[PART I - FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements.) The unaudited statements show a widening net loss to $3.8 million and an accumulated deficit of $59.0 million, raising substantial doubt about its going concern status Condensed Consolidated Balance Sheets (USD) | | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $3,822,122 | $3,623,343 | | Total current assets | $12,496,819 | $14,926,004 | | Total assets | $12,955,153 | $15,709,338 | | **Liabilities and Equity** | | | | Total current liabilities | $4,855,611 | $4,180,932 | | Total liabilities | $7,029,344 | $6,504,665 | | Accumulated deficit | $(58,977,971) | $(55,165,792) | | Total shareholders' equity | $5,925,809 | $9,204,673 | Condensed Consolidated Statements of Operations (USD) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $2,374,139 | $885,298 | | Total operating expenses | $3,957,177 | $2,458,284 | | Net loss | $(3,812,179) | $(2,327,280) | | Loss per ADS (Basic & Diluted) | $(6.50) | $(38.73) | - The company is a late-stage clinical specialty pharmaceutical firm focused on rare diseases, with no commercialized products or revenue to date[22](index=22&type=chunk) - Management has concluded there is **substantial doubt about the company's ability to continue as a going concern** due to a history of net losses and negative cash flows[23](index=23&type=chunk)[25](index=25&type=chunk) - A **1-for-35 reverse ADS split** was executed on April 9, 2025, to regain Nasdaq minimum bid price compliance, with financial data retroactively adjusted[21](index=21&type=chunk)[32](index=32&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) R&D expenses rose 168.2% to $2.4 million, widening the net loss to $3.8 million and reinforcing substantial doubt about the company's going concern status - The company's strategy focuses on completing clinical testing for its lead product QRX003 and preparing for commercialization[78](index=78&type=chunk)[79](index=79&type=chunk) - **Research and development expenses increased by $1.5 million (168.2%)** in Q1 2025 compared to Q1 2024, primarily due to increased clinical study expenditures for QRX003[95](index=95&type=chunk) - Management reiterates **substantial doubt about its ability to continue as a going concern** and the need to raise additional capital for future operations[98](index=98&type=chunk)[99](index=99&type=chunk) Condensed Consolidated Statements of Cash Flows (USD) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,594,179) | $(1,434,372) | | Net cash provided (used) in investing activities | $2,770,000 | $(4,465,774) | | Net cash provided by financing activities | $22,958 | $5,332,472 | [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) The company is exempt from market risk disclosure requirements as a smaller reporting company - The company is a smaller reporting company as defined in Rule 12b-2 of the Exchange Act and is not required to provide the information otherwise required under this Item 3[114](index=114&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls - Based on an evaluation as of the end of the period, the CEO and CFO concluded that the company's **disclosure controls and procedures were effective** at the reasonable assurance level[115](index=115&type=chunk) - There were **no material changes** in the company's internal control over financial reporting during the quarter ended March 31, 2025[116](index=116&type=chunk) [PART II - OTHER INFORMATION](index=37&type=section&id=PART%20II-OTHER%20INFORMATION) [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings.) The company is not a party to any material legal proceedings - The company is currently not a party to any material legal or administrative proceedings and is not aware of any pending or threatened material proceedings against it[118](index=118&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors.) Key risks include potential Nasdaq delisting and the substantial doubt about its ability to continue as a going concern without additional capital - The company's failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a **delisting of its ADSs**[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) - The company must raise additional capital to continue as a going concern, given its **$59.0 million accumulated deficit** and limited cash[126](index=126&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) No unregistered sales of equity securities were reported during the period - None[127](index=127&type=chunk) [Defaults Upon Senior Securities](index=39&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) No defaults upon senior securities were reported - None[128](index=128&type=chunk) [Mine Safety Disclosures](index=39&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to the company - Not applicable[129](index=129&type=chunk) [Other Information](index=39&type=section&id=Item%205.%20Other%20Information.) No directors or executive officers adopted or terminated Rule 10b5-1 trading arrangements in Q1 2025 - During the first quarter of 2025, none of the company's directors or executive officers adopted or terminated any "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement"[130](index=130&type=chunk) [Exhibits](index=40&type=section&id=Item%206.%20Exhibits.) This section lists filed exhibits, including CEO/CFO certifications and financial data in Inline XBRL format - The exhibits filed with the report include CEO and CFO certifications and financial statements in Inline XBRL format[131](index=131&type=chunk)

Q1 2025 Corporate Highlights Continued Progress in Ongoing Late-Stage Netherton Syndrome Studies Announced Positive Clinical Data for Adult and Pediatric Netherton Patients Provided Clear Visual Evidence of QRX003 Mechanism of Action Patent Portfolio Expanded to Support Pipeline Growth Launch of NETHERTON NOW Advocacy Initiative ASHBURN, Va., May 13, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin"), a late clinical-stage, specialty pharmaceutical company focused ...

Investor Relations About Quoin Pharmaceuticals Ltd. Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin's innovative pipeline comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, inclu ...

Core Insights - Quoin Pharmaceuticals has released the second episode of its "Living with Netherton" video series, featuring the story of 79-year-old Norma Coles, who was diagnosed with Netherton Syndrome decades after her initial evaluation [1][2] - The campaign aims to raise awareness and support for individuals affected by Netherton Syndrome, highlighting the challenges faced by patients, including misdiagnosis and lack of treatment options [2][4] - Quoin's lead product candidate, QRX003, is currently undergoing clinical trials, with the goal of becoming the first FDA-approved treatment for Netherton Syndrome [5][6] Company Overview - Quoin Pharmaceuticals is a late clinical-stage specialty pharmaceutical company focused on developing treatments for rare and orphan diseases [1][7] - The company has a pipeline that includes four products targeting various rare conditions, including Netherton Syndrome, Peeling Skin Syndrome, and others [7] - Quoin is committed to addressing unmet medical needs and improving the quality of life for patients and their families [7] Product Development - QRX003 is a topical lotion designed to address the skin barrier issues associated with Netherton Syndrome by promoting a normalized skin-shedding process [6] - Initial data from ongoing clinical trials of QRX003 show promising results, including improvements in skin healing and reductions in inflammation and pruritus [5] - The company aims to complete the development of QRX003 to provide a transformative treatment option for patients who have long awaited effective therapies [5][6]

Core Insights - Quoin Pharmaceuticals has released the second episode of its "Living with Netherton" video series, featuring a 79-year-old patient, Norma Coles, who has lived with Netherton Syndrome for decades, highlighting the need for awareness and treatment [1][2][4] - The company aims to raise awareness and improve education regarding Netherton Syndrome, which currently has no FDA-approved treatment, emphasizing the urgency for effective therapeutic options [2][5] Company Overview - Quoin Pharmaceuticals is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products for rare and orphan diseases [1][7] - The company is committed to addressing unmet medical needs and has a pipeline that includes four products targeting various rare conditions, including Netherton Syndrome [7] Product Development - Quoin's lead product candidate, QRX003, is currently undergoing evaluation in four clinical trials for the treatment of Netherton Syndrome, with initial data showing improvements in skin healing and quality of life [5][6] - QRX003 is a topical lotion designed to normalize skin-shedding processes and strengthen the skin barrier, addressing the underlying issues of Netherton Syndrome [6] Campaign and Advocacy - The NETHERTON NOW campaign is central to Quoin's efforts to raise awareness and support for individuals affected by Netherton Syndrome, sharing real patient experiences to foster understanding [4][5] - The company emphasizes the importance of patient stories, like that of Norma Coles, to illustrate the challenges faced by those living with this rare genetic disorder [2][5]

Core Insights - Quoin Pharmaceuticals Ltd. has reported highly positive clinical data from its ongoing Investigator Pediatric Netherton Syndrome study, indicating that after 6 weeks of treatment with QRX003, the patient's skin is almost completely healed and there is a significant reduction in the need for other medications [1][2][6] - The treatment has led to the elimination of pruritus, allowing the patient to experience uninterrupted sleep for the first time, which is a critical improvement in quality of life for those suffering from Netherton Syndrome [2][6] - No adverse events have been reported during the 6-week treatment period, and the company has received approval to initiate treatment on a second pediatric patient [2][6] Company Overview - Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products for rare and orphan diseases [5] - The company is committed to addressing unmet medical needs and has a pipeline that includes four products targeting various rare conditions, including Netherton Syndrome [5] Product Information - QRX003 is a topical lotion designed to treat Netherton Syndrome by promoting a normalized skin-shedding process and strengthening the skin barrier [4] - The product utilizes a proprietary delivery technology and contains a broad-spectrum serine protease inhibitor, which mimics the function of the LEKTI protein absent in patients with Netherton Syndrome [4]

Continued Clear Visual Evidence of Almost Completely Healed Skin After 6 weeks TreatmentHigh Durability of Treatment Effect of QRX003 with Continuous Daily Dosing Patient Continues Not to Require Previously Necessary MedicationsWith Patient’s Pruritus Almost Completely Eliminated, Patient Continues to Experience Zero Nightly Sleep Disturbance No Adverse Events Reported from 6 Weeks of Whole Body Treatment with QRX003Approval Received to Initiate Whole Body Testing of a Second Pediatric Patient ASHBURN, Va., ...

Target Indications Also Include Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma and Severe Atopic DermatitisThird Quoin Patent Application for Netherton Syndrome If Granted Company Would have Patent Protection for QRX003 for Netherton Syndrome Until 2045 ASHBURN, Va., March 25, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late-stage clinical, specialty pharmaceutical company focused on the development and commercialization of therapeutic prod ...

Financial Performance and Position - The company has incurred net losses every year since inception, with an accumulated deficit of approximately $55.2 million as of December 31, 2024[132]. - Cash balances totaled $3.6 million and investments were $10.4 million as of December 31, 2024, indicating limited cash available for operations[132]. - Significant expenses and increasing operating losses are anticipated for the foreseeable future, with no revenue generated from product sales to date[135]. - Future profitability is uncertain and depends on successful completion of clinical trials and obtaining necessary regulatory approvals[142]. - The company may need to raise additional capital to support operations, which may not be available on acceptable terms[140]. - The company expects significant additional capital will be needed in the future, which may result in substantial dilution for existing shareholders if equity securities are issued[261]. Product Development and Regulatory Challenges - The company does not expect to generate revenue from product sales until successful development and marketing approval of product candidates, which may take several years[133]. - The success of product candidates is contingent on various factors, including successful clinical trial outcomes and regulatory approvals[145]. - The company is currently facing significant challenges in completing preclinical and clinical development, which could lead to increased costs and hinder revenue generation from product sales[153]. - Clinical trials may reveal severe side effects that could delay or prevent regulatory approval, impacting market acceptance and commercialization costs[154]. - The company cannot predict the timing of revenue from future products until regulatory approval is obtained, which may be subject to various delays and complications[157]. - Regulatory authorities may impose restrictions on product distribution, require additional studies, or even withdraw approvals, which could adversely affect the company's financial condition[162]. - The company intends to apply for orphan drug designation for QRX003, but success is uncertain and does not guarantee marketing exclusivity[168]. - The company may pursue Rare Pediatric Disease designation for QRX003, but there is no assurance of obtaining such designation or priority review vouchers[169]. Market Competition and Commercialization - The company faces intense competition from larger pharmaceutical companies with greater resources, which may hinder its ability to successfully develop and market its product candidates[171]. - Currently, there are no approved products for treating NS, but several competitors are in various stages of development, increasing market competition[172]. - The commercial success of the company's product candidates will depend on acceptance by the medical community, which is influenced by factors such as efficacy, safety, and pricing[178]. - The company currently lacks sales and marketing capabilities for pharmaceutical products, which may hinder revenue generation[179]. - Establishing a sales organization or forming strategic alliances is essential for future product commercialization, particularly in the U.S. and Europe[180]. - The company faces competition from well-funded companies with established marketing and sales operations, impacting its ability to generate sufficient product revenue[181]. - International commercialization poses risks, including differing regulatory requirements and potential economic instability in foreign markets[182]. - Coverage and adequate reimbursement for product candidates are uncertain, which could affect market acceptance and profitability[183]. - Legislative and regulatory changes in the healthcare system may negatively impact reimbursement for drug products[184]. Manufacturing and Supply Chain Risks - The company relies on third-party manufacturers for production, which introduces risks related to compliance and supply chain disruptions[189]. - Manufacturing issues could lead to increased costs and delays in regulatory approval, affecting commercialization timelines[194]. - The company intends to rely on third parties for clinical trials, which may impact the quality and timeliness of data collection and regulatory submissions[195]. - Performance failures by third-party logistics providers could delay clinical development and commercialization, resulting in potential revenue losses[199]. Intellectual Property Risks - The company faces risks related to intellectual property rights, which are crucial for competing effectively in the market[200]. - Patent applications may fail to issue or be challenged, potentially threatening the company's ability to commercialize future products[201]. - The lifespan of patents is limited, with one patent expiring in March 2024 and another set to expire in July 2025, exposing the company to competition from generic medications[203]. - The company relies on trade secret protection and confidentiality agreements, but there is no guarantee that these will be enforceable or adequately protect proprietary information[204]. - The company may face claims of intellectual property infringement, which could lead to substantial litigation expenses and distract management from business operations[207]. Management and Operational Risks - The company is dependent on key executives and may struggle to attract and retain qualified personnel due to industry competition[216]. - Future growth may require significant capital expenditures and could divert financial resources from other projects, impacting the company's ability to implement its business strategy[217]. - Employee misconduct poses risks, including noncompliance with regulatory standards, which could lead to significant penalties and harm the company's reputation[219]. - The company must comply with federal and state healthcare fraud and abuse laws, and failure to do so could result in criminal sanctions and diminished profits[220]. Regulatory and Legislative Risks - The company anticipates potential expansion of operations in the EU, including preclinical and clinical trials, subject to GDPR regulations[223]. - Legislative changes, such as the Inflation Reduction Act, may allow the federal government to negotiate drug prices, impacting revenue generation[230]. - The American Rescue Plan Act of 2021 eliminated the statutory cap on Medicaid Drug Rebate Program rebates, potentially increasing costs for pharmaceutical manufacturers[226]. - The ACA provisions may reduce drug product profitability through increased Medicaid rebates and mandatory discounts for Medicare beneficiaries[226]. - Increased scrutiny of drug pricing practices may lead to legislative changes that could affect the company's pricing strategies[229]. - Future healthcare reforms may hinder the company's ability to generate revenue and commercialize product candidates[232]. Liability and Risk Management - The company faces risks related to product liability claims, which could result in substantial costs and impact business reputation[234]. - Cybersecurity risks could lead to operational disruptions and potential legal claims, affecting the company's reputation and financial standing[237]. - The company may incur civil and criminal penalties for violations of healthcare regulations, impacting operations and financial results[224]. - The company plans to obtain product liability insurance, but coverage may not be sufficient to cover potential liabilities[236]. Market and Stock Risks - The company received a deficiency letter from Nasdaq regarding its ADSs not maintaining a minimum closing bid price of $1.00 for 31 consecutive business days[251]. - The company has until April 28, 2025, to regain compliance with Nasdaq's Minimum Bid Price Requirement, or it risks delisting[253]. - If delisted, the company may face additional regulatory burdens and a significant decrease in market liquidity for its ADSs[255]. - The market price for the company's ADSs is likely to be highly volatile, influenced by various factors including clinical trial approvals and regulatory actions[256]. - The company has not paid any cash dividends on its ordinary shares and does not anticipate paying any in the foreseeable future, which may limit investor benefits unless market prices appreciate[262]. - Substantial future sales of the company's ADSs could lead to a decline in their market price, potentially affecting existing shareholders negatively[260]. - Holders of ADSs may not receive the same distributions or dividends as those made to ordinary shareholders, which could lead to a material decline in the value of the ADSs[263]. - The company may face risks of securities class action litigation, particularly related to clinical trial outcomes and regulatory approvals, which could divert management's attention and resources[259]. - The depositary for the ADSs may withhold dividends or distributions due to legal or practical reasons, impacting the value received by ADS holders[263]. - The company may experience significant stock price volatility associated with clinical trials and product approvals, which is common in the medical and biotechnology sectors[259]. - Holders of ADSs must act through the depositary to exercise their rights, which may limit their ability to vote on shareholder matters[264]. - The depositary may close its transfer books at any time, potentially limiting the transferability of ADSs[265]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[335].

Financial Performance - Quoin Pharmaceuticals reported a net loss of approximately $2.3 million for Q4 2024, compared to a net loss of approximately $2.0 million for Q4 2023, and a total net loss of $9.0 million for the full year 2024, up from $8.7 million in 2023[12]. - Operating expenses for Q4 2024 were approximately $9.5 million, slightly higher than $9.4 million in Q4 2023[17]. - Total current assets increased to approximately $14.9 million as of December 31, 2024, compared to $11.3 million in 2023[16]. Cash and Funding - As of December 31, 2024, Quoin had approximately $14.1 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into Q2 2026[12]. - The company completed a $6.8 million public offering on December 20, 2024, enhancing its financial position for ongoing clinical development[9]. Clinical Development - Quoin's ongoing clinical studies for QRX003 have shown significant improvements in disease severity and skin healing for patients with Netherton Syndrome, with one patient experiencing transformational improvement after just two weeks[5]. - The FDA cleared a new whole-body clinical study for QRX003, which will evaluate its safety and efficacy on over 80% of the body surface area in Netherton Syndrome patients[10]. - Quoin filed U.S. and international patent applications for novel topical rapamycin formulations targeting rare dermatological diseases, expanding its product pipeline[4]. Awareness and Education - The company launched the 'NETHERTON NOW' awareness campaign to raise awareness about Netherton Syndrome, including a dedicated website for educational resources[6]. Shareholder Information - The weighted average number of ADSs outstanding increased to 4,688,723 for the year ended December 31, 2024, compared to 900,919 in 2023[17].