Based in the U.S., PrimeGen focuses on the development of Triple Activated Mesenchymal Stem Cells (TA-MSCs), a proprietary platform designed to treat life-threatening conditions. The company’s primary research targets acute liver injury, utilizing cell-based therapies to repair damaged tissue. While the platform has already undergone preliminary animal studies, the merger is expected to provide the capital necessary to transition into human subjects.

Clinical Milestones and FDA Progress

The company reached a significant regulatory milestone in December after completing a pre-investigational new drug application meeting with the U.S. Food and Drug Administration. This meeting established the framework for PrimeGen’s first human clinical trial, which remains the central focus of its near-term roadmap. The move toward clinical validation follows years of research into regenerative stem cell applications.

According to the merger agreement, the transaction carries an implied equity value of $1.5 billion. The boards of both companies have approved the business combination, which is scheduled for completion during the second half of 2024. The deal remains subject to standard regulatory approvals and the consent of DT Cloud Star stockholders.