct