Slide 1: The Next Evolution in Cellular Medicine
The Next Evolution in Cellular Medicine
Slide 2: Disclaimer
CONFIDENTIAL Page 2 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 CAR - T CyCART - 19 B - Cell Malignancies Unmodified Natural Killer Cell CYNK - 001 (cryopreserved) Acute Myel
Slide 10: Manufacturing Overview
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 11: Experienced Management Team
EXPERIENCED MANAGEMENT TEAM With Deep Expertise in Cell Therapy CONFIDENTIAL Page 11 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 12: Celularity Pipeline Overview
Celularity Pipeline Overview
Slide 13: CyCART-19 B-Cell Malignancies
CyCART - 19 B - Cell Malignancies
Slide 14: CyCART-19 Overview: Approach and Advantages
C yCART - 19 OVERVIEW Celularity Approach and Advantages CONFIDENTIAL Page 14 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 15: CyCART-19 Demonstrated T Stem Cell Memory Characteristics
C y C A R T - 1 9 D # 1 C y C A R T - 1 9 D # 2 C y C A R T - 1 9 D # 3 P B M C 0 20 40 60 80 100 CD19 CAR+ T cell Differentiation Status + ( % ) Tscm/ naïve Tcm Tem Teff Marker Naïve Stem Cell Memory Central Memory Effector Memory Phenotype CD45RA + + - +/ - CD27 +++ +++ ++ +/ - CCR7 +++ +++ ++ - C
Slide 16: CyCART-19 Demonstrates Superior Anti-Lymphoma Activities and 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 17: 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 18: CyCART-19 Summary: Key Takeaways
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 19: CYNK-001 AML
CYNK - 001 AML
Slide 20: NK Cell Overview: Approach and Advantages
NK CELL OVERVIEW Celularity Approach and Advantages CONFIDENTIAL Page 20 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 21: 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 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: Phase I Design and 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 24: CYNK-001 Persisted, Matured and Proliferated in AML
0 1 0 0 2 0 0 3 0 0 4 0 0 5 0 0 6 0 0 Day 28 Day 21 Day 14 Day 7 Day 0 screening (-) control (+) control HLA-A/B/C Panel Reactive Antibody Test FITC Geom. Mean CYNK - 001 Persisted, Matured and Proliferated in AML Source: AACR 2019 poster: Immune monitoring of CYNK - 001, an allogeneic, off the shel
Slide 25: 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 26: 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 27: CYNK-101 HER2+ Advanced Esophageal / Gastric Adenocarcinoma
CYNK - 101 HER2+ Advanced Esophageal / Gastric Adenocarcinoma
Slide 28: 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 29: 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 29 Source: Celularity Data ▪ Significant ADCC activity of CYNK - 101 in combination with Herceptin against both gastric cancer cell lines was s
Slide 30: CYNK-101 Provides a Platform for mAb 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 31: 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 32: Degenerative Diseases
Degenerative Diseases
Slide 33: Allogeneic Placental Pluripotent Cells: Scalable and 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 34: Newly Developed APPL Program
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 35: 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 36: 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 37: Transaction Summary
Transaction Summary
Slide 38: 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 39: 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 40: Use of Proceeds
CONFIDENTIAL Page 40 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 41: Near-Term Milestones
NEAR - TERM MILESTONES To Achieve the Next Advance in Placenta - based Cell Therapy CONFIDENTIAL Page 41 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 42: Appendix: Clinical Programs Additional Detail
Appendix Clinical Programs Additional Detail
Slide 43: Celularity IMPACT Platform: Broad IP Protection
CONFIDENTIAL Page 43 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 44: Placenta as a Renewable Allogeneic Source
CELULARITY IMPACT ΠPLATFORM The Placenta as a Renewable Allogeneic Source, with Purpose - Built Commercial Scale Manufacturing CONFIDENTIAL Page 44 PLATFORM APPL - 001 Genetic Modification Lymphocytic Progenitors Lymphocytic Progenitors CYNK - 101 CYNK - 001 CyCART - 19 CAR Transduction Gene Editin
Slide 45: 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 46: 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 47: 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 48: 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 49: 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 50: 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 51: 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 52: 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 53: 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
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