PCT is a cell therapy development and manufacturing services provider and is currently 19.9% owned by Hitachi Chemical. This transaction will redefine Caladrius as a cell therapeutics-only development company with multiple technology platforms and capital resources to fund future programs.
Hitachi Chemical/PCT will continue to provide development and manufacturing services to Caladrius in connection with Caladrius’s T regulatory cell program, for seven years after closing.
Caladrius plans to use the proceeds from this transaction to complete its Phase II trial for its lead candidate, CLBS03 for the treatment of recent-onset type 1 diabetes, to identify clinical development pipeline candidates, and to eliminate $5.5 million of outstanding debt.
“Hitachi Chemical’s purchase of our remaining interest in PCT unlocks the value of this asset for our Company both by transforming Caladrius into a well-capitalized pure play therapeutics development company and by eliminating our need to contribute the tens of millions of dollars of future capital investment in PCT needed for it to fully realize its cell therapy commercial manufacturing growth goals,” said David J. Mazzo, Ph.D., chief executive officer of Caladrius. “The transaction provides considerable non-dilutive capital to fund the execution of our ongoing Phase 2 trial while also allowing us to exploit compelling therapeutic prospects.”
“Hitachi Chemical intends to deploy the capital and engineering expertise needed to leverage PCT’s own engineering and cell therapy development and manufacturing expertise, thereby accelerating the creation of a global commercial manufacturing enterprise,” said Robert A. Preti, Ph.D., president of PCT. “All of our clients and especially Caladrius, with which PCT will maintain a strong client relationship, stand to benefit from PCT’s integration into Hitachi’s global footprint and the resulting access to advanced engineering solutions for process optimization and automation for the cell therapy industry.”