For the quarter ended June 30, the Germantown, Maryland-based company saw its revenue shoot up by 95% to $7.8 million, which easily beat the consensus estimate of $6.4 million.
The company said it ended the quarter with over $16 million in cash and cash equivalents.
Investors responded well, sending Orgenesis shares more than 1% higher to $4.90 in morning trade.
In a statement, Orgenesis CEO Vered Caplan said: “We continue to generate strong sequential and year-over-year growth, which reflects our increasing market share within the cell and gene therapy market."
She chalked up the revenue boost to the company’s “high quality” global contract development and manufacturing organization, or CDMO business.
On the manufacturing side, the company’s subsidiary MaSTherCell Global is a CDMO, which helps companies shorten lead time and lower costs in getting cell therapies and products to the market.
Point-of-care cellular therapy platform
“I am especially pleased to report we generated our first meaningful revenues, nearly $1 million, through our point-of-care cellular therapy platform,” noted Caplan.
“Through this platform, our goal is to accelerate the development of advanced therapy medicinal products through collaborations and in-licensing with research and healthcare institutes.”
Earlier this year, Orgenesis opened new offices and labs at Accessia Pharma in Liège, Belgium for its Belgian subsidiary, Orgenesis SPRL, to support its point-of-care cellular therapy platform. The company is being backed by three of its partners — Theracell, Hemogenyx, and Serpin — to expand cellular therapy development in the Walloon region of Belgium.
Caplan pointed out that the new point-of-care revenue came from out-licensing advanced therapy medicinal products to regional partners to whom it also provided “regulatory services, pre-clinical studies, and co-development services.”
Orphan Drug status for AIP cells
During the quarter, Orgenesis won Orphan Drug designation for Autologous Insulin Producing (AIP) cells as a cell replacement therapy for the treatment of severe diabetes following a pancreatectomy, a surgical procedure performed to treat chronic pancreatitis.
“We have finalized agreements with leading medical centers in the US, Europe and Israel to collect liver tissue from patients to be used for a planned study,” said Caplan. “We also see significant opportunities ahead to expand our indications to include treatment for other causes of diabetes.”
The company’s Israeli subsidiary, Orgenesis Ltd, is also targeting insulin-dependent diabetes. Orgenesis is a pioneer in transdifferentiation, which involves direct reprogramming of an adult tissue or cell into another type of specialized cell with its distinct function.
Transdifferentiation potentially provides the use of a patient's own adult tissues to restore any damaged organs or tissue. This ability to convert one cell type to another holds great promise in the stem-cell field.
Orgenesis founder and chief scientific officer Professor Sarah Ferber is the inventor of the company’s groundbreaking transdifferentiation platform technology. The technology is being exclusively licensed by Orgenesis Ltd from Tel Hashomer Medical Research Infrastructure and Services Ltd (THM) and is based on the work of Professor Ferber, who is a researcher at THM.
Contact Uttara Choudhury at [email protected]
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