SOURCE: Orgenesis Inc.

Orgenesis Inc.

August 01, 2016 09:00 ET

Orgenesis and Atvio Biotech Launch Joint Venture for Gene and Cell Therapy Development Services

Dr. Ohad Karnieli Appointed CEO of Joint Venture

GERMANTOWN, MD--(Marketwired - Aug 1, 2016) - Orgenesis Inc. (OTCQB: ORGS), a fully integrated cell therapy and contract development and manufacturing company (the "Company" or "Orgenesis") has commenced activities under its joint venture agreement with Atvio Biotech Ltd. ("Atvio"). Under the terms of the Joint Venture ("JV"), Atvio is responsible for providing contract development and manufacturing services and supporting the global expansion of MaSTherCell, a wholly-owned subsidiary of Orgenesis.

The parties are pursuing the JV through Atvio, in which Orgenesis holds a 50% participating interest, with the remaining 50% participating interest being held by the other shareholders of Atvio. Under the JV, Orgenesis will integrate Atvio's operations into its global contract manufacturing strategy in the field of cell therapy manufacturing.

Additionally, Atvio announced the appointment of Dr. Ohad Karnieli as CEO of the JV. Dr. Karnieli is a highly experienced professional in the area of cell therapy manufacturing. Dr. Karnieli has expanded his experience as the CEO & Co-founder of Karnieli Ltd, an innovative cell solutions company providing cell therapy innovation and process development solutions, following his position as the VP of Technology and Manufacturing at Pluristem Therapeutics Inc. Dr. Karnieli currently serves as the Chairman of the process and product development committee of the International Society for Cell Therapy. Dr. Karnieli earned his Ph.D. from Tel Aviv University in cell therapy and genetic engineering and an MBA from the Haifa University.

Ohad Karnieli, CEO and Co-founder of Atvio, commented, "MaSTherCell is a leader in cellular therapy products manufacturing with a proven track record in Europe. We are happy to support their expansion beyond Europe through this latest joint venture. We look forward to leveraging their expertise and proven capabilities in order to rapidly enter and establish a dominant position in new and emerging markets in the Middle East, Europe, and Asia."

Vered Caplan, Chairperson and CEO of Orgenesis, commented, "We see a sizable opportunity for contract development and manufacturing of cell and virus therapy products in Israel and around the world, given the rapid growth in regenerative medicine. We appreciate the vision that Atvio has shown through their support of our international expansion, a natural extension of the work we are already performing in Europe. This joint venture will further strengthen the process development capabilities of the group given the proven track record of Atvio's founders in cell therapy process development, upscaling and automation. This agreement also comes on the heels of our recent joint venture with CureCell for contract development and manufacturing of cell therapy products in South Korea."

Atvio Biotech Ltd.

Atvio is a privately held Israeli-based CDMO focused on process development, upscaling, automation and virus manufacturing for cell therapies. The company is located in Haifa utilizing the unique Israeli innovative ecosystem and a highly experienced talent pool.

About Orgenesis Inc.

Orgenesis is a fully integrated cell therapy and regenerative medicine company. The Company is providing manufacturing services for other cell therapy markets in such areas as cell-based cancer immunotherapies and autoimmune diseases. In addition, through its subsidiary, Orgenesis Ltd, the Company is developing a cure for diabetes using a novel "cellular trans-differentiation" technology that transforms an insulin-dependent patient's own adult cells into functional insulin producing cells. The Company has demonstrated that, when exposed ex-vivo to certain pancreatic transcription factors and in specific sequence, human adult cells can be transformed into fully functional, beta cell-like insulin producing cells. Orgenesis Ltd has an exclusive license from Tel Hashomer Hospital for intellectual property directed to the cellular trans-differentiating technology. The joint venture between Orgenesis Inc. and Atvio Biotech Ltd. does not include any intellectual property from Tel Hashomer Hospital.

Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve substantial uncertainties and risks. These forward-looking statements are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including but not limited to the expectations of management regarding the success of the joint venture with Atvio in expanding our market penetration in the CMDO field in Europe and Asia, the successful integration of the JV into our CDMO strategy, the development of our regeneration technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes, our limited financial resources and our ability to raise the working capital needed to fund the commitments under the JV specifically and our development projects and business generally, our technology may not as well as expected, our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new medical procedures; and competitors may develop better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1 of our Annual Report on Form 10-K for the fiscal year ended November 30, 2015, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.

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