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8-K: CLENE REPORTS Second QUARTER 2024 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS

8-K: CLENE REPORTS Second QUARTER 2024 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS

8-K:CLENE公布2024年第二季度财务业绩和近期经营亮点
美股SEC公告 ·  2024/08/07 20:06

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Clene reported Q2 2024 financial results with $21.7M cash position expected to fund operations into Q4 2024. The company's lead drug CNM-Au8 demonstrated approximately 60% decreased risk of death in ALS patients compared to controls over 3.5 years follow-up, with significant improvements in survival and functional status among NfL biomarker responders.Key developments include submission of FDA briefing book for upcoming Type C meeting in Q3 2024, potentially leading to a new drug application later this year. The company enrolled its first ALS patient in the NIH-funded Expanded Access Program in June. Additionally, CNM-Au8 showed promising neuroprotective effects in Rett Syndrome preclinical studies.Q2 financial results showed reduced R&D expenses of $4.2M (vs $6.6M in Q2 2023) and G&A expenses of $3.3M (vs $3.9M). Net loss was $6.8M or $1.06 per share, compared to $25.1M or $5.84 per share in Q2 2023. The company completed a 1-for-20 reverse stock split to regain Nasdaq compliance.
Clene reported Q2 2024 financial results with $21.7M cash position expected to fund operations into Q4 2024. The company's lead drug CNM-Au8 demonstrated approximately 60% decreased risk of death in ALS patients compared to controls over 3.5 years follow-up, with significant improvements in survival and functional status among NfL biomarker responders.Key developments include submission of FDA briefing book for upcoming Type C meeting in Q3 2024, potentially leading to a new drug application later this year. The company enrolled its first ALS patient in the NIH-funded Expanded Access Program in June. Additionally, CNM-Au8 showed promising neuroprotective effects in Rett Syndrome preclinical studies.Q2 financial results showed reduced R&D expenses of $4.2M (vs $6.6M in Q2 2023) and G&A expenses of $3.3M (vs $3.9M). Net loss was $6.8M or $1.06 per share, compared to $25.1M or $5.84 per share in Q2 2023. The company completed a 1-for-20 reverse stock split to regain Nasdaq compliance.
Clene公布了2024年第二季度财务结果,预计2170万美元的现金储备将支持其运营直到2024年第四季度。该公司的首款药物CNm-Au8在对照组中,ALS患者的死亡风险降低约60%(随访3.5年),同时在NfL生物标志物反应者中,生存和功能状态显著改善。关键进展包括向FDA提交即将于2024年第三季度举行的类型C会议的简报材料,这可能导致今年晚些时候的新药申请。该公司于6月份在国家卫生研究院资助的扩展访问项目中招募了第一名ALS患者。此外,CNm-Au8在Rett综合症的临床前研究中显示出有希望的神经保护效果。第二季度财务结果显示,研发费用减少至420万美元(相比2023年第二季度的660万美元)和一般管理费用为330万美元(相比390万美元)。净亏损为680万美元或每股1.06美元,而2023年第二季度为2510万美元或每股5.84美元。该公司完成了一次1比20的反向拆股,以重新获得纳斯达克的合规性。
Clene公布了2024年第二季度财务结果,预计2170万美元的现金储备将支持其运营直到2024年第四季度。该公司的首款药物CNm-Au8在对照组中,ALS患者的死亡风险降低约60%(随访3.5年),同时在NfL生物标志物反应者中,生存和功能状态显著改善。关键进展包括向FDA提交即将于2024年第三季度举行的类型C会议的简报材料,这可能导致今年晚些时候的新药申请。该公司于6月份在国家卫生研究院资助的扩展访问项目中招募了第一名ALS患者。此外,CNm-Au8在Rett综合症的临床前研究中显示出有希望的神经保护效果。第二季度财务结果显示,研发费用减少至420万美元(相比2023年第二季度的660万美元)和一般管理费用为330万美元(相比390万美元)。净亏损为680万美元或每股1.06美元,而2023年第二季度为2510万美元或每股5.84美元。该公司完成了一次1比20的反向拆股,以重新获得纳斯达克的合规性。
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