Orgenesis Third Quarter 2020 Revenue Increases 40% Reflecting Continued Progress of POCare Platform

On November 5, 2020 Orgenesis Inc. (NASDAQ: ORGS) ("Orgenesis" or the "Company"), a global biotech company working to unlock the full potential of cell and gene therapies, reported a business update for the third quarter of 2020. Revenue increased 40% to $1.7 million compared to $1.2 million for the third quarter of 2019 (Press release, Orgenesis, NOV 5, 2020, View Source [SID1234570022]). The Company also reported approximately $88.8 million of cash and cash equivalents as of September 30, 2020.

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Vered Caplan, CEO of Orgenesis, stated, "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 metabolic/auto-immune diseases. A near-term goal is expanding the availability of KYSLECEL from the recent Koligo acquisition. KYSLECEL is commercially available in the United States for chronic and recurrent acute pancreatitis. 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. 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. Additionally, Orgenesis is preparing for a Phase 2 study of Ranpirnase for the treatment of conditions caused by human papilloma virus pending a planned IND submission to the FDA.

"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. 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. Through this unique model, Orgenesis has already signed contracts, which we expect to 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 Tumor Infiltrating Lymphocytes (TILS), CAR-T, CAR-NK, dendritic cell therapies, and mesenchymal stem cell (MSC) based therapies."

"Finally, Orgenesis is ready to announce advancements on proprietary, cell and gene processing units and labs that are being developed using first-in-class 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. Orgenesis intends to roll these OMPULs out in centers that we are establishing across the US, Europe, Asia, and the Middle East."

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 5, 2020 which is available at www.sec.gov and on the Company’s website.