Orgenesis Subsidiary Masthercell Global Announces Plans to Establish New Facility for Cell and Gene Therapy Commercial Manufacturing

New Site Expected to Triple European Capacity

GERMANTOWN, Md., March 25, 2019 (GLOBE NEWSWIRE) --  Orgenesis Inc. (NASDAQ: ORGS), a developer of advanced cell therapies, manufacturer and service provider, today announced plans to establish a new, state-of-the-art production site for its Masthercell Global subsidiary, designed to manufacture late-stage and commercially-approved cell and gene therapy products.  The Company signed a lease agreement for a 5,700 square meter (61,354 square foot) building located within the Gosselies Biopark in Belgium. 

The new commercial facility is expected to be operational early in 2021 and is expected to triple Masthercell Global’s current capacity. The facility will include industry 4.0 precepts such as software integration, intelligent equipment and integrated processes with the objective to provide cell and gene therapy customers an efficient and cost-effective manufacturing solution.  Once the new commercial facility is operational, the current facility, also located within the Gosselies Biopark, will instead focus on industrial manufacturing process development and early to mid-stage, clinically-focused cell and gene therapy products.

Vered Caplan, CEO of Orgenesis, stated, “We are excited to launch this new facility, which will significantly enhance our capacity to meet the growing demand.  Moreover, this new facility will provide our customers unparalleled manufacturing capabilities and a strong competitive advantage.  But most importantly, we believe this facility, in addition to our current global capabilities, will help patients by providing greater access to life saving therapies.”

Dr. Denis Bedoret, President of Masthercell Global, commented, “As a leading CDMO, Masthercell is working hard to address the lack of commercial manufacturing capacity, especially in Europe.  With this facility, we aim to be the first CDMO in Europe to have a dedicated area for large-scale commercial manufacturing.”

“It was natural for us to set up this state-of-the-art plant in the Gosselies Biopark. Not only will it allow us to remain close to our current site and center of excellence; it will enable us to benefit from a first-class environment in terms of skills, people and know-how within this leading biotechnology cluster. This new production plant will create several hundred jobs and allow us to tap into local Belgian expertise to train our teams within the heart of Europe, in support of our international recruitment goals,” added Eric Mathieu, Chief Operating Officer of Masthercell’s Belgium operations. 

About Orgenesis
Orgenesis is a biotechnology company specializing in the development, manufacturing and provision of technologies and services in the cell and gene therapy industry.  The Company operates through two platforms: (i) a point-of-care (“POCare”) cell therapy platform (“PT”) and (ii) a Contract Development and Manufacturing Organization (“CDMO”) platform conducted through its subsidiary, Masthercell Global.  Through its PT business, the Company’s aim is to further the development of Advanced Therapy Medicinal Products (“ATMPs”) through collaborations and in-licensing with other pre-clinical and clinical-stage biopharmaceutical companies and research and healthcare institutes to bring such ATMPs to patients.  The Company out-licenses these ATMPs through regional partners to whom it also provides regulatory, pre-clinical and training, and processing services to support their activity in order to reach patients in a point-of-care hospital setting.  Through the Company’s CDMO platform, it is focused on providing contract manufacturing and development services for biopharmaceutical companies.  The CDMO platform operates through Masthercell Global, which currently consists of MaSTherCell in Belgium, Atvio in Israel and subsidiaries in South Korea and in the United States, each having unique know-how and expertise for manufacturing in a multitude of cell types.  Additional information is available 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 t.  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 success of our reorganized CDMO operations, the success of our partnership with Great Point, our ability to achieve and maintain overall profitability, the sufficiency of working capital to realize our business plans, the development of our transdifferentiation technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes; our technology not functioning as expected; our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new procedures; 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 November 30, 2018, 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:
David Waldman
Crescendo Communications, LLC
Tel: 212-671-1021
Orgs@crescendo-ir.com

Orgenesis.jpg

Source: Orgenesis Inc.