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Wednesday, 6 September 2023

Press Release

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IB Communications

Tel +44 (0)20 89434685

Cell and Gene Therapy Industry Pioneer & GMP Expert, Gerhard Bauer, Joins Orgenesis Business, Octomera, to Drive Continued Expansion of POCare Facilities and Service Support

Germantown, Maryland – September 6, 2023Orgenesis, a global biotech company working to unlock the full potential of cell and gene therapies (CGTs), continues to grow the infrastructure of the advanced therapeutic POCare services and facilities supply business, Octomera. The appointment of Gerhard Bauer as the Vice President of Global Product Implementation at Octomera has been made to enhance the existing process development, regulatory, engineering, equipment, and data/technical service offering and POCare Center hubs. He is also an active contributor to the evolution of the flexible facilities format, Octomera Mobile Process Labs & Units (OMPULs) and network, which allow the traditional facility build time to be cut down from years to under six months.

“Gerhard is an industry pioneer with unmatched expertise. We worked together in his prior role as Director of the UC Davis GMP Laboratory, and I have been continually impressed with his industry knowledge, technical prowess, and leadership skills,” commented Vered Caplan, CEO of Orgenesis and Octomera. “We are thrilled to continue the relationship and see his level of expertise as critical to carrying forward our mission of decentralizing access to advanced medicines. Our platform is built to enable rapid advanced therapy innovation via smart engineering to lower costs, and streamline cell and gene therapy production, to benefit patients worldwide–something Gerhard is truly passionate about.”

Mr. Bauer has been an innovator in the pharmaceutical industry since the 1990s, when he was inspired by personal experiences to pursue a different type of medicine. He began his time at Johns Hopkins University where he was part of the team that developed the first stem cell gene therapy for HIV. Later in the 90s, he went on to pioneer and commercialize a stem cell gene therapy for HIV and ADA SCID (bubble boy disease) at the University of Southern California's Children's Hospital Los Angeles.

In 2002, Bauer moved to set up a new GMP laboratory at Washington University in St. Louis that quickly became acclaimed for its work. In 2006, he was called back to California to work as a professor at UC Davis of Cell Therapy & Hematology/Oncology and, in parallel, open the largest academic GMP facility in Northern California.

“We all understand that the old methods of cell and gene therapy development and production no longer apply. At Octomera, we have the network, applied experience, and passion to support drug developers as they develop and commercialize lifesaving medicines,” said Mr. Bauer. “I first got to know this team as Orgenesis when working at UC Davis and was impressed by how far along the team was in terms of commercializing point-of-care production for autologous therapies. When I retired from my professorship and became aware of the plans to branch the services and facilities into the Octomera brand, I saw a great opportunity to continue working to decentralize and democratize medical innovation. We are driving the inflection point of making CAR-T, TILS, and other advanced medicines a reality for every community.”

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 from its parent company, Orgenesis, to bring lifesaving medicines to patients at the point of care with proprietary Octomera Processing Units & Labs (OMPULs). An established network of POCare Center hubs and partners sites continues to grow in the United States, Europe, and Asia. Register interest at

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:

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.

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