Celularity inks manufacturing deal with BlueSphere Bio

FLORHAM PARK, N.J. - Celularity Inc. (NASDAQ:CELU), a cellular and regenerative medicine company with a market capitalization of approximately $38 million, has announced a collaboration with BlueSphere Bio, Inc. to manufacture cell therapy products. This Master Services Collaboration Agreement will utilize Celularity’s cGMP manufacturing infrastructure to produce BlueSphere’s T cell receptor (TCR) T cell therapies. According to InvestingPro data, the company achieved impressive revenue growth of 226% in the last twelve months, despite challenging market conditions.

The partnership will focus on BlueSphere’s novel therapies for treating high-risk leukemias, starting with its second cell therapy product aimed at Acute Myelogenous Leukemia (AML). Celularity’s Florham Park facility will dedicate staff and part of its 37,000 square foot manufacturing space to the initiative, offering comprehensive support including Chemistry, Manufacturing and Controls (CMC), as well as Quality Assurance and Quality Control.

Celularity’s CEO, Robert J. Hariri, M.D., Ph.D., expressed enthusiasm for the collaboration, highlighting the company’s investment in its manufacturing capabilities designed to support both its own programs and those of partners like BlueSphere. Keir Loiacono, CEO of BlueSphere, emphasized the importance of reliable manufacturing for the success of cell therapy programs and expressed confidence in the quality of Celularity’s facility and business model. InvestingPro analysis reveals the company maintains a healthy gross profit margin of 64%, though it carries a significant debt-to-equity ratio of 4.0.

This agreement marks the second of its kind for Celularity and signifies the company’s intent to leverage its technical capabilities to attract clients within the cell therapy space. The collaboration is expected to benefit both companies by providing BlueSphere with the necessary tools to advance its cell therapy assets while demonstrating the revenue-generating potential of Celularity’s assets. With current revenue of $48.2 million in the last twelve months, the company faces challenges in cash management, as indicated by several InvestingPro Tips (unlock 8+ additional insights with a subscription).

BlueSphere Bio is currently preparing to dose its first patient in the TCX-101 clinical program, targeting AML, in the first half of 2025. The company has also expanded its AML therapy pipeline with the discovery of additional TCRs for clinical development and a lead TCR against mutant NPM-1 for its TCX-102 program, with an IND expected in the second quarter of 2025.

The information in this article is based on a press release statement. It should be noted that forward-looking statements involve risks and uncertainties, and actual results may differ materially from those projected. Celularity’s previous filings with the Securities and Exchange Commission (SEC) outline various risk factors that could affect outcomes.

In other recent news, Celularity Inc. has amended the exercise price of certain warrants, securing approximately $2.46 million in funding. This decision, involving warrants issued in 2020 and 2024, aims to bolster the company’s financial position by providing immediate capital. Meanwhile, Celularity has terminated a significant agreement with an institutional investor due to the investor’s failure to meet payment deadlines. The cancellation of this private placement agreement, initially valued at $2.375 per share, means Celularity will need to explore alternative funding sources.

Additionally, Celularity’s shareholders have elected Robert J. Hariri, M.D., Ph.D., as a Class III Director and ratified EisnerAmper LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2024. The company is also facing potential delisting from the Nasdaq Stock Market due to a delay in filing its quarterly financial report for the period ending September 30, 2024. Despite this, Celularity’s securities continue to be traded, and the company plans to submit a compliance plan by January 20, 2025.

These developments reflect Celularity’s ongoing efforts to navigate financial challenges and maintain compliance with Nasdaq’s listing requirements. CEO Robert J. Hariri has acknowledged the delays in financial reporting and expressed a commitment to timely filings moving forward. The company is actively addressing these issues to ensure continued adherence to regulatory standards.

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