Company Overview – Celularity Inc.

Business Focus

• Core Industry: Regenerative and cellular medicines company
• Primary Goal: Address aging-related and degenerative diseases
• Unique Approach: Harnesses the biology and availability of the placenta to develop therapeutic solutions

Business Segments and Products

1. Advanced Biomaterials Business

• Products:
  • Biovance®: Tri-layer dehydrated human amniotic membrane from full-term placenta; used for soft tissue repair.
  • Biovance® 3L: Tri-layer membrane for covering, barrier, wrap for surgical sites.
  • Biovance® 3L Ocular: For ocular surface disease and surgeries.
  • Interfyl®: Decellularized placental connective tissue matrix for tissue replacement.
  • CentaFlex®: Placental matrix from umbilical cord for tissue repair.
  • Rebound™: Full-thickness extracellular matrix (amnion and chorion) wound covering.
• Market: Tendon repair (~$2.2B market), bone grafts (~$3.4B), wound care (~$14.6B US market), dermal fillers (~$5.1B globally).
• Strategy: Expand product pipeline, increase sales via domestic and international distribution partners, explore contract manufacturing.

2. Cell Therapy Development

• Sources: Placental tissue from healthy, full-term donors.
• Products in Development:
  • Placental-derived allogeneic cells:
    • MLASCs (Mesenchymal-like adherent stromal cells): Clinical trials for diabetic foot ulcer (DFU) and Crohn’s Disease (CD).
    • Natural Killer (NK) cells: Clinical data from Phase I/II; investigating in preclinical senolytic studies.
    • T cells (including CAR-T): Focused on cancer, aging-related, and autoimmune diseases.
    • Genetically modified versions: CAR-T, gene-modified NK cells, CRISPR-edited MLASCs.
  • Exosomes: Placenta-derived exosomes (pEXO) with regenerative and immunomodulatory properties.
• Pipeline Milestones:
  • Submit 510(k) for Tendon Wrap in 2025.
  • Develop FUSE Bone Void Filler for 2026.
  • Develop Placental Matrix (CPM) for 2027.
  • Request FDA End-of-Phase 2 meeting for MLASCs in DFU.
• Special Technology Platforms: Celularity IMPACT – integrated manufacturing platform that sources, processes, attracts, and manufactures placental cells for off-the-shelf therapeutic products.

3. Biobanking Business

• Services: Collection, processing, cryopreservation, and storage of placental tissues, umbilical cord blood, and related biomaterials.
• Customers: Expectant parents requiring biological storage; contracts with hospitals and birth centers.
• Business Status: Acquired from HLI (2017) and CariCord (2018); primarily oriented toward neonatal and placental tissue storage.
• Duration: Storage fees typically paid over 18-25 years.

4. Manufacturing

• Facility: 147,215 sq. ft. purpose-built cGMP facility in Florham Park, NJ.
• Capabilities: Multiple manufacturing suites for cell therapies and biomaterials.
• Production Focus: Manufacturing in-house, supplemented by CMOs as needed.
• Development Process: From sourcing placentas to product-specific manufacturing, CMC, cryopreservation.

5. Research & Development and Strategic Focus

• Pipeline Focus:
  • Cell therapies targeting cancer, autoimmune, and age-related diseases.
  • Medical devices like Tendon Wrap, Bone Void Filler, Placental Matrix.
  • Enhancing manufacturing processes and product characterization.
• Use of Proprietary Technologies: Gene editing, cell expansion, bioprocessing, and exosome production.

6. Intellectual Property

• Over 290 patents and applications covering platform processes, cellular therapies, gene editing, and biomaterials.
• Patents support CAR-T technology, NK cells, MLASCs, exosomes, and biomaterials.

7. Partnerships & Licensing

• License agreements with Celgene (now Bristol Myers Squibb) for certain patents and rights.
• Collaborations include distribution licenses with Arthrex and BioCellgraft.

Financial and Operational Data

• Number of Employees: 139 (as of December 31, 2024)
• Customer Base: Expectant parents for biobanking; strategic distribution partners for biomaterials.
• Revenue: No specific revenue figures provided—business is in development and clinical stages with no approved therapeutics for sale.
• Net Income: Reported net loss of $57.9 million in 2024 and $196.3 million in 2023.
• Cash and Cash Equivalents: Approximately $0.7 million as of December 31, 2024.
• Market Capitalization: Approximate value based on June 30, 2024, stock price: $38.5 million.

Note: The company is predominantly in the R&D and clinical development phase, with a focus on building a broad pipeline of cell therapy and biomaterial products leveraging placental tissues.