Full Press Release Details
Celularity Reports Second Quarter 2022 Financial Results and Corporate Update
- Announced first patient treated in Phase 1/2a clinical trial for CYNK-101 in first-line advanced
HER2 positive gastric and gastroesophageal junction (G/GEJ) cancers-
- Completed a $30 million private placement by a single
leading healthcare-focused institutional investor-
- Named industry leader Diane Parks to Board of Directors-
Florham Park, NJ, August 9, 2022 Celularity Inc. (Nasdaq: CELU) ( Celularity ), a clinical-stage
biotechnology company developing placental-derived allogeneic cell therapies, today announced financial results for the second quarter ended June 30, 2022, and provided a corporate update.
We achieved another exciting milestone during the second quarter with the treatment of our first gastric cancer patient with CYNK-101, which we are evaluating as an add-on therapy to the current standard of care that we believe could extend progression free survival for patients, said Robert
J. Hariri, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Celularity. We continue to make good progress with all three of our ongoing Phase 1 clinical trials, which includes the CYNK-101
gastric cancer trial and CYNK-001 trials in AML and glioblastoma multiforme. We look forward with anticipation to the second half of the year, during which we plan to report multiple data readouts. Celularity
remains committed to demonstrating the potential clinical advantages of our unique approach and leading the next evolution of cellular therapies for the treatment of cancer, infectious and degenerative diseases using our proprietary
placental-derived cell therapy platform.
Second Quarter Clinical and Regulatory Highlights
CYNK-001 for the Treatment of Acute Myeloid Leukemia (AML) and Glioblastoma Multiforme (GBM):
CYNK-101 for the Treatment of G/GEJ Cancers:
CYCART-19 for the Treatment of B-Cell Malignancies:
Second Quarter Corporate Highlights
Second Quarter and Year to Date 2022 Financial Results
Cash and Cash Equivalents
Cash and cash equivalents were
$38.0 million as of June 30, 2022, compared to $37.2 million as of December 31, 2021. In May 2022, we received net cash proceeds of approximately $27.5 million from a private placement of 4,054,055 shares of our Class A
common stock and warrants to purchase up to 4,054,055 shares of our Class A common stock.
Research and Development
Selling, General and Administrative
Celularity Inc. (Nasdaq: CELU) headquartered in Florham Park, N.J., 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.
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 CYNK-101 and its potential for G/GEJ cancers, the progress of its clinical trials
and timing of data readouts, the benefits of its approach to cellular medicine, its ability to resolve FDA questions and commence the CYCART-19 clinical trial, including the timing thereof , 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 Celularity s current funding, as well as developments relating to Celularity s competitors and industry, along with those risk factors
set forth under the caption Risk Factors in Celularity s annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 31, 2022, as amended on
July 15, 2022 and other filings with the SEC. These risks and uncertainties may be amplified by the COVID- 19 pandemic, recent downturn in the U.S. capital markets and inflation. 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.
Celularity Investor Contacts:
Carlos Ramirez, SVP Investor Relations
| Three Months Ended (unaudited) (in thousands) | Six Months Ended (unaudited) (in thousands) | |||||||||||||||
| June 30, 2022 | June 30, 2021 | June 30, 2022 | June 30, 2021 | |||||||||||||
| Total Revenues | $ | 3,776 | $ | 3,197 | $ | 9,711 | $ | 5,857 | ||||||||
| Operating expenses: | ||||||||||||||||
| Cost of goods sold | 3,179 | 1,440 | 7,205 | 2,682 | ||||||||||||
| Research and development | 25,349 | 22,911 | 47,022 | 39,901 | ||||||||||||
| Selling, general and administrative | 15,574 | 28,863 | 32,034 | 36,489 | ||||||||||||
| Change in fair value of contingent liability and amortization | (44,501 | ) | 10,594 | (39,111 | ) | 31,791 | ||||||||||
| Total operating expenses | (399 | ) | 63,808 | 47,150 | 110,863 | |||||||||||
| Operating income (loss) | 4,175 | (60,611 | ) | (37,439 | ) | (105,006 | ) | |||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 41 | 129 | 47 | 269 | ||||||||||||
| Interest expense | (817 | ) | (1,569 | ) | ||||||||||||
| Change in fair value of warrant liabilities | 43,212 | (1,174 | ) | 22,280 | (37,679 | ) | ||||||||||
| Other income (expense), net | 415 | (2,004 | ) | 88 | (2,031 | ) | ||||||||||
| Total other income (expense) | 43,668 | (3,866 | ) | 22,415 | (41,010 | ) | ||||||||||
| Net income (loss) before income taxes | $ | 47,843 | $ | (64,477 | ) | $ | (15,024 | ) | $ | (146,016 | ) | |||||
| Income tax expense | 17 | 17 | ||||||||||||||
| Net income (loss) | $ | 47,826 | $ | (64,477 | ) | $ | (15,041 | ) | $ | (146,016 | ) | |||||
| Net income (loss) per share attributable to common stockholders basic | $ | 0.34 | $ | (2.69 | ) | $ | (0.11 | ) | $ | (6.09 | ) | |||||
| Weighted average common shares outstanding- basic | 140,152,245 | 23,992,184 | 135,302,472 | 23,991,129 | ||||||||||||
| Net income (loss) per share attributable to common stockholders diluted | $ | 0.32 | $ | (2.69 | ) | $ | (0.11 | ) | $ | (6.09 | ) | |||||
| Weighted average common shares outstanding diluted | 151,311,780 | 23,992,184 | 135,302,472 | 23,991,129 |
Selected Balance Sheet Data
| June 30, 2022 (unaudited) | December 31, 2021 | |||||||
| Cash and cash equivalents | $ | 37,996 | $ | 37,240 | ||||
| Total assets | $ | 429,337 | $ | 414,128 | ||||
| Total liabilities | $ | 279,187 | $ | 314,710 | ||||
| Total stockholders equity | $ | 150,150 | $ | 99,418 |