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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) is advancing its focus on cellular therapies for cancer and degenerative diseases. CEO Robert J. Hariri spoke at the Future Investment Initiative in Riyadh, highlighting the company's commitment to global expansion, particularly in Saudi Arabia. Celularity is leveraging placental-derived cell technology to develop therapies aimed at enhancing human health and performance. The firm targets age-related conditions and is exploring collaborations within Saudi Vision 2030 for healthcare innovation across the MENA region.
Imugene Limited and Celularity Inc. have presented preclinical data on their collaboration at the Annual Meeting of the Society for Immunotherapy of Cancer. The study showcases the efficacy of Imugene’s onCARlytics (CF33-CD19) oncolytic virus in combination with Celularity’s CYCART-19 T cells against triple-negative breast cancer. Notably, the results indicate enhanced tumor regression and immune activation. The presentation aims to further clinical development and highlights the potential of this combination therapy in treating solid tumors.
Celularity Inc. (Nasdaq: CELU) reported significant advancements in its clinical trials and management structure. The company announced the first patient treated in Phase 1/2a trial for CYNK-101 in advanced HER2 positive gastric cancer. Financially, Celularity improved its balance sheet with $150 million financing. In Q3 2022, it reported a net income of $4.8 million, a decline from $49.9 million in the prior year, while reducing net losses to $10.2 million YTD. Research expenses rose by $3.7 million year-over-year, highlighting ongoing investment in development.
Celularity Inc. (Nasdaq: CELU) announced the presentation of preclinical data on its CYNK-101, a placental-derived NK cell therapy, at the 37th Annual Meeting of The Society for Immunotherapy of Cancer in Boston. The study highlights CYNK-101's combination with avelumab, demonstrating enhanced antibody-dependent cellular cytotoxicity (ADCC) against PD-L1+ solid tumors, including non-small cell lung cancer and triple-negative breast cancer. The poster will be presented on November 11, 2022, showcasing promising next steps for this innovative cancer therapy.
Celularity Inc. (Nasdaq: CELU) announced the promotion of John R. Haines to Senior Executive Vice President and Chief Administrative Officer, and Brad Glover, Ph.D., to Executive Vice President and Chief Operating Officer. Both will serve on a newly established Executive Committee led by CEO Robert J. Hariri. Haines will spearhead international expansion strategies and oversee business operations, while Glover will manage corporate strategic planning and operational decision-making. These leadership changes aim to enhance Celularity's growth in cell therapy and biomaterials.
Celularity Inc. has appointed Adrian Kilcoyne, M.D., M.P.H., M.B.A. as Executive Vice President and Chief Medical Officer. With over 15 years in oncology and immunology, he has a strong background in advancing clinical programs. His role will be crucial in pushing Celularity’s clinical pipeline towards FDA approval. The company is currently conducting three Phase 1 studies targeting acute myeloid leukemia, glioblastoma multiforme, and gastric cancer, alongside an IND-pending program for B-cell malignancies. Kilcoyne’s expertise is expected to accelerate key clinical milestones.
Celularity Inc. (Nasdaq: CELU), a clinical-stage biotechnology firm, announced that its Founder and CEO, Robert Hariri, will present at the Jefferies Cell and Genetic Medicine Summit on September 30, 2022, at 11 a.m. ET. The presentation will be accessible via a live webcast on Celularity's investor relations page, with a replay available for 30 days post-event. Celularity focuses on developing allogeneic cell therapies derived from the placenta, targeting cancer and infectious diseases. The company aims to provide effective, affordable therapies leveraging the unique biology of the placenta.
Celularity Inc. (Nasdaq: CELU) announced a study published in Frontiers in Immunology highlighting the antiviral properties of its placental-derived NK cells (CYNK-001) against influenza A virus (IAV). The research indicates that CYNK-001 targets IAV-infected cells, potentially benefiting patients with limited treatment options. Celularity's CYNK-001 is recognized as the first FDA-cleared immunotherapy for COVID-19 treatment. Annual costs associated with influenza in the U.S. are estimated at USD 10.4 billion, underscoring the need for effective antiviral therapies.
Celularity Inc. (Nasdaq: CELU) announced a Pre-Paid Advance Agreement with YA II PN, LTD for up to $150 million over 18 months. Each advance can be as much as $40 million, issued at a 2% discount with a 6% interest rate. If an outstanding balance exists, Celularity may need to sell shares at a price tied to a 135% or 95% of the VWAP, with a minimum price of $0.75. Proceeds will be used for working capital and to support R&D initiatives. The agreement is detailed in a shelf registration statement filed with the SEC.
Celularity Inc. (Nasdaq: CELU), a clinical-stage biotech firm, announced that CEO Robert Hariri will participate in investor conferences. He will engage in fireside chats at the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022, at 1:30 p.m. ET, and the Morgan Stanley 20th Annual Global Healthcare Conference on September 14, 2022, at 12:20 p.m. ET. Live webcasts will be available on Celularity's website and archived for 30 days post-event.
Celularity focuses on developing placental-derived cell therapies for cancer and other diseases.
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