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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. appointed Diane Parks to its Board of Directors, enhancing its expertise in cellular therapies. With over 30 years in the pharmaceutical sector, Parks brings a wealth of experience, having held senior roles at Kite Pharma and Amgen. Her proven track record in launching successful therapies aligns with Celularity's strategic goals. Concurrently, Jay R. Bloom has resigned from the board, marking a significant transition for the company during its growth phase.
Celularity Inc. (Nasdaq: CELU) has announced a definitive agreement with a healthcare-focused investor to sell 4,054,055 shares of its Class A common stock for $7.40 each, raising approximately $30.0 million. The deal includes warrants for an additional 4,054,055 shares at an exercise price of $8.25. The transaction, not involving a public offering, is expected to close around May 20, 2022. Celularity plans to file a registration statement with the SEC to cover the resale of shares issued, enhancing future liquidity for investors.
Celularity Inc. (Nasdaq: CELU) reported financial results for Q1 2022, highlighting a total revenue increase to $5.9 million from $2.7 million in Q1 2021. The firm is advancing its clinical trials for NK cell therapies, including CYNK-001 for acute myeloid leukemia and glioblastoma multiforme, and CYNK-101 for gastric cancer, both of which received FDA designations. R&D expenses rose to $21.7 million, and the company faced a net loss of $62.9 million, improving from $81.5 million a year earlier. Cash and equivalents increased to $48 million as of March 31, 2022.
Celularity Inc. (Nasdaq: CELU) reported significant advancements in its clinical programs for cell therapies, particularly CYNK-001 and CYNK-101, which are in ongoing Phase 1 trials for acute myeloid leukemia and HER2+ gastric cancer, respectively. Both candidates received Fast Track and Orphan Drug Designations from the FDA. The company also highlighted a 46% increase in total revenues to $21.3 million for 2021, although it posted a significant net loss of $100.1 million. Strategic partnerships were formed to expand therapeutic applications, indicating a solid growth trajectory.
Celularity Inc. (Nasdaq: CELU), a clinical-stage biotech firm in Florham Park, N.J., is advancing placental-derived allogeneic cell therapies aimed at cancer and other diseases. On March 17, 2022, at 11:20 AM ET, CEO Robert Hariri and President Andrew Pecora will engage in a fireside chat during the Oppenheimer 32nd Annual Healthcare Conference. This event can be accessed via a live webcast on Celularity’s website, with a replay available for 30 days. Celularity focuses on innovative therapies utilizing natural killer cells and CAR T-cells, addressing global health needs.
Celularity (NASDAQ: CELU) announced that the FDA has granted Orphan Drug Designation for CYNK-101, a genetically modified NK cell therapy aimed at treating advanced HER2/neu positive gastric and gastroesophageal junction cancers. This marks the fifth FDA designation received by Celularity in the last year. CYNK-101 is designed to enhance antibody-dependent cellular cytotoxicity when used with standard therapies like chemotherapy, trastuzumab, and pembrolizumab. The FDA's designation highlights the significant unmet medical need for effective treatments in advanced gastric cancer.
Celularity Inc. (NASDAQ: CELU) has received Fast Track Designation from the FDA for its investigational cell therapy, CYNK-101. This therapy is aimed at treating advanced HER2/neu positive gastric and gastroesophageal junction cancer. The Phase 1/2a trial will assess its safety and efficacy in combination with standard chemotherapy and other agents. Celularity's fast track designation for CYNK-101 marks the third such recognition in less than a year, following similar designations for its other NK cell therapies targeting acute myeloid leukemia and glioblastoma.
Celularity Inc. (Nasdaq: CELU) announced that the FDA has granted Fast Track Designation for its CYNK-001, a non-genetically modified NK cell therapy aimed at treating acute myeloid leukemia (AML). The designation aims to expedite the development of treatments for serious conditions with unmet medical needs. CYNK-001 also holds orphan drug designation for malignant gliomas. The therapy utilizes placental-derived NK cells and aims to improve responses and durability in patients suffering from AML.
Celularity (NASDAQ: CELU) presented preclinical data on its placental-derived NK cell therapies (CYNK-101 and CAR19-CYNK) at the 63rd American Society of Hematology Meeting in Atlanta from December 11-14, 2021. Both therapies showed promise in treating hematological malignancies. CYNK-101 demonstrated effective synergy with daratumumab, avoiding fratricide and off-tumor effects. CAR19-CYNK displayed enhanced tumor cell killing against resistant lymphoma. These findings highlight Celularity's innovative approach to cellular therapies drawn from placental cells.
Celularity Inc. (Nasdaq: CELU) has received FDA clearance for its Investigational New Drug (IND) application to evaluate CYNK-101, a genetically engineered NK cell therapy, in combination with chemotherapy, trastuzumab, and pembrolizumab for advanced HER2/neu positive gastric cancer. The Phase 1/2a trial aims to assess the safety and preliminary efficacy of this combination. Notably, gastric cancer ranks fifth in global incidence, with poor survival rates in advanced stages. Celularity seeks to enhance treatment outcomes by leveraging placental-derived NK cell therapy.
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