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424B5: Prospectus

424B5: Prospectus

424B5：募资说明书
美股SEC公告 ·  2024/12/10 07:39

Moomoo AI 已提取核心信息

Clene Inc. has entered into an equity distribution agreement to offer and sell up to $7.39 million of common stock through Canaccord Genuity. The at-the-market offering will be used to fund clinical development of CNM-Au8, Clene's lead drug candidate for neurological disorders like ALS and MS.The company recently received FDA guidance on a potential accelerated approval pathway for CNM-Au8 in ALS. Clene plans to provide additional biomarker data from ongoing expanded access programs to support an NDA submission, expected in Q2 2025. A confirmatory Phase 3 trial is also planned to begin enrollment prior to the NDA filing.Clene faces substantial doubt about its ability to continue as a going concern, with cash of $14.6 million as of September 30, 2023. The company is pursuing additional financing options to fund operations and advance its clinical programs. This offering provides an opportunity to raise capital, though Clene notes there is no assurance it will result in sufficient funding.
Clene Inc. has entered into an equity distribution agreement to offer and sell up to $7.39 million of common stock through Canaccord Genuity. The at-the-market offering will be used to fund clinical development of CNM-Au8, Clene's lead drug candidate for neurological disorders like ALS and MS.The company recently received FDA guidance on a potential accelerated approval pathway for CNM-Au8 in ALS. Clene plans to provide additional biomarker data from ongoing expanded access programs to support an NDA submission, expected in Q2 2025. A confirmatory Phase 3 trial is also planned to begin enrollment prior to the NDA filing.Clene faces substantial doubt about its ability to continue as a going concern, with cash of $14.6 million as of September 30, 2023. The company is pursuing additional financing options to fund operations and advance its clinical programs. This offering provides an opportunity to raise capital, though Clene notes there is no assurance it will result in sufficient funding.
Clene Inc.已签署一项股权分配协议，通过Canaccord Genuity发行和出售高达739万美元的普通股。这项市场上发行将用于资助CNm-Au8的临床开发，这是Clene针对如ALS和MS等神经系统疾病的主要药物候选者。该公司最近收到了FDA关于CNm-Au8在ALS中潜在加速批准路径的指导。Clene计划提供来自正在进行的扩大获取计划的额外生物标志物数据，以支持NDA提交，预计将在2025年第二季度进行。在NDA提交之前，还计划开始确认性三期试验的招募。Clene面临着持续经营能力的重大疑虑，截至2023年9月30日现金为1460万美元。该公司正在寻求额外的融资选择，以资助运营并推进其临床项目。这项发行提供了筹集资本的机会，尽管Clene指出这并不保证将带来足够的资金。
Clene Inc.已签署一项股权分配协议，通过Canaccord Genuity发行和出售高达739万美元的普通股。这项市场上发行将用于资助CNm-Au8的临床开发，这是Clene针对如ALS和MS等神经系统疾病的主要药物候选者。该公司最近收到了FDA关于CNm-Au8在ALS中潜在加速批准路径的指导。Clene计划提供来自正在进行的扩大获取计划的额外生物标志物数据，以支持NDA提交，预计将在2025年第二季度进行。在NDA提交之前，还计划开始确认性三期试验的招募。Clene面临着持续经营能力的重大疑虑，截至2023年9月30日现金为1460万美元。该公司正在寻求额外的融资选择，以资助运营并推进其临床项目。这项发行提供了筹集资本的机会，尽管Clene指出这并不保证将带来足够的资金。
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