财务状况 - 公司拥有约1,260万美元的现金、现金等价物和可流通证券,预计可为公司运营提供资金支持至2025年底[5] - 2024年第二季度净亏损约200万美元,较2023年同期的210万美元有所下降[5] - 2024年上半年净亏损430万美元,较2023年同期的470万美元有所下降[5] 临床研究 - 公司计划启动一项治疗脱皮综合征的临床研究,已确定首个临床试验地点和患者[3] - 公司正在扩大在Netherton综合征的临床试验,将包括沙特阿拉伯在内的国际试验地点[3] 合作与并购 - 公司与爱尔兰科克大学签署研究协议,有望开发多种使用该校专有可溶性微针给药技术的雷帕霉素(西罗莫司)外用制剂[3,4] - 公司继续评估在罕见和孤儿疾病领域的并购机会[3]

临床试验进展 - 公司正在开发用于治疗罕见皮肤病的产品，初步聚焦于Netherton综合征和RDEB[107] - 公司正在进行QRX003的临床试验，包括一项随机双盲试验和一项开放性试验[112,113] - 公司已提交多项临床试验方案修正案，包括增加受试者人数、调整给药频率等[114] - 公司计划将临床试验扩展至沙特阿拉伯等国际地区[115] 研发合作 - 公司与University College Cork签署研究协议,开发用于治疗多种罕见疾病的拉帕霉素外用制剂[116,117] - 公司与Skinvisible Pharmaceuticals, Inc.签订了独家许可协议，需支付100万美元许可费以及获批后5百万美元里程碑付款[165] - 公司与Therapeutics Inc.签订了管理QRX003临床开发的服务协议，预计总成本约为520万美元[166] - 公司与昆士兰科技大学签订了约250,000美元和610,000美元的研发协议[167] - 公司与爱尔兰科克大学签订了约608,000欧元的研发协议[168] 融资情况 - 公司完成了约650万美元的公开发行,募集资金净额约550万美元[118,119,120] - 公司与Alumni Capital LP签署了8000万美元的股权融资协议[121,122,123,124,125] - 公司目前现金和投资总额为1.25亿美元,预计未来还需要额外融资[154,156,157,158,159] - 公司可能需要通过股权融资、债务融资或合作等方式获得额外资金[156,157,158,159] 财务情况 - 研发费用主要包括人员成本、临床试验费用、生产费用等[129,130,131,132] - 一般及行政费用主要包括薪酬、专业服务费等[133,134] - 2024年第二季度研发费用同比下降17%,主要是临床试验费用减少[142] - 2024年上半年研发费用同比下降20.7%,主要是临床试验费用减少[151] - 2024年上半年经营活动现金流出为3.44百万美元[160] - 净现金用于投资活动为1,310,774美元，较上年同期的456,505美元有所增加[163] - 净现金来自筹资活动为5,196,197美元，较上年同期的5,674,266美元有所减少[164] - 现金及现金等价物净增加额为443,928美元，较上年同期的1,898,501美元有所减少[161] - 经营活动产生的净现金流出为3,442,000美元，较上年同期的3,319,000美元有所增加，主要由于应付账款和应计费用的增加较小以及预付费用的增加所致[162] 上市合规 - 公司的ADS交易价格连续31个交易日低于纳斯达克最低1美元的要求,但目前尚未受到任何处罚[126] - 公司有180天的时间来恢复符合纳斯达克最低股价要求[127]

文章核心观点 - 公司正计划在新西兰启动一项调查者主导的临床研究,评估QRX003在一名患有剥脱性皮肤综合征(PSS)的儿科患者中的安全性和有效性 [2][3] - QRX003是公司最先进的管线产品,目前正在美国进行两项晚期临床试验,评估其作为治疗Netherton综合征(NS)的潜在疗法 [2][5] - 公司正积极评估在其他国家开设更多临床试验点 [1] - 目前尚无PSS的批准治疗方法或治愈方法,这为公司在另一种罕见遗传性疾病中获得首个监管批准带来了进一步机会 [3][6] 公司概况 - 公司是一家专注于开发和商业化罕见和孤儿疾病新疗法的临床阶段专业制药公司 [8] - 公司的创新管线包括三种正在开发的产品,可能共同针对多种罕见和孤儿适应症,包括Netherton综合征、剥脱性皮肤综合征、掌跖角化病、表皮松解性水疱症等 [8] QRX003产品信息 - QRX003是一种独特的"全身、终生"的外用乳液,针对皮肤炎症和屏障受损的恶性循环 [4][7] - QRX003含有一种专有递送技术配制的广谱丝氨酸蛋白酶抑制剂,其作用机制旨在执行一种特定蛋白质LEKTI的功能 [7] - LEKTI在Netherton患者中缺失,导致皮肤过度脱落,形成高度多孔和受损的皮肤屏障,QRX003旨在使皮肤脱落过程更加正常化,形成更强大有效的皮肤屏障 [7]

Peeling Skin Syndrome is a rare autosomal disease with no approved treatment or cure Initial clinical site and pediatric patient identified in New Zealand Company actively evaluating opening additional clinical sites in other countries ASHBURN, Va., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin") a clinical stage, specialty pharmaceutical company focused on developing and commercializing novel treatments for rare and orphan diseases, today announced the ...

ASHBURN, Va., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ:QNRX) (the "Company" or "Quoin"), a clinical stage specialty pharmaceutical company focused on rare and orphan diseases, announced today that the Company plans to release its second quarter 2024 financial results before the market opens on Thursday, August 8, 2024. The announcement will provide an operational update regarding the company's achievements during the quarter and will detail financial highlights. About Quoin Pharm ...

Clinical site to be Opened in Saudi Arabia Site Currently Treating Netherton Patients Who Are Eligible for Recruitment into Quoin Studies Experienced Local Clinical Research Organization Has Been Engaged Plans for the Opening of Additional International Sites at an Advanced Stage ASHBURN, Va., June 27, 2024 (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 that it wil ...

ASHBURN, Va., June 25, 2024 (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 that it will be a Bronze Sponsor for the Foundation for Ichthyosis & Related Skin Types (FIRST) 2024 national conference in Albuquerque, New Mexico from June 28-30, 2024. The three-day premier event is held every two years with the aim of connecting individuals seeking information about ich ...

Agreement will focus on the development of novel topical rapamycin (sirolimus) formulations as potential treatments for a number of rare and orphan diseases UCC's proprietary dissolvable microneedles technology and other approaches will be utilized to optimize the local delivery of rapamycin ASHBURN, Va., June 12, 2024 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ:QNRX) (the "Company" or "Quoin"), a specialty pharmaceutical company focused on rare and orphan diseases, today announced that it has si ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to __________ Commission file number: 001-37846 QUOIN PHARMACEUTICALS LTD. (Exact name of registrant as specified in its charter) ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-37846 QUOIN PHARMACEUTICALS LTD. (Exact name of registrant as specified in its charter) State of Israel 92- ...