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Celularity Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update Two ongoing Phase 1 trials of unmodified placental-derived natural killer cell therapy candidate, CYNK-001, in acute my

Key Takeaway: Celularity Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update Two ongoing Phase 1 trials of unmodified placental-derived natural killer cell therapy candidate, CYNK-001, in acute myeloid leukemia (AML) and glioblastoma multiforme (GBM) An

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Celularity Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update
Two ongoing Phase 1 trials of unmodified placental-derived natural killer cell therapy candidate, CYNK-001, in acute myeloid leukemia (AML) and glioblastoma multiforme (GBM)
An ongoing Phase 1 portion of a Phase 1/2a trial of genetically modified placental-derived natural killer cell therapy candidate, CYNK-101, in HER2+ gastric cancer
All three ongoing clinical programs have been granted Fast Track designation by the U.S. Food and Drug Administration (FDA)
CYNK-001 granted Orphan Drug Designation by the FDA for treatment of malignant gliomas, including GBM and CYNK-101 granted Orphan Drug Designation for treatment of HER2+ gastric cancer
Announced three partnerships to expand the potential opportunities for placental-derived cell therapy in additional indications, including combination therapies and new therapeutic areas
Florham Park, NJ, - March 31, 2022 - Celularity Inc. (Nasdaq: CELU) ("Celularity"), a clinical-stage biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies, today reported a corporate update and financial results for the fourth quarter and full year ended December 31, 2021.
"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-101 for the Treatment of HER2+ Gastric Cancer:
CYCART-19 for the Treatment of B-Cell Malignancies:
Corporate Developments
Fourth Quarter and Full Year 2021 Financial Results
Celularity Inc. (Nasdaq: CELU) headquartered in Florham Park, NJ, is a clinical stage biotechnology company leading the next evolution in cellular medicine by developing allogeneic cryopreserved off-the-shelf placental-derived cell therapies, including therapeutic programs using unmodified natural killer (NK) cells, genetically modified NK cells, T-cells engineered with a CAR (CAR-T cells), and mesenchymal-like adherent stromal cells (ASCs). These therapeutic programs target indications in cancer, infectious and degenerative diseases. In addition, Celularity develops and manufactures innovative biomaterials also derived from the postpartum placenta. Celularity believes that by harnessing the placenta's unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies. To learn more, visit celularity.com.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995, as well as within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts are "forward-looking statements," including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "can," "contemplate," "continue," "could," "estimate," "expect," "forecast," "intends," "may," "might," "outlook," "plan," "possible," "potential," "predict," "project," "seek," "should," "strive," "target," "will," "would" and the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. The forward-looking statements in this press release include statements regarding the effects of recent partnerships on Celularity's business objectives, expectations for 2022, including with respect to data readouts from ongoing clinical trials and Celularity's ability to advance the field of cellular medicine and develop treatments for cancer, degenerative and infectious diseases, its recent collaboration with Oncternal Therapeutics and its clinical development plans, among others. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: the inherent risks in biotechnological development, including with respect to the development of novel cellular therapies, and the clinical trial and regulatory approval process; and risks associated with developments relating to Celularity's competitors and industry, along with those risk factors are contained in Celularity's filings and periodic reports filed with the Securities and Exchange Commission (SEC) under the heading "Risk Factors" and elsewhere in such filings and reports, including Celularity's annual report on Form 10-K for the year-ended December 31, 2021 and future filings and reports by Celularity. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Celularity disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances. These risks and uncertainties may be amplified by the ongoing COVID- 19 pandemic. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity's current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity's views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Celularity Investor Contact:
Carlos Ramirez, SVP Investor Relations
CELULARITY INC.
Consolidated Statements of Operations
(in thousands, except share and per share data)
Three Months Ended (unaudited) Year Ended
December 31, 2021 December 31, 2020 December 31, 2021 December 31, 2020
Total Revenues 4,857 3,243 21,335 14,278
Operating expenses:
Cost of goods sold 4,660 1,170 9,653 4,932
Research and development 24,687 13,924 88,353 52,707
Selling, general and administrative 13,208 5,973 71,341 31,336
Change in fair value of contingent liability, amortization, impairments (22,748) (28,879) (38,953) 77,228
Total operating expenses 19,806 (7,812) 130,394 166,203
Operating (loss) income (14,950) 11,055 (109,059) (151,925)
Other income (expense):
Interest income 8 134 332 370
Interest expense (759) (724) (3,171) (2,354)
Loss of sale on business - - - (4,434)
Expenses related to warrant liabilities 11,224 (6,621) 13,482 (58,686)
Other income (expense), net 457 (3) (1,682) 4,096
Total other income (expense) 10,930 (7,214) 8,961 (61,008)
Net loss before income taxes $ (4,020) $ 3,841 $ (100,098) $ (212,933)
Income tax (benefit) expense 20 (69) 20 (4,700)
Net loss $ (4,039) $ 3,910 $ (100,118) $ (208,233)
Net loss per share attributable to common stockholders, basic and diluted $(0.03) $0.21 $(1.49) $(11.31)
Weighted-average common shares outstanding, basic and diluted 124,123,844 18,433,246 67,057,278 18,417,910
Consolidated Statements of Operations
(in thousands, except share and per share data)
Three Months Ended (unaudited) Year Ended
December 31, December 31, December 31, December 31,
2021 2020 2021 2020
Total Revenues 4,857 3,243 21,335 14,278
Operating expenses:
Cost of goods sold 4,660 1,170 9,653 4,932
Research and development 24,687 13,924 88,353 52,707
Selling, general and administrative 13208 5973 71,341 31,336
Change in fair value of contingent liability, amortization, impairments (22,748 ) (28,879 ) (38,953 ) 77,228
Total operating expenses 19,806 (7,812 ) 130,394 166,203
Operating (loss) income (14,950 ) 11,055 (109,059 ) (151,925 )
Other income (expense):
Interest income 8 134 332 370
Interest expense (759 ) (724 ) (3,171 ) (2,354 )
Loss of sale on business - - - (4,434 )
Expenses related to warrant liabilities 11,224 (6,621 ) 13,482 (58,686 )
Other income (expense), net 457 (3 ) (1,682 ) 4,096
Total other income (expense) 10,930 (7,214 ) 8,961 (61,008 )
Net loss before income taxes $ (4,020 ) $ 3,841 $ (100,098 ) $ (212,933 )
Income tax (benefit) expense 20 (69 ) 20 (4,700 )
Net loss $ (4,039 ) $ 3,910 $ (100,118 ) $ (208,233 )
Net loss per share attributable to common stockholders, basic and diluted $ (0.03 ) $ 0.21 $ (1.49 ) $ (11.31 )
Weighted-average common shares outstanding, basic and diluted 124,123,844 18,433,246 67,057,278 18,417,910
Selected Balance Sheet Data
December 31, 2021 December 31, 2020
Cash and cash equivalents 37,240 54,311
Total assets 414,128 431,008
Total liabilities 314,710 412,295
Total stockholders' equity 99,418 (531,400 )
Last updated: Mar 31, 2022