Celularity Inc.

Overview

Celularity is a cellular and regenerative medicine company focused on healthspan and aging-related diseases. The company develops placenta-derived allogeneic cells and placental biomaterials and operates an integrated platform for sourcing, processing, manufacturing, and delivering those therapies (Celularity IMPACT). Its portfolio includes cell therapy candidates and off-the-shelf biologic products.

Key lines of business

1) Placenta-derived allogeneic cellular therapies

• Cell types under development:
  • Natural killer (NK) cells from placental hematopoietic stem cells (CYNK-001; unmodified). Indications: cancer and age-related conditions; NK cells with senolytic/senoablation potential are being explored.
  • Mesenchymal-like adherent stromal cells (MLASCs) from placental tissue (cenplacel-L; PDA-001/002). Focus: immune modulation and anti-inflammatory activity, investigated across autoimmune, degenerative, and aging-related indications.
• Platform capabilities include genetic modification to enhance NK and MLASC products (for example, altering tissue factor to reduce potential toxicities and modifying genes to improve cytotoxic or senolytic activity).
• Development focus areas: aging-related diseases, cancer, regenerative medicine, immune disorders, and infectious diseases; strategies target core aging biology such as cellular senescence, stem cell exhaustion, and immune rejuvenation.
• Regulatory and clinical posture: some programs were previously filed under IND (for example, CYNK-001 in oncology) with subsequent pivots to age-related and senolytic applications. Orphan designation discussions and potential expedited pathways may be pursued for select candidates.

2) Placental-derived advanced biomaterials

• Commercial products:
  • Biovance®: human amniotic membrane allograft for soft tissue repair and reconstruction
  • Biovance® 3L: tri-layer amniotic membrane allograft for covering, barrier, or wrap at surgical sites
  • Biovance® 3L Ocular: tri-layer amniotic membrane for ocular surface disease and related surgeries
  • Interfyl®: decellularized placental connective tissue matrix for integumental tissue support or replacement
  • CentaFlex®: decellularized placental matrix allograft for surgical covering, wrapping, or barricading tissue repair
  • Rebound™: full-thickness placental extracellular matrix for wound covering and protection
• Pipeline and investigational products:
  • Celularity Tendon Wrap (CTW): tendon protection/coverage surgical mesh
  • Fuse Bone Void Filler (FUSE): passive osteoconductive bone filler for skeletal defects
  • Celularity Placental Matrix (CPM): placental extracellular matrix wound covering
• Market strategy: growth through partnerships and private-label arrangements, including a private-label agreement with BioCellgraft for dental/oral healthcare and a collaboration with Defeye for ophthalmic applications in a defined territory.

3) Celularity IMPACT platform

• An end-to-end manufacturing and supply chain for placental-derived cells and products, covering biosourcing, proprietary processing, cell selection, advanced manufacturing, cryopreservation, and distribution.
• Biosourcing is based on postpartum placenta donations from informed-consent donors.
• In-house U.S. manufacturing and packaging operations are located in Florham Park, New Jersey.
• Targeted platform benefits: on-demand off-the-shelf inventory, potential for repeat dosing, scalable production, expanded persistence of placental-derived cells, and reduced risk of graft-versus-host disease due to immunological naiveté.

4) Biobanking and donor material supply

• Services include collection, processing, cryopreservation, and storage of placental-derived tissues and cells, including cord blood and placenta-derived products.
• Revenue model: one-time collection and processing fee plus annual storage fees (typical storage terms cited in materials: 18–25 years).
• Sourcing practices: placenta material is obtained from postpartum donations at hospitals and birth centers with donor informed consent and maintained with chain-of-custody, labeling, and quality review.

5) Contract manufacturing and development services

• Uses in-house manufacturing capabilities to support internal programs and offers contract manufacturing and development services to third parties.
• Services aim to accelerate translational and clinical development and support scale-up from early-stage to commercial volumes.

6) In-house production footprint and capabilities

• Location: Florham Park, New Jersey
• Facility size: 147,215 square feet
• Manufacturing suites: nine Grade C / ISO-7 suites and six Grade D / ISO-8 suites configured for commercial production of cellular therapies and biomaterials
• The company manufactures finished products in-house, while retaining the option to engage third-party CMOs in specific contexts

Financial and workforce highlights (selected)

• Net loss for year ended December 31, 2025: $91.7 million
• Accumulated deficit: $991.5 million
• Cash and cash equivalents as of December 31, 2025: $6.2 million
• Employees: 115 full-time employees and 1 non-employee leased worker (total headcount 116 as of 12/31/2025)
• Headcount reductions announced in Q1 2026 to conserve cash and focus on core sales strategies

The company’s operating footprint and in-house capabilities support ongoing R&D, manufacturing, and commercialization efforts consistent with a high-R&D biotechnology company in a pre-commercial stage.