Quoin Pharmaceuticals Ltd.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 2026
QNRX$3.65-5.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-14.
0001104659-26-097064
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001104659-26-123342
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 65 previous paragraphs and 76 current paragraphs.
33 unchanged; 23 reworded; 20 added; 8 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 38 previous and 38 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (20)
Current report
On July 9, 2026, we announced that the FDA had cleared the IND for QRX003 in PSS, the first IND ever submitted to the FDA for the disease.
Current report
On August 28, 2026, we reported positive interim data from our ongoing Phase 2/3 study of QRX003 in NS. Four of six participants achieved the target 1-grade or greater improvement in investigator global assessment at week 12 (p=0.0087) with statistical significance versus the pre-specified alpha of 0.0215. A key secondary endpoint, global impression of change also achieved statistical significance at week 12 (p=0.0070) versus the pre-specified alpha of 0.0215. All three of the participants who had moderate-severe pruritus (itch) at baseline achieved a clinically meaningful outcome of at least a 3-grade improvement after 12 weeks of treatment with QRX003. No treatment-related serious adverse events were recorded.
Current report
On September 8, 2026, we announced that the FDA had granted Rare Pediatric Disease Designation to QRX003 in PSS.
Current report
On September 22, 2026, we announced that the FDA had granted Fast Track Designation to QRX003 for the treatment of PSS.
Current report
On October 14, 2026, we announced that the European Medicines Agency had granted Orphan Drug Designation to QRX003 for the treatment of PSS
Current report
August 2026 Private Placement
Current report
On August 27, 2026, we entered into a securities purchase agreement (the “Purchase Agreement”) with several institutional and accredited investors (the “Purchasers”) relating to the issuance and sale in a private placement transaction (the “August 2026 Private Placement”) of (i) ordinary shares represented by 2,503,170 ADSs and (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase ordinary shares represented by 3,802,130 ADSs together with ordinary warrants (the “Ordinary Warrants”, and together with the Pre-Funded Warrants, the “Warrants”) to purchase ordinary shares represented by 3,152,650 ADSs. The combined purchase price was $4.88 per each ADS and accompanying Ordinary Warrant and $4.8799 per each Pre-Funded Warrant and accompanying Ordinary Warrant, which pricing was designed to be in accordance with the “Minimum Price” requirement as defined in the Nasdaq rules. The August 2026 Private Placement closed on August 31, 2026 (the “Closing Date”). We received upfront net proceeds of approximately $28 million after deducting offering expenses payable by us, including placement agents fees and expenses.
Current report
We may also receive up to an aggregate of $19.2 million of additional gross proceeds if the Ordinary Warrants are exercised in full for cash.
Current report
The following directors and officers (the “Insider Participants”) participated in the August 2026 Private Placement: Dr. Michael Myers, our Chief Executive Officer and a member of our Board of Directors, Denise Carter, our Chief Operating Officer and a member of our Board of Directors; Sally Lawlor, our Chief Financial Officer and James Culverwell, a member of our Board of Directors. The Insider Participants purchased an aggregate of 57,370 ADSs and 28,865 Ordinary Warrants for a total purchase price of approximately $280,000, at a combined purchase price of $4.88 per ADS and accompanying Ordinary Warrant. The Insider Participants’ purchase price complied with the Nasdaq consolidated closing bid price rule. The Insider Participants’ participation in the August 2026 Private Placement was approved by both the Audit Committee of the Board of Directors and the Board of Directors.
Current report
Description of Warrants
Current report
Beneficial ownership limitation. A holder of the Pre-Funded Warrants or the Ordinary Warrants may not exercise any portion of such holder’s Pre-Funded Warrants or Ordinary Warrants for ADSs to the extent that the holder, together with its affiliates, would beneficially own more than 4.99% of the number of Ordinary Shares outstanding immediately after giving effect to the issuance of the Ordinary Shares represented by the ADSs issuable upon exercise of the applicable warrant (the “Beneficial Ownership Limitation”). In addition, a holder of the Pre-Funded Warrants or the Ordinary Warrants may not exercise any portion of such holder’s Pre-Funded Warrants or Ordinary Warrants for ADSs to the extent that the holder, together with its affiliates, would hold more than 4.99% of our voting power (“Voting Limitation”). By written notice to us, a holder of Pre-Funded Warrants or Ordinary Warrants may from time to time increase or decrease the 4.99% limitations to any other percentage not in excess of 9.99% specified in such notice; provided that any increase in such beneficial ownership limitation will not be effective until the 61st day after such notice is delivered to us; provided further, that any such increase will not be effective until after obtaining shareholder approval described under “-Shareholder Approval.”
Current report
*Pre-Funded Warrants.*The Pre-Funded Warrants have an exercise price of $0.0001 per ADS. The Pre-Funded Warrants are exercisable at any time after their original issuance, subject to the Beneficial Ownership Limitation, and will not expire until exercised in full. In addition, the Pre-Funded Warrants may be exercised, in whole or in part, any time after issuance by means of a cashless exercise.
Current report
Ordinary Warrants. The Ordinary Warrants are exercisable at any time after their original issuance, subject to the Beneficial Ownership Limitation. The Ordinary Warrants have an exercise price of $6.10 per ADS and may be exercised until the earlier of (i) five years from the Closing Date or (ii) 30 days after our public announcement that the primary endpoint has been met in the clinical trial CL-QRX003-004 for the treatment of Netherton Syndrome.
Current report
The exercise price and number of ADSs issuable upon exercise of the Pre-Funded Warrants and the Ordinary Warrants are subject to appropriate adjustment in the event of stock dividends, stock splits, changes in ADS ratio, reorganizations or similar events affecting our ADSs and the exercise price.
Current report
Shareholder Approval. The Purchase Agreement requires us to hold a meeting of shareholders within 90 days after the Closing Date for the purpose of seeking shareholder approval to amend any limitation on ownership of Ordinary Shares (including Ordinary Shares represented by ADSs) imposed on (a) the Purchasers and (b) the investors under that certain Securities Purchase Agreement, dated as of October 10, 2025, by and among us and the investors party thereto (the “October 2025 Purchase Agreement”) in each case so that such limitation (including, without limitation, the Beneficial Ownership Limitation and any corresponding limitation on voting power) is increased from 4.99% to 9.99% of the number of Ordinary Shares (including Ordinary Shares represented by ADSs) outstanding immediately after giving effect to the issuance of the applicable securities, both for purposes of Section 13(d) of the Exchange Act and for purposes of Section 270(5) under the Companies Law. The meeting of shareholders is scheduled to occur on November 12, 2026.
Current report
Exchange Agreements
Current report
On August 27, 2026, we entered into Exchange Agreements (each an “Exchange Agreement”) with three investors, including two of our directors (the “2020 Noteholders”). Each of the 2020 Noteholders had previously purchased a promissory note from Quoin Pharmaceuticals, Inc. (“Quoin Inc.”) dated October 2, 2020 (each a “2020 Note” and collectively, the “2020 Notes”). In connection with the merger transaction (the “Merger”) of Quoin Inc. with Cellect Biotechnology Ltd., the outstanding principal and accrued but unpaid interest of the 2020 Notes was to automatically convert into Ordinary Shares. The accrued interest on the 2020 Notes was not accounted for at the Merger closing and therefore the Ordinary Shares issued to the 2020 Noteholders were under-allocated, resulting in accrued and unpaid interest of approximately $1,146,000 outstanding and owed to the 2020 Noteholders (the “Outstanding Debt”). Pursuant to the Exchange Agreements, we issued an aggregate of 222,574 ADSs in satisfaction of the Outstanding Debt.
Current report
ATM Offering
Current report
On November 4, 2026, the Company entered into a Sales Agreement (the “Sales Agreement”) with Leerink Partners, LLC, as sales agent (the “Sales Agent” or “Leerink Partners”), to sell Ordinary Shares represented by ADSs from time to time in an “at the market offering” program through Leerink Partners. The sales, if any, of ADSs made under the Sales Agreement will be made by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act, including sales made directly on the Nasdaq Capital Market (“Nasdaq”) or on any other existing trading market for the Company’s ADSs (the “ATM Offering”). The ADSs will be offered and sold pursuant to the Company’s effective Registration Statement on Form S-3 (File No. 333-299668) (the “Registration Statement”), which was originally filed with the Securities and Exchange Commission on October 28, 2026 and declared effective on November 4, 2026, a base prospectus, dated November 4, 2026, included as part of the Registration Statement, and a prospectus supplement, dated November 4, 2026, filed with the SEC pursuant to Rule 424(b)(5) under the Securities Act. The aggregate market value of the ADSs eligible for sale under the prospectus supplement is currently $11,000,000, which is based on the limitations of General Instruction I.B.6 of Form S-3.
Current report
Results of Operations – Nine months ended September 30, 2026 compared to the nine months ended September 30, 2025
Removed paragraphs (8)
Previous report
On January 20, 2026, we filed an application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA) for QRX003 for the treatment of Netherton Syndrome. The SFDA’s Breakthrough Medicine Designation program is designed to expedite the development, review, and potential availability of medicines that address serious or life-threatening conditions with high unmet medical need and which meet SFDA eligibility requirements. If granted, the designation will allow for accelerated regulatory review and could enable earlier patient access in Saudi Arabia.
Previous report
On January 27, 2026, we filed an application for Orphan Drug Designation (ODD) with the Japanese Ministry of Health, Labour and Welfare (MHLW) for QRX003 for the treatment of Netherton Syndrome. The MHLW’s Orphan Drug Designation program provides orphan status to therapies intended for the treatment, diagnosis, or prevention of rare diseases that affect fewer than 50,000 people in Japan. This designation provides certain benefits, including R&D subsidies, tax credits for qualified clinical testing, reduction of MHLW application fees, priority review and ten years of market exclusivity. On June 4, 2026, Japan’s MHLW granted the ODD designation to QRX003 for the treatment of Netherton Syndrome.
Previous report
On March 11, 2026, the FDA granted Fast Track Designations to QRX003 lotion (4%) for the treatment of Netherton Syndrome
Previous report
On March 25, 2026, we provided a clinical and regulatory update from our constructive Type C meeting with U.S. FDA for QRX003 in NS (the “March Type C Meeting Minutes”) and reported that the FDA indicated that a single Phase 3 study may be sufficient to support marketing approval in the US and expressed openness to an alternate study design for Phase 3 that would likely not include a traditional upfront vehicle or placebo control.
Previous report
On April 28, 2026, we provided a clinical and regulatory update for our QRX009 topical rapamycin development program announcing the planned initiation of an investigator-led clinical study in Pachyonychia Congenita led by Professor Edel O’Toole, Queen Mary University of London as well as additional investigator-led studies in Gorlin Syndrome and Tuberous Sclerosis Complex. In addition, we announced that we were targeting to submit an IND to the FDA for an additional indication in the third quarter of 2026.
Previous report
On June 16, 2026, we provided a clinical update from our ongoing pediatric Netherton Syndrome compassionate use program. Four of six patients participating in the program were classified as “improved” or “significantly improved” from baseline assessment across key clinical endpoints. All six patients are under 10 years of age, the youngest being 6 months old and treatment duration at the time of release ranged from 3 weeks to 15 months. Furthermore, no treatment-related adverse events were reported for all six patients.
Previous report
On June 23, 2026, we received conditional FDA approval of QYLEKI as the proposed brand name for QRX003 for Netherton Syndrome.
Previous report
Results of Operations – Six months ended June 30, 2026 compared to the six months ended June 30, 2025
Reworded paragraphs (23)
Previous wording
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. QRX003 is entering pivotal registrational clinical testing under an open IND application with the FDA. We have opened six clinical sites in the U.S. along with international sites that are being opened in the UK, Spain, France and the Netherlands. QRX003 is currently being tested in eight pediatric NS patients in a Compassionate Use program in Ireland, Austria, the Netherlands and New Zealand and an additional 3 pediatric patients are expected to be enrolled this year. QRX003 is also being developed as a potential treatment for Peeling Skin Syndrome. We submitted an IND application for QRX003 in Peeling Skin Syndrome in the second quarter of 2026, which was cleared by the FDA on July 9, 2026 and plan to initiate a Phase 2/3 study in the second half of 2026. We have also entered into 9 commercial partnerships for QRX003 spanning 61 countries outside of our core commercial territories of the U.S., Western Europe and Japan. These partnership countries include Canada, Australia, New Zealand, the Middle East, China, Taiwan, Hong Kong, Singapore, Israel, Central and Eastern Europe, Turkey as well as several countries in Latin America. We entered into a Research Agreement with QUT, under which we have obtained an option for a global license to QRX008 for the potential treatment of scleroderma, as well as a Research Agreement with UCC for the development of novel topical formulations of rapamycin (sirolimus), QRX009, as potential treatments for a number of rare and orphan diseases for which there are either limited or no approved therapies or cures, including Pachyonychia Congenita, Gorlin Syndrome, Tuberous Sclerosis Complex, microcystic lymphatic malformations, venous malformations and angiofibromas, as well as other indications that the Company is assessing. We are planning to initiate investigator-led clinical studies in Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex.
Current wording
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 for NS under an open Investigational New Drug (“IND”) application with the United States (“U.S.”) Food & Drug Administration (“FDA”). We have opened six clinical sites in the U.S. and three in the United Kingdom (“U.K”)., along with international sites that we may potentially open in Spain, France and the Netherlands. QRX003 is currently being tested in eight pediatric NS patients in an ongoing Compassionate Use program in Ireland, Austria, the Netherlands and New Zealand, and an additional three pediatric patients are expected to be enrolled this year. QRX003 is also being developed as a potential treatment for Peeling Skin Syndrome (“PSS”). We submitted an IND application for QRX003 in PSS in the second quarter of 2026, which was cleared by the FDA on July 9, 2026, and we plan to initiate a Phase 2/3 study by the end of 2026. QRX003 has received multiple regulatory designations, including Rare Pediatric Disease Designation in the U.S. for both NS and PSS, Orphan Drug Designation for NS in the U.S., Europe and Japan, as well as Orphan Drug Designation in Europe for PSS. Additionally, QRX003 has also been granted Fast Track Designation in the U.S. for both NS and PSS. We have also entered into nine commercial partnerships for QRX003 spanning 61 countries outside of our core commercial territories of the U.S., Western Europe and Japan. These partnership countries include Canada, Australia, New Zealand, the Middle East, China, Taiwan, Hong Kong, Singapore, Israel, Central and Eastern Europe and Turkey, as well as several countries in Latin America. We entered into a Research Agreement with Queensland University of Technology (“QUT”), under which we have obtained an option for a global license to QRX008 for the potential treatment of scleroderma, as well as a Research Agreement with University College Cork (“UCC”) for the development of novel topical formulations of rapamycin (sirolimus), QRX009, as potential treatments for a number of rare and orphan diseases for which there are either limited or no approved therapies or cures, including Pachyonychia Congenita, Gorlin Syndrome, Tuberous Sclerosis Complex, microcystic lymphatic malformations, venous malformations and angiofibromas, as well as other indications that we are assessing. We are planning to initiate investigator-led clinical studies in Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex.
Previous wording
To date, no products have been commercialized and no revenue has been generated. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain marketing approval for one or more of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. We will need to obtain further funding through public or private offerings of our capital stock, debt financing, pursuant to the exercise of warrants issued to investors in our prior public and private offerings, collaboration, strategic and/or licensing arrangements or other sources in order to complete the research and development of our product candidates and to fund our other operating requirements. However, we may be unable to raise
Current wording
To date, no products have been commercialized and no revenue has been generated. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain marketing approval for one or more of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. We will need to obtain further funding through public or private offerings of our capital stock, debt financing, pursuant to the exercise of warrants issued to investors in our prior public and private offerings, collaboration, strategic and/or licensing arrangements or other sources in order to complete the research and development of our product candidates and to fund our other operating requirements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. In addition, any exercise of our outstanding warrants is at the discretion of the warrant holders and is dependent, in part, upon the market price of our ADSs. There can be no assurance that any of our outstanding warrants will ever be in-the-money prior to their expiration and, as such, our outstanding warrants may expire without being exercised. Our failure to obtain additional funding or enter into such other arrangements as and when needed would have a negative impact on our financial condition and our ability to continue our operations. See “Liquidity and Capital Resources”.
Previous wording
On June 2, 2026, we submitted our IND application for QRX003 in Peeling Skin Syndrome to the FDA and IND clearance to initiate a Phase 2 study of QRX003 in Peeling Skin Syndrome was received from the FDA on July 9, 2026.
Current wording
On June 2, 2026, we submitted our IND application for QRX003 in PSS to the FDA and IND clearance to initiate a Phase 2/3 study of QRX003 in PSS was received from the FDA on July 9, 2026.
Previous wording
General and administrative expenses were approximately $1,846,000 and $1,743,000, in the three months ended June 30, 2026 and 2025, respectively, representing an increase of $103,000, or approximately 5.9%. The increase was primarily due to an increase of $16,000 in commercial expenses, $32,000 in payroll and benefits, $64,000 in consulting costs, $50,000 in legal and professional fees and $17,000 in non-cash stock-based compensation expense offset by a decrease of $58,000 in board of director fees as a result of the grant of options in lieu of cash compensation for which the expense is recognized over the vesting period of the options, $10,000 in costs associated with being a public company.
Current wording
General and administrative expenses were approximately $2,267,000 and $1,739,000, in the three months ended September 30, 2026 and 2025, respectively, representing an increase of $528,000, or approximately 30.4%. The increase was primarily due to an increase of $305,000 in non-cash stock-based compensation expense, $263,000 in consulting costs, $115,000 in board of director fees (related to the accounting for the election by certain board members to receive stock options in lieu of cash compensation), $63,000 in recruitment costs and $42,000 in marketing and IT/website costs offset by a decrease of $102,000 in costs associated with being a public company, $88,000 in legal and professional fees, $41,000 in payroll and benefits and $31,000 in insurance costs.
Previous wording
Our research and development expenses during the three months ended June 30, 2026 and 2025 were approximately $3,627,000 and $2,051,000, respectively, representing an increase of $1,576,000, or approximately 76.8%. The increase was primarily due to $1,045,000 in increased external expenditures on our development programs, including work related to the clinical studies for the development of QRX003 and QRX009, an increase of payroll and benefits of $337,000 and $194,000 of non-cash stock-based compensation expense.
Current wording
Our research and development expenses during the three months ended September 30, 2026 and 2025 were approximately $2,656,000 and $2,281,000, respectively, representing an increase of $374,000, or approximately 16.4%. The increase was primarily due to an increase of payroll and benefits of $331,000, $85,000 in increased external expenditures on our development programs, including work related to the clinical studies for the development of QRX003 and QRX009 offset by a decrease of $38,000 in internal allocation of travel costs to our research and development programs and $3,000 of non-cash stock-based compensation expense.
Previous wording
We had approximately $2,000 in unrealized gain and $101,000 in realized and accrued interest income in the three months ended June 30, 2026 from our cash and cash equivalents and investments in marketable debt securities. We had approximately $6,000 in unrealized loss and $103,000 in realized and accrued interest income in the three months ended June 30, 2025 from our cash and cash equivalents and investments in marketable debt securities.
Current wording
We had approximately $125,000 in realized and accrued interest income and $73,000 in unrealized loss in the three months ended September 30, 2026 from our cash and cash equivalents and investments in marketable debt securities. We had approximately $62,000 in realized and accrued interest income and $9,000 in unrealized gain in the three months ended September 30, 2025 from our cash and cash equivalents and investments in marketable debt securities.
Previous wording
The following table sets forth our results of operations for the six months ended June 30, 2026, compared to the six months ended June 30, 2025:
Current wording
The following table sets forth our results of operations for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025:
Previous wording
General and administrative expenses were approximately $3,544,000 and $3,326,000, in the six months ended June 30, 2026 and 2025, respectively, representing an increase of $218,000, or approximately 6.6%. The increase was primarily due to an increase of $88,000 in commercial expenses, $102,000, in payroll and benefits, $38,000 in legal and professional fees and $132,000 in consulting costs offset by a decrease of $115,000 in board of director fees as a result of the grant of options in lieu of cash compensation for which the expense is recognized over the vesting period of the options, $11,000 in travel costs and $13,000 in insurance costs.
Current wording
General and administrative expenses were approximately $5,811,000 and $5,064,000, in the nine months ended September 30, 2026 and 2025, respectively, representing an increase of $747,000, or approximately 14.7%. The increase was primarily due to an increase of $305,000 in non-cash stock-based compensation expense, $268,000 in recruitment cost, $159,000 in consulting costs, $88,000 in commercial expenses, $81,000 in marketing and IT/website costs and $64,000 in payroll and benefits, offset by a decrease of $142,000 in legal and professional fees, $44,000 in insurance costs, $20,000 in travel costs and $14,000 in costs associated with being a public company.
Previous wording
Our research and development expenses during the six months ended June 30, 2026 and 2025 were approximately $7,061,000 and $4,425,000, respectively, representing an increase of $2,636,000, or approximately 59.6%. The increase was primarily due to $1,852,000 in increased external expenditures on our development programs, including work related to the clinical studies for the development of QRX003 and QRX009, an increase of payroll and benefits of $489,000 and $296,000 of non-cash stock-based compensation expense.
Current wording
Our research and development expenses during the nine months ended September 30, 2026 and 2025 were approximately $9,717,000 and $6,706,000, respectively, representing an increase of $3,011,000, or approximately 44.9%. The increase was primarily due to $1,710,000 in increased external expenditures on our development programs, including work related to the clinical studies for the development of QRX003 and QRX009, an increase of payroll and benefits of $1,098,000 and $292,000 of non-cash stock-based compensation expense, offset by a decrease of $88,000 in internal allocation of travel costs to our research and development programs.
Previous wording
We amortize licensed or acquired intellectual property over its expected useful life, included in research and development expenses set out above. Amortization of intangible assets was approximately $50,000 and $50,000 in each of the six month periods ended June 30, 2026 and 2025.
Current wording
We amortize licensed or acquired intellectual property over its expected useful life, included in research and development expenses set out above. Amortization of intangible assets was approximately $75,000 and $75,000 in each of the nine month periods ended September 30, 2026 and 2025.
Previous wording
We had approximately $12,000 in unrealized loss and $248,000 in realized and accrued interest income in the six months ended June 30, 2026 from our cash and cash equivalents and investments in marketable debt securities. We had approximately $6,000 in unrealized loss and $248,000 in realized and accrued interest income in the six months ended June 30, 2025 from our cash and cash equivalents and investments in marketable debt securities.
Current wording
We had approximately $373,000 in realized and accrued interest income, $85,000 in unrealized loss and in the nine months ended September 30, 2026 from our cash and cash equivalents and investments in marketable debt securities. We had approximately $310,000 in realized and accrued interest income and $4,000 in unrealized gain and in the nine months ended September 30, 2025 from our cash and cash equivalents and investments in marketable debt securities.
Previous wording
We have incurred net losses every year since inception and had an accumulated deficit of approximately $81.3 million at June 30, 2026. We have a limited operating history and have historically funded our operations through our founders’ funding expenditures and debt and equity financings. We incurred net losses of approximately $10.4 million and negative cash flows from operations of $8.0 million for the six months ended June 30, 2026. At June 30, 2026, we had cash and cash equivalent balances totaling $3.8 million and investments of $7.0 million. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of planned clinical trials and our expenditures on other research and development activities. Based upon our current business plans and cash, cash equivalents and investments on hand, we have concluded that there is substantial doubt about our ability to continue as a going concern for a period of at least one year from the date of the filing of this Quarterly Report on Form 10-Q. In order to address our capital needs, we intend to consider multiple alternatives, including, but not limited to, the sale of additional equity or debt securities or other debt instruments, collaborative, strategic and/or licensing relationships or grants to support our future operations. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain marketing approval for one or more of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. In addition, any exercise of our outstanding warrants is at the discretion of the warrant holders and is dependent, in part, upon the market price of our ADSs. There can be no assurance that any of our outstanding warrants will ever be in-the-money prior to their expiration and, as such, our outstanding warrants may expire without being exercised. If we are unable to improve our liquidity position, we may not be able to continue as a going concern. We continue to seek sources of financing to fund our continued operations and research and development programs. If we are unable to obtain additional funding when it becomes necessary, the development of our product candidates will be impacted and we would likely be forced to delay, reduce, or terminate some or all of our development programs or cease operations altogether, all of which could have a material adverse effect on our business, results of operations and financial condition.
Current wording
We have incurred net losses every year since inception and had an accumulated deficit of approximately $86.2 million at September 30, 2026. We have a limited operating history and have historically funded our operations through our founders’ funding expenditures and debt and equity financings. We incurred net losses of approximately $15.2 million and negative cash flows from operations of $13.8 million for the nine months ended September 30, 2026. At September 30, 2026, we had cash and cash equivalent balances totaling $10.1 million and investments of $23.1 million having taken into consideration net proceeds of approximately $28 million from the August 2026 Private Placement. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of planned clinical trials and our expenditures on other research and development activities. Based upon our current business plans and cash, cash equivalents and investments on hand, we have determined that we have sufficient resources to effect our business plan for a period of at least one year from the date of the filing of this Quarterly Report on Form 10-Q. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain marketing approval for one or more of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. Additional financing will be required to fund our other operating requirements until we reach commercial profitability, if ever. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. In addition, any exercise of our outstanding warrants is at the discretion of the warrant holders and is dependent, in part, upon the market price of our ADSs. There can be no assurance that any of our outstanding warrants will ever be in-the-money prior to their expiration and, as such, our outstanding warrants may expire without being exercised. If we are unable to obtain additional funding when it becomes necessary, the development of our product candidates will be impacted and we would likely be forced to delay, reduce, or terminate some or all of our development programs or cease operations altogether, all of which could have a material adverse effect on our business, results of operations and financial condition.
Previous wording
Adequate additional funding may not be available to us on acceptable terms, or at all. In addition, the right of participation in certain subsequent financings, which was granted to the purchasers in our October 2025 private placement, may limit our ability to raise capital. If we are unable to raise capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of QRX003 and QRX009, any future product candidate, or potentially discontinue operations.
Current wording
Adequate additional funding may not be available to us on acceptable terms, or at all. If we are unable to raise capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of QRX003 and QRX009, any future product candidate, or potentially discontinue operations.
Previous wording
As of June 30, 2026, we had approximately $10,800,000 in cash and cash equivalents and investments in marketable securities. The table below presents our cash flows for the six month periods ended June 30, 2026 and 2025:
Current wording
As of September 30, 2026, we had approximately $33,184,000 in cash and cash equivalents and investments in marketable securities. The table below presents our cash flows for the nine month periods ended September 30, 2026 and 2025:
Previous wording
Net cash used in operating activities was approximately $8,013,000 and $6,281,000 in the six months ended June 30, 2026 and 2025, respectively. The increase in 2026 was mostly due to an increase in net loss, offset by an increase in stock-based compensation, and an increase in accounts payable and accrued expenses.
Current wording
Net cash used in operating activities was approximately $13,783,000 and $8,506,000 in the nine months ended September 30, 2026 and 2025, respectively. The increase in 2026 was mostly due to an increase in net loss, offset by an increase in stock-based compensation.
Previous wording
Net cash provided by investment activities was approximately $8,137,000 and $4,453,000 in the six months ended June 30, 2026 and 2025, respectively. The cash provided in investing activities for the six months ended June 30, 2026 consisted of net sales of US Treasury Bills and Notes. The cash provided in investing activities for the six months ended June 30, 2025 consisted of net sales of US Treasury Bills and Notes.
Current wording
Net cash used in investment activities was approximately $7,953,000 in the nine months ended September 30, 2026 and net cash provided by investment activities was approximately $6,991,000 in the nine months ended 2025, respectively. The cash used in investing activities for the nine months ended September 30, 2026 consisted of the purchase of U.S. Treasury Bills and Notes partially offset by the net sales and redemptions of U.S. Treasury Bills and Notes. The cash provided by investing activities for the nine months ended September 30, 2025 consisted of net sales and redemptions of U.S. Treasury Bills and Notes.
Previous wording
Net cash used in financing activities was approximately $96,000 for the six months ended June 30, 2026, which included the repayments of amounts due to officers of $300,000, partially offset by the receipt of approximately $204,000 in net proceeds from the exercise of warrants. Net cash used by financing activities was approximately $127,000 for the six months ended June 30, 2025, which included the repayments of amounts due to officers of $300,000, partially offset by the receipt of approximately $173,000 in net proceeds from the exercise of warrants.
Current wording
Net cash provided by financing activities was approximately $28,015,000 for the nine months ended September 30, 2026, which included the proceeds from the sale of equity securities of $28,261,000 and the receipt of approximately $204,000 in net proceeds from the exercise of warrants, partially offset by repayments of amounts due to officers of $450,000. Net cash used in financing activities was approximately $277,000 for the nine months ended September 30, 2025, which included the repayments of amounts due to officers of $450,000, partially offset by the receipt of approximately $173,000 in net proceeds from the exercise of warrants.
Previous wording
In October 2019, we, through our subsidiary Quoin Inc., entered into the Licensing Agreement with Skinvisible, under which Skinvisible granted us an exclusive royalty-bearing license relating to the production and manufacture of prescription drug products related to certain patents held by Skinvisible, including those related to QRX003 and QRX004. We made Skinvisible a one-time non-refundable, non-creditable license fee of $1 million (the “License Fee”). In addition, we agreed to pay Skinvisible a single digit royalty percentage of our net sales revenues for any licensed product covered by the patent rights licensed under the License Agreement. We also agreed to pay Skinvisible 25% of any revenues we receive as royalties in the event that we sublicense any licensed products to a third party. The License Agreement also requires that we make a $5 million payment to Skinvisible upon receiving approval in the U.S. or European Union, whichever occurs first, for the first drug product developed using intellectual property licensed thereunder.
Current wording
In October 2019, we, through our subsidiary Quoin Inc., entered into the Exclusive Licensing Agreement (as amended from time to time, the “License Agreement”) with Skinvisible, under which Skinvisible granted us an exclusive royalty-bearing license relating to the production and manufacture of prescription drug products related to certain patents held by Skinvisible, including those related to QRX003 and QRX004. We made Skinvisible a one-time non-refundable, non-creditable license fee of $1 million (the “License Fee”). In addition, we agreed to pay Skinvisible a single digit royalty percentage of our net sales revenues for any licensed product covered by the patent rights licensed under the License Agreement. We also agreed to pay Skinvisible 25% of any revenues we receive as royalties in the event that we sublicense any licensed products to a third party. The License Agreement also requires that we make a $5 million payment to Skinvisible upon receiving approval in the U.S. or European Union, whichever occurs first, for the first drug product developed using intellectual property licensed thereunder.
Previous wording
In November 2020, we, through our subsidiary Quoin Inc., entered into a Master Service Agreement with Therapeutics Inc. for the management of the pre-clinical and clinical development of QRX003 for Netherton Syndrome. The initial term of the agreement was three years with automatic one-year extensions, and the agreement required the execution of individual work orders. We may terminate any work order for any reason with 90 days written notice subject to costs incurred through termination and a defined termination fee, unless there is a material breach by Therapeutics Inc. A work order was entered into in June 2022 for the first QRX003 clinical study at an expected estimated cost of approximately $4.4 million through 2024. An additional change order was entered into in December 2022 for a second QRX003 clinical study at an expected estimated cost of approximately $830,000. An amended and restated change order for the two studies was entered into in December 2024 at an estimated total remaining cost from August 2024 of approximately $3.6 million for the two studies combined. A further amended and restated change order for the additional studies initiated and planned for 2026 was entered into in July 2026 for an expected costs of approximately $3 million. For the three and six months ended June 30, 2026 and 2025, we incurred research and development expenses under these agreements of approximately $303,000 and $1.4 million and $348,000 and $759,000 respectively. During the three months ended June 30, 2026, the Company received a credit of approximately $377,000 applied to prior expenses incurred during the period of November 2025 to March 2026.
Current wording
In November 2020, we, through our subsidiary Quoin Inc., entered into a Master Service Agreement with Therapeutics Inc. for the management of the pre-clinical and clinical development of QRX003 for Netherton Syndrome. The initial term of the agreement was three years with automatic one-year extensions, and the agreement required the execution of individual work orders. We may terminate any work order for any reason with 90 days written notice subject to costs incurred through termination and a defined termination fee, unless there is a material breach by Therapeutics Inc. A work order was entered into in June 2022 for the first QRX003 clinical study at an expected estimated cost of approximately $4.4 million through 2024. An additional change order was entered into in December 2022 for a second QRX003 clinical study at an expected estimated cost of approximately $830,000. An amended and restated change order for the two studies was entered into in December 2024 at an estimated total remaining cost from August 2024 of approximately $3.6 million for the two studies combined. A further amended and restated change order for the additional studies initiated and planned for 2026 was entered into in July 2026 for expected costs of approximately $3 million. For the three and nine months ended September 30, 2026 and 2025, we incurred research and development expenses under these agreements of approximately $523,000 and $1,940,000 (inclusive of a credit of approximately $377,000 received in June 2026) and $522,000 and $1,281,000 respectively.
Previous wording
In November 2021, we entered into a research agreement with Queensland University of Technology (QUT) for a pre-clinical research program for the development of a product to treat Netherton Syndrome of approximately $250,000. In May 2022, we entered into a second research agreement with QUT for the development of a product to treat Scleroderma of approximately $610,000. Each agreement remains in place until the completion of the research program, which in each case was initially anticipated to be 18 months from execution. For the three and six months ended June 30, 2026 and 2025, we incurred no research and development costs related to these agreements. In July 2025 we announced that, in light of the expected near-term completion of the QRX003 clinical program for Netherton Syndrome, we have discontinued the Netherton Syndrome research program with QUT. We are planning to schedule a meeting with QUT to discuss the future direction of the Scleroderma research program.
Current wording
In November 2021, we entered into a research agreement with Queensland University of Technology (QUT) for a pre-clinical research program for the development of a product to treat Netherton Syndrome of approximately $250,000. In May 2022, we entered into a second research agreement with QUT for the development of a product to treat Scleroderma of approximately $610,000. Each agreement remains in place until the completion of the research program, which in each case was initially anticipated to be 18 months from execution. For the three and nine months ended September 30, 2026 and 2025, we incurred no research and development costs related to these agreements. In July 2025 we announced that, in light of the expected near-term completion of the QRX003 clinical program for Netherton Syndrome, we have discontinued the Netherton Syndrome research program with QUT. We are planning to schedule a meeting with QUT to discuss the future direction of the Scleroderma research program.
Previous wording
On June 10, 2024, we entered into a research agreement with The School of Pharmacy at UCC. The scope of the agreement encompasses the development of novel topical formulations of Rapamycin (sirolimus) as potential treatments for a number of rare and orphan diseases for which there are currently very limited or no approved therapies or cures. Under the terms of the agreement, based on the achievement of certain milestones, we will fund up to approximately €567,000 ($655,000) plus VAT over an anticipated 2-1/2 year period to support the UCC research program to investigate the development of a number of topical rapamycin formulations for future development as potential treatments for several rare and orphan diseases. Following completion of the research program, we will have the option to advance the clinical development of rapamycin formulations developed by UCC. Work on this research project commenced in December 2024. For the three and six months ended June 30, 2026 and 2025, we incurred research and development expenses under these agreements of approximately $0 and $0 and $60,000 and $120,000 respectively.
Current wording
On June 10, 2024, we entered into a research agreement with The School of Pharmacy at UCC. The scope of the agreement encompasses the development of novel topical formulations of Rapamycin (sirolimus) as potential treatments for a number of rare and orphan diseases for which there are currently very limited or no approved therapies or cures. Under the terms of the agreement, based on the achievement of certain milestones, we will fund up to approximately €567,000 ($655,000) plus VAT over an anticipated 2-1/2 year period to support the UCC research program to investigate the development of a number of topical rapamycin formulations for future development as potential treatments for several rare and orphan diseases. Following completion of the research program, we will have the option to advance the clinical development of rapamycin formulations developed by UCC. Work on this research project commenced in December 2024. For the three and nine months ended September 30, 2026 and 2025, we incurred research and development expenses under these agreements of approximately $0 and $0 and $48,000 and $168,000 respectively.
Previous wording
In February 2026, we, through our subsidiary Quoin Inc., signed a research agreement with Evestia Clinical Limited for the management of the UK and European clinical development of QRX003 for Netherton Syndrome. The initial term of the agreement is five years and the agreement requires the execution of individual work orders. We may terminate any work order for any reason with 30 days written notice subject to costs incurred through termination and a defined termination fee, unless there is a material breach by Evestia Clinical Limited. A work order was entered into in March 2026 for the first QRX003 UK and European clinical study at an expected estimated cost of approximately $800,000. For the three and six months ended June 30, 2026, we incurred research and development expenses under this agreement of approximately $280,000 and $344,000 respectively.
Current wording
In February 2026, we, through our subsidiary Quoin Inc., signed a research agreement with Evestia Clinical Limited for the management of the U.K. and European clinical development of QRX003 for Netherton Syndrome. The initial term of the agreement is five years and the agreement requires the execution of individual work orders. We may terminate any work order for any reason with 30 days written notice subject to costs incurred through termination and a defined termination fee, unless there is a material breach by Evestia Clinical Limited. A work order was entered into in March 2026 for the first QRX003 U.K. and European clinical study and extended in September 2026 at an expected estimated cost of approximately $4.4 million. For the three and nine months ended September 30, 2026, we incurred research and development expenses under this agreement of approximately $467,000 and $811,000 respectively.
Previous wording
In April 2026, we, through our subsidiary Quoin Inc., signed a research agreement with Sapro Consulting Pty Limited for the management of a pharmacokinetic study of QRX009. We may terminate the agreement for any reason with 30 days written notice subject to costs incurred through termination unless there is a material breach by Sapro Consulting Pty Limited. The agreement covers an expected estimated cost of approximately AUD$1.8 million ($1.3 million). For the three and six months ended June 30, 2026, we incurred research and development expenses under this agreement of approximately $91,000 respectively.
Current wording
In April 2026, we, through our subsidiary Quoin Inc., signed a research agreement with Sapro Consulting Pty Limited for the management of a pharmacokinetic study of QRX009. We may terminate the agreement for any reason with 30 days written notice subject to costs incurred through termination unless there is a material breach by Sapro Consulting Pty Limited. The agreement covers an expected estimated cost of approximately AUD$1.8 million ($1.3 million). For the three and nine months ended September 30, 2026, we incurred research and development expenses under this agreement of approximately $1,000 and $92,000 respectively.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
additional funds or enter into such other arrangements when needed on favorable terms or at all. In addition, any exercise of our outstanding warrants is at the discretion of the warrant holders and is dependent, in part, upon the market price of our ADSs. There can be no assurance that any of our outstanding warrants will ever be in-the-money prior to their expiration and, as such, our outstanding warrants may expire without being exercised. Our failure to obtain additional funding or enter into such other arrangements as and when needed would have a negative impact on our financial condition and our ability to continue our operations. See “Liquidity and Capital Resources”.