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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the Quarterly Period Ended June 30, 2024

 

or

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the Transition Period from ___________ to ___________

 

Commission file number: 001-38416

 

ORGENESIS INC.

(Exact name of registrant as specified in its charter)

 

Nevada   98-0583166

(State or other jurisdiction

of incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

20271 Goldenrod Lane

Germantown, MD 20876

 

(Address of principal executive offices) (Zip Code)

 

(480) 659-6404

 

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading symbols(s)   Name of each exchange on which registered
Common Stock   ORGS   The Nasdaq Capital Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer   Accelerated filer
Non-accelerated filer   Smaller reporting company
    Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐No

 

As of August 8, 2024, there were 46,925,906 shares of registrant’s common stock outstanding.

 

 

 

 
 

 

ORGENESIS INC.

FORM 10-Q

FOR THE SIX MONTHS ENDED JUNE 30, 2024 AND 2023

 

TABLE OF CONTENTS

 

  Page
   
PART I - FINANCIAL INFORMATION 3
     
ITEM 1 Financial Statements (unaudited) 3
     
  Condensed Consolidated Balance Sheets as of June 30, 2024 and December 31, 2023 3
     
  Condensed Consolidated Statements of Loss and Comprehensive Loss for the Three and Six Months Ended June 30, 2024 and 2023 5
     
  Condensed Consolidated Statements of Changes in Equity for the Three and Six Months Ended June 30, 2024 and 2023 6
     
  Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2024 and 2023 10
     
  Notes to Condensed Consolidated Financial Statements 11
     
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 26
     
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk 36
     
ITEM 4. Controls and Procedures 36
     
PART II - OTHER INFORMATION 37
     
ITEM 1. Legal Proceedings 37
     
ITEM 1A. Risk Factors 37
     
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 40
     
ITEM 3. Defaults Upon Senior Securities 40
     
ITEM 4. Mine Safety Disclosures 40
     
ITEM 5. Other Information 40
     
ITEM 6. Exhibits 41
     
SIGNATURES 42

 

2
 

 

PART I –FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

ORGENESIS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(U.S. Dollars in thousands)

(Unaudited)

 

   June 30, 2024  

December 31, 2023

 
   As of 
   June 30, 2024  

December 31, 2023

 
Assets        
         
CURRENT ASSETS:          
           
Cash and cash equivalents  $77   $837 
Restricted cash   1,079    642 
Accounts receivable, net of credit losses of $29,234 as of June 30, 2024 ($0 as of December 31, 2023)   240    88 
Prepaid expenses and other receivables   952    2,017 
Receivable from related parties   -    458 
Inventory   -    34 
Total current assets   2,348    4,076 
           
NON-CURRENT ASSETS:          
           
Deposits  $249   $38 
Investments to associates   8    8 
Property, plant and equipment, net   15,901    1,475 
Intangible assets, net   8,724    7,375 
Operating lease right-of-use assets   1,805    351 
Goodwill   1,211    1,211 
Other assets   331    18 
Total non-current assets   28,229    10,476 
TOTAL ASSETS  $30,577   $14,552 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

3
 

 

ORGENESIS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (Continued)

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

(Unaudited)

 

   As of 
   June 30, 2024  

December 31, 2023

 
Liabilities net of (Capital Deficiency)          
           
CURRENT LIABILITIES:          
Accounts payable  $10,717   $6,451 
Accounts payable related Parties   2,696    133 
Advance payments from Germfree (See note 11a)   6,720    - 
Accrued expenses and other payables   2,789    2,218 
Income tax payable   767    740 
Employees and related payables   1,634    1,079 
Other payable related parties   -    52 
Advance payments on account of grant   2,733    2,180 
Short-term loans   1,186    650 
Current maturities of finance leases   62    18 
Current maturities of operating leases   465    216 
Short-term and current maturities of convertible loans   1,931    2,670 
TOTAL CURRENT LIABILITIES   31,700    16,407 
           
LONG-TERM LIABILITIES:          
Non-current operating leases  $1,318   $96 
Loans payable   2,762    - 
Convertible loans   5,296    18,967 
Retirement benefits obligation   96    - 
Finance leases   1    4 
Contingent consideration (see note 4)   4,825    - 
Other long-term liabilities   371    61 
TOTAL LONG-TERM LIABILITIES   14,669    19,128 
TOTAL LIABILITIES   46,369    35,535 
           
CAPITAL DEFICIENCY:          
Common stock of $0.0001 par value: Authorized at June 30, 2024 and December 31, 2023: 145,833,334 shares; Issued at June 30, 2024 and December 31, 2023: 47,212,473 and 32,163,630 shares, respectively; Outstanding at June 30, 2024 and December 31, 2023: 46,925,906 and 31,877,063 shares, respectively  $5   $3 
Additional paid-in capital   180,752    156,837 
Accumulated other comprehensive income   302    65 
Treasury stock 286,567 shares as of June 30, 2024 and December 31, 2023   (1,266)   (1,266)
Accumulated deficit   (195,291)   (176,622)
Equity attributable to Orgenesis Inc.   (15,498)   (20,983)
Non-controlling interest   (294)   - 
TOTAL CAPITAL DEFICIENCY   (15,792)   (20,983)
TOTAL LIABILITIES AND CAPITAL DEFICIENCY  $30,577   $14,552 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

4
 

 

ORGENESIS INC.

CONDENSED CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

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

(Unaudited)

 

    June 30, 2024    June 30, 2023    June 30, 2024    June 30, 2023 
    Three Months Ended    Six Months Ended 
    June 30, 2024    June 30, 2023    June 30, 2024    June 30, 2023 
                   
Revenues  $246   $113   $387   $255 
Cost of revenues   538    3,232    1,030    5,954 
Gross profit   (292)   (3,119)   (643)   (5,699)
Cost of development services and research and development expenses   1,489    3,527    3,859    6,808 
Amortization of intangible assets   226    208    379    415 
Change in Contingent consideration   182    -    182    - 
Selling, general and administrative expenses including credit losses of $2,725 for the six months ended June 30, 2024 and $(500) for the three months ended June 30, 2024 and $24,367 for the six months ended June 30, 2023 and $14,878 for the three months ended June 30, 2023   2,061    18,216    8,117    31,744 
Operating loss   4,250    25,070    13,180    44,666 
Loss from deconsolidation of OBI and Octomera (see note 4)   -    5,343    66    5,343 
Other income, net   (8)   -    (8)   (2)
Credit loss on convertible loan receivable   -    -    -    2,688 
Loss from extinguishment in connection with convertible loan   -    -    141    283 
Financial expenses, net   815    692    1,667    1,373 
Convertible loans induced conversion expenses   4,304    -    4,304    - 
Share in net loss profit of associated companies   -    (3)   -    (1)
Loss before income taxes   9,361    31,102    19,350    54,350 
Tax expenses   5    91    21    220 
Net loss   9,366    31,193    19,371    54,570 
Net loss attributable to non-controlling interests (including redeemable)   (462)   (5,650)   (702)   (9,557)
Net loss attributable to Orgenesis Inc.  $8,904   $25,543   $18,669   $45,013 
Loss per share:                
Basic and diluted  $0.23   $0.76   $0.52   $1.63 
                     
Weighted average number of shares used in computation of Basic and Diluted loss per share:                    
Basic and diluted   38,860,727    28,603,597    35,979,567    27,546,229 
                     
Comprehensive loss:                    
Net loss  $9,366   $31,193   $19,371   $54,570 
Other comprehensive loss (income) - translation adjustments   (176)   11    (237)   52 
Release of translation adjustment due to deconsolidation of Octomera   -    (384)   -    (384)
Comprehensive loss   9,190    30,820    19,134    54,238 
Comprehensive loss attributed to non-controlling interests   (462)   (5,650)   (702)   (9,557)
Comprehensive loss attributed to Orgenesis Inc.  $8,728   $25,170   $18,432   $44,681 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

5
 

 

ORGENESIS INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

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

(Unaudited)

 

   Number  

Par

Value

  

Additional

Paid-in

Capital

  

Accumulated

Other

Comprehensive

Income

(Loss)

   Treasury
Shares
  

Accumulated

Deficit

  

Equity

Attributed

to

Orgenesis

Inc.

  

Non-

Controlling

Interest

   Total 
   Common Stock                         
   Number  

Par

Value

  

Additional

Paid-in

Capital

  

Accumulated

Other

Comprehensive

Income

(Loss)

   Treasury
Shares
  

Accumulated

Deficit

  

Equity

Attributed

to

Orgenesis

Inc.

  

Non-

Controlling

Interest

   Total 
Balance at January 1, 2024   31,877,063   $3   $156,837  - $65   $(1,266)  $(176,622)  $(20,983)  $-   $(20,983)
Changes during the six months ended June 30, 2024:                                             
Stock-based compensation   -    -    215    -    -    -    215    -    215 
RSUs vested   82,996    -*    (*)    -    -    -    (*)    -    (*) 
Exercise of options   25,000    -*    13  -  -    -    -    13    -    13 
Issuance of shares to service providers   664,000    -*    690    -    -    -    690    -    690 
Exchange of convertible loans for equity   11,829,128    1    20,310    -    -    -    20,311    -    20,311 
Issuance of warrants with respect to convertible loans   -    -    31    -    -    -    31    -    31 
Issuance of shares and warrants   2,422,719    -*    2,496    -    -    -    2,496    -    2,496 
NCI arising from Octomera reconsolidation   -    -    -    -    -    -    -    408    408 
Issuance of shares due to exercise of warrants   25,000    -*    19    -    -    -    20    -    20 
Extinguishment in connection with convertible loan restructuring   -         141    -    -    -    141    -    141 
Comprehensive income (loss) for the period   -    -    -    237    -    (18,669)   (18,432)   (702)   (19,134)
Balance at June 30, 2024   46,925,906   $5   $180,752  - $302   $(1,266)  $(195,291)  $(15,498)  $(294)  $(15,792)

 

  * Represents an amount lower than $1 thousand.

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

6
 

 

ORGENESIS INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

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

(Unaudited)

 

   Number  

Par

Value

  

Additional

Paid-in

Capital

  

Accumulated

Other

Comprehensive

Income (Loss)

   Treasury
Shares
  

Accumulated

Deficit

  

Equity

Attributed

to

Orgenesis

Inc.

  

Non-

Controlling

Interest

   Total 
   Common Stock                         
   Number  

Par

Value

  

Additional

Paid-in

Capital

  

Accumulated

Other

Comprehensive

Income (Loss)

   Treasury
Shares
  

Accumulated

Deficit

  

Equity

Attributed

to

Orgenesis

Inc.

  

Non-

Controlling

Interest

   Total 
Balance at January 1, 2023   25,545,755   $3   $150,355 -  $(270)  $(1,266)  $(121,261)  $27,561   $1,510   $29,071 
Changes during the six months ended June 30, 2023:                                             
Stock-based compensation   -    -    311    -    -    -    311    -    311 
Issuance of shares and warrants net of issuance costs   1,947,368    -*    3,341    -    -    -    3,341    -    3,341 
Issuance of shares due to exercise of warrants   973,684    -*    -  -  -    -    -    -    -    - 
Issuance of warrants with respect to convertible loans   -    -    449    -    -    -    449    -    449 
Extinguishment in connection with convertible loan restructuring   -    -    287    -    -    -    287    -    287 
Deconsolidation of Octomera   -    -    9,406    384    -    -    9,790    (1,360)   8,430 
Adjustment to redemption value of redeemable non-controlling interest   -    -    (9,406)   -    -    -    (9,406)   -    (9,406)
Comprehensive loss for the period   -    -    -    (52)   -    (45,013)   (45,065)   (150)   (45,215)
Balance at June 30, 2023   28,466,807   $3   $154,743  - $62   $(1,266)  $(166,274)  $(12,732)  $-   $(12,732)

 

  * Represents an amount lower than $1 thousand.

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

7
 

 

ORGENESIS INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

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

(Unaudited)

 

   Number  

Par

Value

  

Additional

Paid-in

Capital

   Receipts on Account of Shares to be Allotted  

Accumulated

Other

Comprehensive

Income

   Treasury
Shares
  

Accumulated

Deficit

  

Equity

Attributed

to

Orgenesis

Inc.

  

Non-

Controlling

Interest

   Total 
   Common Stock                             
   Number  

Par

Value

  

Additional

Paid-in

Capital

   Receipts on Account of Shares to be Allotted  

Accumulated

Other

Comprehensive

Income

   Treasury
Shares
  

Accumulated

Deficit

  

Equity

Attributed

to

Orgenesis

Inc.

  

Non-

Controlling

Interest

   Total 
Balance at April 1, 2024   34,338,782   $4   $159,650   $155   $126   $(1,266)  $(186,386)  $(27,717)  $168   $(27,549)
Changes during the three months ended June 30, 2024:                                                  
Stock-based compensation   -    -    129    -    -    -    -    129    -    129 
RSUs vested   82,996    -*    (*)    -    -    -    -    (*)    -    (*) 
Exercise of options   25,000    -*    13    -    -    -    -    13    -    13 
Issuance of shares to service providers   500,000     -*    464    -    -    -    -    464    -    464 
Exchange of convertible loans for equity   11,829,128    1    20,310    -    -    -    -    20,311    -    20,311 
Issuance of warrants with respect to convertible loans   -    -    31    -    -    -    -    30    -    30 
Issuance of shares and receipts on account of shares and warrants to be allotted   150,000     -*    155    (155)   -    -    -    -    -    - 
Comprehensive income (loss) for the period   -    -    -    -    176    -    (8,904)   (8,728)   (462)   (9,190)
Balance at June 30, 2024   46,925,906   $5   $180,752   $-   $302   $(1,266)  $(195,291)  $(15,498)  $(294)  $(15,792)

 

  * Represents an amount lower than $1 thousand.

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

8
 

 

ORGENESIS INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

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

(Unaudited)

 

   Number  

Par

Value

  

Additional

Paid-in

Capital

  

Accumulated

Other

Comprehensive

Income

   Treasury
Shares
  

Accumulated

Deficit

  

Equity

Attributed

to

Orgenesis

Inc.

  

Non-

Controlling

Interest

   Total 
   Common Stock                         
   Number  

Par

Value

  

Additional

Paid-in

Capital

  

Accumulated

Other

Comprehensive

Income

   Treasury
Shares
  

Accumulated

Deficit

  

Equity

Attributed

to

Orgenesis

Inc.

  

Non-

Controlling

Interest

   Total 
Balance at April 1, 2023   27,861,543   $3   $151,020  - $(311)  $(1,266)  $(140,731)  $8,715   $1,274   $9,989 
Changes during the three months ended June 30, 2023:                                             
Stock-based compensation to employees and directors   -    -    152  -  -    -    -    152    -    152 
Issuance of shares and warrants net of issuance costs   -    -     (100)   -     -     -     (100)   -     (100)
Issuance of shares due to exercise of warrants   605,264    -*    -     -     -     -         -      
Deconsolidation of Octomera   -     -     9,406    384    -     -     9,790    (1,360)   8,430 
Adjustment to redemption value of redeemable non-controlling interest   -     -     (5,735)   -     -     -     (5,735)   -     (5,735)
Comprehensive income (loss) for the period   -    -    -    (11)   -    (25,543)   (25,554)   86    (25,468)
Balance at June 30, 2023   28,466,807   $3   $154,743  - $62   $(1,266)  $(166,274)  $(12,732)  $-   $(12,732)

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

9
 

 

ORGENESIS INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(U.S. Dollars in thousands)

(Unaudited)

 

   June 30, 2024   June 30, 2023 
   Six Months Ended 
   June 30, 2024   June 30, 2023 
        
CASH FLOWS FROM OPERATING ACTIVITIES:          
           
Net loss  $(19,371)  $(54,570)
Adjustments required to reconcile net loss to net cash used in operating activities:          
           
Stock-based compensation   936    311 
Convertible loans induced conversion expenses   4,304    - 
Loss from deconsolidation of OBI and Octomera   66    5,343 
Share in income of associated companies, net   -    (1)
Depreciation and amortization expenses   1,087    1,175 
Credit loss on convertible loan receivable   -    2,688 
Credit loss related to OBI   

2,049

    - 
Effect of exchange differences on inter-company balances   (48)   214 
Net changes in operating leases   24    (67)
Change in Contingent consideration   182    - 
Interest expenses accrued on loans and convertible loans   1,192    300 
Loss from extinguishment in connection with convertible loan restructuring   141    283 
           
Changes in operating assets and liabilities:          
Accounts receivable   (70)   30,144 
Prepaid expenses and other accounts receivable   1,592    (1,857)
Inventory   34    (389)
Other assets   (1)   4 
Change in related parties, net   (1)   - 
Accounts payable   (2,466)   2,891 
Accrued expenses and other payables   12    245 
Employee and related payables   (8)   123 
Deferred taxes, net   (2)   9 
Net cash used in operating activities  $(10,348)  $(13,154)
           
CASH FLOWS FROM INVESTING ACTIVITIES:          
Purchase of property, plant and equipment   (205)   (1,796)
Cash acquired from acquisition of Octomera   139    - 
Impact to cash resulting from deconsolidation of OBI   (5)   - 
Impact to cash resulting from deconsolidation of Octomera   -    (973)
Investment in long-term deposits   2    (33)
Net cash used in investing activities  $(69)  $(2,802)
           
CASH FLOWS FROM FINANCING ACTIVITIES:          
Proceeds from issuance of shares and warrants   2,528    3,341 
Proceeds from issuance of convertible loans   75    5,485 
Proceeds from transaction with redeemable non-controlling interest that do not acquire control of a subsidiary   -    5,000 
Repayment of convertible loans   -    (3,000)
Repayment of short and long-term debt   (145)   (30)
Proceeds from issuance of loans payable   947    - 
Receipt from Germfree (see note 11a)   6,720    - 
Net cash provided by financing activities  $10,125   $10,796 
           
NET CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH  $(292)  $(5,160)
           
EFFECT OF EXCHANGE RATE CHANGES ON CASH, CASH EQUIVALENTS AND RESTRICTED CASH   (31)   18 
           
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF PERIOD   1,479    6,369 
           
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD  $1,156   $1,227 
           
SUPPLEMENTAL NON-CASH FINANCING AND INVESTING ACTIVITIES          
           
Exchange of convertible loans for equity   16,007    - 
Right-of-use assets obtained in exchange for new operation lease liabilities  $191   $753 
Increase (decrease) in accounts payable related to purchase of property, plant and equipment  $-   $14 
Extinguishment in connection with convertible loan restructuring  $-   $287 
           
CASH PAID DURING THE PERIOD FOR:          
Interest  $4   $785 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

10
 

 

ORGENESIS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

For the Six Months Ended June 30, 2024 and 2023

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

(Unaudited)

 

NOTE 1 – DESCRIPTION OF BUSINESS

 

a. General

 

Orgenesis Inc. (the “Company”) is a global biotech company working to unlock the potential of Cell and Gene Therapies (“CGTs”) in an affordable and accessible format. CGTs can be centered on autologous (using the patient’s own cells) or allogenic (using master banked donor cells) and are part of a class of medicines referred to as advanced therapy medicinal products (“ATMPs”). The Company is mostly focused on the development of autologous therapies that can be manufactured under processes and systems that are developed for each therapy using a closed and automated approach that is validated for compliant production near the patient for treatment of the patient at the point of care (“POCare”).

 

As of the date of this report, the Company operates two segments:

 

The “Octomera” segment which includes the Company’s POCare Services that are performed in decentralized hubs which provide harmonized and standardized services to customers (“POCare Centers”). The Company’s subsidiary, Octomera LLC, holds all of the Octomera segment activities.

 

The “Therapies” segment which includes therapy related activities.

 

On January 29, 2024, the Company and Metalmark Capital Partners (“Metalmark” or “MM”) entered into a Unit Purchase Agreement (the “MM UPA”), pursuant to which the Company acquired all of the preferred units of Octomera LLC (“Octomera”) previously owned by MM (the “MM Acquisition”), and effective that date, reconsolidated Octomera into its accounts. The Company currently owns 100% of the equity interests of Octomera. The Company had previously, from June 30, 2023 (“date of deconsolidation”), deconsolidated Octomera from its consolidated financial statements and had recorded its equity interest in Octomera as an equity method investment.

 

These consolidated financial statements include the accounts of Orgenesis Inc. and its subsidiaries.

 

The Company’s common stock, par value $0.0001 per share (the “Common Stock”), is listed and traded on the Nasdaq Capital Market under the symbol “ORGS.” On September 27, 2023, the Company received a notice from the Listing Qualifications Staff (“Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) stating that the bid price of the Common Stock had closed at less than $1.00 per share over the previous 30 consecutive business days, and, as a result, did not comply with Listing Rule 5550(a)(2) (the “Bid Price Rule”). On April 17, 2024, the Company received a notice (the “Notice”) from the Staff in which it determined that in accordance with Listing Rule 5810(c)(2)(A), the Staff stated that it could not accept a plan to regain compliance and the Staff stated that the Company’s securities would be delisted from The Nasdaq Capital Market unless the Company timely requested a hearing before a Nasdaq Hearings Panel (the “Panel”) to address the deficiencies and present a plan to regain compliance. As permitted by the Notice, the Company timely requested a hearing before the Panel, which request stayed any further delisting action by the Staff pending the ultimate outcome of the hearing and the expiration of any extension that may be granted by the Panel. On June 6, 2024, the Company met with the Panel regarding the Company’s potential delisting from The Nasdaq Stock Market as a result of its violation of the Bid Price Rule and non-compliance with the equity requirement in Listing Rule 5550(b)(1) (the “Equity Rule”) or any of the alternative requirements in Listing Rule 5550(b). On June 8, 2024, the Company received the Panel’s decision which granted the Company until October 14, 2024 to regain compliance with the Bid Price and Equity Rules. If the Company is unable to regain compliance with the listing standards of the Nasdaq Capital Market by October 14, 2024, the Company’s securities may be delisted from The Nasdaq Stock Market.

 

As used in this report and unless otherwise indicated, the term “Company” refers to Orgenesis Inc. and its Subsidiaries. Unless otherwise specified, all amounts are expressed in United States Dollars.

 

11
 

 

b.Liquidity

 

Through June 30, 2024, the Company had an accumulated deficit of $195,291 and for the six months ended June 30, 2024 incurred negative operating cashflows of $10,348. The Company’s activities have been funded by generating revenue, through offerings of its securities, and through proceeds from loans. There is no assurance that the Company’s business will generate sustainable positive cash flows to fund its activities.

 

The Company will need to use mitigating actions such as seeking additional financing, refinancing, or amending the terms of existing loans, or postponing expenses that are not based on firm commitments. In order to fund its operations until such time that the Company can generate sustainable positive cash flows, the Company will need to raise additional funds. For the six months ended June 30, 2024 and as of the date of this report, the Company has assessed its financial condition and concluded that based on current and projected cash resources and commitments, as well as other factors mentioned above, there is substantial doubt about its ability to continue as a going concern. The Company is planning to raise additional capital to continue its operations and to repay its outstanding loans when they become due, as well as to explore additional avenues to increase revenues and reduce or delay expenditures. In May 2024, the Company entered into debt exchange agreements with three convertible debt holders pursuant to which a total of $16,007,372 of outstanding principal and accrued interest were exchanged for the right to receive an aggregate of 15,776,947 shares of Common Stock. The Company may also exchange some of its other outstanding loans and accounts payable for securities of the Company. There can be no assurance that the Company will be able to raise additional capital on acceptable terms, or at all, or be able to exchange its outstanding loans and accounts payable for securities of the Company.

 

The Company’s Common Stock is listed for trading on the Nasdaq Capital Market. As mentioned above, the Company must satisfy Nasdaq’s continued listing requirements. Failure to meet continuing listing requirements risks delisting, which may make it more difficult to raise additional capital.

 

The estimation and execution uncertainty regarding the Company’s future cash flows and management’s judgments and assumptions in estimating these cash flows is a significant estimate. Those assumptions include reasonableness of the forecasted revenue, operating expenses, and uses and sources of cash.

 

NOTE 2 - BASIS OF PRESENTATION

 

a. Basis of presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of management, the financial statements reflect all normal and recurring adjustments necessary to fairly state the financial position and results of operations of the Company. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (“SEC”) on April 15, 2024. The year-end balance sheet data was derived from the audited consolidated financial statements as of December 31, 2023, but not all disclosures required by generally accepted accounting principles in the United States (“U.S. GAAP”) are included in this Quarterly Report on Form 10-Q.

 

b. Significant accounting policies

 

The accounting policies adopted are consistent with those of the previous financial year except as described below:

 

Use of Estimates in the Preparation of Financial Statements

 

The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies. The Company bases its estimates on historical experience and on various other assumptions that it believes are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity, the amount of revenues and expenses, determination of loss on deconsolidation, valuation of investments, purchase price allocations, goodwill impairment, and assessment of credit losses and purchase price allocation including contingent consideration. Actual results could differ from those estimates.

 

12
 

 

Recently issued accounting pronouncements, not yet adopted

 

Improvements to Reportable Segments Disclosures

 

In November 2023, the FASB issued ASU 2023-07 “Segment Reporting–Improvements to Reportable Segments Disclosures (Topic 280)” to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The amendments in this ASU (1) require that a public entity disclose, on an annual and interim basis, significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”) and included within each reported measure of segment profit or loss; (2) require that a public entity disclose, on an annual and interim basis, an amount for other segment items by reportable segment and a description of its composition; (3) require that a public entity provide all annual disclosures about a reportable segment’s profit or loss and assets currently required by Topic 280 in interim periods; (4) clarify that if the CODM uses more than one measure of a segment’s profit or loss in assessing segment performance and deciding how to allocate resources, a public entity may report one or more of those additional measures; and (5) require that a public entity disclose the title and position of the CODM and an explanation of how the CODM uses the reported measure or measures of segment profit or loss in assessing segment performance and deciding how to allocate resources. The amendments in this ASU are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, and should be applied retrospectively to all periods presented. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of these amendments on its consolidated financial statements.

 

Improvements to Income Tax Disclosures

 

In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740)–Improvements to Income Tax Disclosures” to enhance the transparency and decision usefulness of income tax disclosures, primarily related to the rate reconciliation and income taxes paid information. The amendments in this ASU require that public entities, on an annual basis, disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. This ASU also requires that all entities disclose, on an annual basis, (1) the amount of income taxes paid disaggregated by federal, state, and foreign taxes, (2) the amount of income taxes paid disaggregated by individual jurisdictions in which income taxes paid is equal to or greater than five percent of total income taxes paid, (3) income or loss from continuing operations before income tax expense or benefit disaggregated between domestic and foreign, and (4) income tax expense or benefit from continuing operations disaggregated by federal, state, and foreign. The amendments in this ASU are effective for annual periods beginning after December 15, 2024, and should be applied on a prospective basis with the option to apply retrospectively. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is currently evaluating the impact of the adoption of these amendments on its consolidated financial statements.

 

NOTE 3 – SEGMENT INFORMATION

 

Segment data for the six months ended June 30, 2024 is as follows:

 

   Octomera   Therapies   Eliminations   Consolidated 
   (in thousands) 
Revenues  $50   $360   $(23)  $387 
Cost of revenues*   (1,047)   (329)   710    (666)
Gross profit   (997)   31    687    (279)
Cost of development services and research and development expenses*   (3,251)   (1,031)   697    (3,585)
Operating expenses*   (546)   (7,037)   (646)   (8,229)
Loss from deconsolidation   -    -    (66)   (66)
Other income   -    8    -    8 
Depreciation and amortization   (870)   (387)   170    (1,087)
Loss from extinguishment in connection with convertible loan   -    (141)   -    (141)
Financial income (expenses), net   (554)   (1,237)   124    (1,667)
Convertible loans induced conversion expenses   -    (4,304)   -    (4,304)
Income (loss) before income taxes  $(6,218)  $(14,098)  $966   $(19,350)

 

*Excluding Depreciation, amortization expenses

 

Segment data for the six months ended June 30, 2023 is as follows:

 

   Octomera   Therapies   Eliminations   Consolidated 
   (in thousands) 
Revenues  $15   $240   $-   $255 
Cost of revenues*   (5,084)   (398)   -    (5,482)
Gross profit   (5,069)   (158)   -    (5,227)
Cost of development services and research and development expenses*   (4,501)   (2,051)   -    (6,552)
Operating expenses*   (27,990)   (3,722)   -    (31,712)
Loss from deconsolidation of Octomera   -    -    (5,343)   (5,343)
Other income, net   2    -    -    2 
Depreciation and amortization   (779)   (396)   -    (1,175)
Loss from extinguishment in connection with convertible loan   -    (283)   -    (283)
Credit losses on convertible loan receivable   -    (2,688)   -    (2,688)
Financial Expenses, net   (495)   (879)   1    (1,373)
Share in net income of associated companies   -    1    -    1 
Loss before income taxes  $(38,832)  $(10,176)  $(5,342)  $(54,350)

 

*Excluding Depreciation, amortization expenses

 

13
 

 

Segment data for the three months ended June 30, 2024 is as follows:

 

   Octomera   Therapies   Eliminations   Consolidated 
   (in thousands) 
Revenues  $21   $225   $-   $246 
Cost of revenues*   (110)   (179)   -    (289)
Gross profit   (89)   46    -    (43)
Cost of development services and research and development expenses*   (1,466)   148    -    (1,318)
Operating expenses*   (483)   (1,518)   (182)   (2,183)
Other income   -    8    -    8 
Depreciation and amortization   (440)   (193)   (73)   (706)
Financial income (expenses), net   (264)   (551)   -    (815)
Convertible loans induced conversion expenses   -    (4,304)   -    (4,304)
Income (loss) before income taxes  $(2,742)  $(6,364)  $(255)  $(9,361)

 

*Excluding Depreciation, amortization expenses

 

Segment data for the three months ended June 30, 2023 is as follows:

 

   Octomera   Therapies   Eliminations   Consolidated 
   (in thousands) 
Revenues  $3   $110   $-   $113 
Cost of revenues*   (2,776)   (220)   -    (2,996)
Gross profit   (2,773)   (110)   -    (2,883)
Cost of development services and research and development expenses*   (2,420)   (975)   -    (3,395)
Operating expenses*   (16,787)   (1,408)   -    (18,195)
Loss from deconsolidation of Octomera   -    -    (5,343)   (5,343)
Depreciation and amortization   (394)   (203)   -    (597)
Financial expenses, net   (229)   (464)   1    (692)
Share in net income of associated companies   -    3    -    3 
Loss before income taxes  $(22,603)  $(3,157)  $(5,342)  $(31,102)

 

*Excluding Depreciation, amortization expenses

 

NOTE 4 – RECONSOLIDATION OF OCTOMERA LLC

 

Pursuant to the MM UPA signed on January 29, 2024, the Company and MM agreed to the following:

 

1.Consideration:

 

Royalty Payments: If Octomera and its subsidiaries generate Net Revenue during the three-year period 2025-2027, then the Company will pay 5% of Net Revenues to MM pursuant to the MM UPA.

 

Milestone Payments: If the Company sells Octomera within ten years from the date of the Closing at a price that is more than $40 million excluding consideration for certain Excluded Assets as per the UPA, the Company shall pay MM 5% of the net proceeds.

 

2.MM’s designated members of the Board of Managers of Octomera resigned and the Company amended the Second Amended and Restated Limited Liability Company Agreement of Octomera (the “Octomera LLC Agreement”) to be a single member agreement reflecting the transactions consummated under the UPA, such that MM no longer (i) is a member of Octomera or a party to the Octomera LLC Agreement, or (ii) has a right to appoint members of the board of managers of Octomera.

 

14
 

 

3.10 secured promissory notes between Orgenesis Maryland LLC and MM, reflecting an aggregate outstanding principal amount of $2,600 (the “Notes”), were amended to, among other things, extend the maturity thereof to January 29, 2034 and to terminate the security interest granted by Orgenesis Maryland LLC in favor of MM that secured the obligations under the Notes.

 

Fair Value of Consideration Transferred

 

Accounting guidance provides that the allocation of the purchase price may be adjusted for up to one year from the date of the acquisition to the extent that additional information is obtained about the facts and circumstances that existed as of the acquisition date. The primary area of the purchase price allocation that is not yet finalized is related to intangible assets, property, plant and equipment, and certain other assets and tax matters and the related impact on goodwill.

 

In evaluating the fair value of the Octomera Equity Investment under the income approach, the Company used a discounted cash flow model of the business, adjusted to the Company’s share in the investment. Key assumptions used to determine the estimated fair value included: (a) internal cash flows forecasts for 5 years following the assessment date, including expected revenue growth, costs to produce, operating profit margins and estimated capital needs; (b) an estimated terminal value using a terminal year long-term future growth determined based on the growth prospects of the reporting units; and (c) a discount rate which reflects the weighted average cost of capital adjusted for the relevant risk associated with the Company’s reporting unit operations and the uncertainty inherent in the Company’s internally developed forecasts. The allocation of the purchase price to the net assets acquired and liabilities assumed resulted in the recognition of other intangible assets, net, which comprised of technology. The useful life of the technology for amortization purposes was determined by considering the period of expected cash flows generated by the assets used to measure the fair value of the intangible assets, adjusted as appropriate for the entity-specific factors including legal, regulatory, contractual, competitive, economic, or other factors that may limit the useful life of intangible assets.

 

The following table summarizes the allocation of purchase price to the fair values of the assets acquired and liabilities assumed as of the Transaction date:

 

   (in thousands) 
Total Contingent consideration to MM for royalty and milestone payments  $4,643 
      
Total assets acquired:     
Cash and cash equivalents  $139 
Property, plants and equipment, net   17,852 
Other Assets   3,478 
Total assets  $21,469 
      
Total liabilities assumed:     
Total current liabilities  $(12,518)
Total long-term liabilities   (5,628)
Total liabilities  $(18,146)
      
Know how Technology   1,728 
      
Total Net Assets  $5,051 
Fair-Value of Non-controlling interests   (408)
Total liability to MM  $4,643 

 

15
 

 

The allocation of the purchase price to the net assets acquired and liabilities assumed resulted in the recognition of an intangible asset know-how of $1,728 and a liability to MM in the amount of $4,643. The know-how has a useful life of 10 years. The useful life of the intangible asset for amortization purposes was determined considering the period of expected cash flows generated by the assets used to measure the fair value of the intangible asset adjusted as appropriate for the entity-specific factors, including legal, regulatory, contractual, competitive, economic or other factors that may limit the useful life of intangible assets.

 

Key inputs for the fair values valuation are summarized below. 

 

Key Valuation Inputs  Jan 29, 2024 
Discount rate   40%
Risk-free interest rate   4.4%
Average 5 years revenue growth   50%

 

The Company incurred transaction costs of approximately $50 and $0 during the six and three months ended June 30, 2024 respectively, which were included in general and administrative expenses in the condensed consolidated statements of operations.

 

The revenues and net loss of Octomera from January 1, 2024 until the reconsolidation date were $23 and $1,244 respectively.

 

Fair value assumptions used in accounting for contingent consideration

 

On January 29, 2024, in connection with the PPA study of Octomera LLC, the Company recognized a contingent consideration to pay MM based on two components:

 

1. Royalties based on revenues in 2025, 2026 and 2027, and;

2. An earnout amount, which is dependent on a future triggering event being either an IPO or exit.

 

The estimated fair value of the contingent consideration is based on management’s assessment of whether, and at what level, the financial metrics will be achieved, and the present value factors associated with the timing of the payments. This fair value measurement is based on significant unobservable inputs in the market and thus represents a Level 3 fair value measurement and used the Monte Carlo pricing model to calculate the fair value, which was $4,643 as of January 29, 2024. As of June 30, 2024, the fair value was $4,825. Changes in the fair value of contingent consideration are recorded in operating expenses. The total revaluation expense for the period ended June 30, 2024 was $182.

 

Key inputs for the simulation are summarized below.

 

Key Valuation Inputs  Jan 29, 2024   June 30, 2024 
Standard Deviation   13.5%   13.5%
Risk-free interest rate   4.4%   4.6%
Possible trigger event examination   Year 10    Year 10 
Average 5 years revenue growth   50%   50%
Trigger events   30%   30%
Revenues multiple   10    9.75 

 

* Based on a Monte Carlo simulation analysis of 30,000 iterations

 

Deconsolidation of Orgenesis Biotech Israel Limited (“OBI”)

 

On February 14, 2024, following a claim for payment by employees of OBI, a fully owned subsidiary of Octomera of past salaries due, the district court in Haifa, Israel appointed a trustee to run the affairs of OBI. As a result of this appointment, effective February 14, 2024, the Company no longer controls OBI and has ceased to consolidate the results of OBI into its consolidated results. The Company recognized a loss as a result of the deconsolidation of $66. The Company does not currently believe that rehabilitation is possible and purchased certain OBI equipment.

 

16
 

 

The Company recorded $2,696 being what it owes to OBI under Accounts payable related Parties on the balance sheet of June 30, 2024.

 

The following table summarizes the deconsolidated assets and liabilities as of February 14, 2024:

 

Total assets acquired:    
Cash and cash equivalents  $4 
Property, plants and equipment, net   2,884 
Other Assets   1,422 
Total assets  $4,310 
      
Total liabilities assumed:  $4,244 
Total Net Assets deconsolidated  $66 
Loss from deconsolidation of OBI  $66 

 

NOTE 5 – EQUITY

 

Private Placement Offering

 

On March 3, 2024, the Company entered into a Securities Purchase Agreement with certain accredited investors, pursuant to which the Company agreed to issue and sell, in a private placement, 2,272,719 shares of Common Stock at a purchase price of $1.03 per share, Warrants to purchase up to 2,272,719 shares of Common Stock at an exercise price of $1.50 per share, and further Warrants to purchase up to 2,272,719 shares of Common Stock at an exercise price of $2.00 per share, all such Warrants exercisable immediately and expiring five years from their date of issuance. The Company received gross proceeds of approximately $2.3 million before deducting related offering expenses. The Offering closed on March 5, 2024.

 

On May 10, 2024, the Company entered into a Securities Purchase Agreement with certain accredited investors, pursuant to which the Company agreed to issue and sell, in a private placement, 150,000 shares of the Company’s Common Stock at a purchase price of $1.03 per share, Warrants to purchase up to 150,000 shares of Common Stock at an exercise price of $1.50 per share, and further Warrants to purchase up to 150,000 shares of Common Stock at an exercise price of $2.00 per share, all such Warrants exercisable immediately and expiring five years from their date of issuance. The Company received gross proceeds of approximately $154 before deducting related offering expenses. The Offering closed on May 10, 2024.

 

17
 

 

NOTE 6 – CONVERTIBLE LOANS

 

The table below summarizes the Company’s outstanding convertible loans as of June 30, 2024.

 

Principal

Amount at

Issuance

   Issuance Date   Current Interest Rate   Current
Maturity
   Current Conversion Price of loan into equity 
    (Year)   %   (Year)   $ 
  
$                      
                       
 100    2019    8%   2024    1.03 
 100    2020    8%   2024    1.03 
 1,150    2022    6%   *2023   4.50 
 5,000    2023    8%   2026    2.46 
$6,350                     

 

  * Was not repaid by June 30, 2024.

 

18
 

 

The table below summarizes the Company’s outstanding convertible loans as of December 31, 2023.

 

Principal Amount

   Issuance Date   Current Interest Rate   Current
Maturity
   Current Conversion Price of loan into equity   Note 
    (Year)   %   (Year)   $     
Convertible Loans Outstanding as of December 31, 2023     
$750    2018    10%   2026    2.50      
 1,500    2019    10%   2026    2.50      
 100    2019    8%   2024    7.00      
 5,000    2019    10%   2026    2.50      
 100    2020    8%   2024    7.00      
 5,000    2022    10%   2026    2.50      
 1,150    2022    6%   **2023   4.50      
 5,000    2023    8%   2026    2.46      
 735    2023    8%   2024    0.85    6a
$19,335                          

 

  ** Was not yet paid by December 31, 2023.    

 

Debt Exchange Agreements

 

On May 21, 2024, the Company entered into debt exchange agreements with three convertible debt holders pursuant to which a total of $16,007 of outstanding principal and accrued interest was exchanged for the right to receive an aggregate of 15,776,947 shares of Common Stock of the Company. A total of 11,829,128 shares of Common Stock have been issued pursuant to the debt exchange agreements as of June 30, 2024. The Company reduced the exchange price from $2.50 to $1.03 per share for a total of $14,784 of outstanding principal. As a result, the Company recorded an induced conversion expense equal to the fair value of the incremental consideration, amounting to $4,304.

 

Additional notes related to changes in convertible loans terms that occurred in 2024

 

In January 2024, the Company and lender agreed to extend the maturity date of the loan amount to December 31, 2026. In consideration for such extension, the Company issued to the lender warrants to purchase 840,000 shares of Common Stock at an exercise price of $0.85 per share. Based on its analysis, the Company concluded that this change in terms should be accounted for as an extinguishment. The loan amount was included in the debt exchange agreement.

 

Koligo convertible loan

 

On September 29, 2023, Koligo entered into a convertible loan agreement with Sai Traders, pursuant to which the Sai Traders agreed to loan Koligo up to $25,000 (the “Sai Convertible Loan”). As of the date of this quarterly report on Form 10-Q, none of the principal of the Sai Convertible Loan had been received by the Company and the Company terminated this loan agreement due to the nonperformance of Sai Traders.

 

NOTE 7 –LOANS

 

The table below summarizes the Company’s outstanding long-term loans as of June 30, 2024 and December 31, 2023, respectively:

 

Principal Amount   Interest Rate   Year of Maturity   June 30, 2024   December 31, 2023 
(in thousands)   %       (in thousands) 
$2,600    10    2034   $2,762   $- 

 

See note 4.

 

19
 

 

The table below summarizes the Company’s outstanding short-term loans as of June 30, 2024 and December 31, 2023, respectively:

 

Currency  Interest Rate   June 30, 2024   December 31, 2023 
   %   (in thousands) 
USD   8   $268   $258 
USD   10    814    61 
USD   (*)8   -    (**)331
USD   6    90    - 
Euro   8    14    - 
        $1,186   $650 

 

(*)Weighted average interest.
(**)The terms of the loan were amended on January 1, 2024. Under the new terms, the loan became convertible into shares of Common Stock and the lender agreed to extend the maturity date to December 31, 2024. In consideration for such extension, the Company issued to the lender warrants to purchase 360,000 shares of the Company’s Common Stock at a price of $0.85 per share and granted lender the right to convert any part of the outstanding balance of the loan into Common Stock of the Company at the conversion rate of $0.85 per share. Based on its analysis, the Company concluded that this change in terms should be accounted for as a modification. This loan was converted as per the debt exchange agreement. See note 6.

 

On July 3, 2024, Koligo entered into a loan agreement (the “Loan Agreement” for this paragraph only) with a lender, pursuant to which the lender agreed to loan the Company $2,000 (the “Loan” for this paragraph only) which was received by the Company according to the terms of the Loan Agreement. The Loan shall bear annual 10% simple interest and is payable no later than 90 days after the receipt, subject to extension at the discretion of lender.

 

NOTE 8 – STOCK-BASED COMPENSATION

 

a.Options Granted to Employees

 

The table below summarizes the terms of options for the purchase of shares in the Company granted to employees during the period from January 1, 2024 to June 30, 2024:

  

   

 

No. of

Options

Granted

   Exercise Price   Vesting Period 

Fair Value at Grant

(in thousands)

  

Expiration

Period

 
Employees    400,000   $0.50-$0.63   Half quarterly over a period of two years and the rest quarterly over a period of four years  $161    10 years 

 

The fair valuation of these option grants is based on the following assumptions:

 

SCHEDULE OF STOCK OPTIONS ACTIVITY

   During the Period from January 1, 2024 to June 30, 2024 
Value of one common share   $0.49-$0.63 
Dividend yield   0%
Expected stock price volatility   79%-85%
Risk free interest rate   3.86%-4.28%
Expected term (years)   5.56-6.06 

 

20
 

 

b.Restricted Stock Units (“RSUs”) Granted to Employees

 

Below is a table summarizing all the RSUs grants to employees during the period from January 1, 2024 to June 30, 2024:

 

SCHEDULE OF RESTRICTED STOCK UNITS GRANTED

  

 

No. of

Options

Granted

   Vesting Period 

Fair Value at Grant

(in thousands)

 
Employees   50,000   Immediate  $26 

 

c.Shares and warrants issued to advisors.

 

Below is a table summarizing all the shares and warrants grants to advisors during the period from January 1, 2024 to June 30, 2024:

 

Date of issue of share or warrant   Reason for issue of share or warrant  Consideration  Exercise price of warrants   Warrant vesting (subject to continued service provided to Company)  Warrant expiry date
January 25, 2024   Consideration for a past debt  164,000 shares of Common Stock           
March 7, 2024   Strategic advisor agreement  500,000 shares of Common Stock and warrants to purchase 500,000 shares of Common Stock  $1.03   One third on March 7, 2024, one third on June 5, 2024, and one third on September 3, 2024.  March 6, 2029
April 18, 2024   Strategic advisor agreement  Warrants to purchase 500,000 shares of Common Stock  $1.03   One third on April 18, 2024, one third on July 18, 2024, and one third on October 18, 2024.  April 17, 2029
April 23, 2024   Strategic advisor agreement  Warrants to purchase 500,000 shares of Common Stock  $1.03   One third on April 16, 2024, one third on July 16, 2024, and one third on October 16, 2024.  April 22, 2029
May 22, 2024   Strategic advisor agreement  Warrants to purchase 475,000 shares of Common Stock  $1.03   One third on May 21, 2024, one third on August 21, 2024, and one third on November 21, 2024.  May 21, 2029

 

   

No. of

Warrants

Granted

   Vesting Period  

Fair Value at Grant

(in thousands)

 
 Warrants    1,975,000    Over a period of six months   $568 
 Shares    664,000    N/A   $326 

 

The fair valuation of these shares grants is based on the market value of the share at the date of grant.

 


The fair valuation of these warrants grants is based on the following assumptions:

 

   During the Period from January 1, 2024 to June 30, 2024 
Value of one common share   $0.51-$0.84 
Dividend yield   0%
Expected stock price volatility   87%-90% 
Risk free interest rate   4.07%-4.68% 
Expected term (years)   5 

 

NOTE 9 – LOSS PER SHARE

 

The following table sets forth the calculation of basic and diluted loss per share for the period indicated:

SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE 

   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   Three Months Ended   Six Months Ended 
   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   (in thousands, except per share data) 
Basic and diluted:                    
Net loss attributable to Orgenesis Inc.  $8,904   $25,543   $18,669   $45,013 
Adjustment of redeemable non-controlling interest to redemption amount   -    (3,671)   -    - 
Net loss attributable to Orgenesis Inc. for loss per share   8,904   $21,872   $18,669   $45,013 
Weighted average number of common shares outstanding   38,860,727    28,603,597    35,979,567    27,546,229 
Net loss per share   $0.23     $0.76    0.52     $1.63  

 

For the six months ended June 30, 2024 and June 30, 2023, all outstanding convertible notes, options and warrants have been excluded from the calculation of the diluted net loss per share since their effect was anti-dilutive.

 

Diluted loss per share excludes 14,247,610 shares underlying outstanding options and warrants and 2,313,348 shares issuable upon conversion of convertible loans for the six months ended June 30, 2024, because the effect of their inclusion in the computation would be antidilutive. Diluted loss per share excludes 16,917,024 shares underlying outstanding options and warrants and 2,313,348 shares issuable upon conversion of convertible loans for the three months ended June 30, 2024, because the effect of their inclusion in the computation would be antidilutive.

 

Diluted loss per share excludes 7,673,798 shares underlying outstanding options and warrants and 7,101,236 shares upon conversion of convertible loans for the six months ended June 30, 2023, because the effect of their inclusion in the computation would be antidilutive. Diluted loss per share excludes 7,916,597 shares underlying outstanding options and warrants and 5,184,127 shares issuable conversion of convertible loans for the three months ended June 30, 2023, because the effect of their inclusion in the computation would be antidilutive.

 

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NOTE 10 – REVENUES

 

Disaggregation of Revenue

 

The following table disaggregates the Company’s revenues by major revenue streams:

 

SCHEDULE OF DISAGGREGATION OF REVENUE

   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   Three Months Ended   Six Months Ended 
   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   (in thousands) 
Revenue stream:                    
Cell process development services and hospital services  $246   $113    $387    $255 
Total  $246   $113   $387   $255 

 

A breakdown of the revenues per customer constituted at least 10% of revenues is as follows:

 

SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER

   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   Three Months Ended   Six Months Ended 
   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   (in thousands) 
Revenue earned:                    
Customer A (United States)  $225   $65   $300   $130 
Customer B (United States)  $-   $-   $60   $- 
Customer C (United States)  $-   $45   $-   $45 
Customer D (United States)  $-   $-   $-   $65 

 

Contract Assets and Liabilities

 

Contract assets are mainly comprised of trade receivables net of allowance for doubtful debts, which includes amounts billed and currently due from customers.

 

The activity for trade receivables is comprised of:

 

SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES

   June 30, 2024   June 30, 2023 
   Six Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
Balance as of beginning of period  $88   $36,183 
Reconsolidation (deconsolidation) of Octomera   82    (5,985)
Additions   380    293 
Collections   (822)   (6,045)
Allowances for credit losses   512    (24,388)
Exchange rate differences   -    (52)
Balance as of end of period  $240   $6 

 

The activity for contract liabilities is comprised of:

 

SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES

   June 30, 2024   June 30, 2023 
   Six Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
Balance as of beginning of period  $200   $70 
Deconsolidation of Octomera   110    (106)
Deconsolidation of OBI   (60)   - 
Additions   110    36 
Realizations   (10)   - 
Balance as of end of period  $350   $- 

 

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NOTE 11 – OTHER SIGNIFICANT TRANSACTIONS AND AGREEMENTS DURING THE SIX MONTHS ENDED JUNE 30, 2024

 

Asset Purchase and Strategic Collaboration Agreement.

 

On April 5, 2024, the Company entered into an Asset Purchase and Strategic Collaboration Agreement (the “Purchase Agreement”) with Griffin Fund 3 BIDCO, Inc., (“Germfree”), for the sale by the Company of five Orgenesis Mobile Processing Units and Labs (“OMPULs”) to Germfree, which will be incorporated into Germfree’s lease fleet and leased back to the Company or to third-party lessees designated by the Company. Pursuant to the Purchase Agreement, and subject to the terms and conditions set forth therein, in consideration for the purchase of the OMPULs, the Orgenesis Quality Management Systems Framework (“OQMSF”) and related intellectual property rights, Germfree is to pay an aggregate purchase price of $8,340 subject to adjustment through a verification mechanism set forth in the Purchase Agreement. Pursuant to the Purchase Agreement, Germfree has paid the Company $6,720 as of June 30, 2024, which has been recorded under current liabilities.

 

NOTE 12 – LEGAL PROCEEDINGS

 

On January 18, 2022, a complaint (the “Complaint”) was filed in the Tel Aviv District Court (the “Court”) against the Company, Orgenesis Ltd (“the Israeli Subsidiary”), Prof. Sarah Ferber, Vered Caplan and Dr. Efrat Asa Kunik (collectively, the “defendants”) by plaintiffs the State of Israel, as the owner of Chaim Sheba Medical Center at Tel Hashomer (“Sheba”), and Tel Hashomer Medical Research, Infrastructure and Services Ltd. (collectively, the “plaintiffs”). In the Complaint, the plaintiffs are seeking that the Court issue a declaratory remedy whereby the defendants are required to pay royalties to the plaintiffs at the rate of 7% of the sales and 24% of any and all revenues in consideration for sublicenses related to any product, service or process that contain know-how and technology of Sheba and any and all know-how and technology either developed or supervised by Prof. Ferber in the field of cell therapy, including in the category of the point-of-care platform and any and all services and products in relation to the defendants’ CDMO activity. In addition, the plaintiffs seek that the defendants provide financial statements and pay NIS 10,000 to the plaintiffs due to the royalty provisions of the license agreement, dated February 2, 2012, between the Israeli subsidiary and Tel Hashomer Medical Research, Infrastructure and Services Ltd. (the “License Agreement”). The Complaint alleges that the Company and the Israeli subsidiary used know-how and technology of Sheba and know-how and technology either developed or supervised by Prof. Ferber while employed by Sheba in the field of cell therapy, including in the category of the point-of-care platform and the services and products in relation to the defendants’ CDMO activity and are entitled to the payment of certain royalties pursuant to the terms of the License Agreement. The defendants have filed their statements of defense responding to this Complaint, the Plaintiffs filed their response and the parties are now conducting disclosure proceedings in accordance with Israel’s civil regulations. In accordance with Israel’s civil regulations, the parties considered alternative means to resolve at least some of the disputes and have consented to engage the services of a mutually agreeable mediator. The mediation is currently taking place. According to management’s estimation, since a loss is not considered probable, no provision was made in the financial statements.

 

On September 6, 2023, a claim (the “Claim”) was filed in the Tel Aviv District Court (the “Court”) against the Company, the Israeli Subsidiary, Octomera LLC, Orgenesis Biotech Israel Ltd, Theracell Laboratories Private Company and Vered Caplan (collectively, the “defendants”) by Ehud Almon (Plaintiff) for certain finders’ fees and / or royalties related to sales made by an Octomera subsidiary to a Greek entity in the amount of $896 and also for other means of compensation. The Israeli Subsidiary and Vered Caplan filed their statement of defense on January 28, 2024 claiming, inter alia, that the Plaintiff did not serve as a broker, but rather served as the Greek entity’s representative and as such he is not entitled to compensation of any kind from the defendants. It was also clarified that the defendants did not enter into a finder’s agreement with the Plaintiff. Additionally, the Israeli subsidiary and Vered Caplan claimed that the Plaintiff concealed material information from the court, including the signed partnership agreement between the Greek entity’s owner and the Plaintiff, as well as certain criminal charges brought against him in Greece. On February 22, 2024, the Plaintiff filed a request for service of process to deliver the Claim to the Company and the other defendants incorporated outside of Israel. This request was denied on the same day. An appeal filed by the Plaintiff on the aforementioned decision was denied. On May 27, 2024, the Plaintiff filed a new request for service of process to deliver the Claim to the Company and the other defendants incorporated outside of Israel. On May 28, 2024 the request was accepted. The court ruled that the Claim be delivered via courier to the Company and Octomera LLC, and delivered in accordance with the Hague Convention to Theracell Laboratories. After requesting a continuance, the court has ruled that the Plaintiff must file proof of the execution of the aforementioned deliveries until August 15, 2024. According to management’s estimation, since the likelihood of the Plaintiff winning the case is less than fifty percent, no provision was made in the financial statements.

 

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On October 26, 2023, a complaint was filed in the Supreme Court of the State of New York by plaintiffs Southern Israel Bridging Fund Two LP and Mr. Amir Hasidim, against the Company, seeking the payment of $1,150 together with interest in the amount of 6%. In the Complaint plaintiffs alleged the amount provided to the Company was based on a Convertible Loan Agreement dated May 17, 2022, which provided for a loan amount of $5,000. Notwithstanding the Convertible Loan Agreement, on August 21, 2023, Company sent the plaintiffs an offset notice in light of the plaintiffs’ breach of obligations under the Convertible Loan Agreement and the damages caused to the Company as a result of said breach. The Company counter sued as well, seeking damages for Plaintiff’s breach of contract, fraud and harassment. Accordingly, the Company disputes whether it owes plaintiffs the amount sought in the Complaint.

 

On November 1, 2023, a claim (the “Claim”) was filed in the Tel Aviv District Court (the “Court”) against the Company, the Israeli Subsidiary, and Vered Caplan (collectively, the “Defendants”) by Fidelity Venture Capital Ltd. and Dror Atzmon (together – the “Plaintiffs”). The claim is based on two agreements the Company entered into with the Plaintiffs on November 2, 2016: (a) an unsecured convertible note agreements for an aggregate amount of NIS 1 million ($280). The loan bears a monthly interest rate of 2% and will mature on May 1, 2017, unless converted earlier and (b) a consultation agreement which awarded the Plaintiffs 800 thousand warrants. The exercise price of the warrants and conversion price were fixed at $0.52 per share (pre-reverse stock split implemented by the Company in November 2017). On April 27, 2017, and November 2, 2017, the Company entered into extension agreements through November 2, 2017 and May 2, 2018, respectively, in connection with the convertible note agreements. In March 2018, the Plaintiffs submitted a notice of their intention to convert into shares the Company’s common stock, the principal amount of the loan, and accrued interest of approximately $383 outstanding. In addition, the Plaintiffs exercised all the warrants awarded in the consultation agreement. In light of the reverse stock split which took place in November 2017, the Company disagreed with the plaintiffs’ calculations regarding the number of issuable shares of Common Stock. The Company responded to the notice and rejected these contentions in their entirety. In April 2018, the Company terminated the agreements based on several claims, including mistake, intentional misrepresentation and bad faith. Therefore, the Company deposited the shares in total amount of 107,985 issued under those agreements and the principal amount and accrued interest of the loan in an escrow account. The deposit of the principal amount and accrued interest presented as restricted cash in the balance sheet as of December 31, 2023. Based on the calculation difference, in their Claim, the Plaintiffs request damages in the amount of NIS 40,140, and the issuance of 11,869,600 shares of the Company. The Defendants filed their statement of defense on April 15, 2024, in which they raised, among others, the aforementioned claims and additional procedural and substantial claims, including laches. The Claim is scheduled for pretrial which will take place on November 5, 2024. Meanwhile, the parties have agreed to start mediation proceeding in connection with the Claim. According to management’s estimation, since the likelihood of the Plaintiffs winning the case is less than fifty percent, no provision was made in the financial statements.

 

On July 11, 2024 the Israeli subsidiary reached a settlement agreement sanctioned by the Tel Aviv Magistrate’s court pursuant to which the subsidiary will pay the amount of NIS 427,000 (approximately $114) including VAT to the lessor of leased premises no later than September 30, 2024, which includes a grace period for late payments. As of the date of this quarterly report on Form 10Q, the Company had paid NIS 140,000 (approximately $37), leaving an amount of NIS 286,000 (approximately $76) still due under the settlement agreement. In the event that the Company fails to meet all of its obligations under the settlement agreement, the Company may be liable to pay an additional NIS 211,000 (approximately $12) over and above the amount still due, in respect of claims for unpaid rentals made by the lessor.

 

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Except as described above, the Company is not involved in any pending material legal proceedings.

 

NOTE 13 – SUBSEQUENT EVENTS

 

On July 10, 2024, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Broaden Bioscience and Technology Corp. (“Broaden”) for the purchase by the Company of the following assets (the “Assets”): The process and algorithms developed by Broaden for processing CAR-T, RACE CAR-T and all oncology products that will enable the Company to develop and sell treatments to third parties, which include Broaden’s rights, title and interests in and to all intellectual property, including, but not limited to, patents, patent applications, know-how, materials, licenses, permits and approvals related thereto. Pursuant to the Purchase Agreement, in consideration for the purchase of the Assets, the Company will pay Broaden an amount equal to the value of the Assets established by a third party valuation firm not to exceed $11,000 (the “Consideration”), less a debt adjustment relating to $10,767 owed to the Company by Broaden for work performed and invoiced between August 2022 and May 2023 (the “Debt”), as detailed in the Purchase Agreement. The Consideration that exceeds the Debt will be payable at the election of the Company in shares of the Company’s common stock at a price of $3.00 per share or 10% above the market price at such time it is paid, whichever is higher, or a note with amortization in 24 months from the date of the Purchase Agreement, including prepayment provisions.

 

On July 12, 2024, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Theracell Advanced Biotechnology S.A, Theracell Advanced Biotechnology LTD and IDNA Genomics Public Limited (collectively, “Theracell”) for the purchase by the Company of the following assets (the “Assets”) owned by Theracell:

 

50% of the outstanding ownership rights and equity interests in Theracell Laboratories IKE (“Theracell IKE”) not currently owned by the Company so that the Company shall own 100% of the outstanding equity interests of Theracell IKE; and
Certain products (the “Products”), which include: (i) the manufacturing processes, algorithms, work instructions, test methods, standard operating procedures and specifications for producing Tumor Infiltrating Lymphocytes (“TILs”) that meet current Good Manufacturing Practice (cGMP) requirements that will enable the Company to potentially use this product as a platform for treating a wide variety of solid tumors; (ii) a 3rd generation GMP lentivirus production process, which is part of a therapy manufacturing process that will enable the Company to potentially treat Beta Thalassemia therapies; (iii) an oncolytic virus cell carrier platform which will enable the Company to potentially develop treatments for an array of cancers; (iv) a process for the potential treatment of mesenchymal stem cells for kidney disorders; (v) a process for controlled isolation of regenerative EVs derived from mesenchymal stem cells for the potential treatment of kidney disorders; and (vi) bioxome encapsulated APIs for improved transdermal delivery and bioavailability for the potential treatment of atopic dermatitis/wound healing; including Theracell’s rights, title and interests in and to all intellectual property, including, but not limited to, patents, patent applications, know-how, materials, licenses, permits and approvals relating to Products as further described in the Purchase Agreement.

 

Pursuant to the Purchase Agreement, in consideration for the purchase of the Assets, the Company will pay Theracell an aggregate purchase price of $13,000 (the “Consideration”), which is equal to the value of the Assets established by a third-party valuation firm, less a debt adjustment in the amount of $10,324 which was owed by Theracell to the Company (the “Debt”). The aggregate Consideration will be paid by the Company as follows: (i) $400 will be paid to Theracell within 60 days after signing of the Purchase Agreement, (ii) $250 will be paid to Theracell within one year after signing of the Purchase Agreement, and (iii) the remaining amount (less any Debt) will be paid to Theracell in four equal annual payments beginning on December 30, 2025 and ending on December 30, 2028.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

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

 

Forward-Looking Statements

 

The following discussion should be read in conjunction with the financial statements and related notes contained elsewhere in this Quarterly Report, as well as our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2024. Certain statements made in this discussion are “forward-looking statements” within the meaning of 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are based upon beliefs of, and information currently available to, the Company’s management as well as estimates and assumptions made by the Company’s management. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. When used herein, the words “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “future,” “intend,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” or the negative of these terms and similar expressions as they relate to the Company or the Company’s management identify forward-looking statements. Such statements reflect the current view of the Company with respect to future events and are subject to risks, uncertainties, assumptions, and other factors, including the risks relating to the Company’s business, industry, and the Company’s operations and results of operations. Other factors that may cause actual results to differ materially from current expectations include, among other things, those listed under Part II, Item 1A. “Risk Factors” and elsewhere in this Quarterly Report. Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

 

Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee future results, levels of activity, performance, or achievements. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results.

 

Our financial statements are prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). These accounting principles require us to make certain estimates, judgments, and assumptions. We believe that the estimates, judgments, and assumptions upon which we rely are reasonable based upon information available to us at the time that these estimates, judgments, and assumptions are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts of revenues and expenses during the periods presented. Our financial statements would be affected to the extent there are material differences between these estimates and actual results. The following discussion should be read in conjunction with our financial statements and notes thereto appearing elsewhere in this report.

 

Unless otherwise indicated or the context requires otherwise, the words “we,” “us,” “our,” the “Company,” “our Company” or “Orgenesis” refer to Orgenesis Inc., a Nevada corporation, and our majority or wholly-owned subsidiaries, Orgenesis Korea Co. Ltd. (the “Korean Subsidiary”); Orgenesis Belgium SRL, a Belgian-based entity (the “Belgian Subsidiary”); Orgenesis Services SRL, a Belgian-based entity (“Orgenesis Services SRL”); Orgenesis Ltd., an Israeli corporation (the “Israeli Subsidiary”); Orgenesis Maryland LLC, a Maryland limited liability company (the “Maryland Subsidiary”); Orgenesis Switzerland Sarl, (the “Swiss Subsidiary”); Orgenesis Biotech Israel Ltd. (“OBI”); Koligo Therapeutics Inc., a Kentucky corporation (“Koligo”); Tissue Genesis International LLC (“Tissue Genesis”) a Texas limited liability company; Orgenesis Germany GmbH (the “German Subsidiary”); Orgenesis CA, Inc. (the “California Subsidiary”); Mida Biotech BV (the “Dutch Subsidiary”); Orgenesis Australia PTY LTD (the “Australian Subsidiary”); Orgenesis Italy SRL (the “Italian Subsidiary”), Theracell Laboratories Private Company (“Theracell Laboratories”), a Greek company, Orgenesis Austria GmbH, an Austrian company; ORGS POC CA Inc, a Delaware company; and Octomera LLC, a Delaware limited liability company.

 

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Business Overview

 

We are a global biotech company working to unlock the potential of CGTs in an affordable and accessible format. CGTs can be centered on autologous (using the patient’s own cells) or allogenic (using master banked donor cells) and are part of a class of medicines referred to as advanced therapy medicinal products, or ATMPs. We are mostly focused on autologous therapies that can be manufactured under processes and systems that are developed for each therapy using a closed and automated approach that is validated for compliant production near the patient for treatment of the patient at the point of care, or POCare. This approach has the potential to overcome the limitations of traditional commercial manufacturing methods that do not translate well to commercial production of advanced therapies due to their cost prohibitive nature and complex logistics to deliver such treatments to patients (ultimately limiting the number of patients that can have access to, or can afford, these therapies).

 

To achieve these goals, we have developed a collaborative worldwide network of research institutes and hospitals who are engaged in the POCare model, or our POCare Network, and a pipeline of licensed POCare advanced therapies that can be processed and produced under such closed and automated processes and systems, or POCare Therapies. We are developing our pipeline of advanced therapies with the goal of entering into out-licensing agreements for these therapies.

 

We have two operating segments – our POCare Services and our therapeutic development operations. We conduct our core POCare operations through our wholly-owned subsidiary Octomera LLC which was a consolidated subsidiary of ours until June 30, 2023 and which became a consolidated subsidiary again effective January 29, 2024 when we entered into a unit purchase agreement pursuant to which we acquired all of the equity interests of Octomera LLC.

 

Octomera segment (mainly POCare Services)

 

The POCare Services that we and our affiliated entities perform include:

 

Process development of therapies, process adaptation, and optimization inside the OMPULs, or “OMPULization”;
Adaptation of automation and closed systems to serviced therapies;
Incorporation of the serviced therapies compliant with GMP in the OMPULs that we designed and built;
Tech transfers and training of local teams for the serviced therapies at the POCare Centers;
Processing and supply of the therapies and required supplies under GMP conditions within our POCare Network, including required quality control testing;

 

The POCare Services are performed in decentralized hubs that provide harmonized and standardized services to customers, or POCare Centers. We are working to expand the number and scope of our POCare Centers. We believe that this provides an efficient and scalable pathway for CGT therapies to reach patients rapidly at lowered costs. Our POCare Services are designed to allow rapid capacity expansion while integrating new technologies to bring together patients, doctors and industry partners with a goal of achieving standardized, regulated clinical development and production of therapies.

 

Therapies segment (POCare Therapies)

 

While the biotech industry struggles to determine the best way to lower the cost of goods and enable CGTs to scale, the scientific community continues to advance and push the development of such therapies to new heights. Clinicians and researchers are excited by many new tools (such as new generations of industrial viruses and big data analysis for genetic and molecular data) and technologies (CRISPR, mRNA, etc.) available, often at a low cost, to perform advanced research in small labs. Most new therapies arise from research at academic institutions or at small spinouts from such institutions. Though such research efforts may manage to progress into a clinical stage, utilizing lab- or hospital-based production solutions, they generally lack the resources to continue the development of such drugs to market approval.

 

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Historically, drug/therapeutic development has required investments of hundreds of millions of dollars to be successful. One significant cause for the high cost is that each therapy often requires unique production facilities and technologies that must be subcontracted or built. Furthermore, the cost of production during the clinical stage is extremely expensive, and the cost of the clinical trial itself is very high. Given these financial restraints, researchers and institutions hope to out-license their therapeutic products to large biotech companies or to spin out new companies and conduct large fundraising rounds. In many cases, however, they lack the resources and the capability to de-risk their therapeutic candidates enough to be attractive for such fundings or partnership.

 

Our POCare Network is an alternative to the traditional pathway of drug development. Orgenesis works closely with many such institutes and is in close contact with researchers in the field. The partnerships with leading hospitals and research institutes gives us a deep insight as to the developments in the field, as well as the market potential, the regulatory landscape and optimal clinical pathway to get these products to market.

 

The ability to produce these products at low cost allows for an expedited development process, and partnership with hospitals around the globe allows for joint grants and lower costs of clinical development. The POCare Therapies division reviews many therapies available for out-licensing and selects the ones they believe have the highest market potential and chance of clinical success and can benefit the most from a point of care approach. It assesses such issues by utilizing its global POCare Network and its internal know-how accumulated over a decade of involvement in the field.

 

The goal of this in-licensing is to quickly adapt such therapies to a point-of- care approach through regional partnerships, and to out-license the products for market approval in non-core geographical regions. This approach lowers overall development costs by minimizing our pre-clinical development costs and enabling us to receive additional funding from grants and/or payments by regional partners.

 

Significant developments during the six-months ended June 30, 2024

 

On January 29, 2024 (“Closing” or “Transaction date” or “Reconsolidation date”), we and Metalmark Capital Partners (“MM”) entered into a Unit Purchase Agreement (the “MM UPA”), pursuant to which we acquired all of the preferred units of Octomera previously owned by MM and reconsolidated Octomera into our accounts with immediate effect (the “MM acquisition”). As consideration for the MM Acquisition, we and MM agreed to the following consideration:

 

Royalty Payments: If Octomera and its subsidiaries generate Net Revenue during the three-year period 2025-2027, then we will pay 5% of Net Revenues to MM pursuant to the MM UPA.

 

Milestone Payments: If we sell Octomera within ten years from the date of the Closing at a price that is more than $40 million excluding consideration for certain Excluded Assets as per the UPA, then we will pay MM 5% of the net proceeds of that sale.

 

Pursuant to the MM acquisition, MM’s designated members of the Board of Managers of Octomera resigned, and we amended the Second Amended and Restated Limited Liability Company Agreement of Octomera (the “Octomera LLC Agreement”) to be a single member agreement reflecting the MM acquisition, such that MM no longer (i) was a member of Octomera or a party to the Octomera LLC Agreement, or (ii) had the right to appoint members of the board of managers of Octomera.

 

In addition, 10 secured promissory notes between Orgenesis Maryland LLC and MM, reflecting an aggregate outstanding principal amount of $2,600 (the “Notes”), were amended to, among other things, extend the maturity thereof to January 29, 2034 and to terminate the security interest granted by Orgenesis Maryland LLC in favor of MM that secured the obligations under the Notes.

 

On February 14, 2024, following a claim for payment by employees of OBI (a fully owned subsidiary of Octomera) of past salaries due, the district court in Haifa, Israel appointed a trustee to run the affairs of OBI. As a result of this appointment, effective February 14, 2024, we no longer controls OBI and have ceased to consolidate the results of OBI into our consolidated results. We recognized a loss as a result of the deconsolidation of $66. We do not currently believe that rehabilitation of OBI is possible, and we purchased certain of OBI’s equipment.

 

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On March 3, 2024, we entered into a Securities Purchase Agreement with certain accredited investors, pursuant to which we agreed to issue and sell, in a private placement, 2,272,719 shares of our Common Stock at a purchase price of $1.03 per share, Warrants to purchase up to 2,272,719 shares of Common Stock at an exercise price of $1.50 per share, and Warrants to purchase up to 2,272,719 shares of Common Stock at an exercise price of $2.00 per share, all such Warrants exercisable immediately and expiring five years from the date of their issuance. We received gross proceeds of approximately $2,300 before deducting related offering expenses. The Offering closed on March 5, 2024.

 

On April 5, 2024, we entered into an Asset Purchase and Strategic Collaboration Agreement (the “Purchase Agreement”) with Griffin Fund 3 BIDCO, Inc. (“Germfree”), for the sale by us of five OMPULs to Germfree, which are to be incorporated into Germfree’s lease fleet and leased back to us or to third-party lessees designated by us. Pursuant to the Purchase Agreement, and subject to the terms and conditions set forth therein, in consideration for the purchase of the OMPULs, the Orgenesis Quality Management Systems Framework (“OQMSF”) and related intellectual property rights, Germfree is to pay us an aggregate purchase price of $8,340 subject to adjustment through a verification mechanism set forth in the Purchase Agreement. Pursuant to the Purchase Agreement, Germfree has paid us $6,720 as of June 30, 2024.

 

On May 10, 2024, we entered into a Securities Purchase Agreement with certain accredited investors, pursuant to which we agreed to issue and sell, in a private placement, 150,000 shares of our Common Stock at a purchase price of $1.03 per share, Warrants to purchase up to 150,000 shares of Common Stock at an exercise price of $1.50 per share, and further Warrants to purchase up to 150,000 shares of Common Stock at an exercise price of $2.00 per share, all such Warrants exercisable immediately and expiring five years from their date of issuance. We received gross proceeds of approximately $154 before deducting related offering expenses. The Offering closed on May 10, 2024.

 

On May 21, 2024 we entered into debt exchange agreements with three convertible debt holders pursuant to which a total of $16,007 of outstanding principal and accrued interest was exchanged for the right to receive an aggregate of 15,776,947 shares of common stock, par value $0.0001 per share, of our Common Stock, of which $14,860 was exchanged for shares at an exchange price of $1.03 per share of Common Stock and $1,147 was exchanged for shares at an exchange price of $0.85 per share of Common Stock.

 

On September 27, 2023, we received a notice from the Listing Qualifications Staff (“Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) stating that the bid price of the Common Stock had closed at less than $1.00 per share over the previous 30 consecutive business days, and, as a result, did not comply with Listing Rule 5550(a)(2) (the “Bid Price Rule”). On April 17, 2024, we received a notice (the “Notice”) from the Staff which stated that it could not accept a plan to regain compliance and the Staff stated that our securities would be delisted from The Nasdaq Capital Market unless we timely requested a hearing before a Nasdaq Hearings Panel (the “Panel”) to address the deficiencies and present a plan to regain compliance. As permitted by the Notice, we timely requested a hearing before the Panel, which request stayed any further delisting action by the Staff pending the ultimate outcome of the hearing and the expiration of any extension that may be granted by the Panel. On June 6, 2024, we met with the Panel regarding our potential delisting from The Nasdaq Stock Market as a result of our violation of the Bid Price Rule and non-compliance with the equity requirement in Listing Rule 5550(b)(1) (the “Equity Rule”) or any of the alternative requirements in Listing Rule 5550(b). On June 8, 2024, we received the Panel’s decision which granted us until October 14, 2024 to regain compliance with the Bid Price and Equity Rules. If we are unable to regain compliance with the listing standards of the Nasdaq Capital Market by October 14, 2024, our securities may be delisted from The Nasdaq Stock Market.

 

29

 

 

Results of Operations

 

Comparison of the Three Months Ended June 30, 2024 to the Three Months Ended June 30, 2023.

 

The following table presents our results of operations for the three months ended June 30, 2024 and 2023:

 

   Three-Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
Revenues  $246   $113 
Cost of revenues   538    3,232 
Total revenues   (292)   (3,119)
Cost of development services and research and development   1,489    3,527 
Amortization of intangible assets   226    208 
Royalties and exit option to MM   182    - 
Selling, general and administrative expenses   2,061    18,216 
Operating loss   4,250    25,070 
Other income, net   (8)   - 
Financial expenses, net   815    692 
Convertible loans induced conversion expenses (See note 4)   4,304    - 
Share in net loss of associated company   -    (3)
Loss from deconsolidation of Octomera   -    5,343 
Loss before income taxes   9,361    31,102 
Tax expense   5    91 
Net loss  $9,366   $31,193 

 

Revenues

 

Our revenues for the three months ended June 30, 2024 were $246, as compared to $113 for the three months ended June 30, 2023, representing an increase of 118%. The revenues were from hospital services provided by Koligo.

 

Expenses

 

Cost of revenue

 

   Three-Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
Salaries and related expenses  $179   $1,091 
Stock-based compensation   1    1 
Professional fees and consulting services   21    1,071 
Raw materials   40    482 
Depreciation expenses, net   249    236 
Other expenses   48    351 
Total  $538   $3,232 

 

Cost of revenues for the three months ended June 30, 2024 were $538, as compared to $3,232 for the three months ended June 30, 2023, representing a decrease of 83%. The decrease was mainly attributable to reduced Octomera segment cost of revenues including the deconsolidation of OBI, cost savings initiatives, and the reduction of activities in the Korean subsidiary. The decrease was mainly manifested in a decline in salaries and related expenses, professional fees and consulting services, and raw materials.

 

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Cost of development services and research and development expenses

 

   Three Months Ended 
   June 30, 2024   June 30,  2023 
   (in thousands) 
Salaries and related expenses  $1,558   $1,856 
Stock-based compensation   49    79 
Professional fees and consulting services   (756)   805 
Lab expenses   30    128 
Depreciation expenses, net   171    132 
Other research and development expenses   536    587 
Less – grant   (99)   (60)
Total  $1,489   $3,527 

 

Cost of development services and research and development for the three months ended June 30, 2024 were $1,489, as compared to $3,527 for the three months ended June 30, 2023, representing a decrease of 58%.

 

The decrease is mainly attributable to cost savings in the Octomera segment, including the deconsolidation of OBI, reduction of activities in the German subsidiary, and a reversal in the amount of $1,327 of an accrual of professional services.

 

Selling, General and Administrative Expenses

 

   Three-Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
Salaries and related expenses  $1,088   $1,088 
Stock-based compensation   79    71 
Accounting and legal fees   830    794 
Professional fees   (862)   525 
Rent and related expenses   94    48 
Business development   721    151 
Depreciation expenses, net   60    21 
Other general and administrative expenses   551    640 
Credit losses   

(500

)   

14,878

 
Total  $2,061   $18,216 

 

Selling, general and administrative expenses for the three months ended June 30, 2024 were $2,061, as compared to $18,216 for the three months ended June 30, 2023, representing a decrease of 89%. The decrease was mainly attributable to 1) a decline in Professional fees as a result of invoice cancellations in the amount of $705 no longer required to be paid and a waiver of fees by a director in the amount of $315; 2) credit losses mainly in the Octomera segment reported in the three months ended June 30, 2023 of $14,878 compared to $(500) credit losses in the three months ended June 30, 2024, offset by 3) an increase in business development expenses as a result of warrants granted to advisers.

 

Financial Expenses, net

 

   Three-Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
Interest expense on convertible loans and loans  $639   $597 
Foreign exchange loss, net   196    94 
Other expenses (income)   (20)   1 
Total  $815   $692 

 

Financial expenses, net for the three months ended June 30, 2024 were $815, as compared to $692 for the three months ended June 30, 2023, representing an increase of 18%. The increase was mainly due to an increase in foreign exchange losses.

 

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Comparison of the Six Months Ended June 30, 2024 to the Six Months Ended June 30, 2023.

 

The following table presents our results of operations for the six months ended June 30, 2024 and 2023:

 

   Six Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
Revenues  $387   $255 
Cost of revenues   1,030    5,954 
Total revenue   (643)   (5,699)
Cost of development services and research and development   3,859    6,808 
Amortization of intangible assets   379    415 
Royalties and exit option to MM   182    - 
Selling, general and administrative expenses included credit losses of $24,367 for the six months ended June 30, 2023   8,117    31,744 
Operating loss   13,180    44,666 
Other income, net   (8)   (2)
Loss from extinguishment in connection with convertible loan   141    283 
Credit loss on convertible loan receivable   -    2,688 
Financial expenses, net   1,667    1,373 
Convertible loans induced conversion expenses (See note 4)   4,304    - 
Share in net loss of associated company   -    (1)
Loss from deconsolidation of Octomera   66    5,343 
Loss before income taxes   19,350    54,350 
Tax (income) expense   21    220 
Net loss  $19,371   $54,570 

 

Revenues

 

Our revenues for the six months ended June 30, 2024 were $387, as compared to $255 for the six months ended June 30, 2023, representing an increase of 52%.The revenues were from hospital services provided by Koligo.

 

Expenses

 

Cost of revenues

 

   Six Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
Salaries and related expenses  $431   $2,204 
Stock-based compensation   2    3 
Professional fees and consulting services   40    1,878 
Raw materials   53    710 
Depreciation expenses, net   364    472 
Other expenses   140    687 
Total  $1,030   $5,954 

 

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Cost of revenues for the six months ended June 30, 2024 were $1,030, as compared to $5,954 for the six months ended June 30, 2023, representing a decrease of 83%. The decrease was mainly attributable to reduced Octomera segment cost of revenues, particularly as a result of the deconsolidation of OBI and reduced activities at the Korean subsidiary, as well as our accounting for Octomera segment cost of revenues from the Reconsolidation date compared to accounting for the full six months of cost of revenues in the six months ended June 30, 2023, where Octomera was a consolidated subsidiary.

 

Cost of development services and research and development expenses

 

   Six Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
Salaries and related expenses  $2,923   $3,484 
Stock-based compensation   85    163 
Professional fees and consulting services   (289)   1,601 
Lab expenses   97    304 
Depreciation expenses, net   274    256 
Other research and development expenses   941    1,141 
Less – grant   (172)   (141)
Total  $3,859   $6,808 

 

Cost of development services and research and development for the six months ended June 30, 2024 were $3,859, as compared to $6,808 for the six months ended June 30, 2023, representing a decrease of 43%.

 

The decrease in salaries and related expenses, lab expenses and other research and development expenses is 1) attributable to our accounting for Octomera segment cost of development services and research and development expenses from the reconsolidation date compared to accounting for the full six months in the six months ended June 30, 2023 where Octomera was a consolidated subsidiary; 2) cost savings in the Octomera segment; 3) the deconsolidation of OBI; as well as a reversal in the amount of $1,327 of an accrual related to professional fees.

 

Selling, General and Administrative Expenses

 

   Six Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
 Salaries and related expenses  $1,794   $2,261 
Stock-based compensation   128    144 
Accounting and legal fees   1,695    2,344 
Professional fees   (339)   886 
Rent and related expenses   150    114 
Business development   885    361 
Depreciation expenses, net   70    32 
Other general and administrative expenses   1,009    1,235 
Credit losses   

2,725

    

24,367

 
Total  $8,117   $31,744 

 

Selling, general and administrative expenses for the six months ended June 30, 2024 were $8,117, as compared to $31,744 for the six months ended June 30, 2023, representing a decrease of 74%.

 

The decrease was mainly as a result of a decrease in 1) salaries and related expenses mainly in the Octomera segment as a result of cost savings and where expenses were accounted for in 2024 from the reconsolidation date as compared to the entire six months ended June 30, 2023 where Octomera was a consolidated subsidiary; 2) accounting and legal fees which in the six months ended June 30, 2023 included charges for increased activities undertaken, not undertaken in the six months ended June 30, 2024; 3) professional fees as a result of invoice cancellations in the amount of $705 no longer required to be paid and a waiver of fees by a director in the amount of $315; 4) credit losses of $2,725 incurred in the six months ended June 30, 2024 compared to $24,367 for the six months ended June 30, 2023 mainly in the Octomera segment, offset by 4) an increase in business development expenses as a result of warrants granted to advisers.

 

33

 

 

Credit Loss

 

   Six Months Ended 
   June 30, 2024  

June 30, 2023

 
   (in thousands) 
Credit loss on convertible loans  $-   $2,688 

 

Credit losses for the six months ended June 30, 2024 were $0 compared to $2,688 for the six months ended June 30, 2023. This was attributable to a provision created for a possible credit loss on a loan in the six months ended June 30, 2023.

 

Financial Expenses, net

 

   Six Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
Interest expense on convertible loans and loans  $1,441   $1,129 
Foreign exchange loss, net   245    242 
Other expenses (income)   (19)   2 
Total  $1,667   $1,373 

 

Financial expenses, net for the six months ended June 30, 2024 were $1,667, as compared to $1,373 for the six months ended June 30, 2023, representing an increase of 21%. The increase was mainly due to interest on new loan agreements entered into.

 

Working Capital

 

   As of 
   June 30, 2024  

December 31, 2023

 
   (in thousands) 
Current assets  $2,348   $4,076 
Current liabilities   31,700    16,407 
Working capital  $(29,352)  $(12,331)

 

Current assets decreased by $1,728 between December 31, 2023 and June 30, 2024 The decrease was mainly attributable to a decline in cash and cash equivalents, prepaid expenses, and receivables from related parties.

 

Current liabilities increased by $15,293 between December 31, 2023 and June 30, 2024 The increase was mainly attributable to:

 

the reconsolidation of Octomera which included an increase in accounts payable, accrued expenses and other payables, employees and related payables, and advance payments on account of grants;
the deconsolidation of OBI where we recorded an increase in accounts payable to related parties;
the Germfree receipt which was recorded in current liabilities.

 

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The above increases were offset by a decline in current maturities of convertible loans, converted to equity.

 

Liquidity and Financial Condition

 

   Six Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
         
Net loss  $(19,371)  $(54,570)
Net cash used in operating activities   (10,348)   (13,154)
Net cash used in investing activities   (69)   (2,802)
Net cash provided by financing activities   10,125    10,796 
Increase in cash and cash equivalents  $(292)  $(5,160)

 

During the six-month ended June 30, 2024, we funded our operations from operations as well as from proceeds raised from equity and debt offerings.

 

Net cash used in operating activities for the six months ended June 30, 2024 was approximately $10,348, as compared to net cash used in operating activities of approximately $13,154 for the six months ended June 30, 2023.

 

The decline was mainly as a result of:

 

● a net loss of $19,371 for the six months ended June 30, 2024 compared to a net loss of $54,570 for the six months ended June 30, 2023;

● non-cash items incurred in the six months ended June 30, 2023 that were not incurred in the six months ended June 30, 2024

 

Net cash used in investing activities for the six months ended June 30, 2024 was approximately $69, as compared to net cash used in investing activities of approximately $2,802 for the six months ended June 30, 2023. The change was mainly as a result of a decline in purchases of property and equipment and the cash impact from the deconsolidation of Octomera which incurred in the six months ended June 30, 2023 not incurred in the six months ended June 30, 2024.

 

Net cash provided by financing activities for the six months ended June 30, 2024 was approximately $10,125, as compared to net cash provided by financing activities of approximately $10,796 for the six months ended June 30, 2023. The decrease was mainly attributable to proceeds raised from equity investments in the amount of $2,528 in the six months ended June 30, 2024 as compared to $3,441 in the six months ended June 30, 2023. In addition, in the six months ended June 30, 2024, we raised convertible loans in the amount of $75 compared to $5,485 in the six months ended June 30, 2023. These decreases were offset by the receipt of $6,720 from Germfree received in the six months ended June 30, 2024.

 

Liquidity & Capital Resources Outlook

 

Through June 2024, we had an accumulated deficit of and for the six months ended June 30, 2024 incurred negative operating cashflows of $10,348. Our activities have been funded by generating revenue, proceeds from convertible loan agreements, and through offerings of our securities. There is no assurance that our business will generate sustainable positive cash flows to fund our operations.

 

35

 

 

The estimation and execution uncertainty regarding our future cash flows and management’s judgments and assumptions in estimating these cash flows is a significant estimate. Those assumptions include reasonableness of the forecasted revenue, operating expenses, and uses and sources of cash.

 

Due to our financial position, we will need to seek additional financing, refinance or amend the terms of existing convertible loans, and/or postpone expenses that are not based on firm commitments. In order to fund our operations until such time that we can generate sustainable positive cash flows, we will need to raise additional funds. As of the date of this report, we have assessed our financial condition and concluded that based on our current and projected cash resources and commitments, as well as other factors mentioned above, there is substantial doubt about our ability to continue as a going concern. We are planning to raise additional capital to continue our operations and to repay our outstanding loans when they become due, as well as to explore additional avenues to increase revenues and reduce or delay expenditures. Failure to remain listed on Nasdaq will make it more difficult to raise additional capital. There can be no assurance that we will be able to raise additional capital on acceptable terms, or at all. Despite our ability to secure capital in the past, there can be no assurance that additional equity or debt financing will be available to us or that we may be able to secure funding from any other sources. In the event that we are not able to secure funding, we may be forced to curtail operations, delay or stop ongoing development activities, cease operations altogether, or file for bankruptcy.

 

Off-Balance Sheet Arrangements

 

We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to stockholders.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

Not applicable.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures (as that term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) that are designed to ensure that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosures. In designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance of achieving the desired control objectives.

 

Our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report. Based upon that evaluation and subject to the foregoing, our principal executive officer and principal financial officer concluded that, as of the end of the period covered by this Quarterly Report, the design and operation of our disclosure controls and procedures were not effective due to the material weakness in our internal control over financial reporting.

 

Management determined that we had the following material weakness in our internal control over financial reporting as of December 31, 2023:

 

We did not perform appropriate analyses related to our internal control over financial reporting in the accounting for whether it is probable we will collect substantially all the consideration to which we are entitled for revenue services provided, as well as our estimated credit losses. As of June 30, 2024, such material weakness has not been remediated.

 

36

 

 

Remediation Activities

 

Management’s remediation activities, which have already commenced and will continue during 2024, include the design of enhanced controls that include a thorough credit assessment of all new customers, analysis of payment history for existing customers and its impact related to the accounting for revenues, and additional controls designed to calculate the expected credit loss on the balances when there is an indication that a customer may not be pay the full receivable amount. These controls are already designed, however, management will need a number of periods in order to ensure their effectiveness.

 

Changes in Internal Control Over Financial Reporting

 

Except as set forth above, there have been no changes in our internal control over financial reporting during the quarter ended June 30, 2024 that have materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings

 

Information regarding legal proceedings is available in Note 12 to the condensed consolidated financial statements in this Report.

 

Except as described above, we are not involved in any pending material legal proceedings.

 

ITEM 1A. RISK FACTORS

 

An investment in the Company’s Common Stock involves a number of very significant risks. You should carefully consider the risk factors included in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on April 15, 2024, in addition to other information contained in our reports and in this quarterly report in evaluating the Company and its business before purchasing shares of our Common Stock. Except as set forth below, there have been no material changes to our risk factors contained in our Annual Report on Form 10-K for the year ended December 31, 2023. The Company’s business, operating results and financial condition could be adversely affected due to any of those risks.

 

We may be unsuccessful in raising the capital necessary to address our going concern issues and to comply with the Nasdaq stockholders’ equity requirements, or if we are successful, it may be on terms that are highly dilutive to existing stockholders.

 

Historically, we funded our operations by raising capital from external sources, including through the sale of common stock and convertible loans. We are currently facing significant challenges to our ability to raise significant amounts of capital through the sale of common stock, including the following factors:

 

in general, it is difficult for development stage companies to raise capital under current market conditions, especially those with early stage programs like ours;
the perception that we may be unable to continue as a going concern may impede our ability to attract further equity investment;

 

37

 

 

our common stock has been trading below $1.00 per share since August 2023 and we may not regain compliance with the bid price and stockholders’ equity requirements for the Nasdaq Capital Market and could be delisted by the Staff if we do not regain compliance by October 14, 2024. The potential delisting of our common stock from Nasdaq could adversely affect our ability to raise additional capital through the public or private sale of equity securities; and
we are currently subject to the “baby shelf” limitations on our potential use of our shelf registration statement, which limits such use to an offering size of no more than one third of our public float.

 

Given these factors, there can be no assurances we will be successful at raising sufficient capital to address our going concern issues or the Nasdaq stockholders’ equity requirements. However, if we are successful, it may be on terms that are very dilutive to existing stockholders. Despite our ability to secure capital in the past, there can be no assurance that additional equity or debt financing will be available to us or that we may be able to secure funding from any other sources. In the event that we are not able to secure funding, we may be forced to curtail operations, delay or stop ongoing development activities, cease operations altogether, or file for bankruptcy.

 

A delisting of our common stock from Nasdaq could adversely affect our ability to raise additional capital through the public or private sale of equity securities and the ability of investors to dispose of, or obtain accurate quotations as to the market value of, our common stock.

 

If our common stock is ultimately delisted by Nasdaq, our common stock may be eligible to trade on the OTC Pink Market or another over-the-counter market. Any such alternative would likely result in it being more difficult for us to raise additional capital through the public or private sale of equity securities and for investors to dispose of, or obtain accurate quotations as to the market value of, our common stock. In addition, there can be no assurance that our common stock would be eligible for trading on any such alternative exchange or markets.

 

Unless our common stock is listed on a national securities exchange, such as the Nasdaq Capital Market, our common stock may also be subject to the regulations regarding trading in “penny stocks,” which are those securities trading for less than $5.00 per share, and that are not otherwise exempted from the definition of a penny stock under other exemptions provided for in the applicable regulations. The following is a list of the general restrictions on the sale of penny stocks:

 

Before the sale of penny stock by a broker-dealer to a new purchaser, the broker-dealer must determine whether the purchaser is suitable to invest in penny stocks. To make that determination, a broker-dealer must obtain, from a prospective investor, information regarding the purchaser’s financial condition, investment experience, and objectives. Subsequently, the broker-dealer must deliver to the purchaser a written statement setting forth the basis of the suitability finding and obtain the purchaser’s signature on such statement.
A broker-dealer must obtain from the purchaser an agreement to purchase the securities. This agreement must be obtained for every purchase until the purchaser becomes an “established customer.”
The Exchange Act requires that before effecting any transaction in any penny stock, a broker-dealer must provide the purchaser with a “risk disclosure document” that contains, among other things, a description of the penny stock market and how it functions, and the risks associated with such investment. These disclosure rules are applicable to both purchases and sales by investors.
A dealer that sells penny stock must send to the purchaser, within 10 days after the end of each calendar month, a written account statement including prescribed information relating to the security.

 

These requirements can severely limit the liquidity of securities in the secondary market because fewer brokers or dealers are likely to be willing to undertake these compliance activities. If our common stock is not listed on a national securities exchange, the rules and restrictions regarding penny stock transactions may limit an investor’s ability to sell to a third party and our trading activity in the secondary market may be reduced.

 

We will likely seek to effect a reverse stock split in order to address the $1.00 minimum bid price requirement under Nasdaq rules. In the event a reverse stock split is implemented, we cannot predict the effect that such reverse stock split would have on the market price for shares of our common stock, and the history of similar reverse stock splits for companies in like circumstances has varied. Some investors may have a negative view of a reverse stock split. Even if such reverse stock split were to have a positive effect on the market price for shares of our common stock, performance of our business and financial results, general economic conditions and the market perception of our business, and other adverse factors which may not be in our control could lead to a decrease in the price of our common stock following such reverse stock split.

 

38

 

 

We conduct certain of our operations in Israel. Conditions in Israel, including the recent attack by Hamas and other terrorist organizations from the Gaza Strip and Israel’s war against them, may affect certain of our operations.

 

Because we conduct certain operations in the State of Israel, some of our business and operations may be affected by economic, political, geopolitical and military conditions in Israel. In October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel. Following the attack, Israel’s security cabinet declared war against Hamas and a military campaign against these terrorist organizations commenced in parallel to their continued rocket and terror attacks. Moreover, the clash between Israel and Hezbollah in Lebanon, may escalate in the future into a greater regional conflict. The intensity and duration of Israel’s current war against Hamas is difficult to predict, as are such war’s economic implications on the Company’s business and operations and on Israel’s economy in general.

 

Any hostilities involving Israel, or the interruption or curtailment of trade within Israel or between Israel and its trading partners could adversely affect certain of our operations and results of operations and could make it more difficult for us to raise capital. The conflict in Israel could also result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions in such agreements. There have been travel advisories imposed relating to travel to Israel, and restriction on travel, or delays and disruptions as related to imports and exports may be imposed in the future. Additionally, certain members of our management and employees are located and reside in Israel. Shelter-in-place and work-from-home measures, government-imposed restrictions on movement and travel and other precautions taken to address the ongoing conflict may temporarily disrupt our management and employees’ ability to effectively perform their daily tasks.

 

The Israel Defense Forces (the “IDF”), the national military of Israel, is a conscripted military service, subject to certain exceptions. Certain of our R&D and finance personnel live in Israel. Certain of our employees are subject to military service in the IDF and have been called to serve, and additional employees may be called to serve in the future. It is possible that there will be further military reserve duty call-ups in the future, which may affect our business due to a shortage of skilled labor and loss of institutional knowledge, and necessary mitigation measures we may take to respond to a decrease in labor availability, such as overtime and third-party outsourcing, for example, may have unintended negative effects and adversely impact our results of operations, liquidity or cash flows. Additionally, the absence of employees of our Israeli suppliers and service providers due to their military service in the current or future wars or other armed conflicts may disrupt their operations, which in turn may adversely affect our ability to deliver or provide products and services to customers.

 

The hostilities with Hamas, Hezbollah and other organizations and countries have included and may include terror, missile and drone attacks. In the event that any of our facilities, including back-up information technology systems located in Israel, are damaged as a result of hostile actions, or hostilities otherwise disrupt our ongoing operations, our ability to deliver or provide products and services in a timely manner to meet our contractual obligations towards customers and vendors could be adversely affected. Our commercial insurance does not cover losses that may occur as a result of events associated with war and terrorism. Although the Israeli government currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, we cannot assure you that this government coverage will be maintained or that it will sufficiently cover our potential damages. Any losses or damages incurred by us could have a material adverse effect on our business. Any armed conflicts or political instability in the region would likely negatively affect business conditions and could harm our results of operations.

 

As of the date of this Quarterly Report, our operations have not been directly negatively affected by the ongoing hostilities in the region. As a result, as of the date of this Quarterly Report, our ability to deliver or provide products and services to our customers has not been materially affected. We cannot currently assess how the ongoing hostilities will affect our business conditions and harm our results of operations in the future, given the factors and risks discussed above.

 

39

 

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

On April 18, 2024 (the “Effective Date”), the Company entered into a strategic advisor agreement with an individual relating to the provision of strategic advice and assistance to the Company for a term of 12 months. In consideration for such services, the Company agreed to issue warrants to purchase up to 500,000 shares of Common Stock at an exercise price of $1.03, which vests one third on April 18, 2024, one third on July 18, 2024, and one third on October 18, 2024. These warrants and the shares of common stock underlying such warrants were issued in reliance upon an exemption from registration afforded by Section 4(a)(2) promulgated under the Securities Act of 1933, as amended.

 

On April 23, 2024 (the “Effective Date”), the Company entered into a strategic advisor agreement with an individual relating to the provision of strategic advice and assistance to the Company for a term of 12 months. In consideration for such services, the Company agreed to issue warrants to purchase up to 500,000 shares of Common Stock at an exercise price of $1.03, which vests one third on April 16, 2024, one third on July 16, 2024, and one third on October 16, 2024. These warrants and the shares of common stock underlying such warrants were issued in reliance upon an exemption from registration afforded by Section 4(a)(2) promulgated under the Securities Act of 1933, as amended.

 

On May 22, 2024 (the “Effective Date”), the Company entered into a strategic advisor agreement with an individual relating to the provision of strategic advice and assistance to the Company for a term of 12 months. In consideration for such services, the Company agreed to issue warrants to purchase up to 475,000 shares of Common Stock at an exercise price of $1.03, which vests one third on May 21, 2024, one third on August 21, 2024, and one third on November 21, 2024. These warrants and the shares of common stock underlying such warrants were issued in reliance upon an exemption from registration afforded by Section 4(a)(2) promulgated under the Securities Act of 1933, as amended.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not Applicable.

 

Item 5. Other Information

 

None.

 

40

 

 

Item 6. Exhibits

 

Exhibits required by Item 601 of Regulation S-K

 

No.   Description
(10)   Material Contracts
10.1   Asset Purchase and Strategic Collaboration Agreement, dated as of April 5, 2024, between Orgenesis Maryland LLC and Griffin Fund 3 BIDCO, Inc. (incorporated by reference to an exhibit to our current report on Form 8-K, filed on April 11, 2024).
10.2  

Debt Exchange Agreement, dated as of May 21, 2024, between Orgenesis Inc. and Yehuda Nir (incorporated by reference to an exhibit to our current report on Form 8-K, filed on May 23, 2024).

10.3   Debt Exchange Agreement, dated as of May 21, 2024, between Orgenesis Inc. and Aharon Lukach (incorporated by reference to an exhibit to our current report on Form 8-K, filed on May 23, 2024).
10.4   Debt Exchange Agreement, dated as of May 21, 2024, between Orgenesis Inc. and Yosef Dotan (incorporated by reference to an exhibit to our current report on Form 8-K, filed on May 23, 2024).
(31)   Rule 13a-14(a)/15d-14(a) Certification
31.1*   Certification Statement of the Chief Executive Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002
31.2*   Certification Statement of the Chief Financial Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002
(32)   Section 1350 Certification
32.1*   Certification Statement of the Chief Executive Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002
32.2*   Certification Statement of the Chief Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002
(101)*   Interactive Data Files
101.INS   XBRL Instance Document
101.SCH   XBRL Taxonomy Extension Schema Document
101.CAL   XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF   XBRL Taxonomy Extension Definition Linkbase Document
101.LAB   XBRL Taxonomy Extension Label Linkbase Document
101.PRE   XBRL Taxonomy Extension Presentation Linkbase Document
104   Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)
     
* Filed herewith.

 

41

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

ORGENESIS INC.  
   
By:  
   
/s/ Vered Caplan  
Vered Caplan  
President & Chief Executive Officer  
(Principal Executive Officer)  
Date: August 8, 2024  
   
/s/ Victor Miller  
Victor Miller  
Chief Financial Officer, Treasurer and Secretary  
(Principal Financial Officer and Principal Accounting Officer)  
Date: August 8, 2024  

 

42

 

 

Exhibit 31.1

 

ORGENESIS INC.

CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Vered Caplan, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 of Orgenesis Inc.;
   
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
   
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
   
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a–15(e) and 15d–15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have:
   
  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
     
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
   
  (a) All significant deficiencies and material weaknesses in the design or operations of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

By:  
   
/s/ Vered Caplan  
Vered Caplan  
President & Chief Executive Officer  
(Principal Executive Officer)  
Date: August 8, 2024  

 

 

 

 

Exhibit 31.2

 

ORGENESIS INC.

CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Victor Miller, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 of Orgenesis Inc.;
   
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
   
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
   
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a–15(e) and 15d–15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have:
   
  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter  (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
     
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
   
  (a) All significant deficiencies and material weaknesses in the design or operations of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

By:  
   
/s/ Victor Miller  
Victor Miller  
Chief Financial Officer, Treasurer and Secretary  
(Principal Financial Officer and Principal Accounting Officer)  
Date: August 8, 2024  

 

 

 

 

Exhibit 32.1

 

ORGENESIS INC.

CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

The undersigned, Vered Caplan, hereby certifies, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

(a) The Quarterly Report on Form 10-Q of Orgenesis Inc. for the quarter ended June 30, 2024 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(b) Information contained in the Quarterly Report on Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of Orgenesis Inc.

 

By:  
   
/s/ Vered Caplan  
Vered Caplan  
President & Chief Executive Officer  
(Principal Executive Officer)  
Date: August 8, 2024  

 

 

 

 

Exhibit 32.2

 

ORGENESIS INC.

CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

The undersigned, Victor Miller, hereby certifies, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

(a)The Quarterly Report on Form 10-Q of Orgenesis Inc. for the quarter ended June 30, 2024 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(b)Information contained in the Quarterly Report on Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of Orgenesis Inc.

 

By:  
   
/s/ Victor Miller  
Victor Miller  
Chief Financial Officer, Treasurer and Secretary  
(Principal Financial Officer and Principal Accounting Officer)  
Date: August 8, 2024  

 

 

 

v3.24.2.u1
Cover - shares
6 Months Ended
Jun. 30, 2024
Aug. 08, 2024
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Quarterly Report true  
Document Transition Report false  
Document Period End Date Jun. 30, 2024  
Document Fiscal Period Focus Q2  
Document Fiscal Year Focus 2024  
Current Fiscal Year End Date --12-31  
Entity File Number 001-38416  
Entity Registrant Name ORGENESIS INC.  
Entity Central Index Key 0001460602  
Entity Tax Identification Number 98-0583166  
Entity Incorporation, State or Country Code NV  
Entity Address, Address Line One 20271 Goldenrod Lane  
Entity Address, City or Town Germantown  
Entity Address, State or Province MD  
Entity Address, Postal Zip Code 20876  
City Area Code (480)  
Local Phone Number 659-6404  
Title of 12(b) Security Common Stock  
Trading Symbol ORGS  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   46,925,906
v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
CURRENT ASSETS:    
Cash and cash equivalents $ 77 $ 837
Restricted cash 1,079 642
Accounts receivable, net of credit losses of $29,234 as of June 30, 2024 ($0 as of December 31, 2023) 240 88
Prepaid expenses and other receivables 952 2,017
Inventory 34
Total current assets 2,348 4,076
NON-CURRENT ASSETS:    
Deposits 249 38
Investments to associates 8 8
Property, plant and equipment, net 15,901 1,475
Intangible assets, net 8,724 7,375
Operating lease right-of-use assets 1,805 351
Goodwill 1,211 1,211
Other assets 331 18
Total non-current assets 28,229 10,476
TOTAL ASSETS 30,577 14,552
CURRENT LIABILITIES:    
Advance payments from Germfree (See note 11a) 6,720
Accrued expenses and other payables 2,789 2,218
Income tax payable 767 740
Employees and related payables 1,634 1,079
Advance payments on account of grant 2,733 2,180
Short-term loans 1,186 650
Current maturities of finance leases 62 18
Current maturities of operating leases 465 216
Short-term and current maturities of convertible loans 1,931 2,670
TOTAL CURRENT LIABILITIES 31,700 16,407
LONG-TERM LIABILITIES:    
Non-current operating leases 1,318 96
Loans payable 2,762
Convertible loans 5,296 18,967
Retirement benefits obligation 96
Finance leases 1 4
Contingent consideration (see note 4) 4,825
Other long-term liabilities 371 61
TOTAL LONG-TERM LIABILITIES 14,669 19,128
TOTAL LIABILITIES 46,369 35,535
CAPITAL DEFICIENCY:    
Common stock of $0.0001 par value: Authorized at June 30, 2024 and December 31, 2023: 145,833,334 shares; Issued at June 30, 2024 and December 31, 2023: 47,212,473 and 32,163,630 shares, respectively; Outstanding at June 30, 2024 and December 31, 2023: 46,925,906 and 31,877,063 shares, respectively 5 3
Additional paid-in capital 180,752 156,837
Accumulated other comprehensive income 302 65
Treasury stock 286,567 shares as of June 30, 2024 and December 31, 2023 (1,266) (1,266)
Accumulated deficit (195,291) (176,622)
Equity attributable to Orgenesis Inc. (15,498) (20,983)
Non-controlling interest (294)
TOTAL CAPITAL DEFICIENCY (15,792) (20,983)
TOTAL LIABILITIES AND CAPITAL DEFICIENCY 30,577 14,552
Related Party [Member]    
CURRENT ASSETS:    
Receivable from related parties 458
CURRENT LIABILITIES:    
Accounts payable 2,696 133
Other payable related parties 52
Nonrelated Party [Member]    
CURRENT LIABILITIES:    
Accounts payable $ 10,717 $ 6,451
v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Statement of Financial Position [Abstract]    
Allowance for credit losses $ 29,234 $ 0
Common stock, par value $ 0.0001 $ 0.0001
Common stock, shares authorized 145,833,334 145,833,334
Common stock, shares issued 47,212,473 32,163,630
Common stock, shares outstanding 46,925,906 31,877,063
Treasury stock, shares 286,567 286,567
v3.24.2.u1
Condensed Consolidated Statements of Loss and Comprehensive Loss (Unaudited) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Income Statement [Abstract]        
Revenues $ 246 $ 113 $ 387 $ 255
Cost of revenues 538 3,232 1,030 5,954
Gross profit (292) (3,119) (643) (5,699)
Cost of development services and research and development expenses 1,489 3,527 3,859 6,808
Amortization of intangible assets 226 208 379 415
Change in Contingent consideration 182 182
Selling, general and administrative expenses including credit losses of $2,725 for the six months ended June 30, 2024 and $(500) for the three months ended June 30, 2024 and $24,367 for the six months ended June 30, 2023 and $14,878 for the three months ended June 30, 2023 2,061 18,216 8,117 31,744
Operating loss 4,250 25,070 13,180 44,666
Loss from deconsolidation of OBI and Octomera (see note 4) 5,343 66 5,343
Other income, net (8) (8) (2)
Credit loss on convertible loan receivable 2,688
Loss from extinguishment in connection with convertible loan 141 283
Financial expenses, net 815 692 1,667 1,373
Convertible loans induced conversion expenses 4,304 4,304
Share in net loss profit of associated companies (3) (1)
Loss before income taxes 9,361 31,102 19,350 54,350
Tax expenses 5 91 21 220
Net loss 9,366 31,193 19,371 54,570
Net loss attributable to non-controlling interests (including redeemable) (462) (5,650) (702) (9,557)
Net loss attributable to Orgenesis Inc. $ 8,904 $ 25,543 $ 18,669 $ 45,013
Loss per share:        
Basic $ 0.23 $ 0.76 $ 0.52 $ 1.63
Diluted $ 0.23 $ 0.76 $ 0.52 $ 1.63
Weighted average number of shares used in computation of Basic and Diluted loss per share:        
Basic 38,860,727 28,603,597 35,979,567 27,546,229
Diluted 38,860,727 28,603,597 35,979,567 27,546,229
Net loss $ 9,366 $ 31,193 $ 19,371 $ 54,570
Other comprehensive loss (income) - translation adjustments (176) 11 (237) 52
Release of translation adjustment due to deconsolidation of Octomera (384) (384)
Comprehensive loss 9,190 30,820 19,134 54,238
Comprehensive loss attributed to non-controlling interests (462) (5,650) (702) (9,557)
Comprehensive loss attributed to Orgenesis Inc. $ 8,728 $ 25,170 $ 18,432 $ 44,681
v3.24.2.u1
Condensed Consolidated Statements of Loss and Comprehensive Loss (Unaudited) (Parenthetical) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Income Statement [Abstract]        
Credit losses expenses $ (500) $ 14,878 $ 2,725 $ 24,367
v3.24.2.u1
Condensed Consolidated Statements of Changes in Equity (Unaudited) - USD ($)
$ in Thousands
Common Stock [Member]
Additional Paid-in Capital [Member]
Receipts On Account Of Shares To Be Alloted [Member]
AOCI Attributable to Parent [Member]
Treasury Stock, Common [Member]
Retained Earnings [Member]
Parent [Member]
Noncontrolling Interest [Member]
Total
Beginning balance, value at Dec. 31, 2022 $ 3 $ 150,355 $ (270) $ (1,266) $ (121,261) $ 27,561 $ 1,510 $ 29,071
Balance, shares at Dec. 31, 2022 25,545,755                
Stock-based compensation to employees and directors 311   311 311
Issuance of warrants with respect to convertible loans 449   449 449
Issuance of shares due to exercise of warrants [1]
Issuance of Shares due to exercise of warrants, shares 973,684                
Extinguishment in connection with convertible loan restructuring 287   287 287
Comprehensive income (loss) for the period   (52) (45,013) (45,065) (150) (45,215)
Issuance of shares and warrants net of issuance costs [1] 3,341   3,341 3,341
Issuance of shares and warrants net of issuance costs, shares 1,947,368                
Deconsolidation of Octomera 9,406   384 9,790 (1,360) 8,430
Adjustment to redemption value of redeemable non-controlling interest (9,406)   (9,406) (9,406)
Ending balance, value at Jun. 30, 2023 $ 3 154,743 62 (1,266) (166,274) (12,732) (12,732)
Balance, shares at Jun. 30, 2023 28,466,807                
Beginning balance, value at Mar. 31, 2023 $ 3 151,020 (311) (1,266) (140,731) 8,715 1,274 9,989
Balance, shares at Mar. 31, 2023 27,861,543                
Stock-based compensation to employees and directors 152 152 152
Issuance of shares due to exercise of warrants [2]      
Issuance of Shares due to exercise of warrants, shares 605,264                
Comprehensive income (loss) for the period   (11) (25,543) (25,554) 86 (25,468)
Deconsolidation of Octomera 9,406   384 9,790 (1,360) 8,430
Adjustment to redemption value of redeemable non-controlling interest (5,735)   (5,735) (5,735)
Issuance of shares and warrants net of issuance costs (100)   (100) (100)
Ending balance, value at Jun. 30, 2023 $ 3 154,743 62 (1,266) (166,274) (12,732) (12,732)
Balance, shares at Jun. 30, 2023 28,466,807                
Beginning balance, value at Dec. 31, 2023 $ 3 156,837 65 (1,266) (176,622) (20,983) (20,983)
Balance, shares at Dec. 31, 2023 31,877,063                
Stock-based compensation to employees and directors 215   215 $ 215
RSUs vested [3]        
RSUs vested, shares                 82,996
Exercise of options [3] 13 13 $ 13
Exercise of options, shares 25,000                
Issuance of shares to service providers [3] 690   690 690
Issuance of shares to service providers, shares 664,000                
Exchange of convertible loans for equity $ 1 20,310   20,311 20,311
Exchange of convertible loans for equity, shares 11,829,128                
Issuance of warrants with respect to convertible loans 31   31 31
Issuance of shares and warrants [3] 2,496   2,496 2,496
Issuance of shares and warrants, shares 2,422,719                
NCI arising from Octomera reconsolidation   408 408
Issuance of shares due to exercise of warrants [3] 19   20 20
Issuance of Shares due to exercise of warrants, shares 25,000                
Extinguishment in connection with convertible loan restructuring   141   141 141
Comprehensive income (loss) for the period   237 (18,669) (18,432) (702) (19,134)
Ending balance, value at Jun. 30, 2024 $ 5 180,752 302 (1,266) (195,291) (15,498) (294) (15,792)
Balance, shares at Jun. 30, 2024 46,925,906                
Beginning balance, value at Mar. 31, 2024 $ 4 159,650 155 126 (1,266) (186,386) (27,717) 168 (27,549)
Balance, shares at Mar. 31, 2024 34,338,782                
Stock-based compensation to employees and directors 129 129 129
RSUs vested [4]      
RSUs vested, shares 82,996                
Exercise of options [4] 13 13 13
Exercise of options, shares 25,000                
Issuance of shares to service providers [4] 464 464 464
Issuance of shares to service providers, shares 500,000                
Exchange of convertible loans for equity $ 1 20,310 20,311 20,311
Exchange of convertible loans for equity, shares 11,829,128                
Issuance of warrants with respect to convertible loans 31 30 30
Comprehensive income (loss) for the period 176 (8,904) (8,728) (462) (9,190)
Issuance of shares and receipts on account of shares and warrants to be allotted [4] 155 (155)
Issuance of shares and receipts on account of shares and warrants to be allotted, shares 150,000                
Ending balance, value at Jun. 30, 2024 $ 5 $ 180,752 $ 302 $ (1,266) $ (195,291) $ (15,498) $ (294) $ (15,792)
Balance, shares at Jun. 30, 2024 46,925,906                
[1] Represents an amount lower than $1 thousand.
[2] Excluding Depreciation, amortization expenses
[3] Represents an amount lower than $1 thousand.
[4] Represents an amount lower than $1 thousand.
v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
CASH FLOWS FROM OPERATING ACTIVITIES:    
Net loss $ (19,371) $ (54,570)
Adjustments required to reconcile net loss to net cash used in operating activities:    
Stock-based compensation 936 311
Convertible loans induced conversion expenses 4,304
Loss from deconsolidation of OBI and Octomera 66 5,343
Share in income of associated companies, net (1)
Depreciation and amortization expenses 1,087 1,175
Credit loss on convertible loan receivable 2,688
Credit loss related to OBI 2,049
Effect of exchange differences on inter-company balances (48) 214
Net changes in operating leases 24 (67)
Change in Contingent consideration 182
Interest expenses accrued on loans and convertible loans 1,192 300
Loss from extinguishment in connection with convertible loan restructuring 141 283
Changes in operating assets and liabilities:    
Accounts receivable (70) 30,144
Prepaid expenses and other accounts receivable 1,592 (1,857)
Inventory 34 (389)
Other assets (1) 4
Change in related parties, net (1)
Accounts payable (2,466) 2,891
Accrued expenses and other payables 12 245
Employee and related payables (8) 123
Deferred taxes, net (2) 9
Net cash used in operating activities (10,348) (13,154)
CASH FLOWS FROM INVESTING ACTIVITIES:    
Purchase of property, plant and equipment (205) (1,796)
Cash acquired from acquisition of Octomera 139
Impact to cash resulting from deconsolidation of OBI (5)
Impact to cash resulting from deconsolidation of Octomera (973)
Investment in long-term deposits 2 (33)
Net cash used in investing activities (69) (2,802)
CASH FLOWS FROM FINANCING ACTIVITIES:    
Proceeds from issuance of shares and warrants 2,528 3,341
Proceeds from issuance of convertible loans 75 5,485
Proceeds from transaction with redeemable non-controlling interest that do not acquire control of a subsidiary 5,000
Repayment of convertible loans (3,000)
Repayment of short and long-term debt (145) (30)
Proceeds from issuance of loans payable 947
Receipt from Germfree (see note 11a) 6,720
Net cash provided by financing activities 10,125 10,796
NET CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH (292) (5,160)
EFFECT OF EXCHANGE RATE CHANGES ON CASH, CASH EQUIVALENTS AND RESTRICTED CASH (31) 18
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF PERIOD 1,479 6,369
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD 1,156 1,227
SUPPLEMENTAL NON-CASH FINANCING AND INVESTING ACTIVITIES    
Exchange of convertible loans for equity 16,007
Right-of-use assets obtained in exchange for new operation lease liabilities 191 753
Increase (decrease) in accounts payable related to purchase of property, plant and equipment 14
Extinguishment in connection with convertible loan restructuring 287
CASH PAID DURING THE PERIOD FOR:    
Interest $ 4 $ 785
v3.24.2.u1
DESCRIPTION OF BUSINESS
6 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
DESCRIPTION OF BUSINESS

NOTE 1 – DESCRIPTION OF BUSINESS

 

a. General

 

Orgenesis Inc. (the “Company”) is a global biotech company working to unlock the potential of Cell and Gene Therapies (“CGTs”) in an affordable and accessible format. CGTs can be centered on autologous (using the patient’s own cells) or allogenic (using master banked donor cells) and are part of a class of medicines referred to as advanced therapy medicinal products (“ATMPs”). The Company is mostly focused on the development of autologous therapies that can be manufactured under processes and systems that are developed for each therapy using a closed and automated approach that is validated for compliant production near the patient for treatment of the patient at the point of care (“POCare”).

 

As of the date of this report, the Company operates two segments:

 

The “Octomera” segment which includes the Company’s POCare Services that are performed in decentralized hubs which provide harmonized and standardized services to customers (“POCare Centers”). The Company’s subsidiary, Octomera LLC, holds all of the Octomera segment activities.

 

The “Therapies” segment which includes therapy related activities.

 

On January 29, 2024, the Company and Metalmark Capital Partners (“Metalmark” or “MM”) entered into a Unit Purchase Agreement (the “MM UPA”), pursuant to which the Company acquired all of the preferred units of Octomera LLC (“Octomera”) previously owned by MM (the “MM Acquisition”), and effective that date, reconsolidated Octomera into its accounts. The Company currently owns 100% of the equity interests of Octomera. The Company had previously, from June 30, 2023 (“date of deconsolidation”), deconsolidated Octomera from its consolidated financial statements and had recorded its equity interest in Octomera as an equity method investment.

 

These consolidated financial statements include the accounts of Orgenesis Inc. and its subsidiaries.

 

The Company’s common stock, par value $0.0001 per share (the “Common Stock”), is listed and traded on the Nasdaq Capital Market under the symbol “ORGS.” On September 27, 2023, the Company received a notice from the Listing Qualifications Staff (“Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) stating that the bid price of the Common Stock had closed at less than $1.00 per share over the previous 30 consecutive business days, and, as a result, did not comply with Listing Rule 5550(a)(2) (the “Bid Price Rule”). On April 17, 2024, the Company received a notice (the “Notice”) from the Staff in which it determined that in accordance with Listing Rule 5810(c)(2)(A), the Staff stated that it could not accept a plan to regain compliance and the Staff stated that the Company’s securities would be delisted from The Nasdaq Capital Market unless the Company timely requested a hearing before a Nasdaq Hearings Panel (the “Panel”) to address the deficiencies and present a plan to regain compliance. As permitted by the Notice, the Company timely requested a hearing before the Panel, which request stayed any further delisting action by the Staff pending the ultimate outcome of the hearing and the expiration of any extension that may be granted by the Panel. On June 6, 2024, the Company met with the Panel regarding the Company’s potential delisting from The Nasdaq Stock Market as a result of its violation of the Bid Price Rule and non-compliance with the equity requirement in Listing Rule 5550(b)(1) (the “Equity Rule”) or any of the alternative requirements in Listing Rule 5550(b). On June 8, 2024, the Company received the Panel’s decision which granted the Company until October 14, 2024 to regain compliance with the Bid Price and Equity Rules. If the Company is unable to regain compliance with the listing standards of the Nasdaq Capital Market by October 14, 2024, the Company’s securities may be delisted from The Nasdaq Stock Market.

 

As used in this report and unless otherwise indicated, the term “Company” refers to Orgenesis Inc. and its Subsidiaries. Unless otherwise specified, all amounts are expressed in United States Dollars.

 

 

b.Liquidity

 

Through June 30, 2024, the Company had an accumulated deficit of $195,291 and for the six months ended June 30, 2024 incurred negative operating cashflows of $10,348. The Company’s activities have been funded by generating revenue, through offerings of its securities, and through proceeds from loans. There is no assurance that the Company’s business will generate sustainable positive cash flows to fund its activities.

 

The Company will need to use mitigating actions such as seeking additional financing, refinancing, or amending the terms of existing loans, or postponing expenses that are not based on firm commitments. In order to fund its operations until such time that the Company can generate sustainable positive cash flows, the Company will need to raise additional funds. For the six months ended June 30, 2024 and as of the date of this report, the Company has assessed its financial condition and concluded that based on current and projected cash resources and commitments, as well as other factors mentioned above, there is substantial doubt about its ability to continue as a going concern. The Company is planning to raise additional capital to continue its operations and to repay its outstanding loans when they become due, as well as to explore additional avenues to increase revenues and reduce or delay expenditures. In May 2024, the Company entered into debt exchange agreements with three convertible debt holders pursuant to which a total of $16,007,372 of outstanding principal and accrued interest were exchanged for the right to receive an aggregate of 15,776,947 shares of Common Stock. The Company may also exchange some of its other outstanding loans and accounts payable for securities of the Company. There can be no assurance that the Company will be able to raise additional capital on acceptable terms, or at all, or be able to exchange its outstanding loans and accounts payable for securities of the Company.

 

The Company’s Common Stock is listed for trading on the Nasdaq Capital Market. As mentioned above, the Company must satisfy Nasdaq’s continued listing requirements. Failure to meet continuing listing requirements risks delisting, which may make it more difficult to raise additional capital.

 

The estimation and execution uncertainty regarding the Company’s future cash flows and management’s judgments and assumptions in estimating these cash flows is a significant estimate. Those assumptions include reasonableness of the forecasted revenue, operating expenses, and uses and sources of cash.

 

v3.24.2.u1
BASIS OF PRESENTATION
6 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
BASIS OF PRESENTATION

NOTE 2 - BASIS OF PRESENTATION

 

a. Basis of presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of management, the financial statements reflect all normal and recurring adjustments necessary to fairly state the financial position and results of operations of the Company. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (“SEC”) on April 15, 2024. The year-end balance sheet data was derived from the audited consolidated financial statements as of December 31, 2023, but not all disclosures required by generally accepted accounting principles in the United States (“U.S. GAAP”) are included in this Quarterly Report on Form 10-Q.

 

b. Significant accounting policies

 

The accounting policies adopted are consistent with those of the previous financial year except as described below:

 

Use of Estimates in the Preparation of Financial Statements

 

The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies. The Company bases its estimates on historical experience and on various other assumptions that it believes are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity, the amount of revenues and expenses, determination of loss on deconsolidation, valuation of investments, purchase price allocations, goodwill impairment, and assessment of credit losses and purchase price allocation including contingent consideration. Actual results could differ from those estimates.

 

 

Recently issued accounting pronouncements, not yet adopted

 

Improvements to Reportable Segments Disclosures

 

In November 2023, the FASB issued ASU 2023-07 “Segment Reporting–Improvements to Reportable Segments Disclosures (Topic 280)” to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The amendments in this ASU (1) require that a public entity disclose, on an annual and interim basis, significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”) and included within each reported measure of segment profit or loss; (2) require that a public entity disclose, on an annual and interim basis, an amount for other segment items by reportable segment and a description of its composition; (3) require that a public entity provide all annual disclosures about a reportable segment’s profit or loss and assets currently required by Topic 280 in interim periods; (4) clarify that if the CODM uses more than one measure of a segment’s profit or loss in assessing segment performance and deciding how to allocate resources, a public entity may report one or more of those additional measures; and (5) require that a public entity disclose the title and position of the CODM and an explanation of how the CODM uses the reported measure or measures of segment profit or loss in assessing segment performance and deciding how to allocate resources. The amendments in this ASU are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, and should be applied retrospectively to all periods presented. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of these amendments on its consolidated financial statements.

 

Improvements to Income Tax Disclosures

 

In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740)–Improvements to Income Tax Disclosures” to enhance the transparency and decision usefulness of income tax disclosures, primarily related to the rate reconciliation and income taxes paid information. The amendments in this ASU require that public entities, on an annual basis, disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. This ASU also requires that all entities disclose, on an annual basis, (1) the amount of income taxes paid disaggregated by federal, state, and foreign taxes, (2) the amount of income taxes paid disaggregated by individual jurisdictions in which income taxes paid is equal to or greater than five percent of total income taxes paid, (3) income or loss from continuing operations before income tax expense or benefit disaggregated between domestic and foreign, and (4) income tax expense or benefit from continuing operations disaggregated by federal, state, and foreign. The amendments in this ASU are effective for annual periods beginning after December 15, 2024, and should be applied on a prospective basis with the option to apply retrospectively. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is currently evaluating the impact of the adoption of these amendments on its consolidated financial statements.

 

v3.24.2.u1
SEGMENT INFORMATION
6 Months Ended
Jun. 30, 2024
Segment Reporting [Abstract]  
SEGMENT INFORMATION

NOTE 3 – SEGMENT INFORMATION

 

Segment data for the six months ended June 30, 2024 is as follows:

 

   Octomera   Therapies   Eliminations   Consolidated 
   (in thousands) 
Revenues  $50   $360   $(23)  $387 
Cost of revenues*   (1,047)   (329)   710    (666)
Gross profit   (997)   31    687    (279)
Cost of development services and research and development expenses*   (3,251)   (1,031)   697    (3,585)
Operating expenses*   (546)   (7,037)   (646)   (8,229)
Loss from deconsolidation   -    -    (66)   (66)
Other income   -    8    -    8 
Depreciation and amortization   (870)   (387)   170    (1,087)
Loss from extinguishment in connection with convertible loan   -    (141)   -    (141)
Financial income (expenses), net   (554)   (1,237)   124    (1,667)
Convertible loans induced conversion expenses   -    (4,304)   -    (4,304)
Income (loss) before income taxes  $(6,218)  $(14,098)  $966   $(19,350)

 

*Excluding Depreciation, amortization expenses

 

Segment data for the six months ended June 30, 2023 is as follows:

 

   Octomera   Therapies   Eliminations   Consolidated 
   (in thousands) 
Revenues  $15   $240   $-   $255 
Cost of revenues*   (5,084)   (398)   -    (5,482)
Gross profit   (5,069)   (158)   -    (5,227)
Cost of development services and research and development expenses*   (4,501)   (2,051)   -    (6,552)
Operating expenses*   (27,990)   (3,722)   -    (31,712)
Loss from deconsolidation of Octomera   -    -    (5,343)   (5,343)
Other income, net   2    -    -    2 
Depreciation and amortization   (779)   (396)   -    (1,175)
Loss from extinguishment in connection with convertible loan   -    (283)   -    (283)
Credit losses on convertible loan receivable   -    (2,688)   -    (2,688)
Financial Expenses, net   (495)   (879)   1    (1,373)
Share in net income of associated companies   -    1    -    1 
Loss before income taxes  $(38,832)  $(10,176)  $(5,342)  $(54,350)

 

*Excluding Depreciation, amortization expenses

 

 

Segment data for the three months ended June 30, 2024 is as follows:

 

   Octomera   Therapies   Eliminations   Consolidated 
   (in thousands) 
Revenues  $21   $225   $-   $246 
Cost of revenues*   (110)   (179)   -    (289)
Gross profit   (89)   46    -    (43)
Cost of development services and research and development expenses*   (1,466)   148    -    (1,318)
Operating expenses*   (483)   (1,518)   (182)   (2,183)
Other income   -    8    -    8 
Depreciation and amortization   (440)   (193)   (73)   (706)
Financial income (expenses), net   (264)   (551)   -    (815)
Convertible loans induced conversion expenses   -    (4,304)   -    (4,304)
Income (loss) before income taxes  $(2,742)  $(6,364)  $(255)  $(9,361)

 

*Excluding Depreciation, amortization expenses

 

Segment data for the three months ended June 30, 2023 is as follows:

 

   Octomera   Therapies   Eliminations   Consolidated 
   (in thousands) 
Revenues  $3   $110   $-   $113 
Cost of revenues*   (2,776)   (220)   -    (2,996)
Gross profit   (2,773)   (110)   -    (2,883)
Cost of development services and research and development expenses*   (2,420)   (975)   -    (3,395)
Operating expenses*   (16,787)   (1,408)   -    (18,195)
Loss from deconsolidation of Octomera   -    -    (5,343)   (5,343)
Depreciation and amortization   (394)   (203)   -    (597)
Financial expenses, net   (229)   (464)   1    (692)
Share in net income of associated companies   -    3    -    3 
Loss before income taxes  $(22,603)  $(3,157)  $(5,342)  $(31,102)

 

*Excluding Depreciation, amortization expenses

 

v3.24.2.u1
RECONSOLIDATION OF OCTOMERA LLC
6 Months Ended
Jun. 30, 2024
Reconsolidation Of Octomera Llc  
RECONSOLIDATION OF OCTOMERA LLC

NOTE 4 – RECONSOLIDATION OF OCTOMERA LLC

 

Pursuant to the MM UPA signed on January 29, 2024, the Company and MM agreed to the following:

 

1.Consideration:

 

Royalty Payments: If Octomera and its subsidiaries generate Net Revenue during the three-year period 2025-2027, then the Company will pay 5% of Net Revenues to MM pursuant to the MM UPA.

 

Milestone Payments: If the Company sells Octomera within ten years from the date of the Closing at a price that is more than $40 million excluding consideration for certain Excluded Assets as per the UPA, the Company shall pay MM 5% of the net proceeds.

 

2.MM’s designated members of the Board of Managers of Octomera resigned and the Company amended the Second Amended and Restated Limited Liability Company Agreement of Octomera (the “Octomera LLC Agreement”) to be a single member agreement reflecting the transactions consummated under the UPA, such that MM no longer (i) is a member of Octomera or a party to the Octomera LLC Agreement, or (ii) has a right to appoint members of the board of managers of Octomera.

 

 

3.10 secured promissory notes between Orgenesis Maryland LLC and MM, reflecting an aggregate outstanding principal amount of $2,600 (the “Notes”), were amended to, among other things, extend the maturity thereof to January 29, 2034 and to terminate the security interest granted by Orgenesis Maryland LLC in favor of MM that secured the obligations under the Notes.

 

Fair Value of Consideration Transferred

 

Accounting guidance provides that the allocation of the purchase price may be adjusted for up to one year from the date of the acquisition to the extent that additional information is obtained about the facts and circumstances that existed as of the acquisition date. The primary area of the purchase price allocation that is not yet finalized is related to intangible assets, property, plant and equipment, and certain other assets and tax matters and the related impact on goodwill.

 

In evaluating the fair value of the Octomera Equity Investment under the income approach, the Company used a discounted cash flow model of the business, adjusted to the Company’s share in the investment. Key assumptions used to determine the estimated fair value included: (a) internal cash flows forecasts for 5 years following the assessment date, including expected revenue growth, costs to produce, operating profit margins and estimated capital needs; (b) an estimated terminal value using a terminal year long-term future growth determined based on the growth prospects of the reporting units; and (c) a discount rate which reflects the weighted average cost of capital adjusted for the relevant risk associated with the Company’s reporting unit operations and the uncertainty inherent in the Company’s internally developed forecasts. The allocation of the purchase price to the net assets acquired and liabilities assumed resulted in the recognition of other intangible assets, net, which comprised of technology. The useful life of the technology for amortization purposes was determined by considering the period of expected cash flows generated by the assets used to measure the fair value of the intangible assets, adjusted as appropriate for the entity-specific factors including legal, regulatory, contractual, competitive, economic, or other factors that may limit the useful life of intangible assets.

 

The following table summarizes the allocation of purchase price to the fair values of the assets acquired and liabilities assumed as of the Transaction date:

 

   (in thousands) 
Total Contingent consideration to MM for royalty and milestone payments  $4,643 
      
Total assets acquired:     
Cash and cash equivalents  $139 
Property, plants and equipment, net   17,852 
Other Assets   3,478 
Total assets  $21,469 
      
Total liabilities assumed:     
Total current liabilities  $(12,518)
Total long-term liabilities   (5,628)
Total liabilities  $(18,146)
      
Know how Technology   1,728 
      
Total Net Assets  $5,051 
Fair-Value of Non-controlling interests   (408)
Total liability to MM  $4,643 

 

 

The allocation of the purchase price to the net assets acquired and liabilities assumed resulted in the recognition of an intangible asset know-how of $1,728 and a liability to MM in the amount of $4,643. The know-how has a useful life of 10 years. The useful life of the intangible asset for amortization purposes was determined considering the period of expected cash flows generated by the assets used to measure the fair value of the intangible asset adjusted as appropriate for the entity-specific factors, including legal, regulatory, contractual, competitive, economic or other factors that may limit the useful life of intangible assets.

 

Key inputs for the fair values valuation are summarized below. 

 

Key Valuation Inputs  Jan 29, 2024 
Discount rate   40%
Risk-free interest rate   4.4%
Average 5 years revenue growth   50%

 

The Company incurred transaction costs of approximately $50 and $0 during the six and three months ended June 30, 2024 respectively, which were included in general and administrative expenses in the condensed consolidated statements of operations.

 

The revenues and net loss of Octomera from January 1, 2024 until the reconsolidation date were $23 and $1,244 respectively.

 

Fair value assumptions used in accounting for contingent consideration

 

On January 29, 2024, in connection with the PPA study of Octomera LLC, the Company recognized a contingent consideration to pay MM based on two components:

 

1. Royalties based on revenues in 2025, 2026 and 2027, and;

2. An earnout amount, which is dependent on a future triggering event being either an IPO or exit.

 

The estimated fair value of the contingent consideration is based on management’s assessment of whether, and at what level, the financial metrics will be achieved, and the present value factors associated with the timing of the payments. This fair value measurement is based on significant unobservable inputs in the market and thus represents a Level 3 fair value measurement and used the Monte Carlo pricing model to calculate the fair value, which was $4,643 as of January 29, 2024. As of June 30, 2024, the fair value was $4,825. Changes in the fair value of contingent consideration are recorded in operating expenses. The total revaluation expense for the period ended June 30, 2024 was $182.

 

Key inputs for the simulation are summarized below.

 

Key Valuation Inputs  Jan 29, 2024   June 30, 2024 
Standard Deviation   13.5%   13.5%
Risk-free interest rate   4.4%   4.6%
Possible trigger event examination   Year 10    Year 10 
Average 5 years revenue growth   50%   50%
Trigger events   30%   30%
Revenues multiple   10    9.75 

 

* Based on a Monte Carlo simulation analysis of 30,000 iterations

 

Deconsolidation of Orgenesis Biotech Israel Limited (“OBI”)

 

On February 14, 2024, following a claim for payment by employees of OBI, a fully owned subsidiary of Octomera of past salaries due, the district court in Haifa, Israel appointed a trustee to run the affairs of OBI. As a result of this appointment, effective February 14, 2024, the Company no longer controls OBI and has ceased to consolidate the results of OBI into its consolidated results. The Company recognized a loss as a result of the deconsolidation of $66. The Company does not currently believe that rehabilitation is possible and purchased certain OBI equipment.

 

 

The Company recorded $2,696 being what it owes to OBI under Accounts payable related Parties on the balance sheet of June 30, 2024.

 

The following table summarizes the deconsolidated assets and liabilities as of February 14, 2024:

 

Total assets acquired:    
Cash and cash equivalents  $4 
Property, plants and equipment, net   2,884 
Other Assets   1,422 
Total assets  $4,310 
      
Total liabilities assumed:  $4,244 
Total Net Assets deconsolidated  $66 
Loss from deconsolidation of OBI  $66 

 

v3.24.2.u1
EQUITY
6 Months Ended
Jun. 30, 2024
Equity [Abstract]  
EQUITY

NOTE 5 – EQUITY

 

Private Placement Offering

 

On March 3, 2024, the Company entered into a Securities Purchase Agreement with certain accredited investors, pursuant to which the Company agreed to issue and sell, in a private placement, 2,272,719 shares of Common Stock at a purchase price of $1.03 per share, Warrants to purchase up to 2,272,719 shares of Common Stock at an exercise price of $1.50 per share, and further Warrants to purchase up to 2,272,719 shares of Common Stock at an exercise price of $2.00 per share, all such Warrants exercisable immediately and expiring five years from their date of issuance. The Company received gross proceeds of approximately $2.3 million before deducting related offering expenses. The Offering closed on March 5, 2024.

 

On May 10, 2024, the Company entered into a Securities Purchase Agreement with certain accredited investors, pursuant to which the Company agreed to issue and sell, in a private placement, 150,000 shares of the Company’s Common Stock at a purchase price of $1.03 per share, Warrants to purchase up to 150,000 shares of Common Stock at an exercise price of $1.50 per share, and further Warrants to purchase up to 150,000 shares of Common Stock at an exercise price of $2.00 per share, all such Warrants exercisable immediately and expiring five years from their date of issuance. The Company received gross proceeds of approximately $154 before deducting related offering expenses. The Offering closed on May 10, 2024.

 

 

v3.24.2.u1
CONVERTIBLE LOANS
6 Months Ended
Jun. 30, 2024
Debt Disclosure [Abstract]  
CONVERTIBLE LOANS

NOTE 6 – CONVERTIBLE LOANS

 

The table below summarizes the Company’s outstanding convertible loans as of June 30, 2024.

 

Principal

Amount at

Issuance

   Issuance Date   Current Interest Rate   Current
Maturity
   Current Conversion Price of loan into equity 
    (Year)   %   (Year)   $ 
  
$                      
                       
 100    2019    8%   2024    1.03 
 100    2020    8%   2024    1.03 
 1,150    2022    6%   *2023   4.50 
 5,000    2023    8%   2026    2.46 
$6,350                     

 

  * Was not repaid by June 30, 2024.

 

 

The table below summarizes the Company’s outstanding convertible loans as of December 31, 2023.

 

Principal Amount

   Issuance Date   Current Interest Rate   Current
Maturity
   Current Conversion Price of loan into equity   Note 
    (Year)   %   (Year)   $     
Convertible Loans Outstanding as of December 31, 2023     
$750    2018    10%   2026    2.50      
 1,500    2019    10%   2026    2.50      
 100    2019    8%   2024    7.00      
 5,000    2019    10%   2026    2.50      
 100    2020    8%   2024    7.00      
 5,000    2022    10%   2026    2.50      
 1,150    2022    6%   **2023   4.50      
 5,000    2023    8%   2026    2.46      
 735    2023    8%   2024    0.85    6a
$19,335                          

 

  ** Was not yet paid by December 31, 2023.    

 

Debt Exchange Agreements

 

On May 21, 2024, the Company entered into debt exchange agreements with three convertible debt holders pursuant to which a total of $16,007 of outstanding principal and accrued interest was exchanged for the right to receive an aggregate of 15,776,947 shares of Common Stock of the Company. A total of 11,829,128 shares of Common Stock have been issued pursuant to the debt exchange agreements as of June 30, 2024. The Company reduced the exchange price from $2.50 to $1.03 per share for a total of $14,784 of outstanding principal. As a result, the Company recorded an induced conversion expense equal to the fair value of the incremental consideration, amounting to $4,304.

 

Additional notes related to changes in convertible loans terms that occurred in 2024

 

In January 2024, the Company and lender agreed to extend the maturity date of the loan amount to December 31, 2026. In consideration for such extension, the Company issued to the lender warrants to purchase 840,000 shares of Common Stock at an exercise price of $0.85 per share. Based on its analysis, the Company concluded that this change in terms should be accounted for as an extinguishment. The loan amount was included in the debt exchange agreement.

 

Koligo convertible loan

 

On September 29, 2023, Koligo entered into a convertible loan agreement with Sai Traders, pursuant to which the Sai Traders agreed to loan Koligo up to $25,000 (the “Sai Convertible Loan”). As of the date of this quarterly report on Form 10-Q, none of the principal of the Sai Convertible Loan had been received by the Company and the Company terminated this loan agreement due to the nonperformance of Sai Traders.

 

v3.24.2.u1
LOANS
6 Months Ended
Jun. 30, 2024
Loans  
LOANS

NOTE 7 –LOANS

 

The table below summarizes the Company’s outstanding long-term loans as of June 30, 2024 and December 31, 2023, respectively:

 

Principal Amount   Interest Rate   Year of Maturity   June 30, 2024   December 31, 2023 
(in thousands)   %       (in thousands) 
$2,600    10    2034   $2,762   $- 

 

See note 4.

 

 

The table below summarizes the Company’s outstanding short-term loans as of June 30, 2024 and December 31, 2023, respectively:

 

Currency  Interest Rate   June 30, 2024   December 31, 2023 
   %   (in thousands) 
USD   8   $268   $258 
USD   10    814    61 
USD   (*)8   -    (**)331
USD   6    90    - 
Euro   8    14    - 
        $1,186   $650 

 

(*)Weighted average interest.
(**)The terms of the loan were amended on January 1, 2024. Under the new terms, the loan became convertible into shares of Common Stock and the lender agreed to extend the maturity date to December 31, 2024. In consideration for such extension, the Company issued to the lender warrants to purchase 360,000 shares of the Company’s Common Stock at a price of $0.85 per share and granted lender the right to convert any part of the outstanding balance of the loan into Common Stock of the Company at the conversion rate of $0.85 per share. Based on its analysis, the Company concluded that this change in terms should be accounted for as a modification. This loan was converted as per the debt exchange agreement. See note 6.

 

On July 3, 2024, Koligo entered into a loan agreement (the “Loan Agreement” for this paragraph only) with a lender, pursuant to which the lender agreed to loan the Company $2,000 (the “Loan” for this paragraph only) which was received by the Company according to the terms of the Loan Agreement. The Loan shall bear annual 10% simple interest and is payable no later than 90 days after the receipt, subject to extension at the discretion of lender.

 

v3.24.2.u1
STOCK-BASED COMPENSATION
6 Months Ended
Jun. 30, 2024
Share-Based Payment Arrangement [Abstract]  
STOCK-BASED COMPENSATION

NOTE 8 – STOCK-BASED COMPENSATION

 

a.Options Granted to Employees

 

The table below summarizes the terms of options for the purchase of shares in the Company granted to employees during the period from January 1, 2024 to June 30, 2024:

  

   

 

No. of

Options

Granted

   Exercise Price   Vesting Period 

Fair Value at Grant

(in thousands)

  

Expiration

Period

 
Employees    400,000   $0.50-$0.63   Half quarterly over a period of two years and the rest quarterly over a period of four years  $161    10 years 

 

The fair valuation of these option grants is based on the following assumptions:

 

SCHEDULE OF STOCK OPTIONS ACTIVITY

   During the Period from January 1, 2024 to June 30, 2024 
Value of one common share   $0.49-$0.63 
Dividend yield   0%
Expected stock price volatility   79%-85%
Risk free interest rate   3.86%-4.28%
Expected term (years)   5.56-6.06 

 

 

b.Restricted Stock Units (“RSUs”) Granted to Employees

 

Below is a table summarizing all the RSUs grants to employees during the period from January 1, 2024 to June 30, 2024:

 

SCHEDULE OF RESTRICTED STOCK UNITS GRANTED

  

 

No. of

Options

Granted

   Vesting Period 

Fair Value at Grant

(in thousands)

 
Employees   50,000   Immediate  $26 

 

c.Shares and warrants issued to advisors.

 

Below is a table summarizing all the shares and warrants grants to advisors during the period from January 1, 2024 to June 30, 2024:

 

Date of issue of share or warrant   Reason for issue of share or warrant  Consideration  Exercise price of warrants   Warrant vesting (subject to continued service provided to Company)  Warrant expiry date
January 25, 2024   Consideration for a past debt  164,000 shares of Common Stock           
March 7, 2024   Strategic advisor agreement  500,000 shares of Common Stock and warrants to purchase 500,000 shares of Common Stock  $1.03   One third on March 7, 2024, one third on June 5, 2024, and one third on September 3, 2024.  March 6, 2029
April 18, 2024   Strategic advisor agreement  Warrants to purchase 500,000 shares of Common Stock  $1.03   One third on April 18, 2024, one third on July 18, 2024, and one third on October 18, 2024.  April 17, 2029
April 23, 2024   Strategic advisor agreement  Warrants to purchase 500,000 shares of Common Stock  $1.03   One third on April 16, 2024, one third on July 16, 2024, and one third on October 16, 2024.  April 22, 2029
May 22, 2024   Strategic advisor agreement  Warrants to purchase 475,000 shares of Common Stock  $1.03   One third on May 21, 2024, one third on August 21, 2024, and one third on November 21, 2024.  May 21, 2029

 

   

No. of

Warrants

Granted

   Vesting Period  

Fair Value at Grant

(in thousands)

 
 Warrants    1,975,000    Over a period of six months   $568 
 Shares    664,000    N/A   $326 

 

The fair valuation of these shares grants is based on the market value of the share at the date of grant.

 


The fair valuation of these warrants grants is based on the following assumptions:

 

   During the Period from January 1, 2024 to June 30, 2024 
Value of one common share   $0.51-$0.84 
Dividend yield   0%
Expected stock price volatility   87%-90% 
Risk free interest rate   4.07%-4.68% 
Expected term (years)   5 

 

v3.24.2.u1
LOSS PER SHARE
6 Months Ended
Jun. 30, 2024
Earnings Per Share [Abstract]  
LOSS PER SHARE

NOTE 9 – LOSS PER SHARE

 

The following table sets forth the calculation of basic and diluted loss per share for the period indicated:

SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE 

   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   Three Months Ended   Six Months Ended 
   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   (in thousands, except per share data) 
Basic and diluted:                    
Net loss attributable to Orgenesis Inc.  $8,904   $25,543   $18,669   $45,013 
Adjustment of redeemable non-controlling interest to redemption amount   -    (3,671)   -    - 
Net loss attributable to Orgenesis Inc. for loss per share   8,904   $21,872   $18,669   $45,013 
Weighted average number of common shares outstanding   38,860,727    28,603,597    35,979,567    27,546,229 
Net loss per share   $0.23     $0.76    0.52     $1.63  

 

For the six months ended June 30, 2024 and June 30, 2023, all outstanding convertible notes, options and warrants have been excluded from the calculation of the diluted net loss per share since their effect was anti-dilutive.

 

Diluted loss per share excludes 14,247,610 shares underlying outstanding options and warrants and 2,313,348 shares issuable upon conversion of convertible loans for the six months ended June 30, 2024, because the effect of their inclusion in the computation would be antidilutive. Diluted loss per share excludes 16,917,024 shares underlying outstanding options and warrants and 2,313,348 shares issuable upon conversion of convertible loans for the three months ended June 30, 2024, because the effect of their inclusion in the computation would be antidilutive.

 

Diluted loss per share excludes 7,673,798 shares underlying outstanding options and warrants and 7,101,236 shares upon conversion of convertible loans for the six months ended June 30, 2023, because the effect of their inclusion in the computation would be antidilutive. Diluted loss per share excludes 7,916,597 shares underlying outstanding options and warrants and 5,184,127 shares issuable conversion of convertible loans for the three months ended June 30, 2023, because the effect of their inclusion in the computation would be antidilutive.

 

 

v3.24.2.u1
REVENUES
6 Months Ended
Jun. 30, 2024
Revenue from Contract with Customer [Abstract]  
REVENUES

NOTE 10 – REVENUES

 

Disaggregation of Revenue

 

The following table disaggregates the Company’s revenues by major revenue streams:

 

SCHEDULE OF DISAGGREGATION OF REVENUE

   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   Three Months Ended   Six Months Ended 
   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   (in thousands) 
Revenue stream:                    
Cell process development services and hospital services  $246   $113    $387    $255 
Total  $246   $113   $387   $255 

 

A breakdown of the revenues per customer constituted at least 10% of revenues is as follows:

 

SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER

   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   Three Months Ended   Six Months Ended 
   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   (in thousands) 
Revenue earned:                    
Customer A (United States)  $225   $65   $300   $130 
Customer B (United States)  $-   $-   $60   $- 
Customer C (United States)  $-   $45   $-   $45 
Customer D (United States)  $-   $-   $-   $65 

 

Contract Assets and Liabilities

 

Contract assets are mainly comprised of trade receivables net of allowance for doubtful debts, which includes amounts billed and currently due from customers.

 

The activity for trade receivables is comprised of:

 

SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES

   June 30, 2024   June 30, 2023 
   Six Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
Balance as of beginning of period  $88   $36,183 
Reconsolidation (deconsolidation) of Octomera   82    (5,985)
Additions   380    293 
Collections   (822)   (6,045)
Allowances for credit losses   512    (24,388)
Exchange rate differences   -    (52)
Balance as of end of period  $240   $6 

 

The activity for contract liabilities is comprised of:

 

SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES

   June 30, 2024   June 30, 2023 
   Six Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
Balance as of beginning of period  $200   $70 
Deconsolidation of Octomera   110    (106)
Deconsolidation of OBI   (60)   - 
Additions   110    36 
Realizations   (10)   - 
Balance as of end of period  $350   $- 

 

 

v3.24.2.u1
OTHER SIGNIFICANT TRANSACTIONS AND AGREEMENTS DURING THE SIX MONTHS ENDED JUNE 30, 2024
6 Months Ended
Jun. 30, 2024
Other Significant Transactions And Agreements During Six Months Ended June 30 2024  
OTHER SIGNIFICANT TRANSACTIONS AND AGREEMENTS DURING THE SIX MONTHS ENDED JUNE 30, 2024

NOTE 11 – OTHER SIGNIFICANT TRANSACTIONS AND AGREEMENTS DURING THE SIX MONTHS ENDED JUNE 30, 2024

 

Asset Purchase and Strategic Collaboration Agreement.

 

On April 5, 2024, the Company entered into an Asset Purchase and Strategic Collaboration Agreement (the “Purchase Agreement”) with Griffin Fund 3 BIDCO, Inc., (“Germfree”), for the sale by the Company of five Orgenesis Mobile Processing Units and Labs (“OMPULs”) to Germfree, which will be incorporated into Germfree’s lease fleet and leased back to the Company or to third-party lessees designated by the Company. Pursuant to the Purchase Agreement, and subject to the terms and conditions set forth therein, in consideration for the purchase of the OMPULs, the Orgenesis Quality Management Systems Framework (“OQMSF”) and related intellectual property rights, Germfree is to pay an aggregate purchase price of $8,340 subject to adjustment through a verification mechanism set forth in the Purchase Agreement. Pursuant to the Purchase Agreement, Germfree has paid the Company $6,720 as of June 30, 2024, which has been recorded under current liabilities.

 

v3.24.2.u1
LEGAL PROCEEDINGS
6 Months Ended
Jun. 30, 2024
Commitments and Contingencies Disclosure [Abstract]  
LEGAL PROCEEDINGS

NOTE 12 – LEGAL PROCEEDINGS

 

On January 18, 2022, a complaint (the “Complaint”) was filed in the Tel Aviv District Court (the “Court”) against the Company, Orgenesis Ltd (“the Israeli Subsidiary”), Prof. Sarah Ferber, Vered Caplan and Dr. Efrat Asa Kunik (collectively, the “defendants”) by plaintiffs the State of Israel, as the owner of Chaim Sheba Medical Center at Tel Hashomer (“Sheba”), and Tel Hashomer Medical Research, Infrastructure and Services Ltd. (collectively, the “plaintiffs”). In the Complaint, the plaintiffs are seeking that the Court issue a declaratory remedy whereby the defendants are required to pay royalties to the plaintiffs at the rate of 7% of the sales and 24% of any and all revenues in consideration for sublicenses related to any product, service or process that contain know-how and technology of Sheba and any and all know-how and technology either developed or supervised by Prof. Ferber in the field of cell therapy, including in the category of the point-of-care platform and any and all services and products in relation to the defendants’ CDMO activity. In addition, the plaintiffs seek that the defendants provide financial statements and pay NIS 10,000 to the plaintiffs due to the royalty provisions of the license agreement, dated February 2, 2012, between the Israeli subsidiary and Tel Hashomer Medical Research, Infrastructure and Services Ltd. (the “License Agreement”). The Complaint alleges that the Company and the Israeli subsidiary used know-how and technology of Sheba and know-how and technology either developed or supervised by Prof. Ferber while employed by Sheba in the field of cell therapy, including in the category of the point-of-care platform and the services and products in relation to the defendants’ CDMO activity and are entitled to the payment of certain royalties pursuant to the terms of the License Agreement. The defendants have filed their statements of defense responding to this Complaint, the Plaintiffs filed their response and the parties are now conducting disclosure proceedings in accordance with Israel’s civil regulations. In accordance with Israel’s civil regulations, the parties considered alternative means to resolve at least some of the disputes and have consented to engage the services of a mutually agreeable mediator. The mediation is currently taking place. According to management’s estimation, since a loss is not considered probable, no provision was made in the financial statements.

 

On September 6, 2023, a claim (the “Claim”) was filed in the Tel Aviv District Court (the “Court”) against the Company, the Israeli Subsidiary, Octomera LLC, Orgenesis Biotech Israel Ltd, Theracell Laboratories Private Company and Vered Caplan (collectively, the “defendants”) by Ehud Almon (Plaintiff) for certain finders’ fees and / or royalties related to sales made by an Octomera subsidiary to a Greek entity in the amount of $896 and also for other means of compensation. The Israeli Subsidiary and Vered Caplan filed their statement of defense on January 28, 2024 claiming, inter alia, that the Plaintiff did not serve as a broker, but rather served as the Greek entity’s representative and as such he is not entitled to compensation of any kind from the defendants. It was also clarified that the defendants did not enter into a finder’s agreement with the Plaintiff. Additionally, the Israeli subsidiary and Vered Caplan claimed that the Plaintiff concealed material information from the court, including the signed partnership agreement between the Greek entity’s owner and the Plaintiff, as well as certain criminal charges brought against him in Greece. On February 22, 2024, the Plaintiff filed a request for service of process to deliver the Claim to the Company and the other defendants incorporated outside of Israel. This request was denied on the same day. An appeal filed by the Plaintiff on the aforementioned decision was denied. On May 27, 2024, the Plaintiff filed a new request for service of process to deliver the Claim to the Company and the other defendants incorporated outside of Israel. On May 28, 2024 the request was accepted. The court ruled that the Claim be delivered via courier to the Company and Octomera LLC, and delivered in accordance with the Hague Convention to Theracell Laboratories. After requesting a continuance, the court has ruled that the Plaintiff must file proof of the execution of the aforementioned deliveries until August 15, 2024. According to management’s estimation, since the likelihood of the Plaintiff winning the case is less than fifty percent, no provision was made in the financial statements.

 

 

On October 26, 2023, a complaint was filed in the Supreme Court of the State of New York by plaintiffs Southern Israel Bridging Fund Two LP and Mr. Amir Hasidim, against the Company, seeking the payment of $1,150 together with interest in the amount of 6%. In the Complaint plaintiffs alleged the amount provided to the Company was based on a Convertible Loan Agreement dated May 17, 2022, which provided for a loan amount of $5,000. Notwithstanding the Convertible Loan Agreement, on August 21, 2023, Company sent the plaintiffs an offset notice in light of the plaintiffs’ breach of obligations under the Convertible Loan Agreement and the damages caused to the Company as a result of said breach. The Company counter sued as well, seeking damages for Plaintiff’s breach of contract, fraud and harassment. Accordingly, the Company disputes whether it owes plaintiffs the amount sought in the Complaint.

 

On November 1, 2023, a claim (the “Claim”) was filed in the Tel Aviv District Court (the “Court”) against the Company, the Israeli Subsidiary, and Vered Caplan (collectively, the “Defendants”) by Fidelity Venture Capital Ltd. and Dror Atzmon (together – the “Plaintiffs”). The claim is based on two agreements the Company entered into with the Plaintiffs on November 2, 2016: (a) an unsecured convertible note agreements for an aggregate amount of NIS 1 million ($280). The loan bears a monthly interest rate of 2% and will mature on May 1, 2017, unless converted earlier and (b) a consultation agreement which awarded the Plaintiffs 800 thousand warrants. The exercise price of the warrants and conversion price were fixed at $0.52 per share (pre-reverse stock split implemented by the Company in November 2017). On April 27, 2017, and November 2, 2017, the Company entered into extension agreements through November 2, 2017 and May 2, 2018, respectively, in connection with the convertible note agreements. In March 2018, the Plaintiffs submitted a notice of their intention to convert into shares the Company’s common stock, the principal amount of the loan, and accrued interest of approximately $383 outstanding. In addition, the Plaintiffs exercised all the warrants awarded in the consultation agreement. In light of the reverse stock split which took place in November 2017, the Company disagreed with the plaintiffs’ calculations regarding the number of issuable shares of Common Stock. The Company responded to the notice and rejected these contentions in their entirety. In April 2018, the Company terminated the agreements based on several claims, including mistake, intentional misrepresentation and bad faith. Therefore, the Company deposited the shares in total amount of 107,985 issued under those agreements and the principal amount and accrued interest of the loan in an escrow account. The deposit of the principal amount and accrued interest presented as restricted cash in the balance sheet as of December 31, 2023. Based on the calculation difference, in their Claim, the Plaintiffs request damages in the amount of NIS 40,140, and the issuance of 11,869,600 shares of the Company. The Defendants filed their statement of defense on April 15, 2024, in which they raised, among others, the aforementioned claims and additional procedural and substantial claims, including laches. The Claim is scheduled for pretrial which will take place on November 5, 2024. Meanwhile, the parties have agreed to start mediation proceeding in connection with the Claim. According to management’s estimation, since the likelihood of the Plaintiffs winning the case is less than fifty percent, no provision was made in the financial statements.

 

On July 11, 2024 the Israeli subsidiary reached a settlement agreement sanctioned by the Tel Aviv Magistrate’s court pursuant to which the subsidiary will pay the amount of NIS 427,000 (approximately $114) including VAT to the lessor of leased premises no later than September 30, 2024, which includes a grace period for late payments. As of the date of this quarterly report on Form 10Q, the Company had paid NIS 140,000 (approximately $37), leaving an amount of NIS 286,000 (approximately $76) still due under the settlement agreement. In the event that the Company fails to meet all of its obligations under the settlement agreement, the Company may be liable to pay an additional NIS 211,000 (approximately $12) over and above the amount still due, in respect of claims for unpaid rentals made by the lessor.

 

 

Except as described above, the Company is not involved in any pending material legal proceedings.

 

v3.24.2.u1
SUBSEQUENT EVENTS
6 Months Ended
Jun. 30, 2024
Subsequent Events [Abstract]  
SUBSEQUENT EVENTS

NOTE 13 – SUBSEQUENT EVENTS

 

On July 10, 2024, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Broaden Bioscience and Technology Corp. (“Broaden”) for the purchase by the Company of the following assets (the “Assets”): The process and algorithms developed by Broaden for processing CAR-T, RACE CAR-T and all oncology products that will enable the Company to develop and sell treatments to third parties, which include Broaden’s rights, title and interests in and to all intellectual property, including, but not limited to, patents, patent applications, know-how, materials, licenses, permits and approvals related thereto. Pursuant to the Purchase Agreement, in consideration for the purchase of the Assets, the Company will pay Broaden an amount equal to the value of the Assets established by a third party valuation firm not to exceed $11,000 (the “Consideration”), less a debt adjustment relating to $10,767 owed to the Company by Broaden for work performed and invoiced between August 2022 and May 2023 (the “Debt”), as detailed in the Purchase Agreement. The Consideration that exceeds the Debt will be payable at the election of the Company in shares of the Company’s common stock at a price of $3.00 per share or 10% above the market price at such time it is paid, whichever is higher, or a note with amortization in 24 months from the date of the Purchase Agreement, including prepayment provisions.

 

On July 12, 2024, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Theracell Advanced Biotechnology S.A, Theracell Advanced Biotechnology LTD and IDNA Genomics Public Limited (collectively, “Theracell”) for the purchase by the Company of the following assets (the “Assets”) owned by Theracell:

 

50% of the outstanding ownership rights and equity interests in Theracell Laboratories IKE (“Theracell IKE”) not currently owned by the Company so that the Company shall own 100% of the outstanding equity interests of Theracell IKE; and
Certain products (the “Products”), which include: (i) the manufacturing processes, algorithms, work instructions, test methods, standard operating procedures and specifications for producing Tumor Infiltrating Lymphocytes (“TILs”) that meet current Good Manufacturing Practice (cGMP) requirements that will enable the Company to potentially use this product as a platform for treating a wide variety of solid tumors; (ii) a 3rd generation GMP lentivirus production process, which is part of a therapy manufacturing process that will enable the Company to potentially treat Beta Thalassemia therapies; (iii) an oncolytic virus cell carrier platform which will enable the Company to potentially develop treatments for an array of cancers; (iv) a process for the potential treatment of mesenchymal stem cells for kidney disorders; (v) a process for controlled isolation of regenerative EVs derived from mesenchymal stem cells for the potential treatment of kidney disorders; and (vi) bioxome encapsulated APIs for improved transdermal delivery and bioavailability for the potential treatment of atopic dermatitis/wound healing; including Theracell’s rights, title and interests in and to all intellectual property, including, but not limited to, patents, patent applications, know-how, materials, licenses, permits and approvals relating to Products as further described in the Purchase Agreement.

 

Pursuant to the Purchase Agreement, in consideration for the purchase of the Assets, the Company will pay Theracell an aggregate purchase price of $13,000 (the “Consideration”), which is equal to the value of the Assets established by a third-party valuation firm, less a debt adjustment in the amount of $10,324 which was owed by Theracell to the Company (the “Debt”). The aggregate Consideration will be paid by the Company as follows: (i) $400 will be paid to Theracell within 60 days after signing of the Purchase Agreement, (ii) $250 will be paid to Theracell within one year after signing of the Purchase Agreement, and (iii) the remaining amount (less any Debt) will be paid to Theracell in four equal annual payments beginning on December 30, 2025 and ending on December 30, 2028.

v3.24.2.u1
BASIS OF PRESENTATION (Policies)
6 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
Basis of presentation

a. Basis of presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of management, the financial statements reflect all normal and recurring adjustments necessary to fairly state the financial position and results of operations of the Company. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (“SEC”) on April 15, 2024. The year-end balance sheet data was derived from the audited consolidated financial statements as of December 31, 2023, but not all disclosures required by generally accepted accounting principles in the United States (“U.S. GAAP”) are included in this Quarterly Report on Form 10-Q.

 

b. Significant accounting policies

 

The accounting policies adopted are consistent with those of the previous financial year except as described below:

 

Use of Estimates in the Preparation of Financial Statements

Use of Estimates in the Preparation of Financial Statements

 

The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies. The Company bases its estimates on historical experience and on various other assumptions that it believes are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity, the amount of revenues and expenses, determination of loss on deconsolidation, valuation of investments, purchase price allocations, goodwill impairment, and assessment of credit losses and purchase price allocation including contingent consideration. Actual results could differ from those estimates.

 

 

Recently issued accounting pronouncements, not yet adopted

Recently issued accounting pronouncements, not yet adopted

 

Improvements to Reportable Segments Disclosures

 

In November 2023, the FASB issued ASU 2023-07 “Segment Reporting–Improvements to Reportable Segments Disclosures (Topic 280)” to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The amendments in this ASU (1) require that a public entity disclose, on an annual and interim basis, significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”) and included within each reported measure of segment profit or loss; (2) require that a public entity disclose, on an annual and interim basis, an amount for other segment items by reportable segment and a description of its composition; (3) require that a public entity provide all annual disclosures about a reportable segment’s profit or loss and assets currently required by Topic 280 in interim periods; (4) clarify that if the CODM uses more than one measure of a segment’s profit or loss in assessing segment performance and deciding how to allocate resources, a public entity may report one or more of those additional measures; and (5) require that a public entity disclose the title and position of the CODM and an explanation of how the CODM uses the reported measure or measures of segment profit or loss in assessing segment performance and deciding how to allocate resources. The amendments in this ASU are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, and should be applied retrospectively to all periods presented. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of these amendments on its consolidated financial statements.

 

Improvements to Income Tax Disclosures

 

In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740)–Improvements to Income Tax Disclosures” to enhance the transparency and decision usefulness of income tax disclosures, primarily related to the rate reconciliation and income taxes paid information. The amendments in this ASU require that public entities, on an annual basis, disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. This ASU also requires that all entities disclose, on an annual basis, (1) the amount of income taxes paid disaggregated by federal, state, and foreign taxes, (2) the amount of income taxes paid disaggregated by individual jurisdictions in which income taxes paid is equal to or greater than five percent of total income taxes paid, (3) income or loss from continuing operations before income tax expense or benefit disaggregated between domestic and foreign, and (4) income tax expense or benefit from continuing operations disaggregated by federal, state, and foreign. The amendments in this ASU are effective for annual periods beginning after December 15, 2024, and should be applied on a prospective basis with the option to apply retrospectively. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is currently evaluating the impact of the adoption of these amendments on its consolidated financial statements.

v3.24.2.u1
SEGMENT INFORMATION (Tables)
6 Months Ended
Jun. 30, 2024
Segment Reporting [Abstract]  
SCHEDULE OF SEGMENT REPORTING

Segment data for the six months ended June 30, 2024 is as follows:

 

   Octomera   Therapies   Eliminations   Consolidated 
   (in thousands) 
Revenues  $50   $360   $(23)  $387 
Cost of revenues*   (1,047)   (329)   710    (666)
Gross profit   (997)   31    687    (279)
Cost of development services and research and development expenses*   (3,251)   (1,031)   697    (3,585)
Operating expenses*   (546)   (7,037)   (646)   (8,229)
Loss from deconsolidation   -    -    (66)   (66)
Other income   -    8    -    8 
Depreciation and amortization   (870)   (387)   170    (1,087)
Loss from extinguishment in connection with convertible loan   -    (141)   -    (141)
Financial income (expenses), net   (554)   (1,237)   124    (1,667)
Convertible loans induced conversion expenses   -    (4,304)   -    (4,304)
Income (loss) before income taxes  $(6,218)  $(14,098)  $966   $(19,350)

 

*Excluding Depreciation, amortization expenses

 

Segment data for the six months ended June 30, 2023 is as follows:

 

   Octomera   Therapies   Eliminations   Consolidated 
   (in thousands) 
Revenues  $15   $240   $-   $255 
Cost of revenues*   (5,084)   (398)   -    (5,482)
Gross profit   (5,069)   (158)   -    (5,227)
Cost of development services and research and development expenses*   (4,501)   (2,051)   -    (6,552)
Operating expenses*   (27,990)   (3,722)   -    (31,712)
Loss from deconsolidation of Octomera   -    -    (5,343)   (5,343)
Other income, net   2    -    -    2 
Depreciation and amortization   (779)   (396)   -    (1,175)
Loss from extinguishment in connection with convertible loan   -    (283)   -    (283)
Credit losses on convertible loan receivable   -    (2,688)   -    (2,688)
Financial Expenses, net   (495)   (879)   1    (1,373)
Share in net income of associated companies   -    1    -    1 
Loss before income taxes  $(38,832)  $(10,176)  $(5,342)  $(54,350)

 

*Excluding Depreciation, amortization expenses

 

 

Segment data for the three months ended June 30, 2024 is as follows:

 

   Octomera   Therapies   Eliminations   Consolidated 
   (in thousands) 
Revenues  $21   $225   $-   $246 
Cost of revenues*   (110)   (179)   -    (289)
Gross profit   (89)   46    -    (43)
Cost of development services and research and development expenses*   (1,466)   148    -    (1,318)
Operating expenses*   (483)   (1,518)   (182)   (2,183)
Other income   -    8    -    8 
Depreciation and amortization   (440)   (193)   (73)   (706)
Financial income (expenses), net   (264)   (551)   -    (815)
Convertible loans induced conversion expenses   -    (4,304)   -    (4,304)
Income (loss) before income taxes  $(2,742)  $(6,364)  $(255)  $(9,361)

 

*Excluding Depreciation, amortization expenses

 

Segment data for the three months ended June 30, 2023 is as follows:

 

   Octomera   Therapies   Eliminations   Consolidated 
   (in thousands) 
Revenues  $3   $110   $-   $113 
Cost of revenues*   (2,776)   (220)   -    (2,996)
Gross profit   (2,773)   (110)   -    (2,883)
Cost of development services and research and development expenses*   (2,420)   (975)   -    (3,395)
Operating expenses*   (16,787)   (1,408)   -    (18,195)
Loss from deconsolidation of Octomera   -    -    (5,343)   (5,343)
Depreciation and amortization   (394)   (203)   -    (597)
Financial expenses, net   (229)   (464)   1    (692)
Share in net income of associated companies   -    3    -    3 
Loss before income taxes  $(22,603)  $(3,157)  $(5,342)  $(31,102)

 

*Excluding Depreciation, amortization expenses

v3.24.2.u1
RECONSOLIDATION OF OCTOMERA LLC (Tables)
6 Months Ended
Jun. 30, 2024
Restructuring Cost and Reserve [Line Items]  
SCHEDULE OF DECONSOLIDATE ASSETS AND LIABILITIES

The following table summarizes the allocation of purchase price to the fair values of the assets acquired and liabilities assumed as of the Transaction date:

 

   (in thousands) 
Total Contingent consideration to MM for royalty and milestone payments  $4,643 
      
Total assets acquired:     
Cash and cash equivalents  $139 
Property, plants and equipment, net   17,852 
Other Assets   3,478 
Total assets  $21,469 
      
Total liabilities assumed:     
Total current liabilities  $(12,518)
Total long-term liabilities   (5,628)
Total liabilities  $(18,146)
      
Know how Technology   1,728 
      
Total Net Assets  $5,051 
Fair-Value of Non-controlling interests   (408)
Total liability to MM  $4,643 
SCHEDULE OF KEY INPUTS FOR THE FAIR VALUES VALUATION

Key inputs for the fair values valuation are summarized below. 

 

Key Valuation Inputs  Jan 29, 2024 
Discount rate   40%
Risk-free interest rate   4.4%
Average 5 years revenue growth   50%
SCHEDULE OF KEY INPUTS

Key inputs for the simulation are summarized below.

 

Key Valuation Inputs  Jan 29, 2024   June 30, 2024 
Standard Deviation   13.5%   13.5%
Risk-free interest rate   4.4%   4.6%
Possible trigger event examination   Year 10    Year 10 
Average 5 years revenue growth   50%   50%
Trigger events   30%   30%
Revenues multiple   10    9.75 

 

* Based on a Monte Carlo simulation analysis of 30,000 iterations
Orgenesis Biotech Israel Limited [Member]  
Restructuring Cost and Reserve [Line Items]  
SCHEDULE OF DECONSOLIDATE ASSETS AND LIABILITIES

The following table summarizes the deconsolidated assets and liabilities as of February 14, 2024:

 

Total assets acquired:    
Cash and cash equivalents  $4 
Property, plants and equipment, net   2,884 
Other Assets   1,422 
Total assets  $4,310 
      
Total liabilities assumed:  $4,244 
Total Net Assets deconsolidated  $66 
Loss from deconsolidation of OBI  $66 
v3.24.2.u1
CONVERTIBLE LOANS (Tables)
6 Months Ended
Jun. 30, 2024
Debt Disclosure [Abstract]  
SCHEDULE OF LONG TERM CONVERTIBLE NOTES

The table below summarizes the Company’s outstanding convertible loans as of June 30, 2024.

 

Principal

Amount at

Issuance

   Issuance Date   Current Interest Rate   Current
Maturity
   Current Conversion Price of loan into equity 
    (Year)   %   (Year)   $ 
  
$                      
                       
 100    2019    8%   2024    1.03 
 100    2020    8%   2024    1.03 
 1,150    2022    6%   *2023   4.50 
 5,000    2023    8%   2026    2.46 
$6,350                     

 

  * Was not repaid by June 30, 2024.

 

 

The table below summarizes the Company’s outstanding convertible loans as of December 31, 2023.

 

Principal Amount

   Issuance Date   Current Interest Rate   Current
Maturity
   Current Conversion Price of loan into equity   Note 
    (Year)   %   (Year)   $     
Convertible Loans Outstanding as of December 31, 2023     
$750    2018    10%   2026    2.50      
 1,500    2019    10%   2026    2.50      
 100    2019    8%   2024    7.00      
 5,000    2019    10%   2026    2.50      
 100    2020    8%   2024    7.00      
 5,000    2022    10%   2026    2.50      
 1,150    2022    6%   **2023   4.50      
 5,000    2023    8%   2026    2.46      
 735    2023    8%   2024    0.85    6a
$19,335                          

 

  ** Was not yet paid by December 31, 2023.    
v3.24.2.u1
LOANS (Tables)
6 Months Ended
Jun. 30, 2024
Loans  
SCHEDULE OF LONG TERM LOANS

The table below summarizes the Company’s outstanding long-term loans as of June 30, 2024 and December 31, 2023, respectively:

 

Principal Amount   Interest Rate   Year of Maturity   June 30, 2024   December 31, 2023 
(in thousands)   %       (in thousands) 
$2,600    10    2034   $2,762   $- 
SCHEDULE OF SHORT TERM LOANS

The table below summarizes the Company’s outstanding short-term loans as of June 30, 2024 and December 31, 2023, respectively:

 

Currency  Interest Rate   June 30, 2024   December 31, 2023 
   %   (in thousands) 
USD   8   $268   $258 
USD   10    814    61 
USD   (*)8   -    (**)331
USD   6    90    - 
Euro   8    14    - 
        $1,186   $650 

 

(*)Weighted average interest.
(**)The terms of the loan were amended on January 1, 2024. Under the new terms, the loan became convertible into shares of Common Stock and the lender agreed to extend the maturity date to December 31, 2024. In consideration for such extension, the Company issued to the lender warrants to purchase 360,000 shares of the Company’s Common Stock at a price of $0.85 per share and granted lender the right to convert any part of the outstanding balance of the loan into Common Stock of the Company at the conversion rate of $0.85 per share. Based on its analysis, the Company concluded that this change in terms should be accounted for as a modification. This loan was converted as per the debt exchange agreement. See note 6.
v3.24.2.u1
STOCK-BASED COMPENSATION (Tables)
6 Months Ended
Jun. 30, 2024
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items]  
SCHEDULE OF RESTRICTED STOCK UNITS GRANTED

Below is a table summarizing all the RSUs grants to employees during the period from January 1, 2024 to June 30, 2024:

 

SCHEDULE OF RESTRICTED STOCK UNITS GRANTED

  

 

No. of

Options

Granted

   Vesting Period 

Fair Value at Grant

(in thousands)

 
Employees   50,000   Immediate  $26 
SCHEDULE OF SHARES AND WARRANTS GRANTS TO ADVISORS

 

Date of issue of share or warrant   Reason for issue of share or warrant  Consideration  Exercise price of warrants   Warrant vesting (subject to continued service provided to Company)  Warrant expiry date
January 25, 2024   Consideration for a past debt  164,000 shares of Common Stock           
March 7, 2024   Strategic advisor agreement  500,000 shares of Common Stock and warrants to purchase 500,000 shares of Common Stock  $1.03   One third on March 7, 2024, one third on June 5, 2024, and one third on September 3, 2024.  March 6, 2029
April 18, 2024   Strategic advisor agreement  Warrants to purchase 500,000 shares of Common Stock  $1.03   One third on April 18, 2024, one third on July 18, 2024, and one third on October 18, 2024.  April 17, 2029
April 23, 2024   Strategic advisor agreement  Warrants to purchase 500,000 shares of Common Stock  $1.03   One third on April 16, 2024, one third on July 16, 2024, and one third on October 16, 2024.  April 22, 2029
May 22, 2024   Strategic advisor agreement  Warrants to purchase 475,000 shares of Common Stock  $1.03   One third on May 21, 2024, one third on August 21, 2024, and one third on November 21, 2024.  May 21, 2029

 

   

No. of

Warrants

Granted

   Vesting Period  

Fair Value at Grant

(in thousands)

 
 Warrants    1,975,000    Over a period of six months   $568 
 Shares    664,000    N/A   $326 
SCHEDULE OF WARRANTS GRANTS ASSUMPTIONS

 

   During the Period from January 1, 2024 to June 30, 2024 
Value of one common share   $0.51-$0.84 
Dividend yield   0%
Expected stock price volatility   87%-90% 
Risk free interest rate   4.07%-4.68% 
Expected term (years)   5 
Options Granted To Employees [Member]  
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items]  
SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES

The table below summarizes the terms of options for the purchase of shares in the Company granted to employees during the period from January 1, 2024 to June 30, 2024:

  

   

 

No. of

Options

Granted

   Exercise Price   Vesting Period 

Fair Value at Grant

(in thousands)

  

Expiration

Period

 
Employees    400,000   $0.50-$0.63   Half quarterly over a period of two years and the rest quarterly over a period of four years  $161    10 years 
SCHEDULE OF STOCK OPTIONS ACTIVITY

The fair valuation of these option grants is based on the following assumptions:

 

SCHEDULE OF STOCK OPTIONS ACTIVITY

   During the Period from January 1, 2024 to June 30, 2024 
Value of one common share   $0.49-$0.63 
Dividend yield   0%
Expected stock price volatility   79%-85%
Risk free interest rate   3.86%-4.28%
Expected term (years)   5.56-6.06 

v3.24.2.u1
LOSS PER SHARE (Tables)
6 Months Ended
Jun. 30, 2024
Earnings Per Share [Abstract]  
SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE

The following table sets forth the calculation of basic and diluted loss per share for the period indicated:

SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE 

   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   Three Months Ended   Six Months Ended 
   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   (in thousands, except per share data) 
Basic and diluted:                    
Net loss attributable to Orgenesis Inc.  $8,904   $25,543   $18,669   $45,013 
Adjustment of redeemable non-controlling interest to redemption amount   -    (3,671)   -    - 
Net loss attributable to Orgenesis Inc. for loss per share   8,904   $21,872   $18,669   $45,013 
Weighted average number of common shares outstanding   38,860,727    28,603,597    35,979,567    27,546,229 
Net loss per share   $0.23     $0.76    0.52     $1.63  
v3.24.2.u1
REVENUES (Tables)
6 Months Ended
Jun. 30, 2024
Revenue from Contract with Customer [Abstract]  
SCHEDULE OF DISAGGREGATION OF REVENUE

The following table disaggregates the Company’s revenues by major revenue streams:

 

SCHEDULE OF DISAGGREGATION OF REVENUE

   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   Three Months Ended   Six Months Ended 
   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   (in thousands) 
Revenue stream:                    
Cell process development services and hospital services  $246   $113    $387    $255 
Total  $246   $113   $387   $255 
SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER

A breakdown of the revenues per customer constituted at least 10% of revenues is as follows:

 

SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER

   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   Three Months Ended   Six Months Ended 
   June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023 
   (in thousands) 
Revenue earned:                    
Customer A (United States)  $225   $65   $300   $130 
Customer B (United States)  $-   $-   $60   $- 
Customer C (United States)  $-   $45   $-   $45 
Customer D (United States)  $-   $-   $-   $65 
SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES

The activity for trade receivables is comprised of:

 

SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES

   June 30, 2024   June 30, 2023 
   Six Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
Balance as of beginning of period  $88   $36,183 
Reconsolidation (deconsolidation) of Octomera   82    (5,985)
Additions   380    293 
Collections   (822)   (6,045)
Allowances for credit losses   512    (24,388)
Exchange rate differences   -    (52)
Balance as of end of period  $240   $6 

SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES

The activity for contract liabilities is comprised of:

 

SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES

   June 30, 2024   June 30, 2023 
   Six Months Ended 
   June 30, 2024   June 30, 2023 
   (in thousands) 
Balance as of beginning of period  $200   $70 
Deconsolidation of Octomera   110    (106)
Deconsolidation of OBI   (60)   - 
Additions   110    36 
Realizations   (10)   - 
Balance as of end of period  $350   $- 
v3.24.2.u1
DESCRIPTION OF BUSINESS (Details Narrative) - USD ($)
6 Months Ended
May 31, 2024
May 21, 2024
Jun. 30, 2024
Jun. 30, 2023
Jan. 29, 2024
Dec. 31, 2023
Sep. 27, 2023
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]              
Commons stock, par value     $ 0.0001     $ 0.0001  
Accumulated deficit     $ 195,291,000     $ 176,622,000  
Net Cash Provided by (Used in) Operating Activities     $ 10,348,000 $ 13,154,000      
Debt Exchange Agreements [Member] | Three Convertible Debt Holders [Member]              
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]              
Outstanding principal and accrued interest $ 16,007,372 $ 16,007          
Number of shares issued 15,776,947 15,776,947          
Octomera LLC [Member]              
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]              
Equity method investment, ownership percentage         100.00%    
ORGS [Member]              
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]              
Commons stock, par value     $ 0.0001        
Minimum closing bid price             $ 1.00
v3.24.2.u1
SCHEDULE OF SEGMENT REPORTING (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Segment Reporting Information [Line Items]        
Revenues $ 246 $ 113 $ 387 $ 255
Cost of revenues (289) [1] (2,996) [2] (666) [3] (5,482) [4]
Gross profit (43) (2,883) (279) (5,227)
Cost of development services and research and development expenses (1,318) [1] (3,395) [2] (3,585) [3] (6,552) [4]
Operating expenses (2,183) [1] (18,195) [2] (8,229) [3] (31,712) [4]
Loss from deconsolidation of Octomera (5,343) (66) (5,343)
Other income 8 8 2
Depreciation and amortization (706) (597) (1,087) (1,175)
Loss from extinguishment in connection with convertible loan (141) (283)
Financial expenses, net (815) (692) (1,667) (1,373)
Convertible loans induced conversion expenses (4,304) (4,304)
Loss before income taxes (9,361) (31,102) (19,350) (54,350)
Credit losses on convertible loan receivable (2,688)
Share in net income of associated companies 3 1
Octomera [Member]        
Segment Reporting Information [Line Items]        
Revenues 21 3 50 15
Cost of revenues (110) [1] (2,776) [2] (1,047) [3] (5,084) [4]
Gross profit (89) (2,773) (997) (5,069)
Cost of development services and research and development expenses (1,466) [1] (2,420) [2] (3,251) [3] (4,501) [4]
Operating expenses (483) [1] (16,787) [2] (546) [3] (27,990) [4]
Loss from deconsolidation of Octomera  
Other income   2
Depreciation and amortization (440) (394) (870) (779)
Loss from extinguishment in connection with convertible loan    
Financial expenses, net (264) (229) (554) (495)
Convertible loans induced conversion expenses    
Loss before income taxes (2,742) (22,603) (6,218) (38,832)
Credit losses on convertible loan receivable      
Share in net income of associated companies    
Therapies [Member]        
Segment Reporting Information [Line Items]        
Revenues 225 110 360 240
Cost of revenues (179) [1] (220) [2] (329) [3] (398) [4]
Gross profit 46 (110) 31 (158)
Cost of development services and research and development expenses 148 [1] (975) [2] (1,031) [3] (2,051) [4]
Operating expenses (1,518) [1] (1,408) [2] (7,037) [3] (3,722) [4]
Loss from deconsolidation of Octomera  
Other income 8   8
Depreciation and amortization (193) (203) (387) (396)
Loss from extinguishment in connection with convertible loan     (141) (283)
Financial expenses, net (551) (464) (1,237) (879)
Convertible loans induced conversion expenses (4,304)   (4,304)  
Loss before income taxes (6,364) (3,157) (14,098) (10,176)
Credit losses on convertible loan receivable       (2,688)
Share in net income of associated companies   3   1
Eliminations [Member]        
Segment Reporting Information [Line Items]        
Revenues (23)
Cost of revenues [1] [2] 710 [3] [4]
Gross profit 687
Cost of development services and research and development expenses [1] [2] 697 [3] [4]
Operating expenses (182) [1] [2] (646) [3] [4]
Loss from deconsolidation of Octomera   (5,343) (66) (5,343)
Other income  
Depreciation and amortization (73) 170
Loss from extinguishment in connection with convertible loan    
Financial expenses, net 1 124 1
Convertible loans induced conversion expenses    
Loss before income taxes $ (255) (5,342) $ 966 (5,342)
Credit losses on convertible loan receivable      
Share in net income of associated companies    
[1] Excluding Depreciation, amortization expenses
[2] Excluding Depreciation, amortization expenses
[3] Excluding Depreciation, amortization expenses
[4] Excluding Depreciation, amortization expenses
v3.24.2.u1
SCHEDULE OF PURCHASE PRICE TO THE FAIR VALUES OF THE ASSETS ACQUIRED AND LIABILITIES ASSUMED (Details) - Octomera [Member]
$ in Thousands
Jun. 30, 2024
USD ($)
Restructuring Cost and Reserve [Line Items]  
Total Contingent consideration to MM for royalty and milestone payments $ 4,643
Total assets acquired:  
Cash and cash equivalents 139
Property, plants and equipment, net 17,852
Other Assets 3,478
Total assets 21,469
Total liabilities assumed:  
Total current liabilities (12,518)
Total long-term liabilities (5,628)
Total liabilities (18,146)
Know how Technology 1,728
Total Net Assets 5,051
Fair-Value of Non-controlling interests (408)
Total liability to MM $ 4,643
v3.24.2.u1
SCHEDULE OF KEY INPUTS FOR THE FAIR VALUES VALUATION (Details) - Octomera [Member]
Jan. 29, 2024
Measurement Input, Discount Rate [Member]  
Restructuring Cost and Reserve [Line Items]  
Measurement input 40
Measurement Input, Risk Free Interest Rate [Member]  
Restructuring Cost and Reserve [Line Items]  
Measurement input 4.4
Measurement Input, Long-Term Revenue Growth Rate [Member]  
Restructuring Cost and Reserve [Line Items]  
Measurement input 50
v3.24.2.u1
SCHEDULE OF KEY INPUTS (Details) - Fair Value, Inputs, Level 3 [Member]
6 Months Ended
Jan. 29, 2024
Jun. 30, 2024
Measurement Input Standard Deviation [Member]    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Measurement input 13.5 13.5
Measurement Input, Risk Free Interest Rate [Member]    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Measurement input 4.4 4.6
Measurement Input Trigger Event [Member]    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Possible trigger event examination 10 years 10 years
Measurement Input, Long-Term Revenue Growth Rate [Member]    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Measurement input 50 50
Measurement Input Trigger Events [Member]    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Measurement input 30 30
Measurement Input, Revenue Multiple [Member]    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Measurement input 10 9.75
v3.24.2.u1
SCHEDULE OF DECONSOLIDATE ASSETS AND LIABILITIES (Details) - Orgenesis Biotech Israel Limited [Member]
$ in Thousands
Feb. 14, 2024
USD ($)
Restructuring Cost and Reserve [Line Items]  
Cash and cash equivalents $ 4
Property, plants and equipment, net 2,884
Other Assets 1,422
Total assets 4,310
Total liabilities assumed: 4,244
Total Net Assets 66
Loss from deconsolidation of OBI $ 66
v3.24.2.u1
RECONSOLIDATION OF OCTOMERA LLC (Details Narrative) - USD ($)
$ in Thousands
1 Months Ended 3 Months Ended 6 Months Ended
Jan. 29, 2024
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
Defined Benefit Plan Disclosure [Line Items]            
Net loss   $ (8,904) $ (25,543) $ (18,669) $ (45,013)  
Recognized loss on deconsolidation       66    
Fair Value, Inputs, Level 3 [Member]            
Defined Benefit Plan Disclosure [Line Items]            
Derivative Assets (Liabilities), at Fair Value, Net $ 4,643 4,825   4,825    
[custom:RevaluationExpense-0]   $ 182   $ 182    
Know How Technology [Member]            
Defined Benefit Plan Disclosure [Line Items]            
Intangible assets useful life   10 years   10 years    
Octomera [Member]            
Defined Benefit Plan Disclosure [Line Items]            
Recognition of intangible asset   $ 1,728   $ 1,728    
Liability to MM   4,643   4,643    
Transaction cost   0   50    
Revenues 23          
Net loss $ 1,244          
10 Secured Promissory Notes [Member]            
Defined Benefit Plan Disclosure [Line Items]            
Original principal amount   2,600   2,600    
Unit Purchase Agreement [Member]            
Defined Benefit Plan Disclosure [Line Items]            
Milestone payments       $ 40,000    
Milestone sales percentage       5.00%    
Metalmark [Member] | Unit Purchase Agreement [Member]            
Defined Benefit Plan Disclosure [Line Items]            
Royalty percentage to be received       5.00%    
Related Party [Member]            
Defined Benefit Plan Disclosure [Line Items]            
Accounts payable related parties   $ 2,696   $ 2,696   $ 133
v3.24.2.u1
EQUITY (Details Narrative) - USD ($)
$ / shares in Units, $ in Thousands
6 Months Ended
May 10, 2024
Mar. 03, 2024
Jun. 30, 2024
Jun. 30, 2023
May 22, 2024
Apr. 23, 2024
Apr. 18, 2024
Mar. 07, 2024
Subsidiary, Sale of Stock [Line Items]                
Purchase of warrants               500,000
Exercise price of warrants         $ 1.03 $ 1.03 $ 1.03 $ 1.03
Gross proceeds from offering     $ 2,528 $ 3,341        
Securities Purchase Agreement [Member]                
Subsidiary, Sale of Stock [Line Items]                
Gross proceeds from offering $ 154              
Securities Purchase Agreement [Member] | Warrant [Member]                
Subsidiary, Sale of Stock [Line Items]                
Purchase of warrants 150,000              
Exercise price of warrants $ 1.50              
Securities Purchase Agreement [Member] | Warrant One [Member]                
Subsidiary, Sale of Stock [Line Items]                
Purchase of warrants 150,000              
Exercise price of warrants $ 2.00              
Securities Purchase Agreement [Member] | Private Placement [Member]                
Subsidiary, Sale of Stock [Line Items]                
Common stock shares issued and sell 150,000 2,272,719            
Sale of stock, price per share $ 1.03 $ 1.03            
Gross proceeds from offering   $ 2,300            
Securities Purchase Agreement [Member] | Private Placement [Member] | Warrant One [Member]                
Subsidiary, Sale of Stock [Line Items]                
Purchase of warrants   2,272,719            
Exercise price of warrants   $ 2.00            
Securities Purchase Agreement [Member] | Private Placement [Member] | Warrant [Member]                
Subsidiary, Sale of Stock [Line Items]                
Purchase of warrants   2,272,719            
Exercise price of warrants   $ 1.50            
v3.24.2.u1
SCHEDULE OF LONG TERM CONVERTIBLE NOTES (Details) - USD ($)
$ / shares in Units, $ in Thousands
6 Months Ended 12 Months Ended
Jun. 30, 2024
Dec. 31, 2023
Jan. 31, 2024
Debt Instrument [Line Items]      
Current Conversion Price of loan into equity     $ 0.85
Convertible Loans One [Member]      
Debt Instrument [Line Items]      
Principal Amount at Issuance $ 100 $ 750  
Issuance Date (Year) 2019 2018  
Current Interest Rate 8.00% 10.00%  
Current Maturity (Year) 2024 2026  
Current Conversion Price of loan into equity $ 1.03 $ 2.50  
Convertible Loans Two [Member]      
Debt Instrument [Line Items]      
Principal Amount at Issuance $ 100 $ 1,500  
Issuance Date (Year) 2020 2019  
Current Interest Rate 8.00% 10.00%  
Current Maturity (Year) 2024 2026  
Current Conversion Price of loan into equity $ 1.03 $ 2.50  
Convertible Loans Three [Member]      
Debt Instrument [Line Items]      
Principal Amount at Issuance $ 1,150 $ 100  
Issuance Date (Year) 2022 2019  
Current Interest Rate 6.00% 8.00%  
Current Maturity (Year) 2023 [1] 2024  
Current Conversion Price of loan into equity $ 4.50 $ 7.00  
Convertible Loans Four [Member]      
Debt Instrument [Line Items]      
Principal Amount at Issuance $ 5,000 $ 5,000  
Issuance Date (Year) 2023 2019  
Current Interest Rate 8.00% 10.00%  
Current Maturity (Year) 2026 2026  
Current Conversion Price of loan into equity $ 2.46 $ 2.50  
Convertible Loans [Member]      
Debt Instrument [Line Items]      
Principal Amount at Issuance $ 6,350 $ 19,335  
Convertible Loans Five [Member]      
Debt Instrument [Line Items]      
Principal Amount at Issuance   $ 100  
Issuance Date (Year)   2020  
Current Interest Rate   8.00%  
Current Maturity (Year)   2024  
Current Conversion Price of loan into equity   $ 7.00  
Convertible Loans Six [Member]      
Debt Instrument [Line Items]      
Principal Amount at Issuance   $ 5,000  
Issuance Date (Year)   2022  
Current Interest Rate   10.00%  
Current Maturity (Year)   2026  
Current Conversion Price of loan into equity   $ 2.50  
Convertible Loans Seven [Member]      
Debt Instrument [Line Items]      
Principal Amount at Issuance   $ 1,150  
Issuance Date (Year)   2022  
Current Interest Rate   6.00%  
Current Maturity (Year) [2]   2023  
Current Conversion Price of loan into equity   $ 4.50  
Convertible Loans Eight [Member]      
Debt Instrument [Line Items]      
Principal Amount at Issuance   $ 5,000  
Issuance Date (Year)   2023  
Current Interest Rate   8.00%  
Current Maturity (Year)   2026  
Current Conversion Price of loan into equity   $ 2.46  
Convertible Loans Nine [Member]      
Debt Instrument [Line Items]      
Principal Amount at Issuance   $ 735  
Issuance Date (Year)   2023  
Current Interest Rate   8.00%  
Current Maturity (Year)   2024  
Current Conversion Price of loan into equity   $ 0.85  
[1] Was not repaid by June 30, 2024.
[2] Was not yet paid by December 31, 2023.    
v3.24.2.u1
CONVERTIBLE LOANS (Details Narrative) - USD ($)
1 Months Ended 6 Months Ended
May 31, 2024
May 21, 2024
Jan. 01, 2024
Jan. 31, 2024
Jun. 30, 2024
May 22, 2024
Apr. 23, 2024
Apr. 18, 2024
Mar. 07, 2024
Dec. 31, 2023
Sep. 29, 2023
Debt Instrument [Line Items]                      
Common stock issued         47,212,473         32,163,630  
Exchange price       $ 0.85              
Number of securities called by warrants or rights                 500,000    
Exercise price of warrants           $ 1.03 $ 1.03 $ 1.03 $ 1.03    
Debt Exchange Agreements [Member]                      
Debt Instrument [Line Items]                      
Debt instrument, maturity date     Dec. 31, 2024 Dec. 31, 2026              
Number of securities called by warrants or rights     360,000 840,000              
Exercise price of warrants     $ 0.85 $ 0.85              
Debt Exchange Agreements [Member] | Three Convertible Debt Holders [Member]                      
Debt Instrument [Line Items]                      
Outstanding principal and accrued interest $ 16,007,372 $ 16,007                  
Number of shares issued 15,776,947 15,776,947                  
Common stock issued         11,829,128            
Outstanding principal         $ 14,784            
Debt conversion expense         $ 4,304            
Debt Exchange Agreements [Member] | Three Convertible Debt Holders [Member] | Maximum [Member]                      
Debt Instrument [Line Items]                      
Exchange price         $ 2.50            
Debt Exchange Agreements [Member] | Three Convertible Debt Holders [Member] | Minimum [Member]                      
Debt Instrument [Line Items]                      
Exchange price         $ 1.03            
Sai Convertible Loan Agreement [Member] | Lender [Member]                      
Debt Instrument [Line Items]                      
Principal loan amount                     $ 25,000
v3.24.2.u1
SCHEDULE OF LONG TERM LOANS (Details) - Long-Term Debt [Member] - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2024
Dec. 31, 2023
Short-Term Debt [Line Items]    
Original principal amount $ 2,600  
Interest rate 10.00%  
Year of maturity 2034  
Long term debt $ 2,762
v3.24.2.u1
SCHEDULE OF SHORT TERM LOANS (Details)
€ in Thousands, $ in Thousands
Jun. 30, 2024
USD ($)
Jun. 30, 2024
EUR (€)
Dec. 31, 2023
USD ($)
Dec. 31, 2023
EUR (€)
Short-Term Debt [Line Items]        
Short term debt $ 1,186   $ 650  
Short-Term Debt [Member]        
Short-Term Debt [Line Items]        
Interest rate 8.00% 8.00%    
Short term debt $ 268   258  
Short Term Debt One [Member]        
Short-Term Debt [Line Items]        
Interest rate 10.00% 10.00%    
Short term debt $ 814   61  
Short Term Debt Two [Member]        
Short-Term Debt [Line Items]        
Interest rate [1] 8.00% 8.00%    
Short term debt   331 [2]  
Short Term Debt Three [Member]        
Short-Term Debt [Line Items]        
Interest rate 6.00% 6.00%    
Short term debt $ 90    
Short Term Debt Four [Member]        
Short-Term Debt [Line Items]        
Interest rate [1] 8.00% 8.00%    
Short term debt | €   € 14 [2]  
[1] Weighted average interest.
[2] The terms of the loan were amended on January 1, 2024. Under the new terms, the loan became convertible into shares of Common Stock and the lender agreed to extend the maturity date to December 31, 2024. In consideration for such extension, the Company issued to the lender warrants to purchase 360,000 shares of the Company’s Common Stock at a price of $0.85 per share and granted lender the right to convert any part of the outstanding balance of the loan into Common Stock of the Company at the conversion rate of $0.85 per share. Based on its analysis, the Company concluded that this change in terms should be accounted for as a modification. This loan was converted as per the debt exchange agreement. See note 6.
v3.24.2.u1
SCHEDULE OF SHORT TERM LOANS - Parenthetical (Details) - $ / shares
1 Months Ended
Jan. 01, 2024
Jan. 31, 2024
May 22, 2024
Apr. 23, 2024
Apr. 18, 2024
Mar. 07, 2024
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Number of securities called by warrants or rights           500,000
Exercise price of warrants     $ 1.03 $ 1.03 $ 1.03 $ 1.03
Conversion price   $ 0.85        
Debt Exchange Agreements [Member]            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Debt instrument, maturity date Dec. 31, 2024 Dec. 31, 2026        
Number of securities called by warrants or rights 360,000 840,000        
Exercise price of warrants $ 0.85 $ 0.85        
v3.24.2.u1
LOANS (Details Narrative) - Loan Agreement [Member]
$ in Thousands
Jul. 03, 2024
USD ($)
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]  
Outstanding principal and accrued interest $ 2,000
Interest rate 10.00%
v3.24.2.u1
SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES (Details) - USD ($)
$ / shares in Units, $ in Thousands
6 Months Ended 12 Months Ended
Jun. 30, 2024
Dec. 31, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Fair value at grant   $ 326
Employees [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
No of options granted 400,000  
Stock options vesting period description Half quarterly over a period of two years and the rest quarterly over a period of four years  
Fair value at grant $ 161  
Expiration period 10 years  
Employees [Member] | Minimum [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Exercise price $ 0.50  
Employees [Member] | Maximum [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Exercise price $ 0.63  
v3.24.2.u1
SCHEDULE OF STOCK OPTIONS ACTIVITY (Details) - Employees [Member]
6 Months Ended
Jun. 30, 2024
$ / shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Dividend yield 0.00%
Minimum [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Value of one common share $ 0.49
Expected stock price volatility 79.00%
Risk free interest rate 3.86%
Expected term (years) 5 years 6 months 21 days
Maximum [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Value of one common share $ 0.63
Expected stock price volatility 85.00%
Risk free interest rate 4.28%
Expected term (years) 6 years 21 days
v3.24.2.u1
SCHEDULE OF RESTRICTED STOCK UNITS GRANTED (Details) - USD ($)
shares in Thousands, $ in Thousands
5 Months Ended 6 Months Ended
Jun. 01, 2024
Jun. 30, 2024
Share-Based Payment Arrangement [Abstract]    
Restricted stock units granted 50,000  
Restricted stock unit vesting period description   Immediate
Fair value at grant of restricted stock units   $ 26
v3.24.2.u1
SCHEDULE OF SHARES AND WARRANTS GRANTS TO ADVISORS (Details) - USD ($)
$ / shares in Units, $ in Thousands
5 Months Ended 6 Months Ended 12 Months Ended
May 22, 2024
Apr. 23, 2024
Apr. 18, 2024
Mar. 07, 2024
Jan. 25, 2024
Jun. 01, 2024
Jun. 30, 2024
Dec. 31, 2022
Reason for issue of share or warrant Strategic advisor agreement Strategic advisor agreement Strategic advisor agreement Strategic advisor agreement Consideration for a past debt      
Number of shares issued 475,000 500,000 500,000 500,000 164,000      
Number of securities called by warrants or rights       500,000        
Exercise price of warrants $ 1.03 $ 1.03 $ 1.03 $ 1.03        
Warrant vesting One third on May 21, 2024, one third on August 21, 2024, and one third on November 21, 2024. One third on April 16, 2024, one third on July 16, 2024, and one third on October 16, 2024. One third on April 18, 2024, one third on July 18, 2024, and one third on October 18, 2024. One third on March 7, 2024, one third on June 5, 2024, and one third on September 3, 2024.        
Warrant expiry date May 21, 2029 Apr. 22, 2029 Apr. 17, 2029 Mar. 06, 2029        
Number of options granted           50,000,000    
Fair value at grant               $ 326
Number of shares granted             664,000  
Warrant [Member]                
Number of options granted             1,975,000  
Vesting peirod description             six months  
Fair value at grant             $ 568  
v3.24.2.u1
SCHEDULE OF WARRANTS GRANTS ASSUMPTIONS (Details) - Warrant [Member]
6 Months Ended
Jun. 30, 2024
$ / shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Dividend yield 0.00%
Options Granted To Non Employees [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Expected term (years) 5 years
Minimum [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Value of one common share $ 0.51
Expected stock price volatility 87.00%
Risk free interest rate 4.07%
Maximum [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Value of one common share $ 0.84
Expected stock price volatility 90.00%
Risk free interest rate 4.68%
v3.24.2.u1
SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Earnings Per Share [Abstract]        
Net loss attributable to Orgenesis Inc. $ 8,904 $ 25,543 $ 18,669 $ 45,013
Adjustment of redeemable non-controlling interest to redemption amount (3,671)
Net loss attributable to Orgenesis Inc. for loss per share $ 8,904 $ 21,872 $ 18,669 $ 45,013
Weighted average number of common shares outstanding - basic 38,860,727 28,603,597 35,979,567 27,546,229
Weighted average number of common shares outstanding - diluted 38,860,727 28,603,597 35,979,567 27,546,229
Net loss per share - basic $ 0.23 $ 0.76 $ 0.52 $ 1.63
Net loss per share - diluted $ 0.23 $ 0.76 $ 0.52 $ 1.63
v3.24.2.u1
LOSS PER SHARE (Details Narrative) - shares
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Options and Warrants [Member]        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Antidilutive securities excluded from computation of earnings per share amount 16,917,024 7,916,597 14,247,610 7,673,798
Shares upon Conversion of Convertible Loans [Member]        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Antidilutive securities excluded from computation of earnings per share amount 2,313,348 5,184,127 2,313,348 7,101,236
v3.24.2.u1
SCHEDULE OF DISAGGREGATION OF REVENUE (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Disaggregation of Revenue [Line Items]        
Total $ 246 $ 113 $ 387 $ 255
Cell Process Development Services And Hospital Services [Member]        
Disaggregation of Revenue [Line Items]        
Total $ 246 $ 113 $ 387 $ 255
v3.24.2.u1
SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Disaggregation of Revenue [Line Items]        
Customer D (United States) $ 246 $ 113 $ 387 $ 255
Customer A [Member] | UNITED STATES        
Disaggregation of Revenue [Line Items]        
Customer D (United States) 225 65 300 130
Customer B [Member] | UNITED STATES        
Disaggregation of Revenue [Line Items]        
Customer D (United States) 60
Customer C [Member] | UNITED STATES        
Disaggregation of Revenue [Line Items]        
Customer D (United States) 45 45
Customer D [Member] | UNITED STATES        
Disaggregation of Revenue [Line Items]        
Customer D (United States) $ 65
v3.24.2.u1
SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES (Details) - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Revenue from Contract with Customer [Abstract]    
Balance as of beginning of period $ 88 $ 36,183
Reconsolidation (deconsolidation) of Octomera 82 (5,985)
Additions 380 293
Collections (822) (6,045)
Allowances for credit losses 512 (24,388)
Exchange rate differences (52)
Balance as of end of period $ 240 $ 6
v3.24.2.u1
SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES (Details) - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Balance as of beginning of period $ 200 $ 70
Additions 110 36
Realizations (10)
Balance as of end of period 350
Octomera [Member]    
Deconsolidation 110 (106)
OBI [Member]    
Deconsolidation $ (60)
v3.24.2.u1
OTHER SIGNIFICANT TRANSACTIONS AND AGREEMENTS DURING THE SIX MONTHS ENDED JUNE 30, 2024 (Details Narrative) - USD ($)
Apr. 05, 2024
Jun. 30, 2024
Other Significant Transactions And Agreements During Six Months Ended June 30 2024    
Aggregate purchase price payable by Germfree $ 8,340  
Advance payments from Germfree   $ 6,720
v3.24.2.u1
LEGAL PROCEEDINGS (Details Narrative)
3 Months Ended 6 Months Ended
Jun. 30, 2024
USD ($)
Nov. 01, 2023
ILS (₪)
Oct. 26, 2023
USD ($)
Jan. 18, 2022
ILS (₪)
Sep. 30, 2024
USD ($)
Jun. 30, 2024
USD ($)
May 22, 2024
$ / shares
Apr. 23, 2024
$ / shares
Apr. 18, 2024
$ / shares
Mar. 07, 2024
$ / shares
Nov. 01, 2023
USD ($)
$ / shares
shares
Nov. 01, 2023
ILS (₪)
shares
Sep. 06, 2023
USD ($)
Jun. 30, 2018
USD ($)
Apr. 30, 2018
shares
Prceedings actions taken by plaintiff description           In the Complaint, the plaintiffs are seeking that the Court issue a declaratory remedy whereby the defendants are required to pay royalties to the plaintiffs at the rate of 7% of the sales and 24% of any and all revenues in consideration for sublicenses related to any product, service or process that contain know-how and technology of Sheba and any and all know-how and technology either developed or supervised by Prof. Ferber in the field of cell therapy, including in the category of the point-of-care platform and any and all services and products in relation to the defendants’ CDMO activity                  
Loss contingency, damages paid, value | ₪       ₪ 10,000,000                      
Royalty guarantee commitments amount                         $ 896,000    
Plaintiffs request damages amount | ₪   ₪ 40,140                          
Warrants exercise price | $ / shares             $ 1.03 $ 1.03 $ 1.03 $ 1.03          
Issuance of shares | shares                     11,869,600 11,869,600      
Common Stock [Member]                              
Principal amount outstanding                           $ 383,000  
Issuance of shares | shares                             107,985
Unsecured Convertible Note Agreements [Member]                              
Unsecured convertible debt                     $ 280,000 ₪ 1,000,000      
Monthly interest rate                     2.00% 2.00%      
Gain loss related to litigation settlement $ 37                            
Proceeds from Legal Settlements 140,000                            
Additional amount to be paid for failure litigation settlement amount awarded from other party 286,000         $ 286,000                  
Unsecured Convertible Note Agreements [Member] | Subsequent Event [Member]                              
Litigation Settlement, Amount Awarded from Other Party         $ 427,000                    
Gain loss related to litigation settlement         114                    
Additional amount to be paid for failure litigation settlement amount awarded from other party         $ 211,000                    
Consultation Agreement [Member]                              
Warrants awarded | shares                     800,000 800,000      
Warrants exercise price | $ / shares                     $ 0.52        
Unsecured Convertible Note One Agreements [Member]                              
Gain loss related to litigation settlement 76                            
Unsecured Convertible Note Two Agreements [Member]                              
Gain loss related to litigation settlement $ 12                            
Mr Amir Hasidim [Member]                              
Unsecured convertible debt     $ 5,000                        
Southern Israel Bridging Fund Two LP [Member] | Mr Amir Hasidim [Member]                              
Plaintiffs request damages amount     $ 1,150                        
Litigation settlement interest percentage     6.00%                        
v3.24.2.u1
SUBSEQUENT EVENTS (Details Narrative) - USD ($)
Jul. 12, 2024
Jul. 10, 2024
Theracell [Member] | Subsequent Event [Member]    
Subsequent Event [Line Items]    
Description of ownership percentage 50% of the outstanding ownership rights and equity interests in Theracell Laboratories IKE (“Theracell IKE”) not currently owned by the Company so that the Company shall own 100% of the outstanding equity interests of Theracell IKE  
Subsequent Event [Member] | Broaden [Member]    
Subsequent Event [Line Items]    
Intangiable asset purchase price valued by third party   $ 11,000
Intangiable asset purchase price valued by third party   $ 10,767
Share price   $ 3.00
Common stock issue price   10.00%
Subsequent Event [Member] | Theracell [Member]    
Subsequent Event [Line Items]    
Intangiable asset purchase price valued by third party   $ 10,324
Intangiable asset purchase price valued by third party $ 13,000  
Payment description as per agreement The aggregate Consideration will be paid by the Company as follows: (i) $400 will be paid to Theracell within 60 days after signing of the Purchase Agreement, (ii) $250 will be paid to Theracell within one year after signing of the Purchase Agreement, and (iii) the remaining amount (less any Debt) will be paid to Theracell in four equal annual payments beginning on December 30, 2025 and ending on December 30, 2028  

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