Orgenesis is a small-cap biotech company focused on making cell and gene therapies (CGTs) more affordable by decentralizing production. Rather than developing proprietary drugs, Orgenesis builds and deploys its Decentralized Cell Processing (DCP) Platform — a modular, automated infrastructure placed at or near hospitals that standardizes CGT production without requiring custom cleanrooms or centralized factories. The company claims this approach cuts CAR-T production costs by roughly 73% versus traditional centralized manufacturing. Orgenesis' most commercially advanced therapy is KYSLECEL (Koligo), an FDA-cleared autologous islet cell therapy for chronic pancreatitis, with over 80 patients treated in the U.S. The company also has a clinically advanced CAR-T program targeting B-cell cancers, an adipose-derived cell therapy platform with over 1,750 patients treated internationally, and several earlier-stage programs. Orgenesis licenses its platform and therapy IP to regional partners, who run local clinical trials and commercialize within their territories in exchange for royalty payments back to Orgenesis. The company also provides cell processing services and R&D support to hospitals and partners through its POCare Centers. Despite the asset-light model, Orgenesis has generated minimal revenue, and the company faces severe financial distress — it carries roughly $65.8M in debt, had approximately $0.1M in cash at year-end 2024, and its auditors have issued a going concern opinion. Orgenesis was delisted from Nasdaq in October 2024 and now trades on the OTC market.