Celularity Inc. · NASDAQ:CELU
Celularity — GX Acquisition — SPAC Merger (April 2021)
51 slides from Celularity's SPAC merger presentation, Apr 28, 2021
Slide 1: The Next Evolution in Cellular Medicine
The Next Evolution in Cellular Medicine April 2021
Slide 2: Disclaimer
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 writing or orally, to you
Slide 3: Our Vision
OUR VISION Next Evolution in Off - the - shelf Allogeneic Cellular Therapies, at Greater Scale & Quality with Attractive Economics To harness the placenta’s unique biology and ready availability to develop therapeutic solutions Lead the evolution in placental - derived therapeutics: advance the disc
Slide 4: Key Investment Highlights
Strong intellectual property portfolio with over 1,500 issued and pending patents worldwide KEY INVESTMENT Highlights Proprietary placenta - based platform developed over a 20 - year history Broad pipeline of novel, investigational product candidates across therapeutic areas and indications of high
Slide 5: Celularity IMPACT Platform
CELULARITY IMPACT Œ PLATFORM Capitalizing on the Benefits of Placenta Derived Cells to Target Multiple Diseases Celularity IM P A CT Œ ( I mm un o - M od u la t ory P lacenta - derived A llogeneic C ell T herapy) INHERENT ADVANTAGES OF PLACENTAL BASED CELLS ▪ Preclinical and early clinical data demo
Slide 6: Corporate, clinical and financial milestones
CORPORATE MILESTONE CLINICAL MILESTONE FINANCIAL MILESTONE K EY : Anthrogenesis Celgene & FIH allogeneic $45M Series $210M Placental IND Safe to IND Safe to Placental T - acquired bluebird bio Placental - A Financing Series B Exosome Proceed Proceed cell/CAR - T by Celgene, autologous CAR - T derive
Slide 7: Pipeline Overview
Pipeline Overview Broad Pipeline Across Oncology and Degenerative Diseases; Catalyst Rich 24 Months Ahead CELL TYPE PROGRAM INDICATION 2021 2022 HEMATOLOGIC M A LI G N A NC I E S Placental CAR - T CyCART - 19 B - Cell M ali g n a n c i es IND Submission Phase I Phase II Pl ace n tal NK Cell Un m o d
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: 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/cG
Slide 10: Executive Leadership Team
Executive Leadership Team Robert J. Hariri, MD, PhD Founder & CEO Xiaokui Zhang, PhD Ch i e f Sc ien t i f i c Officer John Haines Chief Operating Officer David Beers Ch i e f F i nan c ial Officer EXPERIENCED MANAGEMENT TEAM With Deep Expertise in Cell Therapy Chi Li, PhD, MBA, RAC SVP Regulatory A
Slide 11: Celularity Pipeline Overview
Celularity Pipeline Overview
Slide 12: CyCART-19 T cell differentiation status
0 2 0 4 0 6 0 8 0 1 0 0 C D 1 9 C A R + T c e l l D i f f e r e n t i a t i o n S t a t u s + ( % ) T s c m / n a ï v e T e m T c m T e f f Marker Naïve S tem Ce l l Memory Central Me mo ry Effector Me mo ry Phenotype CD45RA + + - +/ - CD27 +++ +++ ++ +/ - CCR7 +++ +++ ++ - CD28 ++ +++ +++ +/ - Func
Slide 13: CyCART-19 anti-lymphoma activity 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 14: CYNK-001 persistence in AML
H L A - A / B / C P a n e l R e a c t i v e A n t i b o d y T e s t ( + ) c o n t r o l ( - ) c o n t r o l s c r e e n i n g D a y 0 D a y 7 D a y 1 4 D a y 2 1 D a y 2 8 F I T C G e o m . M e a n CYNK - 001 Persisted, Matured and Proliferated in AML Source: AACR 2019 poster: Immune monitoring of C
Slide 15: Near-term clinical and regulatory milestones 2021
MULTIPLE NEAR - TERM CLINICAL & REGULATORY MILESTONES - 2021 C O N FI D E N TIAL Page 15 Program Milestones CYNK - 001 ▪ 2H21: Dose Selection & Initiation of Expansion Cohorts (AML) ▪ 2H21: Establish Phase II Dose (GBM) CYNK - 101 ▪ 2H21: IND Submission ▪ 2H21: Phase I/IIa Study Start CyCART - 19 ▪
Slide 16: CyCART-19 B-Cell Malignancies
CyCART - 19 B - Cell Malignancies
Slide 17: CyCART-19 Overview
CyCART - 19 OVERVIEW Celularity Approach and Advantages C O N FI D E N TIAL Page 17 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 ba
Slide 18: CyCART-19 cells do not induce xenogeneic GvHD
▪ 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 in R/R B-Cell NHL study design
CyCART - 19 IN R/R B - CELL NHL Phase I with Expansion Cohort Study Design Part 2: Expansion Cohort s: Part 1: Safety and Dose Finding Phase 1 - Part 1 (safety and dose finding) • CyCART - 19: • Three dose cohorts (iDoses TBD x10 6 transduced, viable CAR - T cells • 3+3 design with dose de - escalat
Slide 20: Key Takeaways: 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 greater in vivo persistence and durab
Slide 21: CYNK-001 AML
CYN K - 001 AML
Slide 22: NK Cell Overview
NK CELL OVERVIEW Celularity Approach and Advantages C O N FI D E N TIAL Page 22 Advantages NK CELL THERAPIES Cell Therapy Technology Scorecard ADULT DONOR DERIVED CELULARITY CYNK - 001 & CYNK - 101 MANUFACTURING COMPLEXITY Source Procurement Non - invasive Collection / Reliable Procurement Lower COG
Slide 23: AML preclinical data
CML, AML, MM IN VITRO KILLING IFN - G PRODUCTION P R I MA R Y AM L K I LL I N G CYNK - 001 activation releases high concentration of IFN - g, favoring Th1 responses CYNK - 001 exerted up to 60% specific lysis a g a inst pr i m a ry A ML sa m ples a t an E f f e ct o r: Target (E:T) ratio of 3:1 AML:
Slide 24: CYNK-001-AML-001 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 25: Key Takeaways: CYNK-001 in AML & GBM
KEY TAKEAWAYS ▪ NK cells are natural 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 ▪ CYNK
Slide 26: CYNK-101 HER2+ Advanced Esophageal / Gastric Adenocarcinoma
CYNK - 101 HER2+ Advanced Esophageal / Gastric Adenocarcinoma
Slide 27: Genetically Modified NK Program rationale
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 28: CYNK-101 antitumor activity against gastric cancer cell lines
CYNK - 101 DEMONSTRATES EFFECTIVE ANTITUMOR ACTIVITY Against Gastric Cancer Cell Lines in Conjunction with Anti - HER2 Monoclonal Antibody ▪ Significant ADCC activity of CYNK - 101 in combination with Herceptin against both gastric cancer cell lines was shown at E:T ratio of 2:1 over 24h in comparis
Slide 29: CYNK-101 provides a backbone for combination therapies
% Specific Lysis ADCC WITH RITUXIMAB ADCC WITH ELOTUZUMAB ADCC WITH DARATUMUMAB % Specific Lysis % Specific Lysis E:T Ratio (Against Daudi) CYNK - 101 + mAb CYNK + mAb CYNK - 101 + IgG CYNK + IgG ▪ Improved ADCC response observed from CYNK - 101 compared to unmodified CYNK cells against lymphoma cel
Slide 30: CYNK-101 Phase 1/2a trial study design
CYNK - 101 PHASE 1/2A TRIAL Study Design Phase 1 study (safety and dose finding) • HER2 +(pos) G/GEJ adenocarcinoma progressed on/after prior trastuzumab based therapy • Dose escalation (3+3) with DLT period of 28 days • N=9 - 18 • General objective: to establish MTD and recommended phase 2 dose (RP
Slide 31: Key Takeaways: CYNK-101 in HER2+ Gastric Cancer
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: 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 35: Newly developed APPL program: genetically modified candidate
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: Key Takeaways: APPL in Crohn's Disease
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 CL I N I CA L P LA N ▪ 1H22: I
Slide 37: Transaction Summary
T ransaction 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 agreement and plan of reorganization (the “Merger Agreement”) – Celularity is a clinical - stage biopharmaceutical company that is
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 stockholder redemptions and that the Celularity Shareholder Equity Rollover is issued at the GX stockholder redemption price
Slide 40: Use of Proceeds
C O N FI D E N TIAL 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 i
Slide 41: Near-Term Milestones
NEAR - TERM MILESTONES To Achieve the Next Advance in Placenta - based Cell Therapy C O N FI D E N TIAL Page 41 M arch 20 2 0: April 2020: Se p tem b er 20 2 0: January 2021: M arch 2021: April 2021: Received FDA Safe to proceed on IND for CYNK - 001 in COVID - 19 Completion of Facility at Florham P
Slide 42: Appendix: Clinical Programs Additional Detail
Appendix Clinical Programs Additional Detail
Slide 43: Celularity IMPACT Platform: Broad IP Protection
PLATFORM CELULARITY IMPACT ΠPLATFORM Broad IP Protection Across All Lead Programs PL A CEN T AL NK PL A CEN T AL CAR - T PL A CEN T AL - DERIVED MESENCHYMAL - LIKE STROMAL CELLS 2 P A TENT F A M ILI E S 15 P A TENT FAMILIES 25 P A TENT FAMILIES PNK Broad Background Patent Genetically Modified PNK P
Slide 44: Placenta as a Renewable Allogeneic Source
CELULARITY IMPACT ΠPLATFORM The Placenta as a Renewable Allogeneic Source, with Purpose - Built Commercial Scale Manufacturing PLATFORM A PP L - 001 Genetic Modification Lymphocytic Progenitors Lymphocytic Progenitors C Y N K - 101 C Y N K - 001 CyCART - 19 CAR Transduction Gene E diting M a s ter
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 most
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 & testing
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: 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 49: 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 50: 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: To ass
Slide 51: Participants in solicitation and additional information
C O N FI D E N TIAL Page 51 GX and its directors and officers may be deemed participants in the solicitation of proxies of GX’s stockholders in connection with the Celularity Business Combination. GX’s stockholders and other interested persons may obtain, without charge, more detailed information re