Company Developments - ESS Tech, Inc. (NYSE:GWH) stock price surged to $4.57, marking a 166.24% increase due to a collaboration with Salt River Project for a renewable energy storage project [1][7] - Quoin Pharmaceuticals, Ltd. (NASDAQ:QNRX) experienced a price increase to $20.84, a 155.48% rise, potentially driven by positive clinical trial results for its lead product QRX003 [2][7] - Safe & Green Holdings Corp. (NASDAQ:SGBX) saw its stock climb to $6.11, an 88.73% increase after regaining compliance with Nasdaq listing requirements through a restructuring deal [3][7] Investor Sentiment - The trading volume for ESS Tech, Inc. spiked to 245,639,308, indicating strong investor interest following the announcement of Project New Horizon [1] - Quoin Pharmaceuticals' significant share price increase suggests strong investor confidence despite a downturn in U.S. stocks [2] - The restructuring deal for Safe & Green Holdings Corp. reduced dilution by over 80%, boosting investor confidence [3] Market Trends - The stock movements reflect a growing investor interest in sectors such as renewable energy, biotechnology, and sustainable construction [6] - ESS Tech, Inc. Warrants (NYSE:GWH-WT) increased to $0.15, up by 61.69%, mirroring positive sentiment around the parent company [4] - enGene Holdings Inc. Warrants (NASDAQ:ENGNW) rose to $1.13, a 56.94% increase, reflecting optimism towards its lead product candidate for bladder cancer [5]

U.S. stocks traded lower midway through trading, with the Nasdaq Composite falling around 2.5% on Friday.The Dow traded up 1.26% to 45,772.50 while the NASDAQ rose 2.46% to 22,459.24. The S&P 500 also rose, gaining, 1.79% to 6,614.73.Check This Out: Top 2 Tech & Telecom Stocks That May Implode This MonthLeading and Lagging SectorsConsumer staples shares jumped by 0.6% on Friday.In trading on Friday, energy stocks fell by 0.6%.Top HeadlineThe University of Michigan consumer sentiment slipped to 55 in October ...

Core Viewpoint - Quoin Pharmaceuticals Ltd. has entered into a securities purchase agreement to potentially raise up to $104.5 million through PIPE financing, aimed at supporting its clinical development and general corporate purposes [1][6]. Financing Details - The financing includes participation from several healthcare-focused institutional investors such as AIGH Capital Management, Soleus Capital, and others [1][2]. - The private placement is priced at a premium to the previous day's closing stock price, with an initial upfront funding of $16.5 million and up to an additional $88.0 million from the exercise of accompanying warrants [1][3]. Securities Issuance - Quoin will issue a total of 1,993,940 American Depository Shares (ADSs) and warrants to purchase up to 7,975,760 ADSs at a combined purchase price of $8.25 per ADS and accompanying warrants [3][4]. - Certain investors are opting for pre-funded warrants at a slightly lower price of $8.2499 per warrant [4]. Warrant Structure - The accompanying warrants consist of four tranches, each with specific exercise prices and expiration conditions related to the FDA's approval process for QRX003, a treatment for Netherton Syndrome [5]. - Series H warrants have an exercise price of $9.075, Series I at $10.3125, and Series J and K at $12.375, with aggregate exercise prices of up to $18.1 million, $20.6 million, and $49.4 million respectively [5]. Use of Proceeds - The net proceeds from the private placement will be used for general corporate purposes, including operating expenses, research and development, and completion of clinical development for QRX003 [6]. Company Overview - Quoin Pharmaceuticals Ltd. is focused on developing therapeutic products for rare and orphan diseases, with a pipeline that includes treatments for conditions such as Netherton Syndrome and others [9].

Core Insights - Quoin Pharmaceuticals has released the fifth episode of the NETHERTON NOW video series, highlighting the social and emotional impact of Netherton Syndrome and the urgent need for an approved treatment [1][4] - The video features twin sisters Allie and Kaleigh Fasanella, who share their lifelong struggles with Netherton Syndrome, emphasizing the disease's unpredictable nature and its toll on their daily lives and mental health [2][3] Company Overview - Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, with a commitment to addressing unmet medical needs [7] - The company is advancing its lead product candidate, QRX003, in pivotal clinical trials for the treatment of Netherton Syndrome, with early data showing encouraging improvements in key clinical outcomes [4][6] Product Information - QRX003 is a topical lotion designed to promote a normalized skin-shedding process and strengthen the skin barrier, addressing the symptoms of Netherton Syndrome [6] - The product is formulated with a proprietary delivery technology and is intended to be applied twice daily to the entire skin surface, excluding the scalp [6] Campaign and Awareness - The Netherton NOW campaign was initiated to increase awareness of Netherton Syndrome, and the positive reaction to the campaign has been significant since its launch over six months ago [4][5] - The personal stories shared by Allie and Kaleigh are aimed at building awareness of the challenges faced by patients and families living with Netherton Syndrome [4][3]

Core Viewpoint - Quoin Pharmaceuticals Ltd. has achieved significant milestones with its NETHERTON NOW awareness campaign, which has garnered over one million video views and more than 14 million impressions, highlighting the realities of Netherton Syndrome [1][2][3] Company Overview - Quoin Pharmaceuticals is a clinical-stage specialty pharmaceutical company focused on developing treatments for rare and orphan diseases, with a commitment to addressing unmet medical needs [5] - The company is advancing its lead investigational candidate, QRX003, through late-stage clinical trials for Netherton Syndrome, with full enrollment expected in early to mid-Q1 2026 [3][4] Campaign Details - The NETHERTON NOW campaign aims to amplify the voices of patients, families, and experts, raising awareness and education about Netherton Syndrome [2][4] - The campaign has been widely circulated on social media and featured in major outlets, including MSN, Today, and CBS News, as well as clinical publications [2] Clinical Development - QRX003 is being studied as both a monotherapy and in combination with off-label systemic treatments, with early data showing encouraging signals [3][4] - The ongoing initiative seeks to improve education and elevate the voices of those affected by Netherton Syndrome, reinforcing the company's commitment to advancing meaningful therapies [4]

Core Viewpoint - Quoin Pharmaceuticals Ltd. has appointed Sally Lawlor as the new Chief Financial Officer to support the advancement of its lead product candidate, QRX003, through pivotal clinical studies and potential commercialization [1][2][4] 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 for patients and has a pipeline that includes four products targeting various rare and orphan indications [5] Leadership Changes - Sally Lawlor brings over 20 years of financial leadership experience from both public and private companies, as well as a Big Four accounting firm [2][3] - Dr. Michael Myers, CEO of Quoin, emphasized the importance of aligning the leadership structure to support the company's growth as it approaches the completion of QRX003 registrational trials [4] Product Development - Quoin is conducting two pivotal clinical studies for QRX003 in Netherton Syndrome, with full enrollment expected in early to mid-Q1 2026 across sites in the U.S., Europe, and the Middle East [4] - The company is also advancing development programs for Peeling Skin Syndrome and a novel topical rapamycin platform targeting a range of rare dermatologic diseases [4]

Core Viewpoint - Quoin Pharmaceuticals is highlighting the urgent need for effective treatments for Netherton Syndrome through the release of a new video featuring a patient advocate, emphasizing the severe impact of the disease on patients' lives and the ongoing development of their lead product candidate, QRX003 [1][5]. Company Overview - Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, with a commitment to addressing unmet medical needs [7]. - The company is advancing its lead product candidate, QRX003, through multiple pivotal clinical trials aimed at treating Netherton Syndrome [4][5]. Product Information - QRX003 is a topical lotion designed to normalize skin-shedding processes and strengthen the skin barrier, targeting the underlying issues caused by the absence of the LEKTI protein in Netherton patients [6]. - Recent data from ongoing studies of QRX003 have shown highly encouraging improvements in key clinical outcomes [4]. Patient Advocacy and Community Impact - Mandy Aldwin-Easton, featured in the video, shares her personal experiences with Netherton Syndrome, highlighting the chronic pain and emotional trauma associated with the disease [2][3]. - The company recognizes the significant physical, emotional, and financial toll that Netherton Syndrome places on patients and their families, reinforcing the importance of advocacy and awareness [4][5].

Core Insights - Quoin Pharmaceuticals reported a net loss of $(6.28) per American Depositary Share (ADS) for Q2 2025, which was better than the consensus estimate of $(6.82) [1] - The company had zero revenue for the quarter, consistent with expectations, while operating expenses surged due to increased investment in its lead asset, QRX003 [1][5] - Despite the financial losses, the company made significant clinical and regulatory progress, including positive data for QRX003 in Netherton Syndrome and regulatory approvals [1][7] Financial Performance - Q2 2025 EPS (GAAP) was $(6.28), an improvement of 54.1% from $(13.68) in Q2 2024 [2] - Operating expenses reached $3.79 million, a 77.4% increase from $2.14 million in Q2 2024 [2] - Research and Development expenses were $2.05 million, reflecting a 247.5% increase from $0.59 million in Q2 2024 [2] - Cash, cash equivalents, and marketable securities at the end of the period were $7.79 million, down from $14.9 million as of December 31, 2024 [2][6] Clinical and Regulatory Developments - QRX003 showed positive six-month data in Netherton Syndrome, indicating improvements in disease severity and patient quality of life [7] - The U.S. FDA granted clearance for a second pivotal trial and Orphan Drug Designation from the European Medicines Agency, which can provide up to 10 years of market exclusivity [7] - QRX003 also received Rare Pediatric Disease Designation from the FDA, making it eligible for a Priority Review Voucher upon approval [7] Strategic Focus - Quoin Pharmaceuticals focuses on developing therapies for rare dermatological diseases, with QRX003 as its primary asset targeting Netherton Syndrome [3] - The company aims to complete recruitment for the second pivotal QRX003 study by the end of Q1 2026 and plans to submit a New Drug Application in late 2026 [10] - Ongoing collaborations with institutions support the pipeline beyond QRX003, and advocacy campaigns like NETHERTON NOW are expanding [4][8] Market Position - QRX003 is one of the few late-stage assets for Netherton Syndrome, with no approved therapies currently available [9] - Other biotech firms are developing products for Netherton Syndrome, but only Azitra is actively dosing subjects in clinical studies as of March 2025 [9] - Intellectual property protection remains a priority, with patents and licensing arrangements in place for core technologies [9]

```markdown [CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND SUMMARY OF RISK FACTORS](index=3&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section provides a cautionary note on forward-looking statements and summarizes key risk factors that could materially impact future results [Forward-Looking Statements Overview](index=3&type=section&id=Forward-Looking%20Statements%20Overview) This section defines forward-looking statements and outlines key risks and uncertainties that could cause actual results to differ materially from projections - Forward-looking statements are characterized by **terms like 'may,' 'will,' 'expect,' 'anticipate,'** and relate to objectives, plans, strategies, financial condition projections, capital needs, and product development[7](index=7&type=chunk)[8](index=8&type=chunk) - Important factors that could cause actual results to differ include limited operating history, history of losses, need for additional capital, lack of revenue, uncertainties of cash flows, ability to obtain regulatory approvals, and ability to generate favorable clinical trial results[10](index=10&type=chunk) - Other risks include obtaining orphan drug designation, manufacturing process validation, difficulties in patient enrollment for clinical trials, requirements of being a publicly traded company, potential adverse effects from internal control failures, and Nasdaq listing compliance[13](index=13&type=chunk) [PART I – FINANCIAL INFORMATION](index=6&type=section&id=PART%20I-FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements.](index=6&type=section&id=Item%201.%20Financial%20Statements.) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, statements of shareholders' equity, and statements of cash flows, along with detailed notes explaining the company's organization, liquidity risks, significant accounting policies, and specific financial line items [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's unaudited condensed consolidated balance sheets as of **June 30, 2025**, and **December 31, 2024** | ASSETS (in $) | June 30, 2025 (unaudited) | December 31, 2024 | | :------------------------ | :------------------------ | :------------------ | | Cash and cash equivalents | 1,668,492 | 3,623,343 | | Investments | 6,121,830 | 10,433,535 | | Total current assets | 8,479,255 | 14,926,004 | | Total assets | 8,912,589 | 15,709,338 | | LIABILITIES AND EQUITY (in $) | June 30, 2025 (unaudited) | December 31, 2024 | | :------------------------ | :------------------------ | :------------------ | | Total current liabilities | 4,337,499 | 4,180,932 | | Total liabilities | 6,361,232 | 6,504,665 | | Total shareholders' equity| 2,551,357 | 9,204,673 | | Total liabilities and shareholders' equity | 8,912,589 | 15,709,338 | [Condensed Consolidated Statements of Operations (Unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(Unaudited)) This section details the unaudited condensed consolidated statements of operations for the three and six months ended **June 30, 2025** and **2024** | Operating Expenses (in $) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | General and administrative| 1,742,594 | 1,549,615 | 3,325,632 | 3,122,601 | | Research and development | 2,050,585 | 587,503 | 4,424,724 | 1,472,801 | | Total operating expenses | 3,793,179 | 2,137,118 | 7,750,356 | 4,595,402 | | Net loss | (3,695,938) | (1,974,033) | (7,508,117) | (4,301,313) | | Loss per ADS (Basic) | (6.28) | (13.68) | (12.79) | (42.09) | - Net loss for the three months ended **June 30, 2025**, increased to **$(3,695,938)** from **$(1,974,033)** in the prior year, primarily driven by a significant increase in research and development expenses[17](index=17&type=chunk) - Net loss for the six months ended **June 30, 2025**, increased to **$(7,508,117)** from **$(4,301,313)** in the prior year, reflecting higher operating expenses[17](index=17&type=chunk) [Condensed Consolidated Statements of Shareholders' Equity (Unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity%20(Unaudited)) This section presents the unaudited condensed consolidated statements of shareholders' equity for the six months ended **June 30, 2025** | Shareholders' Equity (in $) | Balance at January 1, 2025 | Net loss | Exercise of pre-funded warrants and warrants, net | Stock based compensation | Balance at June 30, 2025 | | :-------------------------- | :------------------------- | :------- | :------------------------------------------------ | :----------------------- | :----------------------- | | Total | 9,204,673 | (7,508,117) | 172,958 | 681,843 | 2,551,357 | - Total shareholders' equity decreased from **$9,204,673** at **January 1, 2025**, to **$2,551,357** at **June 30, 2025**, primarily due to net losses[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows (unaudited)](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(unaudited)) This section provides the unaudited condensed consolidated statements of cash flows for the six months ended **June 30, 2025** and **2024** | Cash Flows (in $) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------- | :----------------------------- | :----------------------------- | | Operating activities | (6,280,510) | (3,441,495) | | Investing activities | 4,452,701 | (1,310,774) | | Financing activities | (127,042) | 5,196,197 | | Net change in cash and cash equivalents | (1,954,851) | 443,928 | | Cash and cash equivalents - end of period | 1,668,492 | 2,845,126 | - Net cash used in operating activities significantly increased to **$(6,280,510)** for the six months ended **June 30, 2025**, compared to **$(3,441,495)** in the prior year[20](index=20&type=chunk) - Investing activities provided **$4,452,701** in cash in **H1 2025**, a reversal from using **$1,310,774** in **H1 2024**, primarily due to net sales and redemptions of US Treasury Bills and Notes[20](index=20&type=chunk) [NOTE 1 – ORGANIZATION AND BUSINESS](index=10&type=section&id=NOTE%201%20%E2%80%93%20ORGANIZATION%20AND%20BUSINESS) This note describes the company's organization as a late-stage clinical pharmaceutical company and its lead product development - The company, Quoin Pharmaceuticals Ltd., is a late-stage clinical specialty pharmaceutical company focused on rare and orphan diseases[22](index=22&type=chunk) - Its lead product, QRX003, is in clinical development for Netherton Syndrome (NS) and Peeling Skin Syndrome, with trials expanding internationally[22](index=22&type=chunk) - Effective **April 9, 2025**, the company executed a **1-for-35 reverse split** of its ADSs to regain Nasdaq compliance[21](index=21&type=chunk) [NOTE 2 - LIQUIDITY RISKS AND OTHER UNCERTAINTIES](index=10&type=section&id=NOTE%202%20-%20LIQUIDITY%20RISKS%20AND%20OTHER%20UNCERTAINTIES) This note discusses the company's accumulated deficit, net losses, and the substantial doubt about its ability to continue as a going concern - The company has an accumulated deficit of approximately **$62.7 million** at **June 30, 2025**, and incurred net losses of **$7.5 million** and negative cash flows from operations of **$6.3 million** for the six months ended **June 30, 2025**[23](index=23&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern for at least one year, necessitating additional debt or equity capital[24](index=24&type=chunk)[25](index=25&type=chunk) - The company regained Nasdaq compliance on **April 29, 2025**, following a **1-for-35 reverse split** of its ADSs, but there is no assurance of maintaining compliance[32](index=32&type=chunk)[33](index=33&type=chunk) [NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=12&type=section&id=NOTE%203%20-%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the significant accounting policies used in preparing the interim financial statements, including R&D costs and segment reporting - Financial statements are prepared in accordance with U.S. GAAP for interim financial information, with management making estimates and assumptions affecting reported amounts[34](index=34&type=chunk)[36](index=36&type=chunk) - Research and development costs are expensed as incurred, including personnel costs and third-party contractor expenses for clinical trials and drug supplies[44](index=44&type=chunk) - The company operates in one business segment focused on research and development of therapeutic products for rare and orphan diseases[42](index=42&type=chunk) [NOTE 4 – ACCRUED INTEREST AND FINANCING EXPENSE](index=17&type=section&id=NOTE%204%20%E2%80%93%20ACCRUED%20INTEREST%20AND%20FINANCING%20EXPENSE) This note details the estimated liability for 2020 Notes and the absence of interest expense recognized during the reporting periods - An estimated liability of **$1,146,000** for 2020 Notes was outstanding as of **June 30, 2025**, and **December 31, 2024**, with **$339,000** due to related parties[51](index=51&type=chunk) - No interest expense was recognized for the three and six months ended **June 30, 2025**, and **2024**[52](index=52&type=chunk) [NOTE 5 - FAIR VALUE OF FINANCIAL INSTRUMENTS](index=17&type=section&id=NOTE%205%20-%20FAIR%20VALUE%20OF%20FINANCIAL%20INSTRUMENTS) This note explains the company's application of fair value accounting and classification of financial assets and liabilities - The company applies fair value accounting, classifying financial assets and liabilities based on a three-level hierarchy[53](index=53&type=chunk)[54](index=54&type=chunk)[55](index=55&type=chunk)[56](index=56&type=chunk) | US Treasury Bills and Notes (in $) | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------ | :---------------- | | Level 1 | 6,121,830 | 10,433,535 | | Total | 6,121,830 | 10,433,535 | [NOTE 6 – STOCK BASED COMPENSATION](index=19&type=section&id=NOTE%206%20%E2%80%93%20STOCK%20BASED%20COMPENSATION) This note provides details on stock option activity, stock-based compensation expense, and Black-Scholes valuation assumptions | Stock Option Activity | Outstanding at Dec 31, 2024 | Granted | Outstanding at Jun 30, 2025 | | :-------------------- | :-------------------------- | :------ | :-------------------------- | | ADSs Underlying Options | 55,541 | 124,514 | 180,055 | | Weighted Average Exercise Price | $150.47 | $9.07 | $52.69 | - Stock-based compensation expense was approximately **$321,000** for **Q2 2025** and **$682,000** for **H1 2025**, with **$3.1 million** in unrecognized compensation expense remaining[62](index=62&type=chunk)[64](index=64&type=chunk) | Black-Scholes Assumptions (June 30, 2025) | Value | | :---------------------------------------- | :---- | | Expected volatility | 108.4%| | Risk-free interest rate | 4.4% | | Expected dividend yield | 0.0% | | Expected life of options in years | 6.4 | | Estimate fair value of option | $7.73 | [NOTE 7 – PREPAID EXPENSES](index=20&type=section&id=NOTE%207%20%E2%80%93%20PREPAID%20EXPENSES) This note presents a breakdown of prepaid expenses, including R&D costs, insurance, and other prepaid items | Prepaid Expenses (in $) | June 30, 2025 | December 31, 2024 | | :---------------------- | :------------ | :---------------- | | Prepaid R&D costs | 499,905 | 772,083 | | Prepaid insurance | 135,434 | 309,889 | | Prepaid expense | 53,594 | 87,154 | | Total | 688,933 | 1,169,126 | [NOTE 8 - ACCRUED EXPENSES](index=20&type=section&id=NOTE%208%20-%20ACCRUED%20EXPENSES) This note details the company's accrued expenses, including research contract expenses, payroll, and professional fees | Accrued Expenses (in $) | June 30, 2025 | December 31, 2024 | | :---------------------- | :------------ | :---------------- | | Research contract expenses | 667,310 | 183,094 | | Payroll | 736,656 | 940,539 | | Payroll taxes | 62,264 | 77,726 | | Professional fees | 100,843 | 323,497 | | Other expenses | 150,491 | 4,121 | | Total | 1,717,564 | 1,528,977 | [NOTE 9 – IN-LICENSED TECHNOLOGY](index=21&type=section&id=NOTE%209%20%E2%80%93%20IN-LICENSED%20TECHNOLOGY) This note describes the exclusive royalty-bearing license agreement for QRX003 and QRX004, including license fees and future royalties - The company holds an exclusive royalty-bearing license from Skinvisible Pharmaceuticals for QRX003 and QRX004, involving a **$1 million** license fee and future **single-digit royalties** on net sales[67](index=67&type=chunk) - A one-time **$5 million** payment is due to Skinvisible upon the first drug product approval in the U.S. or EU[67](index=67&type=chunk) [NOTE 10 - INTANGIBLE ASSETS](index=21&type=section&id=NOTE%2010%20-%20INTANGIBLE%20ASSETS) This note presents the intangible assets, specifically the technology license from Skinvisible, and related accumulated amortization | Intangible Assets (in $) | June 30, 2025 | December 31, 2024 | | :----------------------- | :------------ | :---------------- | | Technology license – Skinvisible | 1,000,000 | 1,000,000 | | Accumulated amortization | (566,666) | (516,666) | | Net book value | 433,334 | 483,334 | - Amortization expense was **$25,000** for both **Q2 2025** and **Q2 2024**, and **$50,000** for both **H1 2025** and **H1 2024**[68](index=68&type=chunk) [NOTE 11 - RELATED PARTY TRANSACTIONS](index=21&type=section&id=NOTE%2011%20-%20RELATED%20PARTY%20TRANSACTIONS) This note details transactions with related parties, including repayments to officers and amounts due for salaries and compensation - The company repaid **$150,000** to Dr. Myers and **$150,000** to Ms. Carter in **H1 2025** for accrued indebtedness[69](index=69&type=chunk) | Amounts Due to Officers (in $) | June 30, 2025 | December 31, 2024 | | :----------------------------- | :------------ | :---------------- | | Salaries and other compensation | 2,623,733 | 2,923,733 | | Less: Short-term portion | (600,000) | (600,000) | | Long-term portion | 2,023,733 | 2,323,733 | [NOTE 12 – RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS](index=22&type=section&id=NOTE%2012%20%E2%80%93%20RESEARCH,%20CONSULTING%20AGREEMENTS%20AND%20COMMITMENTS) This note outlines research and consulting agreements, including R&D expenses for clinical studies and other research programs - The company incurred R&D expenses of approximately **$348,000** (**Q2 2025**) and **$759,000** (**H1 2025**) under a Master Service Agreement for QRX003 clinical studies, with an estimated remaining cost of **$3.6 million**[73](index=73&type=chunk) - The Netherton Syndrome research program with QUT has been discontinued, and the Scleroderma research program with QUT is under review[74](index=74&type=chunk) - A research agreement with UCC for novel topical rapamycin formulations involves funding up to **€567,000 ($668,000)** over **2.5 years**, with **$60,000** (**Q2 2025**) and **$120,000** (**H1 2025**) incurred[75](index=75&type=chunk) [NOTE 13 – SHAREHOLDERS' EQUITY](index=23&type=section&id=NOTE%2013%20%E2%80%93%20SHAREHOLDERS'%20EQUITY) This note details changes in shareholders' equity, including warrant exercises and their impact on net proceeds - In **January** and **February 2025**, warrant exercises generated approximately **$173,000** in net proceeds[77](index=77&type=chunk) | Warrant Activity | Outstanding and exercisable at Dec 31, 2024 | Exercised Pre-Funded and Common Warrants | Outstanding and exercisable at Jun 30, 2025 | | :--------------- | :------------------------------------------ | :--------------------------------------- | :------------------------------------------ | | ADSs Underlying Warrants | 1,440,664 | (332,505) | 1,108,159 | | Average Exercise Price Per ADS | $16.80 | $0.58 | $21.92 | [NOTE 14 – CONTINGENCIES](index=23&type=section&id=NOTE%2014%20%E2%80%93%20CONTINGENCIES) This note states that management is unaware of any material legal matters requiring accrual in the financial statements - Management is unaware of any material legal matters requiring accrual in the financial statements[79](index=79&type=chunk) [NOTE 15 – LICENSE AGREEMENTS](index=23&type=section&id=NOTE%2015%20%E2%80%93%20LICENSE%20AGREEMENTS) This note describes the company's commercial license and supply agreements from which future royalties are expected - The company has nine commercial license and supply agreements from which it expects future royalties, but no royalty revenues have been received through **June 30, 2025**[80](index=80&type=chunk) [NOTE 16 – SUBSEQUENT EVENTS](index=23&type=section&id=NOTE%2016%20%E2%80%93%20SUBSEQUENT%20EVENTS) This note reports on subsequent events, including the signing of the One Big Beautiful Bill Act and its potential impact - The One Big Beautiful Bill Act (OBBBA) was signed into law on **July 4, 2025**, and the company is currently assessing its impact on consolidated financial statements[81](index=81&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, including an overview of its business, recent developments, detailed analysis of operating expenses, and a discussion of liquidity and capital resources, emphasizing the ongoing need for financing [Overview](index=24&type=section&id=Overview) This section provides an overview of the company's business as a late-stage clinical pharmaceutical company focused on rare diseases - The company is a late-stage clinical specialty pharmaceutical company focused on rare and orphan diseases, with QRX003 as its lead product for Netherton Syndrome[83](index=83&type=chunk) - Strategic plans include completing QRX003 clinical testing, preparing for commercialization with a U.S. sales infrastructure and international partnerships, and pursuing business development opportunities[85](index=85&type=chunk) - No products have been commercialized, and no revenue has been generated; additional capital is required for development and commercialization[84](index=84&type=chunk) [Recent Developments](index=25&type=section&id=Recent%20Developments) This section highlights recent developments, including regaining Nasdaq compliance after an ADS reverse split - The company regained Nasdaq compliance on **April 29, 2025**, after effecting a **1-for-35 reverse split** of its ADSs on **April 9, 2025**, to meet the Minimum Bid Price Requirement[86](index=86&type=chunk) - There is no assurance of maintaining Nasdaq compliance, and delisting would negatively impact liquidity and future capital raising ability[88](index=88&type=chunk) [Components of Our Results of Operations](index=25&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section explains the components of operating expenses, primarily research and development and general and administrative costs - Operating expenses consist of research and development (R&D) and general and administrative (G&A) expenses[89](index=89&type=chunk) - R&D costs are expensed as incurred and are expected to be significant due to late-stage clinical studies and regulatory preparations for QRX003[90](index=90&type=chunk)[92](index=92&type=chunk) - G&A expenses are expected to increase to support R&D activities, including compensation, personnel, travel, and professional fees[93](index=93&type=chunk) [Results of Operations – Three months ended June 30, 2025 compared to the three months ended June 30, 2024](index=28&type=section&id=Results%20of%20Operations%20%E2%80%93%20Three%20months%20ended%20June%2030,%202025%20compared%20to%20the%20three%20months%20ended%20June%2030,%202024) This section analyzes the company's operating results for the three months ended **June 30, 2025**, compared to the prior year | Operating Expenses (in $) | 2025 | 2024 | Change | | :------------------------ | :------------ | :------------ | :------------ | | General and administrative| 1,742,594 | 1,549,615 | 192,979 | | Research and development | 2,050,585 | 587,503 | 1,463,082 | | Total operating expenses | 3,793,179 | 2,137,118 | 1,656,061 | | Net loss | (3,695,938) | (1,974,033) | (1,721,905) | - General and administrative expenses increased by **$192,979** (**12.5%**) due to higher consulting, marketing, legal fees, and corporate taxes, partially offset by decreases in payroll, travel, and insurance[97](index=97&type=chunk) - Research and development expenses surged by **$1,463,082** (**248.8%**) due to increased external expenditures on QRX003 clinical studies and the University College Cork research collaboration[98](index=98&type=chunk) [Results of Operations – Six months ended June 30, 2025 compared to the six months ended June 30, 2024](index=29&type=section&id=Results%20of%20Operations%20%E2%80%93%20Six%20months%20ended%20June%2030,%202025%20compared%20to%20the%20six%20months%20ended%20June%2030,%202024) This section analyzes the company's operating results for the six months ended **June 30, 2025**, compared to the prior year | Operating Expenses (in $) | 2025 | 2024 | Change | | :------------------------ | :------------ | :------------ | :------------ | | General and administrative| 3,325,632 | 3,122,601 | 203,031 | | Research and development | 4,424,724 | 1,472,801 | 2,951,923 | | Total operating expenses | 7,750,356 | 4,595,402 | 3,154,954 | | Net loss | (7,508,117) | (4,301,313) | (3,206,804) | - General and administrative expenses increased by **$203,031** (**6.5%**) due to higher consulting, legal, public company costs, and marketing expenses, partially offset by lower payroll and insurance costs[102](index=102&type=chunk) - Research and development expenses increased by **$2,951,923** (**200.4%**) due to increased external expenditures on QRX003 clinical studies and the University College Cork research collaboration[103](index=103&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's liquidity position, capital resources, accumulated deficit, and ongoing need for additional financing - The company has an accumulated deficit of **$62.7 million** and incurred a net loss of **$7.5 million** with negative cash flows from operations of **$6.3 million** for **H1 2025**[106](index=106&type=chunk) - As of **June 30, 2025**, cash and cash equivalents totaled **$1.7 million** and investments were **$6.1 million**[106](index=106&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern for at least one year, necessitating additional financing[107](index=107&type=chunk) [Future Funding Requirements](index=31&type=section&id=Future%20Funding%20Requirements) This section outlines the company's future funding needs and the potential consequences of failing to secure adequate additional capital - Future funding requirements depend on factors such as the scope and timing of drug development, clinical trials, regulatory review, commercialization, intellectual property, and operational infrastructure[109](index=109&type=chunk)[110](index=110&type=chunk) - Failure to secure adequate additional funding could lead to significant delays, scaling back, or termination of development programs or even cessation of operations[109](index=109&type=chunk)[112](index=112&type=chunk) - Raising capital through equity or convertible debt securities will dilute existing equity holders, and debt financing may impose restrictive covenants[111](index=111&type=chunk) [Summary Statement of Cash Flows](index=33&type=section&id=Summary%20Statement%20of%20Cash%20Flows) This section provides a summary of the company's cash flows from operating, investing, and financing activities | Cash Flows (in $) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | (6,280,510) | (3,441,495) | | Net cash provided (used) in investing activities | 4,452,701 | (1,310,774) | | Net cash (used) provided in financing activities | (127,042) | 5,196,197 | | Net change in cash and cash equivalents | (1,954,851) | 443,928 | [Operating Activities](index=33&type=section&id=Operating%20Activities) This section details the net cash used in operating activities and its primary drivers for the reporting periods - Net cash used in operating activities increased to approximately **$6.3 million** in **H1 2025** from **$3.4 million** in **H1 2024**, primarily due to an increase in net loss[114](index=114&type=chunk) [Investing Activities](index=33&type=section&id=Investing%20Activities) This section describes the net cash provided by or used in investing activities, primarily related to investments - Investing activities provided **$4.5 million** in net cash in **H1 2025**, primarily from net sales and redemptions of US Treasury Bills and Notes, contrasting with **$1.3 million** used in **H1 2024** for net purchases[115](index=115&type=chunk) [Financing Activities](index=33&type=section&id=Financing%20Activities) This section explains the net cash provided by or used in financing activities, including warrant exercises and officer repayments - Net cash used in financing activities was **$127,042** in **H1 2025**, resulting from **$172,958** from warrant exercises offset by **$300,000** in repayments to officers[116](index=116&type=chunk) - In **H1 2024**, financing activities provided **$5.2 million**, mainly from a public offering, partially offset by officer repayments[116](index=116&type=chunk) [Research and Development Commitments](index=33&type=section&id=Research%20and%20Development%20Commitments) This section outlines the company's commitments related to research and development, including licensing and clinical study agreements - The company has an exclusive licensing agreement with Skinvisible Pharmaceuticals for QRX003 and QRX004, requiring a **$5 million** payment upon the first U.S. or EU approval[117](index=117&type=chunk)[118](index=118&type=chunk) - A Master Service Agreement for QRX003 clinical studies has an estimated total remaining cost of approximately **$3.6 million**[119](index=119&type=chunk) - The Netherton Syndrome research program with QUT has been discontinued, while a research agreement with UCC for rapamycin formulations involves funding up to **€567,000 ($668,000)**[120](index=120&type=chunk)[121](index=121&type=chunk) [Critical Accounting Estimates](index=35&type=section&id=Critical%20Accounting%20Estimates) This section confirms no material changes to the company's critical accounting estimates from the prior annual report - There have been no material changes to the company's critical accounting estimates from those reported in its Annual Report on Form 10-K for the year ended **December 31, 2024**[122](index=122&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk.](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Quoin Pharmaceuticals Ltd. is exempt from providing quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide information under this item[123](index=123&type=chunk) [Item 4. Controls and Procedures.](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures.) This section details the evaluation of the company's disclosure controls and procedures and reports on any changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=36&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section reports on management's conclusion regarding the effectiveness of disclosure controls and procedures - Management, with CEO and CFO participation, concluded that disclosure controls and procedures were effective at the reasonable assurance level as of **June 30, 2025**[124](index=124&type=chunk) [Changes in Internal Control over Financial Reporting](index=36&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section confirms that there were no material changes in internal control over financial reporting during the quarter - There were no material changes in internal control over financial reporting during the quarter ended **June 30, 2025**[125](index=125&type=chunk) [PART II – OTHER INFORMATION](index=37&type=section&id=PART%20II%E2%80%93OTHER%20INFORMATION) This section covers legal proceedings, updated risk factors, equity sales, defaults, mine safety disclosures, other information, and exhibits [Item 1. Legal Proceedings.](index=37&type=section&id=Item%201.%20Legal%20Proceedings.) The company is not currently involved in any material legal or administrative proceedings - The company is not a party to any material legal or administrative proceedings, nor is it aware of any pending or threatened material proceedings[127](index=127&type=chunk) [Item 1A. Risk Factors.](index=37&type=section&id=Item%201A.%20Risk%20Factors.) This section updates and reiterates key risk factors, particularly focusing on the company's ability to maintain Nasdaq listing compliance and its ongoing need for additional capital to continue operations given its history of losses [Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of our ADSs.](index=37&type=section&id=Our%20failure%20to%20meet%20the%20continued%20listing%20requirements%20of%20The%20Nasdaq%20Capital%20Market%20could%20result%20in%20a%20delisting%20of%20our%20ADSs.) This section discusses the risk of delisting from Nasdaq due to failure to meet continued listing requirements, despite recent compliance efforts - The company regained Nasdaq compliance on **April 29, 2025**, after a **1-for-35 ADS reverse split** on **April 9, 2025**, to meet the minimum bid price requirement[130](index=130&type=chunk) - If the company falls out of compliance before **April 9, 2026**, it would not be eligible for an automatic grace period and would face immediate delisting[131](index=131&type=chunk) - Delisting would negatively impact liquidity, the ability to raise future capital, and could lead to lower stock prices and increased trading difficulties[132](index=132&type=chunk)[133](index=133&type=chunk)[136](index=136&type=chunk) [We must raise additional capital to fund our operations in order to continue as a going concern.](index=39&type=section&id=We%20must%20raise%20additional%20capital%20to%20fund%20our%20operations%20in%20order%20to%20continue%20as%20a%20going%20concern.) This section highlights the critical need for additional capital to fund operations and address substantial doubt about the company's going concern ability - As of **June 30, 2025**, the company had an accumulated deficit of **$62.7 million** and cash/investments of **$7.8 million**, leading to substantial doubt about its ability to continue as a going concern[137](index=137&type=chunk) - Additional capital is required through equity, debt, strategic relationships, or grants, and failure to secure it could force the company to curtail or cease operations[137](index=137&type=chunk) [We have incurred significant losses since our inception and have limited cash available for our operations.](index=39&type=section&id=We%20have%20incurred%20significant%20losses%20since%20our%20inception%20and%20have%20limited%20cash%20available%20for%20our%20operations.) This section details the company's history of significant losses and limited cash, emphasizing the need for substantial future funding - The company has incurred net losses every year since inception, with an accumulated deficit of approximately **$62.7 million** at **June 30, 2025**[138](index=138&type=chunk) - Current cash and cash equivalents, along with investments, total **$7.8 million**, which is deemed insufficient for operating the business for the next twelve months[138](index=138&type=chunk) - Expenses are expected to increase substantially with continued clinical development, regulatory approvals, commercialization efforts, and expansion of intellectual property and infrastructure[139](index=139&type=chunk)[140](index=140&type=chunk)[147](index=147&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.](index=41&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company reported no unregistered sales of equity securities or use of proceeds during the period - None[143](index=143&type=chunk) [Item 3. Defaults Upon Senior Securities.](index=41&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) The company reported no defaults upon senior securities during the period - None[144](index=144&type=chunk) [Item 4. Mine Safety Disclosures.](index=41&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to the company - Not applicable[145](index=145&type=chunk) [Item 5. Other Information.](index=41&type=section&id=Item%205.%20Other%20Information.) No Rule 10b5-1 trading arrangements were adopted or terminated by directors or executive officers during the second quarter of 2025 - None of the directors or executive officers adopted or terminated any 'Rule 10b5-1 trading arrangement' or 'non-Rule 10b5-1 trading arrangement' during the second quarter of **2025**[146](index=146&type=chunk) [Item 6. Exhibits.](index=42&type=section&id=Item%206.%20Exhibits.) This section lists all exhibits filed as part of the Form 10-Q, including corporate governance documents, certifications, and financial data in XBRL format - Exhibits include Amended and Restated Articles of Association, CEO and CFO certifications (pursuant to Rules 13a-14(a) or 15d-14(a) and 18 U.S.C. Section 1350), and financial information formatted in Inline XBRL[148](index=148&type=chunk) [SIGNATURES](index=43&type=section&id=SIGNATURES) This section contains the official signatures for the Form 10-Q report [Report Signatures](index=43&type=section&id=Report%20Signatures) The Form 10-Q report was duly signed on behalf of Quoin Pharmaceuticals Ltd. by its Chief Financial Officer - The report was signed by Gordon Dunn, Chief Financial Officer of Quoin Pharmaceuticals Ltd., on **August 7, 2025**[150](index=150&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk) ```

[Introduction](index=1&type=section&id=Introduction) [Company Overview](index=1&type=section&id=Company%20Overview) Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, announcing its Q2 2025 financial results and corporate updates - **Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX)** is a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases[1](index=1&type=chunk) [CEO Statement](index=1&type=section&id=CEO%20Statement) CEO Dr. Michael Myers highlighted Q2 2025 as impactful, citing positive clinical improvements in the pediatric Netherton Syndrome study, impressive Peeling Skin Syndrome data, and the versatility of QRX003. Key regulatory milestones included Orphan Drug Designation in Europe and Rare Pediatric Disease Designation in the US, expected to accelerate QRX003 development. The NETHERTON NOW campaign continues to raise awareness - CEO Dr. Michael Myers stated **Q2 2025** was impactful with meaningful progress on multiple fronts, including **positive and durable clinical improvements** in the ongoing investigator-led pediatric Netherton Syndrome study[2](index=2&type=chunk) - **Impressive Peeling Skin Syndrome data** reported, demonstrating **QRX003's versatility** as a potentially safe and effective treatment for various rare skin diseases[2](index=2&type=chunk) - Received **Orphan Drug Designation in Europe** and **Rare Pediatric Disease Designation in the United States**, expected to help **accelerate QRX003 development**[2](index=2&type=chunk) - The **NETHERTON NOW campaign** continues to elevate awareness for effective Netherton Syndrome treatment options[2](index=2&type=chunk) [Corporate Highlights](index=1&type=section&id=Corporate%20Highlights) [Key Achievements in Q2 2025](index=1&type=section&id=Key%20Achievements%20in%20Q2%202025) Quoin Pharmaceuticals made significant progress in Q2 2025, advancing its lead clinical asset QRX003 into pivotal trials for Netherton Syndrome. Key achievements include positive clinical data for Netherton and Peeling Skin Syndromes, FDA clearance for a second pivotal Netherton study, and important regulatory designations in both Europe and the US - Advanced lead clinical asset, **QRX003**, into **pivotal trials for Netherton Syndrome**, a devastating and life-threatening genetic skin disorder with **no approved therapies**[3](index=3&type=chunk) - Reported **positive 6-month clinical data** for ongoing pediatric Netherton Syndrome study and **initial positive data** from Peeling Skin Syndrome pediatric study[3](index=3&type=chunk) - **FDA cleared a second pivotal study** of QRX003 for Netherton Syndrome[3](index=3&type=chunk) - Granted **Orphan Drug Designation by European Medicines Agency** and **Rare Pediatric Disease Designation by U.S. FDA** for QRX003[3](index=3&type=chunk) [Detailed Clinical and Regulatory Milestones](index=2&type=section&id=Detailed%20Clinical%20and%20Regulatory%20Milestones) Q2 2025 saw several specific milestones for QRX003, including positive clinical data for Netherton and Peeling Skin Syndromes, FDA clearance for a second pivotal Netherton study, and key regulatory designations from both the EMA and FDA, alongside continued expansion of the NETHERTON NOW awareness campaign [Netherton Syndrome Program Updates](index=2&type=section&id=Netherton%20Syndrome%20Program%20Updates) Positive 6-month clinical data from an investigator-led pediatric Netherton Syndrome study showed significant improvements in skin condition and reduced itch with no adverse events. The FDA also cleared a second pivotal clinical study (CL-QRX003-002) for Netherton Syndrome, with recruitment expected to conclude by Q1 2026 and an NDA filing anticipated later in 2026 - **Positive clinical data** from ongoing Investigator Pediatric Netherton Syndrome study reported on April 2, 2025, showing **significant improvements** in patient's skin condition and **reduced itch** after six months of QRX003 treatment, with **no adverse events**[4](index=4&type=chunk) - **FDA clearance** announced on May 22, 2025, for the initiation of a **second pivotal clinical study (CL-QRX003-002)** for QRX003, targeting Netherton Syndrome[8](index=8&type=chunk) - The second pivotal study will include **12–15 subjects**, with **recruitment expected to conclude by the end of Q1 2026** and an **NDA filing anticipated later in 2026**[8](index=8&type=chunk) [Peeling Skin Syndrome Program Updates](index=2&type=section&id=Peeling%20Skin%20Syndrome%20Program%20Updates) Initial positive clinical data from an investigator-led Pediatric Peeling Skin Syndrome (PSS) study demonstrated improvements in disease severity, skin condition, and quality of life metrics after 12 weeks of QRX003 treatment, with no adverse events - **Positive clinical data** announced on May 14, 2025, from an investigator-led Pediatric Peeling Skin Syndrome (PSS) study[6](index=6&type=chunk) - After **12 weeks of treatment** with QRX003, patients showed **improvement in disease severity, skin condition, and quality of life metrics**, with **no adverse events** reported[6](index=6&type=chunk) [Regulatory Designations](index=2&type=section&id=Regulatory%20Designations) QRX003 received Orphan Drug Designation from the European Medicines Agency, granting 10 years of market exclusivity in Europe upon approval, along with scientific advice and fee reductions. The FDA also granted Rare Pediatric Disease Designation for QRX003 for Netherton Syndrome, potentially enabling Priority Review Voucher eligibility - On May 20, 2025, the Company received Orphan Drug Designation from the European Medicines Agency for QRX003, granting **10 years of market exclusivity in Europe** upon approval and offering benefits like scientific advice on study protocols and fee reductions[7](index=7&type=chunk) - On June 24, 2025, the FDA granted **Rare Pediatric Disease Designation** to QRX003 for the treatment of Netherton Syndrome, enabling potential **Priority Review Voucher eligibility** upon marketing approval[9](index=9&type=chunk) [Advocacy Initiatives](index=2&type=section&id=Advocacy%20Initiatives) Quoin continued to expand its NETHERTON NOW awareness campaign, releasing new episodes in its 'Living with Netherton' video series to highlight patient challenges and featuring expert insights on the severe burden of Netherton Syndrome in pediatric patients - On April 10, 2025, Quoin released the **second episode** in its 'Living with Netherton' video series, part of its broader **NETHERTON NOW awareness campaign**, highlighting the daily challenges faced by patients and families[5](index=5&type=chunk) - On June 26, 2025, Quoin launched a new installment in its **NETHERTON NOW campaign**, featuring Professor Jemima Mellerio, a world-renowned expert, emphasizing the **severe burden of Netherton Syndrome in pediatric patients**[10](index=10&type=chunk) [Financial Highlights](index=2&type=section&id=Financial%20Highlights) [Cash Position](index=2&type=section&id=Cash%20Position) As of June 30, 2025, Quoin Pharmaceuticals held approximately $7.8 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into Q1 2026 - Cash, cash equivalents, and marketable securities as of June 30, 2025: approximately **$7.8 million**[11](index=11&type=chunk) - The Company believes this capital will support operations into the **first quarter of 2026**[11](index=11&type=chunk) [Net Loss](index=3&type=section&id=Net%20Loss) Quoin reported an increased net loss for Q2 2025 and the six months ended June 30, 2025, primarily driven by a significant increase in research and development expenditures compared to the same periods in 2024 Net Loss and R&D Expenditure Comparison | Period | Net Loss (2025) | Net Loss (2024) | R&D Expenditure (2025) | R&D Expenditure (2024) | Change in Net Loss (YoY) | Change in R&D (YoY) | | :------------------- | :---------------- | :---------------- | :----------------------- | :----------------------- | :----------------------- | :-------------------- | | Three months ended June 30 | ~$3.7 million | ~$2.0 million | ~$2.1 million | ~$0.6 million | Increased by ~$1.7 million | Increased by ~$1.5 million | | Six months ended June 30 | ~$7.5 million | ~$4.3 million | ~$4.4 million | ~$1.5 million | Increased by ~$3.2 million | Increased by ~$2.9 million | - Net loss for the three months ended June 30, 2025, increased to approximately **$3.7 million** from **$2.0 million** in the prior year, primarily due to a rise in R&D expenditure from **$0.6 million** to **$2.1 million**[12](index=12&type=chunk)[17](index=17&type=chunk) - Net loss for the six months ended June 30, 2025, increased to approximately **$7.5 million** from **$4.3 million** in the prior year, primarily due to a rise in R&D expenditure from **$1.5 million** to **$4.4 million**[12](index=12&type=chunk)[17](index=17&type=chunk) [About Quoin Pharmaceuticals Ltd.](index=3&type=section&id=About%20Quoin%20Pharmaceuticals%20Ltd.) Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company dedicated to developing and commercializing therapies for rare and orphan diseases. Its pipeline includes four products targeting a broad range of indications such as Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, and others - Quoin Pharmaceuticals Ltd. is a **late clinical-stage specialty pharmaceutical company** focused on developing and commercializing therapeutic products that treat **rare and orphan diseases**[13](index=13&type=chunk) - Quoin's innovative pipeline comprises **four products** in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Microcystic Lymphatic Malformations, Venous Malformations, and Angiofibroma[13](index=13&type=chunk) [Cautionary Note Regarding Forward Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward%20Looking%20Statements) This section advises that statements not based on historical facts are forward-looking and subject to risks and uncertainties, meaning actual results may differ materially. It lists various forward-looking statements made in the press release and highlights potential risks, including the ability to deliver safe treatments, obtain regulatory approvals, complete trials, and manage costs. The company disclaims any obligation to update these statements - Statements in this press release that are not descriptions of historical facts are **forward-looking statements** within the meaning of the Private Securities Litigation Reform Act of 1995, and actual results may differ materially due to risks and uncertainties[14](index=14&type=chunk) - Forward-looking statements include expectations regarding **clinical improvements, QRX003 versatility, initiation of new studies, acceleration of development due to designations, campaign awareness, delivering the first approved Netherton Syndrome therapy, recruitment timelines, NDA filing, capital sufficiency, and product pipeline potential**[14](index=14&type=chunk) - Risks and uncertainties include the Company's ability to **deliver a safe and effective treatment, pursue its regulatory strategy, obtain regulatory approvals, complete clinical trials on time, achieve desired results, and manage unanticipated or higher than expected clinical trial costs**[14](index=14&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, Quoin's total assets decreased significantly to $8.91 million from $15.71 million at December 31, 2024, primarily due to reductions in cash, cash equivalents, and investments. Total liabilities slightly decreased, while total shareholders' equity saw a substantial reduction from $9.20 million to $2.55 million, largely due to an increased accumulated deficit Consolidated Balance Sheet Highlights | Item | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :-------------- | :---------------- | :------------------- | | Cash and cash equivalents | $1,668,492 | $3,623,343 | -$1,954,851 | | Investments | $6,121,830 | $10,433,535 | -$4,311,705 | | Total current assets | $8,479,255 | $14,926,004 | -$6,446,749 | | Total assets | $8,912,589 | $15,709,338 | -$6,796,749 | | Total current liabilities | $4,337,499 | $4,180,932 | +$156,567 | | Total liabilities | $6,361,232 | $6,504,665 | -$143,433 | | Total shareholders' equity | $2,551,357 | $9,204,673 | -$6,653,316 | | Accumulated deficit | $(62,673,909) | $(55,165,792) | -$7,508,117 | [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) For the three and six months ended June 30, 2025, Quoin reported increased net losses compared to the prior year, primarily driven by a substantial rise in research and development expenses. Basic and fully-diluted loss per ADS also decreased significantly year-over-year for both periods, despite the increased net loss, due to a higher weighted average number of ADS's outstanding Consolidated Statements of Operations Highlights | Item | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | General and administrative | $1,742,594 | $1,549,615 | $3,325,632 | $3,122,601 | | Research and development | $2,050,585 | $587,503 | $4,424,724 | $1,472,801 | | Total operating expenses | $3,793,179 | $2,137,118 | $7,750,356 | $4,595,402 | | Net loss | $(3,695,938) | $(1,974,033) | $(7,508,117) | $(4,301,313) | | Loss per ADS (Basic) | $(6.28) | $(13.68) | $(12.79) | $(42.09) | | Weighted average ADS's outstanding (Basic) | 588,166 | 144,278 | 587,253 | 102,186 | - Net loss for the three months ended June 30, 2025, increased to approximately **$3.7 million** from **$2.0 million** in the prior year, primarily due to a rise in R&D expenditure from **$0.6 million** to **$2.1 million**[12](index=12&type=chunk)[17](index=17&type=chunk) - Net loss for the six months ended June 30, 2025, increased to approximately **$7.5 million** from **$4.3 million** in the prior year, primarily due to a rise in R&D expenditure from **$1.5 million** to **$4.4 million**[12](index=12&type=chunk)[17](index=17&type=chunk) [Contact Information](index=4&type=section&id=Contact%20Information) This section provides contact details for Quoin Pharmaceuticals Ltd., including the CEO, Dr. Michael Myers, and for investor relations through PCG Advisory, Jeff Ramson - Contact for Quoin Pharmaceuticals Ltd.: **Michael Myers, Ph.D., CEO** (mmyers@quoinpharma.com)[15](index=15&type=chunk) - Investor Contact: **PCG Advisory, Jeff Ramson** (jramson@pcgadvisory.com, (646) 863-6341)[15](index=15&type=chunk)