Celularity Inc Stock Price, News & Analysis

Celularity (Nasdaq: CELU) announced peer-reviewed publication of its Phase 2 trial of PDA-002, a placenta-derived cell therapy for diabetic foot ulcers (DFU) with and without peripheral artery disease (PAD), in the International Wound Journal on October 14, 2025.

The multi-center, randomized, double-blind trial enrolled 159 patients across 35 US sites. Patients received two intramuscular doses (3×10^6, 10×10^6, or 30×10^6 cells) or placebo. In the PAD subgroup, the 3×10^6 dose achieved 38.5% complete wound closure versus 22.6% for placebo. PDA-002 showed faster, more sustained healing, fewer new gangrene and foot infections, and no serious treatment-related safety signals through two years.

Celularity (Nasdaq: CELU), a regenerative medicine company, has filed its Q1 and Q2 2025 Form 10-Q reports and regained compliance with Nasdaq Listing Rule 5250(c)(1). The company has made significant progress in addressing financial challenges, including the retirement of $32.0 million in senior secured debt plus $9.6 million in unpaid interest.

Under CEO Robert J. Hariri's leadership, Celularity has implemented strategic changes including an internal restructuring with dedicated operating subsidiaries for each business unit. The company faced working capital pressures in H1 2025 due to wound care product reimbursement uncertainty and delayed cash collections. Management now believes Celularity is positioned to access traditional working capital facilities to support wound care sales growth and advance its three late-stage 510(k) pipeline products.

Celularity (NASDAQ:CELU), a regenerative and cellular medicine company, announced receiving a notice from Nasdaq on August 21, 2025, regarding its failure to file the Q2 2025 Form 10-Q. This marks the company's second delayed quarterly filing, following the Q1 2025 Form 10-Q.

The company is currently non-compliant with Nasdaq Listing Rule 5250(c)(1), though this notice does not immediately affect CELU's listing status. Nasdaq has given Celularity until September 5, 2025 to update its compliance plan, with a final deadline of November 17, 2025 to file all delinquent reports.

Celularity (NASDAQ:CELU) has completed a significant balance sheet restructuring, successfully retiring all $41.6 million in senior secured debt, including $32.0 million in principal and $9.6 million in unpaid interest. The company executed this through an Asset Purchase Agreement with Celeniv Pte. Ltd., selling its intellectual property assets while maintaining exclusive licensing rights for 5 years with renewal options.

The transaction included a $33.8 million consideration used to retire debt from RWI and a Promissory Note from Mr. Lim. Additionally, Celularity completed an internal restructuring, creating six wholly-owned subsidiaries for its commercial units: biomaterials, longevity cell therapy, biobanking, contract manufacturing, discovery & development, and asset holding.

Celularity (Nasdaq: CELU) has formed a strategic partnership with Fountain Life to provide stem cell therapy products in Florida, leveraging a new state law effective July 1, 2025. The legislation allows qualified physicians to administer stem cell treatments for orthopedic conditions, wound healing, and pain management without FDA IND approval.

Fountain Life operates four longevity centers, including two in Florida (Naples and Lake Nona-Orlando), with Miami opening soon. Celularity will supply clinical-grade, placental-derived stem cells from its FDA-registered facility in New Jersey, offering immediate availability for physician-directed use under the new regulatory framework.

Celularity (Nasdaq: CELU), a regenerative and cellular medicine company, welcomes a new Florida law effective July 1, 2025, that authorizes physicians to provide investigational stem cell therapies for orthopedics, wound care, and pain management. The legislation permits the use of non-FDA approved stem cell treatments under strict safety and ethical guidelines.

The law requires stem cells to be sourced from FDA-registered and certified/accredited facilities that comply with Good Manufacturing Practices. Physicians must obtain patient informed consent before administering treatments. Celularity, operating an FDA-registered facility with extensive stem cell inventory, is positioned to supply ethically sourced placenta-derived stem cells for these authorized therapies.

The company, through its predecessor Anthrogenesis Corporation, pioneered the discovery of placental stem cell recovery methods in 2001, which was acknowledged by President George W. Bush. The Florida Medical Association was actively involved in crafting the legislation to balance public protection and physician regulation.

Celularity announced the immediate termination of CFO David Beers, with the termination being 'without cause' and unrelated to financial or operating results. Joseph DosSantos, current Senior Vice President Finance, has been appointed as interim CFO effective June 10, 2025, while maintaining his existing role without additional compensation. The company has retained CFO Squad, a financial advisory firm, to provide SEC reporting support and consulting services during the transition. CFO Squad will work under John R. Haines, Celularity's Senior Executive Vice President and Chief Administrative Officer, to optimize financial processes and systems.

Celularity (NASDAQ: CELU) has published research in Regenerative Engineering and Translational Medicine demonstrating the effectiveness of their proprietary tri-layer decellularized, dehydrated human amniotic membrane (DDHAM-3L) technology. The study, conducted with North Carolina State University, shows DDHAM-3L's potential as a carrier for induced pluripotent stem cell (iPSC)-derived limbal stem cells in treating limbal stem cell deficiency and ocular surface disorders. The 7-day in vitro study revealed that iPSC-LSCs seeded on DDHAM-3L formed confluent cell sheets, showed epithelial morphology, and demonstrated higher proliferation rates compared to controls. The technology shows promise for delivering patient-specific stem cells for vision restoration and has potential applications beyond ophthalmology.

Celularity (NASDAQ: CELU) has received a notice from Nasdaq on May 28, 2025, regarding its failure to file the Q1 2025 Form 10-Q on time. This non-compliance with Listing Rule 5250(c)(1) gives the company 60 days to submit a compliance plan to Nasdaq. If accepted, Nasdaq may extend the compliance deadline to November 17, 2025. The notice does not immediately affect CELU's listing or trading status. The company states it is working to complete the delayed quarterly report and expects to maintain SEC reporting compliance thereafter.