Orgenesis Consortium Awarded €1.5M EUR Grant from the Walloon Government in Belgium for EXOFASTTRACK Project Dedicated to Accelerated Development of Multiple Therapeutic Exosomes

GERMANTOWN, Md., March 13, 2024 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ:ORGS) ("Orgenesis" or the "Company"), a global leader in decentralizing cell and gene therapies (CGTs), today announced that the Company has been awarded a €1.5 million grant from the Walloon government in Belgium for its EXOFASTTRACK project focused on manufacturing, loading, analytical methods and quality control of therapeutic exosomes. Consortium members include: Orgenesis, Cilyx, CMMI, convExYO, EXO Biologics, ExoXpert, Genflow Biosciences, LiveDrop, ULB, UMONS and Xomexbio. This grant is the second such project awarded to an Orgenesis consortium by the Walloon Government partnership, ATMP-Partenariat d'Innovation Technologique (ATMP-PIT), in collaboration with BioWin, the health cluster of Wallonia, and the Public service of Wallonia.

EXOFASTTRACK is a collaborative project focused on accelerating the development of multiple therapeutic exosomes for rapid clinical evaluation. Mainly isolated from stem cells, which are known for their regenerative and anti-inflammatory properties, exosomes are considered to have opened new horizons in cell therapy and Advanced Therapy Medicinal Products (ATMPs). The main function of exosomes is to act as intercellular messengers over long distances. Therapeutic exosomes are based on very large-scale reproduction, several billion copies, of an intercellular message specific to the producing cells, e.g. stem cells, in the lab. In addition, it is possible to modify the "therapeutic message" by loading a therapeutic agent specific to the targeted disease or "loading," substantially enhancing their field of application. The development of new automated technologies for both the production and loading of exosomes uses a ‘low-footprint' approach, with the aim of significantly reducing the surface area required to implement these processes as well as lowering the costs of manufacturing and energy consumption, which reduces the environmental footprint in terms of greenhouse gas emissions.

Orgenesis' role within the consortium is to develop a therapeutic candidate composed of exosomes derived from adipose tissue MSC (Human Mesenchymal Stem/Stromal Cells) loaded with an active compound and/or fused with Bioxomes™ to treat skin ulcers. Orgenesis has developed a potentially breakthrough manufacturing process for Bioxomes™, liposome-like membrane nanostructures produced from cells and used as a delivery vehicle, potentially increasing the potential of EVs. The production process optimizes scale up and reduces costs, while generating consistent and repeatable results including uniform particle sizes, without the risks and difficulties of administering entire cells to patients.

The production of exosomes will be conducted in partnership with Cilyx and ExoXpert and through automated and controlled modules within GMP facilities. Functional characterization and quality control of the exosomes and exosome-producing cells in microfluidic droplets will be performed in partnership with LiveDrop. Functional evaluation will be performed by ULB-CMMI with the goal of characterization of the exosomes by pre- and post-loading cryo-electron microscopy and tissue imaging for detection of exosomes as well as in vivo and ex vivo bioluminescence imaging methods.

Vered Caplan, CEO of Orgenesis, said, "We are pleased to be awarded this prestigious grant to advance technologies for a new production process for multiple therapeutic exosomes, which we believe represents a true breakthrough in the field of cell therapies and ATMPs. We believe this process could unlock the potential for large-scale GMP-compliant production and loading of exosomes for a variety of therapeutic applications based on the natural intercellular trafficking abilities of exosomes/extracellular vesicles. Through this grant, the production costs per dose for the patient will be significantly reduced, promoting accessibility and availability of potential life-saving therapies to a wider population at an affordable price. We look forward to leveraging the specific expertise of our consortium partners to advance this powerful manufacturing platform with a goal to lower the costs and accelerate the timeline for bringing these innovative therapies through clinicals and into commercialization."

Anne-Christine Hick, Head of R&D of Orgenesis Belgium stated: "We are grateful for the support from the Walloon government, BioWin, and our collaborative partners in establishing this exceptional consortium. It unites key stakeholders in exosome production and therapeutic applications, fostering collaboration and consolidating technological resources to expedite clinical development. This collaborative effort underscores the commitment of the Walloon region to this potential quantum leap in cell therapy. Notably, the allocation of nearly one-third of the Walloon Government's €81M total innovation partnership budget toward developing the exosome value chain reflects the region's keen interest in advancing this innovative area of research."

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.

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, LLC

Tel: 212-671-1021

Email: [email protected]

Communications contact for Orgenesis:

IB Communications

Neil Hunter / Michelle Boxall