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10-Q: Q3 2024 Earnings Report

10-Q: Q3 2024 Earnings Report

10-Q:2024財年三季報
美股SEC公告 ·  2024/11/13 23:33

牛牛AI助理已提取核心訊息

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.報告了2024年第三季度的財務結果,營業收入爲87,000美元,同比下降19%,淨虧損爲800萬人民幣,而2023年第三季度爲240萬人民幣。研發費用減少25%,至450萬人民幣,而一般和行政費用下降7%,至340萬人民幣。公司季度末現金及現金等價物爲1460萬人民幣。公司繼續推進其主要藥物候選CNm-Au8,計劃在2025年第二季度啓動國際第三階段RESTORE-ALS試驗。針對潛在的加速批准途徑,2024年11月1日與FDA召開了類型C會議。對於多發性硬化症,Clene已啓動REPAIR-MS試驗的第二劑量組,預計在2025年中期公佈頂線結果。管理層強調對公司作爲持續經營能力的重大疑慮,指出當前現金資源不足以支持未來12個月的運營。爲解決資金需求,Clene通過註冊直接發行籌集了350萬人民幣,通過2024年10月1日關閉的私募融資籌集了380萬人民幣。公司正在探索其他融資選項並實施節約成本的措施。
Clene Inc.報告了2024年第三季度的財務結果,營業收入爲87,000美元,同比下降19%,淨虧損爲800萬人民幣,而2023年第三季度爲240萬人民幣。研發費用減少25%,至450萬人民幣,而一般和行政費用下降7%,至340萬人民幣。公司季度末現金及現金等價物爲1460萬人民幣。公司繼續推進其主要藥物候選CNm-Au8,計劃在2025年第二季度啓動國際第三階段RESTORE-ALS試驗。針對潛在的加速批准途徑,2024年11月1日與FDA召開了類型C會議。對於多發性硬化症,Clene已啓動REPAIR-MS試驗的第二劑量組,預計在2025年中期公佈頂線結果。管理層強調對公司作爲持續經營能力的重大疑慮,指出當前現金資源不足以支持未來12個月的運營。爲解決資金需求,Clene通過註冊直接發行籌集了350萬人民幣,通過2024年10月1日關閉的私募融資籌集了380萬人民幣。公司正在探索其他融資選項並實施節約成本的措施。

譯文內容由第三人軟體翻譯。


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