Orgenesis reaches next milestone in collaboration with Hospital Infantil Universitario Niño Jesús in Madrid

Orgenesis reaches next milestone in collaboration with Hospital Infantil Universitario Niño Jesús in Madrid

• Orgenesis achieves milestone in the placement of the Orgenesis Mobile Processing Units and Lab (OMPUL) for the development of cell and gene therapies at the Hospital
• OMPULs expected to contribute to significant cost reductions and accelerate development of cell and gene therapies

Germantown, Maryland, US, January 27, 2022 — 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 it has achieved its latest milestone in the second phase of its collaboration with the Hospital Infantil Universitario Nino Jesus (“Hospital”) in Madrid, Spain.

The milestone has been achieved by completing the placement of an Orgenesis Mobile Processing Unit and Lab (OMPUL) on site. This OMPUL is the first in Europe that has been designed specifically to process Tumor Infiltrating Lymphocytes (TILs) and Mesenchymal Stem Cells (MSCs). OMPULs are multi-purpose mobile autonomous good manufacturing practice (GMP) facilities intended to develop, optimize and process cell and gene therapies at the point of care.

Orgenesis first signed a research and development collaboration with Hospital Infantil Universitario Niño Jesús in May 2020, which was established to create a point-of-care center (POCare Center). The OMPUL was delivered in January 2022 and is expected to be operational following certification by the Spanish health authorities and regulatory bodies, which is anticipated in Q2, 2022.

The manufacture and processing of TILs at the point of care is expected to lead to significant development and manufacturing cost reductions for the Hospital. In turn, the OMPUL is also expected to contribute to a significant reduction in the cost of goods of other cell therapies, including the Celyvir therapy, an MSCs based therapy which was licensed from the Hospital in March 2021. The cost of goods has been a major industry barrier to delivering TILs and other cell therapies to patients, many of whom have few alternative therapeutic options.

“We believe the installation of Orgenesis’ OMPULs is critical for the Hospital’s therapies to continue to develop at the point of care, while enabling the Hospital to retain control of the process, as well as delivering cell and gene therapies at a cost that is affordable for patients and healthcare providers,” said Vered Caplan, CEO, Orgenesis. “We are continuing to deliver Orgenesis OMPULs across our Point of Care Network globally. Through our POCare platform, we also enable hospitals and healthcare providers around the world to share data within the network. This decentralized manufacturing and collaboration model is expected to become a key factor for a quicker delivery of approved therapies at an affordable cost, which we believe will be a key enabler for unlocking the full potential of such cell and gene therapies.”

“We have partnered with Orgenesis to rapidly develop our therapies to their full potential. Until now, costs and manufacturing hurdles have inhibited the ability of solid tumor patients to receive practical and sustainable solutions from the cell and gene therapy sector. We believe the OMPUL will help overcome these challenges and allow us to accelerate the process of developing therapies, by providing a scalable and cost-effective solution for development through commercialization,” said Dr. Manuel Ramírez MD, PhD, Head of the Pediatric Advanced Therapies Unit at the Hospital. “I truly believe Orgenesis’ OMPULs will prove invaluable in accelerating the development of TILs, Celyvir and other groundbreaking cell and gene therapies to patients of the Hospital, as well as worldwide through the Orgenesis POCare Network.”

About Hospital Infantil Universitario Nino Jesus

Nino Jesus University Children's Hospital, birthplace of pediatrics in Spain, has been a national benchmark in pediatric healthcare since it was founded in 1877. It is leading the field of ATMPs for childhood and adolescent diseases in Spain, including cancer, transplantation, neuropediatrics and orthopedics, through an ambitious program of research, development, and manufacturing. It has the only authorized GMP facility for both gene and cell therapies in a medical center in Spain. 

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. www.orgenesis.com.

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 effectively use the net proceeds from the sale of Masthercell, our ability to achieve and maintain overall profitability, 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 which could, if successful, be a cure for Type 1 Diabetes, the technology behind our in-licensed ATMPs not functioning as expected, 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, 2019, 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.