ORGS Orgenesis Inc

Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGTs), today announced continued progression of the Point of Care (POCare) network and infrastructure for the advanced therapeutic services and facilities business through its subsidiary Octomera. The teams have been confirmed as an industrial partner to the University of California Davis, a leading academic institution, following a recent California Institute of Regenerative Medicine (CIRM) grant focused on “Creating a Collaborative California Cell and Gene Therapy Manufacturing Network.”

“California leads the way when it comes to looking for impactful advances in medicine. As the field continues to rapidly expand, the need for cell and gene therapy product manufacturing will continue to increase over the next decade, and the state of California needs to be prepared to meet the growing demand from patients for these life-changing therapies,” commented Professor Jan Nolta, PhD, Director of the Institute for Regenerative Cures at UC Davis. “We want to take the best parts of traditional solutions and combine them with the next evolution in manufacturing to expand access to clinical trials of potentially lifesaving therapies such as CAR-Ts.”

“As part of the two-year, $1.7 million CIRM grant, we will work to standardize a lot of our Good Manufacturing Practice (GMP) manufacturing capabilities across California, while also creating a network to harmonize operations,” said Brian Fury, Director of the GMP Facility at UC Davis. “Our goal is to facilitate more accessible patient care production through collaboration with aligned expertise. Being able to expand our service areas while bringing down costs is a necessity for the future of human health.”

UC Davis and Orgenesis announced an initial collaboration in 2020, and the relationship has continued to evolve into 2023. Both parties are interested in expanding on the point of care (POC) network model Orgenesis deploys by aligning the tools, experts, and resources needed to decentralize medical innovation. OMPULs will be deployed for production in 2024.

“We are thrilled to see such a deserving team get support from their state to show the true value of decentralization in California,” Vered Caplan, CEO of Orgenesis commented. “Our shared understanding of the challenges in cell and gene therapy process development and ultimately, GMP manufacturing, will benefit patients in the state by enabling access to therapies that could previously be caught up in bureaucracy.”

To learn more about the partnership, or to talk about partnering, connect with the team at BD@Octomera.com. To learn more about UC Davis and their pioneering work in the cell and gene therapy industry, please visit: https://health.ucdavis.edu/stemcellresearch/.

About Orgenesis

Orgenesis is a global biotech company that has been committed to unlocking the potential of decentralized cell and gene therapies (CGTs) since 2012. Orgenesis established the POCare Network in 2020 to bring academia, hospitals, and Industry together to make these innovations more affordable and accessible to patients. In 2022, the POCare Services business unit responsible for developing and managing the decentralized POCare Centers and proprietary OMPULs was formed. Orgenesis will continue to focus on advancing to market through various partnerships its CGTs 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. Additional information about the Company is available at: www.orgenesis.com.

Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 deconsolidation of Octomera from our consolidated financial statements, 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.

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

Communications contact for OrgenesisIB CommunicationsNeil Hunter / Michelle Boxall