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Celularity Inc. (NASDAQ: CELU), headquartered in Florham Park, N.J., is a trailblazer in the field of cellular medicine. As a clinical-stage biotechnology company, Celularity is at the forefront of developing off-the-shelf, placental-derived allogeneic cell therapies. Its innovative products include unmodified natural killer (NK) cells, genetically-modified NK cells, T-cells engineered with a chimeric antigen receptor (CAR T-cells), and mesenchymal-like adherent stromal cells (ASCs). These therapies target a diverse range of conditions such as cancer, infectious diseases, and degenerative disorders.
Celularity is also a pioneer in the development and manufacture of advanced biomaterials derived from the postpartum placenta. The unique biology and availability of the placenta allow Celularity to create accessible, effective, and affordable therapeutic solutions that address significant global health challenges.
Recent Achievements and Current Projects:
- The company has received IND clearance from the FDA and is set to begin a Phase 1/2 study in 2024 with its placental-derived cell therapy.
- The Healthcare Common Procedure Coding System (HCPCS) Q code approval for Biovance® 3L has been granted by the Centers for Medicare and Medicaid Services (CMS). This code enhances the use of Biovance® 3L for wound care in office settings, enabling broader adoption and growth.
- Celularity has presented promising data from in vivo studies of its PT-CD16VS, a genetically modified allogeneic cell therapy, in combination with various monoclonal antibodies. This data highlights the therapy’s potential in treating HER2-positive cancers and other conditions.
Financial Condition and Partnerships:
The company’s financial health is under scrutiny as it works to regain compliance with Nasdaq listing requirements. Celularity is actively developing a plan to submit to Nasdaq by June 17, 2024, to address its delinquent reports. Meanwhile, the company anticipates continued growth through its advanced cell therapies and biomaterials.
Celularity’s partnerships, particularly in the field of regenerative medicine, exemplify its commitment to innovation and excellence. The company’s state-of-the-art manufacturing facility further supports its ability to produce advanced cell therapies at scale, aiming to meet the unmet needs of patients worldwide.
For more detailed information and the latest updates, visit the official website www.celularity.com.
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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