On March 31, 2022 Celularity Inc. (Nasdaq: CELU) ("Celularity"), a clinical-stage biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies, reported a corporate update and financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Celularity, MAR 31, 2022, View Source [SID1234611285]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The past year has been exciting for Celularity, during which we achieved multiple transformational milestones and significant progress in our unique approach to cellular medicine," said Robert J. Hariri, M.D., Ph.D., founder, Chairperson and Chief Executive Officer of Celularity. "Most notably, we transitioned to a public company through a business combination with GX Acquisition Corp., which along with a companion PIPE, contributed to advancing our preclinical and clinical programs targeting significant unmet medical needs. We also were granted five regulatory designations by the FDA, which we believe provides validation for the potential of our approach to change the cell therapy landscape and improve the lives of patients. Beyond our active clinical development programs, we forged new strategic and commercial partnerships with companies at the forefront of their respective fields, again consistent with our mission to pioneer new, innovative approaches to cellular medicine."
Dr. Hariri continued, "Our achievements over the past year establish a solid foundation for growth through 2022. We expect Phase 1 data readouts in all three ongoing clinical programs and the submission of an investigational new drug application, or IND, for our CYCART-19 program to enable initiation of a Phase 1 trial in B cell malignancies. We believe we are well positioned to lead the next evolution of cellular therapeutics for the treatment of cancer, infectious and degenerative diseases using our proprietary placental-based cell therapy platform."
Clinical and Regulatory Updates
CYNK-001 for the Treatment of AML and GBM:
CYNK-001 is Celularity’s unmodified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy candidate that is enriched with CD56+/CD3- NK cells and expanded from human placental CD34+ cells. CYNK-001 is currently being investigated in two Phase 1 clinical trials, in AML and in GBM.
In March 2021, the FDA granted Fast Track designation to CYNK-001 for the treatment of adults with recurrent GBM.
In April 2021, the FDA granted Orphan Drug Designation to CYNK-001 for the treatment of patients with malignant gliomas, including GBM.
In June 2021, Celularity announced the expansion of its ongoing Phase 1 clinical trial of CYNK-001 in AML (NCT04310592) to include patients with relapsed/refractory AML (r/r AML) in addition to an ongoing trial in patients with minimal residual disease (MRD).
In December 2021, the FDA granted Fast Track designation to CYNK-001 for the treatment of AML.
Also in December 2021, Celularity hosted an AML update with analysts in which the Company highlighted data findings in both r/r AML and MRD (NCT04310592) that provided evidence of a dose effect and biologic activity, and outlined plans to expand with new cohorts in both arms, add interleukin-2 (IL-2) to the treatment regimen, add a fourth dose on day 21 and potentially increase the dose of NK cells. The presentation from the event is available on Celularity’s investor relations website under Events & Presentations.
CYNK-101 for the Treatment of HER2+ Gastric Cancer:
CYNK-101 is a novel allogeneic off-the-shelf human placental CD34+-derived NK cell product candidate that is genetically modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to drive antibody-dependent cell-mediated cytotoxicity. CYNK-101 is currently being investigated in the Phase 1 portion of a Phase 1/2a clinical trial in HER2+ gastric cancer.
In November 2021, Celularity received clearance of its IND by the FDA for the use of CYNK-101 in combination with standard chemotherapy, trastuzumab and pembrolizumab, in patients with first-line locally advanced unresectable or metastatic HER2/neu positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
Also in November 2021, Celularity presented preclinical data in a poster presentation at the Society of Immunotherapy Cancer (SITC) (Free SITC Whitepaper) annual meeting. The data demonstrate the synergistic effect of combining CYNK-101 with Cetuximab to drive antibody-dependent cellular cytotoxicity activity against EGFR+ tumors.
In December 2021, Celularity presented preclinical data for CYNK-101 at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.
In January 2022, the FDA granted Fast Track designation to CYNK-101, which is being developed in combination with standard chemotherapy, trastuzumab and pembrolizumab in first-line locally advanced unresectable or metastatic HER2/neu positive G/GEJ adenocarcinoma.
In February 2022, the FDA granted Orphan Drug Designation to CYNK-101 for the treatment of gastric/gastroesophageal junction cancer.
CYCART-19 for the Treatment of B-Cell Malignancies:
CYCART-19 is an allogeneic Chimeric Antigen Receptor (CAR) engineered human placental -derived T cell that is a potential drug candidate in B-cell malignancies.
In December 2021, preclinical data demonstrating the feasibility and functionality of expressing a CAR directed to CD19 on placental CD34+derived, cryopreserved, off-the-shelf, allogeneic CYNK cells were presented at the ASH (Free ASH Whitepaper) Annual Meeting.
Corporate Developments
In May 2021, Celularity formed a multi-year strategic partnership with Palantir Technologies to leverage the unique combined strengths of Celularity’s deep dataset and Palantir’s Foundry platform to accelerate and advance cellular therapies.
In July 2021, Celularity completed a business combination with GX Acquisition Corp. and commenced trading on the Nasdaq exchange under a new name and new ticker symbols. Gross proceeds from the transaction totaled approximately $138 million, which included funds held in the trust account and a concurrent private placement investment in public equity (PIPE) financing led by existing Celularity stockholders.
Also in July 2021, Celularity entered into an exclusive supply and distribution agreement for multiple commercial products with Arthrex to distribute and commercialize Celularity’s biomaterial products for orthopedic surgery and sports medicine.
In August 2021, Celularity entered into an exclusive strategic partnership to develop the combination of Imugene’s CD19 oncolytic virus technology and Celularity’s CD19 targeting allogeneic CAR T cellular therapy, CYCART-19, for the treatment of solid tumors.
In September 2021, Celularity appointed Andrew L. Pecora, M.D., as President. Dr. Pecora, a hematologist and oncologist, was a Celularity director prior to the business combination with GX Acquisition Corp. and chaired its Scientific Advisory Board.
Also in September 2021, Celularity entered into a research collaboration with Oncternal Therapeutics under which the companies will evaluate placental derived-cellular therapies targeting receptor-tyrosine kinase-like Orphan Receptor 1 (ROR1).
Celularity’s clinical and commercial GMP production facility has been fully operational for over a year and has been developing and supplying all placental-derived cell therapy product candidates, including CYNK-001, CYNK-101, and CYCART-19 as well as Celularity’s tissue-derived therapies including BIOVANCE, BIOVANCE•3L Ocular, and Interfyl.
Fourth Quarter and Full Year 2021 Financial Results
Cash and Cash Equivalents: Cash, cash equivalents and marketable securities were $37.2 million as of December 31, 2021, compared to $54.3 million as of December 31, 2020. Gross proceeds of the business combination and related PIPE transactions, which totaled approximately $138 million, were offset by cash used in operations, capital expenditures and professional fees related to becoming an operating public company.
Total Revenues: Total revenues were $4.9 million for the fourth quarter of 2021 and $21.3 million for the full year ended December 31, 2021, compared to $3.2 million for the fourth quarter of 2020 and $14.3 million for the full year ended December 31, 2020. The increase in revenues was primarily due to recognition of deferred revenue in connection with termination of a license agreement, as well as new distribution agreements.
Research & Development (R&D) Expenses: R&D expenses were $24.7 million for the fourth quarter of 2021 and $88.4 million for the full year ended December 31, 2021, compared to $13.9 million for the fourth quarter of 2020 and $52.7 million for the full year ended December 31, 2020. The increase was primarily driven by increased stock-based compensation as well as costs associated with increases in both preclinical and clinical activities, and headcount.
Selling, General & Administrative (SG&A) Expenses: SG&A expenses were $13.2 million for the fourth quarter of 2021 and $71.3 million for the full year ended December 31, 2021, compared to $6.0 million for the fourth quarter of 2020 and $31.3 million for the full year ended December 31, 2020. The increase in SG&A expenses was primarily caused by increased stock-based compensation expense, a legal settlement charge as well as an increase in headcount and costs associated with being a public company.
Net (loss) income: Net loss attributable to common stockholders was $4.0 million, or $0.03 per share, for the fourth quarter of 2021 and $100.1 million, or $1.49 per share for the year ended December 31, 2021, compared to income of $3.9 million, or $0.21 per share, for the fourth quarter of 2020 and a loss of $208.2 million, or $11.31 per share, for the full year ended December 31, 2020.