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Orgenesis Second Quarter 2019 Revenue Increases 95% to a Record $7.8 Million

1013 Days ago

Generates $1 Million in Sales through New POCare Platform

Ends Quarter with Over $16 Million of Cash and Cash Equivalents

GERMANTOWN, Md., Aug. 12, 2019 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a leading cell and gene therapy enabling company providing centralized CDMO manufacturing and development services through its subsidiary, MTH Global, Inc., as well as localized point-of-care development and processing centers, today reported financial results and provided a business update for the fiscal second quarter ended June 30, 2019.  As a result of the Company’s change in its fiscal year end from November 30 to December 31, the Company is comparing the results for the three months ended June 30, 2019, to the three months ended May 31, 2018.

Vered Caplan, CEO of Orgenesis, commented, “We continue to generate strong sequential and year-over-year growth, which reflects our increasing market share within the cell and gene therapy market. We are rapidly gaining market share within our Contract Development and Manufacturing Organization (“CDMO”) business due to growing demand for our high-quality services. I am especially pleased to report we generated our first meaningful revenues, nearly $1 million, through our POCare platform. Through this platform, our goal is to accelerate the development of Advanced Therapy Medicinal Products (“ATMPs”) through collaborations and in-licensing with research and healthcare institutes. Our revenues are based on our out-licensing of these ATMPs to regional partners to whom we also provide regulatory services, pre-clinical studies, and co-development services to support their activity.  The early traction we are gaining is further validation of the investments we have made in our POCare platform, as we believe our novel approach to the market has the potential to transform the cell and gene therapy markets.”

“I am also pleased to report that during the second quarter the United States Food & Drug Administration granted us Orphan Drug designation for our Autologous Insulin Producing (“AIP”) cells as a cell replacement therapy for the treatment of diabetes resulting from total pancreatectomy.  We have finalized agreements with leading medical centers in the U.S., Europe and Israel to collect liver tissue from patients to be used for a planned study. We also see significant opportunities ahead to expand our indications to include treatment for other causes of diabetes. This is just one example of the many ways we are leveraging our POCare platform to speed the development, lower costs and accelerate the path to market for transformative and lifesaving cell and gene therapies.”

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 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. 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.  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

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