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6-K: Report of foreign private issuer (related to financial reporting)

6-K: Report of foreign private issuer (related to financial reporting)

6-K:外国发行人报告(业绩相关)
美股SEC公告 ·  09/30 16:58
Moomoo AI 已提取核心信息
NeuroSense Therapeutics, a clinical-stage biotechnology company, has reported significant progress in its clinical trials and development programs for its lead product candidate, PrimeC, aimed at treating neurodegenerative diseases such as ALS. The company filed a Form 6-K with the SEC for September 2024, which included condensed interim unaudited financial statements and a summary of its operating and financial review as of June 30, 2024. NeuroSense completed the primary safety and tolerability endpoints of its Phase IIb PARADIGM study and observed positive clinical efficacy in slowing disease progression. The company plans to meet with the FDA and EMA in Q4 2024 and commence a pivotal clinical trial for PrimeC in H1 2025. NeuroSense also completed a long-term toxicity study supporting the long-term use of PrimeC. Financially, NeuroSense incurred net losses of $6.26 million for the six months ended June 30, 2024, and had an accumulated deficit of $32.38 million. The company's existing cash is expected to fund operations into Q4 2024, with future funding requirements dependent on various factors including clinical trial progress and regulatory approvals.
NeuroSense Therapeutics, a clinical-stage biotechnology company, has reported significant progress in its clinical trials and development programs for its lead product candidate, PrimeC, aimed at treating neurodegenerative diseases such as ALS. The company filed a Form 6-K with the SEC for September 2024, which included condensed interim unaudited financial statements and a summary of its operating and financial review as of June 30, 2024. NeuroSense completed the primary safety and tolerability endpoints of its Phase IIb PARADIGM study and observed positive clinical efficacy in slowing disease progression. The company plans to meet with the FDA and EMA in Q4 2024 and commence a pivotal clinical trial for PrimeC in H1 2025. NeuroSense also completed a long-term toxicity study supporting the long-term use of PrimeC. Financially, NeuroSense incurred net losses of $6.26 million for the six months ended June 30, 2024, and had an accumulated deficit of $32.38 million. The company's existing cash is expected to fund operations into Q4 2024, with future funding requirements dependent on various factors including clinical trial progress and regulatory approvals.
NeuroSense Therapeutics,一家处于临床阶段的生物技术公司,报告了其主力产品候选PrimeC在治疗诸如ALS等神经退行性疾病方面的临床试验和开发项目取得的重大进展。该公司向美国证券交易委员会提交了2024年9月的6-k表格,其中包括简明的未经审计的中期财务报表,以及截至2024年6月30日的经营和财务审查摘要。NeuroSense完成了其IIb期PARADIGm研究的主要安全性和耐受性终点,并观察到在减缓病情进展方面的积极临床疗效。该公司计划在2024年第四季度与FDA和EMA会面,并于2025年上半年启动PrimeC的关键临床试验。NeuroSense还完成了支持长期使用...展开全部
NeuroSense Therapeutics,一家处于临床阶段的生物技术公司,报告了其主力产品候选PrimeC在治疗诸如ALS等神经退行性疾病方面的临床试验和开发项目取得的重大进展。该公司向美国证券交易委员会提交了2024年9月的6-k表格,其中包括简明的未经审计的中期财务报表,以及截至2024年6月30日的经营和财务审查摘要。NeuroSense完成了其IIb期PARADIGm研究的主要安全性和耐受性终点,并观察到在减缓病情进展方面的积极临床疗效。该公司计划在2024年第四季度与FDA和EMA会面,并于2025年上半年启动PrimeC的关键临床试验。NeuroSense还完成了支持长期使用PrimeC的长期毒性研究。在财务方面,NeuroSense在截至2024年6月30日的六个月内出现了626万美元的净亏损,并累积亏损达到了3238万美元。预计该公司现有的现金将在2024年第四季度资助运营,未来的资金需求取决于包括临床试验进展和监管批准在内的各种因素。
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