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): December 5, 2025

Celularity Inc.

(Exact name of registrant as specified in its charter)

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 obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

Securities registered pursuant to Section 12(b) of the Act:

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 8.01 Other Events.

On December 1, 2025, Celularity Inc., (the “Company”) received a warning letter (the “Letter”) from the U.S. Food and Drug Administration (the “FDA”). The Letter relates to the use of certain marketing material for Interfyl, a human connective tissue matrix. The Letter states that in order for the product to be marketed consistent with the issued Request for Designation (Section 361 of CFR 1271.10) the Company must limit the use of outcome-based claims and metabolic activity within the body.

The Letter does not restrict the Company’s ability to manufacture or ship products, require recall of any products, nor restrict the Company’s ability to seek FDA 510(k) clearance of products. In 2004, the FDA issued to the Company the Request for Designation for Interfyl.

The Company takes the matters identified in the Letter very seriously and is committed to working with the FDA to resolve them and continue its comprehensive efforts to remediate the observations. The Company is not aware of any additional actions stemming from the Letter that will have a material impact on its previously announced operational or financial expectations. The Company cannot give any assurances that the FDA will be satisfied with the Company’s response or as to the expected date of the resolution of the matters included in the Letter. Until the issues cited in the Letter are resolved to the FDA’s satisfaction, additional regulatory action may be taken without further notice.

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.