Orgenesis completes acquisition of Koligo Therapeutics and announces additional acquisition of Icellator(R) Technology from Tissue Genesis in related transaction

Orgenesis completes acquisition of Koligo Therapeutics and announces additional acquisition of Icellator(R) Technology from Tissue Genesis in related transaction

Icellator(R) commercially available for lipotransfer in first two countries with more approvals expected

Germantown, MD, US – October 19th, 2020 – Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, today announced completion of the previously announced acquisition of Koligo Therapeutics, Inc. (“Koligo”), a regenerative medicine company. Additionally, the Company announced that it has acquired substantially all of the assets of Tissue Genesis, LLC (“Tissue Genesis”), adding to a growing list of POCare  technology resources. 

The acquisition of Tissue Genesis was initially undertaken via Koligo Therapeutics, Inc., and became part of the Koligo acquisition transaction. Orgenesis will now own the entire inventory of Tissue Genesis Icellator(R) devices, related kits and reagents, a broad patent portfolio to protect the technology, registered trademarks, clinical data, and existing business relationships for commercial and development stage use of the Icellator technology.  

The Icellator device is a point-of-care cell isolation technology that rapidly recovers high yields of stromal and vascular cells (“SVF”) from adipose tissue (fat) to be used therapeutically. Adipose tissue is recognized as a superior source for adult stem cells found abundantly in the micro-vasculature and stroma of human fat. Further details include:

• The device is commercially available in Korea and the Bahamas where Orgenesis plans to continue commercial distribution 
• Icellator X clearance is expected in Japan in the first quarter of 2021 subject to completion of manufacturing tests requested by the Japanese Pharmaceutics and Medical Devices Agency
• Tissue Genesis has initiated several phase 1 pilot trials of the Icellator system in the United States under FDA IDEs for use in erectile dysfunction, critical limb ischemia, tissue repair, and other therapeutic indications
• Orgenesis intends to deploy the Icellator technology to potentially develop a broad range of point of care autologous cell therapies with significantly reduced costs across a growing POCare Network that includes leading hospitals and healthcare institutions

“With the Koligo acquisition closed, we believe that we are making rapid progress on a number of fronts,” said Vered Caplan, CEO of Orgenesis. “Specifically, we plan to leverage the therapies and technologies from Koligo and Tissue Genesis across our POCare Platform.  One of our first goals is to accelerate the commercial scaleup of KYSLECEL throughout the United States and, subject to regulatory and logistical considerations, in international markets as well. Subject to FDA review and clearance of our IND application, we also look forward to commencing patient recruitment for a phase 2 randomized clinical trial of KT-PC-301,  an autologous clinical development stage cell therapy candidate for COVID-19-related Acute Respiratory Distress Syndrome, or ARDS.  We plan to use the Icellator device to support scalable, cost-effective production of KT-PC-301. Additionally, Koligo’s development stage 3D-V bioprinting technology for the vascularization of autologous cells to create biodegradable and shelf-stable three-dimensional cell and tissue implants will be explored for diabetes and pancreatitis applications, with longer term applications for neural, liver, and other cell/tissue transplants also potentially explored. 

“The Icellator system is highly complementary to our POCare technology systems, as well as Koligo’s 3D-V bioprinting technology. Technologies such as these support our mission of improving the efficacy and lowering the costs of cell and gene therapies by delivering autologous cell therapies at the point of care through our global network of hospitals and healthcare institutions,” concluded Caplan.

Under the terms of the Koligo merger agreement, Orgenesis acquired all of the outstanding stock of Koligo from its shareholders for approximately USD 14.5 million in shares of Orgenesis common stock valued at USD7.00 per share (with certain non-accredited investors paid approximately USD 20,000 solely in cash) and an assumption of USD 1.9 million in liabilities, estimated to be substantially all of Koligo’s liabilities. Orgenesis acquired substantially all the assets of Tissue Genesis for an additional consideration of USD 500,000 in closing cash and future royalties. Additional details of the transactions will be available in the Company’s Form 8-K, which will be filed with the Securities and Exchange Commission, and will be available at www.sec.gov. 

Pearl Cohen Zedek Latzer Baratz LLP and KPMG advised Orgenesis on the Koligo Transaction.  Maxim Group LLC acted as a finder and Nelson Mullins Riley & Scarborough, LLP advised Koligo on the Transaction.

About Orgenesis

Orgenesis is a global biotech company working to unlock the full potential of cell and gene therapies (CGTs) in an affordable and accessible format at the point of care. The Orgenesis POCare Platform is comprised of three enabling components: a pipeline of licensed POCare Therapeutics that are processed and produced in closed, automated POCare Technology systems across a collaborative POCare Network. Orgenesis identifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. The Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies. Learn more about the work Orgenesis is doing at www.orgenesis.com.

Notice Regarding Forward-Looking Statements 

The information in this release is as of October 19, 2020.  Orgenesis assumes no obligation to update forward-looking statements contained in this release as a result of new information or future events or developments.  This release contains forward looking statements about Orgenesis, Koligo, Koligo’s technology, and potential development and business opportunities of Koligo and Orgenesis following the closing of the Transaction, each of which involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of the Company’s products; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any such regulatory authorities may approved the Company’s development products, and, if approved, whether such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of the Company’s products; uncertainties regarding the impact of COVID-19 on the Company’s business, operations and financial results and competitive developments. 

A further description of risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information,” as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov.