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 (symbol: CELUW) is a clinical-stage biotechnology company specializing in the development and commercialization of placental-derived cell therapies and advanced biomaterial products. With a robust focus on cell therapy, regenerative medicine, and advanced biomaterials, the company harnesses unique biological properties derived from the postpartum placenta to create off‑the‑shelf allogeneic cell therapies. These therapies include genetically modified and unmodified natural killer (NK) cells, engineered T-cells such as CAR-T cells, and mesenchymal-like adherent stromal cells (MLASCs).
Business Segments and Core Operations
Celularity organizes its operations into three distinct business segments that underscore its multifaceted approach to address significant unmet medical needs:
- Cell Therapy: Focused on delivering innovative allogeneic therapies, this segment develops off-the-shelf cell products targeting a range of indications including various cancers and immunologic disorders. The use of advanced genetic modification techniques and a universal receptor approach allows for the combination of cell therapies with approved antibody treatments, thus presenting a novel modality to overcome challenges associated with traditional therapies.
- Degenerative Disease: This segment is dedicated to using placental-derived cellular therapies to address aging-related and degenerative diseases. The therapeutic programs in this area harness the regenerative potential of MLASCs and engineered immune cells to target conditions that result from the progressive deterioration of tissue function and structure.
- Bio-banking: Serving as a critical source of revenue and operational support, the bio-banking segment capitalizes on the unique, ready availability of placental tissue. By establishing a repository of high-quality biological materials, Celularity supports both its internal therapeutic development and potential external applications, reinforcing its reputation in the field of regenerative medicine.
Innovative Approaches and Technological Edge
At the forefront of Celularity’s innovation is its application of cutting-edge cell engineering techniques. The company’s universal receptor platform enables the modification of T-cells to express proprietary receptors such as CD16, which are designed to interact synergistically with various monoclonal antibodies. This methodology addresses challenges like antigen escape and improves treatment tolerability, particularly in hard-to-treat cancers and immunologic disorders.
Market Position and Industry Relevance
Celularity has established itself as a prominent player in the regenerative and cellular medicine landscape by integrating advanced biomaterial technologies with targeted cell therapies. Its strategic positioning through multiple business segments—including a revenue-strong bio-banking unit—demonstrates a comprehensive approach to meet global healthcare challenges. The breadth of its therapeutic programs, which span cancer, immune disorders, infectious diseases, and degenerative conditions, highlights its commitment to addressing complex medical conditions using scientifically validated methods.
Scientific and Operational Expertise
Underpinned by rigorous research and a well-established manufacturing infrastructure, Celularity’s operations reflect deep domain expertise and regulatory diligence. The company emphasizes robust clinical evaluations, in vivo preclinical studies, and strategic collaborations with scientific experts to validate its therapies. This meticulous approach ensures that each therapeutic candidate, whether in cell therapy or regenerative biomaterials, is developed with a high degree of precision and commitment to quality.
Investor and Researcher Insights
For investors and industry analysts, understanding Celularity’s multifaceted business model is crucial. The company bridges the gap between advanced scientific innovation and commercial viability through its three-pronged operational strategy. By combining innovative cell therapies with an efficient bio-banking process and a focus on degenerative disease treatments, Celularity creates a diversified portfolio that is well-positioned within the broader biotechnology and regenerative medicine sectors.
This detailed overview of Celularity Inc provides a comprehensive insight into how the integration of advanced cellular technologies and bio-based materials is revolutionizing therapeutic approaches. The company’s scientific rigor, combined with its operational efficiency and diversified business segments, underscores a commitment to addressing some of the most challenging conditions in modern medicine.
Celularity (NASDAQ: CELU) has raised its full-year 2024 net sales guidance to $54-60 million, up from the previously announced $50-56 million. The company reported expected net sales of $44.4 million through October 2024, with October marking its highest single-month sales at $8.3-8.9 million. The guidance includes $49-54.5 million from advanced biomaterial products and $5.0-5.5 million from biobanking services. The company's new Rebound™ product contributed approximately $9 million to sales. Celularity has also filed its delayed Q2 2024 Form 10-Q, addressing Nasdaq compliance issues.
Celularity Inc. (Nasdaq: CELU) has provided a corporate update to shareholders. The company is working to regain full compliance with Nasdaq's listing requirements and has filed its annual report for 2023 and Q1 2024 report. The Q2 2024 report is expected to be filed soon. Celularity's commercial advanced biomaterials business has seen significant growth, with sales exceeding $24 million in the first half of 2024, surpassing full-year 2023 sales. The company recently acquired Rebound, a placental-derived allograft matrix product, which has already generated over $9 million in sales.
Celularity is developing several new products, including Celularity Tendon Wrap, FUSE Bone Void Filler, and Celularity Placental Matrix, with plans to submit 510(k) notifications to the FDA in 2025 and 2026. The company maintains its guidance of expected combined Net Sales for advanced biomaterial products and biobanking businesses to be between $50 million and $56 million.
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.
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