PrimeGen US announces USD1.5B merger with DT Cloud Star to advance stem cell therapy development

USA—PrimeGen US has entered into a definitive business combination agreement with DT Cloud Star Acquisition, establishing an implied equity value of approximately USD 1.5 billion for the transaction.

This strategic merger marks a significant milestone for PrimeGen US as the company seeks to accelerate its stem cell research and development initiatives and gain crucial access to public-market capital.

The business combination will provide PrimeGen US with the financial resources necessary to advance its clinical studies, navigate complex regulatory pathways, and support potential future commercialization of its innovative therapies.

By merging with DT Cloud Star, a special purpose acquisition company, PrimeGen US aims to strengthen its position in the competitive regenerative medicine sector while maintaining momentum in its therapeutic development programs.

The transaction remains subject to multiple approval requirements and conditions before it can be finalized.

Shareholders of both PrimeGen US and DT Cloud Star must vote to approve the merger, while the companies must also secure necessary regulatory clearances.

These regulatory requirements include compliance with the Hart-Scott-Rodino Antitrust Improvements Act, which applies to certain large mergers and acquisitions in the United States.

Additionally, the deal must satisfy specific redemption thresholds and minimum cash requirements, as well as other standard closing conditions set forth in the merger agreement.

Once the transaction successfully closes, the combined company plans to operate under the PrimeGen US name or through a successor entity.

The merged organization intends to pursue a listing on the Nasdaq stock exchange under a new ticker symbol, though this listing requires approval from the exchange.

The companies currently anticipate completing the transaction in the second half of 2026 but acknowledge that neither the ultimate completion nor the precise timing of the closing can be guaranteed at this stage.

PrimeGen US has built its business around regenerative medicine, drawing on nearly twenty years of dedicated stem cell research and scientific expertise.

The company specializes in developing triple-activated mesenchymal stem cells, which represent an advanced form of cell-based therapy designed to treat acute liver injury and associated critical illnesses.

These triple-activated MSCs undergo a specialized preparation process that the company believes enhances their therapeutic potential compared to conventional stem cell approaches.

The company has recently achieved a notable regulatory milestone by completing a pre-investigational new drug application meeting with the US Food and Drug Administration on December 17, 2025.

This meeting focused specifically on acute alcoholic hepatitis, a severe form of acute liver failure that currently has limited treatment options.

While this FDA interaction marks an important step forward, PrimeGen US acknowledges that FDA approval cannot be guaranteed and that successful clinical trial outcomes remain uncertain.

Furthermore, the company recognizes that results obtained in preclinical studies may not necessarily translate to successful outcomes in human patients.

Despite inherent uncertainties in drug development, PrimeGen US continues to prepare for a clinical trial to further evaluate the safety and efficacy of its triple-activated MSCs for the treatment of acute liver failure, pending necessary regulatory approvals.

Daniel Chiu, co-CEO and chairman of PrimeGen US, expressed optimism about the transaction’s potential to drive the company’s growth.

He noted that the merger should enhance PrimeGen US’s access to capital and resources, thereby supporting the ongoing advancement of both its stem cell and exosome programs.

Chiu emphasized that the company’s team brings significant scientific focus and innovation to their work, which he believes positions PrimeGen US to expand its presence within the regenerative medicine field as the therapeutic landscape continues to evolve.