Equibles

10-Q

Orgenesis Inc. (ORGS)

10-Q 2021-08-05 For: 2021-06-30
View Original
Added on April 06, 2026

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

10-Q

(Mark One)

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

Forthe Quarterly Period Ended ### June 30, 2021

or

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

For

the Transition Period from ___________ to ___________

Commission

file number: 001-38416

ORGENESIS

INC.

(Exact name of registrant as specified in its charter)

Nevada 98-0583166
(State<br> or other jurisdiction<br><br> <br>of<br> incorporation or organization) (I.R.S.<br> Employer<br><br> <br>Identification<br> No.)

20271Goldenrod Lane

Germantown,MD 20876

(Address of principal executive offices) (Zip Code)

(480)659-6404

(Registrant’s telephone number, including area code)

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

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

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

Yes ☒ No ☐

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

Yes ☒ No ☐

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

Large<br> accelerated filer ☐ Accelerated<br> filer ☐
Non-accelerated filer ☒ Smaller<br> reporting company ☒
Emerging<br> growth company ☐

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

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

As

of August 5, 2021, there were 24,537,366 shares of registrant’s common stock outstanding

ORGENESIS

INC.

FORM

10-Q

FOR

THE SIX MONTHS ENDED JUNE 30, 2021 AND 2020

TABLE

OF CONTENTS

Page
PART I - FINANCIAL INFORMATION 3
ITEM<br> 1 Financial Statements (unaudited) 3
Condensed Consolidated Balance Sheets as of June 30, 2021 and December 31, 2020 3
Condensed Consolidated Statements of Comprehensive Loss (Income) for the Three and Six Months Ended June 30, 2021 and 2020 5
Condensed Consolidated Statements of Changes in Equity for the Three and Six Months Ended June 30, 2021 and 2020 6
Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2021 and 2020 10
Notes to Condensed Consolidated Financial Statements 11
ITEM<br> 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 19
ITEM<br> 3. Quantitative and Qualitative Disclosures About Market Risk 26
ITEM<br> 4. Controls and Procedures 27
PART II - OTHER INFORMATION 27
ITEM<br> 1. Legal Proceedings 27
ITEM<br> 1A. Risk Factors 27
ITEM<br> 2. Unregistered Sales of Equity Securities and Use of Proceeds 27
ITEM<br> 3. Defaults Upon Senior Securities 28
ITEM<br> 4. Mine Safety Disclosures 28
ITEM<br> 5. Other Information 28
ITEM<br> 6. Exhibits 28
SIGNATURES 29 
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PART

I –FINANCIAL INFORMATION

Item

  1. Financial Statements

ORGENESIS

INC.

CONDENSED

CONSOLIDATED BALANCE SHEETS

(U.S.Dollars in thousands)

(Unaudited)

June<br> 30, 2021 December 31, 2020
As<br> of
June<br> 30, 2021 December 31, 2020
Assets
CURRENT<br> ASSETS:
Cash<br> and cash equivalents $ 28,431 $ 44,923
Restricted<br> cash 481 645
Accounts<br> receivable, net * 17,196 3,085
Prepaid<br> expenses and other receivables 1,399 1,070
Grants<br> receivable 168 169
Inventory 173 185
Total<br> current assets 47,848 50,077
NON-CURRENT<br> ASSETS:
Deposits $ 361 $ 296
Investments<br> in associates, net 160 175
Property,<br> plant and equipment, net 4,100 3,073
Intangible<br> assets, net 12,435 13,023
Operating<br> lease right-of-use assets 1,253 1,474
Goodwill 8,599 8,745
Other<br> assets 802 821
Total<br> non-current assets 27,710 27,607
TOTAL<br> ASSETS $ 75,558 $ 77,684
* Including related<br>party in the amount of $727 thousand and $744 thousand as of June 30, 2021 and as of December 31, 2020, respectively.
--- ---

The

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

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ORGENESIS

INC.

CONDENSED

CONSOLIDATED BALANCE SHEETS (Cont’d)

(U.S.Dollars in thousands)

(Unaudited)

December<br> 31, 2020
December<br> 31, 2020
Liabilities<br> and Equity
CURRENT<br> LIABILITIES:
Accounts<br> payable 5,212 $ 8,649
Accrued<br> expenses and other payables 2,553 792
Income<br> tax payable 7 7
Employees<br> and related payables 1,971 1,463
Advance<br> payments on account of grant 1,137 692
Short-term<br> loans and current maturities of long-term loans - 145
Contract<br> liabilities 59 59
Current<br> maturities of finance leases 19 19
Current<br> maturities of operating leases 479 485
Current<br> maturities of convertible loans 6,719 3,974
Total<br> current liabilities 18,156 16,285
LONG-TERM<br> LIABILITIES:
Non-current<br> operating leases 792 $ 1,020
Convertible<br> loans 4,656 7,200
Retirement<br> benefits obligation 98 74
Non-current<br> finance leases 52 64
Other<br> long-term liabilities 304 313
Total<br> long-term liabilities 5,902 8,671
TOTAL<br> LIABILITIES 24,058 24,956
EQUITY:
Common<br> stock, par value 0.0001 per share, 145,833,334 shares authorized, 24,537,366 and 24,223,093<br> shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively 3 3
Additional<br> paid-in capital 143,197 140,397
Accumulated<br> other comprehensive income 519 748
Treasury<br> stock 262,090 and 55,309 shares as of June 30, 2021 and December 31, 2020, respectively (1,159 ) (250 )
Accumulated<br> deficit (91,197 ) (88,319 )
Equity<br> attributable to Orgenesis Inc. 51,363 52,579
Non-controlling<br> interest 137 149
Total<br> equity 51,500 52,728
TOTAL<br> LIABILITIES AND EQUITY 75,558 $ 77,684

All values are in US Dollars.

The

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

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ORGENESIS

INC.

CONDENSED

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (INCOME)

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

(Unaudited)

June<br> 30, 2021 June<br> 30, 2020 June<br> 30, 2021 June<br> 30, 2020
Three<br> Months Ended Six<br> Months Ended
June<br> 30, 2021 June<br> 30, 2020 June<br> 30, 2021 June<br> 30, 2020
Revenues $ 9,818 $ 1,470 $ 18,050 $ 2,855
Revenues<br> from related party 727 279 1,884 772
Total<br> revenues 10,545 1,749 19,934 3,627
Cost<br> of services and other research and development expenses 9,727 24,963 15,854 29,836
Amortization<br> of intangible assets 239 (52 ) 477 171
Selling,<br> general and administrative expenses 2,901 3,611 5,869 7,129
Other<br> income, net (3 ) (1 ) (28 ) (4 )
Operating<br> loss 2,319 26,772 2,238 33,505
Financial<br> expenses, net 406 337 639 666
Share<br> in net loss of associated companies - - 15 -
Loss<br> from continuing operation before income taxes 2,725 27,109 2,892 34,171
Tax<br> expenses (income) - 12 (2 ) (35 )
Net<br> loss from continuing operation 2,725 27,121 2,890 34,136
Net<br> income from discontinued operations, net of tax - (6,721 ) - (83,186 )
Net<br> loss (income) 2,725 20,400 2,890 (49,050 )
Net<br> loss (income) attributable to non-controlling interests from continuing operation (66 ) 6 (12 ) (33 )
Net<br> income attributable to non-controlling interests from discontinued operations - - - (492 )
Net<br> loss (income) attributable to Orgenesis Inc. $ 2,659 $ 20,406 $ 2,878 $ (49,575 )
Loss<br> (Earnings) per share:
Basic<br> and diluted from continuing operations $ 0.11 $ 1.26 $ 0.12 $ 1.73
Basic<br> and diluted from discontinued operations $ - $ (0.31 ) $ - $ (4.52 )
Basic<br> and diluted $ 0.11 $ 0.95 $ 0.12 $ (2.79 )
Weighted<br> average number of shares used in computation of Basic and Diluted loss (earnings) per share:
Basic<br> and diluted 24,365,746 21,515,254 24,279,826 19,648,042
Comprehensive<br> loss (income):
Net<br> loss from continuing operations $ 2,725 $ 27,121 $ 2,890 $ 34,136
Net<br> loss (income) from discontinued operations, net of tax - (6,721 ) - (83,186 )
Other<br> comprehensive loss (income)- translation adjustments (48 ) (247 ) 229 397
Release<br> of translation adjustment due to sale of subsidiary - - - (194 )
Comprehensive<br> loss (income) 2,677 20,153 3,119 (48,847 )
Comprehensive<br> income attributed to non-controlling interests from continuing operations (66 ) 6 (12 ) (33 )
Comprehensive<br> income attributed to non-controlling interests from discontinued operations - - - (492 )
Comprehensive<br> loss (income) attributed to Orgenesis Inc. $ 2,611 $ 20,159 $ 3,107 $ (49,372 )

The

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

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ORGENESIS

INC.

CONDENSED

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

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

(Unaudited)

Number Par<br> <br>Value Additional<br> <br>Paid-in<br> <br>Capital Comprehensive<br> <br>Income<br> <br>(Loss) Treasury<br> Shares Accumulated<br> <br>Deficit to Orgenesis<br> <br>Inc. Non-<br> <br>Controlling<br> <br>Interest Total
Common<br> Stock Receipts on<br><br> Account of Accumulated<br><br> <br>Other Equity Attributed
Number Par<br> <br>Value Additional<br> <br>Paid-in<br> <br>Capital Shares to be Allotted Comprehensive<br> <br>Income<br> <br>(Loss) Treasury<br> Shares Accumulated<br> <br>Deficit to Orgenesis<br> <br>Inc. Non-<br> <br>Controlling<br> <br>Interest Total
Balance<br> at January 1, 2021 24,167,784 $ 3 $ 140,397 - $ 748 $ (250 ) $ (88,319 ) $ 52,579 $ 149 $ 52,728
Changes<br> during the six months ended June 30, 2021:
Stock-based<br> compensation to employees and directors - - 612 - - - 612 - 612
Stock-based<br> compensation to service providers - *- 276 - - - 276 - 276
Stock-based<br> compensation for Tamir purchase agreement
Stock-based compensation for Tamir purchase agreement, shares
Beneficial<br> conversion feature of convertible loans
Sale<br> of subsidiaries
Adjustment<br> to redemption value of redeemable non-controlling interest
Issuance<br> of shares and warrants
Issuance<br> of shares and warrants, shares -
Exercise<br> of options 8,750 *- 50 - - - 50 - 50
Issuance<br> of Shares due to exercise of warrants 305,523 *- 1,862 - - - 1,862 - 1,862
Repurchase<br> of treasury stock (206,781 ) - - - (909 ) - (909 ) - (909 )
Comprehensive<br> loss for the period - - (229 ) - (2,878 ) (3,107 ) (12 ) (3,119 )
Balance<br> at June 30, 2021 24,275,276 $ 3 $ 143,197 - $ 519 $ (1,159 ) $ (91,197 ) $ 51,363 $ 137 $ 51,500
* Represents an amount lower<br> than $1 thousand
--- ---

The

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

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ORGENESIS

INC.

CONDENSED

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

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

(Unaudited)

Common<br> Stock Receipts onAccount of Accumulated Equity<br><br> <br>Attributed
Number Par<br> <br>Value Additional<br> <br>Paid-in<br> <br>Capital Shares to be Allotted Other<br><br> <br><br> <br>Comprehensive<br> <br>Income (Loss) Treasury Shares Accumulated<br> <br>Deficit to<br> <br>Orgenesis<br> <br>Inc. Non-<br> <br>Controlling<br> <br>Interest Total
Balance<br> at January 1, 2020 16,140,962 $ 2 $ 94,691 - $ 213 - $ (89,429 ) $ 5,477 $ 601 $ 6,078
Changes<br> during the six months ended June 30, 2020:
Stock-based<br> compensation to employees and directors - - 910 - - - 910 - 910
Stock-based<br> compensation to service providers **270,174 *- 787 - - 787 - 787
Stock-based<br> compensation for Tamir purchase agreement 3,400,000 *- 17,748 - 17,748 17,748
Exercise<br> of options 83,334 *- 300 - - 300 300
Beneficial<br> conversion feature of convertible loans - - 42 - - 42 - 42
Issuance<br> of shares and warrants 2,200,000 *- 8,438 - - 8,438 - 8,438
Sale<br> of subsidiaries - - - - - - (413 ) (413 )
Adjustment<br> to redemption value of redeemable non-controlling interest - - 5,160 - - 5,160 - 5,160
Comprehensive<br> (income) loss for the period (203 ) 49,575 49,372 (33 ) 49,339
Balance<br> at June 30, 2020 22,094,470 $ 2 $ 128,076 - $ 10 - $ (39,854 ) $ 88,234 $ 155 $ 88,389
* Represents an amount<br>lower than $1 thousand
--- ---
** Out of which 135,000<br>shares have additional restrictions on transfer until services have been provided
--- ---

The

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

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ORGENESIS

INC.

CONDENSED

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

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

(Unaudited)

Number Par<br> <br>Value Additional Paid-in<br> <br>Capital Shares<br><br> to be<br><br> Allotted Other<br> Comprehensive Income (Loss) Treasury<br> Shares Accumulated<br> Deficit to Orgenesis<br> <br>Inc. Non-<br> <br>Controlling Interest Total
Common<br> Stock Receipts on<br> Account of Accumulated Equity<br><br>Attributed
Number Par<br> <br>Value Additional Paid-in<br> <br>Capital Shares<br><br> to be<br><br> Allotted Other<br> Comprehensive Income (Loss) Treasury<br> Shares Accumulated<br> Deficit to Orgenesis<br> <br>Inc. Non-<br> <br>Controlling Interest Total
Balance<br> at April 1, 2021 24,411,791 $ 3 $ 142,449 $ 424 $ 471 $ (260 ) $ (88,538 ) $ 54,549 $ 203 $ 54,752
Changes<br> during the three months ended June 30, 2021:
Stock-based<br> compensation to employees and directors - - 292 - - - - 292 - 292
Stock-based<br> compensation to service providers - - 32 - - - - 32 - 32
Issuance<br> of Shares due to exercise of warrants 67,960 *- 424 (424 ) - - - - - -
Repurchase<br> of treasury stock (204,475 ) - - - - (899 ) - (899 ) - (899 )
Comprehensive<br> income (loss) for the period - - - - 48 - (2,659 ) (2,611 ) (66 ) (2,677 )
Balance<br> at June 30, 2021 24,275,276 $ 3 $ 143,197 $ - $ 519 $ (1,159 ) $ (91,197 ) $ 51,363 $ 137 $ 51,500
* Represents an amount<br>lower than $1 thousand
--- ---

The

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

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ORGENESIS

INC.

CONDENSED

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

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

(Unaudited)

Common<br> Stock Receipts on Account of Accumulated Equity<br><br> <br>Attributed
Number Par<br> <br>Value Additional<br> <br>Paid-in<br> <br>Capital Shares to be Allotted Other<br> <br>Comprehensive<br> <br>Income Treasury Shares Accumulated<br> <br>Deficit to<br> <br>Orgenesis<br> <br>Inc. Non-<br> <br>Controlling<br> <br>Interest Total
Balance<br> at April 1, 2020 18,361,050 $ 2 $ 109,197 - $ (237 ) - $ (19,448 ) $ 89,514 $ 149 $ 89,663
Changes<br> during the three months ended June 30, 2020:
Stock-based<br> compensation to employees and directors - - 284 - - 284 - 284
Stock-based<br> compensation to service providers **250,086 *- 547 - - - - 547 - 547
Stock-based<br> compensation for Tamir purchase agreement 3,400,000 *- 17,748 - - 17,748 - 17,748
Exercise<br> of options 83,334 *- 300 - - 300 - 300
Comprehensive<br> income (loss) for the period - - - 247 (20,406 ) (20,159 ) 6 (20,153 )
Balance<br> at June 30, 2020 22,094,470 $ 2 $ 128,076 - $ 10 - $ (39,854 ) $ 88,234 $ 155 $ 88,389
* Represents an amount<br>lower than $1 thousand
--- ---
** Out of which 135,000<br>shares have additional restrictions on transfer until services have been provided
--- ---

The

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

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ORGENESIS

INC.

CONDENSED

CONSOLIDATED STATEMENTS OF CASH FLOWS (*)

(U.S.Dollars in thousands)

(Unaudited)

June<br> 30, 2021 June 30, 2020
Six<br> Months Ended
June<br> 30, 2021 June 30, 2020
CASH<br> FLOWS FROM OPERATING ACTIVITIES:
Net<br> income (loss) $ (2,890 ) $ 49,050
Adjustments<br> required to reconcile net loss to net cash used in operating activities:
Stock-based<br> compensation 888 1,697
Stock-based<br> compensation for Tamir Purchase Agreement - 17,048
Capital<br> loss (gain), net 20 14
Gain<br> on disposal of subsidiaries - (97,020 )
Share<br> in losses of associated company 15 -
Depreciation<br> and amortization expenses 918 739
Effect<br> of exchange differences on inter-company balances 59 124
Net<br> changes in operating leases (13 ) (9 )
Interest<br> expenses accrued on loans and convertible loans (including amortization of beneficial conversion feature) 200 201
Changes<br> in operating assets and liabilities:
Increase<br> in accounts receivable (14,087 ) (2,453 )
Decrease<br> (increase) in inventory 7 (123 )
Increase<br> in other assets (8 ) (20 )
Increase<br> in prepaid expenses and other accounts <br> receivable (371 ) (512 )
Decrease<br> in accounts payable (3,422 ) (4,748 )
Increase<br> in accrued expenses and other payables 1,768 13,451
Increase<br> in employee and related payables 541 12
Decrease<br> in contract liabilities - (64 )
Change<br> in advance payments and receivables on account of<br> grant, net 328 (156 )
Decrease<br> in deferred taxes liability - (65 )
Net<br> cash used in operating activities $ (16,047 ) $ (22,834 )
CASH<br> FLOWS FROM INVESTING ACTIVITIES:
Increase<br> in loan to JV with a related party - (500 )
Sale<br> of property and equipment - 4
Purchase<br> of property and equipment (1,542 ) (974 )
Proceed<br> from sale of subsidiaries - 104,222
Investment<br> in deposits (20 ) -
Repayment<br> from deposits - 20
Net<br> cash provided by (used in) investing activities $ (1,562 ) $ 102,772
CASH<br> FLOWS FROM FINANCING ACTIVITIES:
Repurchase<br> of treasury stock (909 ) -
Proceeds<br> from issuance of shares and warrants (net of transaction costs) 1,912 8,738
Proceeds<br> from issuance of convertible loans (net of transaction costs) - 250
Repayment<br> of convertible loans and convertible bonds - (2,400 )
Repayment<br> of short and long-term debt (10 ) (430 )
Other<br> financing activities - 1
Net<br> cash provided by financing activities $ 993 $ 6,159
NET<br> CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH $ (16,616 ) $ 86,097
EFFECT<br> OF EXCHANGE RATE CHANGES ON CASH, CASH EQUIVALENTS AND RESTRICTED CASH (40 ) (43 )
CASH,<br> CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF PERIOD 45,568 12,041
CASH<br> AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD (*) $ 28,912 $ 98,095
SUPPLEMENTAL<br> NON-CASH FINANCING AND INVESTING ACTIVITIES
Finance<br> leases of property, plant and equipment $ - $ 363
Right-of-use<br> assets obtained in exchange for new operating lease liabilities, net $ - $ 231
Purchase<br> of property, plant and equipment change included in accounts payable $ (9 ) $ 200
Acquisition<br> of other asset $ - $ 700

The

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

(*) See Note 3 for information regarding the discontinued operation. 
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ORGENESIS

INC.

NOTES

TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

For

the Six Months Ended June 30, 2021 and 2020

(Unaudited)

NOTE

1 – DESCRIPTION OF BUSINESS

a. General

Orgenesis Inc., a Nevada corporation, is a global biotech company working to unlock the potential of cell and gene therapies (“CGTs”) in an affordable and accessible treatments, processes, and systems.

CGTs can be centered on autologous (using the patient’s own cells) or allogenic (using master banked donor cells) and are part of a class of medicines referred to as advanced therapy medicinal products (“ATMP”). The Company mostly focusses on autologous therapies, with processes and systems that are developed for each therapy using a closed and automated processing system approach that is validated for compliant production near the patient at their point of care for treatment of the patient. This approach has the potential to overcome the limitations of traditional commercial manufacturing methods that do not translate well to commercial production of advanced therapies due to their cost prohibitive nature and complex logistics to deliver the treatments to patients (ultimately limiting the number of patients that can have access to, or can afford, these therapies).

To achieve these goals, the Company has developed a Point of Care Platform comprised of three enabling components: a pipeline of licensed POCare Therapies that are designed to be processed and produced, automated closed POCare technology systems, and a collaborative POCare Network. The Company is working to provide a more efficient and scalable pathway for advanced therapies to reach patients more rapidly at lowered costs. The Company also draws on extensive medical expertise to identify promising new autologous therapies to leverage within the POCare Platform either via ownership or licensing.

The POCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide with a goal of achieving harmonized, regulated clinical development and production of the therapies.

The Company has worked to develop and validate POCare Technologies that can be combined within mobile production units for advanced therapies. The Company has made significant investments in the development of several types of Orgenesis Mobile Processing Units and Labs (“OMPULs”) with the expectation of use and/or distribution through our POCare Network of partners, collaborators, and joint ventures. As of the date of this report, the OMPULs are still in the development stage.

OMPULs are designed for the purpose of validation, development, performance of clinical trials, manufacturing and/or processing of potential or approved cell and gene therapy products in a safe, reliable, and cost-effective manner at the point of care, as well as the manufacturing of such CGTs in a consistent and standardized manner in all locations. The design delivers a potential industrial solution for the Company to deliver CGTs to practically any clinical institution at the point of care.

Until December 31, 2019, the Company operated the POCare Platform as one of two business separate business segments.

The Company’s other business segment was a Contract Development and Manufacturing Organization (“CDMO”) platform, providing contract manufacturing and development services for biopharmaceutical companies (the “CDMO Business”). The CDMO platform was historically operated mainly through majority-owned Masthercell Global (which consisted mainly of the following two subsidiaries: MaSTherCell S.A. in Belgium and Masthercell U.S., LLC in the United States (collectively, “Masthercell”)). In February 2020, the Company sold its entire equity interests in Masthercell Global Inc. (the “Masthercell Business”), which comprised the majority of the Company’s CDMO Business, to Catalent Pharma Solutions, Inc. (the “Masthercell Sale”). The Company determined that the Masthercell Business (“Discontinued Operation”) met the criteria to be classified as a discontinued operation as of the first quarter of 2020. The Discontinued Operation includes the vast majority of the previous CDMO Business (See Note 3).

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The Company has continued to grow its infrastructure and expand its processing sites into new markets and jurisdictions. In addition, the Company has been investing manpower and financial resources to focus on developing, manufacturing and rolling out several types of OMPULs to be used and/or distributed through our POCare Network of partners, collaborators, and joint ventures.

The Chief Executive Officer is the Company’s chief operating decision-maker who reviews financial information prepared on a consolidated basis. Effective from the first quarter of 2020, all of the Company’s continuing operations are in one segment, being the point-of-care business via our POCare Platform. Therefore, no segment report has been presented.

The Company currently conducts its core CGT business operations through itself and its subsidiaries which are all wholly-owned except as otherwise stated (collectively, the “Subsidiaries”). The Subsidiaries are as follows:

● United<br> States: Orgenesis Maryland Inc. (the “U.S. Subsidiary”) is the center of activity in North America currently focused<br> on setting up of the POCare Network.
● Koligo<br> Therapeutics Inc. (“Koligo”) is a Kentucky corporation that was acquired in 2020 and is currently focused on developing<br> the POCare network and therapies.
● European<br> Union: Orgenesis Belgium SRL (the “Belgian Subsidiary”) and Orgenesis Germany GmbH (incorporated in 2021), (the “German<br> subsidiary”) are currently focused on process development and preparation of European clinical trials.
● Orgenesis<br> Switzerland Sarl (the “Swiss subsidiary”) incorporated in 2020 is currently focused on providing management services<br> to the Company.
● Israel:<br> Orgenesis Ltd. (the “Israeli Subsidiary”) is a provider of regulatory, clinical and pre-clinical services, and Orgenesis<br> Biotech Israel Ltd. (“OBI”) is a provider of cell-processing services in Israel.
● Korea:<br> Orgenesis Korea Co. Ltd. (the “Korean Subsidiary”), is a provider of processing and pre-clinical services in Korea. The<br> Company owns 94.12% of the Korean Subsidiary.

These condensed consolidated financial statements include the accounts of Orgenesis Inc. and its subsidiaries (and in 2020 includes the Discontinued Operation).

The

Company’s common stock, par value $0.0001 per share (the “Common Stock”) is listed and traded on the Nasdaq Capital Market under the symbol “ORGS.”

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

b. Liquidity

As of June 30, 2021, the Company has accumulated losses of approximately $91 Million.

Based on its current cash resources and commitments, the Company believes it will be able to maintain its current planned development activities and expected level of expenditures for at least 12 months from the date of the issuance of these financial statements. If there are further increases in operating costs for facilities expansion, research and development, commercial and clinical activity or decreases in revenues from customers, the Company may decide to seek additional financing.

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NOTE

2 - BASIS OF PRESENTATION

a. Basis of presentation

The accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of management, the financial statements reflect all normal and recurring adjustments necessary to fairly state the financial position and results of operations of the Company. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (“SEC”). The year-end balance sheet data was derived from the audited consolidated financial statements as of December 31, 2020, but not all disclosures required by generally accepted accounting principles in the United States (“U.S. GAAP”) are included.

b. Significant accounting policies

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

POCDevelopment Services

Revenue recognized under contracts for POC development services may, in some contracts, represent multiple performance obligations (where promises to the customers are distinct) in circumstances in which the work packages are not interrelated or the customer is able to complete the services performed.

For arrangements that include multiple performance obligations, the transaction price is allocated to the identified performance obligations based on their relative standalone selling prices.

The Company recognizes revenue when, or as, it satisfies a performance obligation.  At contract inception, the Company determines whether the services are transferred over time or at a point in time. Performance obligations that have no alternative use and that the Company has the right to payment for performance completed to date, at all times during the contract term, are recognized over time. All other performance obligations are recognized as revenues by the company at a point of time (upon completion). In addition, during the three months ended June 30, 2021, the Company started providing support services to its customers. These revenues are recognized as and when the services are provided because the customer simultaneously receives and consumes the benefits provided.

Also included in POC development services is Hospital supplies revenue which is derived principally from the sale or lease of products and the performance of services to hospitals or other medical providers. Revenue is earned and recognized when product and services are received by the customer.

Recentlyissued accounting pronouncements, not yet adopted

In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation— Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815- 40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). The guidance is effective for the Company on January 1, 2022. The Company is currently evaluating the impact of adopting this standard.

Useof Estimates in the Preparation of Financial Statements

The preparation of our consolidated financial statements in conformity with U.S. GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates, judgments and methodologies. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity, the amount of revenues and expenses and determining whether an acquisition is a business combination or a purchase of asset. Actual results could differ from those estimates.

The full extent to which the COVID-19 pandemic may directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets. We examined the impact of COVID-19 on our financial statements, and although there is currently no major impact, there may be changes to those estimates in future periods. Actual results may differ from these estimates.

Reclassifications

Certain reclassifications have been made to the prior year’s financial statements to conform to the current year presentation. These reclassifications had no net effect on previously reported results of operations.

Revisionof Previously Reported Consolidated Financial Statements

In

connection with the preparation of the company’s consolidated financial statements for the fiscal year ended December 31, 2020, the Company identified an immaterial error originating in the first quarter of 2020 related to the gain calculation on the sale of Masthercell. The Company did not adjust the gain calculation for the reversal of previously-recorded accretion adjustments to the carrying amount of the Redeemable Non-Controlling Interest (NCI) in the amount of $5,574. The Company has revised its financial statements presented herein for the six months ended June 30, 2020, respectively, to correct the error. The revision resulted in an increase to additional paid-in capital and a decrease in net income from discontinued operations, net of tax. There is no impact on net loss from continuing operations or earning per share. In addition, there is no impact on the Company’s balance sheet or statement of cash flows.

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The following table summarizes the impact of the revision on additional paid-in capital and net income from discontinued operations, net of tax for the six months ended June 30, 2020:

SCHEDULE OF REVISION OF PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS

As<br> reported Adjustment As<br> revised
(in<br> thousands)
Net<br> income from discontinued operations, net of tax $ 88,760 $ (5,574 ) $ 83,186
Additional<br> paid-in capital 122,502 5,574 128,076

NOTE

3 – DISCONTINUED OPERATION

On February 2, 2020, the Company completed the Masthercell Sale and determined that the Masthercell Business met the criteria to be classified as a discontinued operation.

The financial results of the Masthercell Business are presented as income from discontinued operations, net of tax on the Company’s Condensed Consolidated Statement of Comprehensive Loss (Income). The following table presents the financial results associated with the Masthercell Business operation as reflected in the Company’s Condensed Consolidated Comprehensive loss (Income) (in thousands):

SCHEDULE

OF DISCONTINUED FINANCIAL STATEMENTS

The<br> period from<br><br> <br>January<br> 1, 2020<br><br> <br>until<br> the disposal<br><br> <br>date
OPERATIONS
Revenues $ 2,556
Cost of revenues 1,482
Cost<br> of research and development and research and development services, net 7
Amortization<br> of intangible assets 137
Selling,<br> general and administrative expenses 1,896
Other<br> expenses, net 305
Operating<br> loss 1,271
Financial<br> income, net (29 )
Loss<br> before income taxes 1,242
Tax<br> expenses (30 )
Net<br> loss from discontinuing operation, net of tax $ 1,212
DISPOSAL
Gain<br> on disposal before income taxes $ 97,020
Provision<br> for income taxes (12,622 )
Gain<br> on disposal $ 84,398
Net<br> profit from discontinuing operation, net of tax $ 83,186

The following table represents the components of the cash flows from discontinued operations (in thousands):

The<br> period from<br><br> <br>January<br> 1, 2020<br><br> <br>until<br> the disposal<br><br> <br>date
Net<br> cash flows used in operating activities $ (2,409 )
Net<br> cash flows used in investing activities $ (579 )
Net<br> cash flows used in financing activities $ (51 ) 
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Disaggregationof Revenue

The following table disaggregates the Company’s revenues by major revenue streams related to discontinued operations (in thousands):

SCHEDULE OF DISAGGREGATION OF REVENUE RELATED TO DISCONTINUED OPERATIONS

The<br> period from<br><br> <br>January<br> 1, 2020 until<br><br> <br>the<br> disposal date
Revenue<br> stream:
Cell<br> process development services $ 2,556
Total $ 2,556

NOTE

4 – EQUITY

During

the six months period ended June 30, 2021, the Company received approximately $1.9 million from the exercise of warrants for the purchase of the Company’s Common Stock at a price of $6.24. A total of 305,523 shares were issued during the six months ended June 30, 2021.

During

the six months ended June 30, 2021, the Company received $50 thousand from the exercise of employee options for the purchase of 8,750 shares of the Company’s Common Stock at a weighted average price of $5.56.

NOTE

5 – STOCK-BASED COMPENSATION

OptionsGranted to Employees

The table below summarizes the terms of options for the purchase of shares in the Company granted to employees during the period from January 1, 2021 to June 30, 2021:

SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES

****<br><br>No. of<br> <br>Options<br> <br>Granted Exercise<br><br> <br>Price Vesting<br> Period Fair Value at<br><br> <br>Grant<br> <br>(in thousands) Expiration<br> <br>Period
Employees 125,000 $ 5.12 Quarterly<br> over a period of two years 412 10<br> years

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

SCHEDULE OF STOCK OPTIONS, VALUATION ASSUMPTIONS

During<br> the Period from<br><br> <br>January<br> 1, 2021 to<br><br> <br>June<br> 30, 2021
Value<br> of one common share $ 5.12
Dividend<br> yield 0 %
Expected<br> stock price volatility 77 %
Risk<br> free interest rate 0.96 %
Expected<br> term (years) 5.56 
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NOTE

6 – LOSS (EARNINGS) PER SHARE

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

SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE

June<br> 30, 2021 June<br> 30, 2020 June<br> 30, 2021 June<br> 30, 2020
Three<br> Months Ended Six<br> Months Ended
June<br> 30, 2021 June<br> 30, 2020 June<br> 30, 2021 June<br> 30, 2020
(in<br> thousands, except per share data)
Basic<br> and diluted:
Net<br> loss from continuing operations attributable to Orgenesis Inc. $ 2,659 $ 27,127 $ 2,878 $ 34,103
Net<br> income from discontinued operations attributable to Orgenesis Inc. for earning per share - (6,721 ) - (83,678 )
Adjustment<br> of redeemable non-controlling interest to redemption amount - - - (5,160 )
Basic: Net income (loss) available to common stockholders - (6,721 ) - (88,838 )
Net<br> (income) loss attributable to Orgenesis Inc. for loss (earning) per share 2,659 20,406 2,878 (54,735 )
Weighted<br> average number of common shares outstanding 24,365,746 21,515,254 24,279,826 19,648,042
Loss<br> per common share from continuing operations $ 0.11 $ 1.26 $ 0.12 $ 1.73
Earnings<br> per common share from discontinued operations $ - $ (0.31 ) $ - $ (4.52 )
Net<br> loss (earnings) per share $ 0.11 $ 0.95 $ 0.12 $ (2.79 )

NOTE

7 – REVENUES

Disaggregationof Revenue

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

SCHEDULE OF DISAGGREGATION OF REVENUE

Three<br> Months Ended Six<br> Months Ended
June<br> 30, 2021 June<br> 30, 2020 June<br> 30, 2021 June<br> 30, 2020
(in<br> thousands)
Revenue<br> stream:
POC<br>and hospital services (Mainly POC) $ 9,074 $ 1,174 $ 18,328 $ 3,025
Cell<br>process development services 1,471 575 1,606 602
Total $ 10,545 $ 1,749 $ 19,934 $ 3,627

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

SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER

Three<br> Months Ended Six<br> Months Ended
June<br> 30, 2021 June<br> 30, 2020 June<br> 30, 2021 June<br> 30, 2020
(in<br> thousands)
Revenue<br> earned:
Customer<br> A $ 3,207 $ 906 $ 4,163 $ 1,280
Customer<br> B 1,739 - 4,130 -
Customer<br> C 2,119 319 3,276 806
Customer<br> D 936 - 2,582 -
Customer<br> E 1,216 237 2,009 733 
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ContractAssets and Liabilities

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

The activity for trade receivables is comprised of:

SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES

June<br> 30, 2021 June<br> 30, 2020
Six<br> Months Ended
June<br> 30, 2021 June<br> 30, 2020
(in<br> thousands)
Balance<br> as of beginning of period $ 3,085 $ 1,831
Additions 20,347 2,944
Collections (6,260 ) (828 )
Exchange<br> rate differences 24 3
Balance<br> as of end of period $ 17,196 $ 3,950

The activity for contract liabilities is comprised of:

SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES

June<br> 30, 2021 June<br> 30, 2020
Six<br> Months Ended
June<br> 30, 2021 June<br> 30, 2020
(in<br> thousands)
Balance<br> as of beginning of period $ 59 $ 325
Additions - 597
Realizations - (760 )
Balance<br> as of end of period $ 59 $ 162

NOTE

8 – TRANSACTIONS DURING THE PERIOD

JohnsHopkins University

During the three months ended June 30, 2021, the Company and Johns Hopkins University entered into a sublease and construction agreement for the establishment of a clinical therapeutic development and point of care center in Maryland of approximately 6,830 rentable square feet. Pursuant to the agreements, the Company will pay for certain leasehold improvements in the premises according to plans and specifications to be agreed upon. The Company advanced an initial $510 thousand for this purpose. The annual base rent is initially $260 thousand per year, increasing to $324 thousand per year over the 10-year initial lease term. The Company has an option to renew the sublease for two additional periods of five years each under the same terms and conditions. The Company is expected to gain occupancy of the premises during the fourth quarter of 2021.

Neuro-ImmunotherapyExclusive License Agreement

During

the three months ended June 30, 2021, the Company entered into an exclusive license agreement in the field of neuro-immunotherapy. Pursuant to the agreement, the Company received an exclusive, worldwide, sublicensable, royalty-bearing license of certain technology and patents for the purpose of developing, manufacturing, using, and commercializing the licenced technology. Royalties of between 0.5% and 5% on royalty-bearing sales are payable for up to 15 years from the date of first sale in any country in which licensed products are sold, and sublicense fees at the rate of 12% on sublicense income (but no less than two percent (2.0%) of sublicenses’ net sales). Pursuant to the agreement, the Company is required to invest within thirty-six (36) months of the effective date an aggregate amount of at least $2 million in its efforts to develop the licensed technology.

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CelleskaPty Ltd

During the three months ended June 30, 2021, the Company and Celleska Pty Ltd., an Australian company (“Celleska”), entered into a Joint Venture Agreement (“AJVA”) to facilitate the collaboration in the field of Cell and Gene therapies development and development of the Company’s worldwide POCare network in Australia. Under the AJVA, the Company will hold a 50% share of the equity of the Australian joint venture entity (“AJVE”). Until the AJVE is incorporated, Celleska will manage the joint venture activities. The AJVE will be managed by a steering committee consisting of three members which will act as the AJVE’s board of directors. The Company is entitled to appoint one member, Celleska is entitled to appoint one member, and the Company and Celleska will jointly appoint the third member. The Company has the right to exercise a call option to acquire the Celleska’s entire share in the AJVE based on the occurrence of certain events and according to an agreed-upon mechanism subject to a minimum valuation of $5 million. Each party will provide funding to the AJVE in an amount of up to $10 million, of which $5 million may be funded via in-kind investments. Each of the Company and Celleska will grant to the AJVE an exclusive, sublicensable, royalty-bearing right and license to the relevant party’s background intellectual property as required solely to manufacture, distribute and market and sell such party’s products within the territory of Australia. Each party shall receive royalties in an amount of ten percent (10%) of the net sales generated by the AJVE and/or its sublicensees. In addition, Company shall receive an exclusive, sublicensable, royalty-bearing, right and license to Celleska’s background intellectual property as required solely to manufacture, distribute and market and sell Celleska products outside the territory of Australia in consideration for royalties in an amount of ten percent (10%) of the net sales generated by the Company or its sublicensees with respect to sale of Celleska products. Once the AJVE is profitable, the Company will be entitled (in addition to any of its rights as the holder of the AJVE) to an additional share of fifteen percent (15%) of the AJVE’s GAAP profit after tax, over and above all rights granted pursuant to Company’s participating interest in the AJVE. As of June 30, 2021 the AJVE had not yet been incorporated.

Savicell

On June 14, 2021 the Company and Savicell Ltd (“Savicell”) entered into a collaboration agreement (the “Savicell Agreement”) to collaborate in the evaluation, continued development, validation, and use of Savicell’s platform designed for the early detection and diagnosis of diseases and conditions and for quality control and monitoring purposes, in conjunction with the Company’s systems. Pursuant to the Savicell Agreement, the Company shall provide to Savicell funding for performance of certain tasks agreed upon by the parties in a work plan. In consideration for such funding, Savicell shall supply the Company with products developed under the Savicell Agreement at preferential rates and grant to the Company a worldwide exclusive licence to sell such products in the Company’s point-of-care network of hospitals, clinics and institutions for quality control and monitoring of manufacturing and processing of autologous immune cells manipulated by cell and gene therapies, subject to a royalty of 10%.

StromatisPharma

On

June 15, 2021, the Company and Stromatis Pharma Inc. (“Stromatis”) entered into a Collaboration and Sublicense Agreement (the “Stromatis Agreement”) to collaborate in refining methods for GMP manufacturing of CAR-T/CAR-NK CT109; and the development and validation of the Stromatis technology as it relates to the CAR-T/CAR-NK CT109 antibody up to and inclusive of filing of Investigational New Drug Application relating to Stromatis’ CAR-T/CAR-NK CT109 antibody (“Licensed Product”), in accordance with the agreed project plan (“Project”). The Company will fund the Project by providing Stromatis an amount of up to $1.2 million. Stromatis will grant the Company certain exclusive rights to manufacture, process and supply the Licensed Product (“Manufacturing Rights”) and exclusive rights to market and sell and offer for sale the Licensed Product within the Company’s point of care network (“Marketing Rights”). Stromatis has the option to convert the exclusive Manufacturing Rights to non-exclusive rights subject to payment by Stromatis of an amount equal to funding provided by Company and an additional payment by Stromatis of an ongoing revenue share of five percent (5%) of revenues of any kind received by Stromatis or its affiliates from the sale or transfer of Licensed Products or license of rights under the licensed technology. The Company shall pay Stromatis in consideration for the Marketing Rights and royalties of up to 12% of net revenues of Licensed Products received by the Company. The Company advanced to Stromatis an initial sum of $500 thousand under the Stromatis Agreement, which was recorded as cost of services and other research and development expenses.

NOTE

9 – SUBSEQUENT EVENTS

In July 2021 the Company via the Belgian subsidiary invested approximately $260 thousand in Revacel Srl (“Revacel”), a newly incorporated entity in Belgium. The Company will hold 51% of the share capital of Revacel and have the right to appoint 2 members to the Revacel board of directors. The Company’s partner, Revatis SA, (a Belgian entity) will hold the remaining 49% and has the right to appoint 2 members to the Revacel board of directors. The fifth Revacel board member will be an independent industry expert appointed with the mutual agreement of the Company and Revatis SA. Revacel will develop products in the field of muscle-derived mesenchymal stem/progenitor cells.

2.

On July 28, 2021, the Compensation Committee of the Board of Directors awarded a discretionary bonus to Vered Caplan, the Chief Executive Officer of the Company, in the amount of $3.6 million pursuant to the discretionary bonus provisions of the Personal Employment Agreement between Vered Caplan and Orgenesis Services Sàrl.

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

Forward-LookingStatements

The following discussion should be read in conjunction with the financial statements and related notes contained elsewhere in this Quarterly Report on Form 10-Q, as well as our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed with the Securities and Exchange Commission (the “SEC”) on March 9, 2021. Certain statements made in this discussion are “forward-looking statements” within the meaning of 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are based upon beliefs of, and information currently available to, the Company’s management as well as estimates and assumptions made by the Company’s management. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. When used herein, the words “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “future,” “intend,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” or the negative of these terms and similar expressions as they relate to the Company or the Company’s management identify forward-looking statements. Such statements reflect the current view of the Company with respect to future events and are subject to risks, uncertainties, assumptions, and other factors, including the risks relating to the Company’s business, industry, and the Company’s operations and results of operations and the effects that the COVID-19 outbreak, any of its variants, or similar pandemics, could have on our business and CGT Biotech Platform. 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.

The full extent to which the COVID-19 pandemic may directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets. We have made estimates of the impact of COVID-19 within our financial statements, and although there is currently no major impact, there may be changes to those estimates in future periods. Actual results may differ from these estimates.

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

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

Unless otherwise indicated or the context requires otherwise, the words “we,” “us,” “our,” the “Company,” “our Company” or “Orgenesis” refer to Orgenesis Inc., a Nevada corporation, and our majority or wholly-owned subsidiaries, Orgenesis Korea Co. Ltd. (the “Korean Subsidiary”); Orgenesis Belgium SRL, a Belgian-based entity (the “Belgian Subsidiary”); Orgenesis Ltd., an Israeli corporation (the “Israeli Subsidiary”); Orgenesis Maryland Inc., a Maryland corporation (the “U.S. Subsidiary”); Orgenesis Switzerland Sarl, which was incorporated in October 2020 (the “Swiss Subsidiary”); Orgenesis Biotech Israel Ltd. (“OBI”); Koligo Therapeutics Inc., a Kentucky corporation, purchased in 2020 (“Koligo”), Orgenesis Germany GmbH, a German entity which was incorporated in the second quarter of 2021; and Masthercell Global Inc. (which consisted mainly of the following two subsidiaries: MaSTherCell S.A. in Belgium and Masthercell U.S., LLC in the United States (collectively, “Masthercell”)). The Company sold all of its equity interests in Masthercell and its subsidiaries in February 2020.

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CorporateOverview

Orgenesis Inc., a Nevada corporation, is a global biotech company working to unlock the potential of cell and gene therapies (“CGTs”) in an affordable and accessible format.

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

To achieve these goals, we have developed a Point of Care Platform comprised of three enabling components: a pipeline of licensed POCare Therapies that are designed to be processed and produced in closed, automated POCare Technology systems and a collaborative POCare Network. Via a combination of science, technology, engineering, and networking, we are working to provide a more efficient and scalable pathway for advanced therapies to reach patients more rapidly at lowered costs. We also draw on extensive medical expertise to identify promising new autologous therapies to leverage within the POCare Platform either via ownership or licensing.

The POCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide with a goal of achieving harmonized, regulated clinical development and production of the therapies.

POCarePlatform Operations via Subsidiaries

We currently conduct our core business operations ourselves and through our subsidiaries, which are all wholly-owned except as otherwise stated below (collectively, the “Subsidiaries”). The Subsidiaries are as follows:

UnitedStates

● Orgenesis<br> Maryland Inc. (the “U.S. Subsidiary”) is the center of activity in North America and is currently focused on setting<br> up the POCare Network.
● Koligo<br> Therapeutics Inc. (“Koligo”) is a Kentucky corporation that we acquired in 2020 and is currently focused on developing<br> the POCare network and therapies.

Europe

● Orgenesis<br> Belgium SRL (the “Belgian Subsidiary”) is a center of activity in Europe and is currently focused on process development<br> and the preparation of European clinical trials.
● Orgenesis<br> Germany GmbH (the “German Subsidiary”) is currently focused on certain aspects of clinical trials.
● Orgenesis<br> Switzerland Sarl (the “Swiss Subsidiary”), was incorporated in October 2020, and is currently focused on providing management<br> services to us.
Asia
---
● Orgenesis<br> Ltd. in Israel (the “Israeli Subsidiary”) is a provider of regulatory, clinical and pre-clinical services.
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● Orgenesis<br> Biotech Israel Ltd. (“OBI”), is a provider of cell-processing services in Israel. 
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| --- | | ● | Orgenesis<br> Korea Co. Ltd. (the “Korean Subsidiary”), is a provider of processing and pre-clinical services in Korea. We own 94.12%<br> of the Korean Subsidiary. | | --- | --- |

BusinessStrategy

Our aim is to provide a pathway to bring ATMPs in the cell and gene therapy industry from research to patients worldwide through our POCare Platform. We define point of care as a process of collecting, processing, and administering cells within the patient care environment, namely through academic partnerships in a hospital setting. We believe that this approach is an attractive proposition for personalized medicine because of our strategic partnerships with suppliers that help us to customize closed systems into effective mobile clean room facilities. This will potentially help to minimize or eliminate the need for cell transportation, which is a high-risk and costly aspect of the supply chain.

We aim to build value in various aspects of our company ranging from supply related processes including development and distribution systems, clinical and regulatory services, engineering and devices such as OMPULs discussed below, delivery systems, therapies including immuno-oncology, anti-aging, anti-viral, metabolic, nephrology, dermatology, orthopedic, as well as regenerative technologies.

Over time, we have worked to develop and validate POCare Technologies that can be combined within mobile production units for advanced therapies. We made significant investments in the development of several types of Orgenesis Mobile Processing Units and Labs (“OMPULs”) with the expectation of use and/or distribution through our POCare Network of partners, collaborators, and joint ventures. We anticipate distributing and using the OMPULS through our POCare Network of partners, collaborators, and joint ventures.

OMPULs are designed for the purpose of validation, development, performance of clinical trials, manufacturing and/or processing of potential or approved cell and gene therapy products in a safe, reliable, and cost-effective manner at the point of care, as well as the manufacturing of such CGTs in a consistent and standardized manner in all locations. The design delivers a potential industrial solution for us to deliver CGTs to most clinical institutions at the point of care.

RevenueModel and Business Development

Our Point of Care (“POCare”) Platform is comprised of three enabling components: a multitude of licensed cell based POCare Therapeutics that are produced in closed, automated POCare technology systems and a collaborative POCare Network. Our therapies include, but are not limited to, autologous, cell-based immunotherapies, therapeutics for metabolic diseases, anti-viral diseases, and tissue regeneration. We are establishing and positioning the business to bring point-of-care therapies to patients in a scalable way working directly with hospitals and through regional joint venture partners (“JVs”) and JVs active in autologous cell therapy product development, including facilities in various countries in North America, Europe, Latin America, Asia, the Middle East, and Australia. The POCare Platform’s goal is to enable a rapid, globally harmonized pathway for these therapies to reach large numbers of patients at lowered costs through efficient and decentralized production. The POCare Network brings together industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies.

We are focused on technology in-licensing and therapeutic collaborations, and we out-license therapies marketing rights and manufacturing rights to partners and / or to the JVs. In many cases, the JVs are responsible for the preparation of clinical trials, local regulatory approvals and regional marketing activities. Such licensing includes exclusive or nonexclusive, sublicensable, royalty bearing rights and license to the Orgenesis Background IP as required solely to manufacture, distribute and market and sell Orgenesis Products within the relevant territories. In consideration for the rights and the licenses so granted, we receive a royalty in the range of ten percent of the net sales generated by the JVs and/or its sublicensees (as applicable) with respect to the Orgenesis Products.

In addition, in many cases, once the JVs become profitable, we will be entitled (in addition to any of its rights as holder of the JVs and prior to any other distributions of dividends by the JVs to shareholders of the JVs) to certain royalties pursuant to an Orgenesis License Agreement, to receive from the JVs royalties at a range of 10 to 15 percent of the JV’s audited U.S. GAAP profit, after tax.

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The Company has signed POCare Master Services Agreements (“MSAs”) with our JV partners. During the three months ended June 30, 2021, the Company together with our JV partners reviewed and revised the MSAs to reflect updated services that the Company provides. In terms of the MSAs, we provide certain broadly defined development services that relate to our licensed therapies designed to develop or enhance the therapy with the objective of preparing it for clinical use. Such services, per therapy, include regulatory services, pre-clinical studies, intellectual property services, development services, and GMP process translation.

Resultsof Operations

Comparisonof the Three Months Ended June 30, 2021 to the Three Months Ended June 30, 2020.

The following table presents our results of operations for the three months ended June 30, 2021 and 2020:

Three-Months<br> Ended
June<br> 30, 2021 June<br> 30, 2020
(in<br> thousands)
Revenues $ 9,818 $ 1,470
Revenues<br> to Related Party 727 279
Cost<br> of services and other research and development expenses 9,727 24,963
Amortization<br> of intangible assets 239 (52 )
Selling,<br> general and administrative expenses 2,901 3,611
Other<br> income, net (3 ) (1 )
Financial<br> expenses, net 406 337
Loss<br> before income taxes $ 2,725 $ 27,109

During the three months ended June 30, 2021, we recognized point-of-care development service revenue in the amount of $10,545 thousand, as compared to $1,749 thousand during the three months ended June 30, 2020, representing an increase of 503%. The increase is attributable to increased activity under master service agreements with our customers.

Expenses

Cost of services and other research and development expenses

Three-Months<br> Ended
June<br> 30, 2021 June<br> 30, 2020
(in<br> thousands)
Salaries<br> and related expenses $ 2,531 $ 1,279
Stock-based<br> compensation 150 133
Professional<br> fees and consulting services 3,908 574
Lab<br> expenses 830 531
Tamir<br> purchase agreement - 19,510
Depreciation<br> expenses, net 256 131
Other<br> research and development expenses 2,052 2,858
Less<br> – grant - (53 )
Total $ 9,727 $ 24,963 
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Cost of services and other research and development expenses for the three months ended June 30, 2021 were $9,727 thousand, as compared to $24,963 thousand for the three months ended June 30, 2020, representing a decrease of 61%. The changes contributing to the net decrease during the quarter were attributable to:

● In 2020, we purchased the assets of Tamir Biotechnology Inc., and we accounted for these as Research and Development expenses under ASC 730.

● Salaries and related expenses increased as a result of additional staff hired to continue the development of our CGT product pipeline as we expand our POC operations globally. We continue to invest in the development of automated processing units and processes, owned and licensed advanced therapies to enable commercial production, and in additional work with partners that address POCare needs.

● We experienced an increase in professional fees and consulting services of $3,334 thousand. As indicated above, we continue to invest in the development of automated processing units and processes, owned and licensed advanced therapies to enable commercial production, and in additional work with partners that address POCare needs.

Selling, General and Administrative Expenses

Three-Months<br> Ended
June<br> 30, 2021 June<br> 30, 2020
(in<br> thousands)
Salaries<br> and related expenses $ 744 $ 367
Stock-based<br> compensation 175 697
Accounting<br> and legal fees 829 1,793
Professional<br> fees 425 389
Rent<br> and related expenses 53 68
Business<br> development 158 175
Depreciation<br> expenses, net (30 ) 25
Other<br> general and administrative expenses 547 97
Total $ 2,901 $ 3,611

Selling, general and administrative expenses for the three months ended June 30, 2021 were $2,901 thousand, as compared to $3,611 thousand for the three months ended June 30, 2020, representing a decrease of 20%. The decrease in selling, general and administrative expenses in the three months ended June 30, 2021 compared to the three months ended June 30, 2020 is primarily attributable to a decrease in accounting and legal fees of $964 thousand and as a result of decreased corporate investment activities in 2021 compared to 2020.

Financial Expenses, net

Three-Months<br> Ended
June<br> 30, 2021 June<br> 30, 2020
(in<br> thousands)
Interest<br> expense on convertible loans and loans $ 271 $ 317
Foreign<br> exchange loss (gain), net 138 108
Other<br> expenses (income) (3 ) (88 )
Total $ 406 $ 337

Financial expenses, net, for the three months ended June 30, 2021 were $406 thousand, as compared to $337 thousand for the three months ended June 30, 2020, representing an increase of 20%. The increase was mainly as a result of a decline in other income.

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Comparisonof the Six Months Ended June 30, 2021 to the Six Months Ended June 30, 2020.

The following table presents our results of operations for the six months ended June 30, 2021 and 2020:

Six<br> Months Ended
June<br> 30, 2021 June<br> 30, 2020
(in<br> thousands)
Revenues $ 18,050 $ 2,855
Revenues<br> to Related Party 1,884 772
Cost<br> of services and other research and development expenses 15,854 29,836
Amortization<br> of intangible assets 477 171
Selling,<br> general and administrative expenses 5,869 7,129
Other<br> income, net (28 ) (4 )
Financial<br> expenses, net 639 666
Share<br> in net income of associated company 15 -
Loss<br> before income taxes $ 2,892 $ 34,171

Our revenues for the six months ended June 30, 2021 were $19,934 thousand, as compared to $3,627 thousand for the six months ended June 30, 2020, representing an increase of 450%. The increase in revenues for the six months ended June 30, 2021 was attributable to the increase in point-of-care services revenue as a result of increased activity under master service agreements with our customers.

Expenses

Cost of services and other research and development expenses

Six<br> Months Ended
June<br> 30, 2021 June<br> 30, 2020
(in<br> thousands)
Salaries<br> and related expenses $ 4,767 $ 2,195
Stock-based<br> compensation 308 219
Professional<br> fees and consulting services 6,033 975
Lab<br> expenses 1,457 1,150
Tamir<br> purchase agreement. - 19,510
Depreciation<br> expenses, net 419 263
Other<br> research and development expenses 2,870 5,662
Less<br> – grant - (138 )
Total $ 15,854 $ 29,836

Cost of services and other research and development expenses for the six months ended June 30, 2021 were $15,854 thousand, as compared to $29,836 thousand for the six months ended June 30, 2020, representing a decrease of 47%. The changes contributing to the net decrease during the period were attributable to:

● In 2020, we purchased the assets of Tamir Biotechnology Inc., and we accounted for these as Research and Development expenses under ASC 730.

● Salaries and related expenses increased by $2,572 thousand, as a result of additional staff hired to continue the development of our CGT product pipeline as we expand our POC operations globally. We continue to invest in the development of automated processing units and processes, owned and licensed advanced therapies to enable commercial production, and in additional work with partners that address POCare needs.

● We experienced an increase in professional fees and consulting services of $5,058 thousand. As indicated above, we continue to invest in the development of automated processing units and processes, owned and licensed advanced therapies to enable commercial production, and in additional work with partners that address POCare needs.

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Selling, General and Administrative Expenses

Six<br> Months Ended
June<br> 30, 2021 June<br> 30, 2020
(in<br> thousands)
Salaries<br> and related expenses $ 1,423 $ 869
Stock-based<br> compensation 582 1,028
Accounting<br> and legal fees 1,701 3,417
Professional<br> fees 837 826
Rent<br> and related expenses 83 129
Business<br> development 306 425
Depreciation<br> expenses, net 22 50
Other<br> general and administrative expenses 915 385
Total $ 5,869 $ 7,129

Selling, general and administrative expenses for the six months ended June 30, 2021 were $5,869 thousand, as compared to $7,129 thousand for the six months ended June 30, 2020, representing a decrease of 18%. The decrease was primarily attributable to a decrease in accounting and legal fees of $1,716 thousand, as a result of reduced corporate investment activities in 2021 compared to 2020.

Financial Expenses, net

Six<br> Months Ended
June<br> 30, 2021 June<br> 30, 2020
(in<br> thousands)
Interest<br> expense on convertible loans and loans $ 524 $ 739
Foreign<br> exchange loss, net 194 165
Other<br> expenses (income) (79 ) (238 )
Total $ 639 $ 666

Financial expenses, net for the six months ended June 30, 2021 were $639 thousand, as compared to $666 thousand for the six months ended June 30, 2020, representing a decrease of 4%.

WorkingCapital

As<br> of
June<br> 30, 2021 December 31, 2020
(in<br> thousands)
Current<br> assets $ 47,848 $ 50,077
Current<br> liabilities 18,156 16,285
Working<br>capital gain $ 29,692 $ 33,792

Current assets decreased by $2,229 thousand between December 31, 2020 and June 30, 2021. There was a decrease in cash and cash equivalents of $16,492 thousand as a result of payments of operating expenses. Accounts receivable increased by $14,111 as a result of increased POC revenue.

Current liabilities increased by $1,871 thousand between December 31, 2020 and June 30, 2021 primarily due to an increase in current maturities of convertible loans.

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Liquidityand Financial Condition

Six<br> Months Ended
June<br> 30, 2021 June<br> 30, 2020
(in<br> thousands)
Net<br> income (loss) $ (2,890 ) $ 49,050
Net<br> cash used in operating activities (16,047 ) (22,834 )
Net<br> cash provided by (used in) investing activities (1,562 ) 102,772
Net<br> cash provided by financing activities 993 6,159
Increase<br> in cash and cash equivalents $ (16,616 ) $ 86,097

During six months period ended June 30, 2021, we funded our operations from existing funds.

Net cash used in operating activities for the six months ended June 30, 2021 was approximately $16 million, as compared to net cash used in operating activities of approximately $23 million for the six months ended June 30, 2020.

Net cash used in investing activities for the six months ended June 30, 2021 was approximately $2 million, as compared to net cash provided by investing activities of approximately $103 million for the six months ended June 30, 2020. The change was mainly due to the proceeds from Masthercell in the first quarter of 2020.

Liquidity& Capital Resources Outlook

We believe that our current cash balance as well as revenues from our current operations results will provide sufficient liquidity to fund our operating needs for at least the next 12 months. We expect our general and administrative expenses to increase significantly in the third quarter primarily due to a discretionary bonus in the amount of $3.6 million awarded to our Chief Executive Officer on July 28, 2021 pursuant to the terms of her employment agreement. Additionally, there are factors that can impact our ability to continue to fund our operating needs, including:

● restrictions<br> on our ability to expand sales volume from our CGT Biotech Platform; and
● the<br> need for us to continue to invest in operating activities to remain competitive or acquire other businesses and technologies and<br> to complement our products, expand the breadth of our business, enhance our technical capabilities or otherwise offer growth opportunities.

If there are further increases in operating costs in general and administrative expenses for facilities expansion, funding for some of our collaborations and joint ventures, research and development, commercial and clinical activity or decreases in revenues from customers, we may decide to seek additional financing.

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.

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Item 4. Controls and Procedures

Evaluationof Disclosure Controls and Procedures

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

Our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this report. Based upon that evaluation and subject to the foregoing, our principal executive officer and principal financial officer concluded that, as of the end of the period covered by this report, the design and operation of our disclosure controls and procedures were effective to accomplish their objectives at the reasonable assurance level.

Changesin Internal Control Over Financial Reporting

There have been no changes in our internal control over financial reporting during the quarter ended June 30, 2021 that have materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.

PART

II – OTHER INFORMATION

Item

  1. Legal Proceedings

We know of no material pending legal proceedings to which the Company or its subsidiaries are a party or of which any of its properties, or the properties of its 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.

ITEM

1A. RISK FACTORS

An investment in the Company’s Common Stock involves a number of very significant risks. You should carefully consider the risk factors included in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the SEC on March 9, 2021, in addition to other information contained in our reports and in this quarterly report in evaluating the Company and its business before purchasing shares of our Common Stock. There have been no material changes to our risk factors contained in our Annual Report on Form 10-K for the year ended December 31, 2020. The Company’s business, operating results and financial condition could be adversely affected due to any of those risks.

ITEM

  1. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Salesof Unregistered Equity Securities

There were no sales of unregistered equity securities during the three-month period ended June 30, 2021.

IssuerPurchases of Equity Securities

On May 14, 2020, our Board of Directors approved the stock repurchase plan (the “Stock Repurchase Plan”) pursuant to which we may, from time to time, purchase up to $10 million of our outstanding shares of common stock. The shares may be repurchased from time to time in privately negotiated transactions or the open market, including pursuant to Rule 10b5-1 trading plans, and in accordance with applicable regulations of the SEC. The timing and exact amount of any repurchases will depend on various factors including, general and business market conditions, corporate and regulatory requirements, share price, alternative investment opportunities and other factors. The Repurchase Plan commenced on May 29, 2020 and does not obligate us to acquire any specific number of shares in any period, and may be expanded, extended, modified, suspended or discontinued by the Board of Directors at any time.

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The following table summarizes the share repurchase activity pursuant to the Stock Repurchase Plan during the three months ended June 30, 2021.

Total<br><br> <br>Number<br><br> <br>of<br> Shares <br> Purchased Average<br><br> <br>Price<br> <br> Paid per<br><br> <br>Share Total<br> Number of<br><br> <br>Shares<br> Purchased as<br><br> <br>Part<br> of Publicly<br><br> <br>Announced<br> Plans or<br><br> <br>Programs <br><br><br><br>Maximum Value that May Yet Be Purchased Under the Plans or Programs
(in<br> thousands)
April<br> 2021 8,850 $ 4.49 8,850 $ 9,699
May<br> 2021 195,625 4.34 195,625 8,841
204,475 $ 4.34 204,475 $ 8,841

ITEM

  1. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM

  1. MINE SAFETY DISCLOSURES

Not Applicable.

Item 5. Other Information

None.

Item 6. Exhibits

Exhibits required by Item 601 of Regulation S-K

No. Description
(31) Rule 13a-14(a)/15d-14(a) Certification
31.1* Certification Statement of the Chief Executive Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002
31.2* Certification Statement of the Chief Financial Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002
(32) Section 1350 Certification
32.1* Certification Statement of the Chief Executive Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002
32.2* Certification Statement of the Chief Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002
(101)* Interactive Data Files
101.INS XBRL<br> Instance Document
101.SCH XBRL<br> Taxonomy Extension Schema Document
101.CAL XBRL<br> Taxonomy Extension Calculation Linkbase Document
101.DEF XBRL<br> Taxonomy Extension Definition Linkbase Document
101.LAB XBRL<br> Taxonomy Extension Label Linkbase Document
101.PRE XBRL<br> Taxonomy Extension Presentation Linkbase Document
104 Cover<br> Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)
* Filed herewith. 
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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<br> Caplan
President<br> & Chief Executive Officer
(Principal<br> Executive Officer)
Date:<br> August 5, 2021
/s/ Neil Reithinger
Neil<br> Reithinger
Chief<br> Financial Officer, Treasurer and Secretary
(Principal<br> Financial Officer and Principal Accounting Officer)
Date:<br> August 5, 2021 
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Exhibit31.1

ORGENESISINC.

CERTIFICATIONPURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Vered Caplan, certify that:

1. I<br> have reviewed this Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 of Orgenesis Inc.;
2. Based<br> on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary<br> to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to<br> the period covered by this report;
3. Based<br> on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material<br> respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in<br> this report;
4. The<br> registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures<br> (as defined in Exchange Act Rules 13a–15(e) and 15d–15(e)) and internal control over financial reporting (as defined<br> in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have:
(a) Designed<br> such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,<br> to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others<br> within those entities, particularly during the period in which this report is being prepared;
--- ---
(b) Designed<br> such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our<br> supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements<br> for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated<br> the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about<br> the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;<br> and
(d) Disclosed<br> in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s<br> most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,<br> or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The<br> registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial<br> reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing<br> the equivalent functions):
--- ---
(a) All<br> significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are<br> reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;<br> and
--- ---
(b) Any<br> fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s<br> internal control over financial reporting.

By:

/s/ Vered Caplan
Vered<br> Caplan
President<br> & Chief Executive Officer
(Principal<br> Executive Officer)
Date:<br> August 5, 2021

Exhibit31.2

ORGENESISINC.

CERTIFICATIONPURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Neil Reithinger, certify that:

1. I<br> have reviewed this Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 of Orgenesis Inc.;
2. Based<br> on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary<br> to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to<br> the period covered by this report;
3. Based<br> on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material<br> respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in<br> this report;
4. The<br> registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures<br> (as defined in Exchange Act Rules 13a–15(e) and 15d–15(e)) and internal control over financial reporting (as defined<br> in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have:
(a) Designed<br> such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,<br> to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others<br> within those entities, particularly during the period in which this report is being prepared;
--- ---
(b) Designed<br> such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our<br> supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements<br> for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated<br> the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about<br> the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;<br> and
(d) Disclosed<br> in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s<br> most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,<br> or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The<br> registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial<br> reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing<br> the equivalent functions):
--- ---
(a) All<br> significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are<br> reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;<br> and
--- ---
(b) Any<br> fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s<br> internal control over financial reporting.

By:

/s/ Neil Reithinger
Neil<br> Reithinger
Chief<br> Financial Officer, Treasurer and Secretary
(Principal<br> Financial Officer and Principal Accounting Officer)
Date:<br> August 5, 2021

Exhibit32.1

ORGENESISINC.

CERTIFICATIONPURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

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

(a) The<br> Quarterly Report on Form 10-Q of Orgenesis Inc. for the quarter ended June 30, 2021 fully complies with the requirements of Section<br> 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(b) Information<br> contained in the Quarterly Report on Form 10-Q fairly presents, in all material respects, the financial condition and results of<br> operations of Orgenesis Inc.

By:

/s/ Vered Caplan
Vered<br> Caplan
President<br> & Chief Executive Officer
(Principal<br> Executive Officer)
Date:<br> August 5, 2021

Exhibit32.2

ORGENESISINC.

CERTIFICATIONPURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

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

(a) The<br> Quarterly Report on Form 10-Q of Orgenesis Inc. for the quarter ended June 30, 2021 fully complies with the requirements of Section<br> 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(b) Information<br> contained in the Quarterly Report on Form 10-Q fairly presents, in all material respects, the financial condition and results of<br> operations of Orgenesis Inc.

By:

/s/ Neil Reithinger
Neil<br> Reithinger
Chief<br> Financial Officer, Treasurer and Secretary
(Principal<br> Financial Officer and Principal Accounting Officer)
Date:<br> August 5, 2021

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