Celularity Inc Stock Price, News & Analysis

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.

Celularity Inc. (Nasdaq: CELU) presented preclinical data on its allogeneic NK cell therapy, CYNK-101, at the Society for Immunotherapy of Cancer Annual Meeting from November 10-14, 2021. CYNK-101, derived from genetically modified human placental CD34⁺ cells, demonstrated enhanced antibody-dependent cellular cytotoxicity against EGFR⁺ tumors when combined with Cetuximab. This research suggests potential applications in treating non-small cell lung cancer and head and neck cancers. Celularity aims to develop innovative therapies targeting unmet medical needs.

Celularity Inc. (Nasdaq: CELU) reported third-quarter financial results on Nov. 12, 2021, with revenues of $7.3 million, notably driven by the termination of the Sanuwave license agreement. However, research and development expenses surged by $12.5 million, largely due to increased clinical trial costs and stock-based compensation. The net income for Q3 2021 reached $49.9 million, translating to $0.47 per share (basic). Year to date, the company recorded a net loss of $96.1 million. The firm is advancing its placental-derived cell therapies, highlighting collaborations and innovative approaches targeting cancer.

Celularity Inc. (Nasdaq: CELU) and Oncternal Therapeutics, Inc. (Nasdaq: ONCT) have announced a research collaboration to develop placental-derived cellular therapies targeting the ROR1 receptor. This partnership aims to combine Oncternal's ROR1-targeted monoclonal antibody, cirmtuzumab, with Celularity’s natural killer (NK) cells and investigate ROR1-targeted CAR gene modifications. ROR1 is associated with aggressive tumor behavior in various cancers. Both companies believe that this collaboration may enhance therapeutic options for patients with solid tumors and hematological malignancies.

Celularity Inc. has appointed Dr. Andrew L. Pecora as President, effective immediately. With over 25 years in biotechnology, Dr. Pecora will advance Celularity’s clinical pipeline toward FDA approval, reporting to CEO Dr. Robert J. Hariri. His experience includes leadership roles in cellular medicine and drug development, enhancing the company’s strategic vision. Celularity specializes in placental-derived therapies for cancer and infectious diseases, conducting innovative work in allogeneic cell therapies.

Celularity Inc. (Nasdaq:CELU) secured approximately $138 million in funding through a merger with GX Acquisition Corp. and a PIPE investment. The company expanded its Phase 1 trial for CYNK-001 to include difficult-to-treat patients with acute myeloid leukemia. Additionally, the FDA granted Orphan Drug Designation for CYNK-001. Celularity formed strategic partnerships with Imugene Ltd and Palantir to enhance its therapeutic developments and data analysis capabilities. However, second quarter revenues decreased by $0.3 million, with a net loss of $64.5 million.