Celularity Inc., a clinical-stage biotechnology company, develops off-the-shelf placental-derived allogeneic cell therapies for the treatment of cancer, immune, and infectious diseases. It operates through three segments: Cell Therapy, Degenerative Disease, and BioBanking. The company's lead therapeutic programs include CYCART-19, a placental-derived CAR-T therapy, which is in Phase 1 clinical trial for the treatment of B-cell malignancies; CYNK-001, placental-derived unmodified natural killer (NK) cell that is in Phase 1 clinical trial to treat acute myeloid leukemia, as well as in Phase 1/2a clinical trial for the treatment of glioblastoma multiforme and COVID-19; CYNK-101, an allogeneic genetically modified NK cell, which is in Phase 1 clinical trial to treat HER2+ gastric and gastroesophageal cancers; APPL-001, a placenta-derived mesenchymal-like adherent stromal cell that is in a pre-clinical stage for the treatment of Crohn's disease; and PDA-002, a placenta-derived mesenchymal-like adherent stromal cell, which is in pre-clinical stage for the treatment of facioscapulohumeral muscular dystrophy. It also sells and licenses products that are used in surgical and wound care markets, such as Biovance and Interfyl; collects stem cells from umbilical cords and placentas; and provides cells storage under the LifebankUSA brand. The company was incorporated in 2016 and is headquartered in Florham Park, New Jersey.
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Here are 1-2 brief analogies to describe Celularity (CELU):
- Moderna for placental cell therapies. (Highlights its innovative, platform-based approach to developing new medicines from a unique biological source.)
- Novartis for placental-derived cell therapies. (Connects it to a well-known pharmaceutical company that has pioneered cell therapies, focusing Celularity's distinct approach using placental cells.)
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- Immuno-oncology Cell Therapies: These are off-the-shelf, placenta-derived cell therapies, primarily natural killer (NK) cells and T-cells, being developed for various cancer treatments.
- Regenerative Medicine Biomaterials: Placenta-derived biomaterials and scaffolds used for tissue repair and regeneration in various medical applications.
- Cord Blood and Tissue Banking (LifebankUSA): A service providing private storage of newborn cord blood and cord tissue stem cells for potential future therapeutic use.
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Celularity (CELU) is a clinical-stage biotechnology company focused on developing allogeneic (off-the-shelf) cell therapies derived from placental cells. As of its latest public filings, the company does not currently have any products approved for commercial sale and therefore does not have traditional "major customers" in the sense of selling products or services to other companies or individuals.
Celularity's current revenue streams primarily consist of collaboration revenue related to its research and development activities. Historically, a significant portion of this collaboration revenue has come from an agreement with a major pharmaceutical company:
- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
This collaboration pertains to specific research and development efforts rather than Regeneron being a direct customer purchasing Celularity's finished commercial products. Celularity's business model is currently centered on advancing its pipeline through preclinical and clinical trials.
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Robert J. Hariri, M.D., Ph.D. Chairperson, Founder, and Chief Executive Officer
Dr. Hariri is an accomplished surgeon, biomedical scientist, and serial entrepreneur in the biomedicine and aerospace sectors. He is the founder and CEO of Celularity and was previously the founder and CEO of Anthrogenesis Corporation, which was acquired by Celgene Corporation. Following the acquisition, he served as CEO of Celgene Cellular Therapeutics. Dr. Hariri also co-founded Human Longevity, Inc. and has pioneered the use of stem cells, particularly discovering pluripotent stem cells derived from the human placenta. He holds over 170 issued and pending patents and has served on numerous public boards, including Cryoport (NASDAQ:CYRX).
Joseph DosSantos Interim Chief Financial Officer
Mr. DosSantos was appointed Interim CFO of Celularity effective June 10, 2025, while continuing his role as Senior Vice President Finance. He is an experienced finance executive with a background in global public company financial reporting, accounting operations, and strategic planning. Prior to Celularity, he served as CFO of Luzsana Biotechnology and was previously the Chief Financial Officer of MYOS RENS Technology Inc. (2014-2016), which was acquired by MedAvail Holdings, Inc. His career also includes roles as Executive Director, Finance Operations for Allergan, Inc. (acquired by AbbVie), and Senior Director, Assistant Corporate Controller at Celgene Corporation (acquired by Bristol-Myers Squibb). He has participated in capital raising initiatives for both private and public companies.
John Haines Senior Executive Vice President, Global Manager, and Chief Administrative Officer
Mr. Haines is a seasoned executive with extensive experience in the biotechnology and pharmaceutical industries. He is also the founding chief executive officer of two companies focused on nuclear counterterrorism and particle accelerator technologies: Ionetix Corporation and Andiscern Corporation. Earlier in his career, he co-founded a human stem cell therapeutics company, Anthrogenesis Corporation, where he served as President & Chief Operating Officer. He also has experience as a Managing General Partner at Highgate Ventures.
Stephen Brigido, DPM President, Degenerative Diseases
Dr. Brigido is an accomplished surgeon and entrepreneur with seventeen years of experience in foot and ankle surgery, regenerative medicine, and product development. He has been instrumental in the development of over 40 orthopedic implants and biomaterials and holds numerous patents in the field. Dr. Brigido previously served as Chief of the Foot and Ankle Section at Coordinated Health for ten years and as the Director of its Reconstructive Foot and Ankle Fellowship. He is also a Managing Partner at Venel Holdings LLC and a partner in BBHP Medical LLC, a healthcare incubator company.
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The key risks to Celularity (CELU) include its financial viability, regulatory compliance, and challenges in clinical development and intellectual property.
Financial Viability and Going Concern
Celularity faces significant financial challenges, including a history of net losses since its inception and an accumulated deficit of $899.7 million as of December 31, 2024. The company has limited cash and cash equivalents, raising substantial doubt about its ability to continue as a going concern. Celularity is "quickly burning through cash" and operates with a "significant debt burden." This precarious financial position is further underscored by the recent termination of a significant agreement with an institutional investor, who failed to provide the agreed-upon subscription amount, indicating difficulties in securing critical additional financing.
Regulatory Compliance and Product Approval
The company is exposed to significant regulatory risks given the novel nature of its placental-derived cellular therapy candidates, which creates challenges in obtaining regulatory approval due to the limited experience of regulatory authorities like the FDA with allogeneic cell therapies. Celularity has also faced ongoing issues with Nasdaq compliance due to delayed financial filings, including its Form 10-K and Form 10-Q reports, leading to notices of potential delisting. Furthermore, in December 2025, the company received a warning letter from the FDA concerning the marketing materials for its product Interfyl, indicating regulatory scrutiny regarding product claims.
Clinical Development and Intellectual Property
Celularity's therapeutic candidates are based on new technologies and require extensive, expensive, and time-consuming human clinical trials, which are subject to rigorous regulatory requirements and uncertainty regarding timely completion or success. The company also relies on licensed gene editing technology for its future cell therapy product candidates, and any disputes over intellectual property could impair its ability to maintain these licensing arrangements, thereby affecting the development and commercialization of its therapeutic candidates.
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The rapid advancement and potential for significantly superior clinical outcomes from competing allogeneic cellular therapy platforms utilizing different cell sources (e.g., induced pluripotent stem cells (iPSCs), peripheral blood, or umbilical cord blood) for natural killer (NK) cells or T-cells. If a competitor demonstrates substantially better efficacy, safety, or manufacturing advantages in similar indications during ongoing clinical trials, it could establish a new, higher standard of care, severely diminishing the competitive viability and market potential of Celularity's placental-derived therapies.
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Celularity Inc. (NASDAQ: CELU) operates in the regenerative and cellular medicine industry, leveraging placental-derived cells and biomaterials. The addressable markets for their main products and services are substantial and span several therapeutic areas globally and within the U.S.
Advanced Biomaterials Business
- Tendon Repair Market: The global market for tendon repair was valued at approximately $2.2 billion.
- Bone Graft Substitute Market: The global bone graft substitute market was valued at approximately $3.4 billion.
- Wound Care Market: The U.S. wound care market was valued at approximately $14.6 billion.
- Dermal Filler Market: The global dermal filler market is estimated to be approximately $5.1 billion.
Cell Therapy Development
Celularity is developing off-the-shelf, allogeneic cell therapies, including placental-derived mesenchymal-like adherent stromal cells (MLASCs), Natural Killer (NK) cells, T-cells (including CAR-T), and genetically modified versions.
- Allogeneic Cell Therapy Market: The global allogeneic cell therapy market was estimated at approximately $900 million in 2023 and is projected to reach $1.72 billion by 2030, with a compound annual growth rate (CAGR) of 14% to 27.4%. Another report indicates a market size of $2.31 billion in 2024, expected to grow to $6.79 billion by 2032, at a CAGR of 14.42%. North America is anticipated to capture over 60% of the global market share by 2035 and held the largest market share (80.42%) in 2022.
- Natural Killer (NK) Cell Therapeutics Market: The global natural killer (NK) cell therapeutics market size was estimated at $3.52 billion in 2024 and is expected to grow to $6.17 billion in 2029 at a CAGR of 11.6% to 12%. Other estimates place the global NK Cell Therapy market at approximately $1.5 billion in 2023, expected to reach around $10.2 billion by 2032 with a CAGR of 23.5%. Another projection shows the global market size at $340.25 million in 2024, predicted to increase from $477.10 million in 2025 to approximately $9,997.65 million by 2034, expanding at a CAGR of 40.22%. North America was the largest region in the natural killer (NK) cell therapeutics market in 2024.
- Placental Stem Cell Therapy Solution Market: The global placental stem cell therapy market size was $968 million in 2024 and is projected to reach $1,871.3 million by 2033, exhibiting a CAGR of 7.6% during the forecast period from 2025 to 2033. The U.S. Placental Stem Cell Therapy Market is expected to see significant growth.
Biobanking Business
Celularity's biobanking business involves the collection, processing, cryopreservation, and storage of placental tissues, umbilical cord blood, and related biomaterials. Specific addressable market sizes directly for Celularity's biobanking services were not identified.
- Biobanking Market for Placental Tissues and Umbilical Cord Blood Storage: null
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Here are 3-5 expected drivers of future revenue growth for Celularity (CELU) over the next 2-3 years:
- Growth of Advanced Biomaterial Products: Celularity anticipates continued strong sales from its advanced biomaterial products, particularly within wound care applications. This includes established products like Biovance® and recently launched products such as Rebound™, which has shown strong initial sales performance. The company expects this segment to continue contributing significantly to its revenue outlook over the coming quarters.
- Launch of New Pipeline Products: Celularity is actively advancing several late-stage 510(k) pipeline products. The company expects to submit a 510(k) application for its Celularity Tendon Wrap (CTW) in the second half of 2025, followed by FUSE Bone Void Filler (FUSE) in the second half of 2026, and Celularity Placental Matrix (CPM) in the second half of 2027. These new product introductions are expected to drive future revenue growth.
- Expansion into New Markets via Strategic Partnerships: A strategic partnership with Genting Berhad is anticipated to open up significant opportunities for Celularity in the lucrative Asia Pacific market, thereby contributing to future growth.
- Growth in Biobanking Services: Celularity's biobanking services are noted as a primary revenue source, underpinning the company's financial stability and contributing to its overall revenue alongside its cell therapy innovations.
- Increased Commercial Traction and Market Penetration: The company has demonstrated effective market penetration and distribution strategies, leading to substantial product sales growth. This increasing commercial traction across its product portfolio is expected to continue to be a key revenue driver.
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Share Issuance
- In July 2021, Celularity completed a merger with GX Acquisition Corp. to become a publicly traded company, which generated approximately $138 million in gross proceeds.
- In May 2022, Celularity completed a private placement of Class A common stock and warrants, resulting in gross proceeds of approximately $30.0 million from a single healthcare-focused institutional investor.
- Throughout 2023 and 2025, Celularity raised capital through several registered direct offerings and private placements, including a $6 million offering in April 2023, a $3 million offering in July 2023, and an initial $2 million tranche (with potential for up to $6 million) private placement in October 2025, which included highly dilutive terms for the institutional investor.
Inbound Investments
- Celularity became a public company in July 2021 through a SPAC merger with GX Acquisition Corp., which included approximately $80 million from institutional investors in a concurrent equity financing (PIPE).
- In January 2024, Celularity closed financing transactions totaling $21 million, which included a $15 million amended and restated senior secured loan from an existing lender, Resorts World Inc Pte Ltd, and a $6 million private placement from its largest investor, Dragasac Limited.
- In May 2022, Celularity received approximately $30.0 million from a single healthcare-focused institutional investor through a private placement of Class A common stock and warrants.
Outbound Investments
- In October 2024, Celularity acquired the Rebound product, a full thickness placental-derived allograft matrix product, from Sequence LifeScience, Inc., to expand its commercial portfolio of advanced biomaterial products.
- In October 2025, Celularity made an "in-kind investment" in DefEYE's $12 million Series Seed Preferred Equity round as part of a strategic partnership focused on advancing regenerative therapies in eye care.
Capital Expenditures
- For the last 12 months prior to November 2025, Celularity reported capital expenditures of -$91,000.
- In the quarter ending December 2024, Celularity's capital expenditures were $1.4 million.
- Proceeds from the 2021 SPAC merger were intended, in part, to support the continued build-out of internal discovery capabilities and a new state-of-the-art manufacturing facility.