Orgenesis Achieves Revenue of $7.2 Million for the Second Quarter of 2022

White Plains, New York, UNITED STATES


Secures Funding from Metalmark Capital Partners to Drive Growth

Orgenesis to Host Conference Call Today, August 16, 2022 at 11 AM Eastern Time

GERMANTOWN, Md., Aug. 16, 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 second quarter ending June 30, 2022.

Vered Caplan, CEO of Orgenesis, said, “We are progressing with our transition to the second phase of the planned rollout of our POCare platform. This includes revenue generation from the validation, process development, and supply of advanced therapies that utilize our POCare platform and Orgenesis Mobile Processing Units and Labs (OMPULs). As a result of the successful execution of the first phase, our global supply network now spans North America, Europe, Asia, and the Middle East. Within the U.S. specifically, we are expanding our capacity and collaborations with a number of leading global healthcare institutions such as Johns Hopkins to establish a new POCare Center, also known as the Maryland Center for Cell Therapy Manufacturing.”

“Feedback from within the industry based on Orgenesis’ progress has been overwhelmingly positive. This is a result of our ability to reduce costs and add capacity in significantly less time than required for traditional clean rooms. We have multiple contracts with biotech companies from the U.S., E.U., Asia and the Middle East. Importantly, we believe we have built a highly scalable business model, and expect to benefit from growth in high margin, recurring revenue streams, based on future royalties and long-term contracts for industrializing and supplying these cell and gene therapies.”

Ms. Caplan continued, “I am pleased to report that we secured a $10 million loan within our newly formed subsidiary for Orgenesis’ point of care services business for treating patients (POCare Services) with Metalmark Capital Partners, a premier investment firm with deep expertise in the healthcare sector. Metalmark will provide ongoing advice to help us accelerate the rollout of our POCare platform and these critical CGT services.”

“In addition to our POCare Services platform, we are advancing our POCare therapeutic pipeline, which now spans over 16 distinct clinical programs in the field of immuno-oncology, anti-viral, metabolic/auto-immune diseases, and tissue regeneration. Our cost-efficient strategy involves leveraging government grants and funding from regional partners for our innovations and in-licensed therapies from leading research centers, hospitals and biotech companies. Most recently, in May 2022, we were awarded a €4M European Innovation Council Pathfinder Grant to advance technologies for the production of personalized autologous induced pluripotent stem cells (iPSCs) that can be utilized for regenerative medicine. Overall, we believe our therapeutic pipeline holds unlocked potential as we advance each of these assets through key clinical and pre-clinical milestones.”

The complete financial results for the second quarter of 2022 and details on the $10 million loan to our subsidiary are available on the Company’s website in the Company’s Form 10-Q and 8-K, respectively, which have been filed with the Securities and Exchange Commission.

Conference Call
The Company will host a conference call today, August 16, 2022, at 11:00 AM Eastern Time 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 223911. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2585/46399 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 Wednesday, August 16, 2023. A telephone replay of the call will be available approximately one hour following the call, through Tuesday, August 30, 2022 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: 46399.

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
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.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. Dollars in thousands)
(Unaudited)

         
  As of 
  June 30,
2022
  December 31,
2021
 
Assets        
         
CURRENT ASSETS:        
Cash and cash equivalents $2,303  $5,473 
Restricted cash  457   501 
Accounts receivable, net *  18,786   15,245 
Prepaid expenses and other receivables  793   1,188 
Convertible loan receivable-related party  3,012   3,064 
Grants receivable  -   169 
Inventory  107   118 
Total current assets  25,458   25,758 
         
NON-CURRENT ASSETS:        
Deposits $329  $363 
Investments and loans to associates  1,750   584 
Loans receivable  -   821 
Property, plant and equipment, net  14,388   10,271 
Intangible assets, net  11,207   11,821 
Operating lease right-of-use assets  757   1,015 
Goodwill  8,174   8,403 
Other assets  736   805 
Total non-current assets  37,341   34,083 
TOTAL ASSETS $62,799  $59,841 

 

*Including related party in the amount of $2,039 thousand and $1,972 thousand as of June 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 
  June 30,
2022
  December 31,
2021
 
Liabilities and Equity        
         
CURRENT LIABILITIES:        
Accounts payable $5,203  $5,238 
Accrued expenses and other payables  1,763   485 
Income tax payable  83   54 
Employees and related payables  1,998   1,907 
Advance payments on account of grant  1,144   1,238 
Contract liabilities  70   59 
Current maturities of finance leases  17   18 
Current maturities of operating leases  399   481 
Current maturities of convertible loans  5,568   5,885 
Total current liabilities  16,245   15,365 
         
LONG-TERM LIABILITIES:        
Non-current operating leases $352  $561 
Convertible loans  13,943   4,854 
Retirement benefits obligation  123   101 
Non-current finance leases  29   41 
Other long-term liabilities  264   288 
Total long-term liabilities  14,711   5,845 
TOTAL LIABILITIES  30,956   21,210 
         
EQUITY:        
Common stock of $0.0001 par value: Authorized at June 30, 2022 and December 31, 2021: 145,833,334 shares; Issued at June 30, 2022 and December 31, 2021: 25,107,323 and 24,567,366 shares, respectively; Outstanding at June 30, 2022 and December 31, 2021: 24,820,756 and 24,280,799 shares, respectively  3   3 
Additional paid-in capital  146,919   145,916 
Receipts on account of shares and warrants to be allotted  2,175   - 
Accumulated other comprehensive income (loss)  (270)  207 
Treasury stock 286,567 shares as of June 30, 2022 and December 31, 2021  (1,266)  (1,266)
Accumulated deficit  (115,808)  (106,372)
Equity attributable to Orgenesis Inc.  31,753   38,488 
Non-controlling interest  90   143 
Total equity  31,843   38,631 
TOTAL LIABILITIES AND EQUITY $62,799  $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  Six Months Ended 
  June 30, 2022  June 30, 2021  June 30, 2022  June 30, 2021 
Revenues $6,699  $9,818  $13,276  $18,050 
Revenues from related party  502   727   1,137   1,884 
Total revenues  7,201   10,545   14,413   19,934 
Cost of revenues, development services and research and development expenses  8,901   9,727   16,266   15,854 
Amortization of intangible assets  229   239   461   477 
Selling, general and administrative expenses  2,803   2,901   5,654   5,869 
Operating loss  4,732   2,322   7,968   2,266 
Other income, net  (8)  (3)  (8)  (28)
Financial expenses, net  389   406   602   639 
Share in net loss of associated companies  368   -   915   15 
Loss before income taxes  5,481   2,725   9,477   2,892 
Tax expenses (income)  11   -   12   (2)
Net loss  5,492   2,725   9,489   2,890 
Net loss attributable to non-controlling interests  (65)  (66)  (53)  (12)
Net loss attributable to Orgenesis Inc. $5,427  $2,659  $9,436  $2,878 
                 
Loss per share:                
Basic and diluted $0.22  $0.11  $0.38  $0.12 
                 
Weighted average number of shares used in computation of Basic and Diluted loss per share:                
Basic and diluted  24,820,756   24,365,746   24,711,462   24,279,826 
                 
Comprehensive loss:                
Net loss $5,492  $2,725  $9,489  $2,890 
Other comprehensive loss (income) - translation adjustments  326   (48)  477   229 
Comprehensive loss  5,818   2,677   9,966   3,119 
Comprehensive loss attributed to non-controlling interests  (65)  (66)  (53)  (12)
Comprehensive loss attributed to Orgenesis Inc. $5,753  $2,611  $9,913  $3,107