s
美国
证券交易委员会
华盛顿,DC 20549
表格
根据1934年证券交易法第13或15(d)节的季度报告 |
截至季度结束日期的财务报告
or
根据1934年证券交易法第13或15(d)节的转型报告书 |
从________到________的过渡期。
委员会档案号码:
(根据其章程规定的注册人准确名称)
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(国家或其他管辖区的 公司成立或组织) |
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(IRS雇主 (标识号码) |
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,(主要行政办公地址) |
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(邮政编码) |
(注册人电话号码,包括区号)
(更名前名称,更名前地址和更名前公司财年,如自上次报告以来发生变化): N/A
在法案第12(b)条的规定下注册的证券:
每种类别的证券 |
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交易代码 |
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名称为每个注册的交易所: |
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The |
请勾选以下选项以指示注册人是否在过去12个月内(或在注册人需要提交此类报告的较短时间内)已提交证券交易法1934年第13或15(d)条所要求提交的所有报告,并且在过去90天内已受到此类报告提交要求的影响。
请在以下勾选方框表示注册人是否已在Regulation S-T Rule 405规定的前12个月(或在注册人需要提交此类文件的较短期间内)提交了每个互动数据文件。
请勾选标记以说明注册人是大型快速申报人、加速申报人、非加速申报人、较小的报告公司还是新兴成长型公司。请查看《交易所法》第120亿.2条中“大型快速申报人”、“加速申报人”、“较小的报告公司”和“新兴成长型公司”的定义。
大型加速报告人 |
☐ |
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加速文件提交人 |
☐ |
☒ |
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较小的报告公司 |
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新兴成长公司 |
如果是新兴成长型公司,在选中复选标记的同时,如果公司已选择不使用根据证券交易法第13(a)条提供的任何新的或修订后的财务会计准则的延长过渡期来符合新的或修订后的财务会计准则,则表明该公司已选择不使用根据证券交易法第13(a)条提供的任何新的或修订后的财务会计准则的延长过渡期来符合新的或修订后的财务会计准则。☐
请在勾选符号上注明本公司是否为外壳公司(在证券交易法12b-2规定中定义)。是 ☐ 否
截至11月4日,2024,
corbus pharmaceuticals控股有限公司。
2024年9月30日结束的季度报告10-Q表
目录
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第一部分 |
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财务信息 |
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项目1。 |
3 |
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3 |
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4 |
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5 |
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7 |
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8 |
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事项二 |
19 |
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第3项。 |
26 |
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事项4。 |
26 |
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第II部分 |
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其他信息 |
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项目1。 |
27 |
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项目1A。 |
27 |
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事项二 |
30 |
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第3项。 |
30 |
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事项4。 |
30 |
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项目5。 |
30 |
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项目6。 |
31 |
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32 |
-2-
第一部分 — FI财务信息
项目1. 财务状况ments.
Corbus Pharmaceuticals Holdings,Inc。
缩减式综合账户汇编负债表
(以千为单位,除每股数据外)
(未经审计)
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2024年9月30日 |
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2023年12月31日 |
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资产 |
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流动资产: |
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现金及现金等价物 |
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$ |
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$ |
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投资 |
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受限现金 |
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预付费用和其他流动资产 |
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总流动资产 |
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受限现金 |
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资产和设备,净值 |
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经营租赁权使用资产 |
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其他 |
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资产总额 |
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$ |
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$ |
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负债和股东权益 |
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流动负债: |
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应付票据 |
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$ |
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$ |
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应付账款 |
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应计费用 |
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衍生品负债 |
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经营租赁负债,流动负债 |
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应付贷款 |
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流动负债合计 |
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其他长期负债 |
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非流动营业租赁负债 |
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负债合计 |
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股东权益 |
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优先股,$0.0001 |
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普通股,每股面值为 $0.0001; |
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额外实收资本 |
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累积赤字 |
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累计其他综合收益 (损失) |
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( |
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股东权益(赤字) |
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负债和股东权益总额 |
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$ |
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$ |
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请查看未经审计的简明合并基本报表的说明。
-3-
Corbus Pharmaceuticals Holdings,Inc。
压缩综合收益(亏损)表s 营业费用和全面亏损
(以千为单位,除每股数据外)
(未经审计)
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在这三个月里 |
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九个月来 |
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2024 |
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2023 |
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2024 |
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2023 |
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运营费用: |
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研究和开发 |
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$ |
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$ |
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$ |
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$ |
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一般和行政 |
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运营费用总额 |
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营业亏损 |
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( |
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( |
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( |
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其他收入(支出),净额: |
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其他收入,净额 |
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利息收入 |
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利息支出 |
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( |
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( |
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( |
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( |
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衍生负债公允价值的变化 |
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外币交易收益(亏损),净额 |
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( |
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( |
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其他收入(支出),净额 |
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( |
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( |
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净亏损 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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基本和摊薄后的每股净亏损 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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已发行普通股、基本股和摊薄后普通股的加权平均数 |
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综合损失: |
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净亏损 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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其他综合(亏损)收益: |
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有价债务证券未实现收益的变化 |
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其他综合收入总额 |
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综合损失总额 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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请查看未经审计的简明合并基本报表的说明。
-4-
Corbus Pharmaceuticals Holdings,Inc。
汇编综合财务报表股东权益变动表
(以千为单位,除股份数量外)
(未经审计)
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截至2024年9月30日三个月 |
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普通股 |
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额外的 |
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累积的 |
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累积的 |
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总计 |
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股份 |
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数量 |
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资本 |
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$ |
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损失 |
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股权 |
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2024年6月30日余额 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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普通股股份发行净额(扣除发行成本) |
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— |
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— |
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— |
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现金行使认股权证后普通股的发行 |
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— |
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— |
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— |
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— |
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— |
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行使期权的普通股发行 |
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— |
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— |
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— |
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受限股解禁后普通股的发行 |
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— |
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— |
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— |
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— |
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— |
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股票补偿费用 |
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— |
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— |
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— |
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— |
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可交易债务证券未实现收益(损失)的变动 |
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— |
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— |
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— |
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— |
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净损失 |
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— |
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— |
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— |
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( |
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— |
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( |
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2024年9月30日的余额 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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截至2023年9月30日三个月的时间 |
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普通股 |
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额外的 |
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累积的 |
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累积的 |
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总计 |
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股份 |
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数量 |
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资本 |
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$ |
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损失 |
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股权 |
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2023年6月30日的余额 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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普通股股份发行净额(扣除发行成本) |
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— |
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— |
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— |
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K2贷款和安防-半导体协议转换后发行普通股 |
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— |
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— |
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— |
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— |
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— |
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股票补偿费用 |
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— |
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— |
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可交易债务证券未实现收益(损失)的变动 |
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— |
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净损失 |
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— |
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— |
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( |
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— |
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( |
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2023年9月30日结余 |
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$ |
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$ |
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$ |
( |
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$ |
( |
) |
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$ |
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请查看未经审计的简明合并基本报表的说明。
-5-
Corbus Pharmaceuticals Holdings,Inc。
股东权益的简化合并报表
(以千为单位,除股份数量外)
(未经审计)
|
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2024年9月30日结束的九个月 |
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普通股 |
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额外的 |
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累积的 |
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累积的 |
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总计 |
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股份 |
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数量 |
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资本 |
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$ |
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损失 |
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股权 |
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2023年12月31日结余为 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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普通股股份发行净额(扣除发行成本) |
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— |
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— |
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现金行使认股权证后普通股的发行 |
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— |
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— |
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— |
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— |
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— |
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K2贷款和安防-半导体协议转换后发行普通股 |
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— |
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— |
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— |
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行使期权的普通股发行 |
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— |
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— |
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— |
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受限股解禁后普通股的发行 |
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— |
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— |
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— |
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— |
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— |
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股票补偿费用 |
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— |
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— |
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— |
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— |
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可交易债务证券未实现收益(损失)的变动 |
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— |
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— |
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— |
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— |
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净损失 |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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2024年9月30日的余额 |
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$ |
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$ |
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$ |
( |
) |
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$ |
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$ |
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截止2023年9月30日止九个月 |
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普通股 |
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额外的 |
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累积的 |
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累积的 |
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总计 |
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股份 |
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数量 |
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资本 |
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$ |
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损失 |
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股权 |
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2022年12月31日结存余额 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
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普通股股份发行净额(扣除发行成本) |
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— |
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— |
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— |
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K2贷款和安防-半导体协议转换后普通股发行 |
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— |
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— |
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— |
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行使期权的普通股发行 |
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— |
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— |
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— |
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股票补偿费用 |
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— |
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— |
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— |
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— |
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可交易债务证券未实现收益(损失)的变动 |
|
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— |
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— |
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— |
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— |
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净损失 |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
2023年9月30日结余 |
|
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$ |
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|
$ |
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|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
请查看未经审计的简明合并基本报表的说明。
-6-
Corbus Pharmaceuticals Holdings,Inc。
压缩的综合资产负债表现金流量表注解
(以千为单位)
(未经审计)
|
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九个月结束 |
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|||||
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2024 |
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2023 |
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经营活动现金流量: |
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||
净损失 |
|
$ |
( |
) |
|
$ |
( |
) |
调整为净损失到经营活动现金流量净使用: |
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||
股票补偿费用 |
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折旧费用 |
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投资折价净摊销 |
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( |
) |
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( |
) |
债务折扣摊销 |
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其他 |
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( |
) |
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经营性资产和负债变动: |
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预付费用和其他流动资产减少(增加) |
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( |
) |
|
其他资产减少(增加) |
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( |
) |
|
经营租赁权使用资产减少 |
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其他长期负债(减少)增加 |
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( |
) |
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应付账款的(减少)增加 |
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( |
) |
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应计费用的减少/增加 |
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( |
) |
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经营租赁负债减少 |
|
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( |
) |
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( |
) |
经营活动使用的净现金流量 |
|
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( |
) |
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( |
) |
投资活动现金流量: |
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||
投资购买 |
|
|
( |
) |
|
|
( |
) |
出售和到期投资的收益 |
|
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||
投资活动的净现金流量(使用)/提供的净现金流量 |
|
|
( |
) |
|
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|
|
筹集资金的现金流量: |
|
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|
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|
||
发行普通股收到的款项,净额 |
|
|
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|
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|
||
应付票据还款 |
|
|
( |
) |
|
|
( |
) |
偿还长期借款 |
|
|
( |
) |
|
|
( |
) |
筹集资金的净现金流量 |
|
|
|
|
|
( |
) |
|
现金、现金等价物和受限制的现金的净增加(减少) |
|
|
|
|
|
( |
) |
|
期初现金、现金等价物及受限制的现金 |
|
|
|
|
|
|
||
期末现金、现金等价物及受限制的现金 |
|
$ |
|
|
$ |
|
||
补充现金流信息和非现金交易披露: |
|
|
|
|
|
|
||
期间支付的利息 |
|
$ |
|
|
$ |
|
||
冲销已全额折旧的固定资产和设备 |
|
$ |
|
|
$ |
|
||
尚未支付的普通股发行费用 |
|
$ |
|
|
$ |
|
||
发行普通股以换股债务 |
|
$ |
|
|
$ |
|
请查看未经审计的简明合并基本报表的说明。
-7-
Corbus Pharmaceuticals Holdings,Inc。
未经审计的附注及基本报表的附注
2024年9月30日
1. 业务性质和报告基础
业务性质
Corbus Pharmaceuticals Holdings, Inc.(以下简称"公司"或"corbus pharmaceuticals")是一家拥有多元化组合的肿瘤和肥胖症公司,致力于通过引入创新的科学方法到广为人知的生物通路,帮助人们战胜严重疾病。corbus的管线包括两种针对实体瘤的实验药物:CRb-701,一种针对癌细胞上Nectin-4表达的下一代抗体药物结合物("ADC")以释放细胞毒荷载和CRb-601,一种抗整合素单克隆抗体,可阻止癌细胞上TGFβ的激活。该管线还包括CRb-913,一种高度周围限制的大麻素-1("CB1")受体逆向激动剂,用于肥胖症的治疗。自成立以来,公司几乎全部精力投入于业务规划、研发、招聘管理和技术人员、收购经营资产和筹集资金。公司的业务面临重大风险和不确定性,公司将依赖于筹集大量额外资本,以在实现盈利之前变得赢利,并且可能永远无法实现盈利。
报告范围
附注的未经审计财务报表是根据美国通用会计原则("U.S. GAAP")编制的用于中期财务报告。在公司管理层的意见中,随附的未经审计的简明合并中期财务报表反映了所有必要的调整(仅包括正常的往复性调整),以在所有方面公正、充分呈现截至2024年9月30日公司的简明合并财务状况,以及截至2024年9月30日和2023年公司业绩和股东权益变动情况,以及截至2024年9月30日和2023年的现金流量。2023年12月31日的简明合并资产负债表来源于审计的财务报表。公司按照美国证券交易委员会(“SEC”)的要求,编制了简明合并财务报表进行中报告。因此,一些通常包含在按照美国通用会计原则编制的财务报表中的信息和脚注披露已经被压缩或省略。建议将这些简明合并财务报表与公司截至2023年12月31日年度报告中包括的财务报表和附注一起阅读。于2024年3月12日提交(以下简称“2023年年度报告”)的。此类期间运营结果并不一定代表整个财政年度的运营结果。
合并基础
简明综合财务报表包括公司及其全资子公司的账目。所有重要的公司内部交易和账目在合并中已经予以消除。
在本10-Q表格中编制这些简明综合财务报表所使用的重要会计政策与我们的2023年年度报告中讨论的第3号说明“重要会计政策”一致。
最近的会计声明
2023年11月,FASB发布了ASU 2023-07,分部报告(主题 280):报告服务部门(主题 280)变更披露方式,通过升级对意义重大的分部费用的披露来改进分部报告披露要求。该准则适用于 2023 年 12 月 15 日之后的财年和 2024 年 12 月 15 日之后的财年间隔期。该准则必须适用于财务报表中呈现的所有期间的追溯。该公司目前正在评估该标准对合并财务报表的影响。旨在通过额外披露有关重要分部费用的信息改进可报告部门披露要求。该标准自2023年12月15日后开始的财政年度及2024年12月15日后开始的财政年度内的中期期间生效,可提前采用。修订将会对财务报表中呈现的所有历史期间进行追溯应用。公司预计在2024年12月31日采用该标准将导致其财务报表附注中的披露增加。
-8-
2. 流动性
附带的简明合并财务报表是在假设公司将继续作为一个持续经营的实体下进行准备的,这包括业务的持续性、资产的实现以及在正常业务过程中满足责任和承诺。公司自成立以来一直在持续亏损截止至2024年9月30日,累计赤字约为$
未来融资的来源、时间和可用性将主要取决于市场情况,更具体地取决于公司临床开发项目的进展。当需要融资时,融资可能无法获得,或者可能无法获得公司可接受的条件。缺乏必要的资金可能需要公司延迟、减少或取消部分或全部计划中的临床或临床前试验。有关公司最近融资的补充信息,请参考附注12。
3. 现金、现金等价物和受限现金
公司仅将那些高度流动、易于兑现且在购买之日起90天内到期的投资视为现金等价物。截至2024年9月30日和2023年12月31日,现金等价物由货币市场基金和企业债券组成,其到期日不超过购买之日90天。
截至2024年9月30日,受限现金中包括为一份由房东发放的备用信用证提供担保的安防-半导体或者为一位房东发放的价值为$的备用信用证提供担保
现金、现金等价物和受限现金包括以下内容(以千为单位):
|
|
2024年9月30日 |
|
|
2023年12月31日 |
|
||
现金 |
|
$ |
|
|
$ |
|
||
现金等价物 |
|
|
|
|
|
|
||
现金及现金等价物 |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
限制性现金,流动资产 |
|
|
|
|
|
|
||
非流动限制性现金 |
|
|
|
|
|
|
||
受限现金 |
|
|
|
|
|
|
||
现金、现金等价物和受限现金的总额在现金流量表中显示 |
|
$ |
|
|
$ |
|
截至2024年9月30日,该公司在美国持有的现金及现金等价物约为$至2024年9月30日,公司在美国持有的现金及现金等价物约为$
我们在英国和澳大利亚的外国子公司可能有资格获得可退税的研发税收抵免,形式为现金,该抵免是根据主要发生在美国以外地区的某些研发支出所赚取的。 公司分别从Simon Langelier, Health Diplomats Pte Ltd和Mario Gobbo那里收到了数额为$
-9-
4. 投资
以下表格总结了公司截至 2024年9月30日(以千为单位):
|
|
摊销成本 |
|
|
毛利 |
|
|
毛利 |
|
|
公正价值 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
$ |
|
|
|
|
|
|
|
|
|
|
|
|
||||
美国国债 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
美国政府机构债券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
企业债券 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
总计 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
以下表格总结了公司截至日期的可供出售的市场债务证券的摊销成本和公允价值。 2024年9月30日(以千为单位):
|
|
摊销成本 |
|
|
公正价值 |
|
||
|
|
|
|
|
|
|
||
美国国库券: |
|
$ |
|
|
$ |
|
||
一年后到三年内到期 |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
以下表格总结了公司的投资截至日期。 2023年12月31日 (以千为单位):
|
|
摊销成本 |
|
|
毛利 |
|
|
毛利 |
|
|
公正价值 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
债务证券: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
企业债券 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
总计 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
以下表格总结了公司截至2023年12月31日的持有可供出售的市场债务证券的摊余成本和公允价值(以千美元计): 2023年12月31日(以千美元计):
|
|
摊销成本 |
|
|
公正价值 |
|
||
|
|
|
|
|
|
|
||
一年或更短时间到期 |
|
$ |
|
|
$ |
|
||
|
|
$ |
|
|
$ |
|
5. 金融资产和金融负债的公允价值
以下表格提供了关于公司金融资产和金融负债的信息,这些信息是根据公允价值定期计量的,并指示了用于确定这些公平价值的公平价值层次的级别,截至
|
|
一级 |
|
|
二级 |
|
|
Level 3 |
|
|
总计 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
资产: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
现金等价物: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
货币市场基金 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
企业债券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
投资: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
美国国债 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
美国政府机构债券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
企业债券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
-10-
以下表格展示了公司资产和负债的财务信息,这些信息是按照每年重复使用的公允价值计量,并指出了公允价值层次的级别,用于判断截至2023年12月31日的公允价值。
|
|
一级 |
|
|
二级 |
|
|
Level 3 |
|
|
总计 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
资产: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
现金及现金等价物: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
货币市场基金 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
企业债券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
投资: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
企业债券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
负债: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
衍生工具负债 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
6. 许可协议
该公司与特拉华州私人控股有限责任公司Jenrin Discovery, LLC(“Jenrin”)签订了许可协议(“Jenrin许可协议”),自2018年9月20日起生效。根据Jenrin许可协议,Jenrin授予公司开发和商业化许可产品(定义见Jenrin许可协议)的全球独家权利,其中包括包含600多种化合物的Jenrin库以及多份已发布和待审的专利申请。这些化合物旨在通过靶向内源性大麻素系统来治疗炎症和纤维化疾病。
考虑到Jenrin授予的许可证和其他权利,该公司向Jenrin支付了$
该公司与全景研究公司的子公司银河生物制药有限责任公司(“银河系许可协议”)签订了许可协议(“银河许可协议”),自2021年5月25日起生效。根据银河系许可协议,根据银河系拥有或控制的某些专利权和专有技术,公司获得了独家许可,用于开发、商业化和以其他方式开发含有针对整合素αvβ6和/或整合素αvβ8抗体的产品(“许可产品”),该公司称其中一种产品为CRB-602。根据银河系许可协议的条款,公司全权负责任何许可产品的研究、开发和商业化,并且公司已同意采取商业上合理的努力来开展这些活动。在特定情况下,银河系协议可以提前终止,包括因重大违约而终止或公司在事先通知的情况下终止。公司签署了无理由终止的通知,并于2024年1月25日发送给银河系,终止了自2024年7月23日起生效的银河系协议。
公司与加利福尼亚大学摄政官(“摄政官”)签订了自2021年5月26日起生效的许可协议(“加州大学旧金山分校许可协议”)。根据加州大学旧金山分校的许可协议,公司获得了与针对整合素αvβ8的人源化抗体有关的某些专利的独家许可,该公司称其中一项为CRB-601,以及某些相关专有技术和材料的非独家许可。该公司修订了加州大学旧金山分校与The Regents的许可协议,该协议自2022年11月17日起生效,在该协议中增加了额外的抗体专利。
在 作为根据加州大学旧金山分校许可协议授予公司的许可证和其他权利的对价, 公司向Regents支付了许可证发行费 $
该公司进一步修订了加州大学旧金山分校与The Regents签订的许可协议,以纳入某些新技术权利,并修改了专利权申请的开发里程碑和研究性新药(“IND”)申请的开发里程碑的付款时间表。
-11-
除了许可证颁发费, 公司有义务支付年度许可证维护费, 以及最高 $
该公司与石药集团有限公司的子公司CSPC Megalith Biopharmaceutical Co., Ltd.(“CSPC”)签订了许可协议(“CSPC许可协议”),自2023年2月12日起生效。根据CSPC许可协议,该公司获得了独家许可,可以在美国、加拿大、欧盟(包括欧洲自由贸易区)、英国和澳大利亚开发和商业化一种针对Nectin-4的新型临床阶段抗体偶联物,该公司将其称为CRB-701。
作为根据CSPC许可协议授予公司的许可证的对价, 公司向CSPC支付了预付款 $
公司确定,Jenrin许可协议和CSPC许可协议的几乎所有公允价值都归属于一项不构成业务的在建研发资产。公司确定,银河系许可协议和加州大学旧金山分校许可协议的几乎所有公允价值均归属于不构成业务的单独在建研发资产。该公司得出结论,收购的在建研发资产将来没有任何其他用途。因此,公司在许可协议生效的季度记录了各种研发费用的预付款。在实现相关里程碑期间,公司将把开发、监管和销售里程碑付款记作研发费用或视情况作为无形资产。截至2024年9月30日, 该公司的应计许可费用为 $
7. 物业和设备
房地产和设备的构成如下(以千元计):
|
|
9月30日, |
|
|
12月31日, |
|
||
电脑硬件和软件 |
|
$ |
|
|
$ |
|
||
办公家具和设备 |
|
|
|
|
|
|
||
租赁改良 |
|
|
|
|
|
|
||
234,036 |
|
|
|
|
|
|
||
减:累计折旧 |
|
|
( |
) |
|
|
( |
) |
资产和设备,净值 |
|
$ |
|
|
$ |
|
折旧费用分别为2024年3月31日和2023年3月31日的美元
公司注意到
-12-
8. 承诺和 contingencies
经营租赁承诺
根据公司截至2024年9月30日生效的不可取消租赁协议的条款 2024年9月30日,以下表总结了公司的经营租赁负债到期情况(以千为单位):
2024 |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
总租赁支付 |
|
|
|
|
|
|
|
|
|
减:隐含利息 |
|
|
( |
) |
总计 |
|
$ |
|
转租承诺
9. 应付票据
董事和官员融资
2023年11月,公司与一家融资公司签订了一项贷款协议,金额为$
与K2 HealthVentures LLC签订的贷款和安全协议
于2020年7月28日,公司及其子公司corbus pharmaceuticals Inc.作为借款人与K2 HealthVentures LLC(“K2HV”),一个不相关的第三方签订了一份担保的贷款和安全协议(“贷款和安全协议”),并在签署时收到了$
根据 根据修订后的借款和安全协议,K2HV可以选择将最多$的未偿贷款余额转换成公司普通股
在2019年12月,根据贷款和安防-半导体协议,公司于2020年7月28日向K2HV发行了一份购买普通股份的认购权,行使价格为$
-13-
与修订的贷款和安防-半导体协议相关的总债务折扣约为$
负债元件的净账面价值包括以下内容(单位:千元):
|
|
2024年9月30日 |
|
|
2023年12月31日 |
|
||
|
|
|
|
|
|
|
||
负责人 |
|
$ |
|
|
$ |
|
||
扣除债务折扣 |
|
|
|
|
|
( |
) |
|
债务折扣溢价 |
|
|
|
|
|
|
||
净带余额 |
|
$ |
|
|
$ |
|
10. 应计费用
应计费用包括以下内容(以千为单位):
|
|
9月30日, |
|
|
12月31日, |
|
||
|
|
|
|
|
|
|
||
已发生的临床前和临床费用 |
|
$ |
|
|
$ |
|
||
累积的产品开发成本 |
|
|
|
|
|
|
||
已发生的许可成本 |
|
|
|
|
|
|
||
应计的薪资 |
|
|
|
|
|
|
||
已发生的行政费用 |
|
|
|
|
|
|
||
应计利息 |
|
|
|
|
|
|
||
总计 |
|
$ |
|
|
$ |
|
11. 每普通股净亏损
以下表格列出了截至2024年和2023年9月30日的每股基本和摊薄收益的计算 截至2024年和2023年9月30日的三个和九个月(以千为单位,除了股份和每股金额):
|
|
三个月截止 |
|
|
九个月结束 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
净损失 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
普通股基本摊薄加权平均数 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
每股普通股基本亏损 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
股票期权和认股权证均未行权以及未解除限制的限制性股票单位(见注释13和14)已从摊薄计算中排除,因为所有报告期均亏损,这些证券的影响将导致抗稀释。
-14-
12. 股东权益
优先股
The Company has authorized
普通股
公司已经授权
公开发售
2024年1月31日,公司与Jefferies LLC(“Jefferies”)签订了一项承销协议,Jefferies是数家承销商的代表,涉及一项公开发行的
现有公开市场销售协议
2023年5月31日,公司与Jefferies签订了修正协议编号1,原协议日期为2020年8月6日 (经修订,即“公开市场销售协议”),与销售代理Jefferies签订。 根据公开市场销售协议,公司可以不时通过Jefferies发行和卖出其普通股,合计发行价高达$
根据公开市场销售协议,Jefferies可以通过法律允许的任何方法出售普通股,从法兰克福证券交易所1933年修正案下的第415条(a)(4)规定定义的“市场定价”。公司可以根据公司确定的金额和时间,按照公开市场销售协议的条款和条件出售普通股,但公司无义务出售2024年公开市场发行中的任何普通股。
公司同意向Jefferies支付每次普通股销售的总毛收入
截至2024年9月30日的三个月和九个月期间公司分别按照公开市场出售协议出售了总计
截至2023年9月30日的三个和九个月内公司通过开放市场销售协议出售了总计的股票
其他普通股交易
在2024年9月30日结束的三个月和九个月内,公司发行了股票d
截至2023年9月30日的三个和九个月内根据注14,在2024年6月30日之后,该公司发行了一份涉诉和解的国库股票中的一百万股。
-15-
在2024年9月30日结束的三个和九个月内,公司行使了购买普通股的期权,并从这些行使中获得了收入。发行了普通股股票以行使购买普通股的期权
在2023年9月30日结束的三个和九个月内,公司行使了购买普通股的期权。行使期权后发行的普通股
2024年9月30日结束的三个和九个月内,公司发行了
截至2024年9月30日的三个月和九个月期间,公司i发行了
截至2024年9月30日的三个月和九个月期间根据注14,在2024年6月30日之后,该公司发行了一份涉诉和解的国库股票中的一百万股。
13.
2024年5月16日,公司股东批准了2024年股权补偿计划(以下简称 2024 Plan”),授权最多发行
期权、激励性股票期权、股票增值权、限制性股票、限制性股票单位(“RSUs”)、绩效股份、业绩单位、激励奖金、其他基于现金的奖励和其他基于股票的奖励。根据2024年计划和2014年计划的条款,公司向员工、高管、非雇员董事、顾问和顾问授予股票期权和RSUs。股票期权期限为十年,行权价等于股票授予日本公司普通股的公平市场价。股票期权通常在四年内分
截至2024年9月30日股普通股以用于行使或归属于2014计划和2024计划下未行使奖励。
截至2024年9月30日总共有
股权奖励成本
在2019年12月,与所有以股份为基础的补偿奖励相关的连接,在综合损益表和综合损益表中确认的非现金股份为基础的补偿费用如下(以千为单位):
|
|
截至9月30日的三个月 |
|
|
截至9月30日的九个月 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
研发费用 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
一般及管理费用 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
股权报酬总额 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
-16-
按照奖励类型确认的股票为基础的薪酬支出总额如下(以千为单位):
|
|
截至9月30日的三个月 |
|
|
截至9月30日的九个月 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
股票期权 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
限制性股票单位 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
股权报酬总额 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
股票期权
每份期权奖励的公允价值是根据授予日使用Black-Scholes期权定价模型进行估计的,该模型使用以下表格中指定的假设,非雇员的预期期限如下段所述。根据美国证券交易委员会工作人员会计公告107条规定,“2014计划”和“2024计划”下授予的雇员和非雇员董事期权的预期期限均取决于公司有限的运营历史而确定的简化方法。预期期限适用于整个股票期权授予群体,因为公司预计在员工群体中不会有实质上不同的行使或分发后终止行为。对于非董事非员工期权,公司已选择将合同期限作为预期期限。无风险利率基于与用于估值期权的期限一致的美国国债收益率。公司根据实际发生的弃权计提。
主要用于确定授予员工和非雇员董事的股票期权公允价值的加权平均假设如下:
|
|
截至9月30日的九个月 |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
无风险利率 |
|
|
% |
|
|
% |
||
预期股息收益 |
|
|
% |
|
|
|||
预期期限(员工期权) |
|
|
|
|
|
|||
预期波动率 |
|
|
% |
|
|
% |
下面是截至2024年6月30日的期权活动总结: 2024年9月30日结束的九个月内详细列示如下:
股票期权 |
|
股份 |
|
|
已授予和预期于2021年1月2日授予股份 |
|
|
加权平均 |
|
|
总计 |
|
||||
2023年12月31日未行使的股票期权 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
已行权 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
行使 |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
4,114,834 |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
到期的 |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
截至2024年9月30日应收款项 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
2024年9月30日可行使 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
2024年9月30日结束的九个月内授予的股票期权的加权平均授予日期公允价值分别为$
受限股票单位
RSU代表一股的权利,在RSU役满后获得我公司的一股普通股。每个RSU的公允价值基于授予当日我公司普通股的收盘价。 公司根据实际发生的放弃予以核算。
-17-
A 2024年9月30日结束的九个月的RSU活动摘要如下:
股票 |
|
RSU下属股份数量 |
|
|
已授予和预期于2021年1月2日授予股份 |
|
||
2023年12月31日的未归属股份 |
|
|
|
|
$ |
|
||
已行权 |
|
|
|
|
$ |
|
||
被取消 |
|
|
( |
) |
|
$ |
|
|
34,105 |
|
|
( |
) |
|
$ |
|
|
2024年9月30日前尚未获授的股份 |
|
|
|
|
$ |
|
截至2024年9月30日,未确认的与未投入的RSUs相关的补偿费用达s $
14。认股权证
在截至2024年9月30日的三个月和九个月中,该公司发布了
截至2024年9月30日,有未偿还的认股权证
2018年1月26日,公司与囊性纤维化基金会(“CFF”)签订了投资协议,其中包括发行认股权证,总共购买了
2020年7月28日,公司与K2HV签订了贷款和担保协议,涉及美元的融资
2020年10月16日,公司与一家投资者关系服务提供商签订了专业服务协议。根据该协议,公司发行了可行使的认股权证,总额为
-18-
事项二 |
管理管理层对财务状况和业绩的讨论和分析。 |
我们的财务状况和经营业绩的以下讨论和分析应该结合我们的基本报表、相关附注、以及本季度报告中其他包含的其他财务信息一起阅读。本讨论包含涉及风险和不确定性的前瞻性声明。由于各种因素,我们的实际结果可能与这些前瞻性声明中预期的情况有实质性差异,包括以下讨论和本季度报告中其他地方特别在“风险因素”下讨论的因素。
关于前瞻性声明的注意事项
本Form 10-Q报告包含根据1995年《私人证券诉讼改革法案》第27A条和1933年证券法修正案、1934年证券交易所法修正案的安全港条款所作的前瞻性声明。前瞻性声明包括关于我们信仰、计划、目标、期望、预期、假设、估计、意图和未来表现的声明,涉及已知和未知的风险、不确定性和其他因素,这些因素可能超出我们的控制,并可能导致我们的实际结果、表现或成就与未来结果、表现或成就通过这些前瞻性声明所表达或暗示的方式大相径庭。除历史事实陈述外,所有其他陈述均可能是前瞻性声明。您可以通过我们使用“可能”、“可以”、“预期”、“假设”、“应该”、“表明”、“将”、“相信”、“考虑”、“期待”、“寻求”、“估计”、“继续”、“计划”、“指向”、“项目”、“预测”、“可能”、“打算”、“目标”、“潜在”及其他类似词语和表达未来的表达识别这些前瞻性声明。
有许多重要因素可能会导致我们的任何前瞻性陈述中表达的实际结果与其不同。这些因素包括但不限于:
上述内容并不代表本文档中可能涵盖的所有事项或可能导致我们实际结果与前瞻性声明中预期结果不符的风险因素。 请参阅“风险因素”以了解可能对我们业务和财务表现产生不利影响的额外风险。
所有前瞻性陈述均受此警告通知的明确限制。您应谨慎对待任何前瞻性陈述,它们仅于此报告的日期或纳入此报告的文档的日期发表。我们没有义务,并明确放弃任何更新、修订或更正任何前瞻性陈述的义务,无论是因为新信息、未来事件还是其他原因。我们已经以诚信表达了我们的期望、信仰和预测,并且我们相信它们有合理的基础。但是,我们无法保证我们的期望、信仰或预测会得出或实现。
-19-
概述
Corbus Pharmaceuticals公司是一家肿瘤和肥胖公司,拥有多样化的产品组合,并致力于通过将创新科学方法引入人们熟知的生物通路,帮助人们战胜严重疾病。我们的产品线包括两种针对实体瘤的实验药物:CRb-701,一种下一代抗体药物结合物(“ADC”),靶向癌细胞上Nectin-4的表达,释放细胞毒荷;和CRb-601,一种抗整合素单克隆抗体,阻断癌细胞表达的TGFβ的激活。该产品线还包括CRb-913,一种高度外周限制的大麻素1型(“CB1”)受体拮抗剂,用于肥胖治疗。
我们的肿瘤学管道:
2024年4月2日,我们在美国和欧洲进行的桥接第1期临床试验中首次对患者进行了剂量给药;并于2024年10月,公司完成了该研究剂量递增阶段的招募。第1期试验评估了CRb-701在已知Nectin-4高表达的晚期实体瘤患者中的安全性、药代动力学和疗效。第1期研究采用了三部分设计。第A部分的剂量递增阶段评估了四个预定剂量(1.8毫克/千克、2.7毫克/千克、3.6毫克/千克和4.5毫克/千克),随后进行B部分(剂量优化)和C部分(剂量扩展),以确定推荐/优化剂量并寻找初步的疗效信号。
Our obesity pipeline:
In diet-induced obesity (“DIO”) mouse models, CRB-913 demonstrates a reduction in body weight, body fat content, leptinemia, insulin resistance, liver triglycerides, liver fat deposits, and improvements in liver histology. CRB-913 when used in combination with incretin analogs (tirzepatide, semaglutide, or liraglutide) provides additive weight loss in DIO mice. Furthermore in DIO mice, weight loss induced by an incretin analog (semaglutide) is maintained post withdrawal by replacing it with CRB-913.
-20-
Recent Developments
Open Market Sale Agreement
On May 31, 2023, we entered into the Open Market Sale Agreement with Jefferies, as sales agent. Under the Open Market Sale Agreement, we may issue and sell, from time to time through Jefferies, shares of its common stock having an aggregate offering price of up to $150.0 million. During the three and nine months ended September 30, 2024, we sold an aggregate of 663,730 and 2,484,517 shares of common stock, respectively, under the Open Market Sale Agreement, for net proceeds of approximately $35.6 million and $91.4 million, respectively. As of September 30, 2024, approximately $76.4 million was available for issuance and sale under the Open Market Sale Agreement.
Loan and Security Agreement with K2 HealthVentures LLC
The loan from K2HV matured on August 1, 2024 and we made the final payment in the amount of $11.8 million, which represents $10.1 million principal outstanding on the maturity date, $1.6 million final payment and accrued interest.
Financial Operations Overview
We are an oncology and obesity company and have not generated any revenues from the sale of products. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for the marketing of one of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. We have never been profitable and at September 30, 2024, we had an accumulated deficit of approximately $467.4 million. Our net losses for the three months ended September 30, 2024 and 2023, were approximately $13.8 million and $10.1 million, respectively. For the nine months ended September 30, 2024 and 2023, our net losses were approximately $30.7 million and $36.6 million, respectively.
We expect to continue to incur significant expenses for the foreseeable future. We expect our expenses to increase in 2024 as compared to 2023 as we incur Phase 1 clinical trial costs for both CRB-701 and CRB-601. We will continue to incur significant operating losses as we move into the clinical phase and, accordingly, we will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity, debt financings or other sources, which may include government grants and collaborations with third parties. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenues to achieve profitability, and we may never do so.
We expect to continue to incur operating losses for at least the next several years in connection with our ongoing activities, as we:
Critical Accounting Estimates
Our condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires management to make estimates, assumptions, and judgments that affect the reported amounts of assets, liabilities, revenue, costs of expenses and related disclosures in the condensed consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates and judgments on historical experience, current economic and industry conditions and on various other factors that are believed to be reasonable under the circumstances. This forms the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no changes to the critical accounting estimates we identified in "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" in our 2023 Annual Report.
-21-
Results of Operations
Comparison of Three Months Ended September 30, 2024 and 2023
The following table summarizes our operating expenses for the three months ended September 30, 2024 and 2023 (in thousands):
|
|
Three Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
$ Change |
|
|
% Change |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development expense |
|
$ |
10,808 |
|
|
$ |
6,551 |
|
|
$ |
4,257 |
|
|
|
65 |
% |
General and administrative expense |
|
|
4,697 |
|
|
|
2,937 |
|
|
|
1,760 |
|
|
|
60 |
% |
Total operating expenses |
|
$ |
15,505 |
|
|
$ |
9,488 |
|
|
$ |
6,017 |
|
|
|
63 |
% |
Research and Development. Research and development expenses for the three months ended September 30, 2024 totaled approximately $10.8 million, an increase of $4.3 million from approximately $6.6 million recorded for the three months ended September 30, 2023. The increase in fiscal quarter 2024 as compared to 2023 was primarily attributable to increases of $3.2 million primarily related to CRB-701 clinical trial costs with our contract research organizations ("CROs") and clinical sites, $1.0 million in CRB-913 IND-enabling studies, and $0.4 million in higher compensation costs mainly due to stock-based compensation costs as stock options are being granted at higher current fair values as compared to earlier grants. These increases are offset by a $0.7 million decrease in manufacturing costs for CRB-601.
We have a subsidiary in each of the U.K. and Australia and approximately 41% and 64% of research and development expenses recorded for the three months ended September 30, 2024 and 2023, respectively was recorded in these entities.
General and Administrative. General and administrative expenses for the three months ended September 30, 2024 totaled approximately $4.7 million, an increase of $1.8 million from approximately $2.9 million recorded for the three months ended September 30, 2023. The increase in fiscal quarter 2024 as compared to 2023 was attributable to increases in stock-based compensation costs of $1.2 million primarily due to stock options being granted at higher current fair values as compared to earlier grants and a $0.4 million increase in investor relations expense primarily due to issuing common stock pursuant to a professional services agreement with a service provider.
Other Income (Expense), net. The following table summarizes our other income (expense) for the three months ended September 30, 2024 and 2023 (in thousands):
|
|
Three Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
$ Change |
|
|
% Change |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other income, net |
|
$ |
713 |
|
|
$ |
218 |
|
|
$ |
495 |
|
|
|
227 |
% |
Interest income |
|
|
1,189 |
|
|
|
217 |
|
|
|
972 |
|
|
|
448 |
% |
Interest expense |
|
|
(381 |
) |
|
|
(980 |
) |
|
|
599 |
|
|
|
-61 |
% |
Foreign currency transaction gain (loss), net |
|
|
201 |
|
|
|
(20 |
) |
|
|
221 |
|
|
|
-1105 |
% |
Other income (expense), net |
|
$ |
1,722 |
|
|
$ |
(565 |
) |
|
$ |
2,287 |
|
|
|
-405 |
% |
Other income (expense), net for the three months ended September 30, 2024 was approximately $1.7 million in income as compared to other expense of approximately $0.6 million recorded for the three months ended September 30, 2023. The increase of $2.3 million in 2024 as compared to 2023 was primarily attributable to higher investment income due to higher cash and investment balances and reduced interest expense as principal payments were made on debt in 2024.
-22-
Comparison of Nine Months Ended September 30, 2024 and 2023
The following table summarizes our operating expenses for the nine months ended September 30, 2024 (in thousands):
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
$ Change |
|
|
% Change |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development expense |
|
$ |
23,435 |
|
|
$ |
24,188 |
|
|
$ |
(753 |
) |
|
|
-3 |
% |
General and administrative expense |
|
|
12,681 |
|
|
|
10,786 |
|
|
|
1,895 |
|
|
|
18 |
% |
Total operating expenses |
|
$ |
36,116 |
|
|
$ |
34,974 |
|
|
$ |
1,142 |
|
|
|
3 |
% |
Research and Development. Research and development expenses for the nine months ended September 30, 2024 totaled approximately $23.4 million, a decrease of $0.8 million from approximately $24.2 million recorded for the nine months ended September 30, 2023. The decrease in fiscal 2024 as compared to fiscal 2023 was primarily attributable to decreases in licensing costs of $7.5 million associated with the CSPC License Agreement and $1.2 million associated with the achievement of a development milestone under the UCSF License Agreement, as well as a decrease of $0.6 million in sponsored research agreement expense as the contract ended in January 2024. These decreases are offset by a $6.6 million increase in CRB-701 clinical trial costs with our CROs and clinical sites, as well as an increase of $0.8 million in CRB-913 IND-enabling studies, $0.5 million increase in manufacturing costs primarily related to CRB-701, and $0.5 million in higher compensation costs primarily related to stock-based compensation costs as stock options are being granted at higher current fair values as compared to earlier grants.
We have a subsidiary in each of the U.K. and Australia and approximately 37% and 32% of research and development expenses recorded for the nine months ended September 30, 2024 and 2023, respectively, was recorded in these entities.
General and Administrative. General and administrative expenses for the nine months ended September 30, 2024 totaled approximately $12.7 million, an increase of $1.9 million from approximately $10.8 million recorded for the nine months ended September 30, 2023. The increase in fiscal 2024 as compared to fiscal 2023 was attributable to increases in stock-based compensation costs of $1.4 million primarily due to stock options being granted at higher current fair values as compared to earlier grants, a $0.4 million increase in investor relations expense primarily due to issuing common stock pursuant to a professional services agreement with a service provider, a $0.4 million increase in legal costs and franchise taxes, and additional bonus expense of $0.3 million due to higher bonus accruals. These increases were offset by a $0.8 million reduction in salary expense due to a prior year reduction in staff.
Other Income (Expense), net. The following table summarizes our other income (expense) for the nine months ended September 30, 2024 (in thousands):
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
$ Change |
|
|
% Change |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other income, net |
|
$ |
4,317 |
|
|
$ |
630 |
|
|
$ |
3,687 |
|
|
|
585 |
% |
Interest income |
|
|
2,757 |
|
|
|
711 |
|
|
|
2,046 |
|
|
|
288 |
% |
Interest expense |
|
|
(1,872 |
) |
|
|
(2,928 |
) |
|
|
1,056 |
|
|
|
-36 |
% |
Change in fair value of derivative liability |
|
|
39 |
|
|
|
— |
|
|
|
39 |
|
|
|
— |
|
Foreign currency transaction gain (loss), net |
|
|
196 |
|
|
|
(21 |
) |
|
|
217 |
|
|
|
-1033 |
% |
Other income (expense), net |
|
$ |
5,437 |
|
|
$ |
(1,608 |
) |
|
$ |
7,045 |
|
|
|
-438 |
% |
Other income (expense), net for the nine months ended September 30, 2024 was approximately $5.4 million in income as compared to other expense of approximately $1.6 million recorded for the nine months ended September 30, 2023. The increase of $7.0 million in 2024 as compared to 2023 was primarily attributable to receipt of refundable research and development credits from a foreign tax authority of approximately $2.5 million in 2024, as well as higher investment income due to higher cash and investment balances and reduced interest expense as principal payments were made on debt in 2024.
-23-
Liquidity and Capital Resources
Since inception, we have experienced negative cash flows from operations. We have financed our operations primarily through sales of equity-related securities. At September 30, 2024, our accumulated deficit since inception was approximately $467.4 million.
At September 30, 2024, we had total current assets of approximately $160.9 million and current liabilities of approximately $11.6 million, resulting in working capital of approximately $149.3 million. Of our total cash, cash equivalents, investments, and restricted cash of $160.0 million at September 30, 2024, approximately $156.8 million was held within the U.S.
Cash Flows
The following table summarizes our cash flows for the nine months ended September 30, 2024 and 2023 (in thousands):
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
|
|
|
|
|
|
|
||
Net cash used in operating activities |
|
$ |
(30,852 |
) |
|
$ |
(30,092 |
) |
Net cash (used in) provided by investing activities |
|
|
(130,040 |
) |
|
|
25,254 |
|
Net cash provided by (used in) financing activities |
|
|
166,591 |
|
|
|
(916 |
) |
Net increase (decrease) in cash, cash equivalents, and restricted cash |
|
$ |
5,699 |
|
|
$ |
(5,754 |
) |
Net cash used in operating activities for the nine months ended September 30, 2024 was approximately $30.9 million, which includes a net loss of approximately $30.7 million, adjusted for non-cash expenses of approximately $2.9 million largely related to stock-based compensation expense offset by net amortization on discount of investments, and approximately $3.0 million of cash used in net working capital items principally due to decreases in accrued expenses and operating lease liabilities offset by a decrease in prepaid expenses and other current assets.
Cash used by investing activities for the nine months ended September 30, 2024 totaled approximately $130.0 million, which was principally related to purchases of investments.
Cash provided by financing activities for the nine months ended September 30, 2024 totaled approximately $166.6 million, which was related to the issuance of common stock. On January 31, 2024, we entered into an underwriting agreement with Jefferies, as representative of the underwriters, relating to an underwritten public offering of 4,325,000 shares of our common stock at a price to the public of $19.00 per share. The underwriters were also granted a 30-day option to purchase up to an additional 648,750 shares of common stock at the public offering price. On January 31, 2024, Jefferies gave notice of the underwriters’ election to exercise the option to purchase additional shares, in full. On February 2, 2024, we completed the public offering raising gross proceeds of approximately $94.5 million and net proceeds of $88.6 million, after deducting underwriting discounts and commissions and other offering expenses payable by us. In addition, for the nine months ended September 30, 2024, we sold an aggregate of 2,484,517 shares of common stock under the Open Market Sale Agreement, for net proceeds of approximately $91.4 million.
Future Funding Requirements
We expect our cash, cash equivalents, and investments of approximately $159.4 million at September 30, 2024 will be sufficient to meet our operating and capital requirements to support our operations through the third quarter of 2027, based on current planned expenditures.
We will need to raise significant additional capital to continue to fund the clinical trials for CRB-701, CRB-601 and CRB-913. We may seek to sell common or preferred equity or convertible debt securities, enter into a credit facility or another form of third-party funding or seek other debt financing. In addition, we may seek to raise cash through collaborative agreements or from government grants. The sale of equity and convertible debt securities may result in dilution to our stockholders and certain of those securities may have rights senior to those of our common shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require us to relinquish valuable rights.
-24-
The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our clinical development programs. Funding may not be available when needed, at all, or on terms acceptable to us. Lack of necessary funds may require us, among other things, to delay, scale back or eliminate expenses including some or all of our planned clinical trials.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors, other than future royalty payments under license agreements discussed as follows:
License Agreement with Jenrin
Pursuant to the terms of the license agreement (the "Jenrin License Agreement") with Jenrin Discovery, LLC (“Jenrin”), we are obligated to pay potential milestone payments to Jenrin totaling up to $18.4 million for each compound we elect to develop based upon the achievement of specified development and regulatory milestones. In addition, we are obligated to pay Jenrin royalties in the mid, single digits based on net sales of any Licensed Products, as defined in the Jenrin License Agreement, subject to specified reductions.
The Jenrin License Agreement terminates on a country-by-country basis and product-by-product basis upon the expiration of the royalty term for such product in such country. Each royalty term begins on the date of the first commercial sale of the licensed product in the applicable country and ends on the later of seven years from such first commercial sale or the expiration of the last to expire of the applicable patents in that country. The Jenrin License Agreement may be terminated earlier in specified situations, including termination for uncured material breach of the Jenrin License Agreement by either party, termination by Jenrin in specified circumstances, termination by Corbus with advance notice, and termination upon a party’s insolvency or bankruptcy.
License Agreement with Milky Way
Pursuant to the terms of the license agreement (the "Milky Way License Agreement") with Milky Way BioPharma, LLC (“Milky Way”), we were obligated to pay potential milestone payments to Milky Way totaling up to $53.0 million based upon the achievement of specified development and regulatory milestones. In addition, we were obligated to pay Milky Way royalties in the lower, single digits based on net sales of any Licensed Products, as defined in the Milky Way License Agreement.
The Milky Way License Agreement will remain in effect on a Licensed Product-by-License Product and country-by-country basis, until the expiration of the Royalty Term of the Licensed Product in the country. The "Royalty Term" means the period beginning from the First Commercial Sale of the Licensed Product in the country until the expiration of the last-to-expire Valid Claim in any Licensor Patent in the country that covers the composition of matter of the Licensed Product, the manufacture of the Licensed Product in the country, or a method of use of the Licensed Product for an indication for which Regulatory Approval has been obtained in the country. The Milky Way License Agreement may be terminated earlier in specified situations, including termination for material breach or termination by us with advance notice. A notice of termination without reason was executed by us and sent to Milky Way on January 25, 2024, terminating the Milky Way Agreement effective as of July 23, 2024.
License Agreement with UCSF
Pursuant to the terms of the license agreement (the "UCSF License Agreement") with the Regents of the University of California, we are obligated to pay potential milestone payments totaling up to $153.2 million based upon the achievement of specified development and regulatory milestones, excluding indication milestones for antibodies used for diagnostic products and services that will be an additional $50.0 thousand for each new indication. In addition, we are obligated to pay royalties in the lower, single digits based on net sales of any Licensed Products, as defined in the UCSF License Agreement, and any diagnostic products and services.
The UCSF License Agreement will remain in effect until the expiration or abandonment of the last of the Patent Rights licensed. The Royalty Term is the duration of Patent Rights in that country covering the applicable Licensed Product or Licensed Services Sold in the country. The UCSF License Agreement may be terminated earlier in specified situations, including termination for material breach, termination by us with advance notice, and termination upon a party's bankruptcy.
-25-
License Agreement with CSPC
Pursuant to the terms of the CSPC License Agreement with CSPC, we are obligated to pay potential milestone payments to CSPC totaling up to $130.0 million based upon the achievement of specified development and regulatory milestones and $555.0 million in potential commercial milestone payments. In addition, we are obligated to pay CSPC royalties in the low, double digits based on net sales of any Licensed Products, as defined in the CSPC License Agreement.
The CSPC License Agreement will remain in effect on a Licensed Product and on a country-by-country basis, until the expiration of the Royalty Term of the Licensed Product in the country. The Royalty Term is the period beginning from the First Commercial Sale of the Licensed Product in the country until the later of the expiration of the last-to-expire Valid Claim in any Licensor Patent in the country that Covers the Licensed product, 10 years after the date of the First Commercial Sale in the country, or expiration of the Regulatory Exclusivity for the Licensed Product in the country. The CSPC License Agreement may be terminated earlier in specified situations, including termination for material breach, termination by Corbus with advance notice, and termination upon a party's bankruptcy.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not Applicable.
Item 4. Controls and Procedures.
Evaluation of Our Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to provide reasonable assurance that material information required to be disclosed in our periodic reports filed under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and to provide reasonable assurance that such information is accumulated and communicated to our management, our principal executive officer and our principal financial officer, to allow timely decisions regarding required disclosure. Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act, as amended) as of the end of the period covered by this report.
Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that the information required to be disclosed by us in such reports is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the period to which this report relates that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
-26-
PART II — OTHER INFORMATION
Item 1. Legal Proceedings.
We are not currently subject to any material legal proceedings. However, we may from time to time become a party to various legal proceedings arising in the ordinary course of our business.
Item 1A. Risk Factors.
Except as set forth below, there have been no material changes in or additions to the risk factors included in our Annual Report on Form 10-K for the year ended December 31, 2023.
We are, and will be, completely dependent on third parties to manufacture our drug candidates, and our commercialization of our drug candidates could be halted, delayed or made less profitable if those third parties fail to obtain manufacturing approval from the FDA or comparable foreign regulatory authorities, fail to provide us with sufficient quantities of our drug candidates or fail to do so at acceptable quality levels or prices.
We do not currently have, nor do we plan to acquire, the capability or infrastructure to manufacture the active pharmaceutical ingredients of our drug candidates, or the finished drug products, for use in our clinical trials or for commercial product, if any. As a result, we will be obligated to rely on contract manufacturers if and when our drug candidates are approved for commercialization.
We currently rely on contract suppliers for the manufacturing of our drug candidates. We have limited experience contracting third parties to manufacture our drug candidates and we do not control the manufacturing processes of, and are completely dependent on, our contract manufacturing partners for compliance with current good manufacturing practices ("cGMPs") for manufacture of all active drug substances and finished drug products. These cGMP regulations cover all aspects of the manufacturing, testing, quality control and record keeping relating to our drug candidates. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our drug candidates, if approved.
Our contract manufacturers will be subject to ongoing periodic unannounced inspections by the FDA and corresponding state and foreign agencies for compliance with cGMPs and similar regulatory requirements. We will not have control over our contract manufacturers’ compliance with these regulations and standards. Failure by any of our contract manufacturers to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, failure to grant approval to market our drug candidates, delays, suspensions or withdrawals of approvals, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect our business. In addition, we will not have control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. Failure by our contract manufacturers to comply with or maintain any of these standards could adversely affect our ability to develop, obtain regulatory approval for or market our drug candidates.
If, for any reason, these third parties are unable or unwilling to perform, we may not be able to terminate our agreements with them, and we may not be able to locate alternative manufacturers or formulators or enter into favorable agreements with them and we cannot be certain that any such third parties will have the manufacturing capacity to meet future requirements. If these manufacturers or any alternate manufacturer of finished drug product experiences any significant difficulties in its respective manufacturing processes for our active pharmaceutical ingredient, or API, or our finished products or should cease doing business with us, we could experience significant interruptions in the supply of our drug candidates or may not be able to create a supply of our drug candidates at all. Were we to encounter manufacturing issues, our ability to produce a sufficient supply of our drug candidates might be negatively affected. Our inability to coordinate the efforts of our third-party manufacturing partners, or the lack of capacity available at our third-party manufacturing partners, could impair our ability to supply our drug candidates at required levels. Because of the significant regulatory requirements that we would need to satisfy in order to qualify a new bulk or finished product manufacturer, if we face these or other difficulties with our current manufacturing partners, we could experience significant interruptions in the supply of our drug candidates if we decided to transfer the manufacture of our drug candidates to one or more alternative manufacturers in an effort to deal with the difficulties.
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In addition, we currently rely on foreign third parties to manufacture certain materials used in clinical trials of our product candidates or to provide services in connection with certain clinical trials and will likely continue to rely on foreign third parties in the future. Foreign third parties may be subject to U.S. legislation, including the proposed BIOSECURE bill, trade restrictions and other foreign regulatory requirements. Any manufacturing problem or the loss of a contract manufacturer could be disruptive to our operations and result in lost sales. Additionally, we rely on third parties to supply the raw materials needed to manufacture our potential products. Any reliance on suppliers may involve several risks, including a potential inability to obtain critical materials and reduced control over production costs, delivery schedules, reliability, and quality. Any unanticipated disruption to a future contract manufacturer caused by problems at suppliers could delay shipment of our drug candidates, increase our cost of goods sold and result in lost sales.
We cannot guarantee that our manufacturing and supply partners will be able to manufacture our drug candidates at commercial scale on a cost-effective basis. If the commercial-scale manufacturing costs of our drug candidates are higher than expected, these costs may significantly impact our operating results. In order to reduce costs, we may need to develop and implement process improvements. However, in order to do so, we will need, from time to time, to notify or make submissions with regulatory authorities, and the improvements may be subject to approval by such regulatory authorities. We cannot be sure that we will receive these necessary approvals or that these approvals will be granted in a timely fashion. We also cannot guarantee that we will be able to enhance and optimize output in our commercial manufacturing process. If we cannot enhance and optimize output, we may not be able to reduce our costs over time.
We expect that we will rely on third parties to assist us in conducting clinical trials for our drug candidates. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our drug candidates and our business would be substantially harmed.
We expect to enter into agreements with third-party CROs to assist us in conducting and managing our clinical programs, including contracting with clinical sites to perform our clinical studies. We plan to rely on these parties for execution of clinical studies for our drug candidates and we will control only certain aspects of conducting the clinical studies. Nevertheless, we will be responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on CROs and clinical sites will not relieve us of our regulatory responsibilities. We and our CROs will be required to comply with cGCPs, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European Economic Area and comparable foreign regulatory authorities for any products in clinical development. The FDA enforces these cGCP regulations through periodic inspections of trial sponsors, principal investigators and trial sites. If we or our CROs fail to comply with applicable cGCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, the FDA will determine that any of our clinical trials comply with cGCPs. In addition, our clinical trials must be conducted with products produced under cGMP regulations and will require a large number of test subjects. Our failure or the failure of our CROs or clinical sites to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process and could also subject us to enforcement action up to and including civil and criminal penalties.
Although we intend to design the clinical trials for our drug candidates in consultation with CROs, we expect that the CROs will manage and assist us with the clinical trials conducted at contracted clinical sites. As a result, many important aspects of our drug development programs would be outside of our direct control. In addition, the CROs and clinical sites may not perform all of their obligations under arrangements with us or in compliance with regulatory requirements. If the CROs or clinical sites do not perform clinical trials in a satisfactory manner, or if they breach their obligations to us or fail to comply with regulatory requirements, the development and commercialization of our drug candidates for the subject indications may be delayed or our development program materially and irreversibly harmed. We cannot control the amount and timing of resources these CROs and clinical sites will devote to our program or our drug candidates. If we are unable to rely on clinical data collected by our CROs, we could be required to repeat, extend the duration of, or increase the size of our clinical trials, which could significantly delay commercialization and require significantly greater expenditures.
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In addition, we currently rely on foreign CROs to manufacture certain materials used in clinical trials of our product candidates or to provide services in connection with certain clinical trials and will likely continue to rely on foreign CROs in the future. Foreign CROs may be subject to U.S. legislation, including the proposed BIOSECURE bill, trade restrictions and other foreign regulatory requirements. If any of our relationships with these third-party CROs or clinical sites terminate, we may not be able to enter into arrangements with alternative CROs or clinical sites. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, any such clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our drug candidates. As a result, our financial results and the commercial prospects for our drug candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.
Changes in geopolitical conditions, U.S.-China trade relations and other factors beyond our control may adversely impact our business and operating results.
Our operations and performance depend, in part, on global and regional economic and geopolitical conditions, given our current third-party license agreement with CSPC, which is headquartered in China. Changes in U.S.-China trade policies, including the proposed BIOSECURE bill, and a number of other economic and geopolitical factors both in China and abroad could have a material adverse effect on our business, financial condition, results of operations or prospects. Such factors may include:
As a result of these events, our ability to obtain data or regulatory support from our China-based licensing partner may be limited or adversely affected, and we may ourselves be subject to sanctions, diminished public perception and operational constraints.
Our product candidates may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our development and commercialization efforts.
Our success depends in part on avoiding infringement of the proprietary technologies of others. The pharmaceutical industry has been characterized by frequent litigation regarding patent and other intellectual property rights. Identification of third-party patent rights that may be relevant to our proprietary technology is difficult because patent searching is imperfect due to differences in terminology among patents, incomplete databases, and the difficulty in assessing the meaning of patent claims. Additionally, because patent applications are maintained in secrecy until the application is published, we may be unaware of third-party patents that may be infringed by any of our product candidates. There may be certain issued patents and patent applications claiming subject matter that we may be required to license in order to research, develop or commercialize our product candidates, and we do not know if such patents and patent applications would be available to license on commercially reasonable terms, or at all. Any claims of patent infringement asserted by third parties would be time-consuming and may:
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Although no third party has asserted a claim of infringement against us, others may hold proprietary rights that could prevent our product candidates from being marketed. We are aware of patents or patent applications owned by third parties that relate to some aspects of our programs that are still in development. In some cases, because we have not determined the final methods of manufacture, the method of administration or the therapeutic compositions for these programs, we cannot determine whether rights under such third-party positions will be needed. In addition, in some cases, we believe that the claims of these patents are invalid or not infringed or will expire before commercialization. However, if such patents are needed and found to be valid and infringed, we could be required to obtain licenses, which might not be available on commercially reasonable terms, or to cease or delay commercializing certain product candidates, or to change our programs to avoid infringement. Any patent-related legal action against us claiming damages and seeking to enjoin commercial activities relating to our product candidates or our processes could subject us to potential liability for damages and require us to obtain a license to continue to manufacture or market our product candidates. We cannot predict whether we would prevail in any such actions or that any license required under any of these patents would be made available on commercially acceptable terms, if at all. In addition, we cannot be sure that we could redesign any product candidates or processes to avoid infringement, if necessary. Accordingly, an adverse determination in a judicial or administrative proceeding, or the failure to obtain necessary licenses, could prevent us from developing and commercializing our product candidates, which could harm our business, financial condition, and operating results.
A number of companies, including several major pharmaceutical companies, have conducted research in the same therapeutic areas as our company, which resulted in the filing of many patent applications in the same areas as our research. If we were to challenge the validity of these or any U.S.-issued patent in court, we would need to overcome a statutory presumption of validity that attaches to every U.S.-issued patent. This means that, in order to prevail, we would have to present clear and convincing evidence as to the invalidity of the patent’s claims.
If we were to challenge the validity of these or any U.S. issued patent in an administrative trial before the Patent Trial and Appeal Board in the U.S. Patent and Trademark Office, we would have to prove that the claims are unpatentable by a preponderance of the evidence. There is no assurance that a jury and/or court would find in our favor on questions of infringement, validity, or enforceability.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
On August 21, 2024, the Company issued 4,649 shares of common stock to a service provider in connection with services rendered to the Company. Such issuance was exempt from registration under Section 4(a)(2) of the Securities Act of 1933, as amended.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Director and Officer Trading Arrangements
On
No other directors or officers
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Item 6. Exhibits.
The exhibits listed below are filed or furnished as part of this Quarterly Report on Form 10-Q.
EXHIBIT INDEX
Exhibit No. |
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Description |
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3.1 |
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3.2 |
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31.1 |
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Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).* |
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31.2 |
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Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).* |
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32.1 |
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Certification of Chief Executive Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b).** |
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32.2 |
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Certification of Chief Financial Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b).** |
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101.INS |
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Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents. |
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104 |
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Cover Page Interactive Data File formatted as Inline XBRL and contained in Exhibit 101. |
* |
Filed herewith. |
** |
Furnished, not filed. |
† |
Indicates a management contract or compensation plan, contract or arrangement. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Corbus Pharmaceuticals Holdings, Inc. |
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Date: November 7, 2024 |
By: |
/s/ Yuval Cohen |
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Name: |
Yuval Cohen |
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Title: |
Chief Executive Officer |
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(Principal Executive Officer) |
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Date: November 7, 2024 |
By: |
/s/ Sean Moran |
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Name: |
Sean Moran |
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Title: |
Chief Financial Officer |
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(Principal Financial Officer and Chief Accounting Officer) |
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