Orgenesis Inc (NASDAQ:ORGS), a developer of advanced cell therapies, posted record revenue in its fiscal third-quarter, driven by growth in the company’s global contract development and manufacturing organization, or CDMO business.
For the quarter ended September 30, the Germantown, Maryland-based company saw its revenue shoot up by 46% to $9.1 million.
In a statement accompanying the company’s latest numbers, Orgenesis CEO Vered Caplan said: “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 point-of-care platform.”
Investors respnded to the news, with Orgenesis stock up 3.6% to $3.50 in midday trade Friday.
READ: Orgenesis inks co-development agreement with Accellix to improve quality control in its cellular therapy system
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.
“Within our CDMO segment, we continue to add new customers and partners and expand our relationships with the existing ones,” said Caplan.
“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,” she added.
Point-of-care cellular therapy platform shines
The Orgenesis boss also highlighted that the company generated meaningful revenue, over $1 million, through its point-of-care cellular therapy platform.
“Within our point-of-care platform, we remain focused on accelerating the development of cell and gene therapies through collaborations and in-licensing with research and healthcare institutes,” said Caplan.
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.
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.
Goal is to deliver autologous therapies
“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,” said Caplan. “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.”
Orgenesis recently 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.
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 ground breaking transdifferentiation platform technology. The technology is being licensed by Orgenesis Ltd from Tel Hashomer Medical Research Infrastructure and Services (THM) and is based on the work of Professor Ferber, who is a researcher at THM.
Meanwhile, Caplan said the company continued to expand its capacity in North America and Europe to support “growing demand.”
“We are investing heavily in the future, which includes increased personnel and other expenses. 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,” said Caplan.
“We are excited about the outlook for the company and believe that we have built a highly scalable foundation for long-term growth.”
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Contact Uttara Choudhury at [email protected]
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