Latest news with #QRX003
Yahoo
22-05-2025
- Business
- Yahoo
Quoin Pharmaceuticals Announces FDA Clearance to Initiate Second Pivotal Whole Body QRX003 Netherton Syndrome Clinical Study
Study CL-QRX003-002 will test whole-body application of QRX003 in conjunction with off-label systemic therapy in approximately 12-15 subjects. Study CL-QRX003-002 complements first whole-body pivotal study, CL-QRX003-003, being led by Dr. Amy Paller at Northwestern University and supported by up to six international sites that are expected to open, where subjects are being tested with QRX003 as monotherapy. Combined data from Studies CL-QRX003-002 and CL-QRX003-003 is anticipated to provide QRX003 with the broadest possible label opportunity post-approval as both monotherapy and adjunct therapy in conjunction with off-label systemic treatments. Five U.S. clinical sites have been opened, and six international sites are being opened. All currently have available cohorts of subjects ready to be enrolled into the studies facilitating accelerated recruitment. Quoin anticipates completion of recruitment into both pivotal studies by end of Q1 2026 and filing an NDA for regulatory approval later in the year. ASHBURN, Va., May 22, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the 'Company' or 'Quoin'), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces 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. All subjects recruited into this study are currently receiving off-label systemic therapy and will continue to remain on this treatment for the duration of the study. Study CL-QRX003-002 complements Quoin's other pivotal study, CL-QRX003-003, which is being conducted by Dr. Amy Paller, of Northwestern University, where QRX003 is being administered as monotherapy and subjects do not receive off-label systemic therapy. Quoin anticipates that combined both studies will recruit between 24-30 subjects in 6 U.S. sites and up to 6 international sites. Five of the U.S. sites are already open and the sixth is expected to be opened in June. All international sites are at an advanced stage of preparation for opening. 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 Q1 2026 and to file an NDA for regulatory approval later in the year. Quoin CEO, Dr. Michael Myers, added, 'I am very pleased to announce yet another important and significant milestone for Quoin. With FDA clearance to conduct this study, Quoin is the only company conducting two late-stage whole-body pivotal clinical studies in Netherton Syndrome patients. We believe that the combined data generated from Study CL-QRX003-003, where QRX003 is being administered as monotherapy and this study, CL-QRX003-002, where QRX003 is being tested in conjunction with off-label systemic therapy, has the potential to generate a highly comprehensive safety and efficacy data package that could support the regulatory approval of a treatment for this dreadful disease.' About Quoin Pharmaceuticals Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin's innovative pipeline comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa and others. For more information, visit: or LinkedIn for updates. Cautionary Note Regarding Forward Looking StatementsThe Company cautions that statements in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as 'expect,' 'intend,' 'plan,' 'anticipate,' 'believe,' 'look forward to,' and 'will,' among others. All statements that reflect the Company's expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: study CL-QRX003-002 testing the whole-body application of QRX003 in conjunction with off-label systemic therapy in approximately 12-15 subjects, six international sites opening to support study CL-QRX003-003 testing subjects with QRX003 as monotherapy, combined data from Studies CL-QRX0003-002 and CL-QRX003 providing QRX003 with the broadest possible label opportunity post-approval as both monotherapy and adjunct therapy in conjunction with off-label systemic treatments, available cohorts of subjects being ready to be enrolled into the studies facilitating accelerated recruitment at the clinical sites, completing recruitment into both pivotal studies by end of Q1 2026, filing an NDA for regulatory approval later in the year, combined both studies recruiting between 24-30 subjects in 6 US sites and up to 6 international sites, opening a sixth US site in June, and Quoin's belief that its products in development collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa and others. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the Company's ability to pursue its regulatory strategy; the Company's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; the Company's ability to complete clinical trials on time and achieve desired results and benefits as expected; and other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. For further information, contact: Quoin Pharmaceuticals Myers, Ph.D., CEOmmyers@ Investor RelationsPCG AdvisoryJeff Ramsonjramson@ 863-6341
Reuters
02-04-2025
- Business
- Reuters
Quoin Reports Clinically Meaningful Whole Body Response to QRX003 in Pediatric Netherton Syndrome; Second Patient Cleared for Dosing
ASHBURN, VA, April 2, 2025 (EZ Newswire) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) ('Quoin' or the 'Company'), a late-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced additional encouraging clinical findings from its ongoing investigator-led study in pediatric Netherton syndrome (NS). After six weeks of continuous whole body treatment with QRX003, the enrolled pediatric patient continues to demonstrate significant clinical benefit, including visibly healed skin, sustained relief from symptoms, and elimination of the need for previously required medications. Specifically, the patient's skin remains almost entirely healed, underscoring the durability of effect seen with ongoing daily use of QRX003. Importantly, the subject has not required prior medications such as antibiotics, antivirals, antihistamines, or glucocorticoids. The patient's pruritus (itch) remains virtually eliminated, leading to the continuation of restful, uninterrupted sleep—described by the study team as the first sustained period of undisturbed sleep in the patient's life. No adverse events have been reported after six weeks of full body exposure to QRX003. Based on these results, Quoin has received approval to initiate testing of a second pediatric patient under the same whole body treatment protocol. Dr. Michael Myers, CEO of Quoin, commented: 'We're very encouraged to see continued improvement in this first pediatric patient following whole body application of QRX003. Her skin is now almost completely healed, and she remains free from previously required medications. Most notably, the pruritus that has severely impacted her quality of life since birth is now nearly eliminated, and she is finally experiencing uninterrupted sleep without the need for sedatives. These outcomes provide strong evidence that QRX003 may be addressing the underlying pathology of Netherton syndrome—not just managing symptoms. The absence of adverse events after six weeks of full-body exposure is also highly encouraging. With approval now granted to initiate treatment in a second pediatric subject, we look forward to continuing this important study and reporting further updates.' About Quoin Pharmaceuticals Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin's innovative pipeline comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton syndrome, peeling skin syndrome, SAM syndrome, palmoplantar keratoderma, scleroderma, epidermolysis bullosa, microcystic lymphatic malformations, venous malformations, angiofibroma, and others. For more information, visit: or LinkedIn for updates. Cautionary Note Regarding Forward Looking Statements The Company cautions that 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. Forward-looking statements may be identified by the use of words referencing future events or circumstances, such as 'expect,' 'intend,' 'hope,' 'plan,' 'potential,' 'anticipate,' 'look forward,' 'believe,' 'may,' and 'will,' among others. All statements that reflect the Company's expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: the potential efficacy of QRX003 as a treatment for Netherton syndrome; testing expected to commence in a few weeks on a second pediatric patient; continue with our plans to further expand this study to include additional pediatric subjects; and Quoin's products in development collectively having the potential to target a broad number of rare and orphan indications, including Netherton syndrome, peeling skin syndrome, SAM syndrome, palmoplantar keratoderma, scleroderma, epidermolysis bullosa, microcystic lymphatic malformations, venous malformations, angiofibroma and others. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the Company's ability to deliver a safe and effective treatment for Netherton syndrome; whether the Company's studies successfully generate data that is sufficiently robust and comprehensive to support an NDA filing for QRX003 as an approved treatment for Netherton syndrome; and other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. Media Contact ### SOURCE: Quoin Pharmaceuticals
Yahoo
25-03-2025
- Business
- Yahoo
Quoin Pharmaceuticals Files U.S. Patent Application for Novel Topical Formulations to Treat Netherton Syndrome and Other Skin Diseases
Target Indications Also Include Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma and Severe Atopic Dermatitis Third Quoin Patent Application for Netherton Syndrome If Granted Company Would have Patent Protection for QRX003 for Netherton Syndrome Until 2045 ASHBURN, Va., March 25, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the 'Company' or 'Quoin'), a late-stage clinical, specialty pharmaceutical company focused on the development and commercialization of therapeutic products that treat rare and orphan diseases, today announced it has filed a U.S. patent application for novel topical formulations to treat a number of skin diseases, including Netherton Syndrome (NS). Quoin's lead product, QRX003, is currently being tested in four Netherton Syndrome clinical trials. Three of these trials are being conducted under Quoin's open Investigational New Drug (IND) application with the US Food and Drug Administration (FDA). QRX003 is also currently being tested in a pediatric NS patient at the Children's Hospital in Dublin, Ireland and the Company intends to expand this study to include additional children with NS in Spain, the United Kingdom and potentially other countries. The Company has recently reported positive initial clinical data from the two open label studies for which data is available. This patent application also includes Peeling Skin Syndrome for which Quoin has an ongoing Investigator Clinical Study in a pediatric patient in New Zealand. There are currently no FDA approved treatments for either Netherton Syndrome or Peeling Skin Syndrome. 'While we are fully focused on completing clinical testing for QRX003 in NS, we are also taking multiple steps to ensure that we have the broadest and most extensive patent protection around the product for this disease as well for other rare skin disease applications that we are pursuing or intend to pursue. If granted, this application would provide broad patent protection for our product until 2045.' said Dr. Michael Myers, Chief Executive Officer of Quoin. Quoin is currently enrolling patients in three clinical trials being conducted under its open Investigational New Drug (IND) application, evaluating its QRX003 topical lotion as a potential treatment for Netherton Syndrome as well as in an Investigator led pediatric study. To date, Quoin remains the only company actively recruiting and testing subjects in multiple NS clinical trials that are being conducted under an open IND. To find out more about Quoin's clinical studies relating to Netherton Syndrome, please visit About Quoin Pharmaceuticals Ltd. Quoin Pharmaceuticals Ltd. is a clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin's innovative pipeline comprises five 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, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. For more information, go to: Cautionary Note Regarding Forward Looking Statements The Company cautions that 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. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," 'hope,' "plan," 'potential,' "anticipate," 'look forward,' "believe," 'may,' and "will," among others. All statements that reflect the Company's expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: the Company obtaining patent protection for its Netherton Syndrome product until 2045; QRX003 having the potential to become the first approved treatment for Netherton Syndrome; the potential efficacy of QRX003 as a treatment for Netherton Syndrome; the progress or success of Quoin's ongoing clinical trials; and Quoin's products in development collectively having the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the Company's ability to protect its assets with the new patent applications; the Company's ability to obtain regulatory approvals for the commercialization of its product candidates or to comply with ongoing regulatory requirements; the Company's ability to deliver a safe and effective treatment for Netherton Syndrome; the Company may be unable to submit applications and initiate clinical development as and when planned; and other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. For further information, contact: Quoin Pharmaceuticals Myers, Ph.D., CEOmmyers@ Investor RelationsPCG AdvisoryJeff Ramson jramson@ (646) 863-6341Sign in to access your portfolio
Yahoo
13-03-2025
- Business
- Yahoo
Quoin Pharmaceuticals Provides Corporate Update and Reports Fourth Quarter and Full-Year 2024 Financial Results
ASHBURN, Va., March 13, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin"), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced recent corporate accomplishments and provided an update on its fourth quarter and full-year 2024 progress. Quoin CEO Michael Myers said, "2024 was without a doubt the most significant year in Quoin's history as our team delivered tremendous progress in clinical, regulatory and manufacturing settings. This progress was particularly exemplified in the clinical development of QRX003, our product candidate for Netherton Syndrome, and we are encouraged by the positive data our ongoing studies are generating. The significant improvements observed across multiple clinical endpoints, including a dramatic reduction in disease severity, tangible skin healing and barrier restoration as well as highly positive patient-reported outcomes, have provided further evidence of QRX003's potential to address the underlying pathology of Netherton Syndrome. Our recently announced FDA-cleared 'whole-body' clinical study will represent the most extensive evaluation of QRX003 to date, and we believe will generate a very robust and comprehensive safety and efficacy data set that will become a central component of our regulatory approval submission. As a company, we remain steadfast in our mission to develop the first FDA-approved treatment for Netherton Syndrome, a disease with no approved therapies and a profound impact on patients and families. Additionally, our recent patent filings for novel topical rapamycin formulations mark an important step in expanding our pipeline to address additional rare dermatological diseases. With multiple clinical trials underway, and continued pipeline expansion, 2025 is already shaping up to become a highly pivotal year for Quoin.' Recent AccomplishmentsOn March 4, 2025, Quoin announced it had filed U.S. and international patent applications for novel topical rapamycin formulations targeting microcystic lymphatic malformations, venous malformations and angiofibromas. The products are being developed using Quoin's in-licensed proprietary Invisicare® delivery technology, further expanding Quoin's rare disease pipeline. A week earlier, Quoin announced highly positive whole body clinical data from its ongoing pediatric Netherton Syndrome study. The first patient to receive whole-body application of QRX003 showed transformational improvement after just two weeks, with clear visual evidence of skin healing. Crucially also, the patient was able to fully discontinue previously required medications, including all antihistamines, glucocorticoids, antivirals, and has not needed any antibiotic treatment. Furthermore, the patient is experiencing zero nightly sleep disturbances for the first time in her life. No adverse events were reported. Earlier in February, Quoin launched its 'NETHERTON NOW' awareness campaign, a multi-channel initiative designed to raise awareness of Netherton Syndrome and its impact on patients and families. The company introduced a dedicated website, providing educational resources and support for the Netherton community. In January, Quoin released further clinical evidence from its open label study supporting QRX003's effectiveness. Data showed that within four weeks of discontinuation of treatment all positive clinical improvements observed after 12 weeks of treatment were completely reversed, reinforcing QRX003's mechanism of action as a competitive broad spectrum serine protease inhibitor and the need for ongoing chronic treatment to maintain therapeutic benefits. Earlier in January, Quoin announced additional positive clinical data from its ongoing open-label Netherton Syndrome study. The first subject to complete 12 weeks of twice-daily dosing with QRX003 demonstrated sustained clinical improvement across all measured endpoints. No adverse events were reported throughout the study. Photographic evidence clearly showing direct evidence of skin healing may be accessed on Quoin's website. Fourth Quarter 2024 HighlightsOn Dec. 20, 2024, Quoin announced the successful completion of a $6.8 million public offering, bolstering the company's financial position to support ongoing clinical development and corporate initiatives. The offering included significant participation by Quoin's entire executive team. A day prior, Quoin received FDA clearance to initiate a new whole-body clinical study for QRX003. This groundbreaking study, which will be led by Dr. Amy Paller at Northwestern University, will evaluate the safety and efficacy of twice-daily application of QRX003 to more than 80% of the body surface area in Netherton Syndrome patients, mimicking potential real-world use. This represents the most extensive clinical application of QRX003 to date, with data anticipated to become a cornerstone of the company's regulatory submission package. On Dec. 18, 2024, Quoin announced positive interim data from two of its ongoing Netherton Syndrome clinical studies. The first subject dosed twice daily for six weeks in the company's open-label study demonstrated a significant clinical response across multiple endpoints. In addition, data from Quoin's ongoing pediatric study showed a rapid improvement in skin appearance within 12 days of treatment, with no adverse events reported. Financial Highlights Quoin had approximately $14.1 million in cash, cash equivalents and marketable securities as of December 31, 2024. This is expected to fund the Company's operations into the second quarter of 2026. Net loss for the quarter ended December 31, 2024 was approximately $2.3 million compared to approximately $2.0 million for the quarter ended December 31, 2023. Net loss for the twelve months ended December 31, 2024 was $9.0 million compared to $8.7 million for the twelve months ended December 31, 2023. Investors are encouraged to read the Company's Annual Report on Form 10-K when it is filed with the Securities and Exchange Commission (the 'SEC'), which will contain additional details about Quoin's financial results as of and for the period ended December 31, 2024. About Quoin Pharmaceuticals Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin's innovative pipeline comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, microcystic lymphatic malformations, venous malformations and others. For more information, go to: Cautionary Note Regarding Forward-Looking StatementsThe Company cautions that 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. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as 'expect,' 'intend,' 'hope,' 'plan,' 'potential,' 'anticipate,' 'look forward,' 'believe,' 'may,' and 'will,' among others. All statements that reflect the Company's expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: QRX003's potential to address the underlying pathology of Netherton Syndrome; whole-body' clinical study generating a robust and comprehensive safety and efficacy data set that will become a central component of the Company's regulatory approval submission; the Company developing the first FDA-approved treatment for Netherton Syndrome; the Company's new U.S. and International patent applications for novel topical rapamycin (sirolimus) formulations as potential treatments for a number of rare diseases including microcystic lymphatic malformations, venous malformations and angiofibromas; the progress or success of Quoin's ongoing clinical trials; and Quoin's products in development collectively having the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, microcystic lymphatic malformations, venous malformations and others. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the clinical studies may not generate the results anticipated; the Company ability to recruit additional subjects; the clinical studies not generating data which is sufficiently robust and comprehensive to support an NDA filing; the Company's ability to obtain regulatory approvals; the Company's ability to protect its assets with the new patent applications; the Company's ability to obtain regulatory approvals for the commercialization of its product candidates or to comply with ongoing regulatory requirements; the Company's ability to deliver a safe and effective treatment for Netherton Syndrome; the Company may be unable to submit applications and initiate clinical development as and when planned; and other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2023 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. For further information, contact:Quoin Pharmaceuticals Myers, Ph.D., CEOmmyers@ Investor RelationsPCG AdvisoryJeff Ramson jramson@ 863-6341 QUOIN PHARMACEUTICALS, LTD. Consolidated Balance Sheets December 31, December 31, 2024 2023 ASSETS Current assets: Cash and cash equivalents $ 3,623,343 $ 2,401,198 Investments 10,433,535 8,293,663 Prepaid expenses and other current assets 869,126 591,034 Total current assets 14,926,004 11,285,895 Prepaid expenses - long term 300,000 300,000 Intangible assets, net 483,334 583,334 Total assets $ 15,709,338 $ 12,169,229 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 905,704 $ 526,523 Accrued expenses 1,528,977 1,308,706 Accrued interest and financing expense 1,146,251 1,146,251 Due to officers - short term 600,000 600,000 Total current liabilities 4,180,932 3,581,480 Due to officers - long term 2,323,733 2,923,733 Total liabilities $ 6,504,665 $ 6,505,213 Commitments and contingencies Shareholders' equity: Ordinary shares, no par value per share, 100,000,000 authorized at December 31, 2024 and 2024, respectively - 8,948,164 (8,948,164 ADS's) ordinary shares issued and outstanding at December 31, 2024 and 987,220 (987,220 ADS's) at December 31, 2023 $ - $ - Additional paid in capital 64,370,465 51,867,336 Accumulated deficit (55,165,792 ) (46,203,320 ) Total shareholders' equity 9,204,673 5,664,016 Total liabilities and shareholders' equity $ 15,709,338 $ 12,169,229 QUOIN PHARMACEUTICALS, LTD. Consolidated Statements of Operations Years Ended December 31, Three months ended December 31, 2024 2023 2024 2023 (Audited) (Audited) (Unaudited) (Unaudited) Operating expenses General and administrative $ 5,925,833 $ 6,070,517 $ 1,410,717 $ 1,385,276 Research and development 3,602,632 3,307,987 994,344 832,391 Total operating expenses 9,528,465 9,378,504 2,405,061 2,217,667 Other (income) and expenses Unrealized (gain) loss (7,502 ) 2,683 15,541 (9,243 ) Realized and accrued interest income (558,491 ) (694,614 ) (109,328 ) (158,546 ) Total other (income) expense (565,993 ) (691,931 ) (93,787 ) (167,789 ) Net loss $ (8,962,472 ) $ (8,686,573 ) $ (2,311,274 ) $ (2,049,878 ) Loss per ADS Basic $ (1.91 ) $ (9.64 ) $ (0.35 ) $ (2.08 ) Fully-diluted $ (1.91 ) $ (9.64 ) $ (0.35 ) $ (2.08 ) Weighted average number of ADS's outstanding Basic 4,688,723 900,919 6,527,981 987,220 Fully-diluted 4,688,723 900,919 6,527,981 987,220 Sign in to access your portfolio
Yahoo
04-03-2025
- Business
- Yahoo
Quoin Pharmaceuticals Files U.S. and International Patent Applications for Novel Topical Rapamycin Formulations to Treat Rare Disease Indications
Target Indications Include Microcystic Lymphatic Malformations, Venous Malformations and Angiofibromas Proprietary Invisicare Delivery Technology Designed to Optimize Local Skin Penetration Company Plans to Submit Investigational New Drug Applications and Initiate Clinical Testing This Year ASHBURN, Va., March 04, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the 'Company' or 'Quoin'), a late clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announced it has filed U.S. and International patent applications for novel topical rapamycin (sirolimus) formulations as potential treatments for a number of rare diseases including microcystic lymphatic malformations, venous malformations and angiofibromas. The products are being developed using Quoin's in-licensed proprietary Invisicare delivery technology. There are currently no FDA approved treatments for either microcystic lymphatic malformations or venous malformations. The proprietary Invisicare delivery technology, which Quoin has exclusive rights to for all orphan rare skin disease applications, is designed to optimize penetration of rapamycin deep into dermis where it can be most effective clinically. The Invisicare technology is also being utilized in Quoin's QRX003 topical lotion, which is in late-stage clinical testing as a potential treatment for Netherton Syndrome, a rare genetic disease. Quoin believes QRX003 has the potential to become the first approved treatment for this disease. 'As we continue to advance the clinical development of Quoin's lead product, QRX003, for Netherton Syndrome, we are pleased to announce the filing of this patent and the initiation of the development of our novel formulations as potential treatments for these additional rare skin diseases. By combining the known clinical activity of rapamycin with this optimized delivery system, we believe our novel topical formulations may have the potential to effectively treat these diseases. We have seen other topical formulations of rapamycin underperform in clinical settings across a number of indications, which we believe may be as a result of suboptimal delivery of the drug at the target sites. The Invisicare technology is designed to overcome these limitations. We are now moving forward with our plans to submit IND applications for at least two of these target indications this year and to formally initiating clinical development as soon as possible ' said Dr. Michael Myers, Chief Executive Officer of Quoin. Quoin is currently enrolling patients in three clinical trials being conducted under its open Investigational New Drug (IND) application, evaluating its QRX003 topical lotion as a potential treatment of Netherton Syndrome. To date, Quoin remains the only company actively recruiting subjects into multiple NS clinical trials that are being conducted under an open IND. To find out more about Quoin's clinical studies relating to Netherton Syndrome, please visit About Microcystic Lymphatic MalformationsMicrocystic lymphatic malformation is one subtype of lymphatic malformation (LM), a congenital malformation of the lymphatic vessels in soft tissues, including the skin. LM is classified into the macrocystic type, cysts larger than 2 cm with clear margins (previously known as cystic hygromas), and the microcystic type, consisting of cysts smaller than 2 cm, that appear diffuse, and grow without clear borders (previously known as lymphangioma circumscriptum). When the two types concur it is called the combined type. Microcystic lesions are commonly found inside the mouth, throat, and in the tongue, parotid gland and submandibular gland. Symptoms include deformity, and problems with breathing and feeding. The exact cause is unknown but is likely related to a malformation of the lymphatic system at six to ten weeks of gestation, when some lymphatic tissue fails to communicate with the lymphatic and venous system.1 Lymphatic malformations occurring in 1 in 6000 to 16,000 patients. 2 About Venous MalformationsVenous malformation (VM) is the most common type of congenital vascular malformation (CVM) with an incidence of 1 to 2 in 10,000 and a prevalence of 1%. They can cause significant morbidity, pain and discomfort to patients as they can lead to serious local and systemic complications. Although present at birth, they are not always clinically evident until later in life and tend to grow in concert with the child and without spontaneous regression. VMs are composed of ectatic venous channels found usually in the head, neck, limbs, and trunk and are thought to be sporadic in most cases, though familial inheritance patterns exist. Accurate diagnosis has been a limiting factor in VM management. An increased emphasis has been placed on creating comprehensive classification systems for diagnostic and therapeutic purposes of this chronic condition. Doppler ultrasound (US) and magnetic resonance imaging (MRI) are key imaging methods used to characterize and diagnose VMs. Treatment options include surgery, sclerotherapy, and ablative therapies. 3 About AngiofibromaCutaneous angiofibroma is a benign skin tumor characterized by fibrovascular tissue and presents as a group of lesions with varied clinical appearances but consistent histological features. These benign fibrous neoplasms exhibit a proliferation of stellate and spindled cells, thin-walled blood vessels with dilated lumina in the dermis, and concentric collagen bundles. These growths typically manifest as small, firm, reddish, or flesh-colored papules, most commonly on the face (often referred to as fibrous papules or adenoma sebaceum), particularly around the nose and cheeks.4 About Quoin Pharmaceuticals Ltd. Quoin Pharmaceuticals Ltd. is a clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin's innovative pipeline comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa and others. For more information, go to: Cautionary Note Regarding Forward-Looking Statements The Company cautions that 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. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as 'expect,' 'intend,' 'hope,' 'plan,' 'potential,' 'anticipate,' 'look forward,' 'believe,' 'may,' and 'will,' among others. All statements that reflect the Company's expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: the Company's new U.S. and International patent applications for novel topical rapamycin (sirolimus) formulations as potential treatments for a number of rare diseases including microcystic lymphatic malformations, venous malformations and angiofibromas; Invisicare delivery technology being designed to optimize penetration of rapamycin deep into dermis where it can be most effective clinically; the potential efficacy of QRX003 as a treatment for Netherton Syndrome; the progress or success of Quoin's ongoing clinical trials; combining rapamycin with the Invisicare technology delivery system having the potential to effectively treat these diseases; plans to submit IND applications for at least two of these target indications this year and initiating clinical development as soon as possible; and Quoin's products in development collectively having the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa and others. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the Company's ability to protect its assets with the new patent applications; the Company's ability to obtain regulatory approvals for the commercialization of its product candidates or to comply with ongoing regulatory requirements; the Company's ability to deliver a safe and effective treatment for Netherton Syndrome; the Company may be unable to submit applications and initiate clinical development as and when planned; and other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2023 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. For further information, contact: Quoin Pharmaceuticals Myers, Ph.D., CEOmmyers@ Investor RelationsPCG AdvisoryJeff Ramson jramson@ (646) 863-6341 1 Microcystic lymphatic malformation | About the Disease | GARD2 Genetic and Molecular Determinants of Lymphatic Malformations: Potential Targets for Therapy - PMC3 Venous malformations: clinical diagnosis and treatment - PMC4 Cutaneous Angiofibroma - StatPearls - NCBI BookshelfSign in to access your portfolio
