QNRX on Nasdaq
Quoin Pharmaceuticals Ltd.
In its 2026 annual report the company says: “We are a late-stage clinical specialty pharmaceutical company focused on the development and commercialization of therapeutic products that treat rare and orphan diseases for which there are currently either no approved or very limited treatments or cures. Our lead product, QRX003, is under clinical development as a potential treatment for Netherton Syndrome, a rare hereditary genetic disease. We have opened six clinical sites in the United States along with international sites that are being opened in the UK, Spain, France and the Netherlands.”4 It is headquartered in Ashburn, Virginia.1 Its shares trade on Nasdaq under the symbol QNRX.1
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Last updated Oct 21, 2026.
Overview
- TickerQNRX on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersAshburn, Virginia1
- Incorporated inIsrael3
- Business address42127 Pleasant Forest Court, Ashburn, Va 20148-73493
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation
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We are a late-stage clinical specialty pharmaceutical company focused on the development and commercialization of therapeutic products that treat rare and orphan diseases for which there are currently either no approved or very limited treatments or cures. Our lead product, QRX003, is under clinical development as a potential treatment for Netherton Syndrome (“NS”), a rare hereditary genetic disease. QRX003 is entering pivotal registrational clinical testing under an open Investigational New Drug (“IND”) application with the Food and Drug Administration (“FDA”). We have opened six clinical sites in the United States (“U.S.”) along with international sites that are being opened in the UK, Spain, France and the Netherlands. QRX003 is currently being tested in seven pediatric NS patients in investigator-initiated studies in Ireland, Austria, the Netherlands and New Zealand. QRX003 is also b…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 2021
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.2
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| General and administrative | $6.5M | $5.9M |
| Research and development | $9.8M | $3.6M |
| Total operating expenses | $16.3M | $9.5M |
| Unrealized gain | -$4.0K | -$7.5K |
| Realized and accrued interest income | -$482.1K | -$558.5K |
| Total other income | -$486.1K | -$566.0K |
| Net loss | -$15.8M | -$9.0M |
| Foreign currency translation | -$613 | |
| Total other comprehensive loss | -$613 | |
| Comprehensive loss | -$15.8M | -$9.0M |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.2
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $3.8M | $3.6M | |
| Investments | $14.9M | $10.4M | |
| Prepaid expenses and other current assets | $1.3M | $869.1K | |
| Total current assets | $20.0M | $14.9M | |
| Prepaid expenses - long term | $300.0K | ||
| Intangible assets, net | $383.3K | $483.3K | |
| Total assets | $20.4M | $15.7M | |
| Accounts payable | $1.3M | $905.7K | |
| Accrued expenses | $2.5M | $1.5M | |
| Accrued interest and financing expense | $1.1M | $1.1M | |
| Due to officers - short term | $600.0K | $600.0K | |
| Total current liabilities | $5.5M | $4.2M | |
| Due to officers - long term | $1.7M | $2.3M | |
| Total liabilities | $7.3M | $6.5M | |
| Ordinary shares, no par value per share, 5,000,000,000 and 100,000,000 ordinary shares authorized at December 31, 2025 and December 31, 2024, respectively - 52,441,360 (1,498,325 ADS's) ordinary shares issued and outstanding at December 31, 2025 and 8,948,164 (255,661 ADS's) ordinary shares issued and outstanding at December 31, 2024 | $0 | $0 | |
| Accumulated other comprehensive loss | -$613 | ||
| Additional paid in capital | $84.1M | $64.4M | |
| Accumulated deficit | -$71.0M | -$55.2M | |
| Total shareholders' equity | $13.1M | $9.2M | $5.7M |
| Total liabilities and shareholders' equity | $20.4M | $15.7M | |
| Ordinary shares, par value | $0.00 | $0.00 | |
| Ordinary shares, shares authorized | 5.0B shares | 100.0M shares | |
| Ordinary shares, shares issued | 52.4M shares | 8.9M shares | |
| Ordinary shares, shares outstanding | 52.4M shares | 8.9M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $3.8M | $3.6M | |
| Investments | $14.9M | $10.4M | |
| Prepaid expenses and other current assets | $1.3M | $869.1K | |
| Total current assets | $20.0M | $14.9M | |
| Prepaid expenses - long term | $300.0K | ||
| Intangible assets, net | $383.3K | $483.3K | |
| Total assets | $20.4M | $15.7M | |
| Accounts payable | $1.3M | $905.7K | |
| Accrued expenses | $2.5M | $1.5M | |
| Accrued interest and financing expense | $1.1M | $1.1M | |
| Due to officers - short term | $600.0K | $600.0K | |
| Total current liabilities | $5.5M | $4.2M | |
| Due to officers - long term | $1.7M | $2.3M | |
| Total liabilities | $7.3M | $6.5M | |
| Ordinary shares, no par value per share, 5,000,000,000 and 100,000,000 ordinary shares authorized at December 31, 2025 and December 31, 2024, respectively - 52,441,360 (1,498,325 ADS's) ordinary shares issued and outstanding at December 31, 2025 and 8,948,164 (255,661 ADS's) ordinary shares issued and outstanding at December 31, 2024 | $0 | $0 | |
| Accumulated other comprehensive loss | -$613 | ||
| Additional paid in capital | $84.1M | $64.4M | |
| Accumulated deficit | -$71.0M | -$55.2M | |
| Total shareholders' equity | $13.1M | $9.2M | $5.7M |
| Total liabilities and shareholders' equity | $20.4M | $15.7M | |
| Ordinary shares, par value | $0.00 | $0.00 | |
| Ordinary shares, shares authorized | 5.0B shares | 100.0M shares | |
| Ordinary shares, shares issued | 52.4M shares | 8.9M shares | |
| Ordinary shares, shares outstanding | 52.4M shares | 8.9M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.2
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$15.8M | -$9.0M |
| Stock based compensation | $1.1M | $1.3M |
| Amortization of intangibles | $100.0K | $100.0K |
| Realized and unrealized gain and accrued interest on investments | -$215.9K | -$251.6K |
| Increase (decrease) in accounts payable and accrued expenses | $1.3M | $276.0K |
| Decrease in prepaid expenses and other assets | -$92.8K | -$278.1K |
| Net cash used in operating activities | -$13.5M | -$7.9M |
| Purchase of investments | -$12.3M | -$17.3M |
| Proceeds from redemption of investments | $8.0M | $15.4M |
| Net cash used by investing activities | -$4.3M | -$1.9M |
| Payment of amounts due to officers | -$600.0K | -$600.0K |
| Proceeds from sale of equity securities, net | $18.6M | $11.6M |
| Net cash provided by financing activities | $18.0M | $11.0M |
| Effect of foreign exchange rate on changes on cash | -$613 | |
| Net change in cash and cash equivalents: | $194.8K | $1.2M |
| Offering expenses associated with warrant modification | $1.7M | |
| Accrued offering expenses included in additional paid in capital | $40.9K | $323.5K |
No quarter-by-quarter statement was filed.
Corporate structure
Quoin Pharmaceuticals Ltd. sits at the top of its group. 1 entity on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Quoin Pharmaceuticals Ltd.
- Ikarian Capital, LLC Filed SCHEDULE 13G/A on Quoin Pharmaceuticals Ltd., latest Oct 7, 2026 (3 filings since Dec 15, 2025)
- INTEGRATED CORE STRATEGIES (US) LLC Filed SCHEDULE 13G on Quoin Pharmaceuticals Ltd., latest Jun 2, 2026 (3 filings since Oct 27, 2025)
- ADAR1 Capital Management, LLC Filed SCHEDULE 13G/A on Quoin Pharmaceuticals Ltd., latest May 15, 2026 (2 filings since Feb 17, 2026)
- Stonepine Capital Management, LLC Filed SCHEDULE 13G/A on Quoin Pharmaceuticals Ltd., latest May 15, 2026 (3 filings since Dec 16, 2025)
- Woodline Partners LP Filed SCHEDULE 13G/A on Quoin Pharmaceuticals Ltd., latest May 15, 2026 (2 filings since Feb 17, 2026)
- Aberdeen Group plc Filed SCHEDULE 13G/A on Quoin Pharmaceuticals Ltd., latest Apr 29, 2026 (2 filings since Jan 28, 2026)
- Resolute Capital Asset Partners LLC Filed SCHEDULE 13G on Quoin Pharmaceuticals Ltd., latest Dec 11, 2025
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on Quoin Pharmaceuticals Ltd., latest May 15, 2025 (2 filings since Feb 14, 2025)
- Denise P. Carter Filed SCHEDULE 13D/A on Quoin Pharmaceuticals Ltd., latest Jan 28, 2025 (2 filings since Jan 2, 2025)
- Michael Myers Filed SCHEDULE 13D/A on Quoin Pharmaceuticals Ltd., latest Jan 28, 2025 (2 filings since Jan 2, 2025)
- Lind Global Fund II LP Filed SC 13G/A on Quoin Pharmaceuticals Ltd., latest Nov 14, 2024 (3 filings since Mar 3, 2023)
- CVI Investments, Inc. Filed SC 13G/A on Quoin Pharmaceuticals Ltd., latest Feb 14, 2023 (2 filings since Aug 12, 2022)
- Quoin Pharmaceuticals Ltd. Ashburn, Virginia
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Quoin Pharmaceuticals Ltd. 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.
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $3.8M2 Dec 31, 2025 | $3.6M2 Dec 31, 2024 | +5.4% |
| Marketable securities, current | $14.9M2 Dec 31, 2025 | $10.4M2 Dec 31, 2024 | +43.1% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Intangible assets, net (excluding goodwill) | $383.3K2 Dec 31, 2025 | $483.3K2 Dec 31, 2024 | −20.7% |
| Finite-lived intangibles, gross | $1.0M13 Dec 31, 2024 | $1.0M13 Dec 31, 2023 | 0% |
| Accumulated amortization | $616.7K2 Dec 31, 2025 | $516.7K2 Dec 31, 2024 | +19.4% |
| Finite-lived intangibles, net | $383.3K2 Dec 31, 2025 | $483.3K2 Dec 31, 2024 | −20.7% |
Properties, in its own words
We do not own any property, and we do not have any contracts or options to acquire or lease any property in the future. We are operating out of a virtual office, which is adequate for our present and planned future operations, as our corporate staff has been working remotely.
Item 2 of the 10-K filed Mar 26, 2026.4
Leadership
Who has led Quoin Pharmaceuticals Ltd., and when. Pick a name to see everywhere that person has worked.
Chief financial officer
Chief operating officer
- Chief financial officerSally Bridget Lawlor Sep 8, 2025 to now14
- Chief financial officerGordon Dunn Jan 3, 2023 to Dec 27, 202415
- Chief operating officerDenise P. Carter Jan 3, 2023 to now16
Board members and other officers (6)
- Board memberAnthony James Culverwell Jan 3, 2023 to now17
- Board memberDenise P. Carter Jan 3, 2023 to now16
- Board memberDennis Langer Jan 3, 2023 to now18
- Board memberJoseph Patrick Cooper Jan 3, 2023 to now19
- Board memberNatalie Ee Mun Leong Jan 3, 2023 to now20
- Board memberMichael T. Sember Mar 7, 2023 to now21
Named in SEC Form D filings
People the company listed in its private-offering notices.
Former names
Timeline
- Oct 14, 20268-K Regulation FD disclosure; Other events24
- Sep 22, 20268-K Regulation FD disclosure; Other events25
- Sep 10, 20268-K Regulation FD disclosure; Other events26
- Aug 28, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure27
- Aug 20, 20268-K Executive or director change; Shareholder vote; Other events28
- Aug 14, 20268-K Results of operations29
- Jun 23, 20268-K Regulation FD disclosure; Other events30
- Jun 4, 20268-K Regulation FD disclosure; Other events31
- May 7, 20268-K Results of operations32
- Mar 26, 20268-K Results of operations33
- Mar 11, 20268-K Regulation FD disclosure; Other events34
- Jan 20, 20268-K Regulation FD disclosure; Other events35
Calendar
Coming up
- Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($6.71) a share, on Nov 6, 2025.36
When it reported results
- Aug 14, 2026Reported quarterly or annual results29
- May 7, 2026Reported quarterly or annual results32
- Mar 26, 2026Reported quarterly or annual results33
- Nov 6, 2025Reported quarterly or annual results37
- Aug 7, 2025Reported quarterly or annual results38
- May 14, 2025Reported quarterly or annual results39
- Mar 13, 2025Reported quarterly or annual results40
- Nov 8, 2024Reported quarterly or annual results41
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
319 filings to the SEC since October 2021: 5 annual reports, 11 quarterly reports, 64 major events, 67 insider forms, 32 large holders, 3 private raises, 137 other. The latest 20:
- Oct 14, 20268-K EDGAR
- Oct 7, 2026SCHEDULE 13G/A EDGAR
- Oct 2, 2026DEF 14A EDGAR
- Sep 25, 2026EFFECT EDGAR
- Sep 25, 2026424B3 EDGAR
- Sep 22, 2026PRE 14A EDGAR
- Sep 22, 20268-K EDGAR
- Sep 18, 2026S-3 EDGAR
- Sep 10, 2026D EDGAR
- Sep 10, 20268-K EDGAR
- Sep 1, 20264 OWNERSHIP DOCUMENT EDGAR
- Sep 1, 20264 OWNERSHIP DOCUMENT EDGAR
- Sep 1, 20264 OWNERSHIP DOCUMENT EDGAR
- Sep 1, 20264 OWNERSHIP DOCUMENT EDGAR
- Aug 28, 20264 OWNERSHIP DOCUMENT EDGAR
- Aug 28, 20264 OWNERSHIP DOCUMENT EDGAR
- Aug 28, 20268-K EDGAR
- Aug 20, 20268-K EDGAR
- Aug 14, 20268-K EDGAR
- Aug 14, 202610-Q EDGAR
The 319 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
16 open-market trades by officers, directors and large owners since October 2021: 15 buys and 1 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Aug 31, 2026 | Carter Denise P.Chief Operating Officer | Buy | 20,490 | $4.88 | $100.0K | Form 4 |
| Aug 31, 2026 | Myers MichaelChief Executive Officer | Buy | 20,490 | $4.88 | $100.0K | Form 4 |
| Aug 31, 2026 | Lawlor Sally BridgetChief Financial Officer | Buy | 10,244 | $4.88 | $50.0K | Form 4 |
| Aug 31, 2026 | Culverwell Anthony JamesDirector | Buy | 6,146 | $4.88 | $30.0K | Form 4 |
| Oct 14, 2025 | LANGER DENNISDirector | Buy | 15,152 | $8.49 | $128.6K | Form 4 |
| Dec 23, 2024 | Carter Denise P.Chief Operating Officer | Buy | 555,556 | $0.45 | $250.0K | Form 4 |
| Dec 23, 2024 | Myers MichaelChief Executive Officer | Buy | 555,556 | $0.45 | $250.0K | Form 4 |
| Dec 23, 2024 | Dunn GordonChief Financial Officer | Buy | 122,221 | $0.45 | $55.0K | Form 4 |
| Dec 23, 2024 | Culverwell Anthony JamesDirector | Buy | 100,000 | $0.45 | $45.0K | Form 4 |
| Sep 10, 2024 | Dunn GordonChief Financial Officer | Buy | 20,000 | $0.81 | $16.2K | Form 4 |
| Sep 9, 2024 | Dunn GordonChief Financial Officer | Buy | 8,856 | $0.79 | $7.0K | Form 4 |
| Sep 4, 2024 | Carter Denise P.Chief Operating Officer | Buy | 31,813 | $0.79 | $25.0K | Form 4 |
| Sep 4, 2024 | Myers MichaelChief Executive Officer | Buy | 37,094 | $0.77 | $28.5K | Form 4 |
| Sep 3, 2024 | Carter Denise P.Chief Operating Officer | Buy | 5,922 | $0.65 | $3.9K | Form 4 |
| Sep 3, 2024 | Myers MichaelChief Executive Officer | Buy | 800 | $0.62 | $496 | Form 4 |
| Jun 7, 2024 | LANGER DENNISDirector | Sale | 297 | $0.73 | $217 | Form 4 |
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.
- Ikarian Capital, LLCSCHEDULE 13G/A, 3 filings Dec 15, 2025 to Oct 7, 202642
- INTEGRATED CORE STRATEGIES (US) LLCSCHEDULE 13G, 3 filings Oct 27, 2025 to Jun 2, 202643
- ADAR1 Capital Management, LLCSCHEDULE 13G/A, 2 filings Feb 17, 2026 to May 15, 202644
- Stonepine Capital Management, LLCSCHEDULE 13G/A, 3 filings Dec 16, 2025 to May 15, 202645
- Woodline Partners LPSCHEDULE 13G/A, 2 filings Feb 17, 2026 to May 15, 202646
- Aberdeen Group plcSCHEDULE 13G/A, 2 filings Jan 28, 2026 to Apr 29, 202647
- Resolute Capital Asset Partners LLCSCHEDULE 13G, 1 filing Dec 11, 202548
- ARMISTICE CAPITAL, LLCSCHEDULE 13G/A, 2 filings Feb 14, 2025 to May 15, 202549
- Denise P. CarterSCHEDULE 13D/A, 2 filings Jan 2, 2025 to Jan 28, 202550
- Michael MyersSCHEDULE 13D/A, 2 filings Jan 2, 2025 to Jan 28, 202551
- Lind Global Fund II LPSC 13G/A, 3 filings Mar 3, 2023 to Nov 14, 202452
- CVI Investments, Inc.SC 13G/A, 2 filings Aug 12, 2022 to Feb 14, 202353
- Goldman SachsSC 13G/A, 3 filings Feb 10, 2022 to Feb 14, 202354
- Altium Capital Management LLCSC 13G/A, 2 filings Nov 12, 2021 to Feb 14, 202255
Money raised
Private offerings the company reported to the SEC on Form D.
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Dauntless Investment Group, LLC | 214,987 | $1.0M | 1.8% | +18,395 |
| Ikarian Capital, LLC | 211,538 | $1.0M | 0.2% | No change |
| Stonepine Capital Management, LLC | 199,486 | $965.5K | 0.7% | +146,026 |
| Millennium Management LLC | 112,323 | $543.6K | 0.0% | +36,076 |
| SummitTX Capital, L.P. | 100,300 | $485.5K | 0.0% | No change |
| Woodline Partners LP | 76,446 | $370.0K | 0.0% | −3,136 |
| Aberdeen Group plc | 75,000 | $363.0K | 0.0% | No change |
| Soleus Capital Management, L.P. | 72,730 | $352.0K | 0.0% | No change |
| AIGH Capital Management LLC | 70,000 | $338.8K | 0.0% | +19,000 |
| Boothbay Fund Management, LLC | 59,838 | $289.6K | 0.0% | No change |
| Velan Capital Investment Management LP | 32,372 | $156.7K | 0.1% | −52,477 |
| Barclays PLC | 21,469 | $103.9K | 0.0% | +20,169 |
| Birchview Capital, LP | 20,000 | $96.8K | 0.0% | No change |
| XTX Topco Ltd | 15,006 | $72.6K | 0.0% | New |
| Morgan Stanley | 8,000 | $38.7K | 0.0% | +4,000 |
| UBS Group AG | 6,772 | $32.8K | 0.0% | +4,260 |
| Rhumbline Advisers | 2,332 | $11.3K | 0.0% | +811 |
| GAMMA Investing LLC | 439 | $2.1K | 0.0% | −1,281 |
| SBI Securities Co., Ltd. | 355 | $1.7K | 0.0% | +353 |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Quoin Pharmaceuticals Ltd. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARQuoin Pharmaceuticals Ltd.1
- CIK0001671502
- Employer ID (EIN)92-25931044
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inIsrael4
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address42127 Pleasant Forest Court, Ashburn, VA 20148-73491
- Phone703 980 41821
- Shares outstanding63,126,930 Common Stock shares; 1,803,626 Adr shares as of Mar 23, 20264
- Public float$5.4M as of Jun 30, 20254
- AuditorCBIZ CPAs P.C., Morristown, New Jersey PCAOB ID 199; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceApr 8, 20161
- Filings575 in all: 6-K (176), 8-K (63), 4 (51), 424B3 (48), CORRESP (21), EFFECT (20), SC 13G (14), UPLOAD (14)1
All 53 form types
SC 13G/A (12), 10-Q (11), 3 (10), F-1/A (9), SCHEDULE 13G (9), SCHEDULE 13G/A (9), POS AM (8), S-8 (7), 20-F (6), 424B4 (6), DEF 14A (6), PRE 14A (6), D (5), F-1 (5), 10-K (4), 3/A (4), ARS (4), 424B5 (3), F-4/A (3), S-1 (3), S-1/A (3), 4/A (2), 6-K/A (2), DEFA14A (2), DRS/A (2), DRSLTR (2), F-3 (2), RW (2), S-3 (2), SC 13D/A (2), SCHEDULE 13D (2), SCHEDULE 13D/A (2), 144 (1), 20-F/A (1), 25-NSE (1), 8-A12B (1), 8-K/A (1), CERTNAS (1), DRS (1), F-1MEF (1), F-4 (1), F-6 (1), FWP (1), POS EX (1), SC 13D (1)
- Latest filingsAnnual report (10-K) Mar 26, 2026
Quarterly report (10-Q) Aug 14, 2026
Proxy statement (DEF 14A) Oct 2, 2026
Latest 8-K (8-K) Oct 14, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| American Depositary Shares | QNRX | Nasdaq |
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 Quoin Pharmaceuticals Ltd. names in Item 1A of its 10-K filed Mar 26, 2026: 58 risks under these headings, as written.4
- Risks Related to Our Financial Position and Capital Requirements
- We have a limited operating history that you can use to evaluate us, and the likelihood of our success must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered by a small developing company.
- We must raise additional capital to fund our operations in order to continue as a going concern.
- We have incurred significant losses since our inception and have limited cash available for our operations.
- We have never generated any revenue from product sales or any other sources since inception, and may never be profitable.
- We expect that we will need to raise additional capital, which may not be available on acceptable terms, or at all.
- The terms of our October 2025 private placement may make it difficult for us to procure additional financing.
- Risks Related to the Discovery and Development of Product Candidates
- Pre-clinical and clinical studies of our product candidates may not be successful. If we are unable to generate successful results from pre-clinical and clinical studies of our product candidates, or experience significant delays in doing so, our business may be materially harmed.
- We may not be successful in our efforts to identify or develop potential product candidates.
- If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
- Any of our product candidates may cause undesirable side effects or have other properties impacting safety that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance.
The other 48 risks
- Even if we complete the necessary pre - clinical studies and clinical trials, we cannot predict whether or when we will obtain regulatory approval to commercialize a product candidate and we cannot, therefore, predict the timing of any revenue from a future product.
- Even if we obtain regulatory approval for a product candidate, we will still face extensive regulatory requirements, and our products may face future development and regulatory challenges.
- We may not be able to maintain orphan drug designation or obtain orphan drug exclusivity for our product candidates.
- Our Rare Pediatric Disease designation from the FDA does not guarantee that the NDA for the product will qualify for a priority review voucher upon approval, and it does not lead to a faster development or regulatory review process, or increase the likelihood that any of our product candidates will receive marketing approval.
- We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.
- We expect competition in the marketplace for our product candidates, should any of them receive regulatory approval.
- We face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.
- The commercial success of our product candidates will depend upon the acceptance of these product candidates by the medical community, including physicians, patients and healthcare payors.
- If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate any revenues.
- If we obtain approval to commercialize any approved products outside of the United States a variety of risks associated with international operations could materially adversely affect our business.
- Coverage and adequate reimbursement may not be available for our product candidates, if approved, which could make it difficult for us to sell products profitably.
- Risks Related to Our Reliance on Third Parties
- We rely on third parties to conduct some aspects of our compound formulation, research and pre - clinical studies, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such formulation, research or testing.
- We rely, or will rely, on third-party manufacturers to produce the supply of our pre - clinical product, clinical product candidates and commercial supplies of any approved product candidates.
- We rely on limited sources of supply for the drug substance of product candidates and any disruption in the chain of supply may cause a delay in developing and commercializing these product candidates.
- Manufacturing issues may arise that could increase product and regulatory approval costs or delay commercialization.
- We rely on third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
- Risks Related to Our Intellectual Property
- If we are unable to obtain or protect intellectual property rights related to our future products and product candidates, we may not be able to compete effectively in our markets.
- Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
- If we fail to obtain licenses or comply with our obligations in these agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
- We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
- Other Risks Related to Our Business Operations and Industry
- The pausing or termination of government grants by the United States government could have a major effect on the pharmaceutical industry, and as a result, our operations and prospects.
- Inadequate funding, government shutdowns, workforce reductions or other policy changes affecting the FDA, the SEC or other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- Our future success depends on our ability to attract and retain key executives and to attract, retain and motivate qualified personnel.
- We may need to expand our organization and may experience difficulties in managing our growth, which could disrupt our operations.
- Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
- Future relationships with customers and third-party payors as well as certain of our business operations may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
- Our operations and commercial success may be impacted from changes to current regulations and future legislation.
- We face potential product liability, and, if successful claims are brought against us, we may incur substantial liability and costs.
- Cyber security risks and the failure to maintain the confidentiality, integrity, and availability of our computer hardware, software, and Internet applications and related tools and functions could result in damage to our reputation and/or subject us to costs, fines or lawsuits.
- We have been, and may in the future be, adversely affected by health epidemics and pandemics which may significantly harm our business, prospects, financial condition and operating results.
- Business interruptions could delay us in the process of developing our future products.
- Risks Related to Being an Israeli Company
- Shareholders may have difficulties enforcing a U.S. judgment, including judgments based upon the civil liability provisions of the U.S. federal securities laws, against us or our executive officers and directors, or asserting U.S. securities laws claims in Israel.
- The rights and responsibilities of our shareholders are governed by Israeli law, which may differ in some respects from the rights and responsibilities of shareholders of U.S. corporations.
- Provisions of Israeli law may delay, prevent or otherwise impede a merger with, or an acquisition of, our company, which could prevent a change of control, even when the terms of such a transaction are favorable to us and our shareholders.
- Risks Related to Ownership of Our ADSs and Ordinary Shares
- We do not know whether a market for our securities will be sustained and as a result it may be difficult for shareholders to sell our securities.
- We incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which may harm our business.
- Failure to achieve and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business, results of operation or financial condition. In addition, current and potential shareholders could lose confidence in our financial reporting, which could have a material adverse effect on the price of the ADSs.
- Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of our ADSs.
- The market price for our ADSs may be volatile.
- We may be at risk of securities class action litigation.
- Substantial future sales or perceived potential sales of our ADSs in the public market could cause the price of our ADSs to decline.
- Our shareholders may experience substantial dilution as a result of future issuances of our equity securities.
- We have not paid, and do not intend to pay, dividends on our ordinary shares and, therefore, unless our traded securities appreciate in value, our investors may not benefit from holding our securities.
- If we pay dividends or other distributions, an ADS holder may not receive the same distributions or dividends as those we make to the holders of our ordinary shares, and, in some limited circumstances, an ADS holder may not receive dividends or other distributions on our ordinary shares and an ADS holder may not receive any value for them, if it is illegal or impractical to make them available to such ADS holder.
- Holders of ADSs must act through the depositary to exercise their rights.
- Holders of ADSs may be subject to limitations on the transfer of their ADSs.
Legal proceedings
From time to time, we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business. We are currently not a party to any material legal or administrative proceedings, and we are not aware of any pending or threatened material legal or administrative proceedings against us.
The opening of Item 3, Legal Proceedings.4
Sources
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- 15SEC EDGARGordon Dunn, Chief financial officer
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- 18SEC EDGARDennis Langer, Board member
- 19SEC EDGARJoseph Patrick Cooper, Board member
- 20SEC EDGARNatalie Ee Mun Leong, Board member
- 21SEC EDGARMichael T. Sember, Board member
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- 29SEC EDGARResults of operations
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- 32SEC EDGARResults of operations
- 33SEC EDGARResults of operations
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- 36NasdaqNasdaq calendar
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