ORGS Orgenesis Inc

Orgenesis Inc. (Nasdaq:ORGS) (“Orgenesis” or the “Company”), a global leader in decentralized cell and gene therapies (CGTs), today announced that the Company’s consortium was awarded a €2.0 million grant from the Walloon Government in Belgium, titled: “Monitoring with AI of Decentralized ATMP Manufacturing” (MAIDAM). The consortium members include: Orgenesis Services Belgium, Université catholique de Louvain (UCLouvain) / TRusted AI Labs (TRAIL) and DNAlytics. Advanced Therapy Medicinal Products (ATMPs) are among the most innovative and promising biomedicines designed to address unmet medical needs, including cell, gene, exosome and phage therapies.

On January 17, 2024, the Walloon government launched a partnership, ATMP-Partenariat d’Innovation Technologique (ATMP-PIT), with an €81 million budget over three years, dedicated to ATMPs, in collaboration with BioWin, the health cluster for Wallonia, and the Public Service of Wallonia. This innovative partnership brings together 26 partners for 12 projects driving technological innovation. ATMP-PIT is intended to provide stimulus to Wallonia’s advanced therapy medicines sector, by establishing new partnerships between teaching hospitals, research centers and life science companies, as well as create more than 470 direct and 1,200 indirect jobs over the next five years.

The MAIDAM project is focused on developing AI-based approaches for the monitoring and improvement of decentralized manufacturing processes for ATMPs via federated machine and reinforcement learning utilizing cell therapy processing on small and standardized manufacturing units. The project is intended to address the challenges of decentralization by developing innovative digital tools allowing providers to be more competitive by leveraging data from local production units.

Orgenesis plans to generate processing data on different equipment and integrate the data into its Octomera Mobile Processing Units and Lab (OMPUL) recently installed at Marche-en-Famenne in Belgium for use in autologous cell therapies.

Orgenesis Services Belgium General Manager Pierre Lammeretz said, “We are thrilled the grant accelerates the placement of a CAR-T dedicated OMPUL in Belgium, an important step in making more affordable CAR-T therapies available in the region.”

Vered Caplan, CEO of Orgenesis commented “We are honored to receive this prestigious grant to advance AI technologies for the production of ATMPs that may be utilized for immuno-oncology, gene and cell therapies and tissue regeneration. We believe that this partnership between DNAlytics, a leader in data-driven healthcare, and UCLouvain can become a blueprint for decentralizing the development and manufacturing of ATMPs in a faster and lower-cost manner, while demonstrating the benefits of our OMPUL design for the European and international healthcare markets.”

“OMPULs are multi-purpose, mobile, autonomous facilities that can be rapidly deployed as a standardized industrial cleanroom alternative, at or near the point of care. Through this grant, we plan to utilize cutting-edge single cell bioinformatics research to identify cells of the highest quality and develop a database that will be the basis for AI software to better select cells that meet clinical standards. Through these steps, we are clearly executing on our strategy to make cell and gene therapies more accessible and affordable for patients.”

Thibault Helleputte, CEO of DNAlytics stated: “I believe that the MAIDAM project will allow the Walloon Region to stay at the forefront of innovation in ATMP manufacturing, including integration of digital technologies. This project brings together a top-notch consortium with very complementary expertise in manufacturing of cell therapies, AI, and digitization of biomanufacturing processes. We appreciate the support of BioWin and Wallonia on this important endeavor.”

About Orgenesis

Orgenesis is a global biotech company that has been committed to unlocking the potential of cell and gene therapies (CGTs) since 2012 as well as a paradigm-shifting decentralized approach to processing since 2020. This new model allows Orgenesis to bring academia, hospitals, and industry together to make these essential therapies a reality sooner rather than later. Orgenesis is focusing on advancing its CGTs toward eventual commercialization, while partnering with key industry stakeholders to provide a rapid, globally harmonized pathway for these therapies to reach and treat a larger numbers of patients more cost effectively and with better outcomes through great science and decentralized production. Additional information about the Company is available at: www.orgenesis.com.

About DNAlytics

DNAlytics is a Belgian company providing data sciences expertise to the healthcare industry exclusively. It has served about fifty customers over a hundred of projects over the last decade. It supports biotech, pharma, medtech and academia R&D teams, manufacturing departments, and is also active in real-world medical data interoperability. Regarding biomanufacturing, the company develops and markets its Hercule software suite, bringing valuable data models, statistical routines, as well as machine learning and AI functionalities to develop and improve biomanufacturing process. Hercule has been applied to more than 25 processes so far, half of which are commercial-stage processes. http://dnalytics.com/Hercule .

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, the expected consolidation of Octomera in our consolidated financial statements, our reliance on, and our ability to grow, our decentralized cell therapy platform and OMPUL business, 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, the sufficiency of working capital to realize our business plans and our ability to raise additional capital, the development of our decentralized cell therapy processing, 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, risks relating to legal proceedings against us 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, 2022, 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.

Investor relations contact for Orgenesis:Crescendo Communications, LLCTel: 212-671-1021Orgs@crescendo-ir.com

Communications contact for OrgenesisIB CommunicationsNeil Hunter / Michelle Boxall