CELUW Celularity Inc

 

 

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): February 24, 2025

 

 

Celularity Inc.

(Exact name of registrant as specified in its charter)

 

Delaware		001-38914		83-1702591
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

170 Park Ave Florham Park, New Jersey		07932
(Address of principal executive offices)		(Zip Code)

 

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):

 

☐	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:

 

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Class A Common Stock, $0.0001 par value per share		CELU		The Nasdaq Stock Market LLC
Warrants, each exercisable for one-tenth of 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 8.01 Other Events.

 

On February 24, 2025, Celularity Inc. (the “Company”) issued a press release announcing that it has entered into a Master Services Collaboration Agreement with BlueSphere Bio, Inc. (“BSB”) covering manufacturing activities for certain BSB cell therapy products. The press release issued by the Company is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.		Description
99.1		Press Release of Celularity Inc. dated February 24, 2025
104		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.

 

	CELULARITY INC.
Dated: February 24, 2025
	By:	/s/ Robert J. Hariri
	Name:	Robert J. Hariri, M.D., Ph.D.
	Title:	Chairman and CEO

 

 

 

Exhibit 99.1

 

Celularity Enters Strategic Collaboration Agreement with Clinical Stage Cell Therapy Company

 

Leverages Celularity World-class Manufacturing Capabilities

 

FLORHAM PARK, N.J., February 24, 2025 (GLOBE NEWSWIRE) — Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a cellular and regenerative medicine company, today announced that it has entered into a Master Services Collaboration Agreement with BlueSphere Bio, Inc. (BSB) covering manufacturing activities for certain BSB cell therapy products. This collaboration is the second of its kind for Celularity and demonstrates the Company’s ability to leverage its world class cGMP manufacturing infrastructure and deep expertise to attract clients like BSB, who are seeking differentiated alternatives to manufacture their therapeutic products in an ever-changing landscape. This collaboration further evidences the revenue generating potential of Celularity’s assets.

 

The Collaboration Agreement will initially focus on the production of BSB’s novel T cell receptor (TCR) T cell therapies using the technical and manufacturing capabilities at Celularity’s Florham Park, NJ, cGMP-ready facility. This collaboration will extend to all aspects of cell therapy manufacturing including Chemistry, Manufacturing and Controls (CMC), Quality Assurance and Quality Control. As part of this Collaboration, Celularity will dedicate staff and a small portion of its 37,000 square foot commercial manufacturing footprint. In coordination with Celularity management, BSB and its team will have oversight over production of its second cell therapy product for the treatment of Acute Myelogenous Leukemia (AML) both in the U.S. and abroad.

 

Robert J. Hariri, M.D., Ph.D., Celularity CEO and Chair, said, “We are delighted to announce this important collaboration, which will bring together our core strengths in cell manufacturing, process development and BSB’s development of novel cell therapies to treat high risk leukemias. Celularity has invested significant capital in its manufacturing and development infrastructure, with a vision to not only support its own programs, but to create a collaborative business model for companies like BSB, to leverage Celularity's technical capabilities. This new relationship with BSB further realizes that objective and helps set the stage for future clients seeking transformative alternatives for any GMP manufacturing needs.” 

 

Keir Loiacono, CEO of BlueSphere noted, “Reliable and flexible manufacturing are critical to a successful cell therapy program. The quality of Celularity’s business model and facility will provide BlueSphere with the necessary tools to advance our assets to the clinic in an affordable fashion, without relinquishing control over our processes. The team at Celularity has been welcoming and open to addressing all our needs, and we look forward to working with them.”

 

About Celularity

 

Celularity Inc. (Nasdaq: CELU) is a regenerative and cellular medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all 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. For more information, visit www.celularity.com.

 

 

About BlueSphere Bio

 

BlueSphere Bio is a drug development company with two near-term clinical assets in AML. BSB-1001 is a TCR T cell therapy targeting the minor histocompatibility antigen-1 (HA-1) and is the first clinical candidate in the TCX-101 clinical program. Under the TCX-101 clinical program, BSB-1001 will be dosed simultaneously with allogeneic hematopoietic stem cell transplant in patients with high-risk AML. BlueSphere anticipates dosing its first patient in the TCX-101 program in 1H2025. BSB has also discovered and nominated three additional miHA targeting TCRs for clinical development, all for use in the same clinical setting as BSB-1001.

 

In addition to TCX-101, BSB has further broadened its AML therapy pipeline to address an additional subset of patients by discovering and nominating a lead TCR reactive against mutant NPM-1 for the TCX-102 program. The TCX-102 program will be autologous and not given in combination with stem cell transplant. An IND is expected in the second quarter of 2025.

 

Forward Looking Statements

 

This press release includes “forward-looking statements” (as defined under Federal securities laws). 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,” “could,” “expect,” “forecast,” “may,” “plan,” “project,” “should,” “will,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Celularity’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including 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 July 30, 2024, and other filings with the SEC. 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 contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

 

Carlos Ramirez

Senior Vice President, Celularity Inc.

Carlos.ramirez@celularity.com

 

v3.25.0.1

Cover	Feb. 24, 2025
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 24, 2025
Entity File Number	001-38914
Entity Registrant Name	Celularity Inc.
Entity Central Index Key	0001752828
Entity Tax Identification Number	83-1702591
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	170 Park Ave
Entity Address, City or Town	Florham Park
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	07932
City Area Code	(908)
Local Phone Number	768-2170
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false
Class A Common Stock, $0.0001 par value per share
Title of 12(b) Security	Class A Common Stock, $0.0001 par value per share
Trading Symbol	CELU
Security Exchange Name	NASDAQ
Warrants, each exercisable for one-tenth of one share of Class A Common Stock at an exercise price of $11.50 per share
Title of 12(b) Security	Warrants, each exercisable for one-tenth of one share of Class A Common Stock at an exercise price of $11.50 per share
Trading Symbol	CELUW
Security Exchange Name	NASDAQ

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