CGT Global and Octomera Enter Agreement to Expand Cell & Gene Therapy Development and Patient Access Across the United States

CGT Global and Octomera Enter Agreement to Expand Cell & Gene Therapy Development and Patient Access Across the United States

Germantown, Maryland, September 21, 2023 - Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGTs), continues to grow the Point of Care (POCare) network and infrastructure of its advanced therapeutic services and facilities business through its subsidiary Octomera, by partnering with CGT Global, a biomedical company dedicated to advancing medical science and patient therapies. 

The two companies are collaborating to leverage CGT Global’s extensive network of CGT Clinics and Healthcare partnerships to expand commercialization of CGTs in California and other US locations. Resources will be aligned to place technology-agnostic Octomera Mobile Processing Units & Labs (OMPULs) for leukapheresis and the production of CAR-T and TILS products. The Company expects the footprint to grow as CGT Global partners with 32 hospitals today and anticipates partnering with over 200 hospitals by the end of 2024.

Since 2010, the CGT Global team has been dedicated to accelerating patient care and access by facilitating all components of the industry from R&D to clinical trials, drug manufacturing, and hospital partnerships. Their focus has remained acutely on the urgency of these products and therapies so that the landscape of medical care will be improved. CGT Global has created a bicoastal network of CGT Clinics in the US using state-of-the-art technology and specialized training in leukapheresis. Octomera will align with these sites and teams to help accelerate research and clinical trials into commercial products.

“The missions of CGT Global and Octomera are complementary. Both teams bring equity to the most cutting-edge medicines by decentralizing these complicated processes and capital-intensive expansions. At CGT Global, we have been creating a network of hospitals and CGT Clinics that reach far and wide with the goal of ensuring that all patients, regardless of location and financial status, can have access to the best medicines on the market,” Cate Spears, CEO at CGT Global said. “We have already successfully shortened the timeline to manufacture cells and leukapheresis products to rapidly accelerate clinical trials and access to patients quicker. Together with Octomera, we can take this progress one step further into accessible therapeutic GMP production, while also looking at other innovative solutions to bring therapies to patients in a way that has never been done before.”

“As we make more progress in the autologous advanced therapies space, and as hospitals are starting to seek first-line treatments to enhance quality of care and optimize resources, we see even greater value in decentralization. Over the past decade, our team has worked to engineer an agnostic, decentralized engineering approach for CGT production at the point of care, either in existing infrastructure or even outside of a building,” explained Vered Caplan, CEO of Octomera and Orgenesis. “Together with CGT Global, we will leverage their existing expertise, healthcare network and clinics to rapidly expand the support offering for point of care and advanced therapeutic production services. We are thrilled about the potential to overcome challenges with accessible end to end blood collection and cell production.”

CGT Global will provide expertise gained from being a leading provider of cellular manufacturing, biomedical therapeutic collections, and services through their existing network of CGT Clinics and hospital footprint. Octomera will provide services and support, as well as placement of agnostic OMPULs that are designed to standardize CGT production processes for quality and regulatory compliance across the globe at a fraction of the cost. The OMPULs will be designed based on the process, with consideration for regulatory compliance and quality management with centralized data and IT solutions. The OMPULs can be installed in six months within an existing structure or available outdoor space, and production capacity can easily be scaled through additional units. The interior can be purpose-built to include GMP-compliant production space as well as options for quality control labs. OMPULs can easily be added and stacked inside warehouse spaces. CGT Global has just built out a 52,000 sq ft warehouse facility in Reno, Nevada and with the OMPULs versatility, there are exciting times ahead for this great partnership.

To learn more about the partnership, or to talk about partnering, connect with the team at contact@octomera.com.

About CGT Global

CGT Global is on a mission to transform the life science and medical industries. Their commitment is to expedite research, accelerate clinical trials, streamline the commercialization process, and broaden patient access to life-changing therapies. For over 13 years, the company has achieved success through their rapidly growing healthcare network and their own CGT Clinics positioned around the United States. This global network is enhancing access and enabling patients to receive these therapies. At the of heart of CGT Global’s operational logistics lies cutting-edge cell manufacturing laboratories, equipped with state-of-the-art technology. By speeding up the end-to-end process, they ensure that new cures and treatments are delivered to patients faster than ever before. This means giving precious months and years back to those facing serious medical conditions. Additional information about the Company is available at: www.cgt.global or email press@cgt.global.

About Octomera

Octomera is an evolved advanced therapeutics supplier offering decentralized autologous GMP production services and support with an agnostic, flexible facilities model. The team draws on more than a decade of applied traditional and next-generation cell and gene therapy engineering prowess via holding company, Orgenesis, to bring lifesaving medicines to patients at the point of care with proprietary Octomera Processing Units & Labs (OMPULs). An established network of point of care (POCare) Center hubs and partner sites continues to grow in the United States, Europe, and Asia. Register interest at www.octomera.com.

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 partnership 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 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 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.