UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
In the first quarter of 2022, Celularity Inc. (the “Company”) submitted an Investigational New Drug Application (“IND”) to investigate CYCART-19 for treatment of B-cell malignancies. On April 29, 2022, the Company received an e-mail notification from the United States Food and Drug Administration (the “FDA”) that it will be seeking additional information before the Company can proceed with the planned Phase 1/2 clinical trial. The Company expects to receive formal written communication with additional information from the FDA by late May and plans to work with the FDA in an effort to resolve its questions as promptly as possible. Accordingly, the Company expects to commence the trial in the second half of 2022, assuming clearance of the IND.
Cautionary Notice Regarding Forward-Looking Statements
Various statements in this Current Report on Form 8-K concerning the Company’s future expectations, plans and prospects, including without limitation, the Company’s expectations with respect to the timing of the planned Phase 1/2 clinical trial, may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. The forward-looking statements included in this Current Report on Form 8-K are subject to a number of risks, uncertainties and assumptions, including, without limitation, the expected timing of review by governmental authorities. These statements are based only on facts currently known by the Company and speak only as of the date of this Current Report on Form 8-K. As a result, you are cautioned not to rely on these forward-looking statements and the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
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.
| Date: May 3, 2022 | CELULARITY INC. | |||||
| By: /s/ Keary Dunn | ||||||
| Name: Keary Dunn | ||||||
| Title: General Counsel | ||||||