GERMANTOWN, Md., March 16, 2023 (GLOBE NEWSWIRE) — 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, today announces the signing of a non-binding memorandum of understanding (MOU) with University of California, Davis (UC Davis).
The MOU was signed by Orgenesis POC CA Inc., a Delaware corporation (“Orgenesis POC CA”) incorporated by Orgenesis’ POCare service subsidiary, Morgenesis LLC (“Morgenesis”), and The Regents of the University of California, on behalf of its Davis campus (“University”). The goal of the MOU is to progress towards a wider definitive agreement pursuant to which the University and Orgenesis POC CA expect to roll out Morgenesis’ proprietary Orgenesis Mobile Processing Units and Labs™ (“OMPULs™”) throughout universities within the State of California.
Both Orgenesis, through Orgenesis POC CA, and the University, aim to roll out the OMPULs within the State of California in a staged approach. The first stage involves establishing and validating an OMPUL at UC Davis, anticipated to be within the first 12 months following execution of a definitive agreement between the parties. Thereafter, both parties will agree upon and develop a decentralized model of OMPUL placement in compliance with regulatory requirements, as well as commercialize and install OMPULs at other healthcare sites within the State of California. The intent is to enable the development and manufacture of cell and gene therapies from Orgenesis, its partners, and UC Davis’ partners. Orgenesis POC CA or its affiliates and the University may agree to develop and/or manufacture other therapies initiated from the University and/or third parties for point of care treatment of patients utilizing the OMPUL, subject to a further agreement(s).
“The cell and gene therapy sector continues to expand and develop solutions for patients suffering from a range of conditions. However, despite the sector maturing, there is still yet to be drawn a clearly defined roadmap to enable patients to reach and benefit from these life-saving therapies. Orgenesis has designed its OMPULs to decentralize manufacturing and enable cell and gene therapies to be developed on the site of universities, hospitals and healthcare providers, with the goal of reducing the costs of developing these therapies. This is vital to make the widespread delivery of life-saving therapies to patients a reality. As a result, Orgenesis, through its subsidiary Morgenesis, is installing OMPULs in the US and internationally,” said Vered Caplan, CEO of Orgenesis. “It is anticipated that this partnership with UC Davis and the universities across California will provide decentralized development and manufacturing of CGTs across a major US healthcare state. This could potentially result in the development of CGTs to patients across a range of conditions at a cost that can be supported by payers and the wider society as a whole.”
UC Davis originally signed a collaboration agreement to join Orgenesis’ Point of Care (“POCare”) Network on January 9, 2020. UC Davis Health has been utilizing Orgenesis’ POCare platform to develop, commercialize and supply cell and gene products and therapies. Orgenesis’ POCare Network enables hospitals to expand their capacity to supply cell therapies at the point-of-care site for the treatment of patients. The agreement involved the scaling up and integrating UC Davis’ lentiviral vector process as part of the Orgenesis POCare Service Platform for localized development and processing of cell and gene therapies for treating patients.
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. 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, 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, 2021, 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.
IR contact for Orgenesis:
Crescendo Communications, LLC
Communications contact for Orgenesis
Neil Hunter / Michelle Boxall
Tel +44 (0)20 8943 4685
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