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Quoin Pharmaceuticals Announces Corporate Update and Third Quarter 2025 Financial Results
Globenewswire· 2025-11-06 13:30
Core Insights - Quoin Pharmaceuticals has made significant advancements in its clinical programs, particularly for Netherton Syndrome and Peeling Skin Syndrome, with positive data emerging from ongoing studies [2][3][4] - The company closed a private placement financing in October 2025, raising up to $105.3 million to support operations and R&D efforts [1][4] - Sally Lawlor has been appointed as CFO to enhance the company's financial operations and support its commercialization strategy [1][3][7] Financial Highlights - As of September 30, 2025, Quoin reported a net loss of approximately $3.9 million for the third quarter and $11.5 million for the nine months, an increase from $2.3 million and $6.7 million in the same periods of 2024 [11][17] - The company had approximately $5.4 million in cash and cash equivalents, which, along with the recent financing, is expected to support operations into 2027 [10][11] - Operating expenses for the third quarter totaled approximately $4.0 million, with research and development costs significantly increasing compared to the previous year [17] Clinical and Regulatory Developments - The FDA awarded orphan drug designation to QRX003 for Netherton Syndrome, and pivotal studies for this treatment are set to begin enrollment in Q4 2025 [1][4] - The pediatric clinical program for Netherton Syndrome has been expanded based on positive long-term safety and efficacy data [1][2] - The NETHERTON NOW awareness campaign has gained significant traction, achieving over 1.5 million views within six months of its launch [1][8]
Quoin Pharmaceuticals Announces Recruitment of Three Additional Patients in Investigator Pediatric Netherton Syndrome Study and Provides Positive 9 month ‘Whole Body’ Data Update from Ongoing Study
Globenewswire· 2025-10-28 12:30
Core Insights - Quoin Pharmaceuticals Ltd. has announced the recruitment of three additional pediatric patients for its investigator-led study on Netherton Syndrome (NS) and reported highly positive clinical data from the first pediatric patient after 9 months of treatment with QRX003 [1][3][4] Group 1: Clinical Data and Patient Outcomes - The first pediatric patient treated with QRX003 showed complete healing of the skin after 9 months, with the Investigator's Global Assessment (IGA) score improving from 4 (severe) to 0 (clear) [2][6] - The patient's pruritus score decreased from 5 at baseline to 0 at 9 months, indicating a complete absence of itching [2][6] - The patient has experienced zero nightly sleep disturbances and has not required previously necessary medications such as antibiotics, antivirals, antihistamines, and glucocorticoids during the treatment period [2][4] Group 2: Recruitment and Future Expectations - Three additional pediatric subjects have been recruited for the NS study, with two located in Austria and one in Ireland, all set to receive QRX003 for an initial period of twelve weeks [3][4] - The company anticipates that data from these new subjects will further support the positive clinical outcomes associated with QRX003 as a treatment for NS [3][4] Group 3: About Netherton Syndrome and QRX003 - Netherton Syndrome is a rare hereditary skin disorder caused by a mutation in the SPINK5 gene, leading to severe skin barrier defects and a predisposition to allergies and infections [5][6] - QRX003 is a topical lotion designed to restore skin barrier function by acting as a serine protease inhibitor, addressing the underlying issues caused by the absence of the LEKTI protein in patients [6][7]
Quoin Pharmaceuticals Announces U.S. FDA Grants Orphan Drug Designation for QRX003 in Netherton Syndrome
Globenewswire· 2025-10-21 12:30
Core Points - Quoin Pharmaceuticals has received Orphan Drug Designation from the FDA for its product QRX003, aimed at treating Netherton Syndrome, following a similar designation from the EMA in May 2025 [1][2][3] - The FDA's Orphan Drug Designation provides benefits such as tax credits for clinical testing, waiver of FDA application fees, and seven years of market exclusivity upon approval [2] - QRX003 is currently undergoing two late-stage pivotal clinical trials, with enrollment expected to complete in Q1 2026 and top-line data anticipated in the second half of 2026 [3] Company Overview - Quoin Pharmaceuticals is a late clinical-stage specialty pharmaceutical company focused on developing treatments for rare and orphan diseases [4] - The company's pipeline includes products targeting various rare conditions, including Netherton Syndrome, Peeling Skin Syndrome, and others [4]
Recent Market Movements: Top Gainers Analysis
Financial Modeling Prep· 2025-10-10 22:00
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]
Quoin Pharmaceuticals Announces Private Placement Financing of Up to $104.5 Million
Globenewswire· 2025-10-10 13:24
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].
Quoin Pharmaceuticals’ NETHERTON NOW Campaign Surpasses One Million Video Views, Amplifying Global Awareness of Netherton Syndrome
Globenewswire· 2025-08-21 12:30
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]
Quoin Pharmaceuticals Appoints New Chief Financial Officer to Support Commercialization Strategy
Globenewswire· 2025-08-18 12:30
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]
Quoin Pharmaceuticals Releases Fourth Episode in NETHERTON NOW Video Series Featuring International Patient Advocate Mandy Aldwin-Easton
Globenewswire· 2025-08-12 12:30
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].
Quoin (QNRX) Q2 Loss Beats Estimates
The Motley Fool· 2025-08-08 04:14
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]
Quoin Pharmaceuticals Announces Second Quarter 2025 Financial Results and Corporate Update
Globenewswire· 2025-08-07 12:30
Core Insights - Quoin Pharmaceuticals reported significant clinical progress in its ongoing studies for QRX003, particularly for Netherton Syndrome and Peeling Skin Syndrome, with positive data indicating improvements in patient conditions [2][3][5] - The company received important regulatory designations, including Orphan Drug Designation from the European Medicines Agency and Rare Pediatric Disease Designation from the U.S. FDA, which are expected to accelerate the development of QRX003 [6][8] - The NETHERTON NOW campaign has been expanded to raise awareness about Netherton Syndrome, highlighting the urgent need for effective treatments [2][4][9] Clinical Developments - Positive clinical data from the pediatric Netherton Syndrome study showed significant improvements in skin condition and reduced itch after six months of treatment with QRX003, with no adverse events reported [3] - The Peeling Skin Syndrome study also reported positive outcomes after 12 weeks of treatment, with improvements in disease severity and quality of life metrics [5] - A second pivotal study for QRX003 targeting Netherton Syndrome has been cleared by the FDA, with recruitment expected to conclude by the end of Q1 2026 [7] Financial Overview - As of June 30, 2025, Quoin had approximately $7.8 million in cash and cash equivalents, which is projected to support operations into Q1 2026 [10] - The company reported a net loss of approximately $3.7 million for Q2 2025, an increase from a net loss of approximately $2.0 million in Q2 2024, primarily due to increased research and development expenditures [11][17] - Total operating expenses for the six months ended June 30, 2025, were approximately $7.75 million, compared to $4.60 million for the same period in 2024 [17]