SOURCE: Orgenesis Inc.

Orgenesis Inc.

January 26, 2015 08:48 ET

Orgenesis and Pall Corporation Receive $800,000 Grant From BIRD Foundation for Diabetes Research and Development

TEL AVIV, ISRAEL--(Marketwired - Jan 26, 2015) - Orgenesis Ltd., a wholly-owned subsidiary of Orgenesis Inc. (OTCQB: ORGS), a leader in the emerging fields of cellular therapy and regenerative medicine, today announced that Orgenesis and Pall Corporation have received an $800,000 grant from the Israel-U.S. Binational Industrial Research and Development ("BIRD") Foundation to finance their current $1,600,000 co-development program.

Orgenesis is a pioneer in the development of technology designed to successfully reprogram human liver cells into glucose-responsive, fully functional, Insulin Producing Cells (IPCs). The grant will be used for a research and development project for the manufacturing of Autologous Insulin Producing (AIP) Cells for the treatment of Diabetes. Pall Corporation is the industry leader in the development and supply of innovative new technologies for the manufacturing of cell therapies.

"This grant greatly bolsters our research and development efforts as we move towards human clinical trials," said Vered Caplan, Chairperson and CEO of Orgenesis. "Pall's virus and cell production systems, respectively the Icellis™ and Xpansion™ single-use bioreactors, are pushing this industry forward to new frontiers and enabling the manufacturing of the most advanced cell therapies. We are grateful to Pall Corporation and the BIRD Foundation and for its promotion of this collaboration for providing the financial support necessary for our global initiatives in combating Diabetes."

"Orgenesis has an exciting approach to Diabetes research with its 'cellular trans-differentiation,' a technology that has potential to regenerate glucose-responsive insulin production in patients," said Mario Philips, President single-use technology at Pall. "We believe this has the potential of providing a cure for Type 1 Diabetes and other insulin-dependent disorders. This program will combine two of our leading technologies to provide a complete commercial-scale manufacturing solution."

The BIRD Foundation promotes collaboration between U.S. and Israeli companies in various technological fields for the purpose of joint product development. In addition to providing conditional grants of up to $1 million for approved projects, the Foundation assists by working with companies to identify potential strategic partners and facilitate introductions. Projects submitted to the BIRD Foundation are reviewed by evaluators appointed by the National Institute of Standards and Technology (NIST) and by the Chief Scientist's Office of the Israeli Ministry of Economy.

About Pall Life Sciences
Pall Life Sciences provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biologics and classic pharmaceuticals. The company's membranes and membrane devices optimize detection and sample preparation in the drug research, clinical diagnostics, genomics, and proteomics markets. Pall is a leading provider of automated systems and single-use solutions to pharmaceutical and biotechnology companies -- from upstream, through downstream, to formulation and filling -- and maintains certified ISO9001 manufacturing facilities worldwide. The company's Scientific and Laboratory Services (SLS), Technical Services and Validation Laboratories have been a cornerstone of customer support for more than 30 years providing compatibility studies, extractable/leachable studies, particulate validation and more.

About the BIRD Foundation
The BIRD (Binational Industrial Research and Development) Foundation works to encourage and facilitate cooperation between U.S. and Israeli companies in a wide range of technology sectors and offers funding to selected projects. BIRD has approved over 900 projects over its 37 year history. To date, BIRD's total investment in these projects has been over $300 million and has received approximately $100 million in repayments. BIRD funded projects have generated direct and indirect sales of approximately $10 billion. The BIRD Foundation provides support of up to 50% of a project's budget, or up to $1 million, beginning with R&D and ending with the initial stages of sales and marketing. The Foundation supports projects without receiving any rights in the participating companies or in the project itself. The Foundation shares the risk and requires the investment to be repaid only if the project reaches the sales stage.

About Orgenesis Inc.
Orgenesis is a biotechnology company that is committed to curing Type 1 Diabetes. In pursuit of this goal, the Company has developed a novel technology that combines cellular therapy and regenerative medicine. Through a proprietary biologic process called "cellular trans-differentiation," Orgenesis has proven that, when exposed ex vivo to certain pancreatic transcription factors and in specific sequence, human adult liver cells can be transformed into fully functional, beta cell-like insulin producing cells (IPCs). After ex vivo expansion, the IPCs are re-infused via the portal vein. In pre-clinical models of Type 1 Diabetes (Non-Obese Diabetic mice), the re-introduced IPCs remain in the liver, effectively respond to glucose challenge and successfully maintain glycemic homeostasis. In the same NOD model, the implanted IPCs were not subject to auto-immune attack or cellular ablation. Orgenesis plans to initiate P1/2 trials in the next 12-16 months. 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, the expectations of management that our regeneration technology can be developed as therapeutic treatment for diabetes which could become a cure for diabetes; that our technology combined with Pall's can provide a complete commercial-scale manufacturing solution; that we can initiate P1/2 trials in the next 12-16 months; and that we will receive the full value of grants and advances from BIRD as announced. 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; our ability to retain key employees; our ability to finance development and operations and to comply with all conditions necessary to receive the announced grants; our ability to satisfy the rigorous regulatory requirements for new medical procedures; and competitors may develop better or cheaper alternatives to our products. 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 our periodic reports filed from time-to-time with the Securities and Exchange Commission.

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