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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 10, 2022 |
Celularity Inc.
(Exact name of registrant as specified in its charter)
Delaware |
001-38914 |
83-1702591 |
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(State or other jurisdiction |
(Commission File Number) |
(IRS Employer |
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170 Park Ave |
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Florham Park, New Jersey |
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07932 |
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(Address of principal executive offices) |
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(Zip Code) |
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Registrant’s telephone number, including area code: (908) 768-2170 |
N/A |
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Class A Common Stock, $0.0001 par value per share |
CELU |
The Nasdaq Stock Market LLC |
Warrants, each exercisable for one share of Class A Common Stock at an exercise price of $11.50 per share |
CELUW |
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 10, 2022, Celularity Inc. issued a press release announcing its financial results as of and for the quarter ended September 30, 2022. A copy of the press release is furnished hereto as Exhibit 99.1 and is incorporated herein by reference.
The information contained in this Item 2.02 and in Exhibit 99.1 to this current report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit number |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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CELULARITY INC. |
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Date: |
November 10, 2022 |
By: |
/s/ David Beers |
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David Beers |
Exhibit 99.1
Celularity Reports Third Quarter 2022 Financial Results and Provides 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) cancer
- Appointed Adrian Kilcoyne, M.D., M.P.H., M.B.A., as Chief Medical Officer and announced the promotion of two senior executives and the formation of a new Executive Committee
- Presenting an abstract at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting that supports the scientific rationale of the CYNK-101
- Strengthened balance sheet using a combination of a $150 million at-the-market (ATM) facility and a $150 million pre-paid advance agreement
Florham Park, NJ, – November 10, 2022 – Celularity Inc. (Nasdaq: CELU) (Celularity), a clinical-stage biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, today announced financial results for the quarter ended September 30, 2022, and provided a corporate update.
“We are excited about the progress we have made throughout the third quarter, including treating the first patient in our Phase 1/2a clinical trial of CYNK-101 in patients with G/GEJ cancer,” said Robert J. Hariri, M.D., Ph.D., Founder, Chair and Chief Executive Officer of Celularity. “Our proprietary placental-derived cell therapy platform is a potent innovation engine that drives our discovery and clinical programs, as well as our commercial biomaterials products. As we work to fulfill our mission to positively impact patients’ lives with placental-derived therapeutic solutions, we have strengthened our leadership team, including the appointment of Dr. Adrian Kilcoyne as Celularity’s Chief Medical Officer and the creation of a new Executive Committee. We look forward to upcoming preliminary data readouts across our pipeline in the fourth quarter of 2022 that we believe will support the clinical rationale for placental-derived cell therapies.”
Third 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:
Third Quarter 2022 Corporate Highlights
Third Quarter and Year to Date 2022 Financial Results
Cash and Cash Equivalents
Cash and cash equivalents were $42.6 million as of September 30, 2022, compared to $37.2 million as of December 31, 2021. In September 2022, Celularity received cash proceeds net of discount of approximately $39.2 million as a pre-paid advance from Yorkville. Also in September 2022, Celularity received net proceeds of $4.1 million from the sale of 1,817,830 shares of its Class A common stock pursuant to the ATM program.
Net revenues
Research and Development
Selling, General and Administrative
Net Income (Loss)
About Celularity
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 (MLASCs). 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 Celularity’s ability to address cancer and degenerative diseases and fulfill its mission; timing of data readouts across its pipeline and support for clinical rationale of placental-derived cell therapy; its ability to resolve FDA questions and commence the CYCART-19 clinical trial, including the timing thereof; its pre-paid advance agreement with Yorkville and any share conversions or cash repayments thereunder, as well as access to additional funding; and generating proceeds from sales under its ATM program; 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 liquidity, 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
Celularity Inc.
carlos.ramirez@celularity.com
CELULARITY INC.
Consolidated Statements of Operations
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Three Months Ended |
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Nine Months Ended |
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(unaudited) |
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(unaudited) |
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(in thousands) |
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(in thousands) |
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September 30, 2022 |
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September 30, 2021 |
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September 30, 2022 |
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September 30, 2021 |
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Total Revenues |
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$ |
4,135 |
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$ |
10,622 |
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$ |
13,846 |
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$ |
16,479 |
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Operating expenses |
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Cost of goods sold |
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7,213 |
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2,311 |
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14,418 |
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4,993 |
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Research and development |
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20,351 |
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23,765 |
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67,373 |
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63,666 |
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Selling, general and administrative |
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14,907 |
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21,644 |
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46,941 |
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58,133 |
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Change in fair value of contingent consideration liability and amortization |
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(32,690 |
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(47,996 |
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(71,801 |
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(16,205 |
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Total operating expenses |
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9,781 |
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(276 |
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56,931 |
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110,587 |
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(Loss) income from operations |
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(5,646 |
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10,898 |
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(43,085 |
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(94,108 |
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Other income (expense): |
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Interest income |
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108 |
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55 |
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155 |
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324 |
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Interest expense |
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- |
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(843 |
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- |
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(2,412 |
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Change in fair value of warrant liabilities |
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9,333 |
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39,937 |
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31,613 |
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2,258 |
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Change in fair value of debt |
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(291 |
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- |
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(291 |
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- |
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Other income (expense), net |
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1,278 |
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(109 |
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1,366 |
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(2,140 |
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Total other income (expense) |
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10,428 |
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39,040 |
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32,843 |
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(1,970 |
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Net income (loss) before income taxes |
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$ |
4,782 |
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$ |
49,938 |
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$ |
(10,242 |
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$ |
(96,078 |
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Income tax benefit |
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(17 |
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- |
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- |
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- |
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Net income (loss) |
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$ |
4,799 |
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$ |
49,938 |
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$ |
(10,242 |
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$ |
(96,078 |
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Share information: |
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Net income (loss) per share - basic |
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$ |
0.03 |
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$ |
0.47 |
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$ |
(0.07 |
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$ |
(2.00 |
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Weighted average shares outstanding - basic |
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142,676,953 |
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106,369,910 |
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137,787,645 |
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48,071,685 |
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Net income (loss) per share - diluted |
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$ |
0.03 |
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$ |
0.40 |
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$ |
(0.07 |
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$ |
(2.00 |
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Weighted average shares outstanding - diluted |
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150,546,268 |
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123,582,822 |
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137,787,645 |
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48,071,685 |
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CELULARITY INC.
Selected Balance Sheet Data
(in thousands)
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September 30, 2022 |
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December 31, |
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(unaudited) |
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2021 |
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Cash and cash equivalents |
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$ |
42,649 |
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$ |
37,240 |
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Total asset |
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$ |
437,116 |
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$ |
414,128 |
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Total liabilities |
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$ |
272,881 |
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$ |
314,710 |
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Total stockholders' equity |
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$ |
164,235 |
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$ |
99,418 |
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