SOURCE: Orgenesis Inc.

Orgenesis Inc.

March 09, 2015 06:00 ET

Orgenesis Acquires Cell Therapy Manufacturer MaSTherCell

GERMANTOWN, MD--(Marketwired - Mar 9, 2015) -  Orgenesis Inc. (OTCQB: ORGS) ("Orgenesis" or the "Company"), a leader in the emerging fields of cellular therapy and re-generative medicine for the treatment of Type 1 Diabetes, today announced the Company's plan to increase its global presence and capabilities by acquiring MaSTherCell, an emerging pioneer in the industrialization of cell-based therapeutics, based in Gosselies, Belgium. 

Orgenesis entered into a share exchange agreement with MaSTherCell SA and Cell Therapy Holding SA (collectively "MaSTherCell") and each of the shareholders of the MaSTherCell, which provides for the acquisition by the Company of all of the issued and outstanding shares of MaSTherCell in exchange for the issuance of $24,593,000 in value of shares of common stock in the capital of the Company.

"The acquisition of MaSTherCell creates incremental value for both companies in business-critical ways. First, it allows us to accelerate the transition of our lead product, Autologous Insulin Producing Cells (AIPCs) being developed as a therapeutic for Type 1 Diabetes, from pre-clinical testing into clinical trials. Second, the acquisition will also allow us to diversify our business model and future product offering," said Vered Caplan, chairperson and CEO of Orgenesis. "We are creating a vertically integrated company that will deliver more end-user value and generate a stronger financial position for our overall business. Both businesses will remain operationally independent, but will become strategically aligned in ways that maximize technical, financial and management synergies. As a result of the acquisition, Orgenesis benefits from deeper involvement in the manufacturing process and resulting cost of goods efficiencies, while MaSTherCell benefits by expanding its international presence and by gaining access to public markets and financing for further technology-based investment."

Orgenesis is an innovator in the technology of "cellular trans-differentiation." This process involves re-programming one adult cell type to function like an adult cell of a different type. In the case of AIPCs, the company is transforming a type 1 diabetic patient's own liver cells into insulin-producing cells. Cellular trans-differentiation is accomplished through a complex biologic process, requiring sophisticated manufacturing technology and capabilities. MaSTherCell has in place a best-in-class combination of the process development capabilities and fully closed and tightly controlled GMP systems required to deliver commercial-scale manufacturing for Orgenesis. Prior to the acquisition, the two companies have already been working together under a strategic manufacturing agreement. With the acquisition in place, MaSTherCell will provide services not only to Orgenesis, but will continue to provide broad Contract Development and Manufacturing Services to other cell-based therapeutic companies around the world.

"Cell therapy developments have gained strategic significance in recent years -- particularly in the areas of regenerative medicine, ex-vivo gene therapy and immunotherapy of cancer," said Hugues Bultot, CEO of MaSTherCell. "Research and scientific development in these sectors has seen rapid progress and because of our ability to innovate, our industrialization and manufacturing expertise has not only kept pace with, but has actually led in terms of the ability of our technology to meet the needs of rapidly evolving science. Moving forward with Orgenesis, we will continue to provide for our current clients the same unique services but with a larger geographic reach. By combing our organizations, we will be able to more quickly capitalize on our desires to expand our cell-based therapeutic contract development and manufacturing services internationally. And, importantly, having access to public markets will enhance our ability to invest in the continued evolution of our technology and capabilities."

About MaSTherCell

MaSTherCell SA (Manufacturing Synergies for Therapeutic Cells), a spin-off from ULB (Université Libre de Bruxelles), is a technology-driven, customer-oriented Contract Development and Manufacturing Organization (CDMO) specialized in cell therapy development for advanced medicinal products. MaSTherCell's mission is to help customers bring highly potent cell therapy products faster to the market. www.masthercell.com.

About Orgenesis Inc.

Orgenesis (ORGS) is a pre-clinical cell therapy and regenerative medicine company that is committed to curing Type 1 Diabetes. In pursuit of this goal, the company has developed a novel technology called "cellular trans-differentiation" that turns an insulin-dependent patient's own liver cells into functional insulin producing cells. Orgenesis believes that converting the diabetic patient's own tissue into insulin-producing cells has the potential to overcome the significant issues of donor shortage, cost and exposure to chronic immunosuppressive therapy associated with islet cell transplantation. For more information visit: www.orgenesis.com.

Notice Regarding Forward-Looking Statements

This news release contains "forward-looking statements" which are not purely historical. Such forward-looking statements include, among other things, Orgenesis' belief that MaSTherCell will enable it to advance lead product from pre-clinical to clinical trials and its manufacturing (GMP) process from lab scale to clinical scale, MaSTherCell gives Orgenesis scalability, our combined companies will deliver more end-user value and generate a stronger financial position for our overall business, and diversify our product offering; that we benefit from cost of goods efficiencies; that MaSTherCell will continue to provide contracting services to other therapeutic companies; and our belief that converting the diabetic patient's own tissue into insulin-producing cells has the potential to overcome the significant issues of donor shortage, cost and exposure to chronic immunosuppressive therapy associated with islet cell transplantation. No assurance can be given that any of the events anticipated by the forward-looking statements will occur or, if they do occur, what benefits Orgenesis will obtain from them. Actual results could differ from those projected in any forward-looking statements due to numerous factors, including, among others, the potential failure of development candidates to advance through preclinical studies or demonstrate safety and efficacy in clinical testing; the ability to pass clinical trials so as to move on to the next phase; Orgenesis' ability to retain key employees; Orgenesis' ability to finance development and operations; Orgenesis' ability to satisfy the rigorous regulatory requirements for new medical procedures; the contract manufacturing business may not proceed as planned; we may not be able to integrate the two companies to attain efficiencies or benefits; and competitors may develop better or cheaper alternatives to Orgenesis' products or MaSTherCell's services. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Investors should refer to the risk factors disclosure outlined in Orgenesis' periodic reports filed from time-to-time with the Securities and Exchange Commission.

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