Orgenesis Announces Collaboration Agreement with Tel Aviv Sourasky Medical Center to Advance Point-of-Care Development and Commercialization of Cell and Gene and Therapies

Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, has entered into a collaboration agreement (“Agreement”) with Tel Aviv Sourasky Medical Center to establish a point-of-care (POCare) cell therapy center at the Ichilov Hospital, a leading multidisciplinary healthcare institution in Israel.

Under the agreement, the parties plan to conduct collaborative cell-based research projects, initially focused on advancing the clinical development and validation of Orgenesis’ CD19 CAR-T therapies, including CAR-T derived exosome products, utilizing Orgenesis’ proprietary T-cell culturing and point-of-care processes and systems. The parties also plan to deploy Orgenesis Mobile Processing Units and Labs (“OMPULs”) onsite to support joint research and validation activities for advanced cell and gene therapies developed by both Orgenesis and the Tel Aviv Sourasky Medical Center. OMPULs are multi-purpose, mobile, autonomous good manufacturing practice (GMP) facilities designed to significantly reduce the costs of advanced therapy production and accelerate the clinical development process at the point of care.

Vered Caplan, CEO of Orgenesis, stated, “It is an honor to collaborate with the Tel Aviv Sourasky Medical Center and Professor Irit Avivi, Director of Hematology, to advance the clinical development of potentially breakthrough cell and gene therapies. This latest collaboration agreement also expands our POCare Network capacity and provides further validation of the importance of our OMPULs. We remain focused on finding exceptional partners like the Tel Aviv Sourasky Medical Center to accelerate development of our broad portfolio of therapies, as well as deploy the OMPULs across our network of leading healthcare facilities and partner companies across the U.S., Europe, Asia, and the Middle East.”

Prof Eli Sprecher, Deputy Director General for Research, Development and Innovation at the Tel Aviv Sourasky Medical Center, commented, “We are excited to partner with Orgenesis to help validate these promising immunotherapies, as well as to potentially advance the respective programs into clinical trials utilizing Orgenesis’ point-of-care processes and systems. This collaboration, utilizing Orgenesis’ POCare platform, reflects our commitment to helping bring potential breakthrough cell therapies to market in a cost effective, high quality and scalable manner.”

About Tel Aviv Sourasky Medical Center

Tel Aviv Sourasky Medical Center (Ichilov Hospital) is the largest acute care facility in Israel, treating about 400,000 patients and hosting 1.8 million patient visits per year. A 1500-bed world-class governmental academic medical center, Tel Aviv Sourasky Medical Center serves a population of one million people, including residents from the greater Tel Aviv area and visitors to the metropolis. For more information please visit: https://www.tasmc.org.il/

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 POCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies. www.orgenesis.com

Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and 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, our reliance on, and our ability to grow, our point-of-care cell therapy platform, our ability to achieve and maintain overall profitability, our ability to manage our research and development programs that are based on novel technologies, our ability to control key elements relating to the development and commercialization of therapeutic product candidates with third parties, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, our ability to manage potential disruptions as a result of the coronavirus outbreak, the sufficiency of working capital to realize our business plans, the development of our POCare strategy, our trans differentiation technology as therapeutic treatment for diabetes, the technology behind our in-licensed ATMPs not functioning as expected, our ability to further our CGT development projects, either directly or through our JV partner agreements, and to fulfill our obligations under such agreements, our license agreements with other institutions, our ability to retain key employees, our competitors developing better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, 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.