Business Description

NOTE 1 – DESCRIPTION OF BUSINESS a. General Orgenesis Inc. (the “Company”) is a global biotech company working to unlock the promise of cell and gene therapies (“CGTs”) in an affordable and accessible offering. CGTs can use the patient’s own cells (autologous), or use donor cells (allogenic), and for regulatory purposes, are classified as Advanced Therapy Medicinal Products (“ATMPs”). We are primarily focused on pioneering a paradigm-shifting decentralized approach to CGT therapies utilizing an automated and/or closed approach validated for compliant production at or near the patient care site (“Decentralized Cell Processing or DCP Platform”). This approach has the potential to overcome the limitations of traditional centralized processing methods due to their complex logistics and inefficient unscalable processing methods leading to cost prohibitive products that currently limit the number of patients that can have access to these therapies. To overcome the challenges posed by traditional centralized processing methods, the Company has designed and implemented its DCP Platform - a scalable hub and spoke infrastructure of analytical centers overseeing standardized production platforms, technology and services governed by a central quality system, focusing on replicability and standardization of infrastructure and equipment with centralized monitoring and data management. Features of the DCP Platform include a locally implemented quality system, Standard Operating Procedures (SOPs), Good Manufacturing Practices (“GMP”), training procedures, quality-control testing and hub oversight of the actual production. The Company is leveraging its unique approach to therapy production using its DCP Platform and various manufacturing platforms to address some of the quality, supply chain, scale-up and production challenges, adapting these therapies to validated manufacturing platforms that are adapted to standardized production units that can be placed quickly and a low cost throughout its DCP network. To achieve these goals, the Company is developing a pipeline of POCare advanced therapies that can be processed and produced under such closed and automated processes and systems (“POCare Therapies”) as well as developing a collaborative worldwide network of academia, hospitals, and industry partners (POCare Network”) who are collaborating with the Company to build its DCP Platform. On January 29, 2024 (“date of reconsolidation”), the Company and an affiliate of Metalmark Capital Partners (“Metalmark” or “MM”) entered into a Unit Purchase Agreement (the “UPA”), pursuant to which the Company acquired all of the preferred units of Octomera owned by MM (the “Acquisition”). Accordingly, the Company currently owns 100 % of the equity interests of Octomera. The Company had previously deconsolidated Octomera from its consolidated financial statements (See note 3). These consolidated financial statements include the accounts of Orgenesis Inc. and its subsidiaries. During 2024, the Company acquired Octomera (see note 3) and deconsolidated its OBI, Korea and Belgium subsidiaries (see note 20). On September 20, 2024, the Company implemented a 1-for-10 reverse stock split (the “Reverse Split”) of its authorized and outstanding shares of Common Stock. All share and per share amounts in these financial statements have been retroactively adjusted to reflect the reverse split as if it had been effected prior to the earliest financial statement period included herein. Following the Reverse Split, the number of authorized shares of common stock that the Company is authorized to issue from time to time is 14,583,333 shares. The Company’s common stock, par value $ 0.0001 per share (the “Common Stock”), is traded on the OTCQX under the symbol “ORGS.” On September 27, 2023, the Company received a notice from the Listing Qualifications Staff (“Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) stating that the bid price of the Common Stock had closed at less than $1.00 per share over the previous 30 consecutive business days, and, as a result, did not comply with Listing Rule 5550(a)(2) (the “Bid Price Rule”).…