Orgenesis Inc. and Koligo Therapeutics, Inc. announced that the two companies have entered into a definitive merger agreement, subject to final closing conditions, with expected completion before year-end.
Koligo is a leader in developing personalized cell therapies utilizing the patient’s own (autologous) cells. Koligo has successfully launched its first commercial product, KYSLECEL, and plans to commence a phase 2 trial of KT-PC-301 for COVID-19-related ARDS. Koligo’s development stage technology utilizes 3D bioprinting and vascularization with autologous cells (“3D-V” technology) to create biodegradable and shelf-stable three-dimensional cell and tissue implants. The 3D-V technology is being developed for diabetes and pancreatitis, with longer term applications for neural, liver, and other cell/tissue transplants.
Following closing of the Transaction, Orgenesis plans to accelerate the commercial scaleup of KYSLECEL throughout the United States and, subject to regulatory and logistical considerations, in international markets as well. After closing of the Transaction, and subject to FDA review and clearance of the Company’s Investigational New Drug application, Orgenesis expects to start patient recruitment for a phase 2 randomized clinical trial of KT-PC-301 in COVID-19 patients. Orgenesis also plans to leverage Koligo’s 3D-V bioprinting technology across its POCare platform.
Under the terms of the merger agreement, Orgenesis will acquire all of the outstanding stock of Koligo from its shareholders (the founders and staff of Koligo and a subsidiary of Bergen Special Opportunity Fund, LP, an institutional investor managed by Bergen Asset Management, LLC). The agreed consideration terms are an aggregate of $15 million in shares of Orgenesis’ common stock valued at $7.00 per share which shall be issued to Koligo’s accredited investors (with certain non-accredited investors to be paid solely in cash) and an assumption of $1.3 million in Koligo’s liabilities, estimated to be substantially all of Koligo’s liabilities.