Updated: Oct 4, 2020
Orgenesis Inc., a global biotech company, working to unravel the full potential of cell and gene therapies, and Koligo Therapeutics, Inc., a regenerative medicine company, on Tuesday announced that the two firms have agreed on a definitive merger agreement, subject to final closing terms, with expected completion before the end of the year.
Koligo is a leader in developing personalized cell therapies using the patient's own (autologous) cells. The company has successfully launched its first commercial product, KYSLECEL, and aims to start a phase 2 trial of KT-PC-301 for Covid-19 related ARDS. Koligo's development stage technology uses 3D bioprinting and vascularization with autologous cells ("3D-V" technology) to produce biodegradable and shelf-stable three-dimensional cell and tissue implants. The 3D-V technology is being developed for pancreatitis and diabetes, with long term applications for liver, neural, and other cell/tissue transplants.
Following the completion of the deal, Orgenesis plans to speed up the commercial scaleup of KYSLECEL throughout the US and international markets. The firm also expects to begin patient recruitment for a Phase 2 randomized clinical trial of KT-PC-301 in Covid-19 patients after clearance by the US Food and Drug Administration. Koligo has already closed a pre-investigational New Drug consultation with the FDA to begin clinical trials of KT-PC-301 in Covid-19 related ARDS. Orgenesis also intends to leverage Koligo's 3D-V bioprinting technology across its POCare platform.
Under the terms of the deal, Orgenesis will acquire all of the outstanding stock of Koligo from its shareholders. The agreed consideration terms are a total of $15 million in shares of Orgenesis' common stock priced at $7.00 per share, which shall be issued to Koligo's accredited investors and an assumption of $1.3 million in Koligo's liabilities, estimated to be substantially all of Koligo's liabilities.
Koligo’s management team will also be joining Orgenesis to continue development and commercial activities.
"The merger with Orgenesis marks a major milestone for our company and builds on our recent progress, including the Pre-IND package submitted to the U.S. FDA for KT-PC-301 and our pilot commercial program for KYSLECEL. The Orgenesis team brings extensive clinical, regulatory, and manufacturing expertise well suited to supporting Koligo's goals. Orgenesis' intellectual property is highly complementary to Koligo's technology, and the combined companies will work to advance a robust commercial and development portfolio," said Koligo CEO Matthew Lehman.
Additional details on the deal will be available in the company’s Form 8-K, which will be filed with the Securities and Exchange Commission.