Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 15, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2022 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-38416 | |
Entity Registrant Name | ORGENESIS INC. | |
Entity Central Index Key | 0001460602 | |
Entity Tax Identification Number | 98-0583166 | |
Entity Incorporation, State or Country Code | NV | |
Entity Address, Address Line One | 20271 Goldenrod Lane | |
Entity Address, City or Town | Germantown | |
Entity Address, State or Province | MD | |
Entity Address, Postal Zip Code | 20876 | |
City Area Code | (480) | |
Local Phone Number | 659-6404 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | ORGS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 25,545,755 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 2,303 | $ 5,473 | |
Restricted cash | 457 | 501 | |
Accounts receivable, net | [1] | 18,786 | 15,245 |
Prepaid expenses and other receivables | 793 | 1,188 | |
Convertible loan receivable-related party | 3,012 | 3,064 | |
Grants receivable | 169 | ||
Inventory | 107 | 118 | |
Total current assets | 25,458 | 25,758 | |
NON-CURRENT ASSETS: | |||
Deposits | 329 | 363 | |
Investments and loans to associates | 1,750 | 584 | |
Loans receivable | 821 | ||
Property, plant and equipment, net | 14,388 | 10,271 | |
Intangible assets, net | 11,207 | 11,821 | |
Operating lease right-of-use assets | 757 | 1,015 | |
Goodwill | 8,174 | 8,403 | |
Other assets | 736 | 805 | |
Total non-current assets | 37,341 | 34,083 | |
TOTAL ASSETS | 62,799 | 59,841 | |
CURRENT LIABILITIES: | |||
Accounts payable | 5,203 | 5,238 | |
Accrued expenses and other payables | 1,763 | 485 | |
Income tax payable | 83 | 54 | |
Employees and related payables | 1,998 | 1,907 | |
Advance payments on account of grant | 1,144 | 1,238 | |
Contract liabilities | 70 | 59 | |
Current maturities of finance leases | 17 | 18 | |
Current maturities of operating leases | 399 | 481 | |
Current maturities of convertible loans | 5,568 | 5,885 | |
Total current liabilities | 16,245 | 15,365 | |
LONG-TERM LIABILITIES: | |||
Non-current operating leases | 352 | 561 | |
Convertible loans | 13,943 | 4,854 | |
Retirement benefits obligation | 123 | 101 | |
Non-current finance leases | 29 | 41 | |
Other long-term liabilities | 264 | 288 | |
Total long-term liabilities | 14,711 | 5,845 | |
TOTAL LIABILITIES | 30,956 | 21,210 | |
EQUITY: | |||
Common stock of $0.0001 par value: Authorized at June 30, 2022 and December 31, 2021: 145,833,334 shares; Issued at June 30, 2022 and December 31, 2021: 25,107,323 and 24,567,366 shares, respectively; Outstanding at June 30, 2022 and December 31, 2021: 24,820,756 and 24,280,799 shares, respectively | 3 | 3 | |
Additional paid-in capital | 146,919 | 145,916 | |
Receipts on account of shares and warrants to be allotted | 2,175 | ||
Accumulated other comprehensive income (loss) | (270) | 207 | |
Treasury stock 286,567 shares as of June 30, 2022 and December 31, 2021 | (1,266) | (1,266) | |
Accumulated deficit | (115,808) | (106,372) | |
Equity attributable to Orgenesis Inc. | 31,753 | 38,488 | |
Non-controlling interest | 90 | 143 | |
Total equity | 31,843 | 38,631 | |
TOTAL LIABILITIES AND EQUITY | $ 62,799 | $ 59,841 | |
[1]Including related party in the amount of $ 2,039 1,972 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Accounts receivables related parties current | $ 2,039 | $ 1,972 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 145,833,334 | 145,833,334 |
Common stock, shares issued | 25,107,323 | 24,567,366 |
Common stock, shares outstanding | 24,820,756 | 24,280,799 |
Treasury stock, shares | 286,567 | 286,567 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Loss and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | ||||
Revenues | $ 6,699 | $ 9,818 | $ 13,276 | $ 18,050 |
Revenues from related party | 502 | 727 | 1,137 | 1,884 |
Total revenues | 7,201 | 10,545 | 14,413 | 19,934 |
Cost of revenues, development services and research and development expenses | 8,901 | 9,727 | 16,266 | 15,854 |
Amortization of intangible assets | 229 | 239 | 461 | 477 |
Selling, general and administrative expenses | 2,803 | 2,901 | 5,654 | 5,869 |
Operating loss | 4,732 | 2,322 | 7,968 | 2,266 |
Other income, net | (8) | (3) | (8) | (28) |
Financial expenses, net | 389 | 406 | 602 | 639 |
Share in net loss of associated companies | 368 | 915 | 15 | |
Loss before income taxes | 5,481 | 2,725 | 9,477 | 2,892 |
Tax expenses (income) | 11 | 12 | (2) | |
Net loss | 5,492 | 2,725 | 9,489 | 2,890 |
Net loss attributable to non-controlling interests | (65) | (66) | (53) | (12) |
Net loss attributable to Orgenesis Inc. | $ 5,427 | $ 2,659 | $ 9,436 | $ 2,878 |
Loss per share: | ||||
Basic and diluted | $ 0.22 | $ 0.11 | $ 0.38 | $ 0.12 |
Weighted average number of shares used in computation of Basic and Diluted loss per share: | ||||
Basic and diluted | 24,820,756 | 24,365,746 | 24,711,462 | 24,279,826 |
Comprehensive loss: | ||||
Net loss | $ 5,492 | $ 2,725 | $ 9,489 | $ 2,890 |
Other comprehensive loss (income) - translation adjustments | 326 | (48) | 477 | 229 |
Comprehensive loss | 5,818 | 2,677 | 9,966 | 3,119 |
Comprehensive loss attributed to non-controlling interests | (65) | (66) | (53) | (12) |
Comprehensive loss attributed to Orgenesis Inc. | $ 5,753 | $ 2,611 | $ 9,913 | $ 3,107 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Equity (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Receipts On Account Of Shares To Be Allotted [Member] | AOCI Attributable to Parent [Member] | Treasury Stock [Member] | Retained Earnings [Member] | Parent [Member] | Noncontrolling Interest [Member] | Total | |
Balance at Dec. 31, 2020 | $ 3 | $ 140,397 | $ 748 | $ (250) | $ (88,319) | $ 52,579 | $ 149 | $ 52,728 | ||
Balance, shares at Dec. 31, 2020 | 24,167,784 | |||||||||
Stock-based compensation to employees and directors | 612 | 612 | 612 | |||||||
Stock-based compensation to service providers | [1] | 276 | 276 | 276 | ||||||
Exercise of options | [1] | 50 | 50 | 50 | ||||||
Exercise of options, shares | 8,750 | |||||||||
Comprehensive income (loss) for the period | (229) | (2,878) | (3,107) | (12) | (3,119) | |||||
Issuance of Shares due to exercise of warrants | [1] | 1,862 | 1,862 | 1,862 | ||||||
Issuance of Shares due to exercise of warrants, shares | 305,523 | |||||||||
Repurchase of treasury stock | (909) | (909) | (909) | |||||||
Repurchase of treasury stock, shares | (206,781) | |||||||||
Balance at Jun. 30, 2021 | $ 3 | 143,197 | 519 | (1,159) | (91,197) | 51,363 | 137 | 51,500 | ||
Balance, shares at Jun. 30, 2021 | 24,275,276 | |||||||||
Balance at Mar. 31, 2021 | $ 3 | 142,449 | 424 | 471 | (260) | (88,538) | 54,549 | 203 | 54,752 | |
Balance, shares at Mar. 31, 2021 | 24,411,791 | |||||||||
Stock-based compensation to employees and directors | 292 | 292 | 292 | |||||||
Stock-based compensation to service providers | 32 | 32 | 32 | |||||||
Comprehensive income (loss) for the period | 48 | (2,659) | (2,611) | (66) | (2,677) | |||||
Issuance of Shares due to exercise of warrants | 424 | (424) | ||||||||
Issuance of Shares due to exercise of warrants, shares | 67,960 | |||||||||
Repurchase of treasury stock | (899) | (899) | (899) | |||||||
Repurchase of treasury stock, shares | (204,475) | |||||||||
Balance at Jun. 30, 2021 | $ 3 | 143,197 | 519 | (1,159) | (91,197) | 51,363 | 137 | 51,500 | ||
Balance, shares at Jun. 30, 2021 | 24,275,276 | |||||||||
Balance at Dec. 31, 2021 | $ 3 | 145,916 | 207 | (1,266) | (106,372) | 38,488 | 143 | 38,631 | ||
Balance, shares at Dec. 31, 2021 | 24,280,799 | |||||||||
Stock-based compensation to employees and directors | 463 | 463 | 463 | |||||||
Stock-based compensation to service providers | 37 | 37 | 37 | |||||||
Exercise of options | [2] | 6 | 6 | 6 | ||||||
Exercise of options, shares | 510,017 | |||||||||
Issuance of warrants with respect to convertible loans | 397 | 397 | 397 | |||||||
Receipts on account of shares and warrants to be allotted | 2,175 | 2,175 | 2,175 | |||||||
Issuance of shares related to acquisition of Mida | [2] | 100 | 100 | 100 | ||||||
Issuance of shares related to acquisition of Mida, shares | 29,940 | |||||||||
Comprehensive income (loss) for the period | (477) | (9,436) | (9,913) | (53) | (9,966) | |||||
Balance at Jun. 30, 2022 | $ 3 | 146,919 | 2,175 | (270) | (1,266) | (115,808) | 31,753 | 90 | 31,843 | |
Balance, shares at Jun. 30, 2022 | 24,820,756 | |||||||||
Balance at Mar. 31, 2022 | $ 3 | 146,290 | 56 | (1,266) | (110,381) | 34,702 | 155 | 34,857 | ||
Balance, shares at Mar. 31, 2022 | 24,820,756 | |||||||||
Stock-based compensation to employees and directors | 220 | 220 | 220 | |||||||
Stock-based compensation to service providers | 12 | 12 | 12 | |||||||
Issuance of warrants with respect to convertible loans | 397 | 397 | 397 | |||||||
Receipts on account of shares and warrants to be allotted | 2,175 | 2,175 | 2,175 | |||||||
Comprehensive income (loss) for the period | (326) | (5,427) | (5,753) | (65) | (5,818) | |||||
Balance at Jun. 30, 2022 | $ 3 | $ 146,919 | $ 2,175 | $ (270) | $ (1,266) | $ (115,808) | $ 31,753 | $ 90 | $ 31,843 | |
Balance, shares at Jun. 30, 2022 | 24,820,756 | |||||||||
[1]Represents an amount lower than $1 thousand.[2]Represents an amount lower than $1 thousand. |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (9,489) | $ (2,890) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 500 | 888 |
Capital loss (gain), net | (5) | 20 |
Share in losses of associated companies, net | 915 | 15 |
Depreciation and amortization expenses | 975 | 918 |
Effect of exchange differences on inter-company balances | 142 | 59 |
Net changes in operating leases | (33) | (13) |
Interest expenses accrued on loans and convertible loans | 495 | 200 |
Changes in operating assets and liabilities: | ||
Increase in accounts receivable | (3,724) | (14,087) |
Decrease in inventory | 4 | 7 |
Decrease (increase) in other assets | 17 | (8) |
Decrease (increase) in prepaid expenses and other accounts receivable | 435 | (371) |
Decrease in accounts payable | (923) | (3,422) |
Increase in accrued expenses and other payables | 1,171 | 1,768 |
Increase in employee and related payables | 135 | 541 |
Increase in contract liabilities | 10 | |
Change in advance payments and receivables on account of grant, net | 169 | 328 |
Net cash used in operating activities | (9,206) | (16,047) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Repayment of convertible loan to related party partners | 138 | |
Increase in loan to associates entities | (2,197) | |
Repayment of loan granted | 782 | |
Sale of property and equipment | 68 | |
Purchase of property, plant and equipment | (4,352) | (1,542) |
Cash acquired from acquisition of Mida | 702 | |
Investment in long-term deposits | (4) | (20) |
Net cash used in investing activities | (4,863) | (1,562) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Repurchase of treasury stock | (909) | |
Proceeds from issuance of shares due to exercise of options and warrants (net of transaction costs) | 6 | 1,912 |
Proceeds from issuance of convertible loans (net of transaction costs) | 9,150 | |
Proceeds from receipts on account of shares and warrants to be allotted | 2,175 | |
Repayment of convertible loans and convertible bonds | (416) | |
Repayment of short and long-term debt | (9) | (10) |
Net cash provided by financing activities | 10,906 | 993 |
NET CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (3,163) | (16,616) |
EFFECT OF EXCHANGE RATE CHANGES ON CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (51) | (40) |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF PERIOD | 5,974 | 45,568 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD | 2,760 | 28,912 |
SUPPLEMENTAL NON-CASH FINANCING AND INVESTING ACTIVITIES | ||
Decrease in accounts payable related to purchase of property, plant and equipment | (354) | (9) |
Issuance of common stocks for the acquisition of Mida (see note 8) | $ 100 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
DESCRIPTION OF BUSINESS | 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 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 (“ATMP”). The Company mostly focused 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 for treatment of the patient at the point of care (“POCare”). This approach has the potential to overcome the limitations of traditional commercial manufacturing methods that do not translate well to commercial production of advanced therapies due to their cost prohibitive nature and complex logistics to deliver such treatments to patients (ultimately limiting the number of patients that can have access to, or can afford, these therapies). To achieve these goals, the Company has developed a Point of Care Platform (“POCare Platform”) comprised of three enabling components: (i) a pipeline of licensed POCare advanced therapies that are designed to be processed and produced, (ii) automated closed POCare technology systems, and (iii) a collaborative worldwide network of POCare research institutes and hospitals (“POCare Network”). The POCare Platform relies in particular on the development of its own production capacity, known as “POCare Services”, whose goal is to ensure that therapies are accessible at the point of treatment (the “POCare Center”). POCare Services, which have been expanding worldwide, are based on a global approach and local adaptation that allows replication and expansion. Global harmonization of the POCare Services is ensured by a central quality system, replicability of infrastructure and equipment and centralized monitoring and data management. The POCare Services include: ● Process development of therapies that are intended for use of the POCare Network, ● Adaptation of automation and closed systems to such therapies, ● Incorporation of the processing systems and the Good Manufacturing Processes (“GMP”) in the OMPULs, ● Tech transfers to required POCare Centers and training of local teams, ● Processing and supply and of the therapies and required supplies under GMP conditions by the various POCare centers, including required quality control testing, and ● CRO services for clinical trials. POCare Centers are the decentralized hubs that provide harmonized services to customers and partners. The Company is working to provide a more efficient and scalable pathway for advanced therapies to reach patients more rapidly at lowered costs. The workflow of a POCare Center is designed to allow rapid capacities expansion while integrating new technologies. 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 and industry partners with a goal of achieving harmonized, regulated clinical development and production of POCare advanced 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 the Company’s POCare Network and/or partners, collaborators, and regional distributors. As of the date of this report, the OMPULs have been adapted for processing of CAR-T (chimeric antigen receptor T-cell) therapy, TIL (tumor infiltrating lymphocyte) based products, and are in the qualification stage for clinical use in various locations. Additional 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 advanced 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 OMPUL design delivers a potential industrial solution for us to deliver CGTs to practically any clinical institution at the point of care. The Company has continued to grow its infrastructure and expand its processing sites into new markets and jurisdictions. In addition, the Company has continued investing manpower and financial resources to focus on developing, processing and rolling out several types of OMPULs to be used and/or distributed through its POCare Network and/or partners, collaborators, and regional distributors. The Company started generating revenues from cell-processing services in the second quarter of 2022. The Chief Executive Officer is the Company’s chief operating decision-maker who reviews financial information prepared on a consolidated basis. All of our continuing operations are in one segment, being the point-of-care business via our POCare Platform. Therefore, no segment information 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: ● Orgenesis Maryland Inc. (the “U.S. Subsidiary”) is the center of activity in North America and is currently focused on setting up and providing POCare Services and cell-processing services to the POCare Network. ● Koligo Therapeutics, Inc. (“Koligo”), a Kentucky corporation, is a leading regenerative medicine company, specializing in developing personalized cell therapies. It is currently focused on commercialising its metabolic pipeline via the POCare network throughout the United States and in international markets. ● Orgenesis CA, Inc. (the “California subsidiary”), a Delaware corporation, is currently focussed on development of the Company’s technologies and therapies in California. ● Orgenesis Belgium SRL (the “Belgian Subsidiary”) is currently focused on expanding our POCare network in Europe, process development and the preparation of European clinical trials. ● Orgenesis Switzerland Sarl (the “Swiss Subsidiary”), is currently focused on providing management services to us. ● Orgenesis Germany GmbH (the “German subsidiary”), is currently focused on providing CRO services to the POCare Network. ● Orgenesis Korea Co. Ltd. (the “Korean Subsidiary”), is a provider of cell-processing and pre-clinical services in Korea. The Company owns 94.12% ● Orgenesis Ltd. in Israel (the “Israeli Subsidiary”) is a provider of regulatory, clinical and pre-clinical services in Israel. ● Orgenesis Biotech Israel Ltd. (“OBI”) is a provider of process development and cell-processing services in Israel. ● Mida Biotech BV (the “Dutch Subsidiary”) purchased in 2022 (see note 7) is currently focused on expanding our POCare network in Europe and process development. ● Orgenesis Australia PTY LTD (the “Australian Subsidiary”), incorporated in 2022, is currently focused on expanding our POCare network in Australia and development of the Company’s technologies and therapies. ● Tissue Genesis International LLC (“Tissue Genesis”), formed in Texas in 2022 is currently focussed on development of the Company’s technologies and therapies. ● Orgenesis Italy SRL (the “Italian Subsidiary”), incorporated in 2022, is currently focused on expanding our POCare network in Italy and process development. These consolidated financial statements include the accounts of Orgenesis Inc. and its subsidiaries. The Company’s common stock, par value $ 0.0001 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, 2022, the Company had an accumulated deficit of $ 116 9.2 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 will need to use mitigating actions such as to seek additional financing or postpone expenses that are not based on firm commitments. In addition, in order to fund the Company’s operations until such time that the Company can generate sustainable positive cash flows, the Company may need to raise additional funds. Current and projected cash resources and commitments, as well as other factors mentioned above, raise a substantial doubt about the Company’s ability to continue as a going concern to meet the Company’s current operations for the next 12 months. Management plans include raising additional capital to fund its operations, as well as exploring additional avenues to increase revenue and reduce capital expenditures. If the Company is unable to raise sufficient additional capital or meet revenue targets, it may have to curtail certain activities. The accompanying condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. The estimation and execution uncertainty regarding the Company’s future cash flows and management’s judgments and assumptions in estimating these cash flows to conclude that the Company would have sufficient liquidity to fund its operations for at least the next 12 months is a significant estimate. Those assumptions include reasonableness of the forecasted revenue, operating expenses, and uses and sources of cash. |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
BASIS OF PRESENTATION | NOTE 2 - BASIS OF PRESENTATION a. Basis of presentation The accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of management, the financial statements reflect all normal and recurring adjustments necessary to fairly state the financial position and results of operations of the Company. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, 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, 2021, 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: Recently adopted accounting pronouncements In the first quarter of 2022, the Company early adopted Accounting Standards Update (“ASU”) ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). The update simplifies the accounting for convertible debt instruments and convertible preferred stock by reducing the number of accounting models and limiting the number of embedded conversion features separately recognized from the primary contract. The guidance also includes targeted improvements to the disclosures for convertible instruments and earnings per share. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The Company adopted ASU 2020-06 in the first quarter of 2022 using the modified retrospective method which resulted with no material effect. 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 adopted ASU 2021-24 in the first quarter of 2022 which resulted with no material effect on the Company’s consolidated financial statements. Use of 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 in future periods and actual results may differ from these estimates. Recently issued accounting pronouncements, not yet adopted In June 2016, the FASB issued ASU 2016-13 “Financial Instruments—Credit Losses—Measurement of Credit Losses on Financial Instruments.” This guidance replaces the current incurred loss impairment methodology with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The guidance will be effective for Smaller Reporting Companies (SRCs, as defined by the SEC) for the fiscal year beginning on January 1, 2023, including interim periods within that year. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements. In October 2021, the FASB issued ASU 2021-08 “Business Combinations (Topic 805), Accounting for Contract Assets and Contract Liabilities from Contracts with Customers”, which requires contract assets and contract liabilities acquired in a business combination to be recognized and measured by the acquirer on the acquisition date in accordance with ASC 606, Revenue from Contracts with Customers. The guidance will result in the acquirer recognizing contract assets and contract liabilities at the same amounts recorded by the acquiree. The guidance should be applied prospectively to acquisitions occurring on or after the effective date. The guidance is effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted, including in interim periods, for any financial statements that have not yet been issued. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements. In November 2021, the FASB issued ASU 2021-10 “Government Assistance (Topic 832)”, which requires annual disclosures that increase the transparency of transactions involving government grants, including (1) the types of transactions, (2) the accounting for those transactions, and (3) the effect of those transactions on an entity’s financial statements. The amendments in this update are effective for financial statements issued for annual periods beginning after December 15, 2021. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements. |
EQUITY
EQUITY | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
EQUITY | NOTE 3 – EQUITY On March 30, 2022, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement) with certain investors (collectively, the “Investors”), pursuant to which the Company agreed to issue and sell to the Investors, in a private placement (the “Offering”), an aggregate of 4,933,333 3.00 1,000,000 4.50 The warrants are not exercisable until after six months and expire three years from the date of issuance. 2.175 12.625 725,000 146,959 has agreed to register the resale of the Shares and Underlying Shares on a registration statement on Form S-3 (the “Registration Statement”) to be filed with the United States Securities and Exchange Commission (the “SEC”) within sixty (60) days after the closing of the Offering and to cause the Registration Statement to be declared effective within ninety (90) days after the closing of the Offering (or one hundred and twenty (120) days after the closing of the Offering if the SEC reviews the Registration Statement). |
CONVERTIBLE LOANS
CONVERTIBLE LOANS | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
CONVERTIBLE LOANS | NOTE 4 – CONVERTIBLE LOANS Extension of convertible loan agreements During the year ended December 31, 2021, the Company and certain convertible loan holders agreed to extend the maturity date on loans due during the fourth quarter of 2021 to June 30, 2023. The principal amount extended was $ 2.25 In addition, on June 6, 2019, the Company entered into a private placement subscription agreement with J. Ezra Merkin (the “Lender”), pursuant to which the Lender purchased from the Company a 6% 1,950,000 7.00 3 7.00 ● the Company agrees to pay an initial $ 500,000 ● the interest rate will increase from 6% 8% ● if an event of default has occurred, the interest on the unconverted and then outstanding principal amount shall accrue at the rate of 15% ● the maturity date shall be extended to September 10, 2022 ● as consideration for the maturity date extension, the Company agreed to grant the Lender warrants to purchase up to 330,000 4.50 Convertible loan agreements executed during the three months ended June 30, 2022 During April and May 2022, the Company entered into three convertible loan agreements (the “Convertible Loan Agreements”) with three non-U.S. investors (the “Lenders”), pursuant to which the Lenders agreed to loan the Company an aggregate of $ 13 6% 4.50 In connection with such loans, the Company agreed to issue the Lenders warrants representing the right to purchase an aggregate of 722,223 25 4.50 Such warrants will be exercisable at any time beginning six months and one day after the closing date and ending 36 months after such closing date. The Company has not yet received $ 3.85 313,888 a. Convertible loans outstanding as of June 30, 2022 are as follows: SCHEDULE OF CONVERTIBLE LOANS OUTSTANDING Principal Amount Interest Rate Exercise Price Payable within: (in thousands) One year $ 4,400 2 8% 7.00 Two years 14,150 6 % 4.50 7.00 $ 18,550 b. Redemption of convertible loans During the three months ended June 30, 2022, the Company redeemed the following convertible loans: SCHEDULE OF LONG TERM CONVERTIBLE LOANS Convertible Loans repaid during the period ended June 30, 2022 Principal Amount Issuance Year Interest Rate Maturity Period Exercise Price $ 150 2019 8 % 2.4 $ 7 150 2018 8 % 2.4 7 50 2019 6 % 3.0 7 $ 350 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | NOTE 5 – STOCK-BASED COMPENSATION a. Options Granted to Employees The table below summarizes the terms of options for the purchase of shares in the Company granted to employees during the period from January 1, 2022 to June 30, 2022: SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES No. of Options Granted Exercise Price Vesting Period Fair Value at Grant (in thousands) Expiration Period Employees 367,750 $ 2.00 Quarterly over a period of two years $ 467 10 years The fair valuation of these option grants is based on the following assumptions: SCHEDULE OF STOCK OPTIONS, VALUATION ASSUMPTIONS During the Period from January 1, 2022 to June 30, 2022 Value of one common share $ 2.00 Dividend yield 0 % Expected stock price volatility 71 % Risk free interest rate 3.61 % Expected term (years) 5.56 b. Options Granted to Non-Employees The table below summarizes all the options for the purchase of shares in the Company granted to consultants and service providers during the period from January 1, 2022 to June 30, 2022: SCHEDULE OF STOCK OPTIONS GRANTED TO CONSULTANTS No. of Options Granted Vesting Period Fair Value at Grant (in thousands) Non-employees 28,335 $ 2.00 71% quarterly over a period of two years and the rest annually over a period of four years $ 48 10 years The fair valuation of these option grants is based on the following assumptions: SCHEDULE OF STOCK OPTIONS, VALUATION ASSUMPTIONS During the Period from January 1, 2022 to June 30, 2022 Value of one common share $ 2.00 Dividend yield 0 % Expected stock price volatility 84 % Risk free interest rate 3.6 % Expected term (years) 10 |
LOSS PER SHARE
LOSS PER SHARE | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
LOSS PER SHARE | NOTE 6 – LOSS PER SHARE The following table sets forth the calculation of basic and diluted loss per share for the period indicated: SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE Three Months Ended Six Months Ended June 30, 2022 June 30, 2021 June 30, 2022 June 30, 2021 (in thousands, except per share data) Basic and diluted: Net loss attributable to Orgenesis Inc. $ 5,427 $ 2,659 $ 9,436 $ 2,878 Weighted average number of common shares outstanding 24,820,756 24,365,746 24,711,462 24,279,826 Net loss per share $ 0.22 $ 0.11 $ 0.38 $ 0.12 For the six months ended June 30, 2022 and June 30, 2021, all outstanding convertible notes, options and warrants have been excluded from the calculation of the diluted net loss per share since their effect was anti-dilutive. Diluted loss per share does not include 6,205,193 2,152,298 7,518,936 1,634,559 |
REVENUES
REVENUES | 6 Months Ended |
Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
REVENUES | NOTE 7 – REVENUES Disaggregation of Revenue The following table disaggregates the Company’s revenues by major revenue streams: SCHEDULE OF DISAGGREGATION OF REVENUE Three Months Ended Six Months Ended June 30, 2022 June 30, 2021 June 30, 2022 June 30, 2021 (in thousands) Revenue stream: POC development services $ 6,274 $ 8,834 $ 12,598 $ 17,978 Cell process development services and hospital services 511 1,711 1,399 1,956 POC cell processing 416 - 416 - Total $ 7,201 $ 10,545 $ 14,413 $ 19,934 A breakdown of the revenues per customer constituted at least 10% of revenues is as follows: SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER Three Months Ended Six Months Ended June 30, 2022 June 30, 2021 June 30, 2022 June 30, 2021 (in thousands) Revenue earned: Customer A (China) $ 2,502 $ 2,119 $ 3,729 $ 3,276 Customer B (Greece) $ 1,996 $ 1,216 $ 2,656 $ 2,009 Customer C (United Arab Emirates) $ 1,187 $ 1,739 $ 2,254 $ 4,130 Customer D (Korea) $ 742 $ 3,207 $ 3,425 $ 4,163 Contract Assets and Liabilities Contract assets are mainly comprised of trade receivables net of allowance for doubtful debts, which includes amounts billed and currently due from customers. The activity for trade receivables is comprised of: SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES Six Months Ended June 30, 2022 June 30, 2021 (in thousands) Balance as of beginning of period $ 15,245 $ 3,085 Elimination of acquisition receivables (1,337 ) - Additions 13,953 20,347 Collections (8,892 ) (6,260 ) Exchange rate differences (183 ) 24 Balance as of end of period $ 18,786 $ 17,196 * The activity of the related party included in the trade receivables activity above is comprised of: Six Months Ended June 30, 2022 June 30, 2021 (in thousands) Balance as of beginning of period $ 1,972 $ 744 Additions 1,137 1,884 Collections (1,070 ) (1,901 ) Balance as of end of period $ 2,039 $ 727 The activity for contract liabilities is comprised of: SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES Six Months Ended June 30, 2022 June 30, 2021 (in thousands) Balance as of beginning of period $ 59 $ 59 Additions 11 - Balance as of end of period $ 70 $ 59 |
OTHER SIGNIFICANT TRANSACTIONS
OTHER SIGNIFICANT TRANSACTIONS DURING THE SIX MONTHS ENDED JUNE 30, 2022 | 6 Months Ended |
Jun. 30, 2022 | |
Other Significant Transactions During Six Months Ended June 30 2022 | |
OTHER SIGNIFICANT TRANSACTIONS DURING THE SIX MONTHS ENDED JUNE 30, 2022 | NOTE 8 – OTHER SIGNIFICANT TRANSACTIONS DURING THE SIX MONTHS ENDED JUNE 30, 2022 a) License and research agreement Yeda Research and Development Company Limited On January 25, 2022, the Company and Yeda Research and Development Company Limited (“Yeda”), an Israeli corporation, entered into a license and research agreement. Pursuant to the agreement, Yeda granted to the Company an exclusive, worldwide license to its licensed information and the licensed patents, for the development, manufacture, use, offer for sale, sale and import of products in the Field a field of tumor-infiltrating lymphocytes (TIL) and Chimeric antigen receptor (CAR) T cell immunotherapy platforms (excluding CAR-Cytokine Induced Killer cell immunotherapy). The Company undertakes to make commercially reasonable efforts to develop and commercialize products in the field and to achieve certain milestones. In consideration for the grant of the License, the Company shall pay Yeda: 1. A non-refundable annual license fee of $ 10 2. Royalties of up to 2 3. 25% of all Other Receipts received in respect of a Sublicense first granted or an assignment of rights made prior to the achievement of the dosing of a first patient in a Phase I Clinical Trial; and (ii) 12.5% of all Other Receipts received in respect of a Sublicense first granted or an assignment of rights made on or after the date described in subclause (i) 4. Milestone Events payments: a. $ 50 b. $ 500 c. $ 350 d. $ 250 5. Patent fees already incurred by Yeda in connection with the Licensed Patents in the amount of $ 27 6. Research related expenses based on a budget to be agreed upon. As of June 30, 2022, the Company recognized $ 59 b) Joint venture agreement with Proterna Inc. On January 26, 2022, the Company and Proterna, Inc., a Delaware corporation, (“Proterna”) (together, the “Parties”), entered into a joint venture agreement (“JVA”). During the second quarter of 2022 the Parties decided to terminate the JVA. c) Mida Biotech BV On February 22, 2022, pursuant to the joint venture agreement between the Company and Mida Biotech BV, the Company purchased all the issued shares of Mida for a consideration of $ 100 29,940 d) Joint venture with Deep Med IO Ltd (“Deep Med”) As part of the Deep Med JVA, the Company and Deep Med agreed to collaborate in the development and commercialization of an AI-powered system to be used in the manufacturing and/or quality control of CGTs. The Company has the right to finance its activities under the Deep Med JVA by procuring services, advancing funds under a convertible loan agreement, or by an equity investment. The Deep Med convertible loan bears interest at the annual rate of 6 5 1.9 e) Loan agreement with Revacel SRL As part of the Company’s agreement with Revatis under the Revatis joint venture agreement, the Company and Revacel, in which the Company holds 51 8 |
LEGAL PROCEEDINGS
LEGAL PROCEEDINGS | 6 Months Ended |
Jun. 30, 2022 | |
Legal Proceedings | |
LEGAL PROCEEDINGS | NOTE 9 – LEGAL PROCEEDINGS On January 18, 2022, a complaint (the “Complaint”) was filed in the Tel Aviv District Court (the “Court”) against the Company, the Israeli subsidiary Orgenesis Ltd., Prof. Sarah Ferber, Vered Caplan and Dr. Efrat Assa Kunik (collectively, the “defendants”) by plaintiffs the State of Israel, as the owner of Chaim Sheba Medical Center at Tel HaShomer (“Sheba”), and Tel Hashomer Medical Research, Infrastructure and Services Ltd. (collectively, the “plaintiffs”). In the Complaint, the plaintiffs are seeking that the Court issue a declaratory remedy whereby the defendants are required to pay royalties to the plaintiffs at the rate of 7% of the sales and 24% of any and all revenues in consideration for sublicenses related to any product 10 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 10 – SUBSEQUENT EVENTS Senior Secured Convertible Loan Agreement On August 15, 2022, Morgenesis LLC (“Morgenesis”), a newly formed subsidiary of Orgenesis Inc. (“Orgenesis”) holding substantially all the assets of Orgenesis’ point of care services business for treating patients (“POCare Services”), entered into a senior secured convertible loan agreement (the “Agreement”) with MM OS Holdings, L.P., an affiliate with Metalmark Capital Partners (the “Lender”), pursuant to which the Lender agreed to loan Morgenesis $ 10,000,000 8.0 In connection with such Loan, at the Lender’s option or upon the occurrence of certain contingencies within the Lender’s control, the Outstanding Amount shall be convertible, in whole or in part, into equity of Morgenesis at any time based on certain criteria, subject to the terms and conditions described in the Agreement. At the Lender’s sole option, Morgenesis, must prepay all or a portion of the Loan in an amount specified by the Lender following any equity or debt financing by Morgenesis pursuant to which gross proceeds to Morgenesis exceed $ 10,000,000 . The Loan will otherwise not be pre-payable or callable. |
BASIS OF PRESENTATION (Policies
BASIS OF PRESENTATION (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of presentation | a. Basis of presentation The accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of management, the financial statements reflect all normal and recurring adjustments necessary to fairly state the financial position and results of operations of the Company. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, 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, 2021, but not all disclosures required by generally accepted accounting principles in the United States (“U.S. GAAP”) are included. |
Significant accounting policies | b. Significant accounting policies The accounting policies adopted are consistent with those of the previous financial year except as described below: |
Recently adopted accounting pronouncements | Recently adopted accounting pronouncements In the first quarter of 2022, the Company early adopted Accounting Standards Update (“ASU”) ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). The update simplifies the accounting for convertible debt instruments and convertible preferred stock by reducing the number of accounting models and limiting the number of embedded conversion features separately recognized from the primary contract. The guidance also includes targeted improvements to the disclosures for convertible instruments and earnings per share. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The Company adopted ASU 2020-06 in the first quarter of 2022 using the modified retrospective method which resulted with no material effect. 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 adopted ASU 2021-24 in the first quarter of 2022 which resulted with no material effect on the Company’s consolidated financial statements. |
Use of Estimates in the Preparation of Financial Statements | Use of 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 in future periods and actual results may differ from these estimates. |
Recently issued accounting pronouncements, not yet adopted | Recently issued accounting pronouncements, not yet adopted In June 2016, the FASB issued ASU 2016-13 “Financial Instruments—Credit Losses—Measurement of Credit Losses on Financial Instruments.” This guidance replaces the current incurred loss impairment methodology with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The guidance will be effective for Smaller Reporting Companies (SRCs, as defined by the SEC) for the fiscal year beginning on January 1, 2023, including interim periods within that year. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements. In October 2021, the FASB issued ASU 2021-08 “Business Combinations (Topic 805), Accounting for Contract Assets and Contract Liabilities from Contracts with Customers”, which requires contract assets and contract liabilities acquired in a business combination to be recognized and measured by the acquirer on the acquisition date in accordance with ASC 606, Revenue from Contracts with Customers. The guidance will result in the acquirer recognizing contract assets and contract liabilities at the same amounts recorded by the acquiree. The guidance should be applied prospectively to acquisitions occurring on or after the effective date. The guidance is effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted, including in interim periods, for any financial statements that have not yet been issued. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements. In November 2021, the FASB issued ASU 2021-10 “Government Assistance (Topic 832)”, which requires annual disclosures that increase the transparency of transactions involving government grants, including (1) the types of transactions, (2) the accounting for those transactions, and (3) the effect of those transactions on an entity’s financial statements. The amendments in this update are effective for financial statements issued for annual periods beginning after December 15, 2021. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements. |
CONVERTIBLE LOANS (Tables)
CONVERTIBLE LOANS (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
SCHEDULE OF CONVERTIBLE LOANS OUTSTANDING | SCHEDULE OF CONVERTIBLE LOANS OUTSTANDING Principal Amount Interest Rate Exercise Price Payable within: (in thousands) One year $ 4,400 2 8% 7.00 Two years 14,150 6 % 4.50 7.00 $ 18,550 |
SCHEDULE OF LONG TERM CONVERTIBLE LOANS | During the three months ended June 30, 2022, the Company redeemed the following convertible loans: SCHEDULE OF LONG TERM CONVERTIBLE LOANS Convertible Loans repaid during the period ended June 30, 2022 Principal Amount Issuance Year Interest Rate Maturity Period Exercise Price $ 150 2019 8 % 2.4 $ 7 150 2018 8 % 2.4 7 50 2019 6 % 3.0 7 $ 350 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] | |
SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES | The table below summarizes the terms of options for the purchase of shares in the Company granted to employees during the period from January 1, 2022 to June 30, 2022: SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES No. of Options Granted Exercise Price Vesting Period Fair Value at Grant (in thousands) Expiration Period Employees 367,750 $ 2.00 Quarterly over a period of two years $ 467 10 years |
SCHEDULE OF STOCK OPTIONS GRANTED TO CONSULTANTS | The table below summarizes all the options for the purchase of shares in the Company granted to consultants and service providers during the period from January 1, 2022 to June 30, 2022: SCHEDULE OF STOCK OPTIONS GRANTED TO CONSULTANTS No. of Options Granted Vesting Period Fair Value at Grant (in thousands) Non-employees 28,335 $ 2.00 71% quarterly over a period of two years and the rest annually over a period of four years $ 48 10 years |
Options Granted To Employees [Member] | |
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] | |
SCHEDULE OF STOCK OPTIONS, VALUATION ASSUMPTIONS | The fair valuation of these option grants is based on the following assumptions: SCHEDULE OF STOCK OPTIONS, VALUATION ASSUMPTIONS During the Period from January 1, 2022 to June 30, 2022 Value of one common share $ 2.00 Dividend yield 0 % Expected stock price volatility 71 % Risk free interest rate 3.61 % Expected term (years) 5.56 |
Options Granted To Non Employees [Member] | |
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] | |
SCHEDULE OF STOCK OPTIONS, VALUATION ASSUMPTIONS | The fair valuation of these option grants is based on the following assumptions: SCHEDULE OF STOCK OPTIONS, VALUATION ASSUMPTIONS During the Period from January 1, 2022 to June 30, 2022 Value of one common share $ 2.00 Dividend yield 0 % Expected stock price volatility 84 % Risk free interest rate 3.6 % Expected term (years) 10 |
LOSS PER SHARE (Tables)
LOSS PER SHARE (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE | The following table sets forth the calculation of basic and diluted loss per share for the period indicated: SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE Three Months Ended Six Months Ended June 30, 2022 June 30, 2021 June 30, 2022 June 30, 2021 (in thousands, except per share data) Basic and diluted: Net loss attributable to Orgenesis Inc. $ 5,427 $ 2,659 $ 9,436 $ 2,878 Weighted average number of common shares outstanding 24,820,756 24,365,746 24,711,462 24,279,826 Net loss per share $ 0.22 $ 0.11 $ 0.38 $ 0.12 |
REVENUES (Tables)
REVENUES (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
SCHEDULE OF DISAGGREGATION OF REVENUE | SCHEDULE OF DISAGGREGATION OF REVENUE Three Months Ended Six Months Ended June 30, 2022 June 30, 2021 June 30, 2022 June 30, 2021 (in thousands) Revenue stream: POC development services $ 6,274 $ 8,834 $ 12,598 $ 17,978 Cell process development services and hospital services 511 1,711 1,399 1,956 POC cell processing 416 - 416 - Total $ 7,201 $ 10,545 $ 14,413 $ 19,934 |
SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER | A breakdown of the revenues per customer constituted at least 10% of revenues is as follows: SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER Three Months Ended Six Months Ended June 30, 2022 June 30, 2021 June 30, 2022 June 30, 2021 (in thousands) Revenue earned: Customer A (China) $ 2,502 $ 2,119 $ 3,729 $ 3,276 Customer B (Greece) $ 1,996 $ 1,216 $ 2,656 $ 2,009 Customer C (United Arab Emirates) $ 1,187 $ 1,739 $ 2,254 $ 4,130 Customer D (Korea) $ 742 $ 3,207 $ 3,425 $ 4,163 |
SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES | The activity for trade receivables is comprised of: SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES Six Months Ended June 30, 2022 June 30, 2021 (in thousands) Balance as of beginning of period $ 15,245 $ 3,085 Elimination of acquisition receivables (1,337 ) - Additions 13,953 20,347 Collections (8,892 ) (6,260 ) Exchange rate differences (183 ) 24 Balance as of end of period $ 18,786 $ 17,196 * The activity of the related party included in the trade receivables activity above is comprised of: Six Months Ended June 30, 2022 June 30, 2021 (in thousands) Balance as of beginning of period $ 1,972 $ 744 Additions 1,137 1,884 Collections (1,070 ) (1,901 ) Balance as of end of period $ 2,039 $ 727 |
SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES | The activity for contract liabilities is comprised of: SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES Six Months Ended June 30, 2022 June 30, 2021 (in thousands) Balance as of beginning of period $ 59 $ 59 Additions 11 - Balance as of end of period $ 70 $ 59 |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Common stock, par value | $ 0.0001 | $ 0.0001 | |
Accumulated deficit | $ 115,808 | $ 106,372 | |
Net Cash Provided by (Used in) Operating Activities | $ 9,206 | $ 16,047 | |
Orgenesis Korea Co Ltd [Member] | |||
Equity method investment, ownership percentage | 94.12% |
EQUITY (Details Narrative)
EQUITY (Details Narrative) - Securities Purchase Agreement [Member] - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | |
Mar. 30, 2022 | Jun. 30, 2022 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Sale of stock, shares | 4,933,333 | |
Sale of stock, price per share | $ 3 | |
Purchase of warrants | 1,000,000 | |
Exercise price of warrants | $ 4.50 | |
Warrant exercisable description | The warrants are not exercisable until after six months and expire three years from the date of issuance. | |
Proceeds from private placemenrt | $ 2,175 | |
Common Stock [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Shares issued during period | 725,000 | |
Warrant [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Purchase of warrants | 146,959 | |
Investor [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Proceeds from private placemenrt | $ 12,625 |
SCHEDULE OF CONVERTIBLE LOANS O
SCHEDULE OF CONVERTIBLE LOANS OUTSTANDING (Details) $ / shares in Units, $ in Thousands | Jun. 30, 2022 USD ($) $ / shares |
Debt Instrument [Line Items] | |
Principal amount | $ | $ 18,550 |
One Year [Member] | |
Debt Instrument [Line Items] | |
Principal amount | $ | $ 4,400 |
Exercise price | $ / shares | $ 7 |
One Year [Member] | Minimum [Member] | |
Debt Instrument [Line Items] | |
Interest rate | 2% |
One Year [Member] | Maximum [Member] | |
Debt Instrument [Line Items] | |
Interest rate | 8% |
Two Years [Member] | |
Debt Instrument [Line Items] | |
Principal amount | $ | $ 14,150 |
Interest rate | 6% |
Two Years [Member] | Minimum [Member] | |
Debt Instrument [Line Items] | |
Exercise price | $ / shares | $ 4.50 |
Two Years [Member] | Maximum [Member] | |
Debt Instrument [Line Items] | |
Exercise price | $ / shares | $ 7 |
SCHEDULE OF LONG TERM CONVERTIB
SCHEDULE OF LONG TERM CONVERTIBLE LOANS (Details) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) $ / shares | |
Debt Instrument [Line Items] | |
Principal amount | $ 18,550 |
Convertible Loans One [Member] | |
Debt Instrument [Line Items] | |
Principal amount | $ 150 |
Issuance year | 2019 |
Interest rate | 8% |
Debt instrument term | 2 years 4 months 24 days |
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 7 |
Convertible Loans Two [Member] | |
Debt Instrument [Line Items] | |
Principal amount | $ 150 |
Issuance year | 2018 |
Interest rate | 8% |
Debt instrument term | 2 years 4 months 24 days |
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 7 |
Convertible Loans Three [Member] | |
Debt Instrument [Line Items] | |
Principal amount | $ 50 |
Issuance year | 2019 |
Interest rate | 6% |
Debt instrument term | 3 years |
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 7 |
Convertible Loans [Member] | |
Debt Instrument [Line Items] | |
Principal amount | $ 350 |
CONVERTIBLE LOANS (Details Narr
CONVERTIBLE LOANS (Details Narrative) | 1 Months Ended | 6 Months Ended | ||||||
Jul. 15, 2022 USD ($) $ / shares shares | Jun. 06, 2019 USD ($) $ / shares | Jun. 06, 2019 USD ($) $ / shares | Jun. 30, 2022 USD ($) $ / shares shares | Jun. 05, 2022 | May 31, 2022 USD ($) $ / shares | Apr. 30, 2022 USD ($) $ / shares | Dec. 31, 2021 USD ($) | |
Short-Term Debt [Line Items] | ||||||||
Principal amount | $ 18,550,000 | |||||||
Private Placement Subscription Agreement [Member] | Lender [Member] | ||||||||
Short-Term Debt [Line Items] | ||||||||
Debt instrument conversion percentage | 0.06 | |||||||
Convertible Note Extension Agreement [Member] | Lender [Member] | Minimum [Member] | ||||||||
Short-Term Debt [Line Items] | ||||||||
Interest rate | 6% | |||||||
Convertible Note Extension Agreement [Member] | Lender [Member] | Maximum [Member] | ||||||||
Short-Term Debt [Line Items] | ||||||||
Interest rate | 8% | |||||||
Convertible Note Extension Agreement [Member] | Lender [Member] | Subsequent Event [Member] | ||||||||
Short-Term Debt [Line Items] | ||||||||
Repayments of Long-Term Debt | $ 500,000 | |||||||
Interest rate | 15% | |||||||
Maturity date | Sep. 10, 2022 | |||||||
Purchase of warrants | shares | 330,000 | |||||||
Exercise price of warrants | $ / shares | $ 4.50 | |||||||
Three Convertible Loan Agreements [Member] | ||||||||
Short-Term Debt [Line Items] | ||||||||
Principal amount not yet received | $ 3,850,000 | |||||||
Associated warrants will not be issued | shares | 313,888 | |||||||
Three Convertible Loan Agreements [Member] | Lender [Member] | ||||||||
Short-Term Debt [Line Items] | ||||||||
Principal amount | $ 13,000,000 | $ 13,000,000 | ||||||
Conversion price | $ / shares | $ 4.50 | $ 4.50 | ||||||
Interest rate | 6% | 6% | ||||||
Purchase of warrants | shares | 722,223 | |||||||
Exercise price of warrants | $ / shares | $ 4.50 | |||||||
Common stock percent | 25% | |||||||
Warrants description | Such warrants will be exercisable at any time beginning six months and one day after the closing date and ending 36 months after such closing date. | |||||||
Convertible Loan Holders [Member] | ||||||||
Short-Term Debt [Line Items] | ||||||||
Principal amount | $ 2,250,000 | |||||||
Private Placement Subscription Agreement [Member] | Lender [Member] | ||||||||
Short-Term Debt [Line Items] | ||||||||
Principal amount | $ 1,950,000 | $ 1,950,000 | ||||||
Conversion price | $ / shares | $ 7 | $ 7 | ||||||
Exercisable term | 3 years | |||||||
Share price | $ / shares | $ 7 | $ 7 |
SCHEDULE OF EMPLOYEE STOCK OWNE
SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES (Details) - Employees [Member] - Options Granted To Employees [Member] shares in Thousands | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] | |
No. of options granted | shares | 367,750 |
Exercise price | $ 2 |
Vesting period | 2 years |
Fair value at grant | $ 467,000 |
Expiration period | 10 years |
SCHEDULE OF STOCK OPTIONS, VALU
SCHEDULE OF STOCK OPTIONS, VALUATION ASSUMPTIONS (Details) | 6 Months Ended |
Jun. 30, 2022 $ / shares | |
Options Granted To Employees [Member] | |
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] | |
Value of one common share | $ 2 |
Dividend yield | 0% |
Expected stock price volatility | 71% |
Risk free interest rate | 3.61% |
Expected term | 5 years 6 months 21 days |
Options Granted To Non Employees [Member] | |
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] | |
Dividend yield | 0% |
Expected stock price volatility | 84% |
Risk free interest rate | 3.60% |
Expected term | 10 years |
Value of one common share | $ 2 |
SCHEDULE OF STOCK OPTIONS GRANT
SCHEDULE OF STOCK OPTIONS GRANTED TO CONSULTANTS (Details) - Consultants [Member] - Options Granted To Non Employees [Member] shares in Thousands | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Net of Forfeitures | shares | 28,335 |
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 2 |
Vesting period description | 71% quarterly over a period of two years and the rest annually over a period of four years |
Fair value at grant | $ 48,000 |
Expiration period | 10 years |
SCHEDULE OF BASIC AND DILUTED L
SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Earnings Per Share [Abstract] | ||||
Net loss attributable to Orgenesis Inc. | $ 5,427 | $ 2,659 | $ 9,436 | $ 2,878 |
Weighted average number of common shares outstanding | 24,820,756 | 24,365,746 | 24,711,462 | 24,279,826 |
Net loss per share | $ 0.22 | $ 0.11 | $ 0.38 | $ 0.12 |
LOSS PER SHARE (Details Narrati
LOSS PER SHARE (Details Narrative) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Options and Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share amount | 6,205,193 | 7,518,936 |
Shares upon Conversion of Convertible Notes [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share amount | 2,152,298 | 1,634,559 |
SCHEDULE OF DISAGGREGATION OF R
SCHEDULE OF DISAGGREGATION OF REVENUE (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 7,201 | $ 10,545 | $ 14,413 | $ 19,934 |
Point of Care Development Service [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 6,274 | 8,834 | 12,598 | 17,978 |
Cell Process Development Services And Hospital Serivces [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 511 | 1,711 | 1,399 | 1,956 |
Point Of Care Cell Processing [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 416 | $ 416 |
SCHEDULE OF BREAKDOWN OF REVENU
SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 6,699 | $ 9,818 | $ 13,276 | $ 18,050 |
Customers A [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 2,502 | 2,119 | 3,729 | 3,276 |
Customers B [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 1,996 | 1,216 | 2,656 | 2,009 |
Customers C [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 1,187 | 1,739 | 2,254 | 4,130 |
Customers D [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 742 | $ 3,207 | $ 3,425 | $ 4,163 |
SCHEDULE OF ACTIVITY FOR TRADE
SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES (Details) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | ||
Defined Benefit Plan Disclosure [Line Items] | |||
Balance as of beginning of period | $ 15,245 | [1] | $ 3,085 |
Elimination of acquisition receivables | (1,337) | ||
Additions | 13,953 | 20,347 | |
Collections | (8,892) | (6,260) | |
Exchange rate differences | (183) | 24 | |
Balance as of end of period | 18,786 | [1] | 17,196 |
Related Party [Member] | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Balance as of beginning of period | 1,972 | 744 | |
Additions | 1,137 | 1,884 | |
Collections | (1,070) | (1,901) | |
Balance as of end of period | $ 2,039 | $ 727 | |
[1]Including related party in the amount of $ 2,039 1,972 |
SCHEDULE OF ACTIVITY FOR CONTRA
SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | ||
Balance as of beginning of period | $ 59 | $ 59 |
Additions | 11 | |
Balance as of end of period | $ 70 | $ 59 |
OTHER SIGNIFICANT TRANSACTION_2
OTHER SIGNIFICANT TRANSACTIONS DURING THE SIX MONTHS ENDED JUNE 30, 2022 (Details Narrative) - USD ($) shares in Thousands, $ in Thousands | 6 Months Ended | ||
Feb. 22, 2022 | Jan. 25, 2022 | Jun. 30, 2022 | |
Contract with customer liabilities | $ 59 | ||
Stock Issued During Period, Value, Acquisitions | $ 100 | ||
Revatis Joint Venture Agreement [Member] | |||
Debt Instrument, Interest Rate, Stated Percentage | 8% | ||
Debt interest holding | 51% | ||
License and Research Agreement Yeda Research and Development Company Limited [Member] | |||
Annual license fee | $ 10 | ||
License and research agreement description | 25% of all Other Receipts received in respect of a Sublicense first granted or an assignment of rights made prior to the achievement of the dosing of a first patient in a Phase I Clinical Trial; and (ii) 12.5% of all Other Receipts received in respect of a Sublicense first granted or an assignment of rights made on or after the date described in subclause (i) | ||
Payment for milestone events | $ 50 | ||
Patent fees | 27 | ||
License and Research Agreement Yeda Research and Development Company Limited [Member] | FDA Marketing [Member] | |||
Payment for milestone events | 500 | ||
License and Research Agreement Yeda Research and Development Company Limited [Member] | Non FDA Marketing [Member] | |||
Payment for milestone events | 350 | ||
License and Research Agreement Yeda Research and Development Company Limited [Member] | Additional Non FDA Marketing [Member] | |||
Payment for milestone events | $ 250 | ||
License and Research Agreement Yeda Research and Development Company Limited [Member] | Maximum [Member] | |||
Royalty of net sales percentage | 2% | ||
Mida Biotech BV [Member] | Joint Venture Agreement [Member] | |||
Stock Issued During Period, Value, Acquisitions | $ 100 | ||
Stock Issued During Period, Shares, Acquisitions | 29,940 | ||
Deep Med IO Ltd [Member] | Joint Venture Agreement [Member] | |||
Debt Instrument, Interest Rate, Stated Percentage | 6% | ||
Loan repayable term | 5 years | ||
Joint venture transferred amount | $ 1,900 |
LEGAL PROCEEDINGS (Details Narr
LEGAL PROCEEDINGS (Details Narrative) ₪ in Millions | Jan. 18, 2022 ILS (₪) |
Legal Proceedings | |
Loss Contingency, Actions Taken by Plaintiff | the plaintiffs are seeking that the Court issue a declaratory remedy whereby the defendants are required to pay royalties to the plaintiffs at the rate of 7% of the sales and 24% of any and all revenues in consideration for sublicenses related to any product |
Loss Contingency, Damages Paid, Value | ₪ 10 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - USD ($) | Aug. 15, 2022 | Jun. 30, 2022 |
Subsequent Event [Line Items] | ||
Loan amount | $ 18,550,000 | |
Subsequent Event [Member] | Senior Secured Convertible Loan Agreement [Member] | Lender [Member] | ||
Subsequent Event [Line Items] | ||
Loan amount | $ 10,000,000 | |
Paid-in-kind interest per annum | 8% | |
Proceeds from Loan Originations | $ 10,000,000 |