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PRESS RELEASE
Tuesday 11 July 2023
Press Release
Media Contacts:
IB Communications
Orgenesis announces name change of Morgenesis business unit to Octomera
Name change and rebranding reflects progression of the business and focus on changing the paradigm of CGT production
Germantown, Maryland, July 11, 2023 – Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT) at the point of care, today announced the name change of the POC Services business from Morgenesis to Octomera, effective June 30, 2023, to reflect the growth and focus on providing advanced cell and gene therapy (CGT) services, facilities, and technologies. Morgenesis was originally formed in 2022 to separate Orgenesis’ existing POCare Service and supply solutions from the other operations of Orgenesis. A new Octomera website and rebranding will be unveiled throughout the second half of 2023.
In addition, the Company announced that MM OS Holdings, L.P. (“MM”), an affiliate of Metalmark Capital Partners (“Metalmark”), a leading private equity firm with extensive expertise in the healthcare sector, has deployed additional funds into Octomera. The capital from the MM investment is for the continued development of POCare Centers with a focus on expanding in the US market.
Octomera is focused on changing the paradigm of centralized cell and gene therapy (CGT) production to produce treatments in a decentralized point-of-care manner. Octomera provides the supply and development of decentralized services utilizing the POCare Network of POCare Centers deployed independently and in partnership with academic institutes, hospitals, and industry partners. POCare Centers within the Network are harmonized and standardized by Octomera.
“The centralized biotech manufacturing model simply does not translate to efficient or cost-effective CGT production within the clinical development stage, and even less so for approved products,” said Vered Caplan, CEO of Orgenesis. “We have been working for years to reduce the complexity and cost of development and commercialization of CGT products via decentralization, and this rebranding as Octomera with the support of Metalmark marks a major milestone for both Orgenesis and Octomera. As a result of our efforts, investments, and foresight, we have now built a broad and growing POCare Network of centers across the US, Europe, and other regions, where our services can be rapidly scaled up to meet the growing demand across the industry.”
“Our strong process development capabilities coupled with our growing number of POCare sites enable us to decentralize the supply of cell and gene therapies. By initially developing a robust production process programmed into our proprietary, agnostic, and flexible OMPULs (Octomera Mobile Production Units and Labs), the production can be efficiently scaled and transferred to various locations in the network,” Caplan continued. “Through these steps, we are clearly executing on our strategy to make CGT products and services more accessible, affordable, and available to patients than traditional centralized models of CGT production.”
POCare centers and OMPULs are designed to standardize CGT production processes for quality and regulatory compliance with the ability to scale to full cGMP processing across the globe at a lower cost. A GMP team with significant practical experience oversees the centers and OMPULs and works to implement advanced quality management and IT solutions. Uniquely, OMPULs can be deployed and operational in 2-3 months within an existing structure or in available outdoor space, and production capacity can easily be scaled via additional units. The interior can be purpose-built to include GMP-compliant production space, with options for quality control labs and warehouse spaces.
“Metalmark is pleased to support the launch of Octomera as the company reiterates its focus on providing standardized, decentralized, cost-effective development and production of CGT products,” said Howard Hoffen, Chairman and CEO of Metalmark Metalmark.
To learn more about Octomera, connect with the team at contact@octomera.com.
About Orgenesis
Orgenesis is a global biotech company that has been committed to unlocking the potential of decentralized cell and gene therapies (CGTs) since 2012. Orgenesis established the POCare Network in 2020 to bring academia, hospitals, and Industry together to make these innovations more affordable and accessible to patients. In 2022, the POCare Services business unit responsible for developing and managing the decentralized POCare Centers and proprietary OMPULs was formed. Orgenesis will continue to focus on advancing to market through various partnerships its CGTs to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. Additional information about the Company is available at: www.orgenesis.com.
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 deconsolidation of Octomera from our consolidated financial statements, our reliance on, and our ability to grow, our point-of-care 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, our ability to manage potential disruptions as a result of the COVID-19 pandemic, the sufficiency of working capital to realize our business plans and our ability to raise additional capital, the development of our POCare strategy, our trans differentiation technology as therapeutic treatment for diabetes, the technology behind our in-licensed ATMPs not functioning as expected, 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.