Cell and Gene Therapies Designed for Affordable and Accessible Point of Care Use, Deploying in California: Orgenesis, Inc. (NASDAQ: ORGS)

April 05, 2023 at 16:14 PM EDT

Global Biotech Working to Unlock the Full Potential of Cell and Gene Therapies.
Point of Care Platform Focused on Affordable and Accessible Options.
98% Year-Over-Year Revenue Increase to $13.6 Million for the 4th Quarter of 2022.
MOU with the University of California, Davis to deploy Mobile Processing Units and Labs at UC Davis and other Healthcare Universities Within the State of California.

Orgenesis, Inc. (NASDAQ: ORGS) is a global biotech company working to unlock the full potential of cell and gene therapies (CGTs) in an affordable and accessible format at the point of care. The ORGS POCare Platform is comprised of three enabling components: a pipeline of licensed POCare Therapeutics that are processed and produced in closed, automated POCare Technology systems across a collaborative POCare Network.

ORGS identifies promising new therapies and leverages its POCare Platform 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. The ORGS POCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of therapies.

ORGS Reports 98% Year-Over-Year Increase in Revenue to $13.6 Million for the Fourth Quarter of 2022

On March 21^st ORGS provided a business update for the fourth quarter and year ended December 31, 2022.

Vered Caplan, CEO of ORGS, said, "I am pleased to report that revenue for the fourth quarter of 2022 increased by 98% to $13.6 million, compared to $6.9 million for the same period last year as we are progressing with the planned rollout of our POCare platform. In addition to our strong revenue growth, we reduced our operating loss by 91% for the fourth quarter of 2022 versus the same period last year, which reflects our cost-effective and highly scalable business model. The goal of our ORGS Mobile Processing Units and Labs (OMPUL) strategy is to provide autologous cell and gene therapies to patients in need at the point of care, which, in turn, is expected to dramatically lower costs. Our latest investments have allowed us to increase our capacity and advance our go-to-market strategy as we aim to expand the deployment of our ORGS Mobile Processing Units and Labs (OMPULs). Most recently, we signed a non-binding memorandum of understanding (MOU) with the University of California, Davis (UC Davis) to deploy our OMPULs at UC Davis and other healthcare universities within the State of California. Additionally, we are focused on supporting the POCare Centers located at strategic locations in various countries across North America, Europe, Asia, and the Middle East, which serve as hubs for the respective regions."

Ms. Caplan continued, "ORGS is also advancing our POCare therapeutic pipeline while leveraging grants and partnerships. In 2022, our subsidiary, Koligo Therapeutics, supplied Kyslecel to five medical institutes supplying total pancreatectomy-islet auto transplant (TP-IAT) cases. Production from this one site enabled Koligo to achieve positive cash flow from operations in the fourth quarter of the year as a separate business unit. Additionally, Koligo passed an FDA inspection of this site as a registered tissue production establishment in February. Following this confirmation of the infrastructure design and production protocols, and building on increasing demand, we are now pursuing plans for site expansion in the US and internationally. In the EU, Koligo is utilizing the expertise of ORGS to enable regional production capacity and leverage grants to drive clinical development towards marketing approval."

The complete financial results for the fourth quarter and year ended December 31, 2022, are available on the ORGS website in the Company's Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.

Conference Call

ORGS hosted a conference call to discuss the Company's corporate progress and other developments. A webcast replay will be available on the Company's Investor Events section of the website (https://ir.orgenesis.com/events#/) through Thursday, March 21, 2024.

MOU with the University of California, Davis to Develop an Agreement to Deploy Cell and Gene Therapy Mobile Processing Units and Labs Across California

On March 16^th ORGS announced the signing of a non-binding memorandum of understanding (MOU) with the University of California, Davis (UC Davis).

The goal of the MOU is to progress towards a wider definitive agreement pursuant to which the University and ORGS POC CA expect to roll out Morgenesis' proprietary Orgenesis Mobile Processing Units and Labs™ (“OMPULs™”) throughout universities within the State of California.

Both ORGS and the University, aim to roll out the OMPULs within the State of California in a staged approach. The first stage involves establishing and validating an OMPUL at UC Davis, anticipated to be within the first 12 months following the execution of a definitive agreement between the parties. Thereafter, both parties will agree upon and develop a decentralized model of OMPUL placement in compliance with regulatory requirements, as well as commercialize and install OMPULs at other healthcare sites within the State of California. The intent is to enable the development and manufacture of cell and gene therapies from ORGS, its partners, and UC Davis’ partners. ORGS POC CA or its affiliates and the University may agree to develop and/or manufacture other therapies initiated by the University and/or third parties for point-of-care treatment of patients utilizing the OMPUL, subject to further agreement(s).

For more information on ORGS visit: www.orgenesis.com

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Disclaimer/Safe Harbor:

These news releases and postings may contain forward-looking statements within the meaning of the Securities Litigation Reform Act. The statements reflect the Company’s current views with respect to future events that involve risks and uncertainties. Among others, these risks include the expectation that any of the companies mentioned herein will achieve significant sales, the failure to meet schedule or performance requirements of the companies’ contracts, the companies’ liquidity position, the companies’ ability to obtain new contracts, the emergence of competitors with greater financial resources and the impact of competitive pricing. In light of these uncertainties, the forward-looking events referred to in this release might not occur.

Media Contact
Company Name: Orgenesis, Inc
Contact Person: Vered Caplan, CEO
Email: Send Email
Phone: (480) 659-6404
City: Germantown
State: Maryland
Country: United States
Website: https://orgenesis.com/

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Cell and Gene Therapies Designed for Affordable and Accessible Point of Care Use, Deploying in California: Orgenesis, Inc. (NASDAQ: ORGS)

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