Tillkännagivande • Jul 09
Quoin Pharmaceuticals Receives FDA IND Clearance to Initiate Phase 2 Study of QRX003 in Peeling Skin Syndrome Quoin Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for QRX003 for the treatment of Peeling Skin Syndrome (PSS), enabling initiation of its planned Phase 2 clinical study. Clearance enables Quoin to initiate a Phase 2 clinical study of QRX003 in Peeling Skin Syndrome in the second half of 2026. The study is expected to enroll 6-8 pediatric and adult patients in the United States and Europe. The IND is the first ever submitted to the FDA for Peeling Skin Syndrome, and its clearance now enables the first company-sponsored formal clinical study for the disease to be conducted. PSS is the second IND cleared indication for QRX003, in addition to Netherton Syndrome. In an ongoing investigator-led pediatric study, subject achieved clinically meaningful improvements by 12 weeks across key objective severity endpoints Modified Ichthyosis Area Severity Index (M-IASI), Investigator’s Global Assessment (IGA) and a pediatric dermatology-specific quality-of-life measure (CDLQI). Treatment is ongoing and after continued dosing with QRX003 for over 15 months, no adverse events have been reported. FDA expressed no safety concerns regarding study design and duration of dosing. Quoin submitted the IND on June 2, 2026, and received FDA clearance in July 2026. The Phase 2 study is expected to recruit 6-8 pediatric and adult patients with PSS in both the United States and Europe. In the Phase 2 study, QRX003 will be applied twice-daily to greater than 80% of the patients’ body surface area (BSA) over a 52-week period. The Company is targeting the approval of QRX003 as a potential treatment for PSS in 2028. Generalized inflammatory peeling skin syndrome (PSS) is a rare autosomal recessive genodermatosis caused by loss-of-function disease-causing variants of the corneodesmosin gene (CDSN), resulting in excessive shedding of the superficial layers of the epidermis. Patients generally suffer from a variety of conditions including severe pain and chronic pruritus (itch). There is currently no approved treatment for PSS. QRX003 is an investigational topical serine protease inhibitor lotion in late-stage development for Netherton Syndrome and other orphan skin diseases. QRX003 has been granted Orphan Drug, Rare Pediatric Disease, and Fast Track designations by the U.S. Food and Drug Administration, and Orphan Drug Designation in the European Union and Japan for Netherton Syndrome. QRX003 lotion (4%) is currently being evaluated in Phase 2 whole-body clinical trials in patients with Netherton Syndrome. Quoin’s pivotal Phase 3 study is expected to initiate in the second half of 2026, with a potential NDA filing in 2027. QRX003 is also being evaluated for the treatment of Peeling Skin Syndrome. Tillkännagivande • Jul 07
Quoin Pharmaceuticals, Ltd., Annual General Meeting, Aug 20, 2026 Quoin Pharmaceuticals, Ltd., Annual General Meeting, Aug 20, 2026. Location: at the offices of blank rome llp, one logan square, pa 19103., philadelphia United States Tillkännagivande • Jul 01
Quoin Pharmaceuticals Receives Notice Of Allowance For Patent Covering Combination Treatment For Netherton Syndrome Quoin Pharmaceuticals Ltd. has announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 18/428,570, titled “Combination Treatment for Netherton Syndrome.” The patent supports Quoin’s intellectual property strategy for QRX003, its investigational treatment for Netherton Syndrome, a rare genetic skin disease for which there are currently no approved treatments. The USPTO has issued a Notice of Allowance for U.S. Patent Application No. 18/428,570, titled “Combination Treatment for Netherton Syndrome.” The allowed claims cover a method of treating Netherton Syndrome using a topical serine protease inhibitor, dipalmitoyl hydroxyproline, together with an anti-inflammatory agent. The claims include treatment of patients carrying SPINK5 mutations, the genetic basis of Netherton Syndrome. The patent will be granted following payment of the issue fee. QRX003 (QYLEKI™), Quoin’s investigational topical treatment for Netherton Syndrome, holds Orphan Drug, Rare Pediatric Disease, and Fast Track designations in the United States and Orphan Drug Designation in the European Union and Japan. If approved, QRX003 has the potential to become the first approved treatment for Netherton Syndrome. The allowed claims cover a method of treating Netherton Syndrome by administering a topical serine protease inhibitor, dipalmitoyl hydroxyproline, together with an anti-inflammatory agent. The claims include treatment of patients who carry mutations in the SPINK5 gene, the genetic basis of the disease, and cover application to skin lesions on the arms and lower legs. The allowed claims add to Quoin’s intellectual property position around its topical treatment approach for Netherton Syndrome and support the Company’s long-term commercialization strategy for QRX003. The Notice of Allowance indicates that the application has completed substantive examination and is expected to proceed to issuance following payment of the required fees. Once granted, the patent will add to the Company’s intellectual property position in the United States covering its Netherton Syndrome program. Netherton Syndrome is a rare, serious genetic skin disease caused by mutations in the SPINK5 gene. The condition is characterized by impaired skin barrier function, persistent inflammation, and increased serine protease activity in the skin. There are currently no approved therapies in the United States indicated specifically for Netherton Syndrome. QRX003 is an investigational topical serine protease inhibitor lotion in late-stage development for Netherton Syndrome and other orphan skin diseases. QRX003 has been granted Orphan Drug, Rare Pediatric Disease, and Fast Track designations by the U.S. Food and Drug Administration, and Orphan Drug Designation in the European Union and Japan. The U.S. brand name QYLEKI™ has been accepted by the FDA. QRX003 lotion (4%) is currently being evaluated in Phase 2 whole-body clinical trials in patients with Netherton Syndrome. Quoin’s pivotal Phase 3 study is expected to initiate in the second half of 2026, with a potential NDA filing in 2027. New Risk • Jun 25
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 13% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$16m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Shareholders have been substantially diluted in the past year (241% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (€5.75m market cap, or US$6.53m). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$7.4m net loss in 3 years). Tillkännagivande • Jun 24
Quoin Pharmaceuticals Announces FDA Conditional Approval of Qyleki as Proposed Brand Name for QRX003 for Netherton Syndrome Quoin Pharmaceuticals Ltd. issued a press release announcing that the U.S. Food and Drug Administration (the FDA) has conditionally approved QYLEKI as the proposed brand name for QRX003, the Company's investigational product candidate for the treatment of Netherton Syndrome. FDA acceptance of the Company's proposed brand name represents a milestone for the Company as it executes on its mission to deliver the first approved treatment for Netherton Syndrome. The Company expects to include a request for proprietary name review and final approval for QYLEKI in a New Drug Application (NDA) for QRX003. The FDA has conditionally accepted QYLEKI as the proposed brand name for QRX003, Quoin's investigational topical treatment for Netherton Syndrome. QRX003 holds Orphan Drug Designation in the United States, the European Union, and Japan. The FDA has also granted QRX003 Fast Track and Rare Pediatric Disease Designations. Quoin's pivotal Phase 3 study is expected to initiate in the second half of 2026. A potential NDA filing is anticipated in 2027. There is currently no approved treatment for Netherton Syndrome. If approved, QRX003 could become the first. The proposed name QYLEKI (pronounced "Key-Lek-ee") was developed in accordance with the FDA's guidance on proprietary names. Final approval of the QYLEKI brand name will be obtained upon FDA marketing approval of QRX003. QYLEKI lotion (4%) is currently being evaluated in Phase 2 whole-body clinical trials in patients with Netherton Syndrome. Quoin's pivotal Phase 3 study is expected to initiate in the second half of 2026, with a potential NDA filing in 2027. QYLEKI has received Orphan Drug Designation in the United States, the European Union, and Japan, along with Fast Track and Rare Pediatric Disease Designations from the FDA, providing regulatory recognition across Quoin's three core commercial territories. Netherton Syndrome is a rare, inherited skin disorder caused by mutations in the SPINK5 gene, leading to severe skin barrier dysfunction, chronic inflammation, and a heightened risk of infections and allergic complications. Patients often experience widespread skin redness, scaling, persistent itching, and significant impairment in quality of life. There are currently no FDA-approved therapies for the treatment of Netherton Syndrome, and treatment options are limited to supportive care and off-label therapies. Quoin's innovative pipeline is focused on two key platform products, QRX003 and QRX009, that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, microcystic lymphatic malformations, venous malformations, angiofibromas and others. Tillkännagivande • Jun 16
Quoin Pharmaceuticals Announces Positive Clinical Update from Ongoing Pediatric Netherton Syndrome Compassionate Use Program Quoin Pharmaceuticals Ltd. announced a positive clinical update from its ongoing pediatric Netherton Syndrome (NS) Compassionate Use program. Six pediatric NS patients are currently enrolled in the program, all under 10 years of age, with the youngest being just 6 months old. Four of the six children in the study were classified as ‘Improved’ or ‘Significantly Improved’ from baseline across key clinical endpoints at the time of this release. Three of the four treatment responders achieved a minimum of a one-grade improvement from baseline according to an Investigator’s Global Assessment (IGA) (Scale 0-clear to 4-severe), with one patient achieving a full 5-grade improvement from 4 (severe) at baseline to 0 (clear) at nine months, and the patient continues to remain clear at 15 months. Of these three responders, two achieved at least a 4-grade improvement from baseline for pruritus (scale 0-10), with one patient’s pruritus being completely eliminated. The third responder started with pruritus of 1 and remained at 1 during treatment. The fourth, and youngest patient responder is 6 months old and has only been on treatment for 3 weeks. At baseline, the patient required the application of emollients to their skin 12 times a day, every 2 hours. After 3 weeks of dosing with QRX003, as a result of improvements in the infant’s skin, the parents are using almost no emollient on the treated body sites. In addition, prior to receiving QRX003, the infant’s neutrophil levels were extremely low putting the infant at significant risk of infection complications. After just 3 weeks of treatment with QRX003, these levels have been fully restored to normal levels, which is yet another clear indication of a positive treatment effect. Two of the six patients have not achieved any improvement to date, though for one of these the duration of treatment has been less than 8 weeks and the patient remains on treatment. An additional patient was enrolled into the program on June 15th and two others are scheduled to begin treatment by the end of September. There have been no reports of treatment related adverse events for any of the six patients in the program. Quoin plans a comprehensive release of clinical data from this program and from its ongoing Phase 2 studies in the coming months. Netherton Syndrome, a form of Ichthyosis, is a rare hereditary skin disorder caused by a mutation in the SPINK5 gene (serine protease inhibitor, Kazal Type 5) that leads to severe skin barrier defects and recurring infections, as well as a pronounced predisposition to allergies, asthma, and eczema. Patients often suffer from severe dehydration, chronic skin inflammation and stunted growth. Currently, there is no cure for Netherton Syndrome, nor are there any approved therapeutic treatments. QRX003 is a topical lotion formulated with a proprietary delivery technology that contains a broad-spectrum serine protease inhibitor, whose mechanism of action is intended to perform the function of a specific protein called LEKTI. The absence of LEKTI in Netherton patients leads to excessive skin shedding, resulting in a highly porous and compromised skin barrier. QRX003 is designed to promote a more normalized skin-shedding process and the formation of a stronger and more effective skin barrier. Tillkännagivande • Jun 03
Quoin Pharmaceuticals Submits Ind Application for Qrx003 in Peeling Skin Syndrome Quoin Pharmaceuticals Ltd. announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for QRX003 for the treatment of Peeling Skin Syndrome (PSS). Pending FDA review, Quoin expects to initiate a Phase 2 clinical study in the second half of 2026. The IND submission is supported by clinical observations from Quoin's ongoing investigator-led pediatric PSS study. The initial subject has been treated with QRX003 for over 15 months and significant clinical improvements in skin, sleep patterns and overall quality of life have been achieved. QRX003 has been well tolerated, with no adverse events reported. The Phase 2 study is expected to recruit 6-8 pediatric and adult patients with PSS in both the US and Europe. QRX003 is the second indication for the product, in addition to Netherton Syndrome. Board Change • May 21
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. No highly experienced directors. Co-Founder, CEO & Chairman Michael Myers was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Tillkännagivande • Mar 27
Quoin Pharmaceuticals Ltd. Provides Clinical and Regulatory Update for Qrx003 in Netherton Syndrome Quoin Pharmaceuticals Ltd. provided a clinical and regulatory update from its recent constructive Type C meeting with the U.S. Food and Drug Administration (FDA) for its lead product candidate, QRX003, for the treatment of Netherton Syndrome (NS). FDA acknowledged that a single Phase 3 study may be sufficient to support U.S. marketing approval of QRX003 for Netherton Syndrome, rather than the two Phase 3 studies the Company had originally contemplated. With an established network of U.S. and EU clinical trial sites, the company will be in a position to initiate a pivotal Phase 3 program and fully complete recruitment this year. FDA also expressed openness to an alternative, innovative clinical trial design, such as a randomized withdrawal or randomized delayed start study, which may be more appropriate Phase 3 design in the setting of Netherton Syndrome than a traditional upfront randomized, controlled study. This meeting represents an important milestone for Quoin and the Netherton Syndrome community at large. Key highlights from the meeting include: FDA indicated that a single Phase 3 study may be sufficient to support marketing approval for QRX003 for Netherton Syndrome, which is an alternative to the traditional expectation for two Phase 3 studies in NS patients originally proposed by the Company. FDA expressed openness to an alternative innovative clinical trial design such as a randomized withdrawal or a randomized delayed start for a pivotal Phase 3 study. Such trial design would likely not include a traditional upfront vehicle or placebo control. Based on the feedback from the meeting, Quoin is implementing FDA recommendations consistent with the meeting outcomes, ensuring its readiness to advance toward registrational Phase 3 development. Quoin will submit clinical data from the ongoing Phase 2 and pediatric investigator studies and plans to request a meeting to discuss this data prior to initiating the Phase 3 pivotal program for QRX003 to gain alignment with FDA on the design of the program. Quoin remains on track to complete patient recruitment into its Phase 3 program by the end of 2026 and to potentially file for FDA approval for QRX003 as the first treatment for Netherton Syndrome in 2027. Tillkännagivande • Mar 19
Quoin Pharmaceuticals, Ltd. to Report Q4, 2025 Results on Mar 26, 2026 Quoin Pharmaceuticals, Ltd. announced that they will report Q4, 2025 results Pre-Market on Mar 26, 2026 Tillkännagivande • Mar 12
Quoin Pharmaceuticals Ltd. Announces FDA Grants Fast Track Designation For QRX003 For The Treatment Of Netherton Syndrome Quoin Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome, a rare and severe genetic skin disorder for which there are currently no approved treatments. QRX003 lotion (4%) is currently being evaluated in two late-stage whole-body clinical trials designed to assess safety and efficacy in patients with Netherton Syndrome. QRX003 previously received Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency (EMA) for the treatment of Netherton Syndrome, providing potential benefits including market exclusivity upon approval, tax credits for clinical testing, and certain regulatory fee reductions. QRX003 has also been granted Pediatric Rare Disease Designation by the FDA. Netherton Syndrome is a rare, inherited skin disorder caused by mutations in the SPINK5 gene, leading to severe skin barrier dysfunction, chronic inflammation, and a heightened risk of infections and allergic complications. Patients often experience widespread skin redness, scaling, persistent itching, and significant impairment in quality of life. There are currently no FDA-approved therapies for the treatment of Netherton Syndrome, and treatment options are limited to supportive care and off-label therapies. The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. A therapy granted Fast Track Designation may benefit from more frequent interactions with the FDA, eligibility for rolling review of regulatory submissions, and potential qualification for Accelerated Approval and Priority Review, if relevant criteria are met. Tillkännagivande • Jan 28
Quoin Pharmaceuticals Announces Submission to Japanese MHLW for Orphan Drug Designation for QRX003 in Netherton Syndrome Quoin Pharmaceuticals Ltd. announced that following a successful meeting with the Japanese MHLW that it has submitted an application for Orphan Drug Designation (ODD) for its lead product candidate, QRX003, for the treatment of Netherton Syndrome. At the meeting, the MHLW confirmed that QRX003 qualifies for both ODD and Fast Track regulatory review in Japan. Quoin remains steadfastly committed to completing the clinical development of QRX003 with a high degree of urgency on behalf of patients and families living with this devastating disease." QRX003 lotion (4%) is being evaluated in two late-stage whole body pivotal clinical trials for Netherton Syndrome. Enrollment in both pivotal studies is expected to be completed in 1H 2026, top-line data is anticipated in the second half of 2026, and NDA submission is planned later in the year or early 2027. In 2025, QRX003 was granted Orphan Drug Designation for the treatment of Netherton syndrome by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Tillkännagivande • Jan 21
Quoin, Inc. Announces Application for Breakthrough Medicine Designation with the SFDA for QRX003 On January 20, 2026, the Company announced that it has filed an application for Breakthrough Medicine Designation with the SFDA for QRX003, its lead investigational, late-stage topical product candidate for the treatment of Netherton Syndrome. The SFDA's Breakthrough Medicine Designation program is designed to expedite the development, review, and potential availability of medicines that address serious or life-threatening conditions with high unmet medical need and which meet SFDA eligibility requirements, which include: Targets serious debilitating or life-threatening conditions with unmet medical need. The medicinal product is likely to offer major advantages over methods currently used. The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance. The product is not registered with any regulatory authority at the time of submission of the designation request. Quoin believes that QRX003 meets each of these eligibility requirements. If granted, the designation will allow for accelerated regulatory review and could enable earlier patient access in Saudi Arabia, potentially as early as the second half of 2026. QRX003 has received Orphan Drug and Pediatric Rare Disease Designations from the U.S. Food and Drug Administration and Orphan Drug Designation from the European Medicines Agency for the potential treatment of Netherton Syndrome. Quoin has an established distribution partnership with Genpharm for QRX003 for Saudi Arabia and other MENA countries. QRX003 lotion (4%) is currently being evaluated in two late-stage whole-body pivotal clinical trials in patients with Netherton Syndrome. Enrollment in both studies is expected to be completed in the first half of 2026, with top-line data anticipated in the second half of 20 26. QRX003 plans to submit a New Drug Application (NDA) in the United States and other territories in late 2026/early 2027, subject to successful clinical outcomes. Tillkännagivande • Nov 12
Quoin Pharmaceuticals Announces Achievement of Topical Rapamycin Target Loadings for Two Proprietary Delivery Technologies Quoin Pharmaceuticals Ltd. announced that the target loading concentrations for its two topical rapamycin delivery technologies have been successfully achieved. Specifically, a rapamycin loading concentration of 4% w/w has been achieved for Quoin's proprietary topical formulation while an even higher rapamycin concentration of 5% w/w has been formulated in a proprietary dermal patch system. The Company plans to move forward with the manufacture of clinical trial and stability batches from at least one of the delivery technologies this quarter with a view to commencing clinical testing in the first half of 2026. The initial clinical indications that have been identified by the Company as targets include Microcystic Lymphatic Malformations and Venous Malformations among others. For each of these initial targets, there are currently no FDA approved treatments or cures. Tillkännagivande • Oct 24
Quoin Pharmaceuticals, Ltd. announced that it has received $16.450005 million in funding from a group of investors On October 23, 2025, the Quoin Pharmaceuticals, Ltd. closed the transaction. The company raised the proceeds pursuant to Regulation D from 27 investors. The sales commission of $1,227,995 paid and $75,000 for legal and other out-of-pocket expenses also paid. Tillkännagivande • Oct 10
Quoin Pharmaceuticals, Ltd. announced that it expects to receive $16.450005 million in funding from a group of investors Quoin Pharmaceuticals, Ltd. announced that it has entered into a securities purchase agreement for issuance of 1,993,940 American Depository Shares (or pre-funded warrants in lieu thereof) at a combined purchase price of $8.25 per ADS ($8.2499 per pre-funded warrant) for gross proceeds of $16,450,005 on October 10, 2025. The pre-funded warrants are exercisable at $0.0001. The company will also issue Series H warrants to purchase up to 1,993,940 ADSs at an exercise price of $9.075 per ADS; Series I warrants to purchase up to 1,993,940 ADSs at an exercise price of $10.3125 per ADS; Series J warrants to purchase up to 1,993,940 ADSs at an exercise price of $12.375 per ADS; and Series K warrants to purchase up to 1,993,940 ADSs at an exercise price of $12.375 per ADS. The private placement is expected to close on or about October 14, 2025 subject to satisfaction of customary closing conditions. The offer and sale of the foregoing securities, including the ADSs, pre-funded warrants, and accompanying common warrants, are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. The transaction includes participation from new healthcare-focused investors, including Aigh Capital Management, LLC, Soleus Capital LLC, Nantahala Capital Management, LLC, Diadema Partners, Stonepine Capital Management LLC, ADAR1 Capital Management, LLC, Velan Capital Partners LP, and other investors. Tillkännagivande • Aug 18
Quoin Pharmaceuticals Ltd. Appoints Sally Lawlor as Chief Financial Officer, Effective August 18, 2025 Quoin Pharmaceuticals Ltd. on August 18, 2025 announced the appointment of its new Chief Financial Officer as the Company advances its lead product candidate, QRX003, through pivotal clinical studies and prepares for potential commercialization. Quoin has appointed Sally Lawlor, BCL, FCA, as its new Chief Financial Officer, effective August 18, 2025. Ms. Lawlor is an accomplished finance executive with over 20 years of experience in financial leadership roles in public and private companies as well as a Big Four accounting firm. In her most recent role at Sebela Pharmaceuticals, Ms. Lawlor managed financial reporting under U.S. GAAP and IFRS, oversaw global tax planning and compliance, as well as budgeting, forecasting, and external audits. Prior to Sebela, she served in senior tax leadership positions at Aptiv Plc and spent over a decade at KPMG advising multinational clients, primarily in the pharmaceutical and technology sectors. Ms. Lawlor is a Fellow of Chartered Accountants Ireland and a member of the Irish Taxation Institute. Tillkännagivande • Jul 31
Quoin Pharmaceuticals, Ltd. to Report Q2, 2025 Results on Aug 07, 2025 Quoin Pharmaceuticals, Ltd. announced that they will report Q2, 2025 results at 9:30 AM, US Eastern Standard Time on Aug 07, 2025 Tillkännagivande • Jul 10
Quoin Pharmaceuticals Ltd. Announces Mutual Separation with CFO Gordon Dunn On July 3, 2025, Quoin Pharmaceuticals Ltd. (the “Company” or “Quoin”), and Gordon Dunn, the Company’s Chief Financial Officer, agreed to a mutual separation later this year. Mr. Dunn will continue in his current role until his successor is appointed. Tillkännagivande • Jun 27
Quoin Pharmaceuticals Ltd. Releases New Netherton Now Video Featuring Professor Mellerio, International Expert in Genetic Skin Diseases Quoin Pharmaceuticals Ltd. announced the release of a new episode in its NETHERTON NOW video series. The episode features Professor Jemima Mellerio, a recognized authority in dermatology and genetic skin disorders. In the video, Professor Mellerio, Consultant Dermatologist at St John's Institute of Dermatology at Guy's and St Thomas' NHS Foundation Trust and Honorary Chair of Paediatric Dermatology at King's College London, shares her perspective on the complex and life-threatening challenges of Netherton Syndrome, particularly in infants and young children. The release of this video follows Quoin's recent announcement that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation for its lead product candidate, QRX003, for the treatment of Netherton Syndrome. Together with Orphan Drug status from the European Medicines Agency (EMA), this designation highlights the serious and underserved nature of the disease in pediatric patients. The NETHERTON NOW campaign is an ongoing initiative from Quoin to raise awareness, improve education and elevate the voices of patients, caregivers and experts in the field. Tillkännagivande • May 22
Quoin Pharmaceuticals Ltd. Announces FDA Clearance to Initiate Second Pivotal Whole Body Qrx003 Netherton Syndrome Clinical Study Quoin Pharmaceuticals Ltd. announced FDA clearance to initiate a second Netherton Syndrome (NS) pivotal clinical study CL-QRX003-002 for QRX003. Quoin's lead product, QRX003, is a topical lotion formulated with a broad-spectrum serine protease inhibitor that has been shown to significantly downregulate the hyperactivity of the kallikreins in the skin responsible for the excessive skin shedding associated with this disease. Clinical data from Quoin's ongoing studies has demonstrated clear evidence of rapid, prolonged and almost complete skin healing following twice-daily application of QRX003 to the treatment areas along with the almost complete elimination of key symptoms such as chronic, debilitating pruritus and has facilitated zero nightly sleep disturbances. Study CL-QRX003 -002 builds off of positive clinical data generated in Quoin's earlier stage open-label study where QRX003 was applied to the arms and lower legs or approximately 20% of each subject's body surface area (BSA). In this pivotal study, QRX003 will be applied to approximately 12-15 subjects twice daily to at least 80% of each of the subjects' BSA thereby generating substantially more safety and efficacy data per subject and will match how QRX003 is intended to be used if regulatory approval is obtained. Each of the U.S. and international sites has available cohorts of subjects that are ready to participate in both studies facilitating a rapid pace of recruitment which could enable Quoin to achieve its target of fully completing recruitment before the end of First Quarter 2026 and to file an NDA for regulatory approval later in the year. Tillkännagivande • May 15
Quoin Pharmaceuticals Announces Initial Positive Clinical Data for QRX003 from Pediatric Peeling Skin Syndrome Study Quoin Pharmaceuticals Ltd. announced positive initial clinical data from its ongoing Investigator Pediatric Peeling Skin Syndrome clinical study. After 12 weeks of treatment, clear evidence of skin healing in the area treated with QRX003 compared to baseline was observed. M-IASI: Modified Ichthyosis Area of Severity Index, a score used to assess the severity and extent of skin symptoms associated with ichthyosis. Lower scores indicate improvement. Generalized inflammatory peeling skin syndrome (PSS) is a rare autosomal recessive genodermatosis caused by loss-of-function disease-causing variants of the corneodesmosin gene (CDSN), resulting in excessive shedding of the superficial layers of the epidermis. Patients generally suffer from a variety of conditions including severe pain and chronic pruritus (itch). There is currently no approved treatment for PSS, and patients try to manage symptoms using over-the-counter emollients. Tillkännagivande • May 06
Quoin Pharmaceuticals, Ltd. to Report Q1, 2025 Results on May 13, 2025 Quoin Pharmaceuticals, Ltd. announced that they will report Q1, 2025 results Pre-Market on May 13, 2025 Tillkännagivande • Aug 06
Quoin Pharmaceuticals to Initiate Clinical Study for Peeling Skin Syndrome Quoin Pharmaceuticals Ltd. announced the planned initiation of an investigator-led clinical study in New Zealand to evaluate the safety and efficacy of QRX003 in a pediatric patient with Peeling Skin Syndrome (PSS). QRX003 is Quoin’s most advanced pipeline product and is currently being evaluated in two late stage clinical trials in the United States as a potential treatment for Netherton Syndrome (NS). Both studies are being conducted under an open Investigational New Drug (IND) application with the Food and Drug Administration (FDA). QRX003 is a unique “whole body, whole life” topical lotion that targets the vicious circle of skin inflammation and barrier disruption. QRX003 is a unique “whole body, whole life” topical lotion that targets the vicious circle of skin inflammation and barrier disruption. Generalized inflammatory peeling skin syndrome (PSS) is a rare autosomal recessive genodermatosis caused by loss-of-function disease-causing variants of the corneodesmosin gene (CDSN), resulting in excessive shedding of the superficial layers of the epidermis. Patients generally suffer from a variety of conditions including severe pain and chronic pruritis (itch). There is currently no approved treatment for PSS, and patients manage symptoms using over-the-counter emollients. QRX003 is a topical lotion, formulated with a proprietary delivery technology, and contains a broad- spectrum serine protease inhibitor, whose mechanism of action is intended to perform the function of a specific protein, called LEKTI. The absence of LEKTI in Netherton patients leads to excessive skin shedding resulting in a highly porous and compromised skin barrier. QRX003 is designed to lead to a more normalized skin shedding process and the formation of a stronger and more effective skin barrier. Tillkännagivande • Aug 02
Quoin Pharmaceuticals, Ltd. to Report Q2, 2024 Results on Aug 08, 2024 Quoin Pharmaceuticals, Ltd. announced that they will report Q2, 2024 results Pre-Market on Aug 08, 2024 Tillkännagivande • Jun 28
Quoin Pharmaceuticals, Ltd. Announces International Expansion of Ongoing Clinical Trials for Netherton Syndrome Quoin Pharmaceuticals, Ltd. announces that it will expand its ongoing Netherton Syndrome clinical studies to include international sites. The first international site will be opened at a research hospital in Saudi Arabia. This hospital is currently treating a number of Netherton patients who will now become eligible for recruitment into Quoin’s studies. An experienced Clinical Research Organization has been engaged to manage the study locally. The Saudi site will operate under the auspices of Quoin’s open Investigational New Drug application with the US Food and Drug Administration. Plans to open additional international clinical sites are at an advanced stage. Quoin is conducting two ongoing clinical trials evaluating QRX003, a topical lotion, for the treatment of Netherton Syndrome. Tillkännagivande • May 04
Quoin Pharmaceuticals Receives Written Notice from Nasdaq Regarding Non- Compliance Minimum Bid Price Requirement Per ADS as Required by Nasdaq Listing Rule 5550(a)(2) On April 29, 2024, Quoin Pharmaceuticals Ltd. (the ‘Company’) received written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that for the preceding 31 consecutive business days (March 14, 2024 through April 26, 2024), the Company’s American Depositary Shares (‘ADSs’) did not maintain a minimum closing bid price of $1.00 (‘Minimum Bid Price Requirement’) per ADS as required by Nasdaq Listing Rule 5550(a)(2). The notice has no immediate effect on the listing or trading of the Company’s ADSs and the ADSs will continue to trade on The Nasdaq Capital Market under the symbol ‘QNRX.’ In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of 180 calendar days, or until October 28, 2024, to regain compliance with Nasdaq Listing Rule 5550(a)(2). Compliance may be achieved without further action if the closing bid price of the Company’s ADSs is at or above $1.00 for a minimum of ten consecutive business days at any time during the 180-day compliance period, in which case Nasdaq will notify the Company if it determines it is in compliance and the matter will be closed; however Nasdaq may require the closing bid price to equal or to exceed the $1.00 minimum bid price requirement for more than 10 consecutive business days before determining that a company complies. If, however, the Company does not achieve compliance with the Minimum Bid Price Requirement by October 28, 2024, the Company may be eligible for additional time to comply. In order to be eligible for such additional time, the Company will be required to meet the continued listing requirement for market value of publicly held ADSs and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and must notify Nasdaq in writing of its intention to cure the deficiency during the second compliance period. The Company intends to actively monitor the bid price of its ADSs and will consider available options to regain compliance with the Nasdaq listing requirements. Tillkännagivande • May 03
Quoin Pharmaceuticals, Ltd. to Report Q1, 2024 Results on May 09, 2024 Quoin Pharmaceuticals, Ltd. announced that they will report Q1, 2024 results Pre-Market on May 09, 2024 Tillkännagivande • Mar 08
Quoin Pharmaceuticals, Ltd. to Report Q4, 2023 Results on Mar 13, 2024 Quoin Pharmaceuticals, Ltd. announced that they will report Q4, 2023 results After-Market on Mar 13, 2024 Tillkännagivande • Mar 05
Quoin Pharmaceuticals, Ltd. Announces FDA Clearance to Recruit Teen Subjects into Both Ongoing Netherton Syndrome Clinical Studies Quoin Pharmaceuticals Ltd. announced clearance from the U.S. Food and Drug Administration (FDA) to recruit teen subjects aged 14 years and older into its two ongoing clinical trials for QRX003, which is being developed as a potential treatment for Netherton Syndrome (NS). Both trials are being conducted under Quoin’s open Investigational New Drug Application (IND) for QRX003. This FDA clearance represents the very first time that non-adult Netherton subjects will be tested in clinical studies conducted under an open-IND and, as such, represents a very significant and important step forward for members of this community. Significantly, teens who are currently receiving off-label systemic therapy will be eligible to participate in open-label study, while those who are not receiving such therapy may be recruited into the placebo controlled blinded study. This important feature not only widens the pool of eligible subjects but also eliminates the need for parents or caregivers to make difficult decisions about treatments these patients and loved ones are receiving. The inclusion of this patient population in studies will be, The company believe, a critical component of the development of a robust data set that could result in regulatory approval with a broad label as QRX003 is being tested both as monotherapy and in conjunction with off-label treatments. Tillkännagivande • Feb 13
Quoin Pharmaceuticals, Ltd. has filed a Follow-on Equity Offering. Quoin Pharmaceuticals, Ltd. has filed a Follow-on Equity Offering.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 2,089,552
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 2,089,552
Security Name: Series D Warrants
Security Type: Equity Warrant
Securities Offered: 2,089,552
Security Name: Series E Warrants
Security Type: Equity Warrant
Securities Offered: 2,089,552 Tillkännagivande • Feb 09
Quoin Pharmaceuticals Ltd. Files U.S. and International Patent Applications for Novel Netherton Syndrome Combination Product Quoin Pharmaceuticals Ltd. announced it has filed U.S. and International Patent applications for a novel combination product as a potential treatment of Netherton Syndrome. This new product combines a broad spectrum serine protease inhibitor with an anti-inflammatory agent in a proprietary topical formulation. Quoin anticipates that patents arising from these applications will extend to at least 2044. Quoin is currently enrolling patients in two clinical trials being conducted under its open Investigational New Drug (IND) application, evaluating its QRX003 topical lotion as a potential treatment of Nether ton Syndrome. To date, Quoin remains the only company actively recruiting subjects into NS clinical trials that are being conducted under an open IND. Tillkännagivande • Dec 21
Quoin Pharmaceuticals Ltd. Announces FDA Clearance of Clinical Optimization Plan for QRX003 for Netherton Syndrome Quoin Pharmaceuticals Ltd. announced that it has received U.S. Food and Drug Administration (FDA) clearance to implement a number of protocol amendments to its two ongoing clinical trials for QRX003, which is being developed as a potential treatment for Netherton Syndrome (NS). Both trials are being conducted under Quoin's open Investigational New Drug Application (IND) for QRX003. As a result of positive initial clinical data across multiple endpoints and a strong safety profile to date, the company has made a number of protocol amendments to both ongoing trials. The company believes that implementation of these protocol amendments may result in an even more robust data set and potentially more rapid approval with a broader label. The number of subjects in the blinded trial is increased to 30 from 18. As a result of the positive safety profile observed to date, the lower 2% dose has been eliminated from the trial going forward. All subjects will now receive either 4% QRX003 or a placebo vehicle, both of which will be applied twice-daily instead of the current once-daily treatment. The number of subjects in The open-label trial is increased to 20 from 10, and the dosing frequency will also be twice-daily going forward. All subjects in this trial will continue to receive off-label systemic therapy throughout the duration of treatment. All current clinical endpoints for both trials will remain the same and Quoin plans to open additional clinical sites to efficiently accommodate this increase in the number of enrolled subjects. Interest from subjects and clinical investigators continues to be very high and Quoin remains the only company actively recruiting subjects into NS clinical trials that are being conducted under an open IND. Tillkännagivande • Nov 04
Quoin Pharmaceuticals, Ltd. to Report Q3, 2023 Results on Nov 08, 2023 Quoin Pharmaceuticals, Ltd. announced that they will report Q3, 2023 results After-Market on Nov 08, 2023 Tillkännagivande • Oct 25
Quoin Pharmaceuticals, Ltd. Announces Additional Positive Clinical Data from Open-Label, Single-Arm Clinical Trial in Netherton Syndrome Quoin Pharmaceuticals Ltd. announced additional positive clinical data from its ongoing open-label study evaluating the safety and efficacy of QRX003 as a potential treatment for Netherton Syndrome (NS). This study, which is being conducted under Quoin’s open Investigational New Drug (IND) application, is an open-label, single-arm trial that is evaluating 10 NS patients dosed with QRX003 over a twelve week period. All subjects in the study are continuing to receive off-label systemic therapy for the duration of the trial. Of the available data from six evaluable subjects, five demonstrated a well-defined positive improvement in pruritus, or itch, with those five subjects reporting absent or negligible pruritus on completion of dosing with QRX003 based on the endpoint scoring system. The sixth subject’s pruritus was effectively unchanged on completion of dosing with QRX003. In the Investigator assessed skin scoring system, all six patients experienced an improvement in skin appearance, with three of the six subjects demonstrating improvement throughout the study, while for the other three subjects, signs of improvement were exhibited at various points throughout the dosing period. Importantly, all of the 6 subjects indicated a positive impression of QRX003 across a number of key metrics. The initial safety data across all patients is highly supportive of further product development with no reported treatment related adverse events impacting the study. The active ingredient in QRX003 is a broad-spectrum serine protease inhibitor, whose mechanism of action is intended to down-regulate the hyperactivity of skin kallikreins, leading to a more normalized rate of skin shedding. If proven to be safe and effective, long term daily application of QRX003 could lead to the development of a more normally functioning skin barrier and a significant improvement in the quality of life of Netherton patients. Tillkännagivande • Sep 13
Quoin Pharmaceuticals, Ltd., Annual General Meeting, Oct 19, 2023 Quoin Pharmaceuticals, Ltd., Annual General Meeting, Oct 19, 2023, at 12:00 US Eastern Standard Time. Location: the offices of Blank Rome LLP One Logan Square, Philadelphia Pennsylvania United States Agenda: To elect each of Dr. Michael Myers, Denise Carter, Joseph Cooper, James Culverwell, Dennis H. Langer, Natalie Leong, and Michael Sember to serve as a director of Quoin until Quoin’s next annual general meeting of shareholders and until such director’s successor is duly elected and qualified, or until such director’s earlier resignation or retirement; to adopt an amendment of company's Amended and Restated Articles of Association, as amended (the “Articles of Association”), to increase company's registered share capital from 500,000,000,000 ordinary shares, no par value, to 6,000,000,000,000 ordinary shares, no par value; to adopt an amendment of company's Articles of Association to effect a reverse split of company's ordinary shares at a ratio of 1-for-60,000; to approve an amendment of the terms of employment of Dr. Michael Myers, company's Chief Executive Officer; and to consider other matters. Tillkännagivande • Jul 29
Quoin Pharmaceuticals, Ltd. to Report Q2, 2023 Results on Aug 02, 2023 Quoin Pharmaceuticals, Ltd. announced that they will report Q2, 2023 results After-Market on Aug 02, 2023 Breakeven Date Change • Mar 16
No longer forecast to breakeven The 4 analysts covering Quoin Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$17.3m in 2025. New consensus forecast suggests the company will make a loss of US$6.60m in 2025. Breakeven Date Change • Dec 31
Forecast to breakeven in 2025 The 3 analysts covering Quoin Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$18.3m in 2025. Average annual earnings growth of 47% is required to achieve expected profit on schedule. Tillkännagivande • Dec 14
Quoin Pharmaceuticals, Ltd. Announces Dosing of First Patient in Clinical Trial in Netherton Syndrome Quoin Pharmaceuticals Ltd. announced that the first patient has been dosed in its ongoing clinical trial evaluating the safety and efficacy of QRX003 as a treatment for Netherton Syndrome. Quoin’s first clinical trial is a randomized, double blinded, vehicle-controlled study which is being conducted under a U.S. Investigational New Drug (IND) Application and is assessing two different doses of QRX003 topical lotion versus a vehicle lotion in Netherton patients. The test materials are applied once daily over a twelve-week period, to pre-designated areas of the patient’s body. Based on discussions with the U.S. Food and Drug Administration (FDA), a number of different clinical endpoints will be assessed in the study. In October 2022, Quoin announced it plans to initiate a second study assessing its QRX003 topical lotion in Netherton patients who are currently receiving off-label treatment including systemic therapy for symptomatic relief. This second study, which has now been cleared by the FDA to initiate clinical testing, is an open-label, non-placebo controlled trial that will evaluate 10 Netherton patients over a twelve week period. The study, which will run concurrently with Quoin’s ongoing clinical trial, will be conducted at the same sites and by the same clinical investigators as the first study, thereby optimizing the potential for a rapid recruitment of patients. The active ingredient in QRX003 is a broad-spectrum serine protease inhibitor, whose mechanism of action is intended to down-regulate the hyperactivity of skin kallikreins, leading to a more normalized rate of skin shedding. If proven to be safe and effective, long term daily application of QRX003 could lead to the development of a more normally functioning skin barrier and a significant improvement in the quality of life of Netherton patients. Board Change • Nov 16
High number of new and inexperienced directors There are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 2 experienced directors. No highly experienced directors. Independent Director Natalie Leong is the most experienced director on the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Tillkännagivande • Nov 02
Quoin Pharmaceuticals, Ltd. to Report Q3, 2022 Results on Nov 10, 2022 Quoin Pharmaceuticals, Ltd. announced that they will report Q3, 2022 results at 9:30 AM, US Eastern Standard Time on Nov 10, 2022 Tillkännagivande • Oct 19
Quoin Pharmaceuticals Announces Plans to Initiate a Second Clinical Trial in Netherton Syndrome Patients Quoin Pharmaceuticals Ltd. announced that it is initiating a second clinical trial in Netherton Syndrome patients. This multicenter, open label study will be being conducted under Quoin's currently open U.S. Investigational New Drug (IND) Application and will assess QRX003 topical lotion in Netherton patients who are currently receiving treatment including systemic therapy for symptomatic relief. QRX003 will be applied once daily over a twelve-week period, to pre- designated areas of the patient's body. A number of different clinical endpoints will be assessed in the study. The active ingredient in QRX003 is a broad-spectrum serine protease inhibitor, whose mechanism of action is intended to down-regulate the hyperactivity of skin kallikreins, leading to a more normalized rate of skin shedding. If proven to be safe and effective, long term daily application of QRX003 could lead to the development of a more normally functioning skin barrier and a significant improvement in the quality of life of Netherton patients. Tillkännagivande • Sep 23
Quoin Pharmaceuticals, Ltd., Annual General Meeting, Oct 27, 2022 Quoin Pharmaceuticals, Ltd., Annual General Meeting, Oct 27, 2022, at 12:00 US Eastern Standard Time. Location: The Logan, One Logan Square Philadelphia Pennsylvania United States Agenda: To re-elect Michael Myers, Denise Carter, Joseph Cooper, James Culverwell, Dennis H. Langer, Natalie Leong, and Michael Sember to the Board of Directors of the Company, each to serve as a director of the Company until the Company's next annual general meeting of shareholders; to approve the increase in the Company's registered share capital from 50,000,000,000 ordinary shares to 500,000,000,000 ordinary shares, and to amend the Company's Articles of Association to reflect such increase, in the form attached as Annex A to the Proxy Statement; to appoint Marcum LLP, a public accounting firm registered with the Public Company Accounting Oversight Board, to serve as the Company's independent registered public accounting firm, until the Company's next annual general meeting of shareholders; to present the financial statements of the Company for the fiscal year ended December 31, 2021; and to conduct any other business which may be properly brought before the Annual Meeting. Tillkännagivande • Sep 01
Quoin Pharmaceuticals, Ltd. announced that it has received $0.193537 million in funding On August 31, 2022, Quoin Pharmaceuticals, Ltd. closed the transaction. The transaction included participation from a single investor Breakeven Date Change • Aug 23
No longer forecast to breakeven The 4 analysts covering Quoin Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$12.1m in 2024. New consensus forecast suggests the company will make a loss of US$12.6m in 2024. Tillkännagivande • Aug 12
Quoin Pharmaceuticals, Ltd. to Report Q2, 2022 Results on Aug 18, 2022 Quoin Pharmaceuticals, Ltd. announced that they will report Q2, 2022 results Pre-Market on Aug 18, 2022 Tillkännagivande • Aug 08
Quoin Pharmaceuticals, Ltd. has completed a Follow-on Equity Offering in the amount of $16.799885 million. Quoin Pharmaceuticals, Ltd. has completed a Follow-on Equity Offering in the amount of $16.799885 million.
Security Name: American Depository Shares
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 2,210,000
Price\Range: $5
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,150,000
Price\Range: $4.9999 Tillkännagivande • Jul 29
Quoin Pharmaceuticals Announces Receipt of Constructive Scientific Advice from EMA for QRX003 Development in Europe Quoin Pharmaceuticals Ltd. announced that it has received comprehensive and constructive Scientific Advice from the European Medicines Agency for the clinical and regulatory development of QRX003 in Europe, as a potential treatment for Netherton Syndrome. This Scientific Advice was received in response to a Briefing Submission document filed by Quoin to the EMA on May 26, 2022. Based on standard review periods for such submissions, which may also include an in-person meeting with the EMA, Quoin had anticipated receiving feedback from the EMA in mid-September. Instead, the EMA truncated the standard review period and provided this Scientific Advice to Quoin without the requirement for an in-person meeting. QRX003 is currently in clinical testing in the US in a randomized, double blinded, vehicle-controlled study that is being conducted under an open U.S. Investigational New Drug (IND) Application which will assess two different doses of QRX003 topical lotion versus a vehicle lotion in Netherton patients. The test materials will be applied once daily over a twelve-week period, to pre-designated areas of the patient’s body. Based on discussions with the U.S. Food and Drug Administration (FDA), a number of different clinical endpoints will be assessed in the study. The active ingredient in QRX003 is a broad-spectrum serine protease inhibitor, whose mechanism of action is intended to down-regulate the hyperactivity of skin kallikreins leading to a more normalized rate of skin shedding. If proven to be safe and effective, long term daily application of QRX003 could lead to the development of a more normally functioning skin barrier and a significant improvement in the quality of life of Netherton patients. In conjunction with the company’s strategy of self-commercializing its portfolio of products in the U.S. and Europe, Quoin has established a global network of marketing partnerships for QRX003 in 60 countries that will help support its mission of ensuring that every patient, everywhere, can access Quoin’s products, once approved. Tillkännagivande • Jul 07
Quoin Pharmaceuticals Announces Opening of First Clinical Site for Netherton Syndrome Clinical Study Quoin Pharmaceuticals Ltd. announces that the first clinical site has now been fully opened for its clinical study to evaluate QRX003 for the treatment of the rare genetic disease, Netherton Syndrome. The opening of additional sites is in process and patient recruitment is expected to begin shortly. This randomized, double blinded, vehicle-controlled study is being conducted under a U.S. Investigational New Drug Application and will assess two different doses of QRX003 topical lotion versus a vehicle lotion in Netherton patients. The test materials will be applied once daily over a twelve-week period, to pre-designated areas of the patient’s body. Based on discussions with the U.S. Food and Drug Administration, a number of different clinical endpoints will be assessed in the study. The active ingredient in QRX003 is a broad spectrum serine protease inhibitor, whose mechanism of action is intended to down-regulate the hyperactivity of skin kallikreins leading to a more normalized rate of skin shedding. If proven to be safe and effective, long term daily application of QRX003 could lead to the development of a more normally functioning skin barrier and a significant improvement in the quality of life of Netherton patients. In conjunction with the company’s strategy of self-commercializing its portfolio of products in the U.S. and Europe, Quoin has established a global network of marketing partnerships for QRX003 that will help support its mission of ensuring that every patient, everywhere, can access Quoin’s products, once approved. Tillkännagivande • Jun 16
Quoin Pharmaceuticals Receives Nasdaq Deficiency Notice Regarding Minimum Bid Price Requirement Quoin Pharmaceuticals Ltd. announced that the company received a written notification (the "Notification Letter") from the Nasdaq Stock Market LLC ("Nasdaq") on June 10, 2022, notifying the Company that it is not in compliance with the minimum bid price requirement set forth in Nasdaq Rules for continued listing on Nasdaq. Nasdaq Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of USD 1.00 per share. The Notification Letter does not impact the Company's listing on the Nasdaq Capital Market at this time. In accordance with Nasdaq Rule 5810(c)(3)(A), the Company has been provided 180 calendar days, or until December 7, 2022, to regain compliance with Nasdaq Rule 5550(a)(2). To regain compliance, the Company's American Depositary Shares representing ordinary shares (“ADSs”) must have a closing bid price of at least USD 1.00 per ADS for a minimum of 10 consecutive business days. In the event the Company does not regain compliance by December 7, 2022, the Company may be eligible for additional time to regain compliance or may face delisting. The Company's business operations are not affected by the receipt of the Notification Letter. The Company intends to monitor the closing bid price of its ADSs and may, if appropriate, consider implementing available options to regain compliance with the minimum bid price requirement under the Nasdaq Rules. As previously reported, on April 22, 2022, the Company received a letter from Nasdaq notifying the Company that it was no longer in compliance with the minimum stockholders’ equity requirement for continued listing on Nasdaq. In accordance with Nasdaq Rule 5810(c)(2)(A), within 45 calendar days of receiving this notice, the Company submitted a plan to regain compliance to Nasdaq. If the plan is accepted, Nasdaq can grant an extension of up to 180 calendar days from the date of the letter to evidence compliance. Although Nasdaq notification letters described above have no immediate effect on the Company's listing on Nasdaq, and the Company is working on implementing plans to regain compliance with Nasdaq listing standards, there can be no assurance that the Company will be able to regain compliance with Nasdaq’s minimum stockholders’ equity requirement or minimum bid-price requirement for continued listing. Breakeven Date Change • May 07
Forecast to breakeven in 2024 The 4 analysts covering Quoin Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$4.17m in 2024. Average annual earnings growth of 64% is required to achieve expected profit on schedule. Board Change • Apr 29
High number of new and inexperienced directors There are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 2 experienced directors. No highly experienced directors. Independent Director Natalie Leong is the most experienced director on the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Tillkännagivande • Apr 26
Quoin Pharmaceuticals, Ltd. Announces FDA Clearance of IND for its Lead Asset, QRX003, for Netherton Syndrome Quoin Pharmaceuticals Ltd. announced that it has received U.S. Food and Drug Administration (FDA) clearance to initiate clinical testing for its Investigational New Drug (IND) application for QRX003, the Company’s investigational product for Netherton Syndrome (NS). NS is a rare and devastating genetic disease for which there is currently no approved treatment or cure. QRX003 is a topical lotion, formulated with a proprietary delivery technology, and contains a broad- spectrum serine protease inhibitor, whose mechanism of action is intended to perform the function of a specific protein, called LEKTI. The absence of LEKTI in Netherton patients leads to excessive skin shedding resulting in a highly porous and compromised skin barrier. Daily application of QRX003 is designed to lead to a more normalized skin shedding process and the formation of a stronger and more effective skin barrier. Board Change • Nov 04
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 5 non-independent directors. was the last director to join the board, commencing their role in . The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. 
