Celularity Inc.

What they do

Celularity operates an advanced biomaterials business built primarily on Biovance 3L, a tri-layer decellularized, dehydrated human amniotic membrane used in soft tissue repair and reconstructive procedures, sold directly or through a distribution network. It also runs a fee-based commercial biobanking business that collects, processes and cryogenically stores birth byproducts such as umbilical cord blood and placenta-derived cells for expectant parents, charging an upfront fee plus annual storage fees generally over 18 to 25 years. The company is developing off-the-shelf placental-derived allogeneic cell therapy candidates, including MLASCs such as PDA 001 for Crohn's disease and PDA 002 for diabetic foot ulcers, and cenplacel-L, but has no cellular therapeutics approved for commercial sales.

Revenue drivers

• Advanced biomaterials (Biovance 3L) — Primary commercial business today, consisting mainly of sales of Biovance 3L amniotic membrane products directly or through a distribution network; this drove 2024 revenue of $54.2M, well above the $22.8M reported in 2023.
• Biobanking services — Fee-based collection, processing and cryogenic storage of umbilical cord blood and placenta-derived biomaterials for expectant parents; one-time collection fee plus annual storage fees payable generally over 18 to 25 years.
• Contract manufacturing and development services — Planned service offering leveraging the Celularity IMPACT manufacturing platform, initially targeting development-stage cell therapy companies that need clinical-trial supply; no revenue figure disclosed in the excerpts.

Recent performance

Revenue fell sharply through 2025, from $11.4M in the quarter ended March 31, 2025 to $5.7M, $5.3M and $4.1M in the subsequent quarters, producing full-year 2025 revenue of $26.6M versus $54.2M in 2024. The company reported a 2025 net loss of $91.7M, or $3.59 per diluted share, compared with a $57.9M net loss in 2024. Operating cash flow was negative $13.3M in 2025 versus negative $6.4M in 2024. At December 31, 2025, total assets were $107.3M, total liabilities were $145.4M, shareholders' equity was negative $38.1M, and cash and equivalents were $6.2M.

Strategy

Management describes a portfolio of off-the-shelf placental-derived allogeneic biomaterial products and cell therapies intended to address degenerative and age-related disorders. The stated biomaterials milestones include a 510(k) submission for the Celularity Tendon Wrap, a 510(k) filing for FUSE Bone Void Filler targeted for the second half of 2026, and a 510(k) filing for Celularity Placental Matrix targeted for the second half of 2027. The company says it is assessing opportunities to supply its MLASCs candidates PDA 001 and PDA 002 to physicians under new state laws, including a Florida law effective July 1, 2025, and plans to complete safety and efficacy assessments for Phase III trials in Crohn's disease and diabetic foot ulcers when sufficiently capitalized. It also plans to generate revenue by offering contract development and manufacturing services to third parties. The 10-K states that in the first quarter of 2026 the company reduced headcount and salaries to conserve cash and focus on core sales strategies.

Risks

• Going concern / liquidity — The 10-K states the company has minimal cash on hand, does not generate sufficient cash from operations for the next twelve months, and that substantial doubt exists about its ability to continue as a going concern absent additional equity or debt raises.
• No approved cellular therapeutics — Celularity has no cellular therapeutics approved for commercial sales and has incurred net losses in every period since inception, including $91.7M in 2025.
• Declining revenue and negative equity — Revenue fell from $54.2M in 2024 to $26.6M in 2025 and quarterly revenue declined each quarter of 2025, while shareholders' equity was negative $38.1M at December 31, 2025.
• Listing and corporate events — The company disclosed delisting notices or listing-rule failures in 8-K filings on June 12, 2026 and July 29, 2026, along with several director or officer changes between May and August 2026.

Outlook

Management expects to submit a 510(k) application for the Celularity Tendon Wrap, with FUSE Bone Void Filler targeted for a 510(k) filing in the second half of 2026 and Celularity Placental Matrix targeted for the second half of 2027. The company says it is actively assessing opportunities in Florida and elsewhere to supply its MLASCs candidates PDA 001 and PDA 002 to physicians under state law, and plans to complete safety and efficacy assessments for Phase III trials in Crohn's disease and diabetic foot ulcers when sufficiently capitalized. It also intends to explore diversifying biobanking into adult cell banking. These plans are stated as contingent on obtaining sufficient capital.