Caladrius Biosciences is selling the 80.1% stake it retains in its PCT subsidiary to Hitachi Chemical, which already owns the other 19.9% of the cell therapy manufacturing and development services business. Hitachi Chemical has agreed to pay Caladrius $75 million in cash to acquire PCT outright  and potentially another $5 million on the achievement by PCT of certain revenue-based milestones. The transaction is expected to close in May, subject to customary closing conditions and the approval of Caladrius’ shareholders. If ratified, PCT will continue to provide development and manufacturing services to Caladrius for the latter’s cell therapeutics programs for a period of 7 years after closing.

PCT has more than 130 employees and operates cGMP compliant facilities in the NY/NJ region and in California. The firm’s Center for Innovation and Engineering offers process and analytical development, engineering solutions, and consulting services. PCT president, Robert A. Preti, Ph.D., said all PCT customers, including Caladrius, will benefit from integration of the firm into Hitachi’s global engine. “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.”

Caladrius said it will use funds from the PCT sale to support Phase II development of its lead type 1 diabetes (T1D) candidate CLBS03 to eliminate its $5.5 million in debt and to identify new pipeline candidates. “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., Caladrius CEO. “The transaction provides considerable nondilutive capital to fund the execution of our ongoing Phase II trial while also allowing us to exploit compelling therapeutic prospects.”

Hitachi took its initial 19.1% stake in PCT in March 2016 as part of a licensing deal and collaboration for PCT’s cell therapy manufacturing technology in Japan and parts of Asia.

Cell therapeutics firm Caladrius is exploiting its T-regulatory cell, CD34, and tumor cell/dendritic cell technologies to develop a pipeline of cell therapy candidates for autoimmune and cardiology indications. Lead candidate CLBS03  is an autologous T-regulatory cell therapy in Phase II development for treating recent-onset T1D. The study is partnered with Sanford Research. CLBS03 has been granted Fast Track and Orphan Drug Designation for the T1D indication by the FDA and Advanced Therapeutic Medicinal Product classification by the EMA. In February, Caladrius won up to $12.2 million in funding from the California Institute for Regenerative Medicine (CIRM) to support the CLBS03 development program.

The firm’s second pipeline product, CLBS12, is a CD34 cell therapy, which Caladrius says it plans to partner for the indication of critical limb ischemia, in Japan, under the country’s regenerative medicine law.


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