aibioCelularity regains Nasdaq compliance after filing two late quarterly reports
Tickers CELU
Nasdaq told Celularity on September 2, 2025 that it complies with Listing Rule 5250(c)(1) again, after the company filed its Form 10-Q reports for the periods ended March 31 and June 30, 2025.
Key facts
- Company
- Celularity Inc. (NASDAQ: CELU)
- News type
- Listings
- Primary source
- Celularity Inc. 8-K (2025-09-03)
Celularity Inc. (Nasdaq: CELU) said in a Form 8-K dated September 2, 2025 that Nasdaq notified it that day. Nasdaq has determined that the company complies with Listing Rule 5250(c)(1) again, and that the matter is closed. The determination rests on two quarterly reports: the Form 10-Q for the period ended March 31, 2025, filed August 29, 2025, and the Form 10-Q for the period ended June 30, 2025. Chairman and Chief Executive Officer Robert J. Hariri, M.D., Ph.D., signed the filing.
The 8-K does not say when those reports were due, and it does not describe why they were late. It does not say whether Nasdaq had already moved toward delisting, and it gives no timetable for any further periodic report. A company that catches up on its filings has cleared the notice, but the filing does not show what caused the backlog or whether it has been fixed.
What the company does
Celularity describes itself in its 10-K as a regenerative and cellular medicines company focused on aging-related and degenerative diseases, built on placental biology. Its advanced biomaterials business is made up mainly of sales of Biovance 3L and Rebound, sold directly and through distributors. The product line also includes Biovance, Biovance 3L Ocular, Interfyl, CentaFlex and Rebound, all placental-derived allograft or matrix products for soft tissue repair and reconstructive procedures.
The company also sells contract manufacturing and development services to other cell therapy developers, and it runs a commercial biobanking business. Under that business, families pay a one-time fee for collection, processing and cryogenic preservation, plus an annual storage fee generally over a period of 18 to 25 years. The 10-K says the company holds more than 290 patents and patent applications, and that it is seeking to out-license or find partners for some of its cell therapy programs.
The pipeline and its near-term steps
The 10-K describes the biomaterials pipeline in regulatory terms. The company expected to submit a 510(k) application for its Celularity Tendon Wrap in the second half of 2025, a 510(k) filing for its FUSE Bone Void Filler in the second half of 2026, and a filing for its Celularity Placental Matrix in the second half of 2027.
The cell therapy programs are earlier. The 10-K says the company's MLASCs candidate for diabetic foot ulcers, PDA 002, is prioritized as an advanced-stage program, and that it expected to request an end-of-Phase 2 meeting with the FDA in the first half of 2025 to discuss a Phase 3 plan. For Crohn's disease, the company expected to finish its assessment of previously generated data in the first half of 2025, a step that bears on whether to advance the candidate, PDA 001, to Phase 3. The 10-K also describes natural killer cell candidates that are in preclinical studies as senoablatant candidates.
The 10-K describes Phase I and Phase II datasets for these cell therapy candidates. Several of the steps it dated to the first half of 2025 had passed by the time of the 8-K, and the 8-K does not report whether any of them happened.
The company's history
The 10-K traces the company's roots to Anthrogenesis Corporation, founded under the name Lifebank in 1998 by Robert J. Hariri. Celgene Corporation acquired Anthrogenesis in 2002. The team stayed at Celgene until August 2017, when Celularity acquired Anthrogenesis.
The 8-K is a short notice. It sits beside the company's late reports and a pipeline whose next steps the 10-K dated to 2025 and 2026. The warrants trade as CELUW and can be exercised for one-tenth of one Class A share at $11.50. The 8-K says nothing about how the company plans to keep its reporting on time.