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Orgenesis Provides Business Update for Second Quarter of 2023

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Reports Progress in Advancing the Rollout of the POCare Platform and POCare Therapeutic Pipeline

Orgenesis to Host Conference Call Today at 8:00 AM ET

GERMANTOWN, Md., Aug. 11, 2023 (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 the second quarter ended June 30, 2023.

Vered Caplan, CEO of Orgenesis, said, “We are pleased to report revenue of approximately $7.0 million for the second quarter of 2023, which reflects the ongoing rollout of our POCare platform. We recently rebranded the POC Services business from Morgenesis to Octomera, following an additional investment from MM OS Holdings, L.P. (“MM”), an affiliate of Metalmark Capital Partners (“Metalmark”), a leading private equity firm. We believe their continued investment is further validation of our business model.”

“We continue to support the growth of our global POCare Network, which now includes a number of PoCare Centers located at strategic locations in various countries worldwide, which serve as hubs for the respective regions to help potentially being lifesaving treatments to patients across North America, Europe, Asia, and the Middle East. We also signed a recent partnership agreement with University of California, UC Davis to deploy Octomera Mobile Processing Units and Labs (OMPULs) at UC Davis and other healthcare universities within the State of California. Through these steps, we are clearly executing on our strategy to make advanced cell and gene therapy (CGT) products and services more accessible, affordable, and available to patients than traditional centralized models of CGT production.”

Ms. Caplan concluded, “We are also advancing our POCare therapeutic pipeline by leveraging grants and partnerships to help pay for their development. These programs span immuno-oncology, anti-viral, metabolic/auto-immune diseases, and tissue regeneration. We are focused on identifying the optimal licensing and marketing partners for several of the more advanced product candidates in our pipeline. 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. Overall, we believe we have built a scalable, high margin, recurring revenue business model.”

The complete financial results for the second quarter of 2023 are available on the Company’s website in the Company’s Form 10-Q, which has been filed with the Securities and Exchange Commission. The Company also notes that as a result of the deconsolidation of Octomera, the assets and liabilities of Octomera are not included on the Company’s balance sheet for the period ended June 30, 2023, although the Company still owns approximately 75% of Octomera.

Conference Call

The Company will host a conference call at 8:00 AM Eastern Time today, August 11, 2023, to discuss the Company’s corporate progress and other developments.

The conference call will be available via telephone by dialing toll free 877-545-0523 for U.S. callers or +1 973-528-0016 for international callers and using entry code 132591. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2585/48936 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 Sunday, August 11, 2024. A telephone replay of the call will be available approximately one hour following the call, through Friday, August 25, 2023, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and entering conference ID: 48936.

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, 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.

IR contact for Orgenesis:
Crescendo Communications, LLC
Tel: 212-671-1021
Orgs@crescendo-ir.com

Communications contact for Orgenesis
IB Communications
Neil Hunter / Michelle Boxall
Tel +44 (0)20 8943 4685
neil@ibcomms.agency / michelle@ibcomms.agency

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ORGENESIS INC.
CONSOLIDATED BALANCE SHEETS
(U.S. Dollars, in thousands)
 
 As of
 June 30,
2023
 December 31,
2022
Assets     
      
CURRENT ASSETS:     
Cash and cash equivalents$180 $5,311
Restricted cash 1,047  1,058
Accounts receivable, net 6  36,183
Prepaid expenses and other receivables 4,300  958
Receivables from related parties 966  -
Convertible loan to related party 2,762  2,688
Inventory 34  120
Total current assets 9,295  46,318
      
NON-CURRENT ASSETS:     
Deposits$47 $331
Equity investees 31,484  39
Loans to associates 97  96
Property, plant and equipment, net 1,249  22,834
Intangible assets, net 7,681  9,694
Operating lease right-of-use assets 494  2,304
Goodwill 3,703  8,187
Deferred tax -  103
Other assets 717  1,022
Total non-current assets 45,472  44,610
TOTAL ASSETS$54,767 $90,928


ORGENESIS INC.
CONSOLIDATED BALANCE SHEETS
(U.S. Dollars, in thousands)
 
  As of
  June 30,
2023

  December 31,
2022
Liabilities and Equity     
      
CURRENT LIABILITIES:     
Accounts payable$3,826  $4,429 
Accounts payable related parties 133   - 
Accrued expenses and other payables 2,235   2,578 
Income tax payable 520   289 
Employees and related payables 901   1,860 
Other payables related parties 999   - 
Advance payments on account of grant 1,481   1,578 
Contract liabilities -   70 
Current maturities of finance leases 18   60 
Current maturities of operating leases 254   542 
Short-term and current maturities of convertible loans 2,344   4,504 
Total current liabilities 12,711   15,910 
      
LONG-TERM LIABILITIES:     
Non-current operating leases$184  $1,728 
Convertible loans 17,834   13,343 
Retirement benefits obligation -   163 
Long-term debt and finance leases 13   95 
Advance payments on account of grant -   144 
Other long-term liabilities 60   271 
Total long-term liabilities 18,091   15,744 
TOTAL LIABILITIES 30,802   31,654 
      
REDEEMABLE NON-CONTROLLING INTEREST$-  $30,203 
      
EQUITY:
Common stock of $0.0001 par value: Authorized at June 30, 2023 and December 31, 2022: 145,833,334 shares; Issued at June 30, 2023 and December 31, 2022: 28,753,374 and 25,832,322 shares, respectively; Outstanding at June 30, 2023 and December 31, 2022: 28,466,807 and 25,545,755 shares, respectively
 3   3 
Additional paid-in capital 154,743   150,355 
Accumulated other comprehensive (income) loss 62   (270)
Treasury stock 286,567 shares as of June 30, 2023 and December 31, 2022 (1,266)  (1,266)
Accumulated deficit (129,577)  (121,261)
Equity attributable to Orgenesis Inc. 23,965   27,561 
Non-controlling interest -   1,510 
Total equity 23,965   29,071 
TOTAL LIABILITIES REDEEMABLE NON-CONTROLLING INTEREST AND EQUITY$54,767  $90,928 


ORGENESIS INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(U.S. Dollars, in thousands, except share and per share amounts)
 
 Three Months Ended Six Months Ended
 June 30,
2023
 June 30,
2022
 June 30,
2023
 June 30,
2022
                
                
Revenues$6,975  $6,699  $14,019  $13,276 
Revenues from related party -   502   -   1,137 
Total revenues 6,975   7,201   14,019   14,413 
Cost of revenues 3,232   1,063   5,954   1,777 
Gross profit 3,743   6,138   8,065   12,636 
Cost of development services and research and development expenses 3,527   7,838   6,808   14,489 
Amortization of intangible assets 208   229   415   461 
Selling, general and administrative expenses 3,337   2,803   7,376   5,654 
Operating loss 3,329   4,732   6,534   7,968 
Other income, net -   (8)  (2)  (8)
Loss from extinguishment in connection with convertible loan -   -   283   - 
Financial expenses, net 655   389   1,299   602 
Profit from deconsolidation of Octomera (see note 3) (411)  -   (411)  - 
Share in net loss (profit) of associated companies (3)  368   (1)  915 
Loss before income taxes 3,570   5,481   7,702   9,477 
Tax expenses 91   11   220   12 
Net loss 3,661   5,492   7,922   9,489 
Net income (loss) attributable to non-controlling interests (including redeemable) 466   (65)  394   (53)
Net loss attributable to Orgenesis Inc.$4,127  $5,427  $8,316  $9,436 
            
Loss per share:           
Basic and diluted$0.15  $0.22  $0.30  $0.38 
            
Weighted average number of shares used in computation of Basic and Diluted loss per share:           
Basic and diluted 28,357,779   24,820,756   27,308,183   24,711,462 
            
Comprehensive loss:           
Net loss$3,661  $5,492  $7,922  $9,489 
Other comprehensive loss - translation adjustments 11   326   52   477 
Release of translation adjustment due to deconsolidation of Octomera (384)  -   (384)  - 
Comprehensive loss 3,288   5,818   7,590   9,966 
Comprehensive income (loss) attributed to non-controlling interests 466   (65)  394   (53)
Comprehensive loss attributed to Orgenesis Inc.$3,754  $5,753  $7,984  $9,913 


ORGENESIS INC

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Biotechnology
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United States of America
GERMANTOWN