Slide 1: Turning Nature's Miracle into Medical Breakthroughs
TURNING NATURE’S MIRACLE INTO MEDICAL BREAKTHROUGHS Investor and Analyst Research & Development Day May 21, 2024
Slide 2: Legal Disclaimers
LEGAL DISCLAIMERS All statements in this presentation other than statements of historical facts regarding Celularity Inc. (“Celularity”) are “forward-looking statements” reflecting management’s current beliefs and expectations, including those relating to future events. In some cases, you can identi
Slide 3: Turning Nature's Miracle into Medical Breakthroughs
Addressing the challenges of aging-related diseases. Diversified revenue stream with 280% growth in Q1 YoY. TURNING On track for three 510(k) NATURE’S MIRACLE filings in 2025-2026 with multi- billion $ market potential. INTO Developing first-in-class / MEDICAL best-in-class cellular and regenerative
Slide 4: Building on Two+ Decades of Leadership
BUILDING ON TWO+ DECADES OF LEADERSHIP AUTO/ALLO PATIENTS CUMULATIVE STATE OF THE STEM CELLS TRANSPLANTS TREATED WITH PATENT REVENUE ART GMP BIOBANKED FROM BIOMATERIAL PORTFOLIO GENERATED FACILITY LIFEBANK ® PRODUCTS SINCE 2018 ~ 150,000 ~ $110M > 45,000 > 100 > 250,000 ~1,000 CONFIDENTIAL SQ FT Pag
Slide 5: The Evolution of Celularity
THE EVOLUTION OF CELULARITY 25 Years of Leadership in Cellular and Regenerative Medicine Anthrogenesis CORPORATION Revenue generation Broad Clinical Manufacturing Research Infrastructure Program Clinical Consolidation AGING-RELATED BIOMATERIALS DISEASES & BIOBANKING ONCOLOGY AND MLASCs1 ADVANC
Slide 6: Addressing the Challenges of Aging-Related Diseases
ADDRESSING THE CHALLENGES OF AGING-RELATED DISEASES Aging-related conditions Senescence Aging
Slide 7: Addressing the Challenges of Aging-Related Diseases
ADDRESSING THE CHALLENGES OF AGING-RELATED DISEASES Neuro Cancer Degenerative Auto- degenerative Senescence Disease immune disease
Slide 8: Diversified and Growing Revenue Stream
DIVERSIFIED AND GROWING REVENUE STREAM Biobanking CDMO ADVANCED CELLULAR BIOMATERIALS BIOBANKING MEDICINE • Increase revenue stream • Offer unique placental • Development partners with commercially blood stem cell banking available biomaterials • Pursue commercial • Biovance® • Launch a program with
Slide 9: On Track for Three 510(k) Filings in 2025-2026
ON TRACK FOR THREE 510(K) FILINGS IN 2025-2026 510(k) Development Pre-RFD1 Q-Sub2 510(k) Studies Progress Submission3 Celularity Tendon 80% H1 2025 Wrap Fuse Bone Void 60% H2 2025 Filler Celularity 50% H2 2026 Placental Matrix 1Pre-Request for Designation. 2Q-Submission Program – voluntary program t
Slide 10: Developing First-in-Class / Best-in-Class Cellular and Regenerative Assets
DEVELOPING FIRST-IN-CLASS / BEST-IN-CLASS CELLULAR AND REGENERATIVE ASSETS Advanced Biomaterials Indication Discovery Regulatory Commercialization Celularity Tendon Wrap (CTW) Tendon 510(k) FUSE Bone Void Filler Bone, Spine, Dental 510(k) Celularity Placental Matrix (CPM) Wound Covering 510(k) Cellu
Slide 11: State-of-the-Art Research and GMP Manufacturing Infrastructure
STATE-OF-THE-ART RESEARCH AND GMP MANUFACTURING INFRASTRUCTURE WORLD-CLASS FACILITY FOR COMMERCIAL-SCALE MANUFACTURING • $100M investment in cGMP/cGTP manufacturing • Highly specialized scientists, engineers & technicians • Enables greater control, efficiency and optimization FULLY INTEGRATED COMMER
Slide 12: Degenerative Disease
Degenerative Disease CURRENT COMMERCIAL PRODUCTS PIPELINE PROGRAMS
Slide 13: Quarterly Net Revenue
QUARTERLY NET REVENUE* Growing Revenue from Commercial Biomaterial Product Sales and Biobanking Services Q1’24 Revenue: ~280% 16,000 $14.8M Thousands 14,000 12,000 GROWTH 10,000 Q1'23 vs. Q1'24 8,000 (YoY) Q1’23 6,000 Revenue: $3.9M 4,000 2,000 *The revenues presented are preliminary and unaudited,
Slide 14: Commercial and Marketing Strategy: Robust Sales Network
COMMERCIAL AND MARKETING STRATEGY: ROBUST SALES NETWORK AVAILABLE FOR PIPELINE PRODUCTS 40+sales representatives in wound care and general surgery 100+ sales representatives in the eye care market (through Versea Ophthalmology Inc) 1,000+ sales representatives in orthopedic surgery and sports medici
Slide 15: Current Commercial Biomaterial Products
CURRENT COMMERCIAL BIOMATERIAL PRODUCTS Completely Connective tissue Completely Designed for Completely decellularized matrix (CTM) from decellularized ocular surface decellularized human placenta-derived chorionic plate of placenta-derived diseases and placental umbilical allograft; provides human
Slide 16: Biovance Second-Degree Burn Study
BIOVANCE® SECOND-DEGREE BURN STUDY Treadwell T, Walker D, Nicholson B. The Treatment of Second Degree-Burns with Dehydrated, Decellularized Amniotic Membrane vs a Nanocrystalline Silver Dressing. SAWC Meeting. Orlando, FL; 2014
Slide 17: Interfyl Case Study
INTERFYL® CASE STUDY A 76-year-old Female with Type II diabetic foot ulcer B Complete wound closure after three Interfyl ® treatments
Slide 18: Biovance 3L Human Amniotic Membrane Allograft
BIOVANCE® 3L HUMAN AMNIOTIC MEMBRANE ALLOGRAFT A 65-year-old female; chronic and necrotic dorsal foot wound B Complete wound closure after single application in three weeks
Slide 19: Building Awareness Among Surgeons and Patients
BUILDING AWARENESS AMONG SURGEONS AND PATIENTS
Slide 20: Advanced Biomaterial Pipeline Highlights
ADVANCED BIOMATERIAL PIPELINE HIGHLIGHTS Products Tailored to Clinical Needs Development Strategy 1 Differentiated scientific, clinical, and regulatory approach. 2 Robust intellectual property. 3 Accelerated through strategic partnerships and collaborations. Pipeline Products CELULARITY CELULARITY F
Slide 21: Growing Total Addressable Market
GROWING TOTAL ADDRESSABLE MARKET ~$2.2B1 ~$3.4B2 ~$14.6B3 ~$5.1B4 Global Tendon Global Bone U.S. Wound Global Dermal Wrap Market Fuse Market Care Market Filler Market $4.7 Billion $6.2 Billion $24.0 Billion $14.4 Billion by 2032 by 2032 by 2033 by 2031 7.8% CAGR 6.8% CAGR 5.1% CAGR 10.8% CAGR 1. Glo
Slide 22: The Celularity Tendon Wrap (CTW) Difference
THE CELULARITY TENDON WRAP (CTW) DIFFERENCE: EFFECTIVE MANAGEMENT AND PROTECTION OF TENDON INJURIES 80% H1 2025 Process Prototype Pre-Submission / Q- 510(k) Enabling Studies 510 (k) Submission Commercial R&D Feasibility Pre-RFD Development Characterization Sub & Tech Transfer Runs & Device Launch Cl
Slide 23: The FUSE Difference: Filler for Bone Defects
THE FUSE DIFFERENCE: FILLER FOR BONE DEFECTS OR GAPS OF THE SKELETAL SYSTEM, EXTREMITIES, SPINE AND PELVIS 60% H2 2025 Process Prototype Pre-Submission / Q- 510(k) Enabling Studies 510 (k) Submission Commercial R&D Feasibility Pre-RFD Development Characterization Sub & Tech Transfer Runs & Device La
Slide 24: FUSE: Preclinical Effectiveness
FUSE: PRECLINICAL EFFECTIVENESS Micro Computed Tomography – New Bone Growth with FUSE in a Femur Defect in a Rabbit Model 3 Weeks Post Implantation CONTROL FUSE New Bone Formation Observed in Bone Defects Treated with FUSE
Slide 25: The Celularity Placental Matrix (CPM) Difference
THE CELULARITY PLACENTAL MATRIX (CPM) DIFFERENCE: WOUND MANAGEMENT: CHRONIC, ACUTE, BURNS AND SURGICAL WOUNDS, POST LASER SURGERY 50% H2 2026 Process Prototype Pre-Submission / Q- 510(k) Enabling Studies 510 (k) Submission Commercial R&D Feasibility Pre-RFD Development Characterization Sub & Tech Tr
Slide 26: Other Ongoing Development: Placental Dermal Filler
OTHER ONGOING DEVELOPMENT: PLACENTAL DERMAL FILLER Process Prototype Pre-Submission / Q- PMA Enabling Studies & PMA Submission Commercial R&D Feasibility Pre-RFD Development Characterization Sub Tech Transfer Runs & Device Launch Celularity Placental Dermal Clinical Challenges Filler Difference • In
Slide 27: Cellular Medicine
Cellular Medicine CELULARITY ADVANTAGE - PROPRIETARY CELL PLATFORM UNIVERSAL ENGAGER PLATFORM SENESCENCE NEURODEGENERATIVE
Slide 28: A Leader in Aging-Related Diseases
A LEADER IN AGING-RELATED DISEASES Neuro Degenerative Auto- Cancer degenerative Senescence Disease immune disease
Slide 29: Developing First-in-Class / Best-in-Class Cellular and Regenerative Assets
DEVELOPING FIRST-IN-CLASS / BEST-IN-CLASS CELLULAR AND REGENERATIVE ASSETS Advanced Biomaterials Indication Discovery Regulatory Commercialization Celularity Tendon Wrap (CTW) Tendon 510(k) FUSE Bone Void Filler Bone, Spine, Dental 510(k) Celularity Placental Matrix (CPM) Wound Covering 510(k) Cellu
Slide 30: Celularity Advantage: Proprietary Cell Platform
Celularity Advantage PROPRIETARY CELL PLATFORM
Slide 31: Characteristics of an Ideal Cellular Therapy
CHARACTERISTICS OF AN IDEAL CELLULAR THERAPY • Cytokine Secretion Proliferation • Evade host Resistance • CD4:CD8 Ratio • Targeting immunity • Cytokine • Naïve phenotype • Expression of • Marker of checkpoint Response • Stemness senescence inhibitors and exhaustion Efficacy Persistence Tolerability
Slide 32: Ideal Characteristics Are Inherent in Celularity's Starting Material
IDEAL CHARACTERISTICS ARE INHERENT IN CELULARITY’S STARTING MATERIAL Proliferation* Persistence* Efficacy* ✱✱ ✱✱✱ ✱✱✱ ✱✱✱ ✱✱ ✱✱✱ ✱✱✱ ✱✱✱ ✱✱✱ ✱✱✱✱ 60 100 telomere length (%) ns PBMC-CD19 CAR-T 100 20 % Cytotoxicity 45 P-T CD19 CAR-T 80 Frequency (%) ns 80 CD57+ (%) ns PBMC-T NT 60 15 60 Relative 30 P
Slide 33: Ideal Characteristics Are Inherent in Celularity's Starting Material
IDEAL CHARACTERISTICS ARE INHERENT IN CELULARITY’S STARTING MATERIAL Resistance* Tolerability* ✱✱✱✱ ns ✱✱✱ ✱✱✱ 100 Frequency (%) 80 60 40 20 0 -1 3 3 IT G M PD G LA TI TI Resist expression of Reduced IFNγ production immune checkpoint by P-T CD19 CAR-T may inhibitors LAG3 and lower the potential for
Slide 34: Inherent Characteristics Translate to Enhanced Preclinical Efficacy and Persistence
INHERENT CHARACTERISTICS OF CELULARITY'S PRODUCT TRANSLATE TO ENHANCED PRECLINICAL EFFICACY AND PERSISTENCE Efficacy Proliferation Persistence Survival ✱✱ ns % of live cells (blood) 5.5 4.5 3.5 2.5 1.5 0.5 0.1 0.0 115 129 136 Study day End of Study P-T CD19 CAR-T “stemness” characteristics demonstra
Slide 35: Universal Engager Platform
Universal Engager Platform OUR COMBINATION APPROACH
Slide 36: CD16 Offers the Opportunity for a Cell Therapy/Antibody Combination Platform
CD16 OFFERS THE OPPORTUNITY FOR CD16 expressed on surface of natural killer (NK) cells, A CELL THERAPY/ANTIBODY monocytes, macrophages and COMBINATION PLATFORM neutrophils Identified as Fc receptors FcγRIIIa (CD16a) and FcγRIIIb (CD16b) and involved in antibody-dependent cellular cytotoxicity (ADCC)
Slide 37: PT-CD16 + Trastuzumab: Superior Antitumor Activity
PT-CD16 + Trastuzumab: Superior Antitumor Activity 24-Hour ADCC vs. NCI-N87 **** 100 80 % Cytotoxicity 60 40 20 0 2.5:1 1.25:1 0.625:1 E:T Ratio NK-like Low Cytokine Secretion No On-Target/ Off-Tumor Toxicity More Robust ADCC than NK cells* Profile* Against HER2 Low Normal Cells* Cancer Res (2024) 8
Slide 38: PT-CD16 + Trastuzumab: Superior Antitumor Activity
PT-CD16 + Trastuzumab: Superior Antitumor Activity Low Cytokine Secretion & No On-Target/ Off-Tumor Toxicity Trastuzumab Vehicle (n=12) Trastuzumab (n=12) PT-CD16 (n=12) Enhertu (n=12) PT-CD16 + Trastuzumab (n=12) Tumor volume (mm3) ✱ 300 250 Tumor Volume (mm3) 225 200 200 PT-CD16 + Trastuzumab 125
Slide 39: PT-CD16 + Trastuzumab Killing HER2+ Tumor Cells
PT-CD16 + TRASTUZUMAB KILLING HER2 +VE TUMOR CELLS Page 39
Slide 40: Next Gen PT-CD16: Novel Design Enabling T Cell-Mediated ADCC
NEXT GEN PT-CD16: NOVEL DESIGN ENABLING T CELL-MEDIATED ADCC A FIRST-IN-CLASS ALLOGENEIC “UNIVERSAL ENGAGER” T CELL Tumor targeting Celularity’s Solution • CD16 signaling moderate T cell activation: Low cytokine secretion Controllable signaling through mAb withdrawal Improve Reduce immune • “Uni
Slide 41: CYNK Platform
CYNK PLATFORM CYNK-101 in vivo ADCC Efficacy CYNK-101 in vivo killing HER2 +ve Cancer **p<0.01; ***p<0.001; **** p<0.0001 Page Page 41 41
Slide 42: Senescence
Senescence TARGETING THE COMMON BIOLOGY OF CANCER AND AGE-RELATED DISEASES
Slide 43: Accumulation of Senescent Cells Is Accepted as a Driver of Aging-Related Pathologies
ACCUMULATION OF SENESCENT CELLS IS ACCEPTED AS A DRIVER OF A MAJORITY OF AGING-RELATED PATHOLOGIES Senescence involves cell-cycle arrest and the release of inflammatory cytokines Senescent cells exhibit morphological alterations and abnormal organelles Persistence of senescent cells can be maladapti
Slide 44: Addressing the Challenges of Aging-Related Diseases
ADDRESSING THE CHALLENGES OF AGING-RELATED DISEASES Aging-related conditions Senescence Aging
Slide 45: Preclinical Studies Demonstrate CYNK-001 and CYNK-201 Activity Against Senescent Cells
PRECLINICAL STUDIES DEMONSTRATE CYNK-001 AND CYNK-201 ACTIVITY AGAINST SENESCENT CELLS Both CYNK-001 and CYNK-201 cells demonstrated significantly enhanced elimination of senescent cells Chemo-induced Senescence Cytokine β-Gal expression Cytotoxicity response Page 45
Slide 46: CYNK-001 Cells Exhibit the Capability to Eradicate Senescent Cells
CYNK-001 CELLS EXHIBIT THE CAPABILITY TO ERADICATE SENESCENT CELLS CONFIDENTIAL Page 46
Slide 47: Neurodegenerative
Neurodegenerative
Slide 48: Clinical Studies Demonstrate MLASCs Immunomodulatory and Regenerative Activity
CLINICAL STUDIES DEMONSTRATE MLASCs IMMUNOMODULATORY AND REGENERATIVE ACTIVITY Immunomodulation Regeneration Stroke: vWF (blood vessels) Parkinson’s Disease: TH (DA Neurons) Hindlimb Ischemia: H&E Staining Control MLASCs Page 48
Slide 49: In-Vivo Experiments Suggest Potential of MLASCs in Lewy Body Diseases
IN-VIVO EXPERIMENTS SUGGEST POTENTIAL OF MLASCs IN LEWY BODY DISEASES Nigral Parkinson's Disease Lewy Parkinson's Body Disease Diseases Dementia Reduction of α-Syn alpha- MLASCs can prevent the synuclein aggregates in SN loss of dopamine neurons caused by high dose of associated with PD Lewy Body MP
Slide 50: Facioscapulohumeral Muscular Dystrophy (FSHD)
FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY (FSHD) Muscle Genetic DUX4 Gene Muscle Cell Weakness Activation: Damage: Inflammation: Mutation: and Disruption of normal Inflammatory cytokines Atrophy Activation of DUX4 gene Oxidative stress and cellular functions apoptosis FSHD is currently one of the most
Slide 51: 2024 Recognition of Our Science
2024 RECOGNITION OF OUR SCIENCE ACCEPTED Tri-layer Decellularized, Placental circulating T cells Effect of placental circulating Human Placental Placental circulating T cells: a novel, Emerging technologies Dehydrated Human expressing CD16 in combination T cells expressing CD16 on Hematopoietic Stem
Slide 52: Technical Operations
Technical Operations
Slide 53: State-of-the-Art Research and GMP Manufacturing Infrastructure
STATE-OF-THE-ART RESEARCH AND GMP MANUFACTURING INFRASTRUCTURE WORLD-CLASS FACILITY FOR COMMERCIAL-SCALE MANUFACTURING • $100M investment in cGMP/cGTP manufacturing • Highly specialized scientists, engineers & technicians • Enables greater control, efficiency and optimization FULLY INTEGRATED COMMER
Slide 54: Manufacturing Suites
MANUFACTURING SUITES Production Suites • 9 x Grade C/Class 10,000 • Controlled classified corridors (Grade D); both clean & exit. • Airlocks (Grade C & D) • Cart/Material Pass through • ISO manufacturing environment • BSL 2 environment Support Labs • 6 x Grade D/Class 100,000 • Unidirectional Flow •
Slide 55: Process & Analytical Development Labs
PROCESS & ANALYTICAL DEVELOPMENT LABS • Flexible Lab space to support multiple cell types and products • Capabilities and equipment for small and large processing to support all phases of development and transfer activities • Identical processing at-scale equipment across PD and GMP suite for effici
Slide 56: Celularity's Quality Management System
CELULARITY'S QUALITY MANAGEMENT SYSTEM Celularity is audited/inspected • FDA (Aug 14 – 22, 2023) • Association for the Advancement of Blood and Biotherapies (AABB) (Aug 2-3, 2021) • American Association of Tissue Banks (AATB) (Jul 24-28, 2023) • New York State Department of Health (Apr 5-8, 2022) Th
Slide 57: Celularity's Capability Highlights
Celularity's Capability Highlights Enabled Through Commercial Ready Facility and Expertise in Cell Therapy Product Processing and Manufacturing • Commercial ready facility to support nine (9) cell therapy products Scalable, concurrently – autologous / allogeneic Flexible & Autologous Commercial • •
Slide 58: Collaborations and Partnership
COLLABORATIONS AND PARTNERSHIP
Slide 59: Summary
Addressing the challenge of aging-related diseases. Diversified revenue stream with 280% growth in Q1 YoY. On track for three 510(k) SUMMARY filings in 2025-2026 with multi- billion $ market potential. Developing first-in-class / best-in-class cellular and regenerative therapies. State-of-the-art re