FDA Approves Orgenesis IDE for Pilot Clinical Trial of its Tissue Genesis Icellator2(R) to Treat ARDS Resulting from COVID-19 Infection

FDA Approves Orgenesis IDE for Pilot Clinical Trial of its Tissue Genesis Icellator2(R) to Treat ARDS Resulting from COVID-19 Infection

IDE approval provides important validation of clinical development plans for the Icellator2

Germantown, Md., US, May 7, 2021 - Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, announces it has been granted Investigational Device Exemption (IDE) approval by the United States Food and Drug Administration (FDA) to conduct a first-in-human feasibility study of the Tissue Genesis Icellator2(R) to treat Acute Respiratory Distress Syndrome (ARDS) resulting from COVID-19 infection.

The Tissue Genesis Icellator2 is a point-of-care cell isolation device that rapidly recovers high yields of stromal and vascular cells (“SVF”) from adipose tissue (fat) to be used therapeutically. The SVF derived from the Icellator2 contains a population of mesenchymal stem cells, vascular endothelial cells, and immune cells which migrate to the patient’s lungs and other peripheral sites of inflammation. Published nonclinical and clinical evidence indicate that SVF from the Icellator2 may potentially: (1) stabilize microcirculation to improve oxygenation; (2) maintain T and B lymphocytes to support antibody production; and (3) induce an anti-inflammatory effect. Orgenesis believes the multiple mechanisms of action of the SVF derived from the Icellator2 are important to treat ARDS and other inflammatory disorders.

The FDA IDE approval covers 21 patients at one clinical site in the United States. This is the first trial approved by the FDA for intravenous administration of the SVF produced by the Icellator2.

The rates of hospitalized patients in the U.S. suffering from ARDS resulting from COVID-19 has declined significantly in recent months. Orgenesis will monitor and evaluate current clinical needs prior to initiating this approved pilot trial.   Orgenesis may consider amending its clinical development plan to target treatment of non-COVID-19 related ARDS or treatment of patients who have not recovered from prior COVID-19 infections (so called “long haulers”).

Matthew Lehman, U.S. POCare General Manager, stated, “We believe that the FDA’s IDE authorization of the Tissue Genesis Icellator2 clinical trial is a significant milestone for the Company. We are excited to move forward with clinical development of the Icellator to treat ARDS, COVID-19-related complications, and other serious conditions. Our interactions with the FDA through the IDE process will inform our development plans. We look forward to providing further updates on the progress of our Icellator2 clinical trial.”

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. Learn more about the work Orgenesis is doing 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, 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.