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Quoin Pharmaceuticals, Ltd.

For the period ended Mar 31, 2026. Filed May 7, 2026.

View on SEC.gov

About 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.

Mar 31, 2026 · Filed May 7, 2026

QNRX$3.65-5.2%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-09-30; filed 2025-11-06.

0001104659-25-107785

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-03-31; filed 2026-05-07.

0001104659-26-056941

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 67 previous paragraphs and 58 current paragraphs.

23 unchanged; 23 reworded; 11 added; 18 removed; 3 previous and 1 current paragraphs rearranged.

Tables are not compared: 34 previous and 37 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 (11)

Current report

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”.

Current report

On January 20, 2026, the Company 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.

Current report

On March 11, 2026, the FDA granted Fast Track Designations to QRX003 lotion (4%) for the treatment of Netherton Syndrome

Current report

On March 25, 2026, the Company provided a clinical and regulatory update from its 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.

Current report

On April 28, 2026, the Company provided a clinical and regulatory update for its 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, the Company is targeting to submit an IND to the FDA for an additional indication in Q3, 2026.
Removed paragraphs (18)

Previous report

On August 21, 2025, at our 2025 Annual General Meeting of Shareholders (the “Annual Meeting”), our shareholders approved an amendment to our Amended and Restated Articles of Association, as amended to increase our authorized Ordinary Share capital from 100,000,000 Ordinary Shares to 5,000,000,000 Ordinary Shares.

Previous report

At the Annual Meeting, our shareholders approved the Quoin Pharmaceuticals Ltd. 2025 Equity Incentive Plan (the “2025 Plan”) and authorized the issuance pursuant to the 2025 Plan of up to 3,000,000 Ordinary Shares, subject to an automatic annual increase equal to the smaller of (a) fifteen percent (15%) of the number of Ordinary Shares issued and outstanding on a fully diluted basis on the immediately preceding December 31, or (b) an amount determined by our Board of Directors.

Previous report

On October 10, 2025, we entered into a securities purchase agreement with several institutional and accredited investors relating to the issuance and sale in a private placement transaction (the “Private Placement”) of (i) ordinary shares represented by 15,152 American Depositary Shares (“ADSs”) and (ii) pre-funded warrants to purchase ordinary shares represented by 1,993,939 ADSs, together with (A) Series H Warrants to purchase ordinary shares represented by up to 2,009,091 ADSs, (B) Series I Warrants to purchase ordinary shares represented by up to 2,009,091 ADSs, (C) Series J Warrants to purchase ordinary shares represented by up to 2,009,091 ADSs, and (D) Series K Warrants to purchase ordinary shares represented by up to 2,009,091 ADSs. The Series H Warrants, Series I Warrants, Series J Warrants and Series K Warrants are collectively referred to herein as the “Ordinary Warrants.” The combined purchase price was $8.25 per each ADS and accompanying Ordinary Warrants and $8.2499 per each pre-funded warrant and accompanying Ordinary Warrants, which pricing was designed to be in accordance with the “Minimum Price” requirement as defined in the Nasdaq rules. The private placement closed on October 14, 2025 (the “Closing Date”). We received upfront net proceeds of approximately $15 million from the Private Placement, after deducting estimated offering expenses payable by us, including placement agent fees and expenses. We intend to use the upfront net proceeds from the Private Placement for general corporate purposes, which may include operating expenses, research and development, including completion of clinical development of QRX003 for Netherton Syndrome, working capital, future acquisitions and general capital expenditures. We may also receive up to an aggregate of $88 million of additional gross proceeds if the Ordinary Warrants are exercised in full for cash.

Previous report

Dennis Langer, one of our directors, participated in the Private Placement. Mr. Langer purchased ordinary shares represented by 15,152 ADSs and accompanying Ordinary Warrants for a total purchase price of approximately $128,641, at a combined purchase price of $8.49. In accordance with Nasdaq Rules, Mr. Langer’s purchase price was based upon the consolidated closing bid price from the trading day immediately preceding the date we entered into the securities purchase agreement, plus $0.50.

Previous report

Beneficial ownership limitation. A holder of the pre-funded warrants or the Ordinary Warrants issued in the October 2025 private placement 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.

Previous 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 (as described above) 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.

Previous report

Ordinary Warrants. The Ordinary Warrants are exercisable at any time after their original issuance, subject to the beneficial ownership limitation (as described above). The Series H Warrants have an exercise price of $9.075 per ADS and may be exercised until the earlier of (i) five (5) years from the Closing Date or (ii) 30 days after the public announcement that we have received Type C meeting minutes from the FDA indicating openness to baseline-controlled pivotal studies for QRX003 for the treatment of Netherton Syndrome. The Series I Warrants have an exercise price of $10.3125 per ADS and may be exercised as follows: (i) 50% of the Series I Warrants may be exercised until the earlier of (A) five (5) years from the Closing Date or (B) 30 days after the public announcement that the primary endpoint has been met in the monotherapy pivotal trial of QRX003 for the treatment of Netherton Syndrome, and (ii) 50% of the Series I Warrants may be exercised until the earlier of (A) five (5) years from the Closing Date or (B) 30 days after the public announcement that the primary endpoint has been met in the adjuvant pivotal trial of QRX003 for the treatment of Netherton Syndrome. The Series J Warrants have an exercise price of $12.375 per ADS and may be exercised until the earlier of (i) five (5) years from the Closing Date or (ii) 30 days after the public announcement of the receipt of either accelerated or traditional approval by the FDA of QRX003 for the treatment of Netherton Syndrome. The Series K Warrants have an exercise price of $12.375 per ADS and may be exercised until the earlier of (i) five (5) years from the Closing Date or (ii) 30 days after the public announcement of the sale of a Priority Review Voucher (PRV).

Previous report

December 2024 Warrants Exercise. On October 14, 2025 a further $3.3 million was received by the Company further to the exercise of certain warrants issued by the Company in December 2024.

Previous report

Our research and development expenses during the three months ended September 30, 2025 and 2024 were approximately $2,281,000 and $1,080,000, respectively, representing an increase of $1,202,000, or approximately 111%. The increase was primarily due to $1,174,000 in increased external expenditures on our development programs, as we advance our work related to the clinical studies for the development of QRX003 and a $27,000 increase in non-cash stock-based compensation expense allocated to research and development expenses.

Previous report

Results of Operations – Nine months ended September 30, 2025 compared to the nine months ended September 30, 2024

Previous report

General and administrative expenses were approximately $5,064,000 and $4,571,000, in the nine months ended September 30, 2025 and 2024, respectively, representing an increase of $493,000, or approximately 11%. The increase was primarily due to an increase of $144,000 in payroll and benefits due to severance costs, $243,000 in consulting costs, $225,000 in legal and professional fees, $154,000 in public company costs, $76,000 in marketing and website expenses, $52,000 in corporate Delaware tax costs and $14,000 in office supply expenses offset by decreases of $107,000 in board fees from board members being granted stock options in lieu of cash payments, $58,000 in travel costs, $68,000 in insurance costs, and non-cash stock-based compensation expense of $185,000 due to the reversal of unvested stock options from an employee reduction.
Reworded paragraphs (23)

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes thereto included in Part I-Item 1 of this Form 10-Q. This discussion and other parts of this report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions that are based on the beliefs of our management, as well as assumptions made by, and information currently available to, our management. Our actual results could differ materially from those discussed in these forward-looking statements. See “Cautionary Note Regarding Forward-Looking Statements” in this Form 10-Q.

Current wording

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes thereto included in Part I-Item 1 of this Form 10-Q and the audited financial statements and the other information set forth in the Annual Report on Form 10-K for the year ended December 31, 2025 that we filed with the SEC on March 26, 2026 (the “2025 Form 10-K”). This discussion and other parts of this report contain forward-looking statements that reflect our plans, estimates, beliefs and expectations that involve risks and uncertainties including, but not limited to, those set forth below under “Risk Factors” and elsewhere herein, and those identified under Part I, Item 1A of the 2025 Form 10-K. Our actual results and the timing of events could differ materially from those discussed in these forward-looking statements. See “Cautionary Note Regarding Forward-Looking Statements” in this Form 10-Q.

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 in clinical development as a potential treatment for Netherton Syndrome, a rare hereditary genetic disease. QRX003 is in two pivotal registrational clinical studies under an open IND application with the FDA. We have opened six clinical sites in the US . We have expanded our trials internationally in the Middle East, the United Kingdom and additional countries in Europe, including Spain and Germany. QRX003 is currently being tested in two pediatric NS patients at the Children’s Hospital in Dublin, Ireland and we are expanding this study to include additional children with NS in Austria and potentially in Spain, the United Kingdom and other countries. QRX003 is also being developed as a potential treatment for Peeling Skin Syndrome with the first subject being treated in New Zealand. We are planning to expand this study to include up to three additional pediatric subjects. In addition, we entered into a Research Agreement with the Queensland University of Technology, 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 for the development of novel topical formulations of Rapamycin (sirolimus) as potential treatments for a number of rare and orphan diseases for which there are either limited or no approved therapies or cures, including microcystic lymphatic malformations, venous malformations and angiofibroma’s. We have also entered into 9 commercial partnerships for QRX003 spanning 61 countries outside of its core commercial territories of the US, 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.

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, 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 six pediatric NS patients in investigator-initiated studies in Ireland, Austria, the Netherlands and New Zealand. QRX003 is also being developed as a potential treatment for Peeling Skin Syndrome with the first subject being treated in New Zealand. We are in the process of expanding this study to include up to an additional five pediatric subjects. 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 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 are targeting to submit an IND to the FDA for QRX009 for an additional indication in Q3 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.

Previous wording

Our mission is to develop and commercialize proprietary therapeutic drug products that treat rare and orphan diseases, particularly those where none currently exists. To achieve this, we plan to:

Current wording

Our mission is to develop and commercialize proprietary therapeutic drug products that treat rare and orphan diseases, particularly for those diseases where no approved treatment currently exists. To achieve this, we plan to:

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. Accordingly, we will need to raise additional capital prior to the commercialization of QRX003 or any other product candidate. Until such time, if ever, as we can generate substantial revenue from product sales, we expect to finance our operating activities through a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital 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”.

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

Previous wording

On October 21, 2025, we announced that the FDA has granted Orphan Drug Designation to QRX003, for the treatment of Netherton Syndrome. The designation follows previously granted Orphan Drug Designation by the European Medicines Agency (the “EMA”) in May 2025. The FDA’s Orphan Drug Designation program provides orphan status to therapies intended for the treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the United States. This designation provides certain benefits, including tax credits for qualified clinical testing, waiver or partial payment of FDA application fees and seven years of market exclusivity, if approved.

Current wording

On January 27, 2026, the Company 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, if approved.

Previous wording

Research and development activities will continue to be central to our business plan. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect our research and development expenses to be significant over the next several years as personnel and compensation costs increase and we conduct late-stage clinical studies and prepare to seek regulatory approval for QRX003 and any other future product candidate.

Current wording

Research and development activities will continue to be central to our business plan. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect our research and development expenses to be significant over the next several years as personnel and compensation costs increase and we conduct late-stage clinical studies and prepare to seek regulatory approval for QRX003, as we begin clinical studies for QRX009; and for any other future product candidate.

Previous wording

The duration, costs and timing of clinical trials of QRX003 and any other future product candidate will depend on a variety of factors that include, but are not limited to:

Current wording

The duration, costs and timing of clinical trials of QRX003, QRX009 and any other future product candidate will depend on a variety of factors that include, but are not limited to:

Previous wording

General and administrative expenses were approximately $1,739,000 and $1,448,000, in the three months ended September 30, 2025 and 2024, respectively, representing an increase of $290,000, or approximately 20%. The increase was primarily due to an increase of $379,000 in payroll and benefits due to severance costs, $68,000 in consulting costs, $87,000 in legal and professional fees, $52,000 in public company costs, $29,000 in marketing and website expenses, and $16,000 in office supply expenses offset by, decreases of $151,000 in board fees from board members being granted stock options in lieu of cash payments, $22,000 in travel costs, $14,000 in insurance costs, and non-cash stock-based compensation expense of $159,000 due to the reversal of unvested stock options from an employee reduction.

Current wording

General and administrative expenses were approximately $1,697,000 and $1,583,000, in the three months ended March 31, 2026 and 2025, respectively, representing an increase of $114,000, or approximately 7.2%. The increase was primarily due to an increase of $72,000 in commercial expenses, $71,000, in payroll and benefits, $50,000 in consulting costs and $40,000 in legal and professional fees, 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, $46,000 in public company costs and non-cash stock-based compensation expense of $17,000.

Previous wording

Our research and development expenses during the nine months ended September 30, 2025 and 2024 were approximately $6,706,000 and $2,552,000, respectively, representing an increase of $4,154,000, or approximately 163%. The increase was primarily due to $4,037,000 in increased external expenditures on our development programs, including work related to the clinical studies for the development of QRX003, a $115,000 increase in non-cash stock-based compensation expense allocated to research and development expenses.

Current wording

Our research and development expenses during the three months ended March 31, 2026 and 2025 were approximately $3,434,000 and $2,374,000, respectively, representing an increase of $1,060,000, or approximately 44.7%. The increase was primarily due to $767,000 in increased external expenditures on our development programs, including work related to the clinical studies for the development of QRX003, an increase of payroll and benefits of $192,000 and $101,000 of non-cash stock-based compensation expense.

Previous wording

We had approximately $9,000 in unrealized gain and $62,000 in realized gain and accrued interest income in the three months ended September 30, 2025 from our cash and cash equivalents and investments in marketable debt securities. We had approximately $32,000 in unrealized gain and $146,000 in realized gain and accrued interest income in the three months ended September 30, 2024 from our cash and cash equivalents and investments in marketable debt securities.

Current wording

We had approximately $133,000 in realized and accrued interest income in the three months ended March 31, 2026 from our cash and cash equivalents and investments in marketable debt securities. We had approximately $145,000 in realized and accrued interest income in the three months ended March 31, 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 $66.6 million at September 30, 2025. We have a limited operating history and have historically funded our operations through debt and equity financings. We incurred net losses of approximately $11.5 million and negative cash flows from operations of $8.5 million for the nine months ended September 30, 2025. At September 30, 2025, we had cash and cash equivalent balances totaling $1.8 million and investments of $3.6 million. In addition, on October 10, 2025, the Company entered into a Securities Purchase Agreement with several institutional and accredited investors for the issuance and sale in a private placement of securities for gross proceeds of approximately $16.6 million. On October 14, 2025 a further $3.3 million was received by the Company further to the exercise of certain warrants issued by the Company in December 2024. 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. After taking into account the net proceeds we received in connection with the Private Placement that closed on October 14, 2025, we have determined that we have sufficient resources to effect our business plan for at least one year from the issuance of the unaudited consolidated financial statements included in this report. 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 is subject to uncertainty. Additional financing may be required to fund our other operating requirements until we reach commercial profitability, if ever, which may not be available at acceptable terms, if at all.

Current wording

We have incurred net losses every year since inception and had an accumulated deficit of approximately $76.0 million at March 31, 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 $5.0 million and negative cash flows from operations of $4.9 million for the three months ended March 31, 2026. At March 31, 2026, we had cash and cash equivalent balances totaling $3.1 million and investments of $10.9 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.

Previous wording

We will need to obtain further funding through public or private offerings of our capital stock, debt financing, collaboration and licensing arrangements or other sources, the requirements for which will depend on many factors, including:

Current wording

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, the requirements for which will depend on many factors, including:

Previous 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, 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. In addition, restrictions under the purchase agreement from 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, any future product candidate, or potentially discontinue operations.

Previous wording

To the extent that we raise additional capital through the sale of our equity or convertible debt securities, and pursuant to the exercise of the warrants issued to the investors in our prior public offerings, the ownership interest of our equity holders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our equity holders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

Current wording

To the extent that we raise additional capital through the sale of our equity or convertible debt securities, and pursuant to the exercise of the warrants issued to the investors in our prior public and private offerings, the ownership interest of our equity holders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our equity holders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

Previous wording

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or proposed products, or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market any future product that we would otherwise prefer to develop and market ourselves.

Current wording

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or proposed products, or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market any future product that we would otherwise prefer to develop and market ourselves.

Previous wording

As of September 30, 2025, we had approximately $5,413,000 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, 2025 and 2024:

Current wording

As of March 31, 2026, we had approximately $14,043,000 in cash and cash equivalents and investments in marketable securities. The table below presents our cash flows for the three month periods ended March 31, 2026 and 2025:

Previous wording

Net cash used in operating activities was approximately $8,506,000 and $5,621,000 in the nine months ended September 30, 2025 and 2024, respectively. The increase in 2025 was primarily due to an increase in net loss, offset by an increase in accounts payable and accrued expenses and a decrease in prepaid expenses.

Current wording

Net cash used in operating activities was approximately $4,869,000 and $2,594,000 in the three months ended March 31, 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 a decrease in accounts payable and accrued expenses.

Previous wording

Investment activities provided net cash of $6,991,000 and $1,290,000 in the nine months ended September 30, 2025 and 2024, respectively. The cash provided in investing activities for the nine months ended September 30, 2025 consisted of net sales and redemptions of US Treasury Bills and Notes. The cash provided in investing activities for the nine months ended September 30, 2024 consisted of net purchases of short maturity US Treasury Bills and Notes from the proceeds of the March 2024 public offering.

Current wording

Net cash provided by investment activities was approximately $4,119,000 and $2,770,000 in the three months ended March 31, 2026 and 2025, respectively. The cash provided in investing activities for the three months ended March 31, 2026 consisted of net sales of US Treasury Bills and Notes. The cash provided in investing activities for the three months ended March 31, 2025 consisted of net sales of US Treasury Bills and Notes.

Previous wording

Net cash (used in) financing activities was approximately $277,000 for the nine months ended September 30, 2025. The net cash used in financing activities was due to 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. Net cash provided by financing activities was approximately $5,046,000 for the nine months ended September 30, 2024. The net cash provided increased due to the receipt of approximately $5.5 million in net proceeds from our March 2024 public offering partially offset by repayments of amounts due to officers of $450,000.

Current wording

Net cash provided by financing activities was approximately $56,000 for the three months ended March 31, 2026. The net cash provided increased due to the receipt of approximately $206,000 in net proceeds from the exercise of warrants, partially offset by repayments of amounts due to officers of $150,000. Net cash provided by financing activities was approximately $23,000 for the three months ended March 31, 2025. The net cash provided increased due to the receipt of approximately $173,000 in net proceeds from the exercise of warrants, partially offset by repayments of amounts due to officers of $150,000.

Previous wording

In October 2019, Quoin Inc. entered into the Exclusive Licensing Agreement (as amended from time to time, the “License Agreement”) with Skinvisible Pharmaceuticals, Inc. (“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, 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.

Previous wording

In November 2020, Quoin Inc. entered into a Master Service Agreement with Therapeutics Inc. for the management of the preclinical 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. Quoin Inc. 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. For the three and nine months ended September 30, 2025 and 2024, we incurred a research and development expense under these agreements of approximately $522,000 and $1,281,000 and $275,000 and $926,000 respectively.

Current wording

In November 2020, 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. Quoin Inc. 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 is in preparation between the Company and Therapeutics Inc as of the date of filing of this quarterly report on Form 10-Q. For the three months ended March 31, 2026 and 2025, we incurred research and development expenses under these agreements of approximately $1.1 million and $411,000 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 nine months ended September 30, 2025 and 2024, we did not incur any 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 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 months ended March 31, 2026 and 2025, we incurred de-minimis 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

In June 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 ($665,000) 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, 2025, we incurred a research and development expense under these agreements of approximately $48,000 and $168,000 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 months ended March 31, 2026 and 2025, we incurred research and development expenses under these agreements of approximately $0 and $60,000 respectively.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

In February 2026, we 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. Quoin Inc. 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 months ended March 31, 2026, we incurred research and development expenses under this agreement of approximately $64,000.
Rearranged previous paragraphs (3)

Previous report — wording carried elsewhere

The following table sets forth our results of operations for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024:

Previous report — wording carried elsewhere

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, 2025 and 2024.

Previous report — wording carried elsewhere

We had approximately $4,000 in unrealized gain and $310,000 in realized and accrued interest income in the nine months ended September 30, 2025 from our cash and cash equivalents and investments in marketable debt securities. We earned approximately $23,000 in unrealized gain and $449,000 in realized and accrued interest income in the nine months ended September 30, 2024 from our cash and cash equivalents and investments in marketable debt securities.