Orgenesis Mobile Processing Units and Labs (OMPULs) to be Used for Point-of-Care Production and Commercialization of Cell and Gene Therapies in Collaboration with Dong-a University Hospital and Cure Therapeutics in South Korea

Orgenesis Mobile Processing Units and Labs (OMPULs) to be Used for Point-of-Care Production and Commercialization of Cell and Gene Therapies in Collaboration with Dong-a University Hospital and Cure Therapeutics in South Korea

 Germantown, Md. US, March 8, 2021 - Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGTs), Dong-a University Hospital in South Korea, and Cure Therapeutics, Inc. (“Cure Therapeutics”), a developer of immuno-oncology and cell and gene therapies to target cancer and infectious diseases, today announce the signing of a collaboration agreement. The teams will align to utilise Orgenesis Mobile Processing Units and Labs (“OMPULs”) for point-of-care development of cell and gene therapies and immunotherapies that meet regulatory and governmental approval standards to scale through to commercialization.

OMPULs are multi-purpose mobile autonomous good manufacturing practice (GMP) facilities intended to develop, optimize, and manufacture cell and gene therapies at the point of use. Process development and validation for the therapies will be completed at the Dong-a University leveraging the technologies in the Orgenesis POCare Platform to automate the processes for quality and reproducibility.

This latest collaboration follows a recent joint venture agreement between Orgenesis and Cure Therapeutics, whereby the parties agreed to collaborate in developing and commercializing Cure Therapeutics’ pipeline on a global basis, as well as developing, commercializing, and supplying Orgenesis’ therapeutic pipeline in South Korea and Japan.

“We are excited to expand our collaboration with Orgenesis by utilizing their OMPULs onsite via a partnership with Dong-A University. The OMPULs will be placed onsite with the goal of accelerating development and commercialization of our immunotherapies targeting cancers and infectious disease, while ensuring the highest quality control standards and reducing overall manufacturing costs,” said David Kim, CEO of Cure Therapeutics.

“We are pleased to partner with Cure Therapeutics and Dong-a University Hospital to accelerate the development and market launch of breakthrough cell and gene therapies utilizing our proprietary OMPUL system,” said Vered Caplan, CEO of Orgenesis. “This latest agreement is another step in our efforts to rollout OMPULs throughout our network of leading healthcare facilities and partner companies across the U.S., Europe, Asia, and the Middle East.”

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. The Orgenesis Point of Care 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. Learn more about the work Orgenesis is doing at www.orgenesis.com.

About Cure Therapeutics
Cure Therapeutics is a Korea-based cell and gene and immune-oncology therapy developer to meet unmet medical needs leveraging a data and evidence driven drug development. The therapy portfolio features owned and in-licensed novel platform technology based therapies to provide cure for hard to treat hematological and solid cancers, life-threatening genetic disorders, and chronic liver diseases threatening quality of life. Deep scientific, technological, technical, and regulatory knowledge are melted into a decentralized structure to best deliver cutting edge new therapies to the urgent medical need diseases.

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 press 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 ability to further develop ranpirnase; our reliance on, and our ability to grow, our point-of-care cell therapy platform; our ability to develop cell-based and antiviral technologies; our ability to effectively use the net proceeds from the sale of Masthercell; our ability to achieve and maintain overall profitability; the development of our POCare strategy; the sufficiency of working capital to realize our business plans; our partners’ ability to develop therapies based on our point-of-care cell therapy platform; technology not functioning as expected; our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new procedures and therapies; our competitors developing better or cheaper alternatives; the impact of COVID-19 on our operations 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, 2019, 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.