ORGS Orgenesis Inc

Orgenesis Inc. (Nasdaq:ORGS) (“Orgenesis” or the “Company”), a global leader in decentralizing cell and gene therapies (CGTs), today announced it has entered into a definitive agreement with MM OS Holdings L.P., an affiliate of Metalmark Capital Partners (“Metalmark”), for the acquisition of its approximate 25% stake in Octomera LLC (“Octomera”), the cell processing services subsidiary of the Company, thereby allowing the Company to have 100% ownership of this core strategic business unit. In exchange, Metalmark shall receive a royalty of 5% of the net revenue of Octomera’s cell processing services, for the three calendar years 2025-2027, along with a portion of the proceeds attributable to Octomera’s cell processing services should there be a change of control in the next 10 years.

Vered Caplan, CEO of Orgenesis, commented, “2023 has been a challenging year for the industry as lack of funding for early-stage companies has slowed down many companies, including our own customers and partners, increasing pressure on suppliers to the industry, while accelerating the need for lower-cost and more-efficient development and supply solutions. These factors highlight the need and are driving demand for our decentralized cell therapy approach. Moreover, we believe that further support is coming from FDA and EMEA regulators that are taking initiatives to progress the guidelines for decentralized production, understanding that cost pressures, capacity constraints and surging patient demand are encouraging hospitals to consider the paradigm-shifting decentralized approach that brings processing services closer to the patient and unlocking the associated benefits.”

“In addition to continuing third-party cell therapy services, on the cell therapeutics side, there is growing market awareness around safety issues and the immense cost burden of many first-generation approved cell and gene therapies. In parallel to progressing our decentralized Octomera platform, the Company’s most advanced oncology therapeutic in development continues to make significant advances in terms of decentralized GMP production and proof of concept with respect to efficacy and safety. The growing importance of scaling up for regulatory clinical trials and potential commercialization reinforced our view that it was strategically advantageous to take back control of Octomera.”

Caplan continued, “Through internally generated data from our R&D team, as well as external data through our strategic collaborations, we now have a solid foundation to move forward with the development of our proprietary therapeutics.”

Victor Miller, recently appointed Chief Financial Officer of Orgenesis, stated, “Orgenesis is unlike any other company in biotechnology. Thanks to the extraordinarily talented team in place, we now have unmatched cell processing expertise and a diverse portfolio of potentially groundbreaking therapies that, frankly, I believe is unprecedented in my 24 years of experience across the life science sector. We are very appreciative of Metalmark for supporting us through the biotech winter and seeing our decentralized vision for the future. Partnering with collaborators and hospitals, we believe that we are on the path to increasing healthcare access and improving outcomes for the mass of patients globally.”

Public updates on the portfolio of therapeutics and technologies at Orgenesis will be provided throughout 2024. To learn more, please visit our website.

About Orgenesis

Orgenesis is a global biotech company that has been committed to unlocking the potential of cell and gene therapies (CGTs) since 2012 as well as a paradigm-shifting decentralized approach to processing since 2020. This new model allows Orgenesis to bring academia, hospitals, and industry together to make these essential therapies a reality sooner rather than later. Orgenesis is focusing on advancing its CGTs toward eventual commercialization, while partnering with key industry stakeholders to provide a rapid, globally-harmonized pathway for these therapies to reach and treat a larger numbers of patients more cost effectively and with better outcomes through great science and decentralized production. Additional information about the Company is available at: www.orgenesis.com.

Additional details on the transaction with Metalmark can be found in the Company’s Form 8-K, which has been filed with the Securities and Exchange Commission, and is available on the Company’s website.

Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, the expected consolidation of Octomera in our consolidated financial statements, our reliance on, and our ability to grow, our decentralized cell therapy platform and OMPUL business, our ability to achieve and maintain overall profitability, our ability to manage our research and development programs that are based on novel technologies, our ability to control key elements relating to the development and commercialization of therapeutic product candidates with third parties, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, the sufficiency of working capital to realize our business plans and our ability to raise additional capital, the development of our decentralized cell therapy processing, our ability to further our CGT development projects, either directly or through our JV partner agreements, and to fulfill our obligations under such agreements, our license agreements with other institutions, our ability to retain key employees, our competitors developing better or cheaper alternatives to our products, risks relating to legal proceedings against us and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.

Investor relations contact for Orgenesis:Crescendo Communications, LLCTel: 212-671-1021Orgs@crescendo-ir.com

Communications contact for OrgenesisIB CommunicationsNeil Hunter / Michelle Boxall