Celularity Inc Stock Price, News & Analysis

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.

Celularity (NASDAQ: CELU) reported strong financial results for FY2024, with net revenues reaching $54.2 million, marking a significant 138.1% increase from the previous year. The growth was primarily driven by a 168.7% increase in wound care product sales, contributing $22.2 million to the revenue increase. Operating expenses decreased by 57% to $92.6 million, mainly due to the absence of goodwill and IPR&D impairments. The company's loss from operations improved substantially, decreasing by 80.1% to $38.4 million. The Biovance® product line showed particularly strong performance, and the company received recommendation letters from the FDA Tissue Reference Group for additions to their placental-derived biomaterial products portfolio.

Celularity (CELU) faces potential delisting from Nasdaq due to two separate issues. First, the company failed to pay required fees of $70,000 under Listing Rule 5250(f), which was subsequently paid in full on April 25, 2025. Second, Nasdaq notified the company on April 16, 2024, about its delinquency in filing the Form 10-K for the year ended December 31, 2024, violating Listing Rule 5250(c)(1).

If Celularity doesn't appeal these determinations, trading of its common stock will be suspended on May 1, 2025. The company must address both compliance issues before a Hearings Panel if it appeals. Celularity states it is actively working on filing the 2024 Form 10-K and expects to complete it imminently.

Celularity (NASDAQ: CELU) welcomes the Centers for Medicare & Medicaid Services (CMS) decision to delay the effective date of a Medicare Local Coverage Determination (LCD) for skin substitute products to January 1, 2026. The LCD, originally published in November 2024, concerns skin substitute grafts and cellular products used to treat diabetic foot ulcers and venous leg ulcers.

The delay follows President Trump's January 2025 executive order freezing regulatory guidance not yet in effect. Initially postponed from February 12, 2025, to April 13, 2025, CMS has now further extended the implementation date. This action, led by CMS Administrator Dr. Mehmet Oz, aims to ensure continued Medicare patient access to critical wound care products while allowing time for comprehensive payment system reform.

Celularity (NASDAQ: CELU) announced a publication in Frontiers in Immunology on April 4, 2025, focusing on the relationship between senescence, Natural Killer (NK) cells, and cancer. The publication explores how aging affects the immune system's fight against cancer and highlights the role of senoablative NK cells in disease progression.

The research emphasizes the importance of maintaining NK cell function for healthy aging and discusses the potential of adoptive NK cell therapy to counter immunosenescence. The company's clinical-stage candidate CYNK-001, a placental-derived allogeneic NK cell therapy, has been studied in over 70 subjects with acceptable safety profiles. The therapy aims to eliminate senescent cells that release toxic cytokines promoting inflammation and malignant transformation, potentially benefiting conditions like age-related frailty and sarcopenia.

Celularity Inc. (Nasdaq: CELU) has received recommendation letters from the FDA Tissue Reference Group confirming that its Natalin and Acelagraft™ wound care products meet criteria to be regulated solely under section 361 of the PHS Act as human cell, tissue and cellular and tissue-based products (HCT/P).

Natalin is a decellularized dehydrated amnion derived tri-layer graft, while Acelagraft™ is a decellularized dehydrated amnion derived bi-layer graft. Both products are indicated for use in partial and full thickness acute and chronic wounds.

According to Nova One Advisor, the global Biological Skin Substitutes market was valued at $347.75 million in 2024 and is projected to grow at a CAGR of 8.83% through 2034, reaching $810.50 million. The chronic wounds segment is expected to grow fastest at 9.13% CAGR, with North America representing 42% of the global market.

Celularity (NASDAQ: CELU) has entered into a Master Services Collaboration Agreement with BlueSphere Bio (BSB) for manufacturing BSB's cell therapy products. This marks Celularity's second such collaboration, showcasing its ability to leverage its cGMP manufacturing infrastructure.

The collaboration will initially focus on producing BSB's novel T cell receptor (TCR) T cell therapies at Celularity's 37,000 square foot Florham Park, NJ facility. The agreement covers all aspects of cell therapy manufacturing, including Chemistry, Manufacturing and Controls (CMC), Quality Assurance, and Quality Control. BSB will maintain oversight of its second cell therapy product for treating Acute Myelogenous Leukemia (AML) in the U.S. and internationally.

The partnership aims to provide BSB with affordable clinical advancement opportunities while maintaining process control, utilizing Celularity's technical capabilities and manufacturing infrastructure.

The MASS Coalition has welcomed President Trump's order to freeze regulatory guidance not yet in effect, including Medicare Local Coverage Determinations (LCDs) for skin substitute products. The freeze extends until at least April 13, 2025, allowing for further evaluation and public comment.

This decision particularly benefits Medicare beneficiaries with diabetic foot ulcers and venous leg ulcers, ensuring continued access to treatments that help prevent sepsis and amputations. The Coalition criticized the previous administration's LCD implementation process, stating it was conducted without proper stakeholder consultation and could create a healthcare crisis for diabetics by causing treatment shortages.