UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 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) (State or other jurisdiction ...

Orgenesis Inc. (NASDAQ:ORGS) Q1 2021 Earnings Conference Call May 7, 2021 8:30 AM ET Company Participants David Waldman - Investor Relations Vered Caplan - Chief Executive Officer Neil Reithinger - Chief Financial Officer Conference Call Participants Bruce Jackson - The Benchmark Company Kelvin Seetoh - Slingshot Capital Operator Good day, ladies and gentlemen, and welcome to the Orgenesis First Quarter 2021 Business Update Conference Call. [Operator Instructions] It is now my pleasure to turn the floor ove ...

[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This part presents the unaudited financial statements and management's discussion and analysis for the reporting period [ITEM 1. Financial Statements (Unaudited)](index=4&type=section&id=ITEM%201.%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited condensed consolidated financial statements for Orgenesis Inc., including the balance sheets, statements of comprehensive loss, changes in equity, and cash flows for the periods ended March 31, 2021 and 2020. It also includes detailed notes explaining the company's business, accounting policies, discontinued operations, equity changes, earnings per share, and revenue disaggregation [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity as of March 31, 2021, and December 31, 2020 Condensed Consolidated Balance Sheets (U.S. Dollars in Thousands) | Item | March 31, 2021 | December 31, 2020 | | :-------------------------------- | :------------- | :---------------- | | **Assets** | | | | Cash and cash equivalents | $41,841 | $44,923 | | Accounts receivable, net | $11,354 | $3,085 | | Total current assets | $54,713 | $50,077 | | Total non-current assets | $27,397 | $27,607 | | **TOTAL ASSETS** | **$82,110** | **$77,684** | | **Liabilities and Equity** | | | | Accounts payable | $10,294 | $8,649 | | Total current liabilities | $18,930 | $16,285 | | Total long-term liabilities | $8,428 | $8,671 | | **TOTAL LIABILITIES** | **$27,358** | **$24,956** | | Equity attributable to Orgenesis Inc. | $54,549 | $52,579 | | Non-controlling interest | $203 | $149 | | **Total equity** | **$54,752** | **$52,728** | | **TOTAL LIABILITIES AND EQUITY** | **$82,110** | **$77,684** | - Total assets increased by **$4,426 thousand** from December 31, 2020, to March 31, 2021, primarily driven by an increase in accounts receivable[9](index=9&type=chunk) - Total liabilities increased by **$2,402 thousand**, mainly due to an increase in accounts payable and current maturities of convertible loans[12](index=12&type=chunk) [Condensed Consolidated Statements of Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) This section outlines the company's financial performance, presenting revenues, expenses, and net loss for the three months ended March 31, 2021, and 2020 Condensed Consolidated Statements of Comprehensive Loss (U.S. Dollars in Thousands) | Item | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :------------------------------------------------ | :-------------------------------- | :-------------------------------- | | Total revenues | $9,389 | $1,878 | | Cost of services and other R&D expenses | $6,127 | $4,873 | | Selling, general and administrative expenses | $2,968 | $3,518 | | Operating loss (income) | $(81) | $6,733 | | Net loss from continuing operation | $165 | $7,015 | | Net income from discontinued operations, net of tax | $- | $(76,465) | | Net loss (income) | $165 | $(69,450) | | Net loss (income) attributable to Orgenesis Inc. | $219 | $(69,981) | | Basic and diluted loss per share | $0.01 | $(4.23) | - Total revenues increased significantly by **400%** from **$1,878 thousand** in Q1 2020 to **$9,389 thousand** in Q1 2021[14](index=14&type=chunk) - The company reported a net loss of **$165 thousand** in Q1 2021, a substantial improvement from a net loss of **$69,450 thousand** in Q1 2020, primarily due to the gain on disposal of discontinued operations in the prior year[14](index=14&type=chunk) [Condensed Consolidated Statements of Changes in Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity) This section details the changes in the company's equity, including stock-based compensation, option and warrant exercises, and comprehensive income or loss for the period Changes in Equity (Three Months Ended March 31, 2021, in thousands) | Item | Amount (in thousands) | | :------------------------------------ | :-------------------- | | Stock-based compensation to employees and directors | $320 | | Stock-based compensation to service providers | $244 | | Exercise of options | $50 | | Issuance of Shares due to exercise of warrants | $1,862 | | Repurchase of treasury stock | $(10) | | Comprehensive income (loss) for the period | $(496) | | Balance at March 31, 2021 (Total Equity) | $54,752 | - Equity attributable to Orgenesis Inc. increased from **$52,579 thousand** at January 1, 2021, to **$54,549 thousand** at March 31, 2021[16](index=16&type=chunk) - The increase in equity was primarily driven by the issuance of shares due to warrant exercises (**$1,862 thousand**) and stock-based compensation (**$564 thousand**)[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the cash inflows and outflows from operating, investing, and financing activities for the three months ended March 31, 2021, and 2020 Condensed Consolidated Statements of Cash Flows (U.S. Dollars in Thousands) | Cash Flow Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(4,547) | $(13,693) | | Net cash provided by (used in) investing activities | $(539) | $103,045 | | Net cash provided by financing activities | $1,898 | $6,357 | | NET CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | $(3,188) | $95,709 | | Cash, Cash Equivalents and Restricted Cash at End of Period | $42,312 | $107,666 | - Net cash used in operating activities decreased from **$13,693 thousand** in Q1 2020 to **$4,547 thousand** in Q1 2021[20](index=20&type=chunk) - Net cash provided by investing activities significantly decreased from **$103,045 thousand** in Q1 2020 (due to the Masthercell sale) to net cash used of **$539 thousand** in Q1 2021[20](index=20&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements, covering business description, accounting policies, and specific financial items [NOTE 1 – DESCRIPTION OF BUSINESS](index=11&type=section&id=NOTE%201%20%E2%80%93%20DESCRIPTION%20OF%20BUSINESS) This note describes Orgenesis Inc.'s core business as a global biotech company focused on making cell and gene therapies accessible through its Point of Care Platform - Orgenesis Inc. is a global biotech company focused on making cell and gene therapies (CGTs) affordable and accessible, primarily through autologous therapies[24](index=24&type=chunk)[25](index=25&type=chunk) - The company's strategy revolves around its Point of Care Platform, which includes licensed POCare Therapies, automated POCare Technology systems, and a collaborative POCare Network[26](index=26&type=chunk)[27](index=27&type=chunk) - Orgenesis is developing Orgenesis Mobile Processing Units and Labs (OMPULs) for on-site validation, development, clinical trials, and manufacturing of CGTs[28](index=28&type=chunk)[29](index=29&type=chunk) - Effective from Q1 2020, all continuing operations are consolidated into one segment: the point-of-care business via the POCare Platform, following the sale of the CDMO Business (Masthercell) in February 2020[33](index=33&type=chunk)[35](index=35&type=chunk) [NOTE 2 - BASIS OF PRESENTATION](index=13&type=section&id=NOTE%202%20-%20BASIS%20OF%20PRESENTATION) This note explains the accounting principles used for the unaudited condensed consolidated financial statements, including U.S. GAAP compliance and management estimates - The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP, consistent with annual statements, and include normal and recurring adjustments[39](index=39&type=chunk) - Management makes estimates and judgments, acknowledging potential future impacts from the COVID-19 pandemic, though no major impact was noted for the current period[40](index=40&type=chunk)[41](index=41&type=chunk) - Financial statements for the three months ended March 31, 2020, were revised to correct an immaterial error related to the gain calculation on the sale of MastherCell, resulting in an increase to additional paid-in capital and a decrease in net income from discontinued operations[43](index=43&type=chunk) Impact of Revision on Q1 2020 Financials (in thousands) | Item | As reported | Adjustment | As revised | | :------------------------------------ | :---------- | :--------- | :--------- | | Net income from discontinued operations, net of tax | $82,039 | $(5,574) | $76,465 | | Additional paid-in capital | $103,623 | $5,574 | $109,197 | [NOTE 3 – DISCONTINUED OPERATIONS](index=13&type=section&id=NOTE%203%20%E2%80%93%20DISCONTINUED%20OPERATIONS) This note details the sale of the Masthercell Business in February 2020 and its classification as a discontinued operation, including its financial results - On February 2, 2020, the Company completed the sale of its Masthercell Business, which was subsequently classified as a discontinued operation[45](index=45&type=chunk) Financial Results of Discontinued Operations (January 1, 2020, until disposal date, in thousands) | Item | Amount | | :------------------------------------------ | :----- | | Revenues | $2,556 | | Operating loss | $1,132 | | Net loss from discontinuing operation, net of tax | $1,103 | | Gain on disposal before income taxes | $97,049 | | Provision for income taxes | $(19,481) | | Gain on disposal | $77,568 | | Net profit from discontinuing operation, net of tax | $76,465 | Cash Flows from Discontinued Operations (January 1, 2020, until disposal date, in thousands) | Cash Flow Activity | Amount | | :-------------------------------- | :----- | | Net cash flows used in operating activities | $(2,409) | | Net cash flows used in investing activities | $(579) | | Net cash flows used in financing activities | $(51) | [NOTE 4 – EQUITY](index=16&type=section&id=NOTE%204%20%E2%80%93%20EQUITY) This note outlines changes in equity, specifically focusing on proceeds from warrant and option exercises during the first quarter of 2021 - During Q1 2021, the Company received approximately **$1.9 million** from the exercise of warrants, resulting in the issuance of **237,563 shares** of Common Stock[49](index=49&type=chunk) - Additionally, **$50 thousand** was received from the exercise of options for **8,750 shares** of Common Stock at a weighted average price of **$5.56**[50](index=50&type=chunk) [NOTE 5 – LOSS (EARNINGS) PER SHARE](index=16&type=section&id=NOTE%205%20%E2%80%93%20LOSS%20%28EARNINGS%29%20PER%20SHARE) This note presents the basic and diluted loss per share calculations for continuing operations and overall net loss for the three months ended March 31, 2021, and 2020 Loss (Earnings) Per Share (Three Months Ended March 31, in thousands, except per share data) | Item | March 31, 2021 | March 31, 2020 | | :------------------------------------------------ | :------------- | :------------- | | Net loss from continuing operations attributable to Orgenesis Inc. | $219 | $6,976 | | Net (income) loss attributable to Orgenesis Inc. for loss (earning) per share | $219 | $(75,141) | | Weighted average number of common shares outstanding | 24,192,951 | 17,780,830 | | Loss per common share from continuing operations | $0.01 | $0.39 | | Net loss (earnings) per share | $0.01 | $(4.23) | - Basic and diluted loss per share from continuing operations was **$0.01** for Q1 2021, compared to **$0.39** for Q1 2020[51](index=51&type=chunk) [NOTE 6 – REVENUES](index=16&type=section&id=NOTE%206%20%E2%80%93%20REVENUES) This note disaggregates revenue by stream and major customer for the three months ended March 31, 2021, and 2020, highlighting growth in POC and hospital services Disaggregation of Revenue by Stream (Three Months Ended March 31, in thousands) | Revenue Stream | March 31, 2021 | March 31, 2020 | | :-------------------------- | :------------- | :------------- | | POC and hospital services | $9,254 | $1,851 | | Cell process development services | $135 | $27 | | **Total** | **$9,389** | **$1,878** | - Total revenues increased by **400%** year-over-year, primarily driven by a significant increase in POC and hospital services revenue[53](index=53&type=chunk) Revenue Breakdown by Major Customer (Three Months Ended March 31, in thousands) | Customer | March 31, 2021 | March 31, 2020 | | :--------- | :------------- | :------------- | | Customer A | $2,391 | $- | | Customer B | $1,646 | $- | | Customer C | $1,157 | $487 | | Customer D – related party | $1,157 | $493 | | Customer E | $956 | $374 | | Customer F | $- | $496 | [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations for the three months ended March 31, 2021, compared to the same period in 2020. It covers the corporate overview, business strategy, revenue model, and detailed analysis of revenues, expenses, working capital, and liquidity, highlighting the significant growth in POCare services and the impact of the Masthercell sale in the prior year [Corporate Overview](index=19&type=section&id=Corporate%20Overview) This section provides an overview of Orgenesis Inc.'s mission as a global biotech company focused on making cell and gene therapies affordable and accessible - Orgenesis Inc. is a global biotech company focused on making cell and gene therapies (CGTs) affordable and accessible, primarily through autologous therapies[62](index=62&type=chunk)[63](index=63&type=chunk) - The company's Point of Care Platform consists of licensed POCare Therapies, automated POCare Technology systems, and a collaborative POCare Network[64](index=64&type=chunk)[65](index=65&type=chunk) - Orgenesis operates through various wholly-owned or majority-owned subsidiaries across the United States, Europe, and Asia, focusing on network setup, therapy development, and processing services[66](index=66&type=chunk) [Business Strategy](index=20&type=section&id=Business%20Strategy) This section outlines the company's strategy to deliver Advanced Therapy Medicinal Products (ATMPs) globally through its POCare Platform, emphasizing decentralized production - The company's strategy is to deliver Advanced Therapy Medicinal Products (ATMPs) to patients worldwide through its POCare Platform, emphasizing point-of-care processes to minimize cell transportation risks and costs[67](index=67&type=chunk) - Orgenesis is investing in the development of Orgenesis Mobile Processing Units and Labs (OMPULs) for validation, clinical trials, and manufacturing of CGTs at the point of care[69](index=69&type=chunk)[70](index=70&type=chunk) - The company aims to build value across various aspects, including supply chain, clinical/regulatory services, engineering, devices (OMPULs), delivery systems, and a range of therapies (immuno-oncology, anti-aging, anti-viral, metabolic, etc)[68](index=68&type=chunk) [Revenue Model and Business Development](index=20&type=section&id=Revenue%20Model%20and%20Business%20Development) This section describes the POCare Platform's revenue generation through technology in-licensing, therapeutic collaborations, out-licensing, and R&D services - The POCare Platform aims to enable rapid, globally harmonized, and cost-effective delivery of therapies through decentralized production, working with hospitals and regional joint venture partners (JVs)[71](index=71&type=chunk) - The company generates revenue through technology in-licensing, therapeutic collaborations, and out-licensing marketing and manufacturing rights to partners and JVs, receiving royalties (**10-15%** of net sales or audited GAAP profit after tax)[72](index=72&type=chunk)[73](index=73&type=chunk) - Current revenue streams include R&D services provided to out-licensing partners under POCare Master Services Agreements (MSAs) and hospital supply, which involves the sale/lease of products and performance of processing services[75](index=75&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, including revenues, cost of services, and operating expenses for the three months ended March 31, 2021, and 2020 Key Financial Results (Three Months Ended March 31, in thousands) | Item | March 31, 2021 | March 31, 2020 | Change (%) | | :------------------------------------------ | :------------- | :------------- | :--------- | | Revenues | $8,232 | $1,385 | 494.3% | | Revenues to Related Party | $1,157 | $493 | 134.7% | | Total Revenues | $9,389 | $1,878 | 400.0% | | Cost of services and other R&D expenses | $6,127 | $4,873 | 25.7% | | Selling, general and administrative expenses | $2,968 | $3,518 | -15.6% | | Financial expenses, net | $233 | $329 | -29.2% | | Loss before income taxes | $167 | $7,062 | -97.6% | - Point-of-care development service revenue increased by **400%** to **$9,254 thousand** in Q1 2021, driven by increased activity with existing and new joint venture partners[76](index=76&type=chunk) - Research and development expenses increased by **26%** to **$6,127 thousand**, mainly due to pipeline expansion, increased POC capacity, investments in automated processing units, and hiring additional employees[78](index=78&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) - Selling, general and administrative expenses decreased by **16%** to **$2,968 thousand**, primarily due to a **$752 thousand** decrease in accounting and legal fees from reduced corporate investment activities[81](index=81&type=chunk) [Working Capital](index=23&type=section&id=Working%20Capital) This section details the company's working capital position, including current assets and liabilities, and the factors influencing its change Working Capital (in thousands) | Item | March 31, 2021 | December 31, 2020 | | :---------------- | :------------- | :---------------- | | Current assets | $54,713 | $50,077 | | Current liabilities | $18,930 | $16,285 | | Working capital | $35,783 | $33,792 | - Working capital increased by **$1,991 thousand**, primarily due to an increase in accounts receivable driven by higher revenues, partially offset by an increase in accounts payable from business expansion[84](index=84&type=chunk) [Liquidity and Financial Condition](index=23&type=section&id=Liquidity%20and%20Financial%20Condition) This section assesses the company's ability to meet its short-term and long-term obligations, reviewing cash flows and overall financial health Cash Flow Summary (Three Months Ended March 31, in thousands) | Cash Flow Activity | March 31, 2021 | March 31, 2020 | | :------------------------------------ | :------------- | :------------- | | Net income (loss) | $(165) | $69,450 | | Net cash used in operating activities | $(4,547) | $(13,693) | | Net cash provided by (used in) investing activities | $(539) | $103,045 | | Net cash provided by financing activities | $1,898 | $6,357 | | Increase (decrease) in cash and cash equivalents | $(3,188) | $95,709 | - Net cash used in operating activities decreased from approximately **$14 million** in Q1 2020 to **$5 million** in Q1 2021[86](index=86&type=chunk) - Net cash used in investing activities was approximately **$1 million** in Q1 2021, a significant change from **$103 million** provided in Q1 2020, which included proceeds from the Masthercell sale[87](index=87&type=chunk) - The company believes its current cash balance and revenues will provide sufficient liquidity for at least the next 12 months, but may seek additional financing if operating costs increase or revenues decrease[88](index=88&type=chunk) [Off-Balance Sheet Arrangements](index=24&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of material off-balance sheet arrangements that could significantly impact the company's financial condition or results of operations - The Company has no material off-balance sheet arrangements that would significantly affect its financial condition or results of operations[89](index=89&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there are no quantitative and qualitative disclosures about market risk applicable to the Company for the reporting period - This item is not applicable to the Company[90](index=90&type=chunk) [ITEM 4. Controls and Procedures](index=24&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management, including the principal executive and financial officers, evaluated the effectiveness of the Company's disclosure controls and procedures as of March 31, 2021, concluding they were effective. There were no material changes to internal control over financial reporting during the quarter - Management concluded that disclosure controls and procedures were effective as of March 31, 2021[92](index=92&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended March 31, 2021[93](index=93&type=chunk) [PART II - OTHER INFORMATION](index=24&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This part provides additional information not covered in the financial statements, including legal proceedings, risk factors, equity sales, and exhibits [ITEM 1. Legal Proceedings](index=24&type=section&id=ITEM%201.%20Legal%20Proceedings) The Company reported no material pending legal proceedings involving itself, its subsidiaries, or any related parties, nor any such proceedings contemplated by governmental authorities - The Company is not aware of any material pending legal proceedings to which it or its subsidiaries are a party[95](index=95&type=chunk) - No material proceedings are contemplated by governmental authorities or involve adverse interests from directors, officers, or stockholders[95](index=95&type=chunk)[96](index=96&type=chunk) [ITEM 1A. Risk Factors](index=25&type=section&id=ITEM%201A.%20Risk%20Factors) The Company stated that there have been no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2020 - No material changes to risk factors from the Annual Report on Form 10-K for the year ended December 31, 2020[98](index=98&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=25&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the quarter ended March 31, 2021. The Company repurchased 2,306 shares of common stock in January 2021 under its Stock Repurchase Plan, with approximately $9.74 million remaining for future repurchases - No unregistered sales of equity securities during the three-month period ended March 31, 2021[99](index=99&type=chunk) Share Repurchase Activity (Q1 2021) | Period | Total Number of Shares Purchased | Average Price Paid per Share | Maximum Value that May Yet Be Purchased (in thousands) | | :------- | :------------------------------- | :--------------------------- | :----------------------------------------------------- | | January 2021 | 2,306 | $4.45 | $9,740 | [ITEM 3. Defaults Upon Senior Securities](index=25&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities during the period - No defaults upon senior securities[103](index=103&type=chunk) [ITEM 4. Mine Safety Disclosures](index=25&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the Company - Mine Safety Disclosures are not applicable to the Company[104](index=104&type=chunk) [ITEM 5. Other Information](index=25&type=section&id=ITEM%205.%20Other%20Information) No other information was reported under this item - No other information to report[105](index=105&type=chunk) [ITEM 6. Exhibits](index=26&type=section&id=ITEM%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including various certifications (e.g., Section 302 and 906 of Sarbanes-Oxley Act) and Interactive Data Files (XBRL documents) Exhibits Filed | 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 Instance Document | | 101.SCH | XBRL Taxonomy Extension Schema Document | | 101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | | 101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | | 101.LAB | XBRL Taxonomy Extension Label Linkbase Document | | 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | [SIGNATURES](index=27&type=section&id=SIGNATURES) The Form 10-Q report was duly signed on behalf of Orgenesis Inc. by its President & Chief Executive Officer, Vered Caplan, and its Chief Financial Officer, Treasurer and Secretary, Neil Reithinger, on May 6, 2021 - The report was signed by Vered Caplan, President & CEO, and Neil Reithinger, CFO, Treasurer and Secretary, on May 6, 2021[111](index=111&type=chunk)

Orgenesis. (NASDAQ:ORGS) Q4 2020 Earnings Conference Call March 9, 2021 8:30 AM ET Company Participants David Waldman - Investor Relations Vered Caplan - Chief Executive Officer Neil Reithinger - Chief Financial Officer Conference Call Participants Bruce Jackson - The Benchmark Company Kelvin Seetoh - Slingshot Capital Jason Revland - Revland Wealth Advisors Operator Good morning ladies and gentlemen and welcome to the Orgenesis Fiscal 2020 Year-End Conference Call. At this time, all participants have been ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) Commission file number 001-38416 ORGENESIS INC. (Exact name of registrant as specified in its charter) Nevada 98-0583166 State or other jurisdiction (I.R.S. Employer of incorporation or organization Identification No.) 20271 Goldenrod Lane, Germantown, MD 20876 For the fiscal year ended December 31, 2020 or ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ TRANSITION REPORT PUR ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2020 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) (State or other jurisdi ...

PART I - FINANCIAL INFORMATION [Financial Statements (unaudited)](index=4&type=section&id=ITEM%201.%20Financial%20Statements%20(unaudited)) Orgenesis Inc.'s unaudited condensed consolidated financial statements are presented, reflecting the Masthercell business as a discontinued operation [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to **$119.2 million** from **$92.5 million**, driven by cash from the Masthercell sale, significantly boosting equity to **$88.4 million** Balance Sheet Highlights (in thousands) | Balance Sheet Highlights (in thousands) | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $97,487 | $107 | | Total current assets | $104,312 | $78,348 | | TOTAL ASSETS | $119,196 | $92,495 | | **Liabilities & Equity** | | | | Total current liabilities | $19,758 | $42,434 | | TOTAL LIABILITIES | $30,807 | $55,462 | | Total equity | $88,389 | $6,078 | - The balance sheet no longer includes assets and liabilities of discontinued operations as of June 30, 2020, which amounted to **$75.2 million** and **$31.6 million** respectively at December 31, 2019[10](index=10&type=chunk)[13](index=13&type=chunk) [Condensed Consolidated Statements of Comprehensive Loss (Income)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss%20(Income)) Net loss from continuing operations increased to **$34.1 million**, but a **$54.6 million** gain from discontinued operations resulted in overall net income Income Statement Highlights (in thousands) | Income Statement Highlights (in thousands) | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | | Total revenues | $3,627 | $1,550 | | Operating loss | $33,505 | $13,123 | | Net loss from continuing operation | $34,136 | $13,203 | | Net (income) from discontinued operations | ($88,760) | $1,072 | | **Net (income) loss** | **($54,624)** | **$14,275** | - For the second quarter of 2020, total revenues increased to **$1.75 million** from **$1.13 million** year-over-year, with a net loss from continuing operations of **$27.1 million**, offset by **$6.7 million** income from discontinued operations, resulting in a total net loss of **$20.4 million**[14](index=14&type=chunk) [Condensed Consolidated Statements of Changes in Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity) Total equity surged from **$6.1 million** to **$88.4 million**, driven by **$54.9 million** comprehensive income and increased paid-in capital - For the six months ended June 30, 2020, comprehensive income attributable to Orgenesis Inc. was **$54.9 million**, which reversed the accumulated deficit from **($89.4 million)** to **($34.3 million)**[16](index=16&type=chunk) - Additional paid-in capital increased by approximately **$27.8 million** during the first half of 2020, mainly due to stock-based compensation for the Tamir purchase agreement (**$17.7 million**) and the issuance of shares and warrants (**$8.4 million**)[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by investing activities was **$102.8 million**, primarily from the **$104.2 million** Masthercell sale, leading to an **$86.1 million** increase in cash Cash Flow Summary (in thousands) | Cash Flow Summary (in thousands) | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($22,834) | ($8,168) | | Net cash provided by (used in) investing activities | $102,772 | ($3,947) | | Net cash provided by financing activities | $6,159 | $13,796 | | **Net change in cash** | **$86,097** | **$1,681** | - The primary source of cash was the **$104.2 million** received from the sale of subsidiaries (Masthercell)[29](index=29&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=14&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the strategic shift to a CGT Biotech Platform, the **$315 million** Masthercell sale, and the Tamir Biotechnology asset acquisition - On February 10, 2020, the company sold its Masthercell Business for a nominal purchase price of **$315 million**, receiving net proceeds of approximately **$126.7 million**, and this business is now classified as a Discontinued Operation[36](index=36&type=chunk)[57](index=57&type=chunk) - The gain on disposal of the Masthercell business was **$102.6 million** before taxes, resulting in a net profit from discontinued operations of **$88.8 million** for the six months ended June 30, 2020[60](index=60&type=chunk) - On April 23, 2020, the company acquired assets from Tamir Biotechnology for a total consideration of **$20.2 million**, consisting of **$2.462 million** in cash and **3.4 million** shares of common stock, expensing **$19.5 million** as research and development related to this asset acquisition[41](index=41&type=chunk)[97](index=97&type=chunk)[99](index=99&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic shift to a CGT Biotech Platform after the CDMO business sale, detailing improved liquidity and increased R&D expenses - The company sold its CDMO Business (Masthercell) on February 10, 2020, for a nominal price of **$315 million**, receiving net proceeds of approximately **$126.7 million**, shifting its focus entirely to its point-of-care CGT Biotech Platform[115](index=115&type=chunk) - The company's business strategy is now centered on its CGT Biotech Platform, which consists of three components: POCare Therapeutics, POCare Technologies, and a POCare Network of collaborative partners[116](index=116&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Revenues from continuing operations increased **134%** to **$3.6 million**, while R&D expenses surged **299%** to **$29.4 million** due to the Tamir acquisition Metric (in thousands) | Metric (in thousands) | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | | Total Revenues | $3,627 | $1,550 | | R&D Expenses | $29,423 | $7,373 | | SG&A Expenses | $7,129 | $5,775 | - The primary driver for the **1092%** increase in R&D expenses for Q2 2020 was the recognition of **$19.5 million** in expenses related to the Tamir Purchase Agreement[128](index=128&type=chunk)[130](index=130&type=chunk) - The **23%** increase in SG&A expenses for the first six months of 2020 was mainly due to a **$2.2 million** increase in accounting and legal fees related to recent business and collaboration agreements[137](index=137&type=chunk)[138](index=138&type=chunk) [Liquidity and Financial Condition](index=35&type=section&id=Liquidity%20and%20Financial%20Condition) The Masthercell sale provided **$126.7 million** in net proceeds, significantly strengthening liquidity with working capital at **$84.6 million**, sufficient for the next 12 months - The company received approximately **$126.7 million** from the Masthercell Sale and an additional **$9.24 million** from a private placement in January 2020[140](index=140&type=chunk)[144](index=144&type=chunk) Working Capital (in thousands) | Working Capital (in thousands) | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Current assets | $104,312 | $78,348 | | Current liabilities | $19,758 | $42,434 | | **Working capital** | **$84,554** | **$35,914** | - Management believes that proceeds from the Masthercell Sale and its business plan provide **sufficient liquidity for at least the next 12 months**[143](index=143&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that this section is not applicable - The company states that there are **no applicable quantitative and qualitative disclosures about market risk**[147](index=147&type=chunk) [Controls and Procedures](index=36&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2020[149](index=149&type=chunk) - **No changes** in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal controls[150](index=150&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=37&type=section&id=ITEM%201.%20Legal%20Proceedings) The company reports no material pending legal proceedings involving itself or its subsidiaries - The company is **not aware of any material pending legal proceedings** involving the company, its subsidiaries, directors, or officers[153](index=153&type=chunk)[154](index=154&type=chunk) [Risk Factors](index=37&type=section&id=ITEM%201A.%20Risk%20Factors) This section references prior risk factors and highlights new risks related to potential business disruptions from the COVID-19 outbreak - A **new risk factor** has been identified related to the **COVID-19 outbreak**, which has the potential to cause **disruptions** in the company's business, including its preclinical studies and clinical trials[156](index=156&type=chunk) - The extent of the impact from COVID-19 is **highly uncertain** and will depend on future developments, but could **materially affect business, financial condition, and results of operations**[158](index=158&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the period - **None reported**[159](index=159&type=chunk) [Defaults Upon Senior Securities](index=37&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - **None reported**[160](index=160&type=chunk) [Mine Safety Disclosures](index=37&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - **Not Applicable**[161](index=161&type=chunk) [Other Information](index=37&type=section&id=ITEM%205.%20Other%20Information) The company reported no other information - **None reported**[162](index=162&type=chunk) [Exhibits](index=38&type=section&id=ITEM%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including the Tamir Biotechnology Asset Purchase Agreement and officer certifications - Key exhibits filed include the **Asset Purchase Agreement with Tamir Biotechnology, Inc.** dated April 12, 2020, and **CEO/CFO certifications** pursuant to the Sarbanes-Oxley Act[163](index=163&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2020 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: 000-54329 ORGENESIS INC. (Exact name of registrant as specified in its charter) Nevada 98-0583166 (Stat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 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 000-54329 ORGENESIS INC. (Exact name of registrant as specified in its charter) ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2019 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: 000-54329 ORGENESIS INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction o ...