The agreed upon counterparty terms include $ 15 million of Orgenesis shares valued at $ 7 to be issued to accredited Koligo investors.
Inc () announced on Tuesday the acquisition of Koligo Therapeutics Inc, a regenerative medicine company, before the end of the year.
According to a statement, Koligo is a leader in the development of personalized cell therapy using the patient’s own (autologous) cells. Koligo has successfully launched its first commercial product, KYSLECEL, and plans to begin a Phase 2 trial of KT-PC-301 for acute respiratory distress syndrome (ARDS) linked to COVID-19.
Koligo’s developing technology uses 3D bioprinting and vascularization with autologous cells (3D-V technology) to create biodegradable and stable three-dimensional cell and tissue implants. 3D-V technology is under development for diabetes and pancreatitis, with longer term applications for transplants of neurons, liver and other cells / tissues.
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Following the closing of the transaction, Orgenesis plans to accelerate the commercial ramp-up of KYSLECEL in the United States and in international markets as well.
Also following closure and eventual approval from the U.S. Food and Drug Administration, Orgenesis plans to begin recruiting patients for a Phase 2 randomized clinical trial of KT-PC-301 in COVID-19 patients. Koligo has already completed a pre-investigation new drug consultation with the FDA to begin clinical trials of KT-PC-301 in ARDS linked to COVID-19. Orgenesis also plans to leverage Koligo’s 3D-V bioprinting technology on its POCare platform.
As part of the agreement, Orgenesis will acquire all of the outstanding shares of Koligo from its shareholders. The agreed upon counterparty terms are a total of $ 15 million in Orgenesis common stock valued at $ 7 in shares, which will be issued to Koligo accredited investors (certain non-accredited investors to be paid only in cash) and a assumption of $ 1.3 million in Koligo’s liabilities, estimated at almost all of Koligo’s liabilities.
Koligo’s management team will join Orgenesis to continue business and development activities. Koligo CEO Matthew Lehman is an accomplished executive in biotechnology and regenerative medicine.
“We are delighted to announce this transformative acquisition, which we believe will add vast capabilities to our therapeutics and technology platform, and strengthen our leadership in cell and gene therapy,” said Vered Caplan, CEO of Orgenesis.
“Based on several Phase 1 studies, Koligo’s KT-PC-301, using a patient’s own cells, has demonstrated safety and tolerability, and has shown evidence of efficacy in supporting development. continued development of ARDS linked to COVID-19. If successful in the treatment of ARDS linked to COVID-19, KT-PC-301 is likely to have applications in other acute and chronic respiratory indications, areas that represent a significant unmet medical need.
Koligo CEO Lehman added, “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 US 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 support Koligo’s goals. Orgenesis’ intellectual property is highly complementary to Koligo’s technology and the combined companies will strive to develop a strong portfolio of commercial and development products.
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