Financial Data and Key Metrics Changes - Company reported revenues of $8 million for Q3 2022, a decrease from $8.7 million in Q3 2021, primarily due to a decline in point-of-care (POC) development services [20] - Cost of revenues for development services and R&D decreased to $4.7 million from $10 million, a 53% reduction [21] - SG&A expenses were reduced by 49% to $3.1 million compared to $6.1 million in the same period last year [21] - Operating loss for Q3 2022 was $7 million, down from $7.7 million in Q3 2021, while net loss decreased by 86% to $1.4 million from $10.1 million [22] Business Line Data and Key Metrics Changes - Revenue from cell processing contributed $2.4 million in Q3 2022, marking the beginning of revenue recognition from this segment [20] - The company has developed a low-cost, capital-efficient business model with a pipeline of a dozen distinct therapeutic programs in various stages of development [14] Market Data and Key Metrics Changes - The global supply network now spans North America, Europe, Asia, and the Middle East, with point-of-care centers established as strategic hubs [12] - Expansion of collaboration with Johns Hopkins to establish a new point-of-care center, funded in part by a $5 million grant from the state of Maryland [13] Company Strategy and Development Direction - The company aims to reduce the cost of therapies to tens of thousands of dollars, making them more widely available [12] - A decentralized model is being pursued to address industry challenges, including capacity constraints and excessive costs [10] - The recent investment from Metalmark Capital is expected to accelerate the rollout of point-of-care services while minimizing dilution to existing shareholders [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the business outlook, highlighting the scalable recurring revenue model and the potential for growth in the industry [18] - The investment from Metalmark is seen as a validation of the business model and a means to expand operations, particularly in the U.S. market [26][38] Other Important Information - The company has successfully reduced SG&A expenses by 49% and net loss by 86% compared to the same period last year, achieving nearly breakeven income from operations for Q3 2022 [16] - The company has a strong track record of securing non-dilutive grant funding to support the development of its therapeutic programs [16] Q&A Session Summary Question: Examples of past capital constraints and how new capital will help growth - Management indicated that capital constraints were related to CapEx for setting up new point-of-care sites and hiring staff, and the new capital will enable expansion, especially in the U.S. [25][26] Question: Current number of active OMPULs - Management refrained from providing a specific number but emphasized the importance of capacity utilization over the number of OMPULs [27][29] Question: Highlights from the therapeutic pipeline - Most therapeutic programs are in preclinical or various clinical stages, with progress being made, and potential for revenue generation in the coming year [30] Question: Achievements in cost management - Management attributed the improved financial results to past investments and the maturation of the business, with the new capital expected to facilitate further growth [36] Question: Profitability expectations with new capital infusion - Management indicated a focus on meeting demand while maintaining a growth trajectory, with a goal to avoid losses [38] Question: Growth of cell processing revenue and its significance - Cell processing revenue is recognized as a recurring portion of the business, with expectations for further growth as the company expands its capabilities [39]

PART I [Financial Statements (unaudited)](index=4&type=section&id=ITEM%201.%20Financial%20Statements%20(unaudited)) Unaudited financial statements for the nine months ended September 30, 2022, show decreased revenues, a reduced net loss, increased assets and liabilities, and significant financing cash inflows, including a key investment in Morgenesis LLC [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2022, total assets increased to **$70.7 million**, liabilities rose sharply to **$40.4 million** due to convertible loans, and total equity decreased to **$30.3 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2022 | Dec 31, 2021 | Change | | :--- | :--- | :--- | :--- | | **Total Current Assets** | $31,856 | $25,758 | +$6,098 | | Cash and cash equivalents | $3,015 | $5,473 | -$2,458 | | Accounts receivable, net | $23,744 | $15,245 | +$8,499 | | **Total Assets** | **$70,690** | **$59,841** | **+$10,849** | | **Total Current Liabilities** | $34,168 | $15,365 | +$18,803 | | Short-term convertible loans | $22,488 | $5,885 | +$16,603 | | **Total Liabilities** | **$40,440** | **$21,210** | **+$19,230** | | **Total Equity** | **$30,250** | **$38,631** | **-$8,381** | [Condensed Consolidated Statements of Loss and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) For the nine months ended September 30, 2022, total revenues decreased by **21.7%** to **$22.4 million**, while reduced operating expenses led to an improved net loss of **$10.8 million** Statement of Loss Summary (in thousands, except per share data) | Metric | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $22,401 | $28,610 | -21.7% | | Operating Loss | $7,975 | $9,925 | -19.6% | | Net Loss Attributable to Orgenesis Inc. | $10,792 | $13,037 | -17.2% | | Basic and Diluted Loss Per Share | $0.43 | $0.54 | Improved | [Condensed Consolidated Statements of Changes in Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity) Total equity decreased from **$38.6 million** to **$30.3 million** as of September 30, 2022, primarily due to a **$10.8 million** net loss, partially offset by capital contributions - Equity decreased by **$8.3 million** during the first nine months of 2022, mainly due to the net loss for the period[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2022, net cash used in operating activities improved to **$14.2 million**, while financing activities provided **$20.1 million**, primarily from new convertible loans Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,163) | $(24,402) | | Net cash used in investing activities | $(7,458) | $(6,644) | | Net cash provided by financing activities | $20,095 | $989 | | **Net Change in Cash** | **$(1,526)** | **$(30,057)** | [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's POCare platform, the formation of Morgenesis LLC with a significant Metalmark Capital investment, and disclose substantial doubt about going concern status and a legal proceeding - The company's financial condition raises substantial doubt about its ability to continue as a going concern. Management's plans include raising additional capital and exploring ways to increase revenue and reduce expenditures[43](index=43&type=chunk) - In August 2022, the company formed Morgenesis LLC to hold substantially all assets of its POCare Services business, streamlining service units into one entity[39](index=39&type=chunk) - Subsequent to the quarter end, on November 4, 2022, Metalmark Capital agreed to invest **$30.2 million** in Morgenesis, with potential future payments up to **$20 million** and an optional investment of up to **$60 million**. This investment is intended to finance and expand the POCare Services business[86](index=86&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk) - The company is involved in a legal proceeding with the State of Israel, which is seeking declaratory remedy and payment of royalties related to certain technology. The company believes the claims are without merit and has not made a provision for loss[82](index=82&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic focus on POCare therapies, the formation of Morgenesis LLC with Metalmark Capital investment, and the need for additional capital despite reduced net loss and expenses - The company formed Morgenesis LLC to hold its POCare Services business and secured a strategic investment from Metalmark Capital, expected to provide **$30.2 million** initially, with potential for up to **$80 million** in additional funding[103](index=103&type=chunk)[105](index=105&type=chunk)[107](index=107&type=chunk) - Management acknowledges that current and projected cash resources raise substantial doubt about the company's ability to continue as a going concern, and plans to raise additional capital to fund operations[144](index=144&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) For the nine months ended September 30, 2022, total revenues decreased by **22%** to **$22.4 million**, offset by significant reductions in cost of revenues, R&D, and SG&A expenses Revenue Comparison (in thousands) | Period | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $22,401 | $28,610 | -22% | Expense Comparison (in thousands) | Expense Category | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | Change | | :--- | :--- | :--- | :--- | | Cost of revenues, dev. services & R&D | $20,932 | $25,861 | -19% | | Selling, general and administrative | $8,758 | $11,961 | -27% | - The decrease in SG&A expenses is primarily due to a reduction in salaries and related expenses; a discretionary bonus was paid to the CEO in Q3 2021 which was not repeated in 2022. This was partially offset by higher legal and accounting fees related to 2022 financing activities[128](index=128&type=chunk)[135](index=135&type=chunk) [Liquidity and Financial Condition](index=37&type=section&id=Liquidity%20and%20Financial%20Condition) As of September 30, 2022, the company faced a working capital deficiency of **$2.3 million** due to an **$18.8 million** increase in current liabilities from new convertible loans, offset by **$20.1 million** in financing activities Working Capital (in thousands) | | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Current Assets | $31,856 | $25,758 | | Current Liabilities | $34,168 | $15,365 | | **Working Capital (Deficiency)** | **$(2,312)** | **$10,393** | - Net cash provided by financing activities was **$20.1 million** for the nine months ended Sep 30, 2022, compared to only **$1.0 million** in the prior-year period, due to additional equity and debt financing[142](index=142&type=chunk) - The company states it will need to raise additional capital to fund its operations (separate from the Morgenesis subsidiary) and to repay outstanding convertible loans as they become due[143](index=143&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable to the company's current operations - Not applicable[146](index=146&type=chunk) [Controls and Procedures](index=38&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2022, with no material changes to internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of the end of the reporting period[148](index=148&type=chunk) - No material changes to the internal control over financial reporting were identified during the quarter ended September 30, 2022[149](index=149&type=chunk) PART II [Legal Proceedings](index=39&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is defending against a legal proceeding in Israel seeking royalties related to technology, believing the claims are without merit - A complaint was filed against the company in Israel by the State of Israel and Tel Hashomer Medical Research, seeking royalties and **NIS 10 million** related to a 2012 license agreement. The company considers the claims to be without merit[82](index=82&type=chunk)[151](index=151&type=chunk) [Risk Factors](index=39&type=section&id=ITEM%201A.%20Risk%20Factors) Substantial doubt exists regarding the company's ability to continue as a going concern without significant changes or additional capital - A key risk factor is the substantial doubt about the company's ability to continue as a going concern, which is dependent on raising additional capital or making significant changes to its operating plan[154](index=154&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No shares were repurchased under the company's stock repurchase plan during the three months ended September 30, 2022 - No shares were repurchased under the company's existing stock repurchase plan during the third quarter of 2022[156](index=156&type=chunk) [Defaults Upon Senior Securities](index=39&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported - None[157](index=157&type=chunk) [Mine Safety Disclosures](index=39&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This section is not applicable - Not Applicable[158](index=158&type=chunk) [Other Information](index=39&type=section&id=ITEM%205.%20Other%20Information) No other material information was reported - None[159](index=159&type=chunk) [Exhibits](index=40&type=section&id=ITEM%206.%20Exhibits) The report includes key exhibits such as convertible loan agreements and CEO/CFO certifications - Key exhibits filed include a Convertible Note Extension Agreement and the Senior Secured Convertible Loan Agreement with an affiliate of Metalmark Capital Partners[161](index=161&type=chunk)

Orgenesis, Inc. (NASDAQ:ORGS) Q2 2022 Earnings Conference Call August 16, 2022 11:00 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 Operator Good day, ladies and gentlemen, and welcome to the Orgenesis Business Update Call. [Operator Instructions] It is now my pleasure to turn the floor over to your host, David Waldman from Investor Relations. Sir ...

[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Orgenesis Inc. as of June 30, 2022, show a decrease in total equity driven by a significant increase in net loss compared to the prior year. Total assets grew slightly, while total liabilities increased substantially, primarily due to new convertible loans. The company also reported a significant decrease in revenue for the six-month period [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2022, total assets were $62.8 million, a slight increase from $59.8 million at year-end 2021. Total liabilities increased significantly to $31.0 million from $21.2 million, primarily due to an increase in convertible loans. Consequently, total equity decreased from $38.6 million to $31.8 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2022 (USD) | December 31, 2021 (USD) | | :--- | :--- | :--- | | **Total Current Assets** | $25,458 | $25,758 | | **Total Assets** | **$62,799** | **$59,841** | | **Total Current Liabilities** | $16,245 | $15,365 | | **Total Liabilities** | **$30,956** | **$21,210** | | **Total Equity** | **$31,843** | **$38,631** | [Condensed Consolidated Statements of Loss and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) The company's net loss widened significantly for both the three and six-month periods ended June 30, 2022. For the six-month period, total revenues decreased to $14.4 million from $19.9 million in the prior year, while net loss attributable to Orgenesis Inc. increased to $9.4 million from $2.9 million. This resulted in a basic and diluted loss per share of $0.38 for the six-month period, up from $0.12 in 2021 Statement of Loss Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2022 (USD) | Three Months Ended June 30, 2021 (USD) | Six Months Ended June 30, 2022 (USD) | Six Months Ended June 30, 2021 (USD) | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $7,201 | $10,545 | $14,413 | $19,934 | | Operating Loss | $4,732 | $2,322 | $7,968 | $2,266 | | Net Loss Attributable to Orgenesis Inc. | $5,427 | $2,659 | $9,436 | $2,878 | | Basic and Diluted Loss Per Share | $0.22 | $0.11 | $0.38 | $0.12 | [Condensed Consolidated Statements of Changes in Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity) Total equity decreased from $38.6 million on January 1, 2022, to $31.8 million on June 30, 2022. The decline was primarily driven by a comprehensive loss of $9.9 million for the period, which was partially offset by proceeds from share and warrant allotments and stock-based compensation - Equity attributable to Orgenesis Inc. decreased by **$6.7 million** in the first six months of 2022, from **$38.5 million** to **$31.8 million**, mainly due to a net loss of **$9.4 million**[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2022, net cash used in operating activities was $9.2 million, an improvement from $16.0 million in the same period of 2021. Net cash used in investing activities increased to $4.9 million. These activities were funded by $10.9 million in net cash provided by financing activities, primarily from the issuance of convertible loans Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2022 (USD) | Six Months Ended June 30, 2021 (USD) | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,206) | $(16,047) | | Net cash used in investing activities | $(4,863) | $(1,562) | | Net cash provided by financing activities | $10,906 | $993 | | **Net Change in Cash** | **$(3,163)** | **$(16,616)** | [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business as a global biotech firm focused on cell and gene therapies via its POCare Platform. A significant disclosure is the management's conclusion that there is substantial doubt about the company's ability to continue as a going concern due to accumulated deficits and negative cash flows. The notes also cover revenue disaggregation, recent financing activities including convertible loans and a private placement with defaulting investors, a new legal proceeding, and a significant subsequent financing event - The company's business model is centered on its Point of Care (POCare) Platform, which includes a pipeline of therapies, automated processing systems (OMPULs), and a global network of hospitals and research institutes[37](index=37&type=chunk)[41](index=41&type=chunk) - Management has identified a substantial doubt about the Company's ability to continue as a going concern due to an accumulated deficit of **$116 million** and negative operating cash flows of **$9.2 million** for the six months ended June 30, 2022[47](index=47&type=chunk)[49](index=49&type=chunk) - In a March 2022 private placement, the company received only **$2.175 million** of a planned **$14.8 million** due to defaulting investors[61](index=61&type=chunk) - The company is a defendant in a lawsuit filed by Chaim Sheba Medical Center, which seeks royalties and **NIS 10 million** in damages. The company believes the claims are without merit and has not made a provision for loss[78](index=78&type=chunk) - Subsequent to the quarter's end, on August 15, 2022, a subsidiary entered into a **$10 million** senior secured convertible loan agreement with an affiliate of Metalmark Capital Partners[81](index=81&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a 28% decrease in revenue for the first six months of 2022 compared to 2021, primarily due to the completion of performance obligations under POC development service contracts. Despite lower revenues, the cost of revenues and R&D increased slightly. The company's liquidity position is strained, with working capital decreasing and a reiterated warning of substantial doubt about its ability to continue as a going concern. Operations were funded through convertible loan agreements, though some investors defaulted on their commitments [Results of Operations](index=28&type=section&id=Results%20of%20Operations) For the three months ended June 30, 2022, revenues decreased 32% to $7.2 million from $10.5 million in Q2 2021. For the six-month period, revenues decreased 28% to $14.4 million. The decline was mainly from POC development services. Cost of revenues, development services, and R&D decreased 8% for the quarter but increased 3% for the six-month period, driven by higher salaries and other R&D expenses, offset by lower subcontracting fees. Selling, general, and administrative expenses saw a slight decrease - Revenue for Q2 2022 decreased by **32%** year-over-year, mainly due to a decline in POC development services as major contracts from 2021 were largely completed. The company recognized its first revenue from point-of-care cell processing services (**$416 thousand**)[113](index=113&type=chunk) - For the six months ended June 30, 2022, revenues decreased by **28%** year-over-year, also due to a decline in POC development services[120](index=120&type=chunk) Cost of Revenues, Development Services and R&D (Six Months Ended, in thousands) | Expense Category | June 30, 2022 (USD) | June 30, 2021 (USD) | | :--- | :--- | :--- | | Salaries and related expenses | $6,240 | $4,767 | | Subcontracting, professional and consulting services | $3,426 | $6,033 | | Other research and development expenses | $4,465 | $2,870 | | **Total** | **$16,266** | **$15,854** | [Liquidity and Financial Condition](index=34&type=section&id=Liquidity%20and%20Financial%20Condition) The company's working capital decreased from $10.4 million at year-end 2021 to $9.2 million as of June 30, 2022. Net cash used in operating activities for the first six months of 2022 was $9.2 million. The company reiterates that current resources and commitments raise substantial doubt about its ability to continue as a going concern and that it plans to raise additional capital Working Capital (in thousands) | | June 30, 2022 (USD) | December 31, 2021 (USD) | | :--- | :--- | :--- | | Current Assets | $25,458 | $25,758 | | Current Liabilities | $16,245 | $15,365 | | **Working Capital** | **$9,213** | **$10,393** | - Management states that current and projected cash resources raise substantial doubt about the company's ability to continue as a going concern[134](index=134&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable for the company - The company has indicated that this disclosure is not applicable[136](index=136&type=chunk) [Controls and Procedures](index=35&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures and concluded they were effective as of June 30, 2022. There were 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 the end of the period covered by the report[138](index=138&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, internal controls[139](index=139&type=chunk) [PART II - OTHER INFORMATION](index=36&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Legal Proceedings](index=36&type=section&id=ITEM%201.%20Legal%20Proceedings) The company refers to the notes in the financial statements regarding a legal proceeding. The relevant note details a complaint filed against the company by the State of Israel and Tel Hashomer Medical Research, seeking royalties and damages - Refers to Note 10 (Note 9 in the document) of the financial statements for details on a legal proceeding involving a claim for royalties from Chaim Sheba Medical Center[142](index=142&type=chunk)[78](index=78&type=chunk) [Risk Factors](index=36&type=section&id=ITEM%201A.%20Risk%20Factors) The company states 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, 2021 - There have been no material changes to the risk factors disclosed in the company's 2021 Form 10-K[144](index=144&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company has a stock repurchase plan approved in May 2020 for up to $10 million of its common stock. However, no shares were repurchased under this plan during the three months ended June 30, 2022 - No stock repurchases were made under the company's existing **$10 million** stock repurchase plan during the second quarter of 2022[145](index=145&type=chunk)[146](index=146&type=chunk) [Defaults Upon Senior Securities](index=36&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[147](index=147&type=chunk) [Mine Safety Disclosures](index=36&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - Not Applicable[148](index=148&type=chunk) [Other Information](index=36&type=section&id=ITEM%205.%20Other%20Information) The company reported no other information - None[149](index=149&type=chunk) [Exhibits](index=37&type=section&id=ITEM%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including material contracts such as the Securities Purchase Agreement and various Convertible Loan Agreements, as well as required CEO and CFO certifications - Exhibits filed include the Securities Purchase Agreement from March 2022, various convertible loan agreements from April and May 2022, and Sarbanes-Oxley Act certification statements[151](index=151&type=chunk)

PART I - FINANCIAL INFORMATION [Financial Statements (unaudited)](index=3&type=section&id=ITEM%201%20Financial%20Statements%20(unaudited)) Orgenesis Inc reported Q1 2022 total revenues of $7.2 million, a net loss of $4.0 million, and negative operating cash flow, with total assets decreasing to $58.5 million [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $58.5 million by March 31, 2022, driven by reduced cash, while total liabilities increased to $23.7 million, leading to a decline in total equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $1,123 | $5,473 | | Accounts receivable, net | $17,075 | $15,245 | | Total current assets | $24,010 | $25,758 | | Total non-current assets | $34,528 | $34,083 | | **TOTAL ASSETS** | **$58,538** | **$59,841** | | **Liabilities & Equity** | | | | Total current liabilities | $15,253 | $15,365 | | Total long-term liabilities | $8,428 | $5,845 | | **TOTAL LIABILITIES** | **$23,681** | **$21,210** | | **Total equity** | **$34,857** | **$38,631** | | **TOTAL LIABILITIES AND EQUITY** | **$58,538** | **$59,841** | [Condensed Consolidated Statements of Loss and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) The company reported a net loss of $4.0 million for Q1 2022, a significant increase from $165 thousand in Q1 2021, driven by decreased revenues and higher R&D expenses Consolidated Statements of Loss (in thousands, except per share data) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Total revenues | $7,212 | $9,389 | | Cost of development services and R&D expenses | $6,651 | $5,357 | | Operating loss (income) | $3,236 | $(56) | | Net loss | $3,997 | $165 | | Net loss attributable to Orgenesis Inc | $4,009 | $219 | | Basic and diluted loss per share | $0.16 | $0.01 | [Condensed Consolidated Statements of Changes in Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity) Total equity decreased by $3.8 million to $34.9 million in Q1 2022, primarily due to a comprehensive loss of $4.1 million - Total equity decreased from **$38.6 million** to **$34.9 million** in Q1 2022[17](index=17&type=chunk) - The decrease was primarily driven by a comprehensive loss of **$4.1 million** for the period[17](index=17&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $2.8 million, with total cash decreasing by $4.4 million to $1.6 million due to significant investing outflows Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,792) | $(4,547) | | Net cash used in investing activities | $(1,613) | $(539) | | Net cash provided by financing activities | $1 | $1,898 | | **Net change in cash** | **$(4,404)** | **$(3,188)** | - Cash used in investing activities increased significantly, mainly due to a **$1.5 million** loan granted to an associated entity[23](index=23&type=chunk)[105](index=105&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's biotech business, recent financing, strategic agreements, the Mida Biotech acquisition, and a disclosed legal proceeding - The company is a global biotech firm focused on making cell and gene therapies (CGTs) accessible through its Point of Care (POCare) Platform[26](index=26&type=chunk)[28](index=28&type=chunk) - As of March 31, 2022, the company had an accumulated deficit of **$110 million** and negative operating cash flows of **$3 million** for the quarter, indicating liquidity risks[38](index=38&type=chunk) - In March 2022, the company entered a securities purchase agreement to raise up to **$14.8 million**, though only **$1.8 million** was received by the filing date with the closing extended[52](index=52&type=chunk) - The company is facing a lawsuit from Sheba Medical Center in Israel seeking royalties, but management believes the claims are without merit and has not provisioned for a loss[64](index=64&type=chunk) - Subsequent to the quarter end, in April and May 2022, the company entered into convertible loan agreements for an aggregate of **$13 million**, receiving **$9 million** by the filing date[65](index=65&type=chunk)[67](index=67&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes revenue decline to completed contracts, explains increased R&D, and expresses confidence in liquidity based on recent financing and strategic developments - Revenue from point-of-care development services decreased by **31%** in Q1 2022 compared to Q1 2021, as major performance obligations for setting up customer territories were largely completed in 2021[93](index=93&type=chunk) - Cost of development and R&D expenses increased by **24%** year-over-year, mainly due to hiring more employees to support the expansion and development of new POCare activities and technologies[95](index=95&type=chunk)[96](index=96&type=chunk) - The company believes it has sufficient liquidity to fund operations for at least the **next 12 months**, based on current cash and funds from convertible loan agreements executed in April and May 2022[108](index=108&type=chunk) - Significant developments during the quarter include a license agreement with Yeda for TIL and CAR-T platforms, a joint venture with Proterna for mRNA vaccines, and the acquisition of Mida Biotech[88](index=88&type=chunk)[89](index=89&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=23&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company indicates that this section is not applicable - Not applicable[110](index=110&type=chunk) [Controls and Procedures](index=24&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2022, with no material changes in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were **effective** as of the end of the period covered by the report[112](index=112&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 control[113](index=113&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=24&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is involved in a legal dispute with the State of Israel and Sheba Medical Center seeking royalties, which the company intends to vigorously defend - A complaint was filed against the company and its Israeli subsidiary by the State of Israel (as owner of Chaim Sheba Medical Center) seeking royalties and payment of **NIS 10 million**[115](index=115&type=chunk) - The company believes the allegations are without merit and intends to vigorously defend against the claims[115](index=115&type=chunk) [Risk Factors](index=24&type=section&id=ITEM%201A.%20Risk%20Factors) No material changes to risk factors were reported from the company's Annual Report on Form 10-K for the year ended December 31, 2021 - There have been no material changes to the risk factors from those disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2021[117](index=117&type=chunk) [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) The company issued 29,940 common shares for the Mida Biotech BV acquisition in an unregistered sale, with no equity repurchases during the quarter - On February 22, 2022, the company issued **29,940 shares** of Common Stock, valued at **$100,000**, to acquire Mida Biotech BV. This was an unregistered sale relying on exemptions under the Securities Act[118](index=118&type=chunk) - There was no repurchase activity under the company's Stock Repurchase Plan during the quarter ended March 31, 2022[120](index=120&type=chunk) [Defaults Upon Senior Securities](index=25&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported - None[121](index=121&type=chunk) [Mine Safety Disclosures](index=25&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This section is not applicable - Not Applicable[122](index=122&type=chunk) [Other Information](index=25&type=section&id=ITEM%205.%20Other%20Information) No other information was reported - None[123](index=123&type=chunk) [Exhibits](index=26&type=section&id=ITEM%206.%20Exhibits) This section lists required exhibits, including Sarbanes-Oxley Act certifications and Interactive Data Files (Inline XBRL) - Lists required exhibits, including Sarbanes-Oxley Act certifications and Inline XBRL data files[125](index=125&type=chunk) Signatures

Financial Data and Key Metrics Changes - Revenue for the year ended December 31, 2021, increased over 360% to $35.5 million compared to $7.7 million in 2020, driven by increased activity under service agreements with partners and customers [10][37] - Cost of services and R&D expenses decreased to $36.6 million from $84 million in 2020, a reduction of 56%, primarily due to decreased R&D investments after significant expenditures in 2020 [38] - Selling, general, and administrative expenses decreased to $14.7 million from $19 million in 2020, a decline of 22%, attributed to reduced corporate investment activities and business development expenditures [39] Business Line Data and Key Metrics Changes - The company reported strong year-over-year revenue growth due to increased service agreements and commitments from customers for future revenues exceeding $30 million for 2022 and over $50 million for 2023 [11][10] - The point of care platform is expected to lower costs and enhance distribution, with a focus on processing therapies close to hospital settings [15][20] Market Data and Key Metrics Changes - The company is expanding its global supply network across North America, Europe, Asia, and the Middle East, establishing point of care centers as central hubs for therapy validation and distribution [16][17] - The potential addressable market for KYSLECEL is estimated to exceed $500 million in the U.S. alone, with plans to adjust manufacturing processes for European GMP requirements [33] Company Strategy and Development Direction - The strategy focuses on decentralizing and standardizing the supply of cell and gene therapies, utilizing mobile processing units (OMPULs) to enhance capacity and reduce costs [20][18] - The company aims to qualify production processes at one OMPUL location before expanding to additional sites, leveraging a decade of experience in therapy development [21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about achieving breakeven in 2022, with expectations that revenue growth will cover R&D and SG&A expenses [45][40] - The company is focused on expanding its therapeutic pipeline and leveraging government grants to support growth, indicating a strong outlook for the business [41][35] Other Important Information - The company has received a $5 million grant from the State of Maryland to support the establishment of a new point of care center [23] - A joint venture with Theracell in Greece has been designated as a priority investment, receiving a grant of up to €32 million from the Greek government [24] Q&A Session Summary Question: Next steps for KYSLECEL program and potential sites in Europe - Management indicated ongoing discussions regarding regulatory approvals and the need for more sites in Europe, but no final numbers were available yet [44] Question: Revenue and operating expense expectations for 2022 - Management hopes to achieve breakeven, with most development work completed and remaining expenses covered by grants [45][46] Question: Accounts receivable details and expected collection - Accounts receivable comprises various partners and customers, with a good history of collectability and expectations for timely payments [62][64] Question: Future grant funding expectations - Management noted growing global interest in funding for cell and gene therapies, with potential for additional grants from various governments [68][70] Question: Revenue commitments for 2022 and 2023 - Revenue commitments from customers are expected to be in addition to the $35 million generated in 2021, indicating strong future revenue potential [76] Question: Potential for therapy-related revenues - Management highlighted the complexity of generating therapy-related revenues, with some products potentially entering the market under hospital exemptions [80] Question: Strategic options for raising capital - Management discussed various strategic options for financing, including potential partnerships and collaborations, while emphasizing the importance of long-term value for shareholders [86][90]

PART I [Business](index=7&type=section&id=ITEM%201.%20BUSINESS) The company develops affordable cell and gene therapies via its decentralized Point of Care (POCare) Platform - Orgenesis is a global biotech company focused on making cell and gene therapies (CGTs) affordable and accessible through its **Point of Care (POCare) Platform**[17](index=17&type=chunk) - The POCare Platform consists of a licensed therapy pipeline, automated closed POCare technology systems (OMPULs), and a global network of partners[19](index=19&type=chunk) - The company primarily focuses on **autologous therapies**, using a patient's own cells to reduce costs and logistical complexity[18](index=18&type=chunk) - Orgenesis Mobile Processing Units and Labs (OMPULs) are key to providing a standardized, cost-effective, and scalable manufacturing solution at the point of care[25](index=25&type=chunk)[78](index=78&type=chunk) - In February 2020, Orgenesis sold its Contract Development and Manufacturing Organization (CDMO) business, Masthercell, which is now treated as a **discontinued operation**[30](index=30&type=chunk) [Therapies in Development](index=10&type=section&id=Therapies%20in%20Development) The therapeutic pipeline includes products across clinical, IND-enabling, and pre-clinical stages Orgenesis Therapy Development Pipeline Summary | Stage | Therapy | Indication | | :--- | :--- | :--- | | **Clinical Use** | KYSLECEL® | Total Pancreatectomy (TP-IAT) | | | Tissue Genesis Icellator® | Cell Assisted Lipotransfer | | | Cartil-S / Chondroseal | Osteoarthritis / Cartilage Defects | | **Clinical Trials** | RanTop (Ranpirnase) | HPV-associated external anogenital warts (EGW) | | | Tissue Genesis Icellator® | Erectile Dysfunction, COVID-19 ARDS | | **IND Enabling** | Autologous Insulin-Producing (AIP) Cells | Diabetes | | | CAR-T CD19 | B-ALL, Lymphoma | | | Dual Cellular vaccine (DUVAC) | Pancreatic Cancer | | **Pre-Clinical** | Bioxomes | Drug Delivery Platform | | | MSCP | Wound healing and Psoriasis | | | Kidney Disease Therapies | Chronic Kidney Disease (CKD) | - **KYSLECEL®**, an autologous pancreatic islet cell therapy, is commercially available in the US for patients undergoing total pancreatectomy, with plans for EU expansion[37](index=37&type=chunk) - The FDA granted **Orphan Drug Designation** for the company's Autologous Insulin-Producing (AIP) cells for treating severe hypoglycemia-prone diabetes[49](index=49&type=chunk) [POCare Platform Strategy](index=15&type=section&id=POCare%20Platform%20Strategy) The strategy delivers therapies at the point of care through a decentralized network using mobile OMPUL facilities - The strategy focuses on a **decentralized model** where therapies are collected, processed, and administered close to the clinical setting[70](index=70&type=chunk) - Global harmonization is maintained through a central quality system and supply chain, while local decentralization is achieved via regional POCare Centers[72](index=72&type=chunk)[73](index=73&type=chunk) - **OMPULs** are critical for rapid deployment of GMP-compliant capacity, reducing setup time from 18-24 months to 3-9 months and lowering costs[73](index=73&type=chunk)[78](index=78&type=chunk) - Collaborations, joint ventures, and licensing agreements are key, with partnerships established in North America, Europe, Latin America, Asia, and Australia[82](index=82&type=chunk)[83](index=83&type=chunk) [Revenue Model and Financials](index=19&type=section&id=Revenue%20Model%20and%20Financials) Revenue is generated from therapy out-licensing and POCare services, with total revenues surging 364% in 2021 - The revenue model is based on out-licensing therapies for royalties (typically **10% of net sales**) and JV profits (**10-15%**), plus fees from POCare Services[99](index=99&type=chunk)[100](index=100&type=chunk) - **Total revenues increased by 364%** from $7.65 million in 2020 to $35.5 million in 2021, driven by growth in POC and hospital services[102](index=102&type=chunk)[299](index=299&type=chunk) - Cost of services and other R&D expenses were **$36.6 million** in 2021, a significant decrease from $84.0 million in 2020[103](index=103&type=chunk) POCare Therapy Revenue (2020 vs. 2021) | Revenue Stream | 2021 (in thousands) | 2020 (in thousands) | | :--- | :--- | :--- | | POC and hospital services | $32,819 | $6,068 | | Cell process development services | $2,683 | $1,584 | | **Total** | **$35,502** | **$7,652** | [Risk Factors](index=26&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company faces significant risks in its business model, technology development, operations, and regulatory compliance - **Business & Financial Risks:** The POC business has a limited operating history and an unproven model, and the company is **not yet profitable**[148](index=148&type=chunk)[149](index=149&type=chunk) - **Technology & Development Risks:** Research programs are based on novel cell therapies, which are inherently risky and face an **uncertain regulatory approval pathway**[151](index=151&type=chunk) - **Operational Risks:** The business is affected by the COVID-19 pandemic and depends on the successful development and rollout of its OMPULs[172](index=172&type=chunk)[209](index=209&type=chunk) - **Collaboration & Partnership Risks:** Success depends on strategic collaborations, but the company may not realize the benefits of these alliances or control key elements[167](index=167&type=chunk)[170](index=170&type=chunk) - **Legal & Regulatory Risks:** The company faces risks related to intellectual property protection, potential infringement lawsuits, and extensive government regulation[185](index=185&type=chunk)[189](index=189&type=chunk)[223](index=223&type=chunk) [Properties](index=51&type=section&id=ITEM%202.%20PROPERTIES) The company does not own any real property and leases all its office, laboratory, and production facilities globally - The company **does not own any real property** and operates entirely out of leased facilities[259](index=259&type=chunk) Key Leased Facilities | Entity | Location | Type | | :--- | :--- | :--- | | Orgenesis Inc. | Germantown, MD | Principal Office | | Orgenesis Maryland Inc. | Baltimore, MD | Lab and Office | | Orgenesis Korea | Suwon-si, Republic of Korea | Lab and Office | | Koligo Therapeutics Inc. | New Albany, IN & Leander, TX | Production and Development Labs | | Orgenesis Biotech Israel | Bar Lev Industrial Park, Israel | Labs and Offices | | Orgenesis Belgium | Novalis Science Park, Belgium | Labs and Offices | [Legal Proceedings](index=51&type=section&id=ITEM%203.%20LEGAL%20PROCEEDINGS) The company is involved in a legal dispute with the State of Israel over technology licensing and royalties - A complaint was filed against Orgenesis and its Israeli subsidiary by the State of Israel and Tel Hashomer Medical Research on January 18, 2022[260](index=260&type=chunk) - The plaintiffs are seeking a declaratory remedy for royalties and **NIS 10 million in damages** related to the POCare platform and CDMO activities[260](index=260&type=chunk)[261](index=261&type=chunk) - The company believes the allegations are **without merit** and plans to vigorously defend against the claims[261](index=261&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=53&type=section&id=ITEM%205.%20MARKET%20FOR%20REGISTRANT'S%20COMMON%20EQUITY,%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) The company's stock trades on Nasdaq, no dividends are planned, and a stock repurchase plan is active - The company's common stock is listed on the Nasdaq Capital Market under the symbol **"ORGS"**[266](index=266&type=chunk) - Orgenesis has **never paid dividends** and does not plan to in the foreseeable future, intending to retain earnings for business operations[267](index=267&type=chunk) - A stock repurchase plan of up to **$10 million** was approved in May 2020, under which 24,477 shares were repurchased in November 2021[269](index=269&type=chunk)[271](index=271&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=54&type=section&id=ITEM%207.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Revenue grew 364% in 2021, while net loss from continuing operations narrowed significantly due to lower R&D expenses Consolidated Results of Operations (2020 vs. 2021) | Metric (in thousands) | 2021 | 2020 | | :--- | :--- | :--- | | Total Revenues | $35,502 | $7,652 | | Cost of services and other R&D, net | $36,644 | $83,986 | | Selling, general and administrative | $14,710 | $18,973 | | Operating Loss | $16,800 | $95,785 | | Net Loss from Continuing Operation | $18,059 | $95,127 | | Net Income from Discontinued Operations | $0 | ($95,706) | | **Net Loss (Income)** | **$18,059** | **($579)** | - Revenues for FY2021 **increased by 364% to $35.5 million**, primarily due to a significant increase in point-of-care (POC) services revenue[299](index=299&type=chunk) - Cost of services and other R&D expenses **decreased by 56% to $36.6 million** in 2021, mainly due to the completion of major OMPUL development work in 2020[303](index=303&type=chunk)[304](index=304&type=chunk) - SG&A expenses **decreased by 22% to $14.7 million** in 2021, despite a $3.6 million discretionary bonus to the CEO[306](index=306&type=chunk)[308](index=308&type=chunk) - The company's **working capital decreased from $33.8 million to $10.4 million** at year-end 2021, primarily due to cash used to fund POC operations[312](index=312&type=chunk)[313](index=313&type=chunk) - Net cash used in operating activities was **$26.9 million** in 2021, a significant improvement from $78.0 million used in 2020[315](index=315&type=chunk)[316](index=316&type=chunk) [Financial Statements and Supplementary Data](index=65&type=section&id=ITEM%208.%20FINANCIAL%20STATEMENTS%20AND%20SUPPLEMENTARY%20DATA) Audited financial statements show decreased assets and a net loss in 2021, with a critical audit matter on liquidity Key Consolidated Balance Sheet Data (as of Dec 31) | Account (in thousands) | 2021 | 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $5,473 | $44,923 | | Total Current Assets | $25,758 | $50,077 | | **Total Assets** | **$59,841** | **$77,684** | | Total Current Liabilities | $15,365 | $16,285 | | **Total Liabilities** | **$21,210** | **$24,956** | | **Total Equity** | **$38,631** | **$52,728** | Key Consolidated Comprehensive Loss (Income) Data (Year Ended Dec 31) | Account (in thousands) | 2021 | 2020 | | :--- | :--- | :--- | | Total Revenues | $35,502 | $7,652 | | Operating Loss | $16,800 | $95,785 | | Net loss from continuing operation | $18,059 | $95,127 | | Net income from discontinued operations | $0 | ($95,706) | | **Net Loss (Income)** | **$18,059** | **($579)** | - The auditor's report includes a **Critical Audit Matter related to the company's liquidity**, highlighting uncertainty regarding future cash flows[478](index=478&type=chunk)[479](index=479&type=chunk)[480](index=480&type=chunk) [Controls and Procedures](index=65&type=section&id=ITEM%209A.%20CONTROLS%20AND%20PROCEDURES) Management concluded that both disclosure controls and internal control over financial reporting were effective as of year-end 2021 - Management concluded that the company's **disclosure controls and procedures were effective** as of December 31, 2021[341](index=341&type=chunk) - Based on the COSO framework, management concluded that the company's **internal control over financial reporting was effective** as of December 31, 2021[343](index=343&type=chunk)[344](index=344&type=chunk) - As a smaller reporting company, the annual report **does not include an auditor attestation report** on internal control over financial reporting[344](index=344&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=66&type=section&id=ITEM%2010.%20DIRECTORS,%20EXECUTIVE%20OFFICERS%20AND%20CORPORATE%20GOVERNANCE) The company is led by an experienced executive team and a board of six directors, a majority of whom are independent - The executive team includes Vered Caplan (CEO & Chairperson), Neil Reithinger (CFO), and Efrat Assa Kunik (Chief Development Officer)[350](index=350&type=chunk) - The Board of Directors is composed of six members: Vered Caplan, David Sidransky, Guy Yachin, Yaron Adler, Ashish Nanda, and Mario Philips[350](index=350&type=chunk)[370](index=370&type=chunk) - A **majority of the board members are considered independent** under Nasdaq listing standards[372](index=372&type=chunk)[373](index=373&type=chunk) - The Board has four committees: Audit, Compensation, Nominating and Corporate Governance, and Research and Development[375](index=375&type=chunk) [Executive Compensation](index=71&type=section&id=ITEM%2011.%20EXECUTIVE%20COMPENSATION) CEO compensation in 2021 was dominated by a $3.6 million discretionary bonus, with no new option awards for executives 2021 Summary Compensation Table | Name and Principal Position | Year | Salary ($) | Bonus ($) | All Other Comp. ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | Vered Caplan, CEO | 2021 | 264,483 | 3,600,000 | 112,345 | 3,976,828 | | Neil Reithinger, CFO | 2021 | 239,670 | - | - | 239,670 | | Efrat Assa-Kunik, CDO | 2021 | 169,533 | - | 46,387 | 215,919 | - In July 2021, the Compensation Committee approved a **$3.6 million discretionary bonus** for CEO Vered Caplan[411](index=411&type=chunk) - As of December 31, 2021, CEO Vered Caplan held outstanding options to purchase **1,167,756 shares**[398](index=398&type=chunk)[431](index=431&type=chunk) - Non-employee directors receive an annual cash retainer of **$40,000**, plus additional fees for committee service and annual option grants[422](index=422&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=77&type=section&id=ITEM%2012.%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS) Two beneficial owners hold over 5% of common stock, while the executive and director group holds 7.86% Security Ownership of >5% Beneficial Owners (as of March 30, 2022) | Name of Beneficial Owner | Amount of Beneficial Ownership | Percent | | :--- | :--- | :--- | | Image Securities fzc. | 2,070,919 | 8.34% | | Yehuda Nir | 2,182,164 | 8.79% | - All current directors and executive officers as a group beneficially own 1,949,963 shares, representing **7.86%** of outstanding common stock[427](index=427&type=chunk) - CEO Vered Caplan beneficially owns 1,167,756 shares, or **4.70%** of the company, including shares issuable upon option exercise[426](index=426&type=chunk)[431](index=431&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=81&type=section&id=ITEM%2013.%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20TRANSACTIONS,%20AND%20DIRECTOR%20INDEPENDENCE) The company engages in transactions with the CFO's firm and a major shareholder, including service fees and a loan facility - CFO Neil Reithinger's firm, Eventus Consulting, P.C., received **$240,000** in 2021 for financial consulting services[442](index=442&type=chunk) - The company earned revenues of **$3.9 million** from related party Image Securities fzc in 2021[443](index=443&type=chunk) - In August 2021, Orgenesis entered into a **$5 million convertible loan agreement** with Image Securities fzc, of which $3 million was drawn as of year-end[444](index=444&type=chunk) [Principal Accountant Fees and Services](index=82&type=section&id=ITEM%2014.%20PRINCIPAL%20ACCOUNTANT%20FEES%20AND%20SERVICES) Total fees billed by the independent auditor, a member of PwC, were $274,685 in 2021 Accountant Fees (2020 vs. 2021) | Service Category | 2021 Fees | 2020 Fees | | :--- | :--- | :--- | | Audit Fees | $228,188 | $267,231 | | Audit-Related Fees | $16,634 | $67,405 | | Tax Fees | $29,863 | $12,500 | | All Other Fees | $0 | $10,000 | | **Total Fees** | **$274,685** | **$357,136** | - The Audit Committee is responsible for appointing, compensating, and overseeing the independent auditor and pre-approves all services[449](index=449&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=83&type=section&id=ITEM%2015.%20EXHIBITS%20AND%20FINANCIAL%20STATEMENT%20SCHEDULES) This section lists all exhibits filed with the Form 10-K, including material contracts and required certifications - The report incorporates by reference key agreements such as the Stock Purchase Agreement for the sale of Masthercell and the merger agreement for Koligo Therapeutics[460](index=460&type=chunk) - Material contracts filed include the 2017 Equity Incentive Plan, various collaboration and license agreements, and convertible loan agreements[461](index=461&type=chunk) - Certifications from the CEO and CFO pursuant to the **Sarbanes-Oxley Act** are included as exhibits[462](index=462&type=chunk)

Orgenesis Inc. (NASDAQ:ORGS) Q3 2021 Earnings Conference Call November 4, 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 Operator Good morning, ladies and gentlemen, and welcome to the Orgenesis Third Quarter 2021 Business Update Call. [Operator Instructions]. It is now my pleasure to turn the floor over to your host, David Waldman, Inv ...

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, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from ___________ to ___________ Commission file number: 001-38416 ORGENESIS INC. (Exact name of registrant as specified in its charter) Nevada 98-0583166 (Stat ...

| --- | --- | |-------------------------|-------| | | | | | | | Unlocking the Potential | | Forward Looking Statements This presentation contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and ref ...