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Wednesday, 7 June 2023

Press Release

Media Contacts:

IB Communications

Tel +44 (0)20 89434685

Orgenesis and University of California, Davis sign partnership agreement for rollout of cell and gene therapy mobile processing units and labs throughout California

Germantown, Maryland and Davis, California, US, June 7, 2023 – Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT) at the point of care, and University of California, Davis (UC Davis), today announce an agreement to roll out proprietary Orgenesis Mobile Processing Units and Labs(TM) (“OMPULs(TM)”) at medical or academic institutions within the University of California system. The partnership agreement sets out a staged approach through which Orgenesis will install and operate OMPULs(TM), enabling their proprietary point-of-care (“POCare”) Service Platform to manufacture therapeutics at hospitals throughout California, empowering onsite production for clinical trials like the cell and gene therapies in development at UC Davis Health’s Alpha Stem Cell Clinic.

The first OMPUL will be established and validated at UC Davis, followed by a decentralized model of placement to commercialize and install OMPULs at other healthcare sites within California. These units will enable point-of-care treatment via the development and manufacture of cell and gene therapies from Orgenesis, its partners, and UC Davis’ partners, subject to further agreements.

“We believe that this partnership between Orgenesis, UC Davis, and the University of California system will become a blueprint for decentralizing the development and manufacturing of CGTs, while demonstrating the benefits of our OMPUL design for the US and international healthcare markets,” said Vered Caplan, CEO of Orgenesis. “Our shared goal is the widespread development of life-saving CGTs for patients with a range of conditions, at a cost that can be supported by payers and the wider society as a whole.”

OMPULs are installed in the US and internationally through Orgenesis’ POCare service subsidiary, Morgenesis LLC (“Morgenesis”).

“We are very excited to move forward with this collaboration with Orgenesis,” said Jan Nolta, director of the Stem Cell Program and the Gene Therapy Center at UC Davis Health’s Institute for Regenerative Cures. “The OMPULs will allow wider access to promising cell and gene therapies for patients in different regions of California, improving accessibility and reducing healthcare disparities.”

The agreement was signed by Orgenesis POC CA Inc., a Delaware Corporation (“Orgenesis POC CA”), incorporated by Morgenesis, and The Regents of the University of California, on behalf of its Davis campus.

Since joining the Orgenesis POCare Network in 2020, UC Davis Health has been utilizing Orgenesis’ POCare Service Platform to develop and supply cell and gene products and therapies. The POCare Network enables hospitals to expand their capacity to supply cell therapies at the point-of-care site for the treatment of patients. The first collaboration involved scaling up and integrating UC Davis’ lentiviral vector process for localized development and processing of cell and gene therapies for treating patients.

The latest agreement follows a USD 8 million grant renewal from the California Institute for Regenerative Medicine (CIRM) in December 2022 for UC Davis Health’s Alpha Stem Cell Clinic. The grant enables the clinic to expand its clinical trials operation and advance toward onsite manufacturing of therapies.

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.

About UC Davis Stem Cell Program and Gene Therapy Center

UC Davis’ Stem Cell Program brings together physicians, research scientists, biomedical engineers and a range of experts and partners at its Institute for Regenerative Cures. The USD 62 million facility located on the university’s Sacramento campus was supported by the California Institute for Regenerative Medicine (CIRM). It is the hub for collaborative, team-oriented science that is advancing breakthrough discoveries designed to bring stem cell therapies and cures to patients everywhere. The UC Davis Gene Therapy Center brings together a uniquely comprehensive and established interdisciplinary network of experts and resources to lead the field of gene therapy through research, manufacturing, training and policy. It offers expertise and state-of-the-art facilities and equipment including one of the largest university-based Good Manufacturing Practice (GMP) facilities and a Viral Vector Core.

About UC Davis

UC Davis is one of the top public universities in the United States. Since opening in 1908, it has been known for standout academics, sustainability and Aggie Pride as well as valuing the Northern California lifestyle. These themes are woven into its 100-plus-year history and its reputation for solving problems related to food, health, the environment and society. The university’s health system is based in Sacramento and provides the region's only academic health center. UC Davis Health is focused on discovering and sharing knowledge and providing the highest quality of care. It is a hub of innovation that encompasses UC Davis Medical Center, UC Davis School of Medicine, The Betty Irene Moore School of Nursing at UC Davis and UC Davis Medical Group.

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 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, our ability to manage potential disruptions as a result of the COVID-19 pandemic, the sufficiency of working capital to realize our business plans and our ability to raise additional capital, 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, 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.

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