Private company
Orgenesis Inc.
Orgenesis Inc. is an American pharmaceutical preparations company based in Germantown.2
Last updated Oct 20, 2026.
Overview
- IndustryPharmaceutical Preparations2
- HeadquartersCarson City, United States2
- Incorporated inNV3
- Business address20271 Goldenrod Lane, Germantown, Md 208763
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI549300DCE2FRWERKD7842
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O Business Filings Incorporated, 89701 Carson City, United States2
- Registered withBusiness Center (Secretary of State), E0375472008-92
See how the biggest companies compare on our leaderboards
Islets: The FDA-cleared Koligo platform, with over 80 patients treated at hospitals across the US.4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2024
Where the money goes
Where each dollar of revenue went, fiscal 2024
- Cost of revenue7¢$1.9M
- Research and development36¢$9.6M
- Selling, general and admin56¢$14.8M
- Income tax0¢$97.0K
Out of $1.0M in revenue.5 The company lost money this year.
Financial statements
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Revenue | $18.7M6 | $2.6M7 | $6.2M8 | $31.6M9 | $36.0M10 | $530.0K5 | $1.0M5 |
| Cost of revenue | $10.8M6 | $18.2M6 | $36.6M9 | $5.1M10 | $6.3M5 | $1.9M5 | |
| Gross profit | $7.8M11 | $30.9M10 | -$5.7M5 | -$893.0K5 | |||
| Research and development | $6.5M6 | $14.0M7 | $84.0M8 | $36.6M8 | $21.9M10 | $10.6M5 | $9.6M5 |
| Selling, general and admin | $11.5M7 | $19.0M8 | $14.7M9 | $15.6M10 | $35.1M5 | $14.8M5 | |
| Operating income | -$13.9M6 | $22.0M7 | -$95.8M8 | -$16.8M9 | -$10.1M10 | -$53.6M5 | -$39.8M5 |
| Income before tax | -$18.0M9 | -$12.0M10 | -$64.4M5 | -$48.9M5 | |||
| Income tax | $1.3M6 | $229.0K7 | -$1.6M8 | $108.0K9 | $209.0K10 | $473.0K5 | $97.0K5 |
| Net income | -$18.3M6 | $24.1M7 | $1.1M8 | -$18.1M9 | -$14.9M10 | -$55.4M5 | -$48.2M5 |
| Earnings per share | -$1.436 | $1.777 | -$0.298 | $0.749 | $0.5910 | $19.085 | $11.445 |
| Earnings per share (diluted) | -$1.436 | -$1.776 | $0.5910 | $19.085 | $11.445 | ||
| Shares (weighted, basic) | 24.3M shares9 | 25.1M shares10 | 2.9M shares5 | 4.2M shares5 | |||
| Shares (weighted, diluted) | 25.1M shares10 | 2.9M shares5 | 4.2M shares5 |
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Cash | $15.0M6 | $107.0K7 | $44.9M8 | $5.5M9 | $5.3M10 | $837.0K5 | $78.0K5 |
| Receivables | $15.2M10 | $36.2M5 | $88.0K5 | $40.0K5 | |||
| Inventory | $118.0K9 | $120.0K10 | $34.0K5 | ||||
| Current assets | $28.1M6 | $78.3M7 | $50.1M8 | $25.8M9 | $46.3M10 | $4.1M5 | $761.0K5 |
| Property, plant and equipment | $10.3M9 | $22.8M10 | $1.5M5 | $578.0K5 | |||
| Goodwill | $8.4M10 | $8.2M5 | $1.2M5 | ||||
| Intangible assets | $11.8M9 | $9.7M10 | $7.4M5 | ||||
| Total assets | $73.9M6 | $92.5M7 | $77.7M8 | $59.8M9 | $90.9M10 | $14.6M5 | $1.4M5 |
| Accounts payable | $5.2M9 | $4.4M9 | |||||
| Short-term debt | $650.0K5 | $6.2M5 | |||||
| Current liabilities | $17.2M6 | $42.4M7 | $16.3M8 | $15.4M9 | $15.9M10 | $16.4M5 | $26.9M5 |
| Long-term liabilities | $5.8M9 | $15.7M10 | $19.1M5 | $12.0M5 | |||
| Total liabilities | $22.9M6 | $55.5M7 | $25.0M8 | $21.2M9 | $31.7M10 | $35.5M5 | $38.9M5 |
| Retained earnings | -$106.4M9 | -$121.3M10 | -$176.6M5 | -$224.8M5 | |||
| Shareholders’ equity | $26.1M6 | $5.5M7 | $52.6M8 | $38.5M9 | $27.6M10 | -$21.0M5 | -$37.5M5 |
| Shares outstanding | 15.5M shares6 | 16.1M shares7 | 24.2M shares8 | 24.3M shares9 | 25.5M shares10 | 3.2M shares5 | 5.2M shares5 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Cash from operations | -$15.7M6 | -$13.2M7 | -$78.0M8 | -$26.9M9 | -$24.9M10 | -$14.8M5 | -$17.1M5 |
| Depreciation and amortization | $1.9M9 | $2.0M10 | $1.6M5 | $2.1M5 | |||
| Stock-based compensation | $1.7M9 | $982.0K10 | $463.0K5 | $3.2M5 | |||
| Capital spending | $5.6M6 | $12.1M7 | $1.5M8 | $7.9M9 | $12.4M10 | $2.1M5 | $263.0K5 |
| Free cash flow | -$21.2M | -$25.3M | -$79.6M | -$34.7M | -$37.3M | -$16.9M | -$17.3M |
| Cash from investing | -$12.4M9 | -$14.1M10 | -$3.7M5 | $365.0K5 | |||
| Share buybacks | $250.0K8 | $1.0M8 | |||||
| Cash from financing | -$106.0K9 | $39.6M10 | $13.6M5 | $16.0M5 |
Corporate structure
Orgenesis Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Orgenesis Inc.
- Neurocords LLC Filed SCHEDULE 13G on Orgenesis Inc., latest Mar 14, 2025
- JSAF Holdings, LLC Filed SC 13G/A on Orgenesis Inc., latest Dec 4, 2024
- Jacob Safier Filed SC 13G/A on Orgenesis Inc., latest Dec 4, 2024 (2 filings since Feb 14, 2024)
- Dimensions Trading New Filed SC 13G/A on Orgenesis Inc., latest Sep 7, 2023 (2 filings since Nov 21, 2022)
- NewTech Investment Holdings, LLC Filed SC 13G on Orgenesis Inc., latest Jan 19, 2023
- Bergen Asset Management, LLC Filed SC 13G/A on Orgenesis Inc., latest Feb 14, 2022
- Orgenesis Inc. Carson City, Nevada, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Orgenesis Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $13.2M5 Dec 31, 2024 | $2.0M5 Dec 31, 2023 | +542.1% |
| Accumulated depreciation | $12.6M5 Dec 31, 2024 | $575.0K5 Dec 31, 2023 | +2088.9% |
| Property and equipment, net | $578.0K5 Dec 31, 2024 | $1.5M5 Dec 31, 2023 | −60.8% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $78.0K5 Dec 31, 2024 | $837.0K5 Dec 31, 2023 | −90.7% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Finite-lived intangibles, gross | $11.1M5 Dec 31, 2024 | $9.3M5 Dec 31, 2023 | +18.5% |
| Accumulated amortization | $11.1M5 Dec 31, 2024 | $2.0M5 Dec 31, 2023 | +463.3% |
Properties, in its own words
We do not own any real property. A description of the leased premises we utilize in several of our facilities is as follows:
Entity · Property Description
The rest of Item 2
Orgenesis Inc. · ● · Our principal office is located at 20271 Goldenrod Lane, Germantown, MD 20876.
Orgenesis Maryland LLC · ● · FastForward laboratory and office located at 1812 Ashland Ave, Baltimore, Maryland 21205.
● · Natick, Massachusetts
Mida Biotech BV · Laboratories and offices located in Leiden, The Netherlands
We believe that our facilities are generally in good condition and suitable to carry on our business. We also believe that, if required, suitable alternative or additional space will be available to us on commercially reasonable terms.
Item 2 of the 10-K filed Mar 26, 2026.4
Leadership
Who has led Orgenesis Inc., and when. Pick a name to see everywhere that person has worked.
Chief financial officer
- Chief executive officerVered Caplan Jun 12, 2017 to Jul 25, 202415
- Chief executive officerSav Dipasquale Jan 3, 2013 to Jan 3, 201316
- Chief executive officerJacob Benairie Mar 28, 2012 to Jan 31, 201317
- ChairVered Caplan Oct 25, 2018 to Jul 25, 202418
- PresidentSav Dipasquale Jan 3, 2013 to Jan 3, 201316
- PresidentJacob Benairie Mar 28, 2012 to Jan 31, 201317
- PresidentGilbert Adrias Cuison Apr 18, 2011 to Jul 5, 201119
- Chief financial officerVictor Miller Jan 8, 2024 to Jul 18, 202420
- Chief financial officerElliot Maltz Sep 5, 2023 to Sep 5, 202321
- Chief financial officerNeil Reithinger Mar 5, 2019 to Jun 16, 202222
- Chief financial officerJoseph Tenne May 2, 2014 to May 2, 201423
- Chief financial officerDov Weinberg Jan 30, 2013 to Jan 30, 201324
Board members and other officers (19)
- Chief Development OfficerEfrat Assa Kunik Jan 10, 2022 to Jun 16, 202225
- OfficerDenis Bedoret Mar 5, 2019 to Mar 5, 201926
- Chief Technical OfficerSarah Ferber Mar 22, 2012 to Mar 20, 202027
- TreasurerJerome Peralta Golez Apr 18, 2011 to Jul 5, 201128
- Board memberItzhak Vider Jul 17, 2024 to Dec 16, 202429
- Board memberAdam Pelavin Nov 12, 2024 to Dec 16, 202430
- Board memberJagannathan Bhalaji Nov 12, 2024 to Dec 16, 202431
- Board memberSanthosh Nagaraj Nov 12, 2024 to Dec 16, 202432
- Board memberMario Philips Jan 13, 2020 to Dec 21, 202333
- Board memberAshish Nanda Mar 5, 2019 to Dec 16, 202434
- Board memberDavid Sidransky Oct 25, 2018 to Dec 21, 202335
- Board memberChris Georges Frans Buyse Mar 12, 2015 to Mar 12, 201536
- Board memberHugues Bultot Mar 12, 2015 to Dec 6, 201737
- Board memberEtti Hanochi Feb 28, 2013 to Feb 28, 201338
- Board memberVered Caplan Mar 28, 2012 to Feb 2, 202239
- Board memberGuy Yachin Apr 17, 2012 to Dec 21, 202340
- Board memberYaron Adler Apr 23, 2012 to Dec 16, 202441
- Board memberGilbert Adrias Cuison Apr 18, 2011 to Jul 5, 201119
- Board memberJerome Peralta Golez Apr 18, 2011 to Jul 5, 201128
Former names
- Business Outsourcing Service, Inc.Apr 2, 2009 to Aug 19, 20113
Timeline
- Jun 2, 20268-K Bylaws or fiscal year changed; Shareholder vote42
- Mar 13, 20268-K Executive or director change43
- Jan 26, 20268-K Entered a material agreement; Unregistered sale of shares44
- Sep 16, 20258-K Entered a material agreement; New debt or obligation45
- Aug 25, 20258-K Executive or director change46
- Aug 19, 20258-K Executive or director change47
- Aug 1, 20258-K Other events48
- Jun 6, 20258-K Listing notice or transfer49
- Apr 22, 20258-K Other events50
- Mar 6, 20258-K Entered a material agreement; Completed an acquisition or sale51
- Jan 28, 20258-K Entered a material agreement52
- Dec 27, 20248-K Executive or director change53
- Jun 12, 2017New chief executive Vered Caplan becomes CEO15
- Jan 3, 2013New chief executive Sav Dipasquale becomes CEO16
- Mar 28, 2012New chief executive Jacob Benairie becomes CEO17
Calendar
When it reported results
- Mar 30, 2022Reported quarterly or annual results54
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
177 filings to the SEC since October 2021: 4 annual reports, 13 quarterly reports, 67 major events, 46 insider forms, 8 large holders, 3 private raises, 36 other. The latest 20:
- Jun 2, 20268-K EDGAR
- May 20, 2026DEFR14A EDGAR
- May 5, 2026DEF 14A EDGAR
- Apr 16, 2026PRE 14A EDGAR
- Mar 26, 202610-K EDGAR
- Mar 13, 20268-K EDGAR
- Jan 26, 20268-K EDGAR
- Sep 16, 20258-K EDGAR
- Aug 25, 20258-K EDGAR
- Aug 19, 20258-K EDGAR
- Aug 1, 20258-K EDGAR
- Jun 6, 20258-K EDGAR
- May 16, 2025NT 10-Q EDGAR
- Apr 22, 20258-K EDGAR
- Apr 1, 2025NT 10-K EDGAR
- Mar 18, 20253 EDGAR
- Mar 14, 2025SCHEDULE 13G EDGAR
- Mar 6, 20258-K EDGAR
- Jan 28, 20258-K EDGAR
- Dec 27, 20248-K EDGAR
The 177 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
36 open-market trades by officers, directors and large owners since October 2021: 33 buys and 3 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Jun 24, 2024 | Safier Jacob10% owner | Buy | 10,000 | $0.58 | $5.8K | Form 4 |
| Jun 24, 2024 | Safier Jacob10% owner | Sale | 10,000 | $0.58 | $5.8K | Form 4 |
| Apr 16, 2024 | Safier Jacob10% owner | Buy | 10,000 | $0.51 | $5.1K | Form 4 |
| Apr 16, 2024 | Safier Jacob10% owner | Sale | 10,000 | $0.50 | $5.0K | Form 4 |
| Apr 10, 2024 | Safier Jacob10% owner | Buy | 10,000 | $0.59 | $5.9K | Form 4 |
| Apr 10, 2024 | Safier Jacob10% owner | Sale | 10,000 | $0.54 | $5.4K | Form 4 |
| Feb 1, 2024 | Safier Jacob10% owner | Buy | 10,100 | $0.33 | $3.3K | Form 4 |
| Jan 31, 2024 | Safier Jacob10% owner | Buy | 5,000 | $0.35 | $1.8K | Form 4 |
| Jan 30, 2024 | Safier Jacob10% owner | Buy | 25,000 | $0.33 | $8.2K | Form 4 |
| Jan 26, 2024 | Safier Jacob10% owner | Buy | 25,000 | $0.32 | $8.0K | Form 4 |
| Jan 25, 2024 | Safier Jacob10% owner | Buy | 25,000 | $0.32 | $8.0K | Form 4 |
| Jan 22, 2024 | Safier Jacob10% owner | Buy | 10,000 | $0.29 | $2.9K | Form 4 |
| Jan 18, 2024 | Safier Jacob10% owner | Buy | 10,000 | $0.33 | $3.3K | Form 4 |
| Jan 11, 2024 | Safier Jacob10% owner | Buy | 2,000 | $0.33 | $660 | Form 4 |
| Jan 10, 2024 | Safier Jacob10% owner | Buy | 10,000 | $0.37 | $3.7K | Form 4 |
| Dec 21, 2023 | Safier Jacob10% owner | Buy | 10,000 | $0.45 | $4.5K | Form 4 |
| Dec 12, 2023 | Safier Jacob10% owner | Buy | 3,000 | $0.54 | $1.6K | Form 4 |
| Dec 11, 2023 | Safier Jacob10% owner | Buy | 2,000 | $0.53 | $1.1K | Form 4 |
| Dec 1, 2023 | Safier Jacob10% owner | Buy | 1,016 | $0.46 | $467 | Form 4 |
| Nov 24, 2023 | Safier Jacob10% owner | Buy | 5,000 | $0.54 | $2.7K | Form 4 |
All 36 trades can be filtered by person here when JavaScript is on.
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- Neurocords LLCSCHEDULE 13G, 1 filing Mar 14, 202555
- JSAF Holdings, LLCSC 13G/A, 1 filing Dec 4, 202456
- Jacob SafierSC 13G/A, 2 filings Feb 14, 2024 to Dec 4, 202457
- Dimensions Trading NewSC 13G/A, 2 filings Nov 21, 2022 to Sep 7, 202358
- NewTech Investment Holdings, LLCSC 13G, 1 filing Jan 19, 202359
- Bergen Asset Management, LLCSC 13G/A, 1 filing Feb 14, 202260
Money raised
Private offerings the company reported to the SEC on Form D.
SEC filer profile
How Orgenesis Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGAROrgenesis Inc.1
- CIK0001460602
- Employer ID (EIN)98-05831664
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; a shell company4
- Incorporated inNevada4
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address20271 Goldenrod Lane, Germantown, MD 208761
- Phone(480) 659-64041
- Shares outstanding9,799,538 shares as of Mar 26, 20264
- Public float$7.6M as of Jun 30, 20244
- AuditorKesselman & Kesselman, Haifa, Israel PCAOB ID 1309; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceApr 2, 20091
- Filings531 in all: 8-K (176), 4 (70), 10-Q (46), 3 (33), SC 13D (17), 10-K (16), UPLOAD (16), CORRESP (15)1
All 42 form types
EFFECT (11), DEF 14A (10), NT 10-Q (10), 10-Q/A (9), DEFA14A (9), 424B3 (8), D (8), S-3 (7), SC 13G/A (7), 5 (6), SC 13G (6), PRE 14A (5), 4/A (4), 424B5 (4), NT 10-K (4), S-1/A (4), SC 13D/A (4), 8-K/A (3), 3/A (2), ARS (2), POS AM (2), PRER14A (2), S-1 (2), S-3/A (2), S-8 (2), 10-K/A (1), 25-NSE (1), 424B2 (1), 8-A12B (1), 8-A12G (1), CERT (1), DEFR14A (1), NT 10-Q/A (1), SCHEDULE 13G (1)
- Latest filingsAnnual report (10-K) Mar 26, 2026
Quarterly report (10-Q) Nov 13, 2024
Proxy statement (DEF 14A) May 5, 2026
Latest 8-K (8-K) Jun 2, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001 per share | ORGS |
From the cover page of the 10-K filed Mar 26, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Orgenesis Inc. names in Item 1A of its 10-K filed Mar 26, 2026: 48 risks under these headings, as written.4
- Risks Related to Our Company and POCare Business
- We do not currently have sufficient funds to service our operations and our expenses and other liquidity needs and require additional capital immediately. Our management, as of December 31, 2024, and our independent registered public accounting firm, in its report on our financial statements as of and for the fiscal year ended December 31, 2024, have concluded that there is substantial doubt as to our ability to continue as a going concern.
- Our POCare business has a limited operating history and an unproven business model and faces significant challenges as the cell therapy industry is rapidly evolving. Our prospects may be considered speculative and any failure to execute our business strategy could adversely impact our operations and the price of our common stock.
- We are not profitable as of December 31, 2024, have limited cash flow and, unless we increase revenues and take advantage of any commercial opportunities that arise to expand our POCare business, the perceived value of our company may decrease and our stock price could be affected accordingly.
- Our research and development programs are based on novel technologies and are inherently risky.
- Kyslecel may not achieve patient or market acceptance, which could have a material adverse effect on our business.
- The therapeutic efficacy of Ranpirnase and our other product candidates is unproven in humans, and we may not be able to successfully develop and commercialize Ranpirnase or any of our other product candidates.
- We will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth.
- We require additional capital to support our business, and this capital may not be available on acceptable terms or at all.
- We conduct certain of our operations in Israel. Conditions in Israel, including the October 7, 2023 attack by Hamas and other terrorist organizations from the Gaza Strip and Israel’s war against them, may affect certain of our operations.
- Currency exchange fluctuations may impact the results of our operations.
- We have entered into collaborations and joint ventures and may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
The other 37 risks
- Our success will depend on strategic collaborations with third parties to develop and commercialize therapeutic product candidates, and we may not have control over a number of key elements relating to the development and commercialization of any such product candidate.
- Our success depends on our ability to protect our intellectual property and our proprietary technologies.
- We cannot be certain that the claims in our issued United States methods of use patents will not be found invalid or unenforceable if challenged.
- Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
- It may be difficult to enforce a U.S. judgment against us, our officers and directors and the foreign persons named in this Annual Report on Form 10-K in the United States or in foreign countries, or to assert U.S. securities laws claims in foreign countries or serve process on our officers and directors and these experts.
- We may be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputational damage.
- We are increasingly dependent on information technology and our systems and infrastructure face certain risks, including cybersecurity and data storage risks.
- There can be no assurance that we will be able to develop in-house sales and commercial distribution capabilities or establish or maintain relationships with third-party collaborators to successfully commercialize any product in the United States or overseas, and as a result, we may not be able to generate product revenue.
- If we are unable to integrate acquired businesses effectively, our operating results may be adversely affected.
- Risks Related to Our Decentralized Production Units or OMPULs (“DPU & Os”)
- We may not be able to operate our DPU & Os in all cities or desired locations and the sizes and use of our laboratories in such DPU & Os may be restricted due to zoning, environmental, medical waste, or other licensing regulations.
- If our existing DPU & O facilities become damaged or inoperable or if we are required to vacate our existing facilities, our ability to perform our tests and pursue our research and development efforts may be jeopardized.
- Changes in the price and availability of our raw materials could be detrimental to our DPU & O operations.
- We are dependent on skilled human capital for our DPU & Os.
- If we are unable to successfully secure our locations and premises, we may be unable to operate out of our DPU & Os or keep our employees and laboratory equipment safe.
- Our DPU & Os are operated in a heavily regulated industry, and changes in regulations or violations of regulations may, directly or indirectly, reduce our revenue, adversely affect our results of operations and financial condition, and harm our business.
- Risks Related to Our Trans-Differentiation Technologies for Diabetes and the THM License Agreement
- THM is entitled to cancel the THM License Agreement.
- Risks Related to Development and Regulatory Approval of Our Therapies and Product Candidates
- Research and development of biopharmaceutical products is inherently risky.
- Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development, manufacturing and distribution capabilities.
- Regulatory approval may be delayed, limited or denied for a number of reasons, including insufficient clinical data, the product not meeting safety or efficacy requirements or any relevant manufacturing processes or facilities not meeting applicable requirements.
- We have generated limited revenue from therapeutic product sales, and our ability to generate any significant revenue from product sales and become profitable depends significantly on our success in a number of factors.
- When we commence any clinical trials, we may not be able to conduct our trials on the timelines we expect.
- Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences.
- Our product candidates are biologics, and the manufacture of our product candidates is complex, and we may encounter difficulties in production, particularly with respect to process development or scaling-out of our manufacturing capabilities.
- Cell-based therapies rely on the availability of reagents, specialized equipment, and other specialty materials, which may not be available to us on acceptable terms or at all. For some of these reagents, equipment, and materials, we rely or may rely on sole source vendors or a limited number of vendors, which could impair our ability to manufacture and supply our products.
- There can be no assurance that we will be able to further develop in-house sales and commercial distribution capabilities or establish or maintain relationships with third-party collaborators to successfully commercialize any product in the United States or overseas, and as a result, we may not be able to generate product revenue.
- We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
- We are highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
- Risks Related to our Common Stock
- Our common stock has been delisted from Nasdaq.
- We have not been able, and may continue to be unable, to timely file periodic reports with the SEC.
- If we issue additional shares of common stock in the future, it will result in the dilution of our existing stockholders.
- If the Lender converts its outstanding loan amount into shares representing up to 80% of our outstanding common stock, the Lender could significantly influence the outcome of our corporate matters.
- Our stock price and trading volume may be volatile, which could result in losses for our stockholders.
- We do not intend to pay dividends on any investment in the shares of stock of our company.
- We have identified material weaknesses in our internal control over financial reporting. Failure to achieve and maintain effective internal controls over financial reporting could adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner, which could have an adverse impact on our business.
Legal proceedings
See note 23 of Item 8 of this Annual Report on Form 10-K for details of pending legal proceedings.
Except as described therein, we are not involved in any pending material legal proceedings.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
- 1SEC EDGAROrgenesis Inc. filings on SEC EDGAR
- 2
- 3SEC EDGAROrgenesis Inc. filings on SEC EDGAR
- 4
- 5SEC EDGAROrgenesis Inc. 10-K for fiscal 2024
- 6SEC EDGAROrgenesis Inc. 10-K for fiscal 2018
- 7SEC EDGAROrgenesis Inc. 10-K for fiscal 2019
- 8SEC EDGAROrgenesis Inc. 10-K for fiscal 2020
- 9SEC EDGAROrgenesis Inc. 10-K for fiscal 2021
- 10SEC EDGAROrgenesis Inc. 10-K for fiscal 2022
- 11SEC EDGAROrgenesis Inc. 10-K for fiscal 2018
- 12SEC EDGAROrgenesis Inc. 10-Q for fiscal 2024
- 13SEC EDGAROrgenesis Inc. 10-Q for fiscal 2024
- 14SEC EDGAROrgenesis Inc. 10-Q for fiscal 2024
- 15
- 16
- 17
- 18SEC EDGARVered Caplan, Chair
- 19SEC EDGARGilbert Adrias Cuison, President
- 20
- 21
- 22
- 23
- 24
- 25
- 26SEC EDGARDenis Bedoret, Officer
- 27
- 28SEC EDGARJerome Peralta Golez, Treasurer
- 29SEC EDGARItzhak Vider, Board member
- 30SEC EDGARAdam Pelavin, Board member
- 31SEC EDGARJagannathan Bhalaji, Board member
- 32SEC EDGARSanthosh Nagaraj, Board member
- 33SEC EDGARMario Philips, Board member
- 34SEC EDGARAshish Nanda, Board member
- 35SEC EDGARDavid Sidransky, Board member
- 36
- 37SEC EDGARHugues Bultot, Board member
- 38SEC EDGAREtti Hanochi, Board member
- 39SEC EDGARVered Caplan, Board member
- 40SEC EDGARGuy Yachin, Board member
- 41SEC EDGARYaron Adler, Board member
- 42
- 43SEC EDGARExecutive or director change
- 44
- 45
- 46SEC EDGARExecutive or director change
- 47SEC EDGARExecutive or director change
- 48SEC EDGAROther events
- 49SEC EDGARListing notice or transfer
- 50SEC EDGAROther events
- 51
- 52SEC EDGAREntered a material agreement
- 53SEC EDGARExecutive or director change
- 54
- 55
- 56
- 57
- 58
- 59
- 60