Orgenesis Enters into Collaboration Agreement with MIDA to Deploy OMPULs for Point-of-Care Research and Development of Promising Cell and Gene…

Posted: March 24, 2021 at 12:46 pm

GERMANTOWN, Md., March 18, 2021 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (Orgenesis or the Company), a global biotech company working to unlock the full potential of celland gene therapies, announces that it has entered a collaboration with MIDA Biotech B.V. (MIDA). Together, the companies will work to establish point-of-care centers at hospitals and other medical institutions across western Europe.

Orgenesis and MIDA plan to deploy Orgenesis Mobile Processing Units and Labs (OMPULs) at leading hospitals for the onsite development of promising cell and gene therapies and immunotherapies from MIDA. The OMPULs are multi-purpose, mobile, autonomous good manufacturing practice (GMP) facilities used to develop, optimize, and manufacture cell and gene therapies at the point of care. Via the collaboration, the teams will align with various hospitals with projects focused on scaling the therapies through to commercialization with regulatory compliance and governmental approval standards as guiding principles.

In connection with the Agreement, Orgenesis and MIDA entered into agreements to establish point-of-care centers and deploy OMPULs within leading hospitals in Italy, Germany, Spain and Benelux, as well as other activities including joint research, development and validation activities related to the development of cell and gene therapies.

These agreements mark a major milestone towards the commercial launch of our OMPULs across Europe, and we believe provide further validation of our platform, as each of the respective hospitals conducted extensive due diligence and verification around our technology and capabilities prior to signing the agreements, stated Vered Caplan, CEO of Orgenesis. We see MIDA as an ideal partner based on their established relationships with the leading medical centers across western Europe and their promising science. Our teams are aligned in the desire to help lower costs and eliminate the logistical nightmares of building a centralized production facility or cleanrooms in the hospitals, which can stand in the way of getting a therapy to market effectively.

The additional sites will significantly expand the Orgenesis POCare Network capacity, which already includes active development centers in the United States, Belgium, Israel, and South Korea, as well as a growing number of joint venture agreements with regional partners and ongoing therapeutic development programs.

About OrgenesisOrgenesis is a global biotech company working to unlock the full potential of celland gene therapies (CGTs) in an affordable and accessible format at the point of care. The Orgenesis POCarePlatform is comprised of three enabling components: a pipeline of licensedPOCare Therapeuticsthat are processed and produced in closed, automatedPOCare Technologysystems across a collaborativePOCare Network. Orgenesisidentifies 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. Learn more about the work Orgenesis is doing atwww.orgenesis.com.

Notice Regarding Forward-Looking StatementsThis 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.

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

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Orgenesis Enters into Collaboration Agreement with MIDA to Deploy OMPULs for Point-of-Care Research and Development of Promising Cell and Gene...

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