Welcome to our dedicated page for Celularity news (Ticker: CELUW), a resource for investors and traders seeking the latest updates and insights on Celularity stock.
Overview of Celularity Inc.
Celularity Inc. (NASDAQ: CELUW) is a clinical-stage biotechnology company revolutionizing regenerative medicine through its innovative use of placental-derived cellular therapies. Headquartered in the United States, Celularity is pioneering the development and commercialization of advanced biomaterial products and off-the-shelf, cryopreserved allogeneic cell therapies that address significant unmet medical needs across oncology, immunologic, infectious, and degenerative diseases. By harnessing the unique biological properties of the postpartum placenta, the company aims to provide scalable, consistent, and cost-effective therapeutic solutions that improve patient outcomes globally.
Core Business Areas
Celularity operates through three distinct business segments, each contributing to its mission of advancing human health:
- Cell Therapy: This segment focuses on developing genetically modified and unmodified natural killer (NK) cells, engineered T cells (including CAR-T cells), and mesenchymal-like adherent stromal cells (MLASCs). These therapies target a range of conditions, including cancers, immune disorders, and aging-related diseases.
- Degenerative Disease: Leveraging its expertise in regenerative medicine, Celularity develops therapies aimed at addressing aging-related and degenerative conditions characterized by the progressive loss of tissue function and structure.
- Bio-banking: The company generates the majority of its revenue from this segment, which involves the collection, processing, and storage of placental material for future therapeutic use. This service not only supports Celularity's internal pipeline but also provides valuable resources for external collaborators.
Innovative Use of Placental Biology
What sets Celularity apart is its unique approach to using the postpartum placenta as a source of therapeutic cells. Placental-derived cells offer several advantages over traditional sources, such as peripheral blood or bone marrow. These include enhanced scalability, reduced risk of immune rejection, and inherent biological 'stemness,' which supports greater persistence and efficacy in therapeutic applications. By utilizing this readily available and renewable resource, Celularity addresses critical challenges in the cellular therapy landscape, such as manufacturing consistency and accessibility.
Therapeutic Pipeline and Product Portfolio
Celularity's therapeutic programs span a wide range of applications, including:
- Oncology: The company is advancing cutting-edge CAR-T and NK cell therapies designed to target hematological and solid tumors. Its PT-CD16VS platform, for example, demonstrates promise in combination with monoclonal antibodies to address difficult-to-treat cancers.
- Immune Disorders: Celularity's therapies aim to modulate immune responses, offering potential solutions for autoimmune diseases and other immune-related conditions.
- Aging-Related Diseases: Using mesenchymal-like adherent stromal cells, the company targets conditions associated with aging, such as degenerative diseases and cellular senescence.
- Advanced Biomaterials: Products like Biovance®3L and Rebound, derived from human placental tissue, support wound healing and tissue regeneration. These products are regulated as medical devices under FDA guidelines.
Competitive Positioning
Celularity operates in a highly competitive biotechnology landscape, with key competitors including companies specializing in CAR-T therapies, NK cell platforms, and regenerative medicine. However, its vertical integration—from placental sourcing to in-house manufacturing—provides a significant competitive edge. By controlling the entire value chain, Celularity ensures high-quality, scalable, and cost-efficient production of its therapies, setting it apart from peers.
Challenges and Opportunities
While Celularity's innovative approach positions it as a leader in regenerative medicine, the company faces challenges typical of its industry, such as regulatory hurdles, financial constraints, and the need for clinical validation. Despite these obstacles, its focus on affordability and accessibility aligns with global healthcare priorities, offering significant growth potential in both developed and emerging markets.
Looking Ahead
Celularity's commitment to harnessing the placenta's unique biology continues to drive its mission to transform healthcare. With a robust therapeutic pipeline, a scalable manufacturing platform, and a focus on addressing unmet medical needs, the company is well-positioned to make a lasting impact on the fields of oncology, regenerative medicine, and immune health.
Celularity Inc. (Nasdaq: CELU) has received a delisting notice from Nasdaq due to delayed filings of its Q1 and Q2 2024 Forms 10-Q. The company plans to appeal the decision and request a hearing to present its compliance plan. CELU stock continues trading on Nasdaq Capital Market under symbols 'CELU' and 'CELUW'.
The company has filed its 2023 annual report and Q1 2024 report, with Q2 2024 report expected in the coming weeks. CEO Robert J. Hariri attributes the delays to financial challenges and resource constraints, not accounting issues. He expresses confidence in the company's future, citing the recent Rebound™ product acquisition as a boost to cash position and operational stability.
Celularity Inc. (Nasdaq: CELU) has expanded its commercial portfolio of placental-derived advanced biomaterial products by acquiring Rebound™, a full thickness placental-derived allograft matrix product, from Sequence LifeScience, Inc. This acquisition is expected to contribute significantly to Celularity's fourth quarter 2024 sales and help fulfill the company's projected full-year 2024 biomaterial sales.
Celularity's Chairman, CEO, and founder, Robert J. Hariri, M.D., Ph.D., highlighted that the company's biomaterial product sales in the first half of 2024 exceeded $24 million, surpassing their full-year sales in 2023. The addition of Rebound complements Celularity's existing portfolio and enhances its ability to address a broader patient population in wound care and soft tissue repair.
This strategic acquisition aligns with Celularity's vision of expanding its offerings and reinforces its leadership in the field of placental-derived biomaterials. The company continues to differentiate itself in the regenerative medicine market by leveraging the unique properties of placental tissues to provide advanced, natural solutions designed to improve healing outcomes.
Celularity (Nasdaq: CELU), a regenerative and cellular medicine company, announced its participation in H.C. Wainwright's 26th Annual Global Investment Conference. The event will take place at the Lotte New York Palace Hotel from September 9-11, 2024. Robert J. Hariri, M.D., Ph.D., Chairman, CEO, and founder of Celularity, is scheduled to present on Monday, September 9, 2024, at 12:30 p.m. ET.
In addition to the presentation, Celularity will engage in one-on-one investor meetings during the conference. Interested parties can contact H.C. Wainwright representatives or KCSA Strategic Communications to schedule meetings. A replay of the presentation will be available on Celularity's website for at least 90 days following the event.
Celularity Inc. (Nasdaq: CELU) has appointed Richard J. Berman to its Board of Directors. Berman brings over 40 years of experience in venture capital, senior management, and mergers and acquisitions. He has served as a director and/or officer of more than a dozen public and private companies, with six reaching over $1 billion in market value. Berman's background includes working at Goldman Sachs and as Senior Vice President at Bankers Trust Company, where he established the M&A Leveraged Buyout Departments. He has advised on over $4 billion in M&A transactions, completing over 300 deals. Celularity's CEO, Robert J. Hariri, welcomed Berman's unique depth of experience in guiding public companies and executing growth plans.
Celularity Inc. (Nasdaq: CELU), a regenerative and cellular medicine company, received a notification from Nasdaq on August 22, 2024, regarding non-compliance with listing requirements due to delayed filing of its Q2 2024 Form 10-Q. The company also remains delinquent in filing its Q1 2024 Form 10-Q. This notice does not immediately affect the listing of Celularity's common stock and warrants, which continue to trade on the Nasdaq Capital Market.
Celularity must submit a compliance plan to Nasdaq by September 6, 2024, and if accepted, has until October 14, 2024, to implement it. The company intends to submit a plan and is working to file both Q1 and Q2 2024 Form 10-Qs. However, there is no guarantee that Nasdaq will accept the plan or that Celularity will regain compliance within the given timeframe.
Celularity Inc. (Nasdaq: CELU) reported full year 2023 combined net sales of $22.8 million, a 26.7% increase over 2022. The company expects first half 2024 combined net sales of $25.8 to $27.8 million, representing a 290% growth over the first half of 2023. For Q1 2024, Celularity anticipates combined net sales of $14.8 million, surpassing previous guidance. The company is on track to file a 510(k) premarket submission for its Celularity Tendon Wrap in the second half of 2025. Celularity's product portfolio includes four commercial-stage products and three development pipeline candidates, focusing on placental-derived allogeneic allografts and connective tissue matrices for soft tissue repair and reconstructive procedures.
Celularity has presented promising in vivo data at the ASCO Annual Meeting showing the potential of its T-cell therapy platform, PT-CD16VS, in targeting multiple hematological and solid tumors. The platform leverages genetically modified allogeneic cell therapy derived from human placental circulating T (P-T) cells and can be combined with various monoclonal antibodies. Previous data at AACR demonstrated efficacy against HER2-positive cancers, and the recent findings extend this potential to a broader range of cancers. The company is also expanding its pipeline to tackle aging-related healthcare issues such as cellular senescence.
Celularity (Nasdaq: CELU), a regenerative medicine company, received a Nasdaq notice on May 21, 2024, for not filing its Q1 2024 Form 10-Q and 2023 Form 10-K on time. This puts Celularity in non-compliance with Nasdaq's listing requirements, but it doesn't affect the current trading of its stock and warrants. Celularity must submit a compliance plan by June 17, 2024, and has until October 14, 2024, to regain compliance if the plan is accepted. The company is working to complete its filings but cannot guarantee Nasdaq will accept the plan or that it will meet future requirements.
Celularity (NASDAQ: CELU) has announced that data published in the Journal for ImmunoTherapy of Cancer highlights the benefits of its placental-derived T-Cell platform for CAR-T therapies. The study revealed that CAR-T cells from Celularity's platform demonstrated greater persistence, resistance to exhaustion, and efficacy compared to those derived from adult peripheral blood mononuclear cells (PBMCs). Key findings include longer telomeres and attenuated cytokine responses without loss of cytotoxicity. These advantages may lead to more effective and scalable CAR-T therapies. Dr. Robert Hariri, CEO of Celularity, emphasized the potential of their platform to deliver improved and durable allogeneic CAR-T products.
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