Survival analyses with CNM-Au8® 30 mg treatment compared to matched PRO-ACT controls demonstrated improved survival up to 3.5 years post-baselineCNM-Au8 treated participants in the HEALEY ALS Platform Trial with substantial neurofilament light (NfL) declines (CNM-Au8 NfL Responders) demonstrated significant clinical improvements in survival, functional status (slowed ALSFRS-R decline), and combined function and survival (CAFS scores) compared to NfL non-respondersCNM-Au8 demonstrated neuroprotective effects ...

新药申请和审批进度 - 公司提交了新的后期分析数据给FDA,以讨论加速审批的监管途径[12] - 公司计划于今年晚些时候提交新药申请[4] 临床试验结果 - CNM-Au8 NfL响应者组显示平均NfL水平下降28%,表明持续减少轴突损伤[10] - CNM-Au8 30mg治疗组的生存率较匹配的PRO-ACT对照组降低约60%[8] - CNM-Au8在瑞特综合征体外模型中显示神经保护作用[14] 研发进展 - 公司获得NIH资助,启动CNM-Au8的扩大获取计划,并已于6月入组首位ALS患者[13] 财务状况 - 公司现金及现金等价物为2170万美元,预计可支持运营至2024年第四季度[16] - 研发费用同比下降,主要由于获得NIH资助的ALS扩大获取计划的费用抵消[17] - 总其他收益同比大幅增加,主要由于普通股认股权公允价值下降[19] - 公司完成1:20逆向股票拆分,以满足纳斯达克最低股价要求[15] - 总收入为9,100万美元[26] - 产品收入为6,400万美元[26] - 特许权使用费收入为2,700万美元[26] - 研发费用为4,150万美元[26] - 一般及行政费用为3,314万美元[26] - 净亏损为6,785万美元[26] - 现金及现金等价物为2.17亿美元[30] - 应付账款为1,066万美元[31] - 应计负债为5,927万美元[31] - 短期借款为2.05亿美元[31]

新药物开发 - 公司正在开发一种名为CNM-Au8的新药物,主要针对神经系统疾病如ALS、多发性硬化症和帕金森病[99] - CNM-Au8在ALS治疗中显示出改善生存率和降低神经元损伤标志物NfL水平的效果[102][103] - CNM-Au8 NfL响应者组显示平均NfL水平下降28%,提示持续降低轴突损伤[102] - CNM-Au8 NfL响应者组生存率、功能评分和综合生存功能评分均优于非响应者组[103] - 独立于NfL响应状态,长期使用CNM-Au8 30mg剂量也显示生存率较对照组有显著提高[103] - 公司宣布了CNM-Au8在多个临床结果指标上显示持续的临床获益,包括视力和认知功能的改善[105] - CNM-Au8治疗组在低对比视力字母测试中有超过一半的参与者改善10个或更多字母,最高改善38个字母[105] - CNM-Au8治疗组在符号数字测试中最高改善29分(满分110分)[105] - CNM-Au8治疗组在视觉诱发电位测试中显示神经信号强度和传导速度的显著改善,反映了神经修复和再髓鞘化[105] - MRI检查显示CNM-Au8治疗组大脑T2加权病变和髓鞘水分含量及磁化率转移比值(髓鞘标志物)均有改善,证实了再髓鞘化[105] - 公司计划与FDA等监管机构密切合作,推进CNM-Au8进入III期临床试验和未来获批[106] 财务状况 - 公司的研发费用将随着III期试验的推进而增加,同时也将增加与监管活动相关的费用[111] - 公司的一般及行政费用未来可能会增加,以支持药物开发活动的扩大和商业化准备[112] - 公司总体经营亏损,2024年上半年亏损1660万美元,2023年上半年亏损2110万美元[131] - 公司现金、现金等价物和有价证券总额为2170万美元,2023年12月31日为3500万美元,经营活动净现金流出1340万美元[131] - 公司预计未来12个月内现金不足以维持当前经营和偿还到期债务,存在持续经营重大不确定性[131] - 公司计划通过股权融资、债务融资、与第三方的许可或合作安排等方式筹集资金[131] - 公司已采取成本节约措施,包括推迟和减少某些研发项目和商业化工作,裁减部分员工[131] - 公司未来12个月的主要资金需求包括研发、人员、监管和临床试验费用,以及支持药物开发和获批前商业化活动的一般及行政费用[132] - 公司未来12个月以外的主要资金需求包括研发、人员、监管和临床试验费用,以及支持药物开发活动的一般及行政费用[133] - 公司经营活动净现金流出1340万美元,投资活动净现金流入632万美元,筹资活动净现金流入0.9万美元[134] - 公司主要使用现金用于研发、监管和其他临床试验费用,以及一般公司支出[135] - 公司在2024年上半年经营活动产生的净现金流出为1,340万美元[136] - 公司在2023年上半年经营活动产生的净现金流出为1,620万美元[136] - 公司在2024年上半年投资活动产生的净现金流入为630万美元[137] - 公司在2023年上半年投资活动产生的净现金流入为480万美元[137] - 公司在2024年上半年融资活动产生的净现金流入为9,000美元[139] - 公司在2023年上半年融资活动产生的净现金流入为4,240万美元[139] - 公司于2023年6月进行了4,000万美元的公开发行[140] - 公司在2023年上半年通过ATM协议销售了144,755股普通股,获得4.5百万美元的毛收益[141] - 公司在2023年上半年通过与林肯公园的购买协议销售了20,000股普通股,获得40万美元的毛收益[142] 会计处理 - 公司将部分可转换债券和认股权证确认为衍生工具负债,并按公允价值计量[144][145] - 公司采用基于公允价值的方法对股票激励计划进行会计处理[147] - 公司使用Black-Scholes期权定价模型估算股票期权的公允价值，需要做出重大判断[147] - 公司使用蒙特卡罗模拟方法估算限制性股票的公允价值[147] - 公司选择按实际发生的权益工具失效情况进行会计处理，而非预估失效率[147] - 作为小型报告公司,公司无需披露市场风险的定量和定性信息[148]

SALT LAKE CITY, July 12, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will present at the Emerging Growth Conference. Virtual Presentation DetailsDat ...

SALT LAKE CITY, July 12, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will present at the Emerging Growth Conference. Virtual Presentation DetailsDa ...

SALT LAKE CITY, July 11, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced plans to submit a briefing book by July 13 to the U.S. Food and Drug Administration (FDA) in a ...

SALT LAKE CITY, July 11, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced plans to submit a briefing book by July 13 to the U.S. Food and Drug Administration (FDA) in a ...

SALT LAKE CITY, July 09, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that it will effect a 1-for-20 reverse stock split at 12:01 a.m. Eastern Time, on July 11, 2024 ...

SALT LAKE CITY, July 09, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that it will effect a 1-for-20 reverse stock split at 12:01 a.m. Eastern Time, on July 11, 202 ...

SALT LAKE CITY, June 24, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will present at H.C. Wainwright's 5th Annual Neuro Perspectives Virtual Confere ...