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Orgenesis sees 3Q revenue rise by 40%, driven by rapid progress in its point-of-care network

Published: 09:59 05 Nov 2020 EST

Orgenesis - Orgenesis sees 3Q revenue rise by 40%driven by rapid progress in its point-of-care network
CEO Vered said given the firm's focus on the coronavirus space, it was planning patient recruitment for a phase 2 clinical trial of KT-PC-301, subject to FDA clearance of an IND application

Orgenesis Inc (NASDAQ:ORGS) (FRA:45O) posted third-quarter results on Thursday that saw its revenue jump 40% year-over-year on the back of growth in its Point of Care (POCare) cell and gene therapy (CGT) network. 

For the period ended September 30, 2020, the Germantown, Maryland-based company reported revenue of $1.7 million, compared to $1.2 million in the same period in 2019.

Orgenesis said it had ample cash and equivalents of $88.8 million as of September 30, 2020.

READ: Orgenesis completes acquisition of Koligo Therapeutics and acquires assets of Tissue Genesis LLC

In a statement accompanying the numbers, Orgenesis CEO Vered Caplan said: “OrGenesis continues to gain traction with a disruptive, point-of-care strategy for potentially commercializing life-changing treatments at reduced costs for large numbers of patients. In Q3 2020, we expanded the POCare Platform to include new POCare Therapeutics, technologies, and a growing global network.”

Orgenesis recently completed an acquisition of Koligo Therapeutics Inc, a regenerative medicine company, including substantially all of the assets of Tissue Genesis LLC. This acquisition helped to expand our therapeutic and technology resources, while adding a highly experienced US team to help further bolster Orgenesis’ POCare Network in the US.”

On the therapeutic front, Orgenesis is focused on several key verticals, including Immuno-oncology, anti-viral, and auto-immune diseases.

The Orgenesis boss said the firm’s near-term goal is expanding the availability of KYSLECEL from the recent Koligo acquisition. KYSLECEL, is made from a patient's own pancreatic islets – the cells that make insulin to regulate blood sugar – and is commercially available in the US for chronic and recurrent acute pancreatitis.

She also told investors the company was focused on the coronavirus (COVID-19) space.

“We are also planning patient recruitment for a phase 2 randomized clinical trial of KT-PC-301, subject to FDA review and clearance of an investigational new drug (IND) application,” said Caplan.

“KT-PC-301 is an autologous clinical development-stage cell therapy candidate for COVID-19-related Acute Respiratory Distress Syndrome, which we also acquired as part of the Koligo acquisition.”

In addition, Orgenesis is gearing up for a Phase 2 study of Ranpirnase for the treatment of conditions caused by human papilloma virus, pending a planned IND submission to the Food and Drug Administration.

“Orgenesis intends to leverage our network of regional partners to advance the development and commercialization of our therapeutic pipeline. Towards this end, our partners have committed to funding the clinical programs,” said Caplan. “In turn, Orgenesis typically grants its partners geographic rights in exchange for future royalties, and a partnership with Orgenesis to support the supply of the targeted therapies.”

Caplan said that through this unique model, Orgenesis has already signed contracts, which could generate over $40 million in revenue over the next three years, if fully realized.

“There are also plans to continue to develop, license and form partnerships around a variety of POCare Technologies to support work in areas such as tumour-infiltrating lymphocytes (TILS), CAR-T, CAR-NK, dendritic cell therapies, and mesenchymal stem cell (MSC) based therapies,” she added.

Orgenesis said it is it gearing up to announce advancements on its proprietary, cell and gene processing units and labs that are being developed using automation technologies.

“Orgenesis Mobile Processing Units & Labs (OMPULs) are designed to provide an economical industrial alternative for our POCare Network partners to produce cell and gene therapies at the point of care,” said Caplan.

“We intend to roll these OMPULs out in centers that we are establishing across the US, Europe, Asia, and the Middle East.”

Contact the author Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

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