Celularity, Inc.

Oct. 30, 2025 -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company addressing age-related and degenerative diseases, announced today a strategic partnership with DefEYE, Inc. (“DefEYE”), a newly established ophthalmic product and technology company. Celularity has executed an exclusive license & pricing arrangement with DefEYE on the backend of Celularity’s in-kind investment in DefEYE’s $12MM Series Seed Preferred Equity funding round. DefEYE was established to build on Verséa Ophthalmics’ commercial momentum, reflected in significant year-over-year sales growth since its August 2022 launch. According to DefEYE, sales increased in 2024 by nearly 70% over the prior year. DefEYE expects to use the proceeds of its Series Seed Preferred Equity round to launch and scale a robust portfolio of decellularized biologic solutions for eye care, including: Single and tri-layer Decellularized Amniotic Basement Membrane, Biovance® and Biovance® 3L Ocular, respectively. Interfyl®, a flowable human connective tissue derived from the chorionic plate. Collaborative research and development for future commercial products. Celularity granted DefEYE an exclusive sublicense to Celularity’s ophthalmic biologics portfolio, which includes Biovance®, Biovance® 3L, Interfyl®, and CentaFlex. Celularity will be the exclusive contract manufacturer for DefEYE’s portfolio of ophthalmic biologics solutions. “The partnership reflects a strategic opportunity to align for both companies and signals the start of a promising new chapter for regenerative therapies in eye care,” said Robert J. Hariri, M.D., Ph.D., Celularity’s Chairman and CEO. “Our in-kind investment and exclusive license and pricing agreement exemplify Celularity’s commitment to drive innovation through strategic partnerships. We are excited to be part of DefEYE’s focused expansion into the ophthalmic space and to demonstrate the transformative power of placental-derived regenerative biologic solutions. This strategy fits into our objective of accessing new markets for our portfolio of commercial products,” Hariri said. DefEYE’s leadership includes key personnel from the original Verséa Ophthalmics team, ensuring continuity of expertise and relationships in the rapidly evolving eye care market. Celularity has the right to name one member of DefEYE’s five-member board of directors. “This strategic collaboration with Celularity strengthens our capabilities and core competencies,” said Rob Sambursky, M.D., CEO of DefEYE, Inc. “With Celularity’s deep scientific and manufacturing expertise, we believe that we will be well positioned to scale and deliver meaningful clinical management solutions to both physicians and patients.” Celularity Inc. (Nasdaq: CELU) is a regenerative and aging-related cellular medicine company developing, manufacturing, and commercializing advanced biomaterial products and allogeneic and autologous cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies that target fundamental aging mechanisms like cellular senescence, age-related chronic inflammation, and tissue degeneration. DefEYE, Inc. is a rapidly growing ocular company on a mission to transform and personalize therapeutic approaches in eye care. The company focuses on delivering a portfolio of innovative decellularized biologic solutions that optimize treatment and management of various eye care conditions, including ocular surface diseases, pterygium surgery, and other surgical interventions. The content above comes from the network. if any infringement, please contact us to modify.

First-in-class regenerative therapy for diabetic foot ulcers complicated by peripheral artery diseaseCelularity PDA-002 achieved durable wound healing with just two intramuscular dosesAs a qualified stem cell therapy under Florida statute (§ 458.3245), effective July 1, 2025 authorizing use in wound care, orthopedics, and pain management, PDA-002 may offer licensed Florida physicians an important new tool in treating DFU patients. FLORHAM PARK, N.J., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company addressing age-related and degenerative diseases, today announced the publication of its Phase 2 study titled “Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial,” in the International Wound Journal. Results of this study demonstrated safety and efficacy in a complex type of serious wounds in the setting of diabetes and peripheral vascular disease. Celularity’s Chairman and CEO, Robert J. Hariri, M.D., Ph.D., also commented on PDA-002 as a stem cell therapy which qualifies under a recently enacted Florida law expanding access in the state to stem cell therapies not yet approved by the U.S. Food and Drug Administration. Approximately two million individuals in the United States are affected each year by diabetic foot ulcers (DFU), nearly half of whom have coexisting peripheral artery disease (PAD). DFU complicated by PAD represents one of the most difficult and costly challenges in wound care. Currently, there are no U.S. Food and Drug Administration (FDA)-approved therapies specifically indicated for DFU with PAD. The estimated annual economic burden of treating DFU alone exceeds $9 billion in the United States. The presence of PAD significantly compromises lower-extremity perfusion, leading to chronic tissue ischemia, impaired angiogenesis, and delayed wound repair. PAD-associated DFUs are further characterized by persistent inflammation, altered immune response, and diminished responsiveness to standard wound care interventions. Despite five FDA-approved DFU therapies, none are currently approved for DFU complicated by PAD, underscoring the need for novel regenerative approaches that restore tissue perfusion and accelerate wound closure. The published study included 159 adult patients with chronic diabetic foot ulcers (both with and without PAD) and was conducted across 35 clinical sites in the United States. Participants received two intramuscular doses of either PDA-002, a placenta-derived cell therapy developed by Celularity, at one of three dosage levels (3 × 10⁶, 10 × 10⁶, or 30 × 10⁶ cells), or a placebo. The primary efficacy endpoint was the number of patients who achieved complete wound closure within three months with healing that remained intact for at least four additional weeks—a more rigorous measure of durability than the standard FDA definition, which requires only two weeks of durable healing. In patients with PAD, the highest rates of wound closure were observed with the lowest PDA-002 dose (3 × 10⁶ cells), where 38.5% of ulcers completely healed versus 22.6% in the placebo group. The data also showed faster and more sustained healing in treated patients along with fewer cases of new gangrene and foot infections compared to those who received a placebo. Across all groups, PDA-002 was well tolerated, with no serious side effects linked to the treatment. This favorable safety profile remained consistent through two years of follow-up. The study’s findings highlight the regenerative and angiogenic potential of PDA-002 in promoting durable ulcer closure in patients with DFUs complicated by PAD, using only two doses and no retreatment. "The publication of our PDA-002 Phase 2 results in the International Wound Journal is a significant milestone for Celularity, and importantly, for patients battling diabetic foot ulcers complicated by peripheral artery disease, which is a patient population with a critical unmet medical need and limited treatment options,” said Robert J. Hariri, M.D., Ph.D., Celularity’s Chairman and CEO. “Our data show that our investigational therapy, PDA-002, a placenta-derived, mesenchymal stromal-like cell therapy, can drive meaningful wound closure rates, reduce serious complications, and do so with a favorable safety profile. We believe PDA-002 has potential to transform the future of ischemic wound care, and these findings position us for a confirmatory Phase 3 trial aimed at delivering the first FDA-approved targeted therapy in regenerative wound care for DFU/PAD patients with this urgent and unmet need. We also believe these clinical results support additional development in clinical indications where underlying microvascular disease is a contributing factor.” Commenting on recent developments, Dr. Hariri said, “Celularity is actively assessing opportunities to apply these findings in jurisdictions such as Florida, where PDA-002 qualifies as a stem cell therapy under a new law authorizing use by Florida physicians in wound care, orthopedics, and pain management.” Diabetes afflicts an estimated 2.1 million Floridians according to a January 2025 Florida Diabetes Advisory Council report, which found that the percentage of adult Floridians diagnosed with diabetes grew by almost half since 2002 and is now above the national average (12.2% versus 11.6%). That percentage jumps to 25.4% among Floridians ages 65 and older, or some 1.25 million people, a fifth to a third of whom will go on to develop a DFU, for which the 5-year recurrence rate is 65%. “By unleashing promising stem cell therapies like PDA-002, Florida has given physicians a potentially important new tool for the treatment of diabetic foot ulcers, a serious condition that afflicts over a quarter of a million Floridians ages 65 and older,” said Dr. Hariri. About PDA-002 PDA-002 is a mesenchymal stromal-like cell therapy product derived from the postpartum placenta. These cells possess potent angiogenic, immunomodulatory, and tissue-repair properties, offering a novel approach to wound healing in patients for whom current therapies are inadequate. About Celularity Inc. Celularity Inc. (Nasdaq: CELU) is a regenerative and aging-related cellular medicine company developing, manufacturing, and commercializing advanced biomaterial products and allogeneic and autologous cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies targeting fundamental aging mechanisms, such as cellular senescence, age-related chronic inflammation, and tissue degeneration. For more information about Celularity and its cutting-edge regenerative medicine solutions, please visit www.celularity.com. Forward Looking Statements Certain statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding: (i) our future sales or sales growth; (ii) our expectations for future financial results, including levels of net sales; (iii) our expectations regarding new products, including our 510K products; and (iv) future demand for our products. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “could,” “continue,” “expect,” “improving,” “may,” “observed,” “potential,” “promise,” “should,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Celularity’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K and Form 10-K/A for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on May 8, 2025 and May 21, 2025, respectively, and other filings with the SEC. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements contained herein, whether because of any new information, future events, changed circumstances, or otherwise, except as otherwise required by law. Carlos RamirezSenior Vice President, Celularity Inc.Carlos.ramirez@celularity.com(908) 845-4181

Retired all principal and accrued interest owed its two senior secured lenders, Resorts World Inc. Pte. Ltd., or RWI, and C.V. Starr and Co., Inc., eliminating all senior secured debt from its balance sheet. Entered into an Asset Purchase Agreement with Celeniv Pte. Ltd., or Celeniv, to monetize Celularity intellectual property assets and eliminate senior secured debt. In connection therewith entered into a License Agreement with Celeniv to license back the intellectual property assets on an exclusive basis with an exclusive five-year repurchase option. Completed an internal restructuring and realignment to create wholly owned operating subsidiaries for its four commercial businesses—advanced biomaterial products, longevity-focused cell therapy, biobanking, and contract development and manufacturing. Aug. 18, 2025 -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company focused on addressing age-related and degenerative diseases, announced today that it has completed a major balance sheet restructuring resulting in the retirement of all $32.0 million of the Company’s senior secured debt plus $9.6 million in associated unpaid interest. As part of this restructuring, Celularity entered into an Asset Purchase Agreement and a License Agreement with Celeniv Pte. Ltd. (“Celeniv”), a Singapore company formed by Resorts World Inc. Pte. Ltd., or RWI, one of Celularity’s two senior secured lenders, and Tan Sri Dato Lim Kok Thay (“Mr. Lim”), executive chairman/non-independent executive director of Genting Group and former Celularity director. Under the Asset Purchase Agreement, Celularity sold its intellectual property assets to Celeniv, which under the License Agreement licensed those assets to Celularity on an exclusive basis for an initial term of five (5) years renewable for additional five-year terms. Celularity is required to make quarterly license payments to Celeniv under the License Agreement based on the value of the assets sold under the Asset Purchase Agreement. Celularity also has an exclusive five-year option under the Asset Purchase Agreement to repurchase the assets from Celeniv. Celularity received consideration under the Asset Purchase Agreement in the amount of $33,812,230, which it used to retire the $27,000,000 senior secured loan outstanding from RWI and the $6,812,230 Promissory Note outstanding from Mr. Lim (which Mr. Lim previously assigned to Celeniv). Previously, Celularity used part of the proceeds it received under the Promissory Note to retire the senior secured loan outstanding from C.V. Starr and Co., Inc., or Starr. Celularity was advised in the transactions by Faithstone Capital Partners. “Under the Celeniv agreements announced today, we successfully monetized Celularity’s intellectual property assets to retire the Company’s senior secured debt in its entirety while retaining exclusive use of the assets for our cell therapy, advanced biomaterials, and biobanking businesses. An exclusive five-year right to repurchase those assets from Celeniv gives us additional optionality going forward,” said Robert J. Hariri, M.D., Ph.D., Celularity’s Chairman and CEO. “We believe this agreement results in a major improvement of Celularity’s balance sheet with the removal of all the Company’s senior secured debt, which was due for repayment in February 2026, as well as the senior secured lenders’ general security interest in all Company assets. We accomplished this while preserving our exclusive use of intellectual property that is operationally aligned with our programs and commercial activities and expect to gain greater financial flexibility and potential access to lower cost traditional financing sources. We are deeply grateful to both RWI and Mr. Lim for their continued support of Celularity’s mission as we embark on this new chapter.” Celularity also completed an internal restructuring including establishing operating subsidiaries for each of its functional business units, as follows: Celularity Biomaterials LLC, its advanced biomaterial products commercial unit. Celularity Longevity LLC, its cellular therapeutics products commercial unit. Celularity Advanced Manufacturing LLC, its contract development and manufacturing, or CDMO, commercial unit. Celularity Biorepository LLC, its neonatal (Lifebank) and adult cell and tissue banking commercial unit. Celularity Discovery & Development, LLC, its internal discovery and development unit. Celularity Asset Holding LLC, its internal services unit. “This internal restructuring formalizes how we manage Celularity to optimize efficiency and financial performance across the Company’s commercial units—advanced biomaterial products, longevity-focused cellular therapeutics, biobanking services, and contract manufacturing and development services—as well as our internal discovery and development unit that supports the four commercial units with new product discovery, development, and technology transfer services, and our internal business services unit. We wanted better visibility around the fact that Celularity operates four commercial businesses under one roof, in contrast to the more typical biotechnology enterprise’s single-shot discovery or development stage programs,” said Dr. Hariri. Celularity Inc. (Nasdaq: CELU) is a regenerative and aging-related cellular medicine company developing, manufacturing, and commercializing advanced biomaterial products and allogeneic and autologous cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies that target fundamental aging mechanisms like cellular senescence, age-related chronic inflammation, and tissue degeneration. The content above comes from the network. if any infringement，please contact us to modify.