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Celularity Receives Fast Track Designation From US FDA

FLORHAM PARK, NJ, December 27, 2021 (GLOBE NEWSWIRE) – Celularity Inc. (Nasdaq: CELU) (“Celularity”), a clinical-stage biotechnology company that develops allogeneic cell therapies derived from the placenta, today announced The Drug Administration (FDA) has granted Fast Track designation for its natural killer (NK) cell therapy derived from cryogenically modified human placental hematopoietic stem cells, CYNK-001, in development for the treatment of acute myeloid leukemia (AML) .

“The majority of AML patients continue to have poor long-term outcomes, especially those who have relapsed or have measurable residual disease, which requires the development of new therapies, including CYNK-001,” said Andrew Pecora, MD, president of Celularity. Robert Hariri, MD, Ph.D., Founder, President and CEO of Celularity added, “We believe that the unique properties of our cellular source, including the ability to proliferate and maintain activity, could be the key to improving response rates. and sustainability for patients. We are delighted to receive this accelerated designation from the FDA for AML supporting the continued development of our placenta-derived NK cell platform. CYNK-001 has previously received orphan drug designation for malignant glioma and accelerated designation for glioblastoma multiforme.

About Expedited Designation

Expedited Designation is an FDA process designed to facilitate the development and expedite the review of new drugs to treat serious illness that may meet unmet medical needs. The purpose of the Fast Track designation is to speed up the process of obtaining important new drugs for patients. The designation may offer frequent interactions with the FDA review team on product development, and the product may be eligible for ongoing review and priority review if certain criteria are met.

About CYNK-001

Celularity’s primary therapeutic program based on its unmodified placental-derived NK cell type is CYNK-001, an unmodified allogeneic NK cell in development for the treatment of hematologic malignancies, solid tumors and infectious diseases. CYNK-001 is a ready-to-use cryopreserved allogeneic cell therapy enriched with CD56 + / CD3-NK cells developed from human CD34 + placental cells. The safety and efficacy of CYNK-001 have not been established and CYNK-001 has not been approved for use by the United States Food and Drug Administration or any similar regulatory authority.

About Celularity

Celularity Inc. (Nasdaq: CELU) headquartered in Florham Park, NJ, is a clinical-stage biotechnology company leading the next evolution in cellular medicine by developing cryopreserved allogeneic cell therapies derived from the placenta, including therapeutic programs using an unmodified natural killer. cells (NK), genetically modified NK cells, T cells modified with a CAR (CAR T cells) and adherent stromal cells (ASC) of the mesenchymal type. These therapeutic programs target indications in cancers, infectious and degenerative diseases. In addition, Celularity develops and manufactures innovative biomaterials also derived from the postpartum placenta. Celularity believes that by harnessing the unique biology of the placenta and its immediate availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible and affordable therapies.

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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 fact are “forward-looking statements”, including those relating to future events. In some cases, you may identify forward-looking statements by words such as “anticipate”, “believe”, “may”, “contemplate”, “continue”, “might”, “estimate”, “expect”, ” predict, “” intends “,” may “,” could “,” prospect “,” plan “,” possible “,” potential “,” foresee “,” plan “,” seek “,” should ” , “strive”, “target”, “will”, “would” and the negative of terms like these or other comparable terms, and other words or terms with a similar meaning. Forward-looking statements contained in this press release include statements regarding the ability to improve response rates and durability, and other statements regarding the development of CYNK-001 and Celularity’s ability to develop effective, accessible therapies. and affordable, among others. There are many factors that could cause actual results to differ materially from those described in these forward-looking statements, including, but not limited to: risks inherent in biotechnology development, including with respect to the development of new cell therapies , and clinical trial and regulatory approval to process; and the risks associated with developments relating to Celularity’s competitors and industry, as well as the risk factors set out under “Risk Factors” in Celularity’s proxy circular / prospectus filed with the Securities and Exchange Commission (SEC) August 12, 2021 and other filings with the SEC. These risks and uncertainties may be magnified by the COVID-19 pandemic. If any of these risks materialize or if the underlying assumptions prove to be incorrect, actual results could differ materially from the results suggested by these forward-looking statements. There may be additional risks that Celularity is not currently aware of, or that Celularity currently considers to be immaterial, which could also cause actual results to differ from those contained in forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans or forecasts regarding future events and views as of the date of this communication. Subsequent events and developments could cause the assessments to change. Accordingly, forward-looking statements should not be taken to represent the views of Celularity at any later date, and Celularity assumes no obligation to update any forward-looking statements to reflect events or circumstances after the date hereof, whether 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.
[email protected]

Celularity media contact
Jason Braco, Ph.D.
LifeSci Communications
[email protected]