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10-Q: Q3 2024 Earnings Report

10-Q: Q3 2024 Earnings Report

10-Q:2024财年三季报
美股SEC公告 ·  2024/11/13 20:33

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Clene Inc. reported Q3 2024 financial results with revenue of $87,000, down 19% YoY, and a net loss of $8 million compared to $2.4 million in Q3 2023. Research and development expenses decreased 25% to $4.5 million, while general and administrative costs declined 7% to $3.4 million. The company ended the quarter with $14.6 million in cash and cash equivalents.The company continues to advance its lead drug candidate CNM-Au8, with plans to execute an international Phase 3 RESTORE-ALS trial expected to initiate in Q2 2025. A Type C meeting was held with the FDA on November 1, 2024 regarding potential accelerated approval pathway. For multiple sclerosis, Clene has initiated a second dosing cohort of REPAIR-MS trial with topline results expected by mid-2025.Management highlighted substantial doubt about the company's ability to continue as a going concern, noting current cash resources are insufficient to fund operations for the next 12 months. To address funding needs, Clene raised $3.5 million through a registered direct offering and $3.8 million from private placements that closed on October 1, 2024. The company is exploring additional financing options and implementing cost-saving initiatives.
Clene Inc. reported Q3 2024 financial results with revenue of $87,000, down 19% YoY, and a net loss of $8 million compared to $2.4 million in Q3 2023. Research and development expenses decreased 25% to $4.5 million, while general and administrative costs declined 7% to $3.4 million. The company ended the quarter with $14.6 million in cash and cash equivalents.The company continues to advance its lead drug candidate CNM-Au8, with plans to execute an international Phase 3 RESTORE-ALS trial expected to initiate in Q2 2025. A Type C meeting was held with the FDA on November 1, 2024 regarding potential accelerated approval pathway. For multiple sclerosis, Clene has initiated a second dosing cohort of REPAIR-MS trial with topline results expected by mid-2025.Management highlighted substantial doubt about the company's ability to continue as a going concern, noting current cash resources are insufficient to fund operations for the next 12 months. To address funding needs, Clene raised $3.5 million through a registered direct offering and $3.8 million from private placements that closed on October 1, 2024. The company is exploring additional financing options and implementing cost-saving initiatives.
Clene Inc.报告了2024年第三季度的财务结果,营业收入为87,000美元,同比下降19%,净亏损为800万人民币,而2023年第三季度为240万人民币。研发费用减少25%,至450万人民币,而一般和行政费用下降7%,至340万人民币。公司季度末现金及现金等价物为1460万人民币。公司继续推进其主要药物候选CNm-Au8,计划在2025年第二季度启动国际第三阶段RESTORE-ALS试验。针对潜在的加速批准途径,2024年11月1日与FDA召开了类型C会议。对于多发性硬化症,Clene已启动REPAIR-MS试验的第二剂量组,预计在2025年中期公布顶线结果。管理层强调对公司作为持续经营能力的重大疑虑,指出当前现金资源不足以支持未来12个月的运营。为解决资金需求,Clene通过注册直接发行筹集了350万人民币,通过2024年10月1日关闭的私募融资筹集了380万人民币。公司正在探索其他融资选项并实施节约成本的措施。
Clene Inc.报告了2024年第三季度的财务结果,营业收入为87,000美元,同比下降19%,净亏损为800万人民币,而2023年第三季度为240万人民币。研发费用减少25%,至450万人民币,而一般和行政费用下降7%,至340万人民币。公司季度末现金及现金等价物为1460万人民币。公司继续推进其主要药物候选CNm-Au8,计划在2025年第二季度启动国际第三阶段RESTORE-ALS试验。针对潜在的加速批准途径,2024年11月1日与FDA召开了类型C会议。对于多发性硬化症,Clene已启动REPAIR-MS试验的第二剂量组,预计在2025年中期公布顶线结果。管理层强调对公司作为持续经营能力的重大疑虑,指出当前现金资源不足以支持未来12个月的运营。为解决资金需求,Clene通过注册直接发行筹集了350万人民币,通过2024年10月1日关闭的私募融资筹集了380万人民币。公司正在探索其他融资选项并实施节约成本的措施。
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