Loading, Please Wait...
GERMANTOWN, MD, Nov. 08, 2019 (GLOBE NEWSWIRE) -- Orgenesis Inc. (Nasdaq: ORGS) (“Orgenesis” or the “Company”), a leading cell and gene therapy enabling company providing centralized Contract Development and Manufacturing Organization (“CDMO”) manufacturing and development services through its subsidiary, Masthercell Global, Inc., as well as localized point-of-care (“POCare”) development and processing centers, today provided a business update for the fiscal third quarter ended September 30, 2019.
Vered Caplan, Chief Executive Officer of Orgenesis, commented, “We continue to generate strong year-over-year growth, which reflects the traction we are gaining within our CDMO business, as well as our evolving POCare platform. Specifically, revenue for the third quarter of 2019 increased 46% to a record $9.1 million and we generated over $1 million in sales through our new POCare platform. Year-to-date, revenue has increased 88% versus the same period last year. Within our CDMO segment, we continue to add new customers and partners and expand our relationships with the existing ones. As each of these customers advance through the clinic, and ultimately into commercialization, assuming the respective trials are successful, we would expect our revenues to increase. Moreover, within our POCare platform, we remain focused on accelerating the development of cell and gene therapies through collaborations and in-licensing with research and healthcare institutes. By applying our industrial manufacturing know-how, along with process automation within closed systems, our goal is to deliver autologous therapies in a cost effective, high quality and scalable manner to patients at point of care. We believe this approach has the potential to significantly impact the cell and gene therapy market by lowering the costs and expanding the supply of these therapies.”
“I am also pleased to report the continued expansion of our capacity in North America and Europe to support the growing demand. We are investing heavily in the future, which includes increased personnel and other expenses; however, as we continue to ramp up our capacity, as well as our activities, we expect to generate significant margin expansion as additional sites begin generating revenue. We are excited about the outlook for the Company and believe that we have built a highly scalable foundation for long-term growth.”
The Company’s complete financial results are available in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 2019, which is available at www.sec.gov and on the Company’s website. 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 September 30, 2019, to the three months ended August 31, 2018.
Orgenesis is a biopharmaceutical company specializing in the development, manufacturing and processing of technologies and services in the cell and gene therapy industry. The Company operates through two platforms: (i) a POCare cell therapy platform (“PT”) and (ii) a CDMO platform conducted through its subsidiary, Masthercell Global, Inc. 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 Partners, LLC; 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:
Crescendo Communications, LLC