Slide 1: A Fully Integrated Cellular and Regenerative Medicine Company
A Fully Integrated Cellular and Regenerative Medicine Company February 2025 v.1.1.0
Slide 2: Disclaimers
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, y
Slide 3: Celularity Today
C e l u l a r i t y To d a y • We are an advanced stage cellular and regenerative medicine company, that is a hybrid of a commercial & developmental stage business: • Biomaterials: Six commercial stage products, and three FDA Medical Device 510(k) filings expected in 2025-27. • Cell Therapy: Two adv
Slide 4: Value Drivers and Commercial Opportunities
• Six commercial stage products with net revenue of $32mm (389% YoY growth) & gross margins of 79% for the nine months ended 9/30/2024. • We expect to grow brand visibility in: • Wounds • Orthopedics R E G E N E R AT I V E M E D I C I N E • Aesthetics VALUE DRIVERS AND • Expand R&D, and product deve
Slide 5: Advanced Biomaterial Products
ADVANCED BIOMATERIAL PRODUCTS Product Names/Candidates Indication Discovery Regulatory Pathway Commercialization Amniotic Membrane Allograft Wound Care 361 HCT/P Tri-Layer Amniotic Membrane Allograft Wound Care 361 HCT/P Tri-Layer Amniotic Membrane Allograft Ocular Protective Cover 361 HCT/P Amnioti
Slide 6: Strong Biomaterial Sales Growth
STRONG BIOMATERIAL SALES GROWTH CURRENT COMMERCIAL BUSINESS: REGENERATIVE BIOMATERIAL PRODUCTS Can be leveraged across chronic wound, orthopedics, ophthalmology, and aesthetics markets. Placenta-derived Connective tissue Placenta-derived allograft; provides matrix (CTM) from allograft; 3-layer derma
Slide 7: Building Awareness Among Surgeons and Patients
BUILDING AWARENESS AMONG SURGEONS AND PATIENTS 7
Slide 8: Three FDA 510(k) Filings Planned in 2025-27
THREE FDA 510(K) FILINGS PLANNED IN 2025-27 510(k) Indication Market Size Development Pre- 510(k) Q-Sub Studies 2023 2031 CAGR** RFD* Submission Progress Celularity Tendon Wrap (Tendon Repair) 80% H2 2025 $ 2.2B $ 4.7B +7% Fuse Bone Void Filler (Bone Void Filler) 60% H2 2026 $ 3.4B $ 6.2
Slide 9: The CTW Difference: Effective Durable Tendon Repair
THE CTW DIFFERENCE: EFFECTIVE DURABLE TENDON REPAIR 80% Anticipated 510(K) Celularity Tendon wrap Filing H2 2025 Process Prototype Pre-Submission / Q- ies 510(k) Enabling Studies 510 (k) Submission Commercial R&D Feasibility Pre-RFD Development Characterization Sub & Tech Transfer Runs & Device Laun
Slide 10: Celularity Tendon Wrap Potential Expanded Indications
CELULARITY TENDON WRAP POTENTIAL EXPANDED INDICATIONS Urology Gynecology General/Plastic Surgery Market Market Market • $13.07 billion in 2024 • $9.74 billion in 2023 • $2.03 billion in 2024 projected to increase to $23.8 projected to reach USD 22 expected to increase at billion by 2034, at a CAGR o
Slide 11: The FUSE Difference: Regenerative Bone Management
THE FUSE DIFFERENCE: REGENERATIVE BONE MANAGEMENT 60% Anticipated 510(k) Fuse bone void filler Filling H2 2026 Process Prototype Pre-Submission / Q- ling Studies 510(k) Enabling studies Studies 510 (k) Submission Commercial R&D Feasibility Pre-RFD Development Characterization Sub Transfer & Tech Tra
Slide 12: FUSE Potential Expanded Indications
FUSE POTENTIAL EXPANDED INDICATIONS Dental Bone Grafting Cranio-maxillofacial (CMF) Joint Reconstruction Market Market Market • $1.14 billion in 2024, and • $2.2 billion in 2024, and • $28.91 billion in 2024 and is projected to reach $2.53 projected to reach $4.2 billion projected to reach $37.21 bi
Slide 13: The CPM Difference: Regenerative Wound & Soft Tissue Management
THE CPM DIFFERENCE: REGENERATIVE WOUND & SOFT TISSUE MANAGEMENT 50% Anticipated 510(k) Celularity placental matrix Filling H2 2027 Process Prototype Pre-Submission / Q- 510(k) 5 Enabling Enabling studies Studies Studies 510 (k) Submission Commercial R&D Feasibility Pre-RFD Development Characterizati
Slide 14: Celularity Placental Matrix Potential Expanded Indications
CELULARITY PLACENTAL MATRIX POTENTIAL EXPANDED INDICATIONS Mucosal Tissue Repair Peri-implantitis Gastroenterology: Fistula Repair Market Market Market • $7.39 billion in 2024 and a 5.6% • $3.05 billion in 2024 expected • $701.3 million in 2023 projected CAGR, to reach US$12.78 billion by to grow to
Slide 15: Cell Therapy: Disruptive Value Opportunity
• Proprietary placental cell therapy platform. Substantial human clinical experience across multiple indications. • Narrowed our focus on two advanced stage cell therapy programs. One in diabetic foot ulcer (“DFU”), and another in Crohn’s disease (“CD”). • Compelling Phase II data vs publicly availa
Slide 16: Transformative Platform Opportunities
TRANSFORMATIVE PLATFORM OPPORTUNITIES ABILITY TO TARGET AGE RELATED DISEASES INCLUDING AUTOIMMUNE DISEASE, DEGENERATIVE DISEASES AND CANCER AUTOIMMUNE / ONCOLOGY AND DEGENERATIVE Placental Derived Placental Natural Killer Cells AGE-RELATED DISEASES Adherent Cells (CYNK-001) SENESCENCE (PDA-001 & PDA
Slide 17: Cell Therapy Pipeline
CELL THERAPY PIPELINE Platform Candidate Optimization Indications Discovery Pre-clinical Phase 1/2 Phase 3 PDA- Autoimmune (Crohn’s) & Phase 2 Studies Complete MLASC Unmodified 001/002 Degenerative Disease (DFU) (Pending FDA EOP-2 meeting) MLASC PDA-002 Unmodified FSHD Phase 1 Ready CAR + Persistenc
Slide 18: PDA Cells: Preliminary Research Findings
PDA CELLS: PRELIMINARY RESEARCH FINDINGS Immune Reprogramming* Angiogenesis* Myogenesis* Hind Limb Ischemia Model Hind Limb Ischemia Model PDA-001/002 Reduced T cell activation and Locally injected PDA PDA resulted in increased proliferation T cell skewing improved blood flow in new muscle fibers an
Slide 19: PDA-001 & PDA-002: Advanced Stage Clinical Candidates
PDA-001 & PDA-002: ADVANCED STAGE CLINICAL CANDIDATES • Compelling Clinical Data: Clinical dataset across several clinical studies among 233 subjects with both PDA-001 (Intravenous) and PDA-002 (Intramuscular) in 6 placebo-controlled trials across 5 indications1. • Safety: PDA-001 and PDA-002 were w
Slide 20: PDA-002: Diabetic Foot Ulcer Phase II Study Results
PDA-002: DIABETIC FOOT ULCER PHASE II STUDY RESULTS PDA-002 vs. Publicly Available Data on Approved Products • PDA-002 has the potential to be the pioneer product in 60.00% the treatment of DFU with PAD population as no other 50.00% Percentage of subjects products are currently approved in this sub-
Slide 21: PDA-001: Crohn's Disease Phase I & Phase II Results
PDA-001: CROHN’S DISEASE PHASE I & PHASE II RESULTS Efficacy: PDA-001 Vs. Publicly Available Data in Approved Products at 1-year and 2-year Time Period 70% • Three studies (Phase I and Phase II) 60% were conducted with PDA intravenous Percentage of Subjects 50% in Crohn’s Disease vs placebo. 40% • C
Slide 22: NK Cell Platform: Pre-Clinical Evaluation for Senoablation/Frailty
NK CELL PLATFORM: PRE-CLINCAL EVALUATION FOR SENOABLATION/FRAILTY • NK Cell Platform: We have dosed a total of 71 subjects across several clinical stage indications1. • Safety: Human safety experience was well-tolerated with transient Grade 1 or 2 cytokine release syndrome (CRS) attributed to the pr
Slide 23: NK Cells Play a Fundamental Immunological Role in Eliminating Senescent Cells
NK CELLS PLAY A FUNDAMENTAL IMMUNOLOGICAL ROLE IN ELIMINATING SENESCENT CELLS • Clearance of senescent cells (Senoablation): NK cells are critical in eliminating senescent cells from the body. They directly kill senescent cells and produce cytokines that activate macrophages to remove these cells. 1
Slide 24: CYNK-001 Scientific Rationale: Placental NK Cells Activity Against Cancer and Senescent Cells
CYNK-001 SCIENTIFIC RATIONALE: PLACENTAL NK CELLS EXHIBIT ACTIVITY AGAINST CANCER AND SENESCENT CELLS IN VITRO Senescence Induction of A549 Senoablation Against Senoablation Against (Lung Cancer Cells) Senescent A549 Senescent HFLS Chemo-induced Senescence Cytotoxicity Against A549 Cells CYNK-001 (G
Slide 25: Opportunities in Age-Related Diseases: Targets with PDA Cells and NK Cells
OPPORTUNITIES IN AGE-RELATED DISEASES: CURRENT TARGETS WITH BOTH PDA CELLS AND NK CELLS PDA-001/002 MOA - CYNK-001 Cell MOA- Senoablation Sarcopenia 1. Targets expressed stress ligands on 1. Immunomodulatory senescent cells 2. Anti-inflammatory 2. NKG2D recognition 3. Angiogenesis, Myogenesis, 3. Pe
Slide 26: Leveraging Capabilities and Capacity
LEVERAGING CAPABILITIES AND CAPACITY Purpose Built Facility for Commercial-scale Cellular Therapeutic Manufacturing $100M investment in cGMP/cGTP manufacturing Enables greater control, efficiency and optimization than is achievable by outsourcing to contract manufacturing organizations (CMOs) al
Slide 27: Anticipated Milestones
ANTICIPATED MILESTONES Advance the Advance the development of our Submit a 510(k) development of our Celularity Placental application for our FUSE Bone Void Filler Matrix with the Celularity Tendon Wrap with the objective of a objective of a 510(k) in the second half of 510(k) filing in the filing i
Slide 28: Investment Highlights
• Established commercial and developmental stage company in cellular and regenerative medicine. • Proven track record in product development and growing commercial experience with innovative technologies. • Leveraging pro-active regulatory strategy to broaden commercial portfolio. INVESTMENT • Advan