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    Orgenesis Achieves Revenue of $8.0 Million for the Third Quarter of 2022

    11/10/22 4:30:00 PM ET
    $ORGS
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $ORGS alert in real time by email

    Secures up to $50 Million of Funding from Metalmark Capital Partners Expected to Accelerate Rollout of Point-of-Care Services

    Reduces operating expenses by 49% to achieve nearly breakeven income from operation for the third quarter of 2022

    Orgenesis to Host Conference Call on Friday, November 11, 2022 at 8:00 AM Eastern Time

    GERMANTOWN, Md., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ:ORGS) ("Orgenesis" or the "Company"), a global biotech company working to unlock the full potential of cell and gene therapies (CGT), today provided a business update for third quarter ending September 30, 2022.

    Vered Caplan, CEO of Orgenesis, said, "We have made significant progress in advancing the rollout of our POCare platform. As recently announced, we secured up to $50 million in funding from Metalmark Capital Partners, a premier private equity firm, into a recently formed point of care services subsidiary, Morgenesis LLC. This transaction was highly strategic for the Company and we believe that it provides further validation of our business model. Notably, Metalmark valued this one subsidiary alone at a pre-money valuation of $125 million for its investment, which represents a significant premium to the market cap of our entire company. Moreover, this investment structure allowed us to fund the POCare services business, while minimizing dilution given the current state of the public markets."

    "We are highly encouraged by industry feedback related our POCare Platform. There is a shortage of production capacity in the cell and gene therapy space, and we believe that our process is far more scalable and cost-effective than the traditional centralized CDMO (Contract Development and Manufacturing Organization) model.   Moreover, our POCare platform addresses many of the key challenges facing the industry, including capacity constraints and excessive costs. We believe our model is uniquely positioned to address these challenges through a highly innovative decentralized model, which lowers costs, streamlines logistics, and expands capacity."

    "While we are pleased to have achieved revenue of approximately $8.0 million for the third quarter, we were limited by capital constraints. With Metalmark's support, we look forward to capitalizing on the broad demand and accelerating the deployment of our Orgenesis Mobile Processing Units and Labs (OMPULs) to potentially bring lifesaving treatments to patients across North America, Europe, Asia, and the Middle East."

    "It is important to note that separate from Morgenesis, we have a deep therapeutics pipeline in various stages of development. These programs span immuno-oncology, anti-viral, metabolic/auto-immune diseases, and tissue regeneration, and we have established co-development partnerships to help pay for their development. As these programs progress, we expect to increasingly benefit from revenue sharing and royalty agreements with our partners as we seek to advance the respective therapies through commercialization. Through these partnerships and prudent cash management, we have dramatically reduced our SG&A expenses by 49% and our net loss by 86%. As a result, we achieved nearly breakeven income from operations for the third quarter of 2022. Overall, we have built a scalable, high margin, recurring revenue business model."

    The complete financial results for the third quarter of 2022 are available on the Company's website in the Company's Form 10-Q, which has been filed with the Securities and Exchange Commission.

    Conference Call

    The Company will host a conference call on Friday, November 11, 2022 at 8:00 AM ET to discuss the company's corporate progress and other developments.

    The conference call will be available via telephone by dialing toll free 888-506-0062 for U.S. callers or +1 973-528-0011 for international callers and using entry code 849908. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2585/47112 or on the Company's Investor Events section of the website here.

    A webcast replay will be available on the Company's Investor Events section of the website (https://ir.orgenesis.com/events#/) through Saturday, November 11, 2023. A telephone replay of the call will be available approximately one hour following the call, through Friday, November 25, 2022 and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331for international callers and entering conference ID: 47112.

    About Orgenesis

    Orgenesis 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 Orgenesis 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. Orgenesis 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 POCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies. 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, 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, 2021, 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.

    IR contact for Orgenesis:

    Crescendo Communications, LLC

    Tel: 212-671-1021

    [email protected]

    Communications contact for Orgenesis

    IB Communications

    Neil Hunter / Michelle Boxall

    Tel +44 (0)20 8943 4685

    [email protected] / [email protected]

    (tables follow)

    ORGENESIS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (U.S. Dollars in thousands)

    (Unaudited)

            
     As of 
     September 30,

    2022
      December 31,

    2021
     
    Assets       
            
    CURRENT ASSETS:       
    Cash and cash equivalents$3,015  $5,473 
    Restricted cash 1,452   501 
    Accounts receivable, net * 23,744   15,245 
    Prepaid expenses and other receivables 899   1,188 
    Convertible loan receivable-related party 2,651   3,064 
    Grants receivable -   169 
    Inventory 95   118 
    Total current assets 31,856   25,758 
            
    NON-CURRENT ASSETS:       
    Deposits$309  $363 
    Investments and loans to associates 1,739   584 
    Loans receivable -   821 
    Property, plant and equipment, net 16,526   10,271 
    Intangible assets, net 10,720   11,821 
    Operating lease right-of-use assets 1,040   1,015 
    Goodwill 7,764   8,403 
    Other assets 736   805 
    Total non-current assets 38,834   34,083 
    TOTAL ASSETS$70,690  $59,841 
            
    *Including related party in the amount of $2,186 thousand and $1,972 thousand as of September 30, 2022 and as of December 31, 2021, respectively.

    ORGENESIS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS (Cont'd)

    (U.S. Dollars in thousands)

    (Unaudited)

     As of 
     September 30,

    2022
      December 31,

    2021
     
    Liabilities and Equity       
            
    CURRENT LIABILITIES:       
    Accounts payable$4,538  $5,238 
    Accrued expenses and other payables 3,305   485 
    Income tax payable 37   54 
    Employees and related payables 1,835   1,907 
    Advance payments on account of grant 1,392   1,238 
    Contract liabilities 70   59 
    Current maturities of finance leases 16   18 
    Current maturities of operating leases 487   481 
    Current maturities of convertible loans 22,488   5,885 
    Total current liabilities 34,168   15,365 
            
    LONG-TERM LIABILITIES:       
    Non-current operating leases$522  $561 
    Convertible loans 5,162   4,854 
    Retirement benefits obligation 123   101 
    Non-current finance leases 24   41 
    Advance payments on account of grant 201   - 
    Other long-term liabilities 240   288 
    Total long-term liabilities 6,272   5,845 
    TOTAL LIABILITIES 40,440   21,210 
            
    EQUITY:       
    Common stock of $0.0001 par value: Authorized at September 30, 2022 and December 31, 2021: 145,833,334 shares; Issued at September 30, 2022 and December 31, 2021: 25,832,322 and 24,567,366 shares, respectively; Outstanding at September 30, 2022 and December 31, 2021: 25,545,799 and 24,280,799 shares, respectively 3   3 
    Additional paid-in capital 149,465   145,916 
    Receipts on account of shares and warrants to be allotted -   - 
    Accumulated other comprehensive income (loss) (826)  207 
    Treasury stock 286,567 shares as of September 30, 2022 and December 31, 2021 (1,266)  (1,266)
    Accumulated deficit (117,164)  (106,372)
    Equity attributable to Orgenesis Inc. 30,212   38,488 
    Non-controlling interest 38   143 
    Total equity 30,250   38,631 
    TOTAL LIABILITIES AND EQUITY$70,690  $59,841 

    ORGENESIS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

    (U.S. Dollars in thousands, except share and loss per share amounts)

    (Unaudited)

                    
     Three Months Ended  Nine Months Ended 
     September

    30, 2022
      September

    30, 2021
      September

    30, 2022
      September

    30, 2021
     
    Revenues$7,841  $7,606  $21,117  $25,656 
    Revenues from related party 147   1,070   1,284   2,954 
    Total revenues 7,988   8,676   22,401   28,610 
    Cost of revenues, development services and research and development expenses 4,666   10,007   20,932   25,861 
    Amortization of intangible assets 225   236   686   713 
    Selling, general and administrative expenses 3,104   6,092   8,758   11,961 
    Operating loss 7   7,659   7,975   9,925 
    Other (loss) income, net 2   (3)  (6)  (31)
    Loss from extinguishment in connection with convertible loan -   1,865   -   1,865 
    Financial expenses, net 1,100   545   602   639 
    Share in net loss of associated companies 274   18   1,189   33 
    Loss before income taxes 1,383   10,084   10,860   12,976 
    Tax expenses (income) 25   67   37   65 
    Net loss 1,408   10,151   10,897   13,041 
    Net loss attributable to non-controlling interests (52)  8   (105)  (4)
    Net loss attributable to Orgenesis Inc.$1,356  $10,159  $10,792  $13,037 
                    
    Loss per share:               
    Basic and diluted$0.05  $0.42  $0.43  $0.54 
                    
    Weighted average number of shares used in computation of Basic and Diluted loss per share:               
    Basic and diluted 25,403,907   24,275,276   24,944,814   24,278,292 
                    
    Comprehensive loss:               
    Net loss$1,408  $10,151  $10,897  $13,041 
    Other comprehensive loss (income) - translation adjustments 556   229   1,033   458 
    Comprehensive loss 1,964   10,380   11,930   13,499 
    Comprehensive loss attributed to non-controlling interests (52)  8   (105)  (4)
    Comprehensive loss attributed to Orgenesis Inc.$1,912  $10,388  $11,825  $13,495 


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