PrimeGen US and DT Cloud Star Acquisition have entered a definitive business combination agreement at an implied equity value of around $1.5bn.

The agreement aims to advance PrimeGen US’s stem cell research and development and will provide access to public markets capital for progressing clinical studies, regulatory activities, and potential future commercialisation.

The proposed transaction is subject to several conditions, including approval from the shareholders of both PrimeGen US and DT Cloud Star; regulatory clearances such as compliance with the Hart-Scott-Rodino Antitrust Improvements Act, where applicable; redemption thresholds; minimum cash requirements; and other customary closing stipulations as outlined in the agreement.

Upon completion, the merged entity intends to operate under the PrimeGen US name or a successor entity and anticipates listing under a new ticker symbol on Nasdaq, pending approval.

The closing is expected during the second half of 2026; however, there is no assurance regarding its ultimate completion or timing.

PrimeGen US focuses on regenerative medicine using nearly two decades of stem cell research. The company develops triple-activated mesenchymal stem cells (MSCs) as an advanced cell-based therapy for acute liver injury and related critical illnesses.

Recent advancements include a completed pre-investigational new drug (IND) application meeting with the US Food and Drug Administration (FDA) for acute alcoholic hepatitis (acute liver failure) on 17 December 2025.

The company emphasises that FDA approval or successful clinical trials cannot be guaranteed, and preclinical outcomes may not translate directly to humans.

PrimeGen US is preparing for a clinical trial pending regulatory approval to further evaluate triple-activated MSCs for potential treatment of acute liver failure.

PrimeGen US co-CEO and chairman Daniel Chiu said: “This transaction is expected to enhance our access to capital and resources, supporting the continued development of our stem cell and exosome programmes. Our team’s scientific focus and innovation position us to further build our presence in the regenerative medicine field.”