Full Press Release Details
Reports Second Quarter 2021 Financial Results
Park, NJ - August 16, 2021 - Celularity Inc. ("Celularity") (Nasdaq:CELU), a clinical-stage biotechnology
company developing off-the-shelf placental-derived allogeneic therapies, today reported financial results for the quarter ended June
30, 2021, and provided a summary of recent corporate highlights.
has been an exciting time for Celularity, with the achievement of 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, this quarter marked our transition to a public company through a merger with GX Acquisition Corp., which
along with a companion PIPE provided significant funds to support our work. Additionally, we made noteworthy advances in our clinical
programs, including the expansion of our Phase 1 trial in patients with acute myeloid leukemia, to include difficult to treat patient
populations. Beyond our program development, we forged new strategic and commercial partnerships with companies at the forefront of their
respective fields that continue our legacy of pioneering new and innovative approaches to cellular medicine. We look forward to continuing
to advance the field of cellular medicine and developing treatments capable of addressing significant unmet needs in cancer, autoimmune
and infectious disease."
| Celularity closed the merger with GX Acquisition Corp. ("GXGX"). Proceeds from the transaction totaled approximately $138 million, which included funds held in GXGX's trust account and a concurrent private placement investment in public equity (PIPE) financing led by existing Celularity shareholders. | ||
| Celularity expanded its ongoing Phase 1 clinical trial of CYNK-001 in patients with acute myeloid leukemia (AML) (NCT04310592) to include patients with relapsed/refractory AML (r/r AML) in addition to its ongoing trial in patients positive for minimal residual disease (MRD). | ||
| The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to Celularity's CYNK-001, a non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, for the treatment of patients with malignant gliomas. | ||
| Celularity entered an exclusive strategic partnership with Imugene Ltd. to develop a novel oncolytic virus - allogeneic chimeric antigen receptor (CAR) T-cell immunotherapy combination for the treatment of solid tumors. The collaboration will initially explore the therapeutic potential of a combination of Imugene's CF33-CD19 oncolytic virus (onCARlytics ) and Celularity's placental-derived CD19 targeting CAR T-cell therapy, CYCART-19. | ||
| Celularity established a partnership to leverage Palantir's next generation software and computational capabilities to analyze Celularity's cellular data and accelerate research and development activities. | ||
| On July 1, 2021, Celularity announced its agreement with Arthrex whereby Arthrex would receive exclusive rights to distribute and commercialize Celularity's placental-derived biomaterial products for orthopedics and sports medicine in the U.S. Under the terms of the agreement, Celularity will provide Arthrex with exclusive commercial distribution rights for orthopedic surgery and sports medicine and will continue to be responsible for product manufacturing and supply. |
Quarter 2021 Financial Results
Celularity (Nasdaq: CELU)
Inc. (Nasdaq: CELU) headquartered in Florham Park, N.J., is a clinical stage biotechnology company leading the next evolution in cellular
medicine by developing off-the-shelf placental-derived allogeneic cell therapies, including 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) targeting indications across
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 will
be able to develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies.To
learn more, visit celularity.com.
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 advancing the field of cellular medicine and developing treatments for cancer, autoimmune and infectious
diseases, , 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 set forth under the caption
"Risk Factors" in Celularity's prospectus filed with the Securities and Exchange Commission (SEC)
on August 12, 2021 and other filings with the SEC. These risks and uncertainties may be amplified by the COVID- 19 pandemic. If
any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results
implied by these forward-looking statements. 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.
in thousands, except share and per share data)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, 2021 | June 30, 2020 | June 30, 2021 | June 30, 2020 | |||||||||||||
| Net revenues | ||||||||||||||||
| Product sales and rentals | $ | 1,045 | $ | 2,074 | $ | 1,885 | $ | 4,866 | ||||||||
| Services | 1,597 | 1,398 | 2,861 | 2,814 | ||||||||||||
| License, royalty and other | 555 | - | 1,111 | - | ||||||||||||
| Total revenues | 3,197 | 3,472 | 5,857 | 7,680 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of revenues (excluding amortization of acquired intangible assets) | ||||||||||||||||
| Product sales and rentals | 869 | 794 | 1,387 | 1,650 | ||||||||||||
| Services | 571 | 698 | 1,295 | 1,079 | ||||||||||||
| Licenses, royalties and other | - | - | - | - | ||||||||||||
| Research and development | 22,911 | 15,804 | 39,901 | 27,566 | ||||||||||||
| Selling, general and administrative | 28,863 | 7,586 | 36,489 | 17,036 | ||||||||||||
| Change in fair value of contingent consideration liability | 10,048 | 114,738 | 30,704 | 116,463 | ||||||||||||
| Amortization of acquired intangible assets | 546 | 1,030 | 1,087 | 2,060 | ||||||||||||
| Total operating expenses | 63,808 | 140,650 | 110,863 | 165,854 | ||||||||||||
| Loss from operations | (60,611 | ) | (137,178 | ) | (105,006 | ) | (158,174 | ) | ||||||||
| Other (expense) income: | ||||||||||||||||
| Interest income | 129 | 32 | 269 | 144 | ||||||||||||
| Interest expense | (817 | ) | (924 | ) | (1,569 | ) | (924 | ) | ||||||||
| Expense related to warrant liabilities | (1,174 | ) | (1,239 | ) | (37,679 | ) | (15,105 | ) | ||||||||
| Other (expense) income, net | (2,004 | ) | 3,698 | (2,031 | ) | 3,595 | ||||||||||
| Total other (expense) income | (3,866 | ) | 1,567 | (41,010 | ) | (12,290 | ) | |||||||||
| Net loss before income taxes | (64,477 | ) | (135,611 | ) | (146,016 | ) | (170,464 | ) | ||||||||
| Income tax benefit | - | 7 | - | (4,646 | ) | |||||||||||
| Net loss | $ | (64,477 | ) | $ | (135,618 | ) | $ | (146,016 | ) | $ | (165,818 | ) | ||||
| Per share information: | ||||||||||||||||
| Net loss per share - basic and diluted | $ | (2.69 | ) | $ | (5.66 | ) | $ | (6.09 | ) | $ | (6.92 | ) | ||||
| Weighted average shares outstanding - basic and diluted | 23,992,184 | 23,955,562 | 23,991,129 | 23,954,238 |