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Orgenesis and Theracell Joint Venture to Receive up to €32 Million From Greek Government to Accelerate Rollout of POCare Centers and Deployment of OMPULs

JV named a “Priority Investment of Strategic National Importance” by the government of Greece

Granted fast-track licensing and approval status

GERMANTOWN, Md., Nov. 29, 2021 (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, today announces that its joint venture (JV) with Theracell Advanced Biotechnology S.A. (Theracell) in Greece has been designated a “Priority Investment of Strategic National Importance.” The designation was awarded by Enterprise Greece, the official Greek national investment and trade promotion agency, which is responsible for the allocation of the government funds.

As a result of this designation, the JV will be inducted into Greece’s fast-track licensing and approval process. This is expected to help advance development and clinical use of Theracell’s cell and gene therapies within the point-of-care setting, subject to regulatory requirements. In addition, the JV has been approved to receive a grant of up to €32 million from the Greek government upon its request depending on the JV’s requirements. These funds will be used to accelerate the development of Theracell’s therapies. The funds are also intended to support the process development and manufacturing of the therapies at the clinical sites, utilizing Orgenesis Mobile Processing Units and Labs (“OMPULs”). OMPULs are multi-purpose mobile autonomous good manufacturing practice (GMP) facilities intended to develop, optimize and manufacture cell and gene therapies at the point of care.

This JV builds on an original agreement signed by Orgenesis and Theracell in March 2019. This was extended in December 2019, with a strategic partnership agreement to implement Orgenesis’ POCare cell therapy platform for clinical development and commercialization of cell and gene therapies within public and private hospitals in Greece.

The new program has been constructed with the intention to provide the Greek National Health System with resources to specifically advance clinical development and deliver personalized, advanced therapies across its network. These therapies are expected to target a wide range of diseases in oncology, hematology and other serious unmet medical needs. The program aims to provide patients in Greece with cell and gene therapy treatments that are affordable, available and accessible.

“We believe that Enterprise Greece designating this JV a ‘Priority Investment of Strategic National Importance’ illustrates the expanding realization by major international governments and public sector bodies on the importance of developing and delivering cell and gene therapies at the point of care centers. We are thankful for the resources and other support to be invested by the Greek government. We believe that this designation demonstrates Enterprise Greece’s confidence in Orgenesis’ POCare platform to potentially transform the cell and gene therapy market, by bringing life-saving therapies to market in a much more time and cost-effective manner,” said Vered Caplan, CEO of Orgenesis. “Greece is pushing ahead as a regional technological hub where entrepreneurship drives innovation and technological advancement. Theracell has proven to be an ideal partner for Orgenesis, contributing extensive experience and capabilities in autologous cell therapy and regenerative medicine, with operations in Greece and strong relationships throughout the region. At the same time, we remain focused on establishing and expanding additional POCare locations and partnerships with hospitals and healthcare networks in other countries and regions around the world.”

“In the last two years, the collaboration with Orgenesis in Greece and other territories has been important for Theracell’s aim to advance development of cell and gene therapies for both clinical research and patient treatment utilizing the Orgenesis POCare platform,” said Fotis Sakellaridis, CEO of Theracell. “We thank Enterprise Greece for its trust in our program. We believe that the Greek government is providing essential support required to position Greece as a center of medical innovation in Southeast Europe. Most importantly, this supports the goal of providing Greek patients with greater access to these important therapies.”

About Theracell

Theracell is a regenerative biotechnology company with operations in Greece, where its laboratories and primary facilities are located. The Company focuses in the areas of autologous cell therapy and regenerative medicine. Theracell has extensive experience in the isolation, processing and application of adipose derived stem cells (ADSCs), as well as somatic cells and has developed a patented platform for tissue engineering and cell therapies in the areas of Dermatology, Chondral Defects and Chronic Kidney Injury and has expanded its activity in the Immuno-Oncology area.

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.

Notice Regarding Forward-Looking Statement

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, 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 coronavirus outbreak, the sufficiency of working capital to realize our business plans, 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 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, 2020, 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.

Source: GlobeNewsWire & Orgenesis Inc.