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Orgenesis Announces Anti-Viral “BioShield” Program Designed to Potentially Increase Preparedness, Rapidly Address Virus Spread and Protect Against Future Outbreaks such as COVID-19

GERMANTOWN, Md., June 10, 2020 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a pioneering global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs), today announces the launch of its BioShield Program, which is designed to accelerate the potential discovery and validation of neutralizing human antibodies as a possible rapid defense of the population and to potentially mitigate the spread of viruses such as COVID-19.  The goal of the BioShield Program is to increase the level of preparedness to fight against emerging outbreaks and help avoid a global pandemic.

Orgenesis plans to leverage its POCare anti-viral technologies as part of the development efforts of the BioShield Program, including exploration of alternative and breakthrough processes to induce neutralizing antibody discovery and validation against targeted pathogens. The BioShield Program is designed to combine different technologies in preclinical stage to induce a response of the immune system within selected animal models, which could potentially speed the discovery of neutralizing antibodies. Orgenesis’ cell-based vaccine approach, which utilizes irradiated permissive cells that have the ability to activate an endogenous immune response, is a component of the BioShield Program.  When Orgenesis’ cell-based vaccine is infused into a humanized mouse model, these activated cells are designed to induce generation of neutralizing antibodies.

If the Company is successful in validating these technologies, Orgenesis believes this could represent a platform for the potential rapid identification and isolation of human neutralizing antibodies to be tested as antiviral therapies against current and future emerging outbreaks. Given the health emergency and the need for preparedness against future pathogen outbreaks, Orgenesis has committed resources to immediately pursue development of the BioShield Program.

Vered Caplan, CEO of Orgenesis, commented, “When faced with new infectious diseases, there is a need for a rapid, affordable and effective solution to shut down the pathogen outbreak. By specifically leveraging Orgenesis’ POCare anti-viral platform, our objective with the BioShield Program is to provide a rapid and affordable solution to contain the spread of a viral pathogen or new emerging outbreaks.”

Frédéric Tonglet, General Manager of Orgenesis (Belgium) said, “We are excited to lead this anti-viral platform development with first-in-class partners from the Belgian biotech ecosystem, including CTMA (Centre for Applied Molecular Technologies), a clinical research-oriented biotechnological platform of the Université catholique de Louvain (UCLouvain). We look forward to providing further updates as this program evolves.”

Professor Jean-Luc Gala, MD, PhD, ret. Col, Head of UCLouvain-CTMA (Belgium) said, “We are honored to contribute to the BioShield Program by helping select and validate the best set of antibodies, which could potentially be used for the treatment of infected patients, as well as the development of a next  generation diagnostic solution.”

About Orgenesis
Orgenesis is a pioneering global biotech company which is unlocking the full potential of personalized therapies and closed processing systems through its Cell & Gene Therapy Biotech Platform, with the ultimate aim of providing life changing treatments at the Point of Care to large numbers of patients at low cost. The Platform consists of: (a) POCare Therapeutics, a pipeline of licensed cell and gene therapies (CGTs), and proprietary scientific knowhow; (b) POCare Technologies, a suite of proprietary and in-licensed technologies which are engineered to create customized processing systems for affordable point of care therapies; and (c) POCare Network, a collaborative, international ecosystem of leading research institutes and hospitals committed to clinical development and supply of CGTs at the point of care. By combining science, technologies and a collaborative network, Orgenesis is able to identify the most promising new therapies and provide a pathway for them to reach patients more quickly, more efficiently and at scale, thereby unlocking the power of cell and gene therapy for all. Additional information is available at: www.orgenesis.com.

About UCL-CTMA
CTMA (Centre for Applied Molecular Technologies) is a clinical research-oriented biotechnological platform of the Université catholique de Louvain. UCLouvain-CTMA is a joint academic-clinical-military science and technology unit where each of the three pillars mutualizes resources for the other two components: (1) Experimental and Clinical Research Institute (IREC/UCL) which is the civilian UCLouvain academic pillar; (2) CBRN-Defence Laboratories Department for the BE-Defence (DLD/BE-MOD) which is the military CBRN research and CBRN operational pillar working for DLD; and (3) St Luc academic hospital (Cliniques Universitaires St Luc, CUSL) for which clinical development and testing in molecular genetics and associated clinical (human) and environmental research is provided. Specialized in infectious disease genetics and molecular genetics, CTMA fulfils synergistically academic and clinical research work to the benefit of CUSL and UCLouvain. As specified in the framework convention UCLouvain-Belgian Defence, CTMA is assigned the role of Biothreat control unit of the Defence Laboratory Department (i.e. DLD-Bio of the Belgian Ministry of Defence).

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 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, the development of our trans-differentiation technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes; our technology not functioning as expected; our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new procedures; 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 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.

Contact for Orgenesis:
David Waldman
Crescendo Communications, LLC
Tel: 212-671-1021
ORGS@crescendo-ir.com

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