UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

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

For the Quarterly Period EndedAugustMay 31, 20172018

or

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

For the Transition Period from _________to _________ to _________

Commission file number:000-54329

ORGENESIS INC.
(Exact name of registrant as specified in its charter)

Nevada98-0583166
(State or other jurisdiction of incorporation or(I.R.S. Employer Identification No.)
organization) 

20271 Goldenrod Lane
Germantown, MD 20876
(Address of principal executive offices) (zip code)

(480) 659-6404
(Registrant’s telephone number, including area code)

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 [X]   No [  ]

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 [X]   No [  ]

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” and “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                                       [X][X]
(Do not check if a smaller reporting company)Emerging Growth Company[   ]

1


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 [X].

As of OctoberJuly 16, 2017,2018, there were 121,779,25214,569,359 shares of registrant’s common stock outstanding.

12


ORGENESIS INC.
FORM 10-Q
FOR THE THREE AND NINESIX MONTHS ENDED AUGUSTMAY 31, 2018 AND 2017AND 2016

TABLE OF CONTENTS

 Page
PART I.I - FINANCIAL INFORMATIONUNAUDITED FINANCIAL INFORMATION4
 3
ITEM 1Financial Statements (unaudited)34
Condensed Consolidated Balance Sheets as of AugustMay 31, 20172018 and November 30, 2016201734
Condensed Consolidated Statements of OperationsComprehensive Loss for the Three and NineSix Months Ended AugustMay 31, 20172018 and 20165
Condensed Consolidated Statements of Changes in Equity for the Nine Months Ended August 31, 2017 and 20166
Condensed Consolidated Statements of Cash Flows for the NineSix Months Ended AugustMay 31, 20172018 and 2016201778
 Notes to Condensed Consolidated Financial Statements89
ITEM 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations1926
ITEM 3.Quantitative and Qualitative Disclosures about Market Risk2637
ITEM 4.Controls and Procedures26 37
PART II.II - OTHER INFORMATIONOTHER INFORMATION38
28 
ITEM 1.Legal Proceedings28 38
ITEM 1A.Risk Factors28 38
ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds28 38
ITEM 3.Defaults Upon Senior Securities28 38
ITEM 4.Mine Safety Disclosures28 39
ITEM 5.Other Information29 39
ITEM 6.Exhibits29 39
SIGNATURES  
30SIGNATURES40

23


PART I – UNAUDITED FINANCIAL INFORMATION

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

ORGENESIS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. Dollars in Thousands)
(Unaudited)

  August 31,  November 30, 
  2017  2016 
Assets      
CURRENT ASSETS:      
     Cash and cash equivalents$ 762 $ 891 
     Accounts receivable, net 2,106  1,229 
     Prepaid expenses and other receivables 1,668  779 
     Grants receivable 173  906 
     Inventory 965  400 
Total current assets 5,674  4,205 
       
NON CURRENT ASSETS:      
   Property and equipment, net 5,025  4,573 
   Restricted cash 6  5 
     Intangible assets, net 15,480  15,050 
     Goodwill 10,683  9,584 
     Investments in associate, net 475  - 
     Other assets 79  70 
Total non-current assets 31,748  29,282 
TOTAL ASSETS$ 37,422 $ 33,487 

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

3


ORGENESIS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. Dollars in Thousands)
(Unaudited)

  August 31,  November 30, 
  2017  2016 
       
                                       Liabilities and equity      
CURRENT LIABILITIES:      
       Short-term bank credit$ - $ 21 
       Accounts payable 3,689  4,554 
       Accrued expenses and other payables 1,408  1,205 
       Employees and related payables 2,343  1,680 
       Related parties 44  42 
       Advance payments on account of grant 1,978  243 
       Short-term loans and current maturities of long term loans 376  1,111 
       Deferred income 4,944  1,273 
       Current maturities of convertible loans 2,789  2,541 
       Convertible bonds -  1,818 
       Price protection derivative -  76 
       Investments in associate, net -  12 
TOTAL CURRENT LIABILITIES 17,571  14,576 
       
LONG-TERM LIABILITIES:      
       Loans payable 3,397  3,291 
       Convertible loans 1,444  1,059 
       Warrants 873  1,843 
       Retirement benefits obligation 5  5 
       Put option derivative 273  273 
       Deferred taxes 2,608  1,862 
TOTAL LONG-TERM LIABILITIES 8,600  8,333 
TOTAL LIABILITIES 26,171  22,909 
COMMITMENTS      
EQUITY:      
       Common stock 12  12 
       Additional paid-in capital 50,518  41,605 
       Receipts on account of shares to be allotted 852  - 
       Accumulated other comprehensive loss 1,214  (1,205)
       Accumulated deficit (41,345) (29,834)
TOTAL EQUITY 11,251  10,578 
TOTAL LIABILITIES AND EQUITY$ 37,422 $ 33,487 
  May 31,  November 30, 
  2018  2017 
       
Assets      
CURRENT ASSETS:      
     Cash and cash equivalents$ 4,502 $ 3,519 
     Restricted Cash 383  - 
     Accounts receivable, net 1,298  1,336 
     Prepaid expenses and other receivables 3,408  841 
     Receivables from related party 1,377  691 
     Call option derivative 792  - 
     Grants receivable 749  183 
     Inventory 1,229  725 
Total current assets 13,738  7,295 
       
NON-CURRENT ASSETS:      
     Call option derivative -  339 
     Investments in associates, net 1,136  1,321 
     Property and equipment, net 7,517  5,104 
     Intangible assets, net 14,011  15,051 
     Goodwill 10,549  10,684 
     Other assets 82  78 
Total non-current assets 33,295  32,577 
TOTAL ASSETS$ 47,033 $ 39,872 

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

4


ORGENESIS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Cont’d)
(U.S. Dollars in Thousands)
(Unaudited)

  May 31,  November 30, 
  2018  2017 
       
Liabilities and equity      
CURRENT LIABILITIES:      
       Accounts payable$ 2,388 $ 3,914 
       Accrued expenses and other payables 1,104  1,435 
       Employees and related payables 2,303  2,961 
       Related parties 126  116 
       Advance payments on account of grant 1,415  1,719 
       Short-term loans and current maturities of long term loans 376  378 
       Other 107  - 
       Deferred income 4,596  3,611 
       Current maturities of convertible loans 557  2,780 
TOTAL CURRENT LIABILITIES 12,972  16,914 
       
LONG-TERM LIABILITIES:      
       Loans payable$ 1,902 $ 2,118 
       Convertible loans -  2,415 
       Retirement benefits obligation 5  6 
       Deferred taxes 32  690 
       Other 199  - 
TOTAL LONG-TERM LIABILITIES 2,138  5,229 
TOTAL LIABILITIES 15,110  22,143 
COMMITMENTS      
REDEEMABLE NON-CONTROLLING INTEREST 6,122  3,606 
EQUITY:      
       
Common stock of $0.0001 par value, 145,833,334 shares authorized, 
               13,300,676 shares issued and outstanding as of May 31, 2018
 1  1 
       Additional paid-in capital 76,831  55,334 
       Receipts on account of shares to be allotted 238  1,483 
       Accumulated other comprehensive income 1,076  1,425 
       Accumulated deficit (52,345) (44,120)
TOTAL EQUITY 25,801  14,123 
TOTAL LIABILITIES AND EQUITY$ 47,033 $ 39,872 

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

5


ORGENESIS INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(U.S. Dollars in thousands, except share and loss per share amounts)
(Unaudited)

 Three Months Ended  Nine Months Ended  Three Months Ended  Six Months Ended 
 August 31,  August 31,  August 31,  August 31,  May 31,  May 31,  May 31,  May 31, 
 2017  2016  2017  2016  2018  2017  2018  2017 
REVENUES$ 2,562 $ 1,849 $ 6,712 $ 4,501 $ 3,987 $ 2,298 $ 6,623 $ 4,150 
COST OF REVENUES 1,867  1,829  4,900  5,273  2,195  1,128  3,839  3,033 
GROSS PROFIT (LOSS) 695  20  1,812  (772)
GROSS PROFIT 1,792  1,170  2,784  1,117 
                        
RESEARCH AND DEVELOPMENT EXPENSES,net 500  775  1,906  1,663  788  665  1,554  1,406 
AMORTIZATION OF INTANGIBLE ASSETS 423  408  1,201  1,217  445  397  881  777 
SELLING, GENERAL AND ADMINISTRATIVEEXPENSES 3,184  1,279  7,887  4,618  3,323  2,432  6,667  4,703 
            
OTHER INCOME -  -  316  - 
OPERATING LOSS 3,412  2,442  9,182  8,270  2,764  2,324  6,002  5,770 
FINANCIAL EXPENSES (INCOME),net (2,032) 574  1,488  (645)
SHARE IN LOSSES OF ASSOCIATED COMPANY 152  -  348  - 
FINANCIAL (INCOME) EXPENSES,net (587) 503  2,094  2,578 
SHARE IN NET LOSSES OF ASSOCIATED COMPANY 576  107  530  196 
            
LOSS BEFORE INCOME TAXES 1,532  3,016  11,018  7,625  2,753  2,934  8,626  8,544 
TAX EXPENSES (BENEFIT) 421  (372) 493  (1,313)
TAX (INCOME) EXPENSES (277) (444) (673) 71 
NET LOSS$1,953 $ 2,644 $11,511 $ 6,312 $ 2,476 $ 2,490 $ 7,953 $ 8,616 
NET INCOME ATTRIBUTABLE TOREDEEMABLE NON-CONTROLLING INTERESTS 138  -  272  - 
                        
EARNINGS (LOSS) PER SHARE:            
NET LOSS ATTRIBUTABLE TO THE COMPANY$ 2,614 $ 2,489 $ 8,225 $ 8,616 
            
LOSS PER SHARE:            
Basic$ (0.02)$ (0.02)$ (0.10)$ (0.06)$0.20 $ 0.26 $0.69 $ 0.93 
Diluted$ (0.02)$ (0.02)$ (0.10)$ (0.06)$0.20 $ 0.26 $0.69 $ 0.93 
WEIGHTED AVERAGE NUMBER OF SHARESUSED IN COMPUTATION OF BASIC ANDDILUTED EARNINGS (LOSS) PER SHARE:        
WEIGHTED AVERAGE NUMBER OF SHARES USED
IN COMPUTATION OF BASIC AND DILUTED
(LOSS) PER SHARE:
        
Basic 123,349,597  111,188,616  113,433,712  108,784,862  13,140,119  9,568,413    11,971,389  9,221,039 
Diluted 124,625,412  111,188,616  113,746,212  108,784,862  13,140,119  9,568,413    11,971,389  9,221,039 
            
OTHER COMPREHENSIVE LOSS:                        
Net Loss$1,953 $ 2,644 $11,511 $ 6,312 $ 2,614 $ 2,489 $ 8,225 $ 8,616 
Translation adjustments (1,430) 36  (2,419) (1,047) 1,056  (1,084) 349  (988)
TOTAL COMPREHENSIVE LOSS$523 $ 2,680 $9,092 $ 5,265 $ 3,670 $ 1,405 $ 8,574 $ 7,628 

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

56


ORGENESIS INC.
CONDENSEDCONSOLIDATEDSTATEMENTS OFCHANGES INEQUITY
(U.S.Dollars inthousands, except shareamounts)
(Unaudited)

  Common Stock                
           Receipts on  Accumulated       
        Additional  Account of  Other       
     Par  Paid-in  Share to be  Comprehensive  Accumulated    
  Number  Value  Capital  Allotted  Loss  Deficit  Total 
                      
Balance at December 1, 2015 55,835,950 $ 6 $ 14,229 $ 1,251 $ (1,286)$ (20,640)$ (6,440)
Changes during the nine months ended August 31, 2016:                     
                      
     Stock-based compensation to employees and directors       990           990 
     Stock-based compensation to service providers       1,148           1,148 
     Warrants and shares to be issued due to
           extinguishment of a convertible loan
     114        114 
     Beneficial conversion feature of convertible loans       245           245 
     Issuances of shares from investments and
          conversion of convertible loans
 12,844,455  1  1,948  (1,251)     698 
Reclassification of redeemable common stock* 42,401,724  4  21,454           21,458 
Receipts on account of shares to be allotted          887        887 
     Comprehensive income (loss) for the period             1,047  (6,312) (5,265)
                      
Balance at August 31, 2016 111,082,129 $ 11 $ 40,128 $ 887 $ (239)$ (26,952)$ 13,835 
                      
Balance at December 1, 2016 114,096,461 $ 12 $ 41,605 $ -,- $ (1,205)$ (29,834)$ 10,578 
Changes during the nine months ended August 31, 2017:                     
                      
     Stock-based compensation to employees and directors       1,156           1,156 
     Stock-based compensation to service providers 950,000  -  1,824           1,824 
     Issuance of warrants and beneficial conversion
         feature of convertible loans
     2,550        2,550 
     Issuance of shares and receipts on account of
         shares and warrants to be allotted and
         cancelation of contingent shares
 2,936,918  -  3,383  852      4,235 
     Comprehensive income (loss) for the period             2,419  (11,511) (9,092)
     Balance at August 31, 2017 117,983,379 $ 12 $ 50,518 $ 852 $ 1,214 $ (41,345)$ 11,251 
  Common Stock                
           Receipts on  Accumulated       
        Additional  Account of  Other       
     Par  Paid-in  Share to be  Comprehensive  Accumulated    
  Number of Shares  Value  Capital  Allotted  Loss  Deficit  Total 
Balance at December 1, 2016 9,508,068 $ 1 $ 45,454 $ - $ (1,205)$ (31,753)$ 12,497 
Changes during the six months ended May 31, 2017:                     
     Stock-based compensation to employees and directors       771           771 
     Stock-based compensation to service providers 79,167     2,066           2,066 
     Issuances of shares from investments and conversion of
          convertible loans
 328,388     2,214  595        2,809 
       Comprehensive loss for the period             988  (8,616) (7,628)
       Beneficial conversion feature of convertible loans and
           Warrants issued
       2,241           2,241 
Balance at May 31, 2017 9,915,623 $ 1 $ 52,746 $ 595 $ (217)$ (40,369)$ 12,756 
                      
Balance at December 1, 2017 9,872,659  1  55,334  1,483  1,425  (44,120) 14,123 
Changes during the six months ended May 31, 2018:                     
     Stock-based compensation to employees and directors       801           801 
     Stock-based compensation to service providers       1,026           1,026 
     Issuance of shares and warrant due to conversion of
         convertible loans
 1,341,134  *  7,330           7,330 
     Issuance of shares and receipts on account of shares and
          warrants to be allotted
 1,958,806  *  11,218  (1,245)     9,973 
     Beneficial conversion feature of convertible loans and
          Warrants issued
       323           323 
     Issuance of Shares due to exercise of warrants 128,077  *  799           799 
     Comprehensive loss for the period             (349) (8,225) (8,574)
     Balance at May 31, 2018 13,300,676 $ 1 $ 76,831 $ 238 $ 1,076 $ (52,345)$ 25,801 

*Including outstanding contingent shares.represent an amount lower than $ 1 thousand

Theaccompanying notes are anintegral part of these condensedconsolidatedfinancialstatements.

6


ORGENESIS INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. Dollars in thousands)
(Unaudited)

  Nine months ended 
  August 31,  August 31, 
  2017  2016 
CASH FLOWS FROM OPERATING ACTIVITIES:      
     Net loss$ (11,511)$ (6,312)
     Adjustments required to reconcile net loss to net cash used in operating activities:      
       Stock-based compensation 2,817  2,085 
       Loss from extinguishment of a convertible loan -  229 
       Share in losses of associated company 348  - 
       Depreciation and amortization expenses 1,874  1,987 
       Change in fair value of warrants and embedded derivatives (1,276) (1,172)
       Change in fair value of convertible bonds (157) (115)
       Interest expenses accrued on loans and convertible loans (including amortization of
            beneficial conversion feature)
 818  494 
     Changes in operating assets and liabilities:      
         Increase in accounts receivable (682) (603)
         Increase in inventory (484) (73)
         Increase in other assets (1) (17)
         Increase in prepaid expenses and other accounts receivable (818) (220)
         Increase (decrease) in accounts payable (1,230) 637 
         Increase in accrued expenses and other payables 192  242 
         Increase in employee and related payables 554  523 
         Increase in deferred income 3,268  402 
         Increase in advance payments and receivables on account of grant, net 2,358  50 
         Increase (decrease) in deferred taxes 494  (1,314)
       Net cash used in operating activities (3,436) (3,177)
CASH FLOWS FROM INVESTING ACTIVITIES:      
   Purchase of property and equipment (639) (1,049)
   Disposals of property and equipment 31  - 
   Investments in associate (835) - 
       Net cash used in investing activities (1,443) (1,049)
CASH FLOWS FROM FINANCING ACTIVITIES:      
     Short-term line of credit (21) 17 
     Proceeds from issuance of shares and warrants (net of transaction costs) 4,307  1,488 
     Proceeds from issuance of convertible loans (net of transaction costs) 4,932  1,258 
     Repayment of convertible loans and convertible bonds (3,766) - 
     Repayment of short and long-term debt (1,102) (2,446)
             Net cash provided by financing activities 4,350  317 
NET CHANGE IN CASH AND CASH EQUIVALENTS (529) (3,909)
EFFECT OF EXCHANGE RATE CHANGES ON CASH ANDCASH EQUIVALENTS 400  11 
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 891  4,168 
CASH AND CASH EQUIVALENTS AT END OF PERIOD$ 762 $ 270 
       
SUPPLEMENTAL NON-CASH FINANCING ACTIVITIES      
Conversion of loans and bonds (including accrued interest) to common stock and warrants$ 106 $ 1,028 
Reclassification of redeemable common stock to equity   $ 21,458 

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

7


ORGENESIS INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. Dollars in thousands)
(Unaudited)

  Six Months Ended 
  May 31,  May 31, 
  2018  2017 
CASH FLOWS FROM OPERATING ACTIVITIES:      
     Net loss$ (7,953)$ (8,616)
     Adjustments required to reconcile net loss to net cash used in operating activities:    
         Stock-based compensation 1,827  2,707 
         Share in losses of associated company 530  196 
         Depreciation and amortization expenses 1,282  1,207 
         Change in fair value of embedded derivatives (490) 131 
         Change in fair value of convertible bonds -  (110)
         Interest expenses accrued on loans and convertible loans (including 
         amortization of beneficial conversion feature)
 2,522  589 
     Changes in operating assets and liabilities:      
         Increase in accounts receivable (19) (1,606)
         Increase in inventory (533) (466)
         Increase in related parties, net (680) - 
         Increase in Other assets (9) (1)
         Increase in prepaid expenses and other accounts receivable (411) (645)
         Decrease in accounts payable (1,509) (1,268)
         Increase (decrease) in accrued expenses and other payables (327) 168 
         Increase  (decrease) in employee and related payables (654) 493 
         Increase in deferred income 1,070  2,814 
         Increase (decrease) in advance payments and receivables on account of grant, net (878) 2,557 
         Increase (decrease) in deferred taxes (673) 72 
           Net cash used in operating activities (6,905) (1,778)
CASH FLOWS FROM INVESTING ACTIVITIES:      
     Purchase of property and equipment (2,634) (465)
     Disposals of property and equipment -  22 
     Investments in associate (345) (459)
           Net cash used in investing activities (2,979) (902)
CASH FLOWS FROM FINANCING ACTIVITIES:      
     Short-term line of credit -  (21)
     Proceeds from issuance of shares and warrants (net of transaction costs) 10,773  2,810 
     Proceeds from issuance of convertible loans (net of transaction costs) 720  3,912 
     Repayment of convertible loans and convertible bonds (177) (3,641)
     Repayment of short and long-term debt (213) (706)
           Net cash provided by financing activities 11,103  2,354 
NET CHANGE IN CASH AND CASH EQUIVALENTS 1,219  (326)
EFFECT OF EXCHANGE RATE CHANGES ON CASH ANDCASH EQUIVALENTS 147  91 
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 3,518  891 
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT ENDOF PERIOD$4,884 $656 
       
SUPPLEMENTAL NON-CASH FINANCING ACTIVITIES      
Conversion of loans and bonds (including accrued interest) to common stock and warrants$7,330   
       
Redeemable non-controlling interest$2,258    
       
Leasing of Fixed assets$337    

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

8


ORGENESIS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For the Three and NineSix Months Ended AugustMay 31, 20172018 and August 31, 20162017

NOTE 1 - GENERAL AND BASIS OF PRESENTATION

a.

General

Orgenesis Inc., a Nevada corporation, is a biopharmaceuticalservice and research company in the field of regenerative medicine industry with expertise and experience ina focus on cell therapy development and manufacturing specializing in cell therapy development for advanced medicinal products serving the regenerative medicine industry.

products. In addition, the Company is focused on developing a novel and proprietary cell therapy trans-differentiation technologies for the treatment of diabetes. The consolidated financial statements include the accounts of Orgenesis Inc., its subsidiaries MaSTherCell S.A (“MaSTherCell S.A.”), its Belgian-based subsidiary and a contract development and manufacturing organization, or CDMO, specialized in cell therapy technologydevelopment and manufacturing for advanced medicinal products; Orgenesis SPRL (the “Belgian Subsidiary”), a Belgian-based subsidiary which is engaged in development and manufacturing activities, together with clinical development studies in Europe, Orgenesis Maryland Inc. (the “U.S. Subsidiary”), a Maryland corporation, and Orgenesis Ltd., an Israeli corporation, (the “Israeli Subsidiary”).

The Company’s goal is to industrialize cell therapy for fast, safe and cost-effective production in order to provide rapid therapies for any market around the world through a world-wide network of CDMOs joint venture partners. The Company’s trans-differentiation technologies for treating diabetes, which will be referred to as the cellular therapy (“CT”) business, is based on the research work of Prof. Sarah Ferber, the Company's Chief Science Officer and a researcher attechnology licensed by Tel Hashomer Medical Research (“THM”), a leading medical hospital and research center in Israel, who established a proof of concept to the Israeli Subsidiary that demonstrates the capacity to induce a shift in the developmental fate of cells from the liver and transdifferentiatingtrans-differentiating (converting) them into “pancreatic beta cell-like” insulin-producing cells.

            The combination of proprietary cell therapy trans-differentiation technologies forOn March 14, 2016, the treatment of diabetesCompany and CureCell Co., Ltd. (“CureCell”) entered into a revenue-generatingJoint Venture Agreement (the “CureCell JVA”) pursuant to which the parties are collaborating in the contract development and manufacturing service business providesof cell therapy products in Korea. As to the Company exercise of the "call option" to which it was entitled under the CureCell JVA agreement see note 10(12).

On May 10, 2016, the Company and Atvio Biotech Ltd., (“Atvio”) entered into a Joint Venture Agreement (the “Atvio JVA”) pursuant to which the parties agreed to collaborate in the contract development and manufacturing of cell and virus therapy products in the field of regenerative medicine in Israel. As to the Company exercise of the "call option" to which it was entitled under the Atvio JVA agreement see note 10(12).

On June 28, 2018, the Company and a newly formed Delaware subsidiary of the Company which is engaged in the contract manufacturing for cell therapy companies (CDMO) ("Masthercell Global") entered into a series of definitive strategic agreements intended to finance, strengthen and expand Orgenesis' CDMO business, which included entry into a Stock Purchase Agreement (the "SPA") with unique capabilities.an affiliate of Great Point Partners, LLC, a manager of private equity funds focused on growing small to medium sized heath care companies ("Great Point"), pursuant to which such Great Point affiliate purchased 378,000 shares of newly designated Series A Preferred Stock of Masthercell Global (the "Masthercell Global Preferred Stock"), representing 37.8% of the issued and outstanding share capital of Masthercell Global, for cash consideration to be paid into Masthercell Global of up to $25 million, subject to certain adjustments. See Note 10(12).

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

On November 16, 2017, the Company implemented a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-12 shares. The reverse stock split has been reflected in these condensed consolidated financial statements.

On March 13, 2018, the Company's common stock began to be quoted and traded on the Nasdaq Capital Market under the symbol “ORGS.”

9



a.

Liquidity

As of May 31, 2018, the Company accumulated losses of approximately $52.3 million. Although the Company is showing positive revenue and gross profit trends in its CDMO division, the Company expects to incur further losses in the CT division.

To date, the Company has been funding operations primarily from the proceeds from private placements of the Company’s convertible debt and equity securities and from revenues generated by MaSTherCell S.A. From December 1, 2017 through May 31, 2018, the Company received, through MaSTherCell S.A., proceeds of approximately $5.7 million in revenues and accounts receivable from customers, and $11.7 million from the private placement to accredited investors of the Company's equity and equity linked securities and convertible loans, out of which $2.5 million are from the institutional investor with whom the Company entered into definitive agreements in January 2017 for the private placement of units of the Company's securities for aggregate subscription proceeds of $16 million. The subscription proceeds are payable on a periodic basis through August 2018. In addition, from June 1, 2018 through July 16, 2018, the Company raised $7.8 million from the private placement to assignees of the investor referred to above of unsubscribed units under such investor’s subscription agreement, the exercise of warrants by an investor, and received, through Masthercell Global, $10.3 million as part of Great Point investment and proceeds of approximately $2.1 million in accounts receivable from customers of MaSTherCell S.A. See also note 10, Subsequent Events.

Basis of Presentation

These unaudited condensed consolidated financial statements of the Company have been prepared in accordance with U.S. GAAP, pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”) for interim financial statements. Accordingly, they do not contain all information and notes required by U.S. GAAP for annual financial statements. In the opinion of management, the unaudited condensed consolidated interim financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of AugustMay 31, 2017,2018, and the consolidated statements of comprehensive loss for the three and ninesix months ended AugustMay 31, 20172018 and 2016,2017, and the changes in equity and cash flows for the nine monthssix-month period ended AugustMay 31, 20172018 and 2016.2017. The interim results are not necessarily indicative of the results to be expected for the year ending November 30, 2017.2018. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended November 30, 2016.2017.

Going Concern

            The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As of August 31, 2017, the Company, had accumulated losses of approximately $41 million and expects to incur further losses in the development of its business. Presently, the Company does not have sufficient cash to meet its requirements in the following twelve months. These factors raise substantial doubt about the Company's ability to continue as a going concern. The Company’s continuation as a going concern is dependent on its ability to obtain additional financing as may be required and ultimately to attain profitability. In the event that the remaining subscription proceeds from a private placement with an institutional investor referred to below, in the aggregate amount of $12 million (out of total committed amount $16 million) will not be paid periodically through August 2018, then the Company will need to raise significant funds in order to continue to meet its liquidity needs, realize its business plan and maintain operations. The Company’s current cash balance is not sufficient to support its operations as presently conducted or permit it to take advantage of business opportunities that may arise. Management of the Company is continuing its efforts to generate sustainable profits from its CDMO business and to secure funds through equity and/or debt instruments for its operations and business opportunities investments.

8


            The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. There can be no assurance that management will be successful in implementing its business plan or that the successful implementation of its business plan will actually improve the Company’s operating results. If the Company is unable to raise the necessary capital, the Company may have to cease curtail or reduce operations.

            The Company has been funding its operations primarily from the proceeds from private placements of the Company’s convertible debt and equity securities and from revenues generated by MaSTherCell. From December 2016 through August 2017, the Company received, through MaSTherCell, proceeds of approximately $6.1 million in revenues and accounts receivable from customers and $9 million from the private placement to accredited investors of its equity and equity linked securities and convertible loans, out of which $3.5 are million from the institutional investor definitive agreements in January 2017 for the private placement of units of the Company’s securities for aggregate subscription proceeds to the Company of $16 million. The subscription proceeds are payable on a periodic basis through August 2018. In addition, from September 1, 2017 through October 16, 2017, the Company raised an additional $1.1 million from the proceeds of the private placement to certain accredited investors of its equity and equity linked securities and Company received, through MaSTherCell, proceeds of approximately $1 million in accounts receivable from its customers.

NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The accounting policies adopted are consistent with those of the previous financial year.year, except as noted below regarding the adoption of new accounting pronouncements.

Recently Issued Accounting Pronouncements- adopted by the Company

1)     In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (a Consensus of the FASB Emerging Issues Task Force) (“ASU 2016-18”), which requires entities to include amounts generally described as restricted cash and restricted cash equivalents in cash and cash equivalents when reconciling beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for annual reporting periods (including interim periods within those annual reporting periods) beginning after December 15, 2017. The Company adopted this standard in the three months ended May 31, 2018. The Company did not have restricted cash in the previously presented period. Therefore, there is no impact for the new adoption on previously reported periods.

2)     In July 2017, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2017-11, "Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480; Derivatives and Hedging (Topic 815)", ("ASU 2017-11"). This update was issued to address complexities in accounting for certain equity-linked financial instruments containing down round features. The amendment changes the classification analysis of these financial instruments (or embedded features) so that equity classification is no longer precluded. The amendments in ASU 2017-11 are effective for annual reporting periods beginning after December 15, 2018, including interim reporting periods within those annual reporting periods. Early adoption is permitted. The Company elected to early adopt the standard effective September 1, 2017, retrospectively. Following is the results of the adoption on the Company’s condensed consolidated financial statements previously reported:

10


Shareholders’ Equity

  May 31, 2017 
     Impact    
  As reported  of    
  Previously  adoption  As revised 
     In thousands    
          
Additional paid-in capital$ 48,898 $ 3,838 $ 52,736 
Accumulated deficit$ (39,392)$ (977)$ (40,369)
Total equity$ 9,898 $ 2,861 $ 12,759 

StatementofComprehensive Loss

  Six months ended May 31, 2017  Three months ended May 31, 2017 
  As        As       
  reported  Impact of  As  reported  Impact of  As 
  Previously  adoption  revised  Previously  adoption  revised 
  In thousands 
                   
Financial expenses, net$ 3,520 $ (942)$ 2,578 $ (1,428)$ 1,931 $ 503 
Loss before income taxes$ 9,486 $ (942)$ 8,544 $ 1,003 $ 1,931 $ 2,934 
Net loss$ 9,558 $ (942)$ 8,616 $ 559 $ 1,931 $ 2,490 

NOTE 3 - SEGMENT INFORMATION

The Chief Executive Officer ("CEO") is the Company’s chief operating decision-maker ("CODM").

Based on the Company's organizational structure, its business activities and information reviewed by the CODM for the purposes of allocating resources and assessing performance, management has determined that there are two operating segments.

CDMO

The CDMO activity is comprised of a specialization in cell therapy development for advanced therapeutic products and is comprised of two types of services to its customers: (i) process and assay development services and (ii) cGMP contract manufacturing services. The CDMO activities include the operations of MaSTherCell.

CTBCT Business

The Cellular TherapyCT Business (“CTB”) activity is based on theour technology licensed by the Israeli Subsidiary, that demonstrates the capacity to induce a shift in the developmental fate of cells from the liver and differentiating (converting) them into “pancreatic beta cell-like” insulin producing cells for patients with Type 1 Diabetes. This segment is comprised of all entities aside from MaSTherCell.

The Company assessesCODM does not review assets by segment, therefore the performance based on a measure of "Adjusted EBIT" (earnings before financial expenses and tax, and excluding share-based compensation expenses and non-recurring income or expenses). The measure of assets has not been disclosed for each segment.

911


Reconciliation of segment performance to loss for the three months ended May 31, 2018:

Segment data for the ninesix months ended AugustMay 31, 20172018 is as follows:

        Corporate    
        and    
  CDMO  CTB  Eliminations  Consolidated 
  (in thousands) 
Revenues from external customers$ 7,705     (993)$ 6,712 
Cost of revenues (4,358)    403  (3,955)
Research and development expenses, net    (1,932) 590  (1,342)
Operating expenses (916) (6,060)    (6,976)
Depreciation and amortization expenses (2,145) (7)    (2,152)
Segment Performance$ 286  (8,000) -  (7,714)
             
Stock-based compensation       (2,817) (2,817)
Financial expenses, net*       (139) (139)
Share in losses of associated company       (348) (348)
Loss before income taxes          (11,018)
                                         
        Corporate    
        and    
  CDMO  CT  Eliminations  Consolidated 
  (in thousands) 
Revenues from external customers$ 7,715 $ - $ (1,092)$ 6,623* 
Cost of revenues (3,918) -  388  (3,530)
Gross profit (loss) 3,797  -  (704) 3,093 
Research and development expenses, net -  (1,866) 704  (1,162)
Operating expenses (2,183) (2,995) -  (5,178)
Other income 316     -  316 
Operating profit (loss) 1,930  (4,861)    (2,931)
Adjustments to presentation of segment            
Adjusted EBIT            
     Depreciation and amortization (1,240) (4)      
Segment performance 690  (4,865)      

* Excluding $1,389 thousand stock based compensation included in financial expenses.The Company's revenues consist of: $5,019 from services and $1,604 from goods sold.

                          Segment dataReconciliation of segment performance to loss for the ninesix months ended AugustMay 31, 2016 is as follows:2018:

        Corporate    
        and    
  CDMO  CTB  Eliminations  Consolidated 
  (in thousands) 
Net revenues from external customers$ 4,826 $  $(325)$ 4,501 
Cost of revenues (4,968)    463  (4,505)
Research and development expenses, net    (1,239) (138) (1,377)
Operating expenses (1,518) (1,299)    (2,817)
Depreciation and amortization expense (1,984) (3)    (1,987)
Segment Performance$ (3,644)$ (2,541) -  (6,185)
             
Share-based compensation       (2,085) (2,085)
Financial income, net       645  645 
Loss before income taxes         $ (7,625)
Six months
ended May 31,
2018
in thousands
Segment performance(4,175)
   Stock-based compensation(1,827)
   Financial expenses, net(2,094)
   Share in losses of associated companies(530)
   Loss before income tax$ (8,626)

Segment data for the three months ended AugustMay 31, 2018 is as follows:

        Corporate    
        and    
  CDMO  CT  Eliminations  Consolidated 
  (in thousands) 
Revenues from external customers$ 4,534 $ - $ (547)$ 3,987* 
Cost of revenues (2,193) -  148  (2,045)
Gross profit (loss) 2,341  -  (399) 1,942 
Research and development expenses, net -  (979) 399  (580)
Operating expenses (1,101) (1,639)    (2,740)
Other income -  -       
Operating profit (loss) 1,240  (2,618)    (1,378)
Adjustments to presentation of segment            
Adjusted EBIT            
     Depreciation and amortization (643) (2)      
Segment performance 597  (2,620)      

* The Company's revenues consist of: $2,993 from services and $994 from goods sold.

12



Three months
ended May
31, 2018
in thousands
Segment performance(2,023)
Stock-based compensation(741)
Financial expenses, net587
Share in losses of associated companies(576)
Loss before income tax(2,753)

Segment data for the six months ended May 31, 2017 is as follows:

        Corporate    
        and    
  CDMO  CTB  Eliminations  Consolidated 
  (in thousands) 
Net revenues from external customers$ 2,956     (394) 2,562 
Cost of revenues (1,439)    95  (1,344)
Research and development expenses, net    (688) 299  (389)
Operating expenses (1,641) (1,272)    (2,913)
Depreciation and amortization expense (945) -     (945)
Segment Performance$ (1,069) (1,960) -  (3,029)
             
Share-based compensation       (108) (108)
Financial income, net*       1,757  1,757 
Share in losses of associated company       (152) (152)
Loss before income taxes          1,532 
        Corporate    
        and    
  CDMO  CT  Eliminations  Consolidated 
  (in thousands) 
Revenues from external customers$ 4,749 $ - $ (599)$ 4,150* 
Cost of revenues (2,919) -  308  (2,611)
Gross profit (loss) 1,830  -  (291) 1,539 
Research and development expenses, net    (1,244) 291  (953)
Operating expenses 725  (4,790) -  (4,065)
Operating profit (loss) 2,555  (6,034) -  (3,479)
Adjustments to presentation of segment            
Adjusted EBIT            
     Depreciation and amortization (1,200) (7)      
Segment performance 1,355  (6,041)      

* Excluding $275 thousand stock based compensation included in financial income.The Company's revenues consist of: $3,585 from services and $565 from goods sold.

10Reconciliation of segment performance to loss for the six months ended May 31, 2017:

Six months
ended May
31, 2017
in thousands
Segment performance(4,686)
Stock-based compensation(1,084)
Financial expenses, net(2,578)
Share in losses of associated companies(196)
Loss before income tax$ (8,544)

13


Segment data for the three months ended AugustMay 31, 20162017 is as follows:

        Corporate    
        and    
  CDMO  CTB  Eliminations  Consolidated 
  (in thousands) 
Revenues from external customers$ 1,852 $  $(3)$ 1,849 
Cost of revenues (1,748)    164  (1,584)
Research and development expenses, net    (565) (161) (726)
Operating expenses (453) (448)    (901)
             
             
             
Depreciation and amortization expense (651) (1)    (652)
Segment Performance$ (1,000)$ (1,014) -  (2,014)
             
Share-based compensation       (428) (428)
Financial income (expenses), net       (574) (574)
Loss before income taxes         $ (3,016)
        Corporate    
        and    
  CDMO  CT  Eliminations  Consolidated 
  (in thousands) 
Revenues from external customers$ 2,605 $ - $ (307)$ 2,298* 
Cost of revenues (1,058) -  141  (917)
Gross profit (loss) 1,547  -  (166) 1,381 
Research and development expenses, net -  (643) 166  (477)
Operating expenses (987) (1,200) -  (2,187)
Operating profit (loss) 560  (1,843) -  (1,283)
Adjustments to presentation of segment            
Adjusted EBIT            
     Depreciation and amortization (608) (7)      
Segment performance (48) (1,850)      

* The Company's revenues consist of: $2,202 from services and $96 from goods sold.

Reconciliation of segment performance to loss for the three months ended May 31, 2017:

Three months
ended May
31, 2017
in thousands
Segment performance(1,898)
Stock-based compensation(426)
Financial expenses, net(503)
Share in losses of associated companies(107)
Loss before income tax$ (2,934)

Geographic, Product and Customer Information

Substantially all the Company's revenues and long-lived assets are located in Belgium through its controlled subsidiary, MaSTherCell. Manufacturing activities show a significant increase ofNet revenues in line with the company Business Plan. It reflects market recognition in CDMO business expertise and the adequacy of the Company strategy.

     Revenues from single customers from the CDMO segment that exceed 10% of total net revenues are:

 Three Months Ended  Nine Months Ended  Six Months Ended  Three Months Ended 
 August 31,  August 31,  August 31,  August 31, 2016  May 31,  May 31,  May 31,  May 31, 
 2017  2016  2017     2018  2017  2018  2017 
 (in thousands)  (in thousands) 
Customer A$852 $ 1,031 $2,813 $ 2,626 $ 1,791 $ 1,961 $ 896 $ 771 
Customer B -  291  -  1,163  2,257  -  1,300  - 
Customer C 809     1,904     2,157  1,095  1,186  803 
Customer D$679 $  $ 1,637 $  $ - $ 958 $  $ 703 

CDMO business has substantially diversified revenues by source signing contracts with leading Biotech companies in their respective cell-based therapy field and strengthened its revenue base over the last three quarters.  In January 2017, MaSTherCell entered into a service agreement with Les Laboratoires Servier (“Servier”) for the development of its CAR-T cell therapy manufacturing platform and in June 2017, MaSTherCell entered into a service agreement with CRISPR  Therapeutics AG  (“CRISPR”) for the development and manufacturing of allogeneic cell therapies.14


NOTE 4 – CONVERTIBLE LOAN AGREEMENTS

(a)      On January 12, 2017, the Company repaid the outstanding principal amount and accrued interest in the amount of $51 thousand on convertible loans that were issued during September 2016. The transaction had no material impact on the comprehensive loss for the period.

11


(b)        During the ninesix months ended AugustMay 31, 2017,2018, the Company entered into several unsecured convertible noteloan agreements with accredited or offshore investors for an aggregate amount of $3.95 million.$720 thousand. The loans bear an annual interest rate of 6% and mature in six months or two years from the closing date, of issuance, unless earlier converted earlier.subject to the terms defined in the agreements.

The notesloans provide that the entire principal amount under the notes and accrued interest automatically convert into units as in the agreement upon the earlier to occura Unit, consisting of anyone share of the following: (i) the closingCommon Stock and one three-year warrant exercisable into an additional share of an offering of equity securities of the Company with gross proceeds to the Company greater than $10 million (ii) the trading of the Company’s common stock par value $0.0001at a per share (the “Common Stock”) on the over-the counter market or an exchange at a weighted averageexercise price of at least $0.52 (adjusted for$6.24, upon certain capital events such as stock splits) for fifty (50) consecutive trading days, or (iii)conditions, including the listing of the Company’s Common Stockshares on a U.S. National Exchange.exchange. In addition, the Company issued to certain investors 40,064 three-year warrant to purchase up to an additional one share of the Company’s Common Stock at a per share exercise price of $6.24.

Since the closing price of the Company’sCompany's publicly traded stock is greater than the effective conversion price on the closing date, the conversion feature is considered "beneficial" to the holders and equal to $2.24 million. The difference is treated as issued equity and reduces the carrying value of the host debt; the discount is accreted as deemed interest on the debt.

            The transaction costs were approximately $405 thousand, out of which $129 thousand was the fair value of warrants for the purchase of 434,436 shares of Common Stock granted to three holders as a success fee, exercisable at $0.52 per share for three years. The fair value of those warrants as of the date of grant was evaluated using the Black-Scholes valuation model.

(c)        During the nine months ended August 31, 2017, the Company entered into several unsecured convertible note agreements with accredited or offshore investors for an aggregate amount of $0.8 million. The notes have 0% or 6% interest rate and are scheduled to mature between nine months and one year unless converted earlier. At any time, all or a portion of the outstanding principal amount and accrued but unpaid interest thereon may be converted at the Holder’s option into shares of the Company common stock at a price of $0.52 per share. The Company also issued to the investors three-year warrants to purchase up to 1,746,063 shares of the Company’s Common Stock at a per share exercise price of $0.52.

            Since the closing price of the Company’s publicly traded stock is greater than the effective conversion price on the measurement date, the conversion feature is considered "beneficial" to the holders and equal to $81$193 thousand. The difference is treated as issued equity and reduces the carrying value of the host debt; the discount is accreted as deemed interest on the debt.

(d)        On January 23, 2017, the Company and a Non-U.S. institutional investor, entered into an agreement pursuant to which the investor advanced to the Company $400,000 at per annum rate of 6% and with a maturity date of April 23, 2017.

The transaction costs for the convertible notes received during the three months ended May 31, 2018 were approximately $71$89 thousand, out of which $35$31 thousand as stock basedare stock-based compensation due to issuance of 76,923 warrants and 32,051 shares. The fair value(See also Note 7(b)). Through May 31, 2018, $650 thousand in principal amount out of those warrants asthese convertible loans were converted into units of the dateCompany's securities. See additional information in Note 4b.

(b)      During the six months ended May 31, 2018, holders of grant was evaluated by using the Black-Scholes valuation model.

            Theapproximately $8.4 million in principal amount and accrued interest were repaid by the Company on March 7, 2017of convertible loans ("converted amounts") with maturity dates between June 2018 and January 2020 converted these outstanding amounts, in accordance with the terms of the agreement, the Company issued to the investor 650,000 restricted sharesspecified in such loans, into units of the Company’s Common Stock. The fair value of the shares as of March 7, 2017, was $494 thousand and was recorded as financial expenses.

(e)        In January 2017 MaSTherCell repaid all but one of its bondholders (originally issued on September 14, 2014), and the aggregate payment amounted to $1.7 million (€1.5 million). On January 17, 2017, the remaining bondholder agreed to extend the duration of his Convertible bond until March 21, 2017. In consideration for the extension, the Company issued to the bondholder warrants to purchase 102,822 shares of the Company’s Common Stock, exercisable over a three-year periodsecurities at a deemed per share exercise priceunit conversion rate of $0.52. The fair value of those warrants as of the date of grant was $20 thousand using the Black-Scholes valuation model.

12


            On March 20, 2017, the remaining bondholder agreed to convert his convertible bonds into 488,182 shares of the Company’s Common Stock.

            The Company returned to treasury from the escrow arrangement entered into in March 2015 in connection$6.24, with the MaSTherCell acquisition a total of 3,157,716 consideration, in accordance with the terms of the MaSTherCell acquisition agreement. These shares have been retired and cancelled.

(f)        On February 27, 2017, the Company and Admiral Ventures Inc. (“Admiral”) entered into an agreement resolving the payment of amounts owed to Admiral. Under the terms of the settlement agreement, Admiral extended the maturity date to June 30, 2018. The Company agreed to pay to Admiral, on or before March 1, 2017, between $0.3 million and $1.5 million. Further, beginning April 2017, the Company agreed to make a monthly payment of $125 thousand on account of remaining unpaid balance, and also agreed to remit 25% of all amounts received from equity financing raised above $1 million and 20% of such amounts above $500 thousand on account of amounts owed. The Company accounted for the above changes as a modification of the old debt.

            On March 1 and July 17, 2017, the Company repaid $1.5 million and $125 thousand on account of the principal amount of the loan and accrued interest, respectively. As of August 31, 2017, the Company was in arrears in its payment obligations under such agreement. See also Note 10(c).

NOTE 5 – COMMITMENTS

Grants

            In April 2016, the Belgian Subsidiary received the formal approval from the Walloon Region, Belgium (Service Public of Wallonia, DGO6) (“DGO6”) for a budgeted €1.3 million ($1.5 million) support program for CTB activity. The financial support is awarded to the Belgian subsidiary Orgenesis as a recoverable advance payment at 55% of budgeted costs, or for a total of €0.7 million thousand ($0.8 million). The grant will be paid over the project period. On December 19, 2016, the Belgian Subsidiary received a first payment of €359 thousand ($374 thousand).

            On October 8, 2016, the Belgian subsidiary received the formal approval from the DGO6 for an additional budget of €12.3 million ($12.8 million) support program for the GMP production of AIP cells for two clinical trials that will be performed in Germany and Belgium. The project will be held during a period of three years commencing January 1, 2017. The financial support is awarded to the Belgium subsidiary at 55% of budgeted costs, a total of €6.8 million ($7 million). The grant will be paid over the project period. On December 19, 2016, the Belgian Subsidiary received a first payment of €1.7 million ($1.8 million).

NOTE 6 – EQUITY

Financings

            1)        During the nine months ended August 31, 2017, the Company entered into definitive agreements with accredited and other qualified investors relating to a private placement (the “Private Placement”) ofeach unit comprised of: (i) 1,286,944 sharesone (1) share of the Company’s Common Stock and (ii) one warrant, exercisable for a period of three year warrants to purchase up toyears from the date of issuance, for an additional 1,286,944 sharesshare of the Company’s Common Stock, at a per share exercise price of $0.52$6.24. As a result of these conversions, the holders are entitled to 1,341,134 shares of Common Stock and $0.65 respectively. The purchased securities were issued pursuant to subscription agreements between the Company and the purchasersthree-year warrants for aggregate proceeds to the Companyan additional 1,341,134 shares of $699 thousand.common stock at a per share exercise price of $6.24.

The Company allocated the proceeds from the Private Placementconverted amounts based on the fair value of the warrants and the shares. The table below presents the fair valueconverted amounts of the instruments issuedproceeds as of the closing dates and the allocation of the proceeds:date:

  Total FairProceed 
  ValueAllocation 
  (in thousands) 
Warrants component$ 2513,297 
Shares component 4485,071 
Total$ 6998,368 

13The fair value of these warrants determined using a Black-Scholes Model based on the following assumptions:

Six Months Ended
May 31, 2018
Value of one common share$7.61-$13.85
Dividend yield0%
Expected stock price volatility90.6%-94.12%
Risk free interest rate2.29%-2.43%
Expected term (years)3

These loans had beneficial conversion features ("BCF"), therefore the Company recognized the unamortized BCF as of the conversion date as interest expenses.

15


            2)(c)      In March 2018, a former Israel-based consultant exercised warrants issued in November 2016 to purchase shares of the Company’s Common Stock. A related party of such consultant submitted at the same time notice of its intention to convert into shares of the Company’s common stock the principal amount and accrued interest of approximately $382 thousand outstanding under a loan originally advanced to the Company in November 2016. The exercise price in the warrants and conversion price were fixed at $0.52 per share (pre-reverse stock split implemented by the Company in November 2017). There is a significant disagreement between the Company and these two entities as to the number of shares of Common Stock issuable to these entities, and they contend that the number of shares of Common Stock issuable to them should not take into account the reverse stock split. The Company rejects these contentions in their entirety and, based on the advice of specially retained counsel, believes that these claims are without legal merit and not made in good faith. The Company intends to vigorously defend its interests and pursue other avenues of legal address. Through its counsel, the Company has advised these entities that unless they withdraw their request within a specified period, the Company will cancel the above referenced agreements and these parties’ right to receive any shares of the Company’s Common Stock. In April 2018, the Company withdrew the aforementioned agreements and deposited the principle amount and accrued interest of the loan in an escrow account presented as restricted shares in the balance sheet as of May 31, 2018.

NOTE 5 – COMMITMENTS

"MSA" with Adva Biotechnology Ltd.

On January 28, 2018, the Company and Adva Biotechnology Ltd. (“Adva”), entered into a Master Services Agreement (“MSA”), under which the Company and/or its affiliates are to provide certain services relating to development of products to Adva, as may be agreed between the parties from time to time. Under the MSA, the Company undertook to provide Adva with in kind funding in the form of materials and services having an aggregate value of $749,900 at the Company’s own cost in accordance with a project schedule and related mutually acceptable project budget. The Company entered into agreement with Atvio Biotech Ltd, its Israeli-based joint venture, to fulfill its obligations pursuant this MSA. In March 2018, the Company incurred a total expense of $82 thousand.

In consideration for and subject to the fulfillment by the Company of such in-kind funding commitment, Adva agreed that upon completion of the development of the products, the Company and/or its affiliates and Adva shall enter into a supply agreement pursuant to which for a period of eight (8) years following execution of such supply agreement, the Company and/or its affiliates (as applicable) is entitled (on a non-exclusive basis) to purchase the products from Adva at a specified discount pricing from their then standard pricing . The Company and/or its affiliates were also granted a non-exclusive worldwide right to distribute such products, directly or through any of their respective contract development and manufacturing organization (CDMO) service centers during such term. The MSA shall remain in effect for 10 years unless earlier terminated in accordance with its terms.

Grants

On December 18, 2017, MaSTherCell, as coordinator of the “Icone” project with a consortium of private and public searchers, received the approval of a new grant from the Walloon Region with a direct financial support of Euro 1 million ($1.2 million) in program for development of iPS-derived Cortical Neurons. The program started in 2017 for a 4-year period until 2021. After 2 years, project partners will make a decision continue the program upon pre-defined scientific milestone achievements. During the six months ended May 31, 2018, MaSTherCell received an advance payment of Euro 0.6 million ($0.7 million).

16


NOTE 6 – EQUITY

Financings

1)      In January 2017, the Company entered into definitive agreements with an institutional investor for the private placement of 30,769,2312,564,115 units of the Company’s securities for aggregate subscription proceeds to the Company of $16 million at $0.52$6.24 price per unit. Each unit is comprised of one share of the Company’s Common Stock and a warrant, exercisable over a three-years period from the date of issuance, to purchase one additional share of Common Stock at a per share exercise price of $0.52.$6.24. The subscription proceeds are payable on a periodic basis through AugustSeptember 2018. Each periodic payment of subscription proceeds will be evidenced by the Company’s standard securities subscription agreement.

During the ninesix months ended AugustMay 31, 20172018 the investor remitted to the Company $3.5$2.5 million, in consideration of which, the investor is entitled to 6,730,767400,643 shares of the Company’s Common Stock and three-year warrants to purchase up to an additional 6,730,767400,643 shares of the Company’s Common Stock at a per share exercise price of $0.52 $6.24.

The Company allocated the proceeds based on the fair value of the warrants and the shares. The table below presents the allocation of the proceeds as of the closing date:

  Total FairProceeds 
  ValueAllocation 
  (in thousands) 
Warrants component$ 1,207910 
Shares component 2,2931,590 
Total$ 3,5002,500 

            AsThe fair value of August 31, 2017, 1,923,076 shares have not been issued thereforethese warrants determined using a Black-Scholes Model based on the Company recorded $624 thousand net of transaction costs in Receipts on Account of Shares to be Allotted.following assumptions:

Six Months Ended
May 31, 2018
Value of one common share$6.5-$14.68
Dividend yield0%
Expected stock price volatility90.6%-93.8%
Risk free interest rate1.99%-2.73%
Expected term (years)3

In connection therewith,with certain installments of the investment, the Company undertook to pay a fee of 5%, resulting in the payment of $175$25 thousand (classified as Additional Paid-in Capital in the statement of equity) and the issuance of 336,5384,006 restricted shares of Common Stock. The fair value of the shares as of the date of grant was $145$29 thousand using the share price on the date of grant.

Through May 31, 2018 the Company has received a total of $8,000 thousand out of the committed $16,000 thousand subscription proceeds. See also note 10(9).

17


2)      During the six months ended May 31, 2018, the Company entered into definitive agreements with accredited and other qualified investors relating to a private placement of 1,237,649 units. Each unit is comprised of (i) one share of the Company’s common stock and (ii) three-year warrant to purchase up to an additional one share of the Company’s Common Stock at a per share exercise price of $6.24, for aggregate proceeds to the Company of approximately $7.7 million.

The Company allocated the proceeds based on the fair value of the warrants and the shares. The table below presents the allocation of the proceeds as of the closing date:

Proceeds
Allocation
(in thousands)
Warrants component$ 2,956
Shares component4,767
Total$ 7,723

In connection with $2.8 million out of these private placements, the Company undertook to pay a fee of 8%, resulting in the payment of $224 thousand and the issuance of 21,630 three-year warrants to purchase each up to an additional one share of the Company’s Common Stock exercisable at $6.24 to $12.39 per share. The fair value of the warrants as of the date of grant was $125 thousand using a Black Scholes option pricing model.

NOTE 7 – STOCK BASED COMPENSATION

a.

Options Granted to employees

a. Options Granted to Employees and Directors

            On December 9, 2016,Below is a table summarizing the Companyterms of options granted to an employee during the six months ended May 31, 2018:

  No. of options  Exercise     grant  Expiration 
  granted  price  Vesting period  (in thousands)  period 
Employee 50,000 $4.42  Quarterly over a
period of 1 year
 $163  10 years 
MaSTherCell's
employee
 15,000 $8.43  Quarterly over a
period of 2 years
 $99  10 years 
MaSTherCell's*
employees
 55,300 $8.43  Quarterly over a
period of 2 years
 $391  10 years 
MaSTherCell's*
employees
 134,050 $8.43  Quarterly over a
period of 4 years
 $991  10 years 

*      In May 2018, the compensation committee of the Company’s Board of Directors (the “Compensation Committee”) approved the option grants for MaSTherCell's employees and directors 7,300,000 options and on and June 1,under the Company’s 2017 the Company granted to the Chief Executive Officer 1,000,000 options, which are summarizedEquity Incentive Plan. The grant date on the table below:option is in June 2018.


No. of options
granted
Exercise price
Vesting period
Fair value at grant
(in thousands)
Expiration
period
Directors
2,000,000
$0.4
Quarterly vested
over 2 years
vest immediately-
$558
10 years
Employees

5,300,000

$0.4

Quarterly vested
over 4 years
$1,480

10 years

Chief Executive
Officer
1,000,000

$0.6

Semi Annually
vested over one
year
$435

10 years

The fair value of each stockthese option grant is estimated at the date of grant using a Black Scholes option pricing model. The volatility is based on historical volatility of the Company, by statistical analysis of the weekly share price for the last two years. The expected term is the mid-point between the vesting date and the maximum contractual term for each grant equal to the contractual life. The fair value of each option grantgrants is based on the following assumptions:

Six Months Ended
May 31, 2018
Value of one common share$4.42-$9.22
Dividend yield0%
Expected stock price volatility90%-97%
Risk free interest rate2.11%-3.04%
Expected term (years)5-7

1418



 December 9,June 1, 2017
 2016 
Value of one common share$0.39$0.62
Dividend yield0%0%
Expected stock price volatility94%95%
Risk free interest rate1.89%1.76%
Expected term (years)55
b.

Options Granted to non-employees

b. OptionsBelow is a table summarizing all the options granted to consultants and service providers during the six months ended May 31, 2018:

           Fair value at    
  No. of options  Exercise     grant  Expiration 
  granted  price  Vesting period  (in thousands)  period 
Non-employee 5,200 $4.42  6-month period $20  10 years 
Non-employee 8,333 $6.4  Annual over a period
of 5 year
 $48  10 years 

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

Six Months Ended
May 31, 2018
Value of one common share$4.42-$6.4
Dividend yield0%
Expected stock price volatility97%-98%
Risk free interest rate2.33%-2.54%
Expected term (years)5

c.

Shares and Warrants Granted to non-employees

1)     During the six months ended May 31, 2018, the Company granted to several consultants 30,174 warrants with each exercisable at $6.24 to $15.41 per share for three years as a Consultantssuccess fee with respect to the issuance of the convertible loans and part of the private placement. The fair value of those warrants as of the date of grant using the Black-Scholes valuation model was $156 thousand.

On2)     In December 9, 2016,2017, the Company entered into investors relation services, marketing and related services agreement. Under the terms of the agreement, the Company agreed to grant the consultant 100,000 shares of restricted common stock, of which the first 25,000 shares will vest after 30 days from the signing date, and 75,000 shares are to vest monthly over 15 months commencing February 2018. As of May 31, 2018, 45,000 shares are vested. The fair value of the shares was $862 thousand using the fair value of the shares at May 31, 2018, out of which $367 thousand was recognized during the three months ended May 31, 2018. The unrecognized costs will be utilized on a monthly basis until May 2019.

3)     In December 2017, the Company entered into an investor relations services, marketing and related services agreement. Under the terms of the agreement, the Company agreed to grant the consultant 95,000 shares of restricted common stock, of which the first 25,000 shares will vest after 30 days from the signing date, and 70,000 shares are to vest monthly over 14 months commencing February 2018. As of May 31, 2018, 45,000 shares vested. The fair value of the shares was $819 thousand using the fair value of the shares at May 31, 2018, out of which $367 thousand was recognized during the three months ended May 31, 2018. The unrecognized costs will be utilized on a monthly basis until April 2019.

4)     In January 2018, the Company entered into consulting agreements for the provision of professional servicesagreement with financial advisor for a period of one year. Under the terms of the agreement,agreements, the consultant was paid $20 thousand per month for three months and 19,000 units of the Company grantedsecurities. Each unit is comprised of (i) one share of the Company’s common stock and (ii) a three-year warrant to purchase up to an additional one share of the Company’s Common Stock at a consultants 200,000 options exercisable at $0.40 per share. The options are to vest quarterly over a periodshare exercise price of one year.$6.24. The fair value of those optionsthe units as of the date of grant was $68$171, out of which $62 thousand reflect the fair value of the warrants using the Black-Scholes valuation model.

5)     On July 6, 2018, as part of an amendment to a prior agreement, the Company issued to a consultant additional 6,629 units of share and warrants for the purchase of the Company’s common stock, exercisable at a per share exercise price of $6.24. See also note 10(6).

19


6)     In April 2018, a U.S.-based accredited investor who held 128,077 warrants issued in November 2015, exercised their warrants into 128,077 shares of the Company’s Common Stock at a per share exercise price of $6.24, for aggregate proceeds to the Company of $799 thousand.

NOTE 8 – LOSS PER SHARE

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

 Three Months Ended  Nine Months Ended 
 August 31,  August 31,  Six Months Ended  Three Months Ended 
 2017  2016  2017  2016  May 31,  May 31, 
 (in thousands, except per share data)  2018  2017  2018  2017 
             (in thousands, except per share data) 
Basic:             
Loss for the period$1,953 $ 2,644 $11,511 $ 6,312 $ 8,225 $ 8,616 $ 2,614 $ 2,489 
Weighted average number of common shares outstanding 123,349,597  111,188,616  113,725,909  108,784,862  11,971,389  9,221,039  13,140,119  9,568,413 
Loss per common share$ 0.02 $ 0.02 $ 0.10 $ 0.06 $ 0.69 $ 0.93 $ 0.20 $ 0.26 
Diluted:             
Loss for the period$1,953 $ 2,644 $11,511 $ 6,312 $ 8,225 $ 8,616 $ 2,614 $ 2,489 
Changes in fair value of embedded derivative and interest expense on convertible loans 238    137  87 
Changes in fair value of embedded
derivative and interest expense on
convertible bonds
 -  -  -  - 
Loss for the period$ 2,191 $ 2,644 $11,648 $ 6,399 $ 8,225 $ 8,816 $ 2,614 $ 2,489 
             
Weighted average number of shares used in the computation of basic and diluted loss per share 123,349,597  111,188,616  113,725,909  108,704,862  11,971,389  9,221,039  13,140,119  9,568,413 
Number of dilutive shares related to convertible loans 1,275,815    312,500   
Weighted average number of common shares outstanding 124,625,412  111,188,616  114,038,409  108,704,862 
            
Loss per common share$ 0.02 $ 0.02 $ 0.10 $ 0.06 $ 0.69 $ 0.93 $ 0.20 $ 0.26 

Diluted loss per share does not include 52,510,2736,048,269 shares underlying outstanding options and warrants and 29,551,172201,416 shares upon conversion of convertible notes for the six months ended May 31, 2018, because the effect of their inclusion in the computation would be anti-dilutive.

Diluted loss per share does not include 4,059,824 shares underlying outstanding options and warrants and 1,354,257 shares upon conversion of convertible notes for the three and ninesix months ended AugustMay 31, 2017, because the effect of their inclusion in the computation would be anti-dilutive.

            Diluted loss per share does not include 16,954,564 shares underlying outstanding options, 20,971,190 shares issuable upon exercise of warrants, 800,000 shares due to stock-based compensation to service providers and

15


7,365,719 shares upon conversion of convertible notes for the nine and three months ended August 31, 2016, because the effect of their inclusion in the computation would be anti-dilutive.

NOTE 9 - FAIR VALUE PRESENTATION

The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below:

Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.

Level 2: Observable inputs that are based on inputs not quoted on active markets but corroborated by market data.

Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.

In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs, to the extent possible, and considers credit risk in its assessment of fair value.

20


As of AugustMay 31, 2017,2018, and November 30, 2016,2017, the Company’s assets and liabilities that are measured at fair value and classified as level 3 fair value are as follows (in thousands):

  August 31,  November 30, 
  2017  2016 
  Level 3  Level 3 
Warrants (1)$ 873 $ 1,843 
Price protection derivative (1) -  76 
Embedded derivatives convertible loans*(1) 20  240 
Put option derivatives 273  273 
Convertible bonds (2)$ - $ 1,818 
  May 31,  November 30, 
  2018  2017 
  Level 3  Level 3 
Embedded derivatives convertible loans*(1)$ - $ 37 
Call/Put option derivatives$ (792)$ (339)

*

* The embedded derivative is presented in the Company's balance sheets on a combined basis with the related host contract (the convertible loans).

(1)

The fair value is determined by using a Black-Scholes Model.

            (1)        The fair value of the warrants, price protection derivative and embedded derivatives is determined by using a Monte Carlo Simulation Model. This model, in contrast to a closed form model, such as the Black-Scholes Model, enables the Company to take into consideration the conversion price changes over the conversion period of the loan, and therefore is more appropriate in this case.

            (2)        The fair value of the convertible bonds described in Note 7 of the Annual Report is determined by using a binomial model for the valuation of the embedded derivative and the fair value of the bond was calculated based on the effective rate on the valuation date (6%). The binomial model used the forecast of the Company share price during the convertible bond's contractual term. Since the convertible bond is in Euro and the model is in USD, the Company has used the Euro/USD forward rates for each period. In order to solve for the embedded derivative fair value, the calculation was performed as follows:

•        Stage A - The model calculates several potential future share prices of the Company based on the volatility and risk-free interest rate assumptions.

•        Stage B - the embedded derivative value is calculated "backwards" in a way that considers the maximum value between holding the bonds until maturity or converting the bonds.

16


As of August 31, 2017, the convertible bonds have been repaid or converted see Note 4(e).

The following table presents the assumptions that were used for the models as of August 31, 2017:

     Embedded 
  Warrants  Derivative 
Fair value of shares of Common Stock$ 0.32 $ 0.32 
Expected volatility 92%  82% 
Discount on lack of marketability 13%  - 
Risk free interest rate 1.25%-1.31%  0.95%-1.03% 
Expected term (years) 1.2-1.8  0.08-0.33 
Expected dividend yield 0%  0% 
Expected capital raise dates October 31,    
  2017  - 

The fair value of the convertible bonds is equal to their principal amount and the aggregate accrued interest.

The table below sets forth a summary of the changes in the fair value of the Company’s financial liabilities classified as Level 3 for the ninesix months ended AugustMay 31, 2017:2018:

        Convertible  Price  Put Option 
     Embedded  Bonds  Protection  Derivative 
  Warrants  Derivatives     Derivative    
  (in thousands) 
Balance at beginning of the year$ 1,843 $ 240 $ 1,818 $ 76 $ 273 
Changes in fair value during the period (970) 635  22  (76)   
Repayment and conversion of convertible bonds and convertible loan   (855) (1,827)    
Translation adjustments       (13)      
Balance at end of the period$ 873 $ 20 $ - $ - $ 273 
  Embedded  Put Option 
  Derivatives  Derivative 
       
Balance at beginning of the year$ 37 $ (339)
Repayment (14) - 
Changes in fair value during the period (23) (453)
Balance at end of the year$ - $ (792)

(*) There were no transfers to Level 3 during the ninethree months ended AugustMay 31, 2017.2018.

The table below sets forth a summary of the changes in the fair value of the Company’s financial assets and liabilities classified as Level 3 for the year ended November 30, 2016:2017:

        Convertible  Price  Put Option 
     Embedded  Bonds  Protection  Derivative 
  Warrants  Derivatives     Derivative    
     (in thousands)          
Balance at beginning of the year$ 1,382 $ 289 $ 1,888 $ 1,533 $  
Additions 802  40     120  273 
Conversion    (10)         
Changes in fair value related to Price               
Protection Derivative expired*          (108)   
Changes in fair value during the period (341) (87) (84) (1,469)   
Changes in fair value due to extinguishment of convertible loan   8       
Translation adjustments       14       
Balance at end of the year$ 1,843 $ 240 $ 1,818 $ 76 $ 273 
  Embedded  Convertible  Put Option 
  Derivatives  Bonds  Derivative 
          
Balance at beginning of the year$ 240 $ 1,818 $ 273 
Repayment (876) (1,827)   
Changes in fair value during the period 662  22  (612)
Translation adjustments 11  (13)   
Balance at end of the year$ 37 $ - $ (339)

(*) During the twelve months ended November 30, 2016, 11,732,916 Price Protection Derivative have expired.

There were no transfers to Level 3 during the twelve months ended November 30, 2016.2017.

17


NOTE 10 - SUBSEQUENT EVENTS

a.        During September1)     In connection with the Subscription and Shareholders Agreement entered into on November 15, 2017 by and among the Company, enteredMaSTherCell S.A. and the Belgian Sovereign Funds Société Fédérale de Participations et d'Investissement (“SFPI”), SPFI has paid into unsecured convertible note agreements with accredited or offshore investors for an aggregate amountMaSTherCell S.A. the balance of $0.6 million.Euro 1.9 million (approximately $2.3 million) on June 13, 2018. The notes bear an annualCompany reflected the impact of this payment as other receivable and redeemable non -controlling interest rate of 6% and mature in two years from the closing date, unless earlier converted subject to the terms defined in the agreements. The notes provide that the entirebalance sheet as of May 31. 2018.

21


2)     On June 11, 2018, a holder of $181 thousand in principal amount under the notes and accrued interest automatically convertof a convertible loan outstanding from November 2014 converted these outstanding amounts, in accordance with the terms specified in such note, into units as in the agreement upon the earlier to occur of any of the following: (i) the closing of an offering of equity securities of the Company with gross proceeds to the Company greater than $10 million (ii) the tradingshares of the Company’s common stock par value $0.0001at a deemed conversion price of $4.80 per share. As a result of this conversion, the Company will issue 37,662 shares of common stock.

3)     On June 15, 2018, the Compensation Committee approved the grant under the Company’s 2017 Equity Incentive Plan of options for an aggregate of 30,500 shares to two employees, at a per share (the “Common Stock”) onexercise price of $8.91. The options are to vest quarterly over eight quarters commencing July 1, 2018.

         On June 26, 2018, the over-the counter market orCompensation Committee approved the grant under the Company’s 2017 Equity Incentive Plan of options for an exchangeaggregate of 8,600 shares to two consultants, exercisable at a weighted averageper share exercise price of $8.34. The options vested upon grant.

4)     On June 28, 2018, the Compensation Committee approved the grant under the Company’s 2017 Equity Incentive Pan of options for 250,000 shares to the Company’s Chief Executive Officer in accordance with the terms of the employment agreement dated March 30, 2017, as subsequently amended. The options are exercisable into the Company’s common stock at least $0.52 (adjusteda per share exercise price of $8.36 and vest in two semi-annual installments of 125,000 options in each of the sixth and twelfth month anniversary from the date of grant.

5)     On July 6, 2018, the Compensation Committee issued to two consultants warrants for certain capital eventsthe purchase of an aggregate of 13,558 shares of common stock, exercisable at a per share exercise price of $11.19.

6)     On July 6, 2018, as part of an amendment to a prior agreement, the Company issued to a consultant 6,629 warrants for the purchase of the Company’s common stock, exercisable at a per share exercise price of $6.24. In addition, the Company issued the consultant 6,629 shares of the Company’s common stock. See also note 7c4.

7)     On June 18, 2018, a holder of 8,569 investor warrants issued on January 17, 2017 exercised such as stock splits) for fifty (50) consecutive trading days, or (iii) the listingwarrants into 8,569 shares of the Company’s Common Stock onat a U.S. National Exchange.per share exercise price of $6.24, for aggregate proceeds to the Company of $53,471.

b.8)     In October 2017,July 2018, the Company entered into definitive agreements with assignees of the institutional investor referred ot in Note 6(1) whereby these assignees remitted $4.5 million in respect of the units available under the original subscription agreement that have not been subscribed for, entitling such investors top 692,308 units, with each unit being comprised of (i) one share of the Company's common stock and (ii) one three-year warrant to purchase up to an additional one share of the Company’s common stock at a per share exercise price of $6.24.

9)     In July 2018, the Company raised $1 million from the institutional investor referred to in Note 6b, remitted to the Company $0.5 million in subscription proceeds6 (1) entitling such investor to 961,538160,256 shares of Common Stock and three-year warrants for an additional 961,538160,256 shares. As of October 16, 2017,Following this remittance and those under item 8 above, the Company has received, as of July 16, 2018, a total of $4$12.5 million out of the committed $16 million subscription proceeds.proceeds under such agreement.

c.10)    On September 29, 2017,June 19, 2018, the Company paidand Mircod Limited, a company formed under the laws of Cyprus (“Mircod”) entered into a Collaboration and License Agreement (the “Collaboration Agreement”) for the research, development and commercialization of potential key technologies related to Admiral $125 thousand on accountbiological sensing for our clinical development and manufacturing projects (the “Development Project”). Within 45 days of the debt owed. execution of the Collaboration Agreement, the parties are to approve a written project development plan outlining each party’s responsibilities with respect to the Development Project, and we will be funding the projected development costs as outlined in the development plan. Under the terms of the Collaboration Agreement, the Company remitted to Mircod an upfront payment of $50,000.

18         Under the Collaboration Agreement, all results of such collaboration (“Project Results”) shall be jointly owned by Mircod and the Company. The Company was granted an exclusive, worldwide sub licensable license under Mircod’s right in such Project Results to use and commercialize Project Results in consideration for a royalty of 5% of Net Sales (as defined in the Collaboration Agreement) of products incorporating Project Results.

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         Subject to completion of the Development Project, Mircod and the Company are to negotiate and enter into a manufacturing and supply agreement under which Mircod is to manufacture and supply products incorporating the Project Results and, at the Company’s request, to provide support and maintenance service for such products. If for whatever reason the parties fail to enter into such manufacturing and supply agreement within 90 days of the completion of the Development Project or if Mircod is unable to perform such services, the Company is entitled to manufacture the products, in which event Mircod will be entitled to a payment of $80,000 and royalties on Net Sales are to increase to 8% of Net Sales.

11)    On June 28, 2018, the Company and Masthercell Global Inc., a Delaware company and a newly formed subsidiary of Orgenesis the Company that holds the Company's CDMO business (“Masthercell Global”), Great Point Partners, LLC, a manager of private equity funds focused on growing small to medium sized heath care companies (“Great Point”), and certain of Great Point’s affiliates, entered into a series of definitive strategic agreements intended to finance, strengthen and expand Orgenesis’ CDMO business. In connection therewith, the Company, Masthercell Global and GPP-II Masthercell, LLC, a Delaware limited liability company (“GPP-II”) and an affiliate of Great Point entered into Stock Purchase agreement (the “SPA”) pursuant to which GPP-II purchased 378,000 shares of newly designated Series A Preferred Stock of Masthercell Global (the “Masthercell Global Preferred Stock”), representing 37.8% of the issued and outstanding share capital of Masthercell Global, for cash consideration to be paid into Masthercell Global of up to $25 million, subject to certain adjustments (the “Consideration”). Orgenesis holds 622,000 shares of Masthercell Global’s Common Stock, representing 62.2% of the issued and outstanding equity share capital of Masthercell Global. An initial cash payment of $11.8 million of the Consideration was remitted at closing, with a follow up payment of $6,600,000 to be made in each of years 2018 and 2019 (the “Future Payments”), or an aggregate of $13.2 million, if (a) Masthercell Global achieves specified EBITDA and revenues targets during each of these years, and (b) the Orgenesis’ shareholders approve on or before December 31, 2019 certain provisions of the Stockholders’ Agreement entered into by these parties. None of the future Consideration amounts, if any, will result in an increase in GPP-II’s equity holdings in Masthercell Global beyond the 378,000 shares of Series A Preferred Stock issued to GPP-II at closing. Notwithstanding the foregoing, GPP-II may, in its sole discretion, elect to pay all or a portion of the future Consideration amounts even if the financial targets described above have not been achieved and the Orgenesis Stockholder Approval has not been obtained.

         In connection with the entry into the SPA described above, each of the Company, Masthercell Global and GPP-II entered into the Masthercell Global Inc. Stockholders’ Agreement (the “Masthercell Global Stockholders Agreement”) providing for certain restrictions on the disposition of Masthercell Global securities, the provisions of certain options and rights with respect to the management and operations of Masthercell Global, a right to exchange the Masthercell Global Preferred Stock for shares of Orgenesis common stock and certain other rights and obligations.In addition, after the earlier of the second anniversary of the closing or certain enumerated circumstances, GPP-II is entitled to effectuate a spinoff of Masthercell Global and the Masthercell Global Subsidiaries (the “Spinoff”). The Spinoff is required to reflect a market value determined by one of the top ten independent accounting firms in the U.S. selected by GPP, provided that under certain conditions, such market valuation shall reflect a valuation of Masthercell Global and the Masthercell Global Subsidiaries of at least $50 million. in addition, upon certain enumerated events, GPP-II is entitled, at its option, to put to the Company (or, at Company’s discretion, to Masthercell Global if Masthercell Global shall then have the funds available to consummate the transaction) its shares in Masthercell Global or, alternatively, purchase from the Company its share capital in Masthercell Global at a purchase price equal to the fair market value of such equity holdings as determined by one of the top ten independent accounting firms in the U.S. selected by GPP-II.

         The Stockholders’ Agreement further provides that GPP-II is entitled, at any time, to convert its share capital in Masthercell Global for the Company’s common stock in an amount equal to the lesser of (a)(i) the fair market value of GPP-II’s shares of Masthercell Global Preferred Stock to be exchanged, as determined by one of the top ten independent accounting firms in the U.S. selected by GPP-II and the Company, divided by (ii) the average closing price per share of Orgenesis Common Stock during the thirty (30) day period ending on the date that GPP-II provides the exchange notice (the “Exchange Price”) and (b)(i) the fair market value of GPP-II’s shares of Masthercell Global Preferred Stock to be exchanged assuming a value of Masthercell Global equal to three and a half (3.5) times the revenue of Masthercell Global during the last twelve (12) complete calendar months immediately prior to the exchange divided by (ii) the Exchange Price; provided, that in no event will (A) the Exchange Price be less than a price per share that would result in Orgenesis having an enterprise value of less than $250,000,000 and (B) the maximum number of shares of Orgenesis Common Stock to be issued shall not exceed 2,704,247 shares of outstanding Orgenesis Common Stock (representing approximately 19.99% of then outstanding Orgenesis Common Stock), unless Orgenesis obtains shareholder approval for the issuance of such greater amount of shares of Orgenesis Common Stock in accordance with the rules and regulations of the Nasdaq Stock Market.

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         Great Point, Masthercell Global and the Company entered into an advisory agreement pursuant to which Great Point is to provide management services to Masthercell Global for which Great Point will be compensated at an annual base compensation equal to the greater of (i) $250,000 per each 12 month period or (ii) 5% of the EBITDA for such 12 month period, payable in quarterly installments; provided, that these payments will (A) begin to accrue immediately, but shall not be paid in cash to Great Point until such time as Masthercell Global generates EBITDA of at least $2,000,000 for any 12 month period or the sale of or change in control of Masthercell Global, and (B) shall not exceed an aggregate annual amount of $500,000.

         Contemporaneous with the execution of the SPA and the Masthercell Global Stockholders Agreement, the Company and Masthercell Global entered into a Contribution, Assignment and Assumption Agreement pursuant to which Company contributed to Masthercell Global the Orgenesis’ assets relating to the CDMO business (as defined below), including the CDMO subsidiaries. In furtherance thereof, Masthercell Global, as Orgenesis’ assignee, acquired all of the issued and outstanding share capital of Atvio Biotech Ltd. (“Atvio”), the Company’s Israel based CDMO partner since May 2016, and 94.2% of the share capital of Curecell Co. Ltd. (“Curecell”), the Company’s Korea based CDMO partner since March 2016. Orgenesis exercised the ”call option” to which it was entitled under the joint venture agreements with each of these entities to purchase from the former shareholders their equity holding. The consideration for the outstanding share equity in each of Atvio and Curecell consisted solely of Company Common Stock. In respect of the acquisition of Atvio, Orgenesis Inc. will be issuing to the former Atvio shareholders an aggregate of 84,085 shares of Company Common Stock. In respect of the acquisition of Curecell, the Company agreed to issue to the former Curecell shareholders an aggregate of 195,927 shares of Orgenesis Common Stock subject to a third-party valuation. Together with MaSTherCell S.A., Atvio and Curecell are directly held subsidiaries under Masthercell Global.

12)    On July 11, 2018, the Company and HekaBio K.K., a corporation organized under the laws of Japan (“HB”) entered into a Joint Venture Agreement (the “JVA”) pursuant to which the parties will collaborate in the clinical development and commercialization of regeneration and cell and gene therapeutic products (hereinafter the “Products”) in Japan. The parties intend to pursue the joint venture through a newly established Japanese company (hereinafter the “JV Company”) which the Company by itself, or together with a designee, will hold a 49% participating interest therein, with the remaining 51% participating interest being held by HB. HB will fund, at its sole expense, all costs associated with obtaining the requisite regulatory approvals for conducting clinical trials, as well as performing all clinical and other testing required for market authorization of the Products in Japan.

         Under the JVA, each party may invest up to $10 million, which may take the form of a loan, if required, as determined by the steering committee. The terms of such investment, if any, will be on terms mutually agreeable to the parties, provided that the minimum pre-money valuation for any such investment shall not be less than $10 million. Additionally, HB was granted an option to effect an equity investment in the Company in up to $15 million within the next 12 months on mutually agreeable terms. If such investment is in fact consummated, the Company agreed to invest in the JV Company by way of a convertible loan an amount to HB’s pro-rata participating interest in the JV Company, which initially will be at 51%. Such loan may then be converted by the Company into share capital of the JV company at an agreed upon formula for determining JV Company valuation which in no event shall be less than $10 million. Under the JVA, the Company can require HB to sell to the Company its participating (including equity) interest in the JV Company in consideration for the issuance of the Company’s common stock based on an agreed upon formula for determining JV Company valuation which in no event shall be less than $10 million.

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13)    On July 11, 2018, the Company and Image Securities Ltd., a corporation with its registered office in Grand Cayman, Grand Caman Islands (“India Partner”) entered into a Joint Venture Agreement (the “India JVA”) pursuant to which the parties will collaborate in the in the development and/or marketing, clinical development and commercialization of cell therapy products in India (the “Cell Therapy Products”). The India Partner will collaborate with a network of healthcare facilities and a healthcare infrastructure as well as financial partners to advance the development and commercialization of the cell therapy products.

        The India JVA becomes effective upon the consummation of an equity investment by the India partner in the Company of $5 million within 150 days of the execution of the India JVA through the purchase of units of Orgenesis securities at a per unit purchase price payable into the Company of $6.24, with each unit comprised of one share of Company common stock and three-year common stock purchase warrant for an additional share of common stock at a per share exercise price of $6.24. Subject to the consummation of such equity investment in the Company, the Company is to advance to the JV Company a convertible loan in the amount of $5 million. The loan is convertible into equity capital of the JV Company at an agreed upon formula for determining JV Company valuation. The investment in the Company by the India Partner would be the consummation of the previously disclosed private placement subscription agreement entered into in December 2016 between the Company and an affiliate of the India Partner pursuant to which the closing of such subscription agreement was by the terms thereof delayed until such time as terms comprising the India JV were mutually agreed to.

         Under the India JVA, the India Partner agreed to invest in the JV $10 million within 12 months of the incorporation of the JV Company. If for whatever reason such investment is not made by the India Partner within such time, then Orgenesis is authorized to convert its above-referenced loan into 50% of the equity capital of the JV Company on a fully diluted basis, provided that if the pre-money valuation of the JV Company is then independently determined to be less than $5 million, then such conversion to be effected in the basis of such valuation.

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward-Looking Statements

This Quarterly Report on Form 10-Q and other reports filed by the Company from time to time with the U.S. Securities and Exchange Commission (collectively, the “Filings”) containcontains or may contain forward-looking statements within the meaning of 27A of the Securities Act of 1933, as amended, and information thatSection 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 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 in the Filings, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” 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. 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.

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.

Corporate Overview

Orgenesis Inc. is amonga vertically integrated service and research company in the firstfield of the regenerative medicine industry with a new breed of regenerative therapy companies with expertise and unique experience infocus on cell therapy development and manufacturing for advanced medicinal products serving the regenerative medicine industry. In addition, we are focused on developing a novel and proprietary cell therapy trans-differentiation technologies for the treatment of diabetes, with a revenue generating contract development and manufacturing service business to serve the regenerative medicine industry.

Our vertically integrated manufacturing capabilities are being used to serve to emerging technologies of other cell therapy markets in such areas as cell-based cancer immunotherapies and neurodegenerative diseases and also to optimize our abilities to scale-up our technologies for clinical trials and eventual commercialization of our proposed diabetes treatment. The combinationOur hybrid business model of combining our own proprietary cell therapy trans-differentiation technologies for the treatment of diabetes and a revenue-generating contract development and manufacturing service business provides us with unique capabilities and supports our business philosophymission of bringing to market significantaccelerating the development and ultimate marketing of breakthrough life-improving medical treatments.

We seek to differentiate our company from other cell therapy companies bythrough MaSTherCell Global, which consists of MaSTherCell and our wholly-owned, Belgian-based CDMO subsidiary, MaSTherCell S.A.,subsidiaries in Korea and a world-wide network of partnersIsrael, who have built a unique and fundamental base platform of know-how and expertise for manufacturing in a multitude of cell types manufacturing.types. The goal is to industrialize cell therapy for fast, safe and cost-effective production in order to provide rapid therapies for any market around the world. All theseMaSTherCell Global strives to provide services that are alreadyall compliant with GMP requirements, ensuring identity, purity, stability, potency and robustness of cell therapy products for clinical phase I, II, III through commercialization. The goal is to become the premier service provider in the regenerative medicine industry by leveraging the experience and expertise of MaSTherCell as a recognized leader in cell therapy development and manufacturing.

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            MaSTherCell is developing premier technologies for other cell therapy companies such as cell-based cancer immunotherapies and neoconservative diseases. Our vertical integration responds to the main challenges faced by most biotechnology companies such as cost of goods sold and logistics. Our global manufacturing network is envisioned as offering a global one-stop-shop manufacturing and logistics services and breakthrough technologies enabling promising therapies to more rapidly reach the market at a fraction of the costs.

            MaSTherCell currently operates facilities qualified under cGMPs in Belgium. We acquired MaSTherCell in March 2015. As the industry continues to mature and a growing number of cell therapy companies approach commercialization, we believe that MaSTherCell is well positioned to serve as an outsourcing manufacturing source for cell therapy companies.

            We are leveraginghave leveraged the recognized expertise and experience in cell process development and manufacturing of MaSTherCell, Atvio and our international global network of CDMO joint ventures,Curecell, in Israel and Korea, to build a global and fully integrated bio-pharmaceutical company in the cell therapy development and manufacturing area. We believe that cell therapy companies need to be global in order to truly succeed. In furtherance of that belief, we intend to expand our establishment of CDMO facilities to the United States and other international markets. We target the international manufacturing market as a key priority through joint-venture agreements that provide development capabilities, along with manufacturing facilities and experienced staff. All of these capabilities offered to third-parties will be mobilized for our internal development projects, allowing us to be in a position to bring new products to the patients faster and in a cost-effective way.

Our celltrans-differentiation technologies for treating diabetes, which we refer to as our cellular therapy technology for diabetes(“CT”) business, is based on the research work of Prof. Sarah Ferber,a technology licensed by our Chief Science Officer and a researcher at Tel Hashomer Medical Center, a leading medical hospital and research center in Israel (“THM”), who established a proof of conceptIsraeli Subsidiary, that demonstrates the capacity to induce a shift in the developmental fate of cells from the liver or other tissues and transdifferentiating (converting) them into “pancreatic beta cell-like” insulin-producing cells. Furthermore,Autologous Insulin Producing (“AIP”) cells for patients with Type 1 Diabetes, acute pancreatitis and other insulin deficient diseases. Moreover, those cells weremay be found to be resistant to autoimmune attack and to produce insulin in a glucose-sensitive manner in relevant animal models.models which significantly broadens the potential of the technology for other therapeutics areas; this has yet to be proven in human clinical trials. Our trans-differentiation technology for diabetes is based on the work of Prof. Sarah Ferber, our Chief Science Officer and a researcher at Tel Hashomer Medical Research Infrastructure and Services Ltd. (“THM”) in Israel. Our development for our cellular therapy business (CTB), which is conducted through our Israeli subsidiary,plan calls for conducting additional preclinical safety and efficacy studies with respect to diabetes and other potential indications.indications prior to initiating clinical trials. In parallel, we work on establishing the GMP manufacturing process which development is already accomplished.

Significant Recent Corporate HighlightsIn furtherance of our CT business, we are pursuing strategic partnerships to bring autologous cell and gene therapies to the clinic. In pursuit of this, the following factors are enabling this objective:

            Management continues•     Strategic relationships with other local partners in its effortsinternational countries where we currently may not operate. We intend to raise operating capital. In connection therewith,pursue working directly with hospitals and strategic groups to build relationships with the hospitals in January 2017 we entered into definitive agreements with an institutional investormaking available supply and future on-site manufacturing of therapeutic products, either for the private placement of units ofclinical stage or for the marketing stage. We intend to focus the partnerships on our securities for aggregate subscription proceeds to us of $16 million. The subscription proceeds are payable on a periodic basis through August 2018. Each periodic payment of subscription proceeds will be evidencedin-house technologies, although we can also support third party services by utilizing our standard securities subscription agreement. AsCDMO business.

•     Therapeutic collaborations licensed from academic centers around the world. Because of the date of this quarterly report on Form 10-Q,expected close relationships built with these academic hospitals, we also intend to build the investor has remittedservice, CRO and preclinical framework to us $4 million in subscription proceeds. Each unit is comprised of one share of our common stock and a warrant to purchase an additional share of common stock at a per share exercise price of $0.52. Pursuant to the investment, the investor designated a director to serve on our board of directors for an initial two-year period and thereafter so long as the investor holds at least 10% of the Company’s outstanding Common Stock. The investor’s right to designate the board designee is subject to the payment in full as provided in the definitive agreements of the remaining subscription proceeds.

            In January 2017, Servier appointed MaSTherCell forsupport the development of its CAR-T cell therapy manufacturing platform. Under the master service agreement, MaSTherCell is developing a CAR-T cell therapy manufacturing platform, which will enable industrialthese products.

•     Developing and commercial manufacturinglicensing of Servier cell therapy products. This is a critical step in development of these products for later stage clinical trial. Servier selected MaSTherCell because of its leading global cell therapy CDMO position as well as its essential broad expertise in immunotherapy products. MaSTherCell has a track record of designing and delivering cost-effective cell therapy manufacturing platforms. MaSTherCell anticipatestechnology systems. We expect that it will complete the development of the initial CAR-T platform in 2018.

            In May 2017, we improved the equity-debt ratio of our subsidiary MaSTherCell by converting the loan advanced to it in the amount of $1.1 million (EUR 1 million) into share capital of MaSTherCell.

            In June 2017, CRISPR, a leader in gene-editing based therapeutics, and MaSTherCell signed a service agreement for the development and licensing of certain technologies, such as interconnectivity systems (i.e. Internet of Things), automated systems, sensor technologies, media supply and other technology developments will enable us to manufacture on site in a closed system.

•     Additional CDMO expansion through Masthercell Global. We intend expand our existing global CDMO network in order to seek additional partnerships in the global CDMO business that allow us to expand local manufacturing of allogeneic CART-Tneeds during the clinical stage that have unique know-how regarding the market and a close relationship with third parties that may in the future want to use our existing CDMO network to supply their products.

We operate our CDMO and the CT business as two separate business segments.

Revenue Model

Companies developing cell therapies.

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            In September 2017, we fulfilled our obligation undertherapies need to decide early on in their approach to the joint venture agreement with Atvio dated May 10, 2016,transition from the lab to the clinic regarding the manufacturing and remitted the balance of $54 thousandproduction of the convertible loancells necessary for their respective treatments. Of the companies active in this market, only a small number have established their own GMP manufacturing facilities due to the aggregate amounthigh costs and expertise required to develop and maintain such production centers. In addition to the limitations imposed by a limited number of $1 million.

            As further discussed below,trained personnel and high infrastructure/operational costs, we believe that the industry faces a need for custom innovative process development and manufacturing solutions. In this context, we have grown total revenue from $6.4 million in our subsidiary MaSTherCell S.A., had revenues of approximately $6.7fiscal year November 30, 2016 to $10.1 million duringfor fiscal year November 30, 2017 and from $4.1 million for the ninesix months ended August 31, 2017 representing an increase of 49% over the same period last year.

            While we believe, the above developments position us to further our business development efforts and realize our business plan, we can provide no assurance that we will be successful in achieving our business plan.

Results of Operations

Comparison of the Three and Nine Months Ended AugustMay 31, 2017 to the Three and Nine Months Ended August 31,2016

            Our financial results$6.6 million for the three and ninesix months ended AugustMay 31, 2017 are summarized as follows in comparison to the three and nine months ended August 31, 2016:

  Three Months Ended August 31,  Nine Months Ended August 31, 
  2017  2016  2017  2016 
  (in thousands) 
Revenues$ 2,562 $ 1,849 $ 6,712 $ 4,501 
Cost of revenues 1,867  1,829  4,900  5,273 
Research and development expenses, net 500  775  1,906  1,663 
Amortization of intangible assets 423  408  1,201  1,217 
Selling, general and administrative expenses 3,184  1,279  7,887  4,618 
Financial expenses (income), net (2,032) 574  1,488  (645)
Share in losses of associated company 152  -  348  - 
Loss before income taxes$1,532 $ 3,016 $ 11,018 $ 7,625 

Revenues

            All2018. The increased revenues were derivedderive from our Belgian Subsidiary, MaSTherCell S.A. Manufacturing activities show a significant increase of revenues in line with the company’s Business Plan. It reflects market recognition in CDMO business expertise and the adequacy of the Company’s strategy with industry need. Revenues diversification by source in the CDMO segment together with a leading position in CAR-T cell therapy development and manufacturing strengthen MaSTherCell resilience.

            Our revenues for the three and nine months ended August 31, 2017 were $2,562 thousand and $6,712 thousand, respectively, as compared to $1,849 thousand and $4,501 thousand for the corresponding periods in 2016, representing an increase of 39% and 49% respectively, compared to the same period last year.

  Three Months Ended August 31,  Nine Months Ended August 31, 
  2017  2016  2017  2016 
  (in thousands)  (in thousands) 
Services$ 2,015 $ 1,086 $ 5,600 $ 2,430 
Goods 547  763  1,112  2,071 
Total revenues$ 2,562 $ 1,849 $ 6,712 $ 4,501 

            The increase in revenues for each of the three and nine months ended August 31,2017 is attributable to an increase in the volume of the services provided by our CDMO segment, namely our Belgian-based subsidiary, MaSTherCell, resulting from the extension by MaSTherCell of existingthrough its customer service contracts with existing customers and the entry into new customer service contracts with leading biotech companies, as well as from revenues generated from existing manufacturing agreements.

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Recent Significant Developments

Funding from SFPI

On November 15, 2017, we, MaSTherCell and the Belgian Sovereign Funds Société Fédérale de Participations et d'Investissement (“SFPI”) entered into a Subscription and Shareholders Agreement (the “Agreement”) pursuant to which SFPI completed an equity investment in MaSTherCell in the aggregate amount of €5million (approximately $5.9 million), for approximately 16.7% of MaSTherCell. Following the SFPI investment in MaSTherCell, in November 2017, MaSTherCell announced the expansion by 600m² of its facility in Belgium with a dedicated, late-stage clinical and commercial cGMP unit, anticipated to be operational by the fourth quarter of 2018. This new expansion enables MaSTherCell to augment its commercial capabilities in Europe with five state-of-the-art advanced manufacturing units and extended GMP-accredited quality control (QC) laboratories. On June 13, 2018, SPFI has paid into MaSTherCell S.A. the balance of Euro 1.9 million (approximately $2.3 million).

Collaboration Agreements/ Joint Ventures

On June 19, 2018, we and Mircod Limited, a company formed under the laws of Cyprus (“Mircod”) entered into a Collaboration and License Agreement for the research, development and commercialization of potential key technologies related to biological sensing for our clinical development and manufacturing projects (the “Development Project”). Within 45 days of the execution of the Collaboration Agreement, the parties are to approve a written project development plan outlining each party’s responsibilities with respect to the Development Project, and we will be funding the projected development costs as outlined in the development plan. Under the terms of the Collaboration Agreement, we remitted to Mircod an upfront payment of $50,000.

On July 11, 2018, we and HekaBio K.K., a corporation organized under the laws of Japan ("HB") entered into a Joint Venture Agreement (the "JVA") pursuant to which the parties will collaborate in the clinical development and commercialization of regeneration and cell and gene therapeutic products (hereinafter the "Products") in Japan. The parties intend to pursue the joint venture through a newly established Japanese company (hereinafter the "JV Company") which the Company by itself, or together with a designee, will hold a 49% participating interest therein, with the remaining 51% participating interest being held by HB. HB will fund, at its sole expense, all costs associated with obtaining the requisite regulatory approvals for conducting clinical trials, as well as performing all clinical and other testing required for market authorization of the Products in Japan.

On July 11, 2018, we and Image Securities Ltd., a corporation with its registered office in Grand Cayman, Grand Caman Islands ("India Partner") entered into a Joint Venture Agreement (the "India JVA") pursuant to which the parties will collaborate in the in the development and/or marketing, clinical development and commercialization of cell therapy products in India (the "Cell Therapy Products"). The India Partner will collaborate with a network of healthcare facilities and a healthcare infrastructure as well as financial partners to advance the development and commercialization of the cell therapy products.

The India JVA becomes effective upon the consummation of an equity investment by the India partner in the Company of $5 million through the purchase of units of Orgenesis securities at a per unit purchase price payable into the Company of $6.24, with each unit comprised of one share of Company common stock and three-year common stock purchase warrant for an additional share of common stock at a per share exercise price of $6.24.

Consolidation of CDMO Entities and Strategic Funding

On June 28, 2018, the Company and Masthercell Global Inc., a Delaware company and a newly formed subsidiary of Orgenesis the Company that holds our business relating to the third party contract manufacturing for cell therapy companies (CDMO) (“Masthercell Global”), Great Point Partners, LLC, a manager of private equity funds focused on growing small to medium sized heath care companies (“Great Point”), and certain of Great Point’s affiliates, entered into a series of definitive strategic agreements intended to finance, strengthen and expand Orgenesis’ CDMO business. In connection therewith, the Company, Masthercell Global and GPP-II Masthercell, LLC, a Delaware limited liability company (“GPP-II”) and an affiliate of Great Point entered into Stock Purchase agreement (the “SPA”) pursuant to which GPP-II purchased 378,000 shares of newly designated Series A Preferred Stock of Masthercell Global (the “Masthercell Global Preferred Stock”), representing 37.8% of the issued and outstanding share capital of Masthercell Global, for cash consideration to be paid into Masthercell Global of up to $25 million, subject to certain adjustments (the “Consideration”). Orgenesis holds 622,000 shares of Masthercell Global’s Common Stock, representing 62.2% of the issued and outstanding equity share capital of Masthercell Global. An initial cash payment of $11.8 million of the Consideration was remitted at closing, with a follow up payment of $6,600,000 to be made in each of years 2018 and 2019 (the “Future Payments”), or an aggregate of $13.2 million, if (a) Masthercell Global achieves specified EBITDA and revenues targets during each of these years, and (b) the Orgenesis’ shareholders approve certain provisions of the Stockholders’ Agreement referred to below on or before December 31, 2019. None of the future Consideration amounts, if any, will result in an increase in GPP-II’s equity holdings in Masthercell Global beyond the 378,000 shares of Series A Preferred Stock issued to GPP-II at closing. The proceeds of the investment will be used to fund the activities of Masthercell Global and its consolidated subsidiaries. Notwithstanding the foregoing, GPP-II may, in its sole discretion, elect to pay all or a portion of the future Consideration amounts even if the financial targets described above have not been achieved and the Orgenesis Stockholder Approval has not been obtained.

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Masthercell Global, through the Masthercell Global Subsidiaries, will be engaged in the business of providing manufacturing and development services to third parties related to cell therapy products, and the creation and development of technology, and optimizations in connection with such manufacturing and development services for third parties. Under the terms of these agreements, the Company agreed that so long as it owns equity in Masthercell Global and for two years thereafter it will not engage in the CDMO Business, except through Masthercell Global (but may continue to engage in its other areas of business). In addition, except for certain limited circumstances, each of Orgenesis and GPP-II agreed to not recruit or solicit or hire any officer or employee of Masthercell Global that was or is involved in the CDMO Business.

We intend, through our direct subsidiaries, to continue to engage in the manufacturing, researching, marketing, developing, selling and commercializing (either alone or jointly with third parties) products that are not directly related to the CDMO business, including, joint ventures, collaboration, partnership or similar arrangement with a third party.

Results of Operations

Comparison of the Three Months Ended May 31, 2018 to the Three Months Ended May 31, 2017

Our financial results for the three months ended May 31, 2018 are summarized as follows in comparison to the three months ended May 31, 2017:

  Three Months Ended May 31, 
  2018  2017 
  (in thousands) 
Revenues$ 3,987 $ 2,298 
Cost of sales 2,195  1,128 
Research and development expenses, net 788  665 
Amortization of intangible assets 445  397 
Selling, general and administrative expenses 3,323  2,432 
Share in losses of associated company (576) (107)
Financial expense (income), net (587) 503 
Loss before income taxes$ 2,753 $ 2,934 

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Revenues

  Three Months Ended May 31, 
  2018  2017 
  (in thousands) 
Services$ 2,993 $ 2,202 
Goods 994  96 
       
Total$ 3,987 $ 2,298 

All revenues were derived from our Belgian Subsidiary, MaSTherCell S.A. We believe that revenue diversification by source in the CDMO segment, together with a leading position in immunotherapy and, in particular, CAR T-cell therapy development and manufacturing, strengthen MaSTherCell’s resilience in the industry.

Our revenues for the three months ended May 31, 2018 were $3,987 thousand, as compared to $2,298 thousand for the corresponding period in 2017, representing an increase of 73.5% . The increase in revenues for the three months ended May 31, 2018 compared to the corresponding period in 2017 is attributable to an increase of $1.7 million in the volume of the services provided by MaSTherCell, resulting primarily from the extension of existing customer service contracts with biotech clients, as well as from revenues generated from existing manufacturing agreements.

In January 2017, MaSTherCell signed a master service agreement with Servier for the development of a manufacturing platform for allogeneic cell therapies. Under the master service agreement, MaSTherCell is developing a CAR T-cell therapy manufacturing platform, which will enable industrial and commercial manufacturing of Servier's cell therapy products. This is a critical step in the development of these products for later stage clinical trials.

In June 2017, MaSTherCell signed an agreement with CRISPR Therapeutics to develop and manufacture allogeneic CAR T-cell therapies. MaSTherCell will be responsible for the development and cGMP manufacturing of CTX101 for use in clinical studies. CTX101 is an allogeneic CAR T-cell therapy currently in development by CRISPR Therapeutics for the treatment of CD19 positive malignancies.

Expenses

Cost of Revenues

  Three Months Ended May 31, 
  2018  2017 
  (in thousands) 
Salaries and related expenses$ 975 $ 502 
Professional fees and consulting services -  87 
Raw materials 992  238 
Depreciation and amortization expenses, net 169  211 
Other expenses 59  90 
 $ 2,195 $ 1,128 

Cost of revenues for the three and nine months ended AugustMay 31, 20172018 were $1,867$2,195 thousand, and $4,900 thousand, respectively, as compared to $1,829$1,128 thousand, and $5,237 thousand, respectively, during the same periodsperiod in 2016,2017, representing an increase and decrease of 2% and 7%, respectively.94.6% . The decrease in cost of revenuesincrease for the ninethree months periodended in 2017May 31, 2018, as compared to the corresponding period in 20162017 is primarily attributableattributed to a decreasethe following: (i) An increase in salaries and related expenses associated withprimarily attributable to an increase of 77% in head-count in production and development department. The increase was partially offset by a decrease attributable to an internal transformation program implemented in MaSTherCell in the second quarter of 2017 to evolve from an organization based on project to a matrix organization supported by transversal departments focusing on value creation. As part of the program, we changed the business positions of certain employees from laboratory managers to general manager positions in order to reflect the current period’s business activity. Consequently, these changes in business positions resulted in a subsequent shift of costs into general and administration expenses. (ii) An increase of $760 thousand in raw materials due to the growth in the volume of the services provided by MaSTherCell, as well as from revenues generated from existing manufacturing agreements.

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Research and Development Expenses

  Three Months Ended May 31, 
  2018  2017 
  (in thousands) 
Salaries and related expenses$ 365 $ 258 
Stock-based compensation 157  186 
Professional fees and consulting services 253  66 
Lab expenses 149  377 
Other research and development expenses 104  55 
Less – grant (240) (277)
Total$ 788 $ 665 

Research and Development Expensesdevelopment expenses for the three and nine months ended AugustMay 31, 20172018 were $500$788 thousand, and $1,906 thousand, respectively, as compared to $775$665 thousand and $1,663 thousand, respectively, for the same periodsperiod in 2016,2017, representing a decrease of 35% andan increase of 15%, respectively.18%. The increase in research and development expenses in the ninethree months period in 2017ended May 31, 2018 is primarily attributable to an increase in laboratoryprofessional fees and salaries and related expenses resulting fromincurred as a result of an increase in our pre-clinical studies in the U.S., Israel and Belgium. The increase in Researchresearch and Developmentdevelopment expenses is a reflection ofreflects management’s determination to move transdifferentiatingfocus on moving our trans-differentiation technology with first indication toin Type 1 Diabetes Type I to the next the stage towards clinical studies.trials.

Selling, General and Administrative Expenses

  Three Months Ended May 31, 
  2018  2017 
  (in thousands) 
Salaries and related expenses$ 1,101 $ 834 
Stock-based compensation 580  238 
Accounting and legal fees 597  453 
Professional fees 210  331 
Rent and related expenses 296  60 
Business development 356  136 
Expenses related to a joint venture -  344 
Other general and administrative expenses 183  36 
Total$ 3,323 $ 2,432 

Selling, general and administrative expenses for the three and nine months ended AugustMay 31, 20172018 were $3,184$3,323 thousand, and $7,887 thousand, respectively, as compared to $1,279 and $4,618$2,432 thousand respectively, for the same periodsperiod in 2016,2017, representing an increase of 149% and 71% respectively.36.6% . The increase in selling, general and administrative expenses in each ofthe three and nine monthmonths ended May 31, 2018 compared to the same period in 2017 periods is primarily attributable to the following: (i) An increase in salaries as result of additional managerial positions, as well as an internal transformation program implemented in MaSTherCell in the following:

1.

Stock based compensation: (i)second quarter of 2017 to evolve from an organization based on projects to a matrix organization supported by transversal departments focusing on value creation. As part of the program, we altered the business designations of certain employees from laboratory managers to general manager positions in order to reflect the current period’s business activity. Subsequently, these changes in position designation resulted in a shift costs from cost of revenues. (ii) An increase of approximately $207 thousand in salaries as a result of bonus paid to the CEO and certain employees. (iii) An increase of $342 thousand in non-cash stock-based compensation resulting from grants of options to consultants and key personnel during the first half of 2018. (iv) An increase of $236 thousand is mainly results to rental of additional space for new production area and offices in MasTherCell due to an increase in non-cash stock based compensation resulting from grants of options to employees during December 2016 offset by decrease in stock based compensation in the 2017 periods attributable to the termination of the vesting period of options and shares awarded to executives and consultants in 2016.

2.

Corporate governance, reflecting our commitment to remediate to material weaknesses, an increase in (i) salaries and related expenses resulting from the retention of new senior management at MaSTherCell and new accounting staff in our financial department in Israel and (ii) professional fees resulting from the appointment of a qualified independent third party to assess our risk management framework to manage enterprise risk and (iii) accounting and legal expenses associated with exploring new strategic collaboration arrangements, new capital raising initiatives, repayment of bonds issued by MaSTherCell and preparation of applications for new patents under our CTB division.

3.

CTB intellectual property: legal expenses associated with the preparation of applications for new patents under our CTB division.

4.

Setting-up a global CDMO network : (i) expenses related to a joint venture which primarily consisted of salary expenses and set up related cost of the new production facility in Korea under our joint venture with CureCell.

5.

Legal expenses associated with exploring new strategic collaboration arrangements, new capital raising initiatives.

            The expenses incurred in Item (2) above [Corporate Governance] reflects our commitment to address material weaknesses in our internal controls. Our expenses under Item 4 above [Setting up a Global CDMO Network] reflects our mission to build a global fully integrated bio-pharmaceutical company in the cell therapy development and manufacturing area. We target the international manufacturing market as a key priority through joint-venture agreements that provide development capabilities, along with manufacturing facilities and experienced staff, offering a unique response to industry challenges;CDMO operation.

2231


            We apply a strict monitoring of the selling, general and administrative expenses and has implemented a shared services program in corporate functions to benefit from intra-group cost reduction and synergies.

Financial Expenses, (Income), net

 Three Months Ended August 31,  Nine Months Ended August 31,  Three Months Ended May 31, 
 2017  2016  2017  2016  2018  2017 
 (in thousands)     (in thousands)  (in thousands) 
            
            
Increase (decrease) in fair value of warrants and financial liabilities measured at fair value$ (2,349)$ 555 $ (1,343)$ (1,057)
Stock-based compensation related to warrants granted to bondholder and shares and units granted to creditor (273) -  1,351  - 
Interest expense on loans and convertible loans 300  75  987  339 
Changes in fair value financial liabilities and assets measured at fair value$ (606)$ (1,005)
Stock-based compensation related to warrants granted to bondholder -   
Stock-based compensation related to shares to be issued to creditor -  1,084 
Interest expense on convertible loans and loans 177  288 
Foreign exchange loss, net 289  (111) 481  (75) (167) 131 
Other expenses 1  55  12  148  9  5 
Total$ (2,032)$ 574 $1,488 $ (645)$ (587)$ 503 

Financial expenses, (income), net for the three months ended AugustMay 31, 2017,2018, decreased by 454% or $2,606$1,090 thousand, compared to the same period in 2016.2017. The decrease in financial expenses is mainly attributable to a decrease of $2.9 million$1,084 thousand of stock-based compensation expenses related to convertible loan agreement repaid in the change2017 as well as a decrease in interest expenses on convertible loans due to conversion of the fair valuemajority of warrants due to the fact that, inconvertible loans during the three months ended August 31, 2017, there was a strong impactFebruary 28, 2018.

Comparison of the decreaseSix Months Ended May 31, 2018 to the Six Months Ended May 31, 2017

Our financial results for the six months ended May 31, 2018 are summarized as follows in comparison to the six months ended May 31, 2017:

  Six Months Ended May 31, 
  2018  2017 
  (in thousands) 
Revenues$ 6,623 $ 4,150 
Cost of sales 3,839  3,033 
Research and development expenses, net 1,554  1,406 
Amortization of intangible assets 881  777 
Selling, general and administrative expenses 6,667  4,703 
Share in losses of associated company (530) (196)
Financial expense, net 2,094  2,578 
Other income 316  - 
Loss before income taxes$ 8,626 $ 8,544 

Revenues

  Six Months Ended May 31, 
  2018  2017 
  (in thousands) 
Services$ 5,019 $ 3,585 
Goods 1,604  565 
       
Total$ 6,623 $ 4,150 

Our revenues for the six months ended May 31, 2018 were $6,623 thousand, as compared to $4,150 thousand for the corresponding period in 2017, representing an increase of 60%. The increase in revenues for the six months ended May 31, 2018 compared to the corresponding period in 2017 is attributable to an increase of $2.2 million in the share price,volume of the services provided by MaSTherCell, resulting primarily from the extension of existing customer service contracts with biotech clients, as well as from revenues generated from existing manufacturing agreements. The increase was partially offset by a MaSTherCell client project closure in 2016 and a settlement in February 2018. The income derived from such settlement totaling $316 thousand is recognized as other income for the three months ended February 28, 2018.

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In January 2017, MaSTherCell signed a master service agreement with Servier for the development of a manufacturing platform for allogeneic cell therapies. Under the master service agreement, MaSTherCell is developing a CAR T-cell therapy manufacturing platform, which was $0.32 on August 31,will enable industrial and commercial manufacturing of Servier's cell therapy products. This is a critical step in the development of these products for later stage clinical trials.

In June 2017, as opposedMaSTherCell signed an agreement with CRISPR Therapeutics to $0.59 ondevelop and manufacture allogeneic CAR T-therapies. MaSTherCell will be responsible for the development and cGMP manufacturing of CTX101 for use in clinical studies. CTX101 is an allogeneic CAR T-cell therapy currently in development by CRISPR Therapeutics for the treatment of CD19 positive malignancies.

Expenses

Cost of Revenues

  Six Months Ended May 31, 
  2018  2017 
  (in thousands) 
Salaries and related expenses$ 1,742 $ 1,536 
Professional fees and consulting services -  173 
Raw materials 1,643  756 
Depreciation and amortization expenses, net 328  422 
Other expenses 126  146 
 $ 3,839  3,033 

Cost of revenues for the six months ended May 31, 2017.2018 were $3,839 thousand, as compared to $3,033 thousand, during the same period in 2017, representing an increase of 27%. The increase for the six months ended in May 31. 2018, as compared to the corresponding period in 2017 is primarily attributed to the following: (i) An increase in salaries and related expenses mainly results of an increase in head-count in production and development department. The Increase was partially offset by a decrease attributable to an internal transformation program implemented in MaSTherCell in the second quarter of 2017 to evolve from an organization based on project to a matrix organization supported by transversal departments focusing on value creation. As part of the program, we changed the business positions of certain employees from laboratory managers to general manager positions in order to reflect the current period’s business activity. Consequently, these changes in business positions resulted in a subsequent shift of costs into general and administration expenses. (ii) An increase of $887 in raw materials due to increase in the volume of the services provided by MaSTherCell, as well as from revenues generated from existing manufacturing agreements.

Research and Development Expenses

  Six Months Ended May 31, 
  2018  2017 
  (in thousands) 
Salaries and related expenses$ 651 $ 551 
Stock-based compensation 339  453 
Professional fees and consulting services 440  110 
Lab expenses 310  550 
Other research and development expenses 173  96 
Less – grant (359) (354)
Total$ 1,554 $ 1,406 

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Research and development expenses for the six months ended May 31, 2018 were $1,554 thousand, as compared to $1,406 thousand for the same period in 2017, representing an increase of 11%. The increase in research and development expenses in the six months ended May 31, 2018 is primarily attributable to professional fees incurred as a result of an increase in our pre-clinical studies in the U.S., Israel and Belgium. The increase in research and development expenses reflects management’s focus on moving our trans-differentiation technology with first indication in Type 1 Diabetes to the next the stage towards clinical trials.

Selling, General and Administrative Expenses

  Six Months Ended May 31, 
  2018  2017 
  (in thousands) 
Salaries and related expenses$ 1,903 $ 1059 
Stock-based compensation 1,488  631 
Accounting and legal fees 925  854 
Professional fees 974  725 
Rent and related expenses 576  304 
Business development 665  260 
Expenses related to a joint venture -  602 
Other general and administrative expenses 136  268 
Total$ 6,667 $ 4,703 

Selling, general and administrative expenses for the six months ended May 31, 2018 were $6,667 thousand, as compared to $4,703 thousand for the same period in 2017, representing an increase of 42%. The increase in selling, general and administrative expenses in the six-month period in 2018 compared to the same period in 2017 is primarily attributable to the following: (i) An increase of $844 thousand in salaries and related expenses is mainly a result of An increase in salaries as result of additional managerial positions as well as an internal transformation program implemented in MaSTherCell in the second quarter of 2017 to evolve from an organization based on projects to a matrix organization supported by transversal departments focusing on value creation. As part of the program, we altered the business designations of certain employees from laboratory managers to general manager positions in order to reflect the current period’s business activity. Subsequently, these changes in position designation resulted in a shift costs from cost of revenues. (ii) An increase of $857 thousand in non-cash stock-based compensation mainly resulting from grants of options to consultants and key personnel during the first half of 2018. (iii) An increase in professional fees and business development, primarily attributable to costs incurred in the establishment of a global CDMO network and related expenses of implementing a Quality Management System of MaSTherCell to the new production facility in Korea under our joint-venture with CureCell Co. Ltd., our CDMO partner in Korea. (iv) An increase of $405 thousand is mainly results to rental of additional space for new production area and offices in MasTherCell due to increase in CDMO operation.

Financial Expenses, net

  Six Months Ended May 31, 
  2018  2017 
  (in thousands) 
Changes in fair value financial liabilities and assets measured at fair value$ (489)$ 64 
Stock-based compensation related to shares to be issued to creditor -  1,624 
Interest expense on convertible loans and loans 2,659  686 
Foreign exchange loss, net (94) 194 
Other expenses 18  10 
Total$ 2,094 $ 2,578 

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Financial expenses, (income), net for the ninesix months ended AugustMay 31, 2017, increased2018, decreased by 331%19%, or $2,133$484 thousand, compared to the same period in 2016.2017. The increasedecrease in financial expenses is mainly attributable to anthe following: (i) An increase of $1.32 million$453 thousand in the Stock-based compensation related attributable to $20fair value of the put option of Atvio (ii) A decrease of $1,111 thousand of stock-based compensation expenses related to 102,822 warrants granted to the remaining bondholderconvertible loan agreement repaid in consideration2017 (iii) A decrease of the extension of his bonds and $1.3 milliond $520 thousand of stock-based compensation expenses related to restricted shares and warrants issued in accordance with the terms of the convertible loan agreements.agreement dated January 23, 2017. The decrease was partially offset by an increase of $2,148 thousand in interest expenses on convertible loans due to recognition of the unrecognized discount related to a beneficial conversion feature as additional interest expenses upon conversion of convertible loans.

Working Capital Deficiency

 August 31,  November 30,  May 31,  November 30, 
 2017  2016  2018  2017 
 (in thousands)     (in thousands) 
Current assets$ 5,674 $ 4,205 $ 13,738 $ 7,295 
Current liabilities 17,571  14,576  12,972  16,914 
Working capital deficiency$ (11,897)$ (10,371)
Working capital (deficiency)$ 766 $ (9,619)

Current assets increased by $1.5 million,$6,443 thousand, which was primarily attributable to anthe following: (i) An increase in cash and cash equivalents due to proceeds from private placements of debt and equity securities during the first six-month period of 2018 (ii) An increase of $1.7$566 thousand in grant receivables primarily attributable to an approval of a new grant in MaSTherCell from Intitule ICONE with a financial support of Euro 1 million ($1.2 million) in accounts receivable and $0.9program for development of iPS-derived Cortical Neurons (iii) An increase in prepaid expenses andof other receivables mainlyin amount of 1.9 million Euro ($2.3 million) related to SFPI investment paid to MaSTherCell on June 13, 2018 (iv) An increase of $792 in put option derivative due to increase of $453 thousand in the convertible loan invested in CureCell which was invested in the equipmentits fair value and constructionclassification of the Korean CDMO facility as part of our strategy to build up a global cell therapy development and manufacturing area.$339 from long-term assets into current assets.

Current liabilities increaseddecreased by $3 million,$3,942 thousand, which was primarily attributable to a decrease (i) of $2.2 million in current maturities of convertible loans due to the conversion of the outstanding amounts on these loans into units of shares of common stock and warrants in the first half of 2018 and (ii) of $657 thousand in employees and related payables relating primarily to a thirteen-month salary accrual that was paid in December 2017. (iii) A decrease of $1,857 thousand in account payable and accrued expenses and other payables mainly as a results of new payment schedule process and payment of debts to services providers during the six months ended May 31, 2018. The decrease was partly offset by an increase (i) of $1.7 million in advanced payments on account of grant in connection with the new grant approved by the DGO6 to support a clinical study in Germany and Belgium (ii) of $3.7 million$985 thousand in deferred income due upfront and paid by our new and old customers under new agreements signed in the CDMO segment. The increase in deferred income reflects the financial orthodoxy applied in the CDMO area. The increase was partly offset by a decrease (i) of $2.5 million due to repayments of loans and convertible bonds (ii) of $0.1 million in convertible bonds due to conversion.

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Liquidity and Financial Condition

 Nine Months Ended August 31,  Six Months Ended May 31, 
 2017  2016  2018  2017 
 (in thousands)  (in thousands) 
Net loss$ (11,511)$ (6,312)$ (7,953)$ (8,616)
      
Net cash used in operating activities (3,436) (3,177) (6,905) (1,778)
Net cash used in investing activities (1,443) (1,049) (2,979) (902)
Net cash provided by financing activities 4,350  317  11,103  2,354 
Decrease in cash and cash equivalents$ (529)$ (3,909)
Increase (decrease) in cash and cash equivalents$ 1,219 $ (326)

Since inception, we have funded our operations primarily through the sale of our securitiesprivate placements and more recently,debt instruments and through revenuerevenues generated from the activities of MaSTherCell, our Belgian Subsidiary. As of AugustMay 31, 2017,2018, we had negativepositive working capital of $12$0.8 million, including cash and cash equivalents and restricted cash of $0.8$4.9 million.

35


Net cash used in operating activities was approximately $3.4$6.9 million for the ninesix months ended AugustMay 31, 2017,2018, as compared with net cash used in operating activities of approximately $3.1$1.8 million for the same period in 2016.2017. We successfully expanded our pre-clinical studies in the U.S., Israel and Belgium. The increase reflects management’s focus on moving our trans-differentiation technology with first indication in Type 1 Diabetes to the next the stage towards clinical trials. We also expended our global activity of the CDMO division while maintainmaintaining the same level of cash used in operating activities as a result of the increased revenues at our subsidiary MaSTherCell, thereby significantly increasing gross profit and generating cash to pay our ongoing operating expenses. Additionally, major part of our services providers was paid during the six months ended May 31, 2018.

Net cash used in investing activities for the ninesix months ended AugustMay 31, 20172018 was approximately $1.4$2.9 million, as compared with approximately $ 1$0.9 million for the same period in 2016.2017. Net cash used in investing activities was primarily for additions to fixed assets at our subsidiary, MaSTherCell, and investments in our joint venture with Atvio.CureCell.

During the ninesix months ended AugustMay 31, 2017,2018, our financing activities consisted of (i) proceeds from private placements of our equity securities and exercise of equity-linked instruments in the following:

            •        Closing on $4net amount of approximately $10.7 million net of transaction costs in private placement equity offerings through the issuance of 7,786,788 million1,766,369 restricted shares of common stock and additional 1,638,292 three-year common stock purchase warrants for an additional 7,786,788 and 230,923 shares of our common stock exercisable at a per share exercise price of $0.52 or $0.65, respectively.

            •        Closing on $4.7 million, in private placement debt offerings through the$6.24 and (ii) proceeds of $720 thousand from issuance of 1,746,063 warrants and our convertible promissory notes with maturity datesloans from July 2016 to January 2018. Through May 31, 2018, these convertible loans were converted into units of between six and twenty-four months, convertible as of August 31, 207 into 10,030,917 shares of our common stock and 7,695,260 three-year warrants to purchase up to an additional 7,695,260 shares of our common stock at a per share exercise price of $0.52.the Company's securities.

Liquidity & Capital Resources Outlook

            Management believesWe believe that funds on hand, as well as the subscription proceeds of $12 million that we anticipate receiving on a periodic basis from June 2017 through August 2018 (out of a total of $16 million subscription proceeds that we are to receive through such date), will allow us to conduct operations as presently conducted through the end of 2018. We intend to raise additional operating capital in order to further expand the scope of our operations and realize our multi- year business plan of future years and will likelyprovide sufficient liquidity to fund our operating needs for the next 12 months. However, there are factors that can impact our ability continue to fund our operating needs, including:

•  

Our ability to expand sales volume, which is highly dependent on implementing our growth strategy in MaSTherCell Global;

•  

Restrictions on our ability to continue receiving government funding for our CT business;

•  

Additional CDMO expansion into other regions that we may decide to undertake; and

•  

The need for us to continue to invest in operating activities to remain competitive or acquire other businesses and technologies and to complement our products, expand the breadth of our business, enhance our technical capabilities or otherwise offer growth opportunities.

If we cannot effectively manage these factors, we may need to raise additional capital before such date to fund our operating capital in fiscal 2019 in orderneeds.

From December 1, 2017 to maintain operations. Without additional sources of cash and/or the deferral, reduction, or elimination of significant planned expenditures and debt repayment, we may not have the cash resources to continue as a going concern thereafter.

            To meet our short and long-term liquidity needs, we expect to use existing cash balances, cash from our revenue generating activities and the subscription proceeds anticipated periodically through the end of fiscal year 2018, as well as a variety of other means, including raising capital through potential issuances of debt or equity securities in public or private financings, partnerships and/or collaborations. In addition, we will continue to seek, as appropriate, grants for expanding our facility in Belgium and scientific and clinical studies from various governmental agencies and foundations. There can be no assurance that additional financing will be available when needed or, if available, that can be obtained on commercially reasonable terms. If we will not be able to obtain the additional financing on a timely basis as required, or generate significant material revenues from operations, we will not be able to meet our other obligations as they become due and will be forced to scale down or perhaps even cease our operations.

24


Going Concern

            The accompanying condensed consolidated financial statements have been prepared assuming that we will continue as a going concern. As of August 31, 2017, we have accumulated losses of approximately $41 million. Although we are now showing positive revenue and gross profit trends in our CDMO division, we expect to incur further losses in the CTB division. Presently, we don’t not have sufficient cash to meet our requirements in the following twelve months. These factors raise substantial doubt about our ability to continue as a going concern. Our continuation as a going concern is dependent on our ability to obtain additional financing as may be required and ultimately to attain profitability. In the event that the remaining subscription proceeds from a private placement with an institutional investor referred to below, in the aggregate amount of $12 million (out of total committed amount $16 million) will not be paid periodically through August 2018, then we will need to raise significant funds in order to continue to meet our liquidity needs, realize our business plan and maintain operations. The Company’s current cash balance is not sufficient to support its operations as presently conducted or permit it to take advantage of business opportunities that may arise. Management of the Company is continuing its efforts to generate quality of earnings from its CDMO business and to secure funds through equity and/or debt instruments for its operations and business opportunities investments.

            The condensed consolidated financial statements do not include any adjustments that might result from the outcomedate of this uncertainty. There can be no assurance that management will be successfulreport on Form 10-Q, we raised an aggregate of $19.5 million in implementing a business plan or thatprivate placements of our equity and equity-linked securities and convertible loans.

For the successful implementation of a business plan will actually improve our operating results. Ifsix months ended May 31, 2018, we unable to obtain the necessary capital, we may have to cease operations.

            We havehad been funding operations primarily from the proceeds from private placements of our convertible debt and equity securities and from revenues generated by MaSTherCell. From December 20162017 through August 2017,May 2018, we received, through MaSTherCell, proceeds of approximately $6.1$5.7 million in revenues and accounts receivable from customers and $9$11.7 million from the private placement to accredited investors of our equity and equity linkedequity-linked securities and convertible loans, outloans.

The equity investment in November 2017 by SFPI in MaSTherCell of €5 million (approximately $5.9 million), which $3.5includes the conversion of €1 million arein an outstanding loan by SFPI to MaSTherCell, will cover costs associated with an expansion of MaSTherCell’s manufacturing and production capabilities.

We believe that the investment consummated in June 2018 by an affiliate of Great Point in our newly formed subsidiary, Masthercell Global, which included an initial gross subscription amount of $11.8 million and, subject to meeting certain specified financial targets over the course of 2018 and 2019, an additional $13.2 million, should cover the costs associated with the current business plan of Masthercell Global.

From June 1 through July 15, 2018, we raised $1 million from the institutional investor with whom we entered into definitive agreements in January 2017 for the private placement of units of our securities for aggregate subscription proceeds to us of $16 million. The subscription proceeds aremillion payable on a periodic basis through August 2018. In addition, from September 1, 2017 through October 16, 2017,during this same period, we raised an additional $1.1$4.5 million from assignees of such investor who purchased units under the proceedsoriginal subscription agreement then available. Following such investments, $12.5 million of a private placementthe committed subscription amount under such institutional investor’s agreement has been remitted to certain accredited investors of our equity and equity linked securities and we received, through MaSTherCell, proceeds of approximately $1 million in accounts receivable from its customers.the Company.

Cash Requirements

            Our plan of operation during the next twelve months as of August 31, 2017 is to:

Continue our activities according to the work plan approved by the DGO6;
Explore options for collaboration and additional grants in the U.S.; and
Support our manufacturing activity in Europe.

            We estimate that our operating resources, expenses and debt servicing for the next twelve months as of August 31, 2017 will be as follows:

Resources$ *36,819
Expenses and debt servicing(25,142)
Total$ 11,675

2536


* The amount of cash resources include the subscription proceeds we are to receive on a periodic basis through August 2018 in the aggregate net amount of $11.4 million.

Future Financing

            We will require additional funds to implement our growth strategy for our business. In addition, while we have received various grants that have enabled us to fund our clinical developments, these funds are largely restricted for use for other corporate operational and working capital purposes. We may raise the additional funds required through equity financing, debt financing, or other sources, which may result in further dilution in the equity ownership of our shares. There can be no assurance that additional financing will be available when needed or, if available, that can be obtained on commercially reasonable terms. If we will not be able to obtain the additional financing on a timely basis as required, or generate significant material revenues from operations, we will not be able to meet our other obligations as they become due and will be forced to scale down or perhaps even cease our operations.

Off-Balance Sheet Arrangements

The Company has no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on the Company’s 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

            The Company maintainsAs of May 31, 2018, we conducted an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer regarding the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rule 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934 (the "Exchange Act"). The term "disclosure controls and procedures" means controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in the Company’s reports filedthat it files or submits under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the requisite time periods specified in the SEC’s rules and forms, and that such disclosure controls and procedures were effective to ensure that information required to be disclosed by the company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’sits management, including the Company’s president and chief executive officer (who is the Company’sits principal executive officer) and the Company’s chief financial officer, treasurer, and secretary (who is the Company’s principal financial officer and principal accounting officer)officers, or persons performing similar functions, as appropriate to allow for timely decisions regarding required disclosure. In designing and evaluatingBased on the Company’sevaluation of our disclosure controls and procedures the Company’s management recognizesas of May 31, 2018, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures are designed onwere not effective at reasonable assurance level due to a risk-based approachmaterial weakness in internal control over financial reporting, as further described below.

Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. The Company’stheir objectives and management is required to applynecessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. The continuous improvementAs disclosed in Item 9A of the Company’s disclosure controls and procedures is based on material weaknesses identification in the Company’s internal control over financial reporting.

Management’sour Annual Report on Internal Control over Financial Reporting

            Management is responsibleForm 10-K for establishing and maintaining adequate internal control over the Company’s financial reporting. In order to evaluate the effectiveness of internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act of 2002,year ended November 30, 2017, our management with the participation of the Company’s principal executive officer and principal financial officer has conducted an assessment, including testing, using the criteria in Internal Control - Integrated Framework, issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) (2013). Our system of internal control over financial reporting is designed 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. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. This assessment included review of the documentation of controls, evaluation of the design effectiveness of controls, testing of the operating

26


effectiveness of controls and a conclusion on this evaluation. Based on this evaluation, the Company’s management concluded itsthat our internal control over financial reporting was not effective asat November 30, 2017. A material weakness is a deficiency, or a combination of August 31, 2017.deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis. The limitation of the Company’s internal control over financial reporting was due to the applied risk-based approach which is indicative of many small companies with limited number of staff in corporate functions implying:

(i)

inadequate consistency ofImproved but insufficient segregation of duties with control objectives; and

(ii)

ineffectiveInsufficient controls over period end financial disclosure and reporting processes.

Our management believes the weaknesses identified above have not had any material effect on our financial results. Management has taken additional steps

We are committed to address the causes of the above weaknesses and to improve ourmaintaining a strong internal control over financial reporting, including the re-designenvironment and believe that our remediation efforts specified in Item 9A of our accounting processes and control procedures andAnnual Report on Form 10-K for the identification of gapsyear ended November 30, 2017 represent significant improvements in our skills base andcontrol environment. We expect that our remediation efforts will continue through 2018, although the expertise of our staff as required to meetmaterial weakness will not be considered remediated until the financial reporting requirements of a public company. In particular, during the first quarter, we have retained qualified independent third-party personnel, to conduct a comprehensive review of ourapplicable internal controls operate for a sufficient period, and formalization of our review and approval processes in order. The appointed qualified independent third party assessed the Company’s risk management framework to manage enterprise risk. During the third quarter, the appointed qualified independent third party designed a remediation plan which, among other things, prevents fraudulent transactions. The risk based approach identified by the Company reflects the awareness of an acceptable level of risk to manage the Company considering the strategy, resources and regulatory environment. This measure led to an overarching remediation plan and program brief to be followed by a detailed action plan for each major risk selected. Subsequently, it is expected to lead to an improvement in our internalhas concluded, through testing, that these controls which will enable us to expedite our month-end close process, thereby facilitating the timely preparation of financial reports and to strengthen our segregation of duties at the Company. We are also hired a full time Chief Financial Officer at MaSTherCell scheduled to begin September 2017 and a full-time controller in our Israeli subsidiary. Finally, we are exploring implementing a new initiative to ease and automate data gathering from all affiliated companies (data warehousing) and implement quantitative and qualitative controls.operating effectively.

            Our management will continue to monitor and evaluate the relevance of our risk-based approach and the effectiveness of our internal controls and procedures over financial reporting on an ongoing basis and is committed to taking further action and implementing additional enhancements or improvements, as necessary and as funds allow.37

            Because of its inherent limitations, internal controls over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.


Changes in Internal Control Over Financial Reporting

            DuringWe regularly review our system of internal control over financial reporting and make changes to our processes and systems to improve controls and increase efficiency, while ensuring that we maintain an effective internal control environment. Changes may include such activities as implementing new, more efficient systems, consolidating activities, and migrating processes.

Except for the three monthsmaterial weakness and associated remediation plan, during the quarter ended AugustMay 31, 2017,2018, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

27


PART II – OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

We know of no material pending legal proceedings to which the Company or its Subsidiariessubsidiaries are a party or of which any of its properties, or the properties of its Subsidiaries,subsidiaries, are the subject. In addition, we do not know of any such proceedings contemplated by any governmental authorities.

We know of no material proceedings in which any of the Company’s directors, officers or affiliates, or any registered or beneficial stockholder is a party adverse to the Company or its Subsidiaries or has a material interest adverse to the Company or its Subsidiaries.subsidiaries.

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 the Annual Report on Form 10-K for the year ended November 30, 2016,2017, as filed with the Securities & Exchange Commission on February 28, 2017,2018, in addition to other information contained in those reports and in this quarterly report in evaluating the Company and its business before purchasing shares of our common stock. The Company’s business, operating results and financial condition could be adversely affected due to any of those risks.

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

The following paragraph sets forth certain information with respect to all securities sold by us during the three months ended AugustMay 31, 20172018 without registration under the Securities Act:

During the three months ended AugustMay 31, 2017,2018, we privately placed 1,923,076 shares of our Common Stock and three-year warrants to purchase up to an additional 1,923,076 shares of the Company’s Common Stock at a per share exercise price of $0.52. The purchased securities were sold pursuant to subscription agreements between us and the institutional investor for aggregate proceeds to the Company of $1 million.

            During the three months ended August 31, 2017, the Company entered into definitive agreements with accredited and other qualified investors relating to a private placement of 1,272,496 units. Each unit is comprised of (i) 665,539 sharesone share of the Company’s Common Stockcommon stock and (ii) three-year warrantswarrant to purchase up to an additional 665,539 sharesone share of the Company’s Common Stock at a per share exercise price of $0.52 or $0.65. The purchased securities were issued pursuant to subscription agreements between the Company and the purchasers$6.24, for aggregate proceeds to the Company of $376 thousand.approximately $7.9 million.

These securities were not registered under the Securities Act of 1933, as amended (the "Securities Act"), but qualified for exemption under Section 4(a)(2) of the Securities Act and Regulation S promulgated thereunder. The securities were exempt from registration under Section 4(a)(2) of the Securities Act and Regulation S because the issuance of such securities by the Company did not involve a "public offering," as defined in Section 4(a)(2) of the Securities Act, the Investor’s representations that it is not a U.S. Person as that term is defined in Rule 902(k) of Regulation S, and that it is acquiring the securities for its own account for investment purposes and not as nominee or agent, and not with a view to the resale or distribution thereof, and that the Investorinvestor understands that the securities may not be sold or otherwise disposed of without registration under the Securities Act and any applicable state securities laws, or an applicable exemption therefrom.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

38


ITEM 4. MINE SAFETY DISCLOSURES

Not Applicable.

28


ITEM 5. OTHER INFORMATION

            None.Joint Venture Agreement with HekaBio K.K.

On July 11, 2018, the Company and HekaBio K.K., a corporation organized under the laws of Japan ("HB") entered into a Joint Venture Agreement (the "JVA") pursuant to which the parties will collaborate in the clinical development and commercialization of regeneration and cell and gene therapeutic products (hereinafter the "Products") in Japan. The parties intend to pursue the joint venture through a newly established Japanese company (hereinafter the "JV Company") which the Company by itself, or together with a designee, will hold a 49% participating interest therein, with the remaining 51% participating interest being held by HB. HB will fund, at its sole expense, all costs associated with obtaining the requisite regulatory approvals for conducting clinical trials, as well as performing all clinical and other testing required for market authorization of the Products in Japan.

Subject to obtaining the requisite approval needed to commence commercialization in Japan and H's compliance with its undertakings, the Company has agreed to grant to the JV Company, under a separate sub-license agreement (the "License Agreement"), an exclusive sub-license to the intellectual property underlying the Company's Products solely for commercialization of the Company's products in Japan. It is anticipated that the License Agreement will also contain, among other things, minimum sales requirements as well as other provisions common in licensing agreements for international biotech licensing agreements. In consideration thereof, the Company is to receive royalty payments in a minimum amount of 10 percent (10%) of the net sales generated by the JV Company and/or its sublicensees with respect to the Products, as well as and any additional payments provided for in the specific licensing agreements. As part of and as a condition to the License Agreement, the JV Company will grant the Company and its affiliates a license, on a non-exclusive, worldwide (other than Japan), sublicensable royalty free and fully-paid up basis, to make use of the project intellectual property for any and all lawful purposes (outside of Japan), including without limitation, for their respective worldwide operations without further charge to the Company or any of its affiliates.

Under the JVA, each party may invest up to $10 million, which may take the form of a loan, if required, as determined by the steering committee. The terms of such investment, if any, will be on terms mutually agreeable to the parties, provided that the minimum pre-money valuation for any such investment shall not be less than $10 million. Additionally, HB was granted an option to effect an equity investment in the Company in up to $15 million within the next 12 months on mutually agreeable terms. If such investment is in fact consummated, the Company agreed to invest in the JV Company by way of a convertible loan an amount to HB's pro-rata participating interest in the JV Company, which initially will be at 51%. Such loan may then be converted by the Company into share capital of the JV company at an agreed upon formula for determining JV Company valuation which in no event shall be less than $10 million. Under the JVA, the Company can require HB to sell to the Company its participating (including equity) interest in the JV Company in consideration for the issuance of the Company's common stock based on an agreed upon formula for determining JV Company valuation which in no event shall be less than $10 million.

Joint Venture Agreement with Image Securities Ltd.

On July 11, 2018, the Company and Image Securities Ltd., a corporation with its registered office in Grand Cayman, Grand Caman Islands ("India Partner") entered into a Joint Venture Agreement (the "India JVA") pursuant to which the parties will collaborate in the in the development and/or marketing, clinical development and commercialization of cell therapy products in India (the "Cell Therapy Products"). The India Partner will collaborate with a network of healthcare facilities and a healthcare infrastructure as well as financial partners to advance the development and commercialization of the cell therapy products.

The India JVA becomes effective upon the consummation of an equity investment by the India partner in the Company of $5 million within 150 days of the execution of the India JVA through the purchase of units of Orgenesis securities at a per unit purchase price payable into the Company of $6.24, with each unit comprised of one share of Company common stock and three-year common stock purchase warrant for an additional share of common stock at a per share exercise price of $6.24. Subject to the consummation of such equity investment in the Company, the Company is to advance to the JV Company a convertible loan in the amount of $5 million. The loan is convertible into equity capital of the JV Company at an agreed upon formula for determining JV Company valuation. The investment in the Company by the India Partner would be the consummation of the previously disclosed private placement subscription agreement entered into in December 2016 between the Company and an affiliate of the India Partner pursuant to which the closing of such subscription agreement was by the terms thereof delayed until such time as terms comprising the India JV were mutually agreed to.

Under the India JVA, the India Partner agreed to invest in the JV $10 million within 12 months of the incorporation of the JV Company. If for whatever reason such investment is not made by the India Partner within such time, then Orgenesis is authorized to convert its above-referenced loan into 50% of the equity capital of the JV Company on a fully diluted basis, provided that if the pre money valuation of the JV Company is then independently determined to be less than $5 million, then such conversion to be effected in the basis of such valuation.

Issuance of Previously Subsrcribed Units

Between July 13, 2018 and July 16, 2018, we accepted subscription agreements from assignees of the institutional investor who committed in February 2017 to purchase an aggregate of $16 million of units of our securities through August 2018, at a per unit purchase price of $6.24, where each unit is comprised of one share of common stock and one common stock purchase warrant exercisable at a per share exercise price of $6.24. These investors purchased in the aggregate, 692,308 shares of common stock and three year warrants for an additional 692,308 shares of our common stock at per share exercise price of $6.24.

The issuance of shares of Orgenesis common stock to these investors will be made in reliance on one or more exemptions or exclusions from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), including Section 4(a)(2) of the Securities Act, Regulation D promulgated under the Securities Act, and Regulation S promulgated under the Securities Act, and the exemption from qualification under applicable state securities laws.

ITEM 6. EXHIBITS

Exhibit
NumberNo.


Description

10.1*Collaboration and License Agreement, dated as of June 19, 2018, between Orgenesis Inc. and Mircod Limited
(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-OxleySarbanes Oxley Act of 2002

31.2*

Certification Statement of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-OxleySarbanes Oxley Act of 2002

(32)

Section 1350 Certification

32.1*

Certification Statement of the Chief Executive Officer pursuant to Section 906 of the Sarbanes-OxleySarbanes Oxley Act of 2002

32.2*

Certification Statement of the Chief Financial Officer pursuant to Section 906 of the Sarbanes-OxleySarbanes 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


*

Filed herewith.

29*      Filed herewith.

39


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: OctoberJuly 16, 20172018 

/s/ Neil Reithinger 
Neil Reithinger 
Chief Financial Officer, Treasurer and Secretary 
(Principal Financial Officer and Principal Accounting 
Officer) 
Date: OctoberJuly 16, 20172018 

3040