美国
证券交易委员会
华盛顿特区20549
表格
(标记一)
根据1934年证券交易法第13或15(d)节的季度报告 |
季度期间 结束了
或者
根据1934年证券交易法第13或15(d)节的转型报告书 |
过渡期从开始到结束
委托文件编号:001-39866
(依据其宪章指定的注册名称)
(该州或其他司法管辖区 公司成立或组织) |
(IRS雇主 |
,(主要行政办公地址) |
(邮政编码) |
公司电话号码,包括区号:(
在法案第12(b)条的规定下注册的证券:
每一类的名称 |
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交易 符号: |
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在其上注册的交易所的名称 |
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The |
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可赎回的认股权证,每张认股权证可行使权利购买1/1,050股th普通股一股行使价为12,075.00美元 |
|
REVBW |
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纳斯达克证券交易所 LLC |
请在以下复选框中打勾,指示注册人:(1)在前12个月(或注册人被要求提交这些报告的更短期间内)已经提交了1934年证券交易法第13或15(d)条规定需要提交的所有报告;以及(2)在过去的90天内一直受到了此类文件提交要求的限制。
请在以下复选框中打勾,指示注册人是否已经电子提交了根据Regulation S-T规则405条(本章节的§232.405条)需要提交的所有互动数据文件在过去的12个月内(或注册人被要求提交这些文件的更短期间内)。
勾选以下选框,指示申报人是大型加速评估提交人、加速评估提交人、非加速评估提交人、小型报告公司或新兴成长型公司。关于“大型加速评估提交人”、“加速评估提交人”、“小型报告公司”和“新兴成长型公司”的定义,请参见《交易所法规》第12亿.2条。
大型加速报告人 |
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☐ |
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加速文件提交人 |
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☐ |
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☒ |
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较小的报告公司 |
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新兴成长公司 |
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如果是新兴成长型企业,请勾选复选标记,表明注册者已选择不使用延长过渡期来符合根据证券交易法第13(a)条规定提供的任何新财务会计准则。
请在以下空格内打勾,表示注册人是不是外壳公司(按交易所法则120亿.2条定义)。 是 ☐ 否
截至2024年11月4日,注册人员已
目录
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第 1 项。 |
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第 2 项。 |
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第 3 项。 |
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第 4 项。 |
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第二部分。 |
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第 1 项。 |
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第 1A 项。 |
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第 2 项。 |
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第 3 项。 |
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第 4 项。 |
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第 5 项。 |
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第 6 项。 |
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33 |
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第一部分——财务信息
项目1 控件m 1. 总资产负债表(未经审计)
REVELATION生物科技股份有限公司。
浓缩 合并资产负债表
(未经审计)
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9月30日, |
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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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延迟募资成本 |
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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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资产和设备,净值 |
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资产总额 |
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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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应付账款 |
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$ |
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应计费用 |
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待摊费用 |
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认股权负债 |
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流动负债合计 |
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负债合计 |
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(注4) |
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股东权益: |
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普通股,每股面值$ |
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股本溢价 |
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累积赤字 |
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股东权益总额 |
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负债和股东权益总额 |
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请参见简明合并财务报表的附注。
1
REVELATION生物科技股份有限公司。
基本报表: 综合结果表
(未经审计)
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三个月已结束 |
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九个月已结束 |
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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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一般和行政 |
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运营费用总额 |
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运营损失 |
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其他(支出)收入: |
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认股权证负债公允价值的变化 |
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其他(支出)收入,净额 |
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其他(支出)收入总额,净额 |
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净(亏损)收益 |
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$ |
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$ |
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$ |
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基本每股净(亏损)收益 |
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$ |
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$ |
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$ |
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用于计算每股净(亏损)收益的加权平均股票,基本 |
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摊薄后的每股净(亏损)收益 |
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$ |
( |
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$ |
( |
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$ |
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$ |
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用于计算每股净(亏损)收益的加权平均股票,摊薄后 |
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请参见简明合并财务报表的附注。
2
REVELATION生物科技股份有限公司。
综合简明财务报表股东权益(赤字)变动表
(未经审计)
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A类 |
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普通股 |
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共计 |
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累积的 |
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总计 |
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股份 |
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金额 |
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股份 |
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金额 |
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资本 |
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赤字 |
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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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赎回A系列优先股 |
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( |
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— |
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— |
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— |
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— |
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— |
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2023年2月公开发行普通股 |
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— |
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— |
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— |
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C类预先融资认股权行使 |
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— |
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C类普通股权证的替代无现金行使 |
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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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— |
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净利润 |
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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3月31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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$ |
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C类预先拟定认股权证行使 |
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— |
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— |
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— |
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可替代非现金行使C类普通股认股权 |
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— |
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— |
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— |
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发放的RSU奖励 |
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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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— |
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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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( |
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截至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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$ |
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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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— |
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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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截至2023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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$ |
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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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$ |
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2024年2月公开发行普通股 |
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— |
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— |
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— |
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D类可提前行使认股权证 |
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( |
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替代性无现金行使C类普通股权证 |
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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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— |
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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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( |
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2024年3月31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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$ |
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因服务发行的普通股 |
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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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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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( |
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2024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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$ |
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D级普通股认股权行使 |
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— |
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— |
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— |
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认股权诱因行使 |
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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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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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$ |
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请参见简明合并财务报表的附注。
3
REVELATION生物科技股份有限公司。
基本报表: 合并现金流量表
(未经审计)
|
|
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(亏损)利润 |
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$ |
( |
) |
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调整以将净(损失)收入调节为经营活动中使用的净现金流量: |
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股票补偿费用 |
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以股票形式发放服务 |
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折旧费用 |
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权证赔偿金额的变化 |
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( |
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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 |
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( |
) |
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( |
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延迟募资成本 |
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应付账款 |
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应计费用 |
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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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( |
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投资活动现金流量: |
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购置固定资产等资产支出 |
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( |
) |
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投资活动产生的净现金流出 |
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( |
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筹集资金的现金流量: |
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2024年2月公开发行的款项净额 |
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来自D类普通股权证行使的款项 |
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来自权证诱因行使的款项,净额 |
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D类预付认股证行权所得款项 |
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筹资活动产生的现金净额 |
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与权证诱因相关的E类普通股权证的公允价值 |
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请参见简明合并财务报表的附注。
4
REVELATION生物科技股份有限公司。
No基本报表的总汇编财务报表
1。组织和演示依据
Revelation Biosciences, Inc.(及其全资子公司,统称为 “我们”、“我们的”、“Revelation” 或 “公司”)是一家临床阶段的生物制药公司,专注于开发或商业化 关于利用其专有配方Gemini利用经过训练的免疫力来预防和治疗疾病。我们有多个正在进行的评估Gemini的项目,包括作为术后感染的预防、急性肾损伤的预防和慢性肾脏病的治疗。 该公司于2019年11月20日在特拉华州注册成立(原名Petra Acquisition, Inc.),总部位于加利福尼亚州圣地亚哥。
该公司的普通股和公开认股权证分别在纳斯达克资本市场上市,代码分别为 “REVB” 和 “REVBW”。
反向股票分割
2024 年 1 月 25 日,公司 影响了批准的 反向拆分我们的普通股。 除非此处另有特别规定,否则本季度报告中随后的股票和每股信息反映了反向股票拆分的影响。
纳斯达克合
正如先前报道的那样,2024年10月16日,公司收到了纳斯达克股票市场有限责任公司(“纳斯达克”)上市资格部门(“员工”)的退市信(“最低出价退市函”),通知该公司未遵守纳斯达克上市规则5550(a)(2),该规则要求上市公司维持最低出价为美元
通常,公司将有180个日历日的时间来证明遵守了最低出价要求。但是,根据上市规则第5810 (c) (3) (A) (iv) 条,该公司没有资格在《上市规则》第5810 (c) (3) (A) 条规定的任何合规期内进行过一次或多次反向股票分割,累计比率为
除了先前披露的最低出价退市信外,公司于2024年8月14日收到了纳斯达克工作人员的一封信(“股东权益要求缺陷信” 和最低出价退市信,即 “纳斯达克信函”),通知公司未遵守纳斯达克上市规则5550(b)(1),该规则要求公司维持最低限额为美元
公司打算采取一切合理的措施,恢复纳斯达克上市规则的合规性,并继续在纳斯达克上市。公司有权通过要求独立小组举行听证会,对最低出价退市书提出上诉,该公司于2024年10月23日提交了听证会。在听证程序结束以及听证会后小组批准的任何额外延期期到期之前,听证请求暂停了任何暂停或除名行动。但是,无法保证该公司将获得小组的任何延期,并最终恢复遵守继续上市的所有适用要求。《纳斯达克快报》和公司的违规行为都不会对公司普通股或认股权证的上市或交易产生直接影响,这些普通股或认股权证将继续在纳斯达克资本市场上分别以 “REVB” 和 “REVBW” 的代码进行交易。
5
流动性和资本资源
企业持续经营评估
公司自成立以来一直遭受着不断的亏损,包括 $
To continue as a going concern, the Company will need, among other things, to raise additional capital resources. The Company plans to seek additional funding through public or private equity or debt financings. The Company may not be able to obtain financing on acceptable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. If the Company is unable to obtain funding, it could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect the Company’s business operations.
2024年9月30日的未经审计的简明综合基本报表是基于公司将继续作为持续经营实体,不包括任何调整以反映资产的可收回性和分类以及可能由于公司无法继续作为持续经营实体而导致的负债的金额和分类。
报告范围
附属的基本报表是根据美国通用会计准则(“GAAP”)编制的。所有公司间交易和余额在合并时已被消除。
6
2。重要会计政策摘要
未经审计的中期简明合并财务报表
未经审计的中期简明合并财务报表的编制基础与截至2023年12月31日的已审计财务报表以及截至2023年12月31日的年度财务报表相同,管理层认为,这些调整反映了公允列报公司财务状况所必需的所有调整,仅包括正常的经常性调整。截至2024年9月30日的三个月和九个月的简明合并财务报表附注中包含的财务数据和其他财务信息未经审计。截至2024年9月30日的三个月和九个月的经营业绩不一定表示截至2024年12月31日的年度或任何其他未来年度或中期的预期业绩。简明合并财务报表及其附注应与2024年3月22日向美国证券交易委员会提交的10-k表中包含的截至2023年12月31日的公司经审计的财务报表及其附注一起阅读。随附的截至2023年12月31日的简明合并资产负债表来自上述参考的10-k表中包含的截至2023年12月31日的经审计的资产负债表。
估算值的使用
根据公认会计原则编制简明合并财务报表需要管理层进行估算es和有关未来事件的假设,这些事件会影响报告的资产和负债金额,或有资产和负债的披露以及报告的支出金额。这些估计和假设基于公司的最佳估计和判断。公司定期使用历史和行业经验以及其他因素评估其估计和假设;但是,实际业绩可能与这些估计存在重大差异,并可能对公司的简明合并财务报表产生不利影响。
现金和现金等价物
公司将自购买之日起三个月或更短期限购买的所有高流动性投资视为现金等价物。公司将现金存入支票和储蓄账户。储蓄账户中持有的现金产生的收入记作利息收入。公司储蓄账户的账面价值包含在现金中,近似于公允价值。
信用风险的集中度
可能使公司受到信用风险集中的金融工具主要包括现金和现金等价物。银行存款由认可的金融机构持有,这些存款有时可能超过联邦保险限额。该公司通过将现金和现金等价物存放在其认为高质量的金融机构来限制与现金及现金等价物相关的信用风险。该公司的现金或现金等价物存款没有遭受任何损失。
延期发行成本
在融资完成之前,公司将与正在进行的股权融资直接相关的某些法律、专业会计和其他第三方费用作为延期发行成本进行资本化。股权融资完成后,这些成本记作发行所得收益的减少额。如果计划中的股权融资被放弃,延期发行成本将立即记作简报中的运营费用 合并运营报表。
财产和设备,净额
财产和设备按成本减去累计折旧后列报。折旧是使用资产估计使用寿命的直线法计算的,即
7
租约
The Company determines if an arrangement is a lease at inception. Lease right-of-use assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. For operating leases with an initial term greater than 12 months, the Company recognizes operating lease right-of-use assets and operating lease liabilities based on the present value of lease payments over the lease term at the commencement date. Operating lease right-of-use assets are comprised of the lease liability plus any lease payments made and excludes lease incentives. Lease terms include options to renew or terminate the lease when the Company is reasonably certain that the renewal option will be exercised or when it is reasonably certain that the termination option will not be exercised. For an operating lease, if the interest rate used to determine the present value of future lease payments is not readily determinable, the Company estimates the incremental borrowing rate as the discount rate for the lease. The Company’s incremental borrowing rate is estimated to approximate the interest rate on a collateralized basis with similar terms and payments, and in similar economic environments. Lease expense for lease payments is recognized on a straight-line basis over the lease term.
研发费用
研发费用主要包括用于研发公司的产品候选药物GEm-AKI,GEm-CKD,GEm-PSI和其他产品候选药物的成本。search and development costs are charged to expense as incurred. The Company records accrued expenses for estimated preclinical, clinical study and research expenses related to the services performed but not yet invoiced pursuant to contracts with research institutions, contract research organizations, and clinical manufacturing organizations that conduct and manage preclinical studies, clinical studies, research services, and development services on the Company’s behalf. Payments for these services are based on the terms of individual agreements and payment timing may differ significantly from the period in which the services were performed. Estimates are based on factors such as the work completed, including the level of patient enrollment. The Company monitors patient enrollment levels and related activity to the extent reasonably possible and makes judgments and estimates in determining the accrued balance in each reporting period. The Company’s estimates of accrued expenses are based on the facts and circumstances known at the time. If the Company underestimates or overestimates the level of services performed or the costs of these services, actual expenses could differ from estimates. As actual costs become known, the Company adjusts accrued expenses. To date, the Company has not experienced significant changes in estimates of clinical study and development services accruals.
专利成本
与已批准专利和专利申请相关的法律费用按发生计入费用,因为这些支出的收回性不确定。这些费用记录在综合财务和行政费用中 资产负债表的综合经营结果中
2021年6月,公司采用了2021年员工、董事和顾问股权激励计划(“2021计划”),并进行了修改,授权公司授予最多83,564股普通股。2022年,公司修改了2021计划,并将计划授权的股票总数增加至2,748,818股。2024年1月,公司采用了2024年员工、董事和顾问股权激励计划(“2024计划”),授权公司授予最多3,900,000股普通股,加上2021计划中剩余的未授予或被放弃的股票。截至2024年3月31日,还有3,939,333股可供授予。公司的股票期权根据授予协议中的条款授予,通常按比例赠与。
公司承认与股票期权、第三方认股权证和受限制的员工股票单位(“ RSU”)授予有关的股票基础补偿费用,基于授予日股票基础奖励的估计公允价值。员工股票期权和第三方认股权的公允价值通常使用黑-斯科尔斯期权定价模型确定,使用各种输入,包括历史波动率、期限、无风险利率和未来股利估计。具有分级解锁的股票基础奖的授予日公允价值按每个股票基础奖的必要服务期间的直线法识别,这通常是各自股票基础奖的解锁期。公司在出现弃权时予以确认。
所得税
所得税按照资产负债法核算。根据这种方法,对由现有资产和负债的财务报表账面金额与其相应税基之间差异以及经营亏损和税前抵免产生的未来税后果予以确认。使用通过税率计算的对临时差异预计将实现的应税所得进行衡量的递延税资产和负债。对税率变更对递延税资产和负债的影响,在含有颁布日期的期间中认可为收入或损失。当必要时设立减少递延税资产至预计实现金额的准备金。与未确认税收优惠相关的利息和罚款包括在所得税提供中。迄今为止,没有可报告的税前利益。
8
公正价值
公司的金融工具是根据活跃市场上的报价或基于其他可观察到的输入值进行估值的。货币市场基金被分类为1级金融资产。存单、商业票据、市政债券、企业债务证券和美国政府机构证券属于2级金融资产。2级资产的公正价值是基于使用当前可观察安全的市场信息的定价模型进行估算的。公司的2级投资包括美国政府支持的证券和企业证券,这些证券是根据可观察的输入进行估值的,这些可观察的输入可能包括基准收益率、报告的交易、经纪/报价、发行人差价、两侧市场、基准证券、要约、报盘和参考数据,包括市场研究出版物。商业票据的公允价值是基于到期日和使用三个月国库券利率进行折现。截至2024年6月30日,公司的2级投资的平均剩余期限不足12个月,并且这些投资的评级为S&P和Moody’s的AAA或AA-评级的证券和A1、A2、P1或P2评级的商业票据。
• 第1级—活跃市场上针对相同资产或负债的报价。
• 第2级—除第1级以外的可观察输入,可以是直接或间接可观察到的,例如类似资产或负债的报价;在非活跃市场上的报价;或者是可观察到的或者可以通过可观察市场数据证实的其他输入,在几乎整个资产或负债期限内都是可观察的。
• 第3级—不可观察的输入,几乎没有市场活动支持,并且对资产或负债的公允价值具有重要意义。
公司已经确定 Class C 普通股权证的公允价值衡量是一个第3级公允价值衡量,并使用蒙特卡洛模拟模型进行估值(参见注释10)。
权证负债
公司审查债务工具、股权工具和其他融资安排的条款,以确定是否存在应拆分并单独列报为衍生金融工具的嵌入式衍生特征,包括需要进行拆分的嵌入式转换选择权。此外,在发行融资工具的情况下,公司可能发行独立的期权和认股权证。
公司根据ASC 480“区分负债和股本的准则”和ASC 815“衍生品和套期保值”处理其普通股认股权证。根据ASC 480和ASC 815的规定,如果认股权证不符合权益分类标准,公司将其视为流动负债。初始将被视为负债的普通股认股权证在授予日按公允价值记录,并在每个资产负债表日重新计价,抵销调整记录在财务报表中的认股权证负债公允价值变动内。
公司使用蒙特卡洛模型对按流动负债分类的C类普通股认股权证进行估值。
每股基本及摊薄净(亏损)收益
基本每股净(亏损)收益是通过将净收益(亏损)除以期间内流通的普通股加权平均股份数计算出来,不考虑潜在的普通股份。稀释每股净(亏损)收益是通过将净收益(亏损)除以流通的普通股加权平均股份数加上潜在的普通股份数计算出来。按换股基础计算的可转换优先股,RSU奖励,认股权证和期权均被视为潜在的普通股份,并在计算稀释每股净(亏损)收益时使用库藏股法,当其作用为稀释时。如果潜在的普通股份具有抗稀释作用,将被排除在稀释每股净(亏损)收益的计算之外。截至2024年9月30日,共有
综合(损失)收益
公司除了净(损)收入之外,没有综合(损)收入的组成部分。因此,综合(损)收益与净(损)收入相同对于可能使公司集中面临信贷风险的金融工具包括该账户,该账户是一个在某些时候可能会超过250,000美元的联邦存款保险覆盖的金融机构现金账户。截至2023年和2022年12月31日,公司未在该账户上经历损失,管理层认为公司没有面临任何显著的风险。
9
《修订和重新制定的2020年The Aaron's Company, Inc.股权和激励计划》,(参考到2024年5月16日提交给美国证券交易委员会的S-8表格附注4.3)。
经营部门被定义为实体的组成部分,有关这些部分的单独离散信息可供首席经营决策人或决策团队评估,以便在评估绩效并决定如何分配资源时做出决策。
公司在加利福尼亚州为其办公空间租赁了一个子租约,该租约于2023年11月开始,最初租约期至2026年1月。该租约替代了同一地址于2022年1月开始的租约,最初租约期至2024年1月(于2024年1月结束)。此外,该公司还租用其他租期少于十二个月的空间;因此,在资产负债表上不承认此租约为营运租约。
最近的会计声明
2023年11月,财务会计准则委员会(“FASB”)发布了会计准则更新(“ASU”)2023-07, 报告部门披露的改进(“ASU 2023-07”)通过增强有关重要部门费用的披露,改进了关于报告部门披露要求,该指南对公司截至2024年12月31日的年度报告和2025财年的中期报告实行生效。允许提前采纳。公司正在评估采纳该指南对其合并财务报表的影响。 预计采纳该指南不会对公司的财务报表产生实质影响。
3. Balance Sheet Details
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following:
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September 30, |
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December 31, |
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Prepaid insurance costs |
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$ |
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Other prepaid expenses & current assets |
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$ |
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Property and Equipment, Net
Property and equipment, net consisted of the following:
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September 30, |
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December 31, |
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Lab equipment |
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$ |
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$ |
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Total property and equipment, gross |
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Accumulated depreciation |
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Total property and equipment, net |
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$ |
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Depreciation expense was $
Accrued Expenses
Accrued expenses consisted of the following:
|
|
September 30, |
|
|
December 31, |
|
||
Accrued payroll and related expenses |
|
$ |
|
|
$ |
|
||
Accrued clinical study expenses |
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|
|
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|
|
||
Accrued professional fees |
|
|
|
|
|
|
||
Accrued clinical development costs |
|
|
|
|
|
|
||
Total accrued expenses |
|
$ |
|
|
$ |
|
10
4. Commitments and Contingencies
Lease Commitments
The Company leases
Rent expense was $
Future minimum lease payments under the operating lease as of September 30, 2024 is $
Commitments
The Company enters into contracts in the normal course of business with third party service providers and vendors. These contracts generally provide for termination on notice and, therefore, are cancellable contracts and not considered contractual obligations and commitments.
Contingencies
From time to time, the Company may become subject to claims and litigation arising in the ordinary course of business. The Company is not a party to any material legal proceedings, nor is it aware of any material pending or threatened litigation.
11
5. 2023 Public Offering
On February 13, 2023, the Company closed a public offering of
Roth Capital Partners, LLC (“Roth”) was engaged by the Company to act as its exclusive placement agent for the February 2023 Public Offering. The Company paid Roth a cash fee equal to
The shares of common stock underlying the Class C Pre-Funded Warrants and the shares of common stock underlying the Class C Common Stock Warrants were registered with the SEC on Form S-1 (File No. 333-268576) and was declared effective by the SEC on February 9, 2023.
Between February 14, 2023 and April 6, 2023, the Company received notices of cash exercise for the Class C Pre-Funded Warrants issued in connection with the February 2023 Public Offering for
Using a Monte-Carlo simulation model, the Class C Common Stock Warrants were valued in the aggregate at $
From March 13, 2023 to September 30, 2024, the Company received notices of alternative cashless exercises for
As part of the February 2024 Public Offering, the exercise price of the Class C Common Stock Warrants was reset from $
6. 2024 Public Offering
On February 5, 2024, the Company closed a public offering of
Roth was engaged by the Company to act as its exclusive placement agent for the February 2024 Public Offering. The Company paid Roth a cash fee equal to
The shares of common stock underlying the Class D Pre-Funded Warrants and the shares of common stock underlying the Class D Common Stock Warrants were registered with the SEC on Form S-1 (File No. 333-276232) and was declared effective by the SEC on January 31, 2024.
Between February 5, 2024 and February 13, 2024, the Company has received notices of cash exercise for the Class D Pre-Funded Warrants issued in connection with the February 2024 Public Offering for
Using the Black-Scholes option pricing model, the Class D Common Stock Warrants were valued in the aggregate at $
As part of a common stock issuance to a third party consultant on June 11, 2024 for services provided, the exercise price of the Class D Common Stock Warrants was reset from $
12
Warrant Inducement
On August 21, 2024, the Company entered into warrant exercise inducement offer letters (the “Inducement Letters”) with certain holders (the “Holders”) of its existing Class D Common Stock Warrants exercisable for an aggregate of
In consideration for the immediate exercise of the Class D Common Stock Existing Warrants for cash and the payment of $
In connection with the Warrant Inducement, the Company entered into a financial advisory services agreement, dated August 21, 2024, with Roth, pursuant to which the Company agreed to pay Roth a cash fee of $
The shares of common stock issued from the exercise of the Class D Common Stock Existing Warrants were registered pursuant to a registration statement on Form S-1, as amended (File No. 333-276232), which was declared effective by the SEC on January 31, 2024.
The Class E Common Stock Warrants offered in the private placement were not registered under the Securities Act or applicable state securities laws as of the issuance date, however, as part of the transaction, the Company filed a resale registration statement on Form S-3 with the SEC on September 03, 2024, which was declared effective on September 12, 2024.
The Holders collectively exercised an aggregate of
The lowering of the exercise price of the Class D Common Stock Existing Warrants is considered a warrant modification under the guidance of ASC 815-40, Derivatives and Hedging—Contracts in Entity’s Own Equity (“ASC 815-40”). In addition, the warrant modification is consistent with the equity issuance classification under that guidance as the reason for the warrant modification was to induce the Holders of the Class D Common Stock Existing Warrants to a cash exercise. As pursuant to the guidance of ASC 480 and ASC 815 the Class D Common Stock Existing Warrants were classified as equity instruments before and after the warrant modification. The Company recognized the effect of the warrant modification of approximately $
Additionally, using the Black-Scholes option pricing model, the Class E Common Stock Warrants issued in connection with the Warrant Inducement are treated as equity and the Company recognized approximately $
Total cash and non-cash equity issuance costs recognized in the Class D Common Stock Existing Warrants modification and the issuance of the Class E Common Stock Warrants of $
As of September 20, 2024, there are
13
7. Preferred Stock
Revelation Authorized Preferred Stock
The Company is authorized under its articles of incorporation, as amended, up to
Series A Preferred Stock
On December 19, 2022, the Company closed the sale of one share of the Company’s Series A Preferred Stock, par value $
8. Common Stock
The Company is authorized under its articles of incorporation, as amended, to issue up to
Common Stock Issuance during the year ended December 31, 2023
On February 13, 2023, the Company issued
From February 14, 2023 to April 6, 2023, the Company issued
From March 13, 2023 to June 30, 2023, the Company issued
On April 18, 2023, the Company issued
Common Stock Issuance during the nine months ended September 30, 2024
On January 29, 2024, the Company issued
On February 5, 2024, the Company issued
Between February 5, 2024 and February 13, 2024, the Company issued
On June 11, 2024, the Company issued
On August 22, 2024, the Company issued
Between August 22, 2024 and September 20, 2024, the Company issued
14
As of September 30, 2024 and December 31, 2023,
The total shares of common stock reserved for issuance are summarized as follows:
|
|
September 30, |
|
|
September 30, |
|
||
Public Warrants (exercise price of $ |
|
|
|
|
|
|
||
Class A Common Stock Warrants (exercise price of $ |
|
|
|
|
|
|
||
Class A Placement Agent Common Stock Warrants (exercise price of $ |
|
|
|
|
|
|
||
Class B Common Stock Warrants (exercise price of $ |
|
|
|
|
|
|
||
Class B Placement Agent Common Stock Warrants (exercise price of $ |
|
|
|
|
|
|
||
Class C Common Stock Warrants (exercise price of $ |
|
|
|
|
|
|
||
Class D Common Stock Warrants (exercise price of $ |
|
|
|
|
|
— |
|
|
Class E Common Stock Warrants (exercise price of $ |
|
|
|
|
|
— |
|
|
Rollover Warrants (exercise price of $ |
|
|
|
|
|
|
||
Rollover RSU awards outstanding |
|
|
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|
||
Stock options outstanding (minimum exercise price $ |
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|
||
Shares reserved for issuance |
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|
|
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|
||
Shares available for future stock grants under the 2021 Equity Incentive Plan |
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|
||
Total common stock reserved for issuance |
|
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|
|
9. Stock-Based Compensation
2021 Equity Incentive Plan
In January 2022, in connection with the Business Combination, the Board of Directors and the Company’s stockholders adopted the 2021 Equity Incentive Plan (the “2021 Plan”). The 2021 Plan is administered by the Board of Directors. Vesting periods and other restrictions for grants under the 2021 Plan are determined at the discretion of the Board of Directors. Grants to employees, officers, directors, advisors, and consultants of the Company typically vest over to
On July 14, 2023 at the Company’s 2023 Annual Meeting of Stockholders, an amendment to the 2021 Equity Incentive Plan to increase the number of shares reserved under the Plan to
On May 15, 2024 at the Company’s 2024 Annual Meeting of Stockholders, an amendment to the 2021 Equity Incentive Plan to increase the number of shares reserved under the Plan to
Under the 2021 Plan, stock options and stock appreciation rights are granted at exercise prices determined by the Board of Directors which cannot be less than
As of September 30, 2024, there were
Restricted Stock Units
At the Closing Date of the Business Combination, all Revelation Sub RSU award holders received a Rollover RSU award in exchange for each RSU award of Revelation Sub that vest in accordance with the original terms of the award. The Company determined this to be a Type I modification but did not record any incremental stock-based compensation expense since the fair value of the modified awards immediately after the modification was not greater than the fair value of the original awards immediately before the modification.
The Rollover RSU awards have time-based and milestone-based vesting conditions.
15
As of September 30, 2024 and December 31, 2023, the Company has a total of
Stock Options
The Company has granted stock options which
The activity related to stock options during the nine months ended September 30, 2024 is summarized as follows:
|
|
Shares |
|
|
Weighted-average Exercise Price |
|
|
Weighted-average Remaining Contractual Term (Years) |
|
|||
Outstanding at December 31, 2023 |
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|
|
$ |
|
|
|
|
|||
Granted |
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|
|
|
|
|
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|
|||
Exercised |
|
|
— |
|
|
|
— |
|
|
|
|
|
Expired and forfeited |
|
|
( |
) |
|
|
|
|
|
|
||
Outstanding at September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|||
Exercisable at September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
For the nine months ended September 30, 2023, the weighted-average Black-Scholes value per stock option was $
Volatility |
|
|
% |
|
Expected term (years) |
|
|
|
|
Risk-free interest rate |
|
|
% |
|
Expected dividend yield |
|
|
% |
Expected volatility is based on the historical volatility of shares of the Company’s common stock. In determining the expected term of stock options, the Company uses the “simplified” method. Under this method, the expected term is presumed to be the midpoint between the average vesting date and the end of the contractual term. The risk-free interest rate is based on the U.S. Treasury yield for a period consistent with the expected term of the stock options in effect at the time of the grants. The dividend yield assumption is based on the expectation of no future dividend payments by the Company. In addition to assumptions used in the Black-Scholes model, the Company reduces stock-based compensation expense based on actual forfeitures in the period that each forfeiture occurs.
16
Stock-Based Compensation Expense
For the three and nine months ended September 30, 2024 and 2023, the Company recorded stock-based compensation expense for the period indicated as follows:
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
General and administrative: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
RSU awards |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Stock Options |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
RSU awards |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stock Options |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
As of September 30, 2024, there was $
10. Warrants
Public Warrants
In connection with Petra's initial public offering (“IPO”), Petra issued and has outstanding as of September 30, 2024
The Company may redeem the Public Warrants at a price of $
Rollover Warrants
Prior to the Merger, Revelation Sub issued warrants to a placement agent to purchase up to
On February 2, 2022, the Company received a notice of cash exercise for the Company’s Rollover Warrants for
The fair value of the Rollover Warrants were estimated using the Black-Scholes option pricing model with the following assumptions:
Volatility |
|
|
% |
|
Expected term (years) |
|
|
|
|
Risk-free interest rate |
|
|
% |
|
Expected dividend yield |
|
|
% |
17
Class A Common Stock Warrants
In connection with the closing of a private placement on January 25, 2022 (“PIPE Investment”), the Company issued warrants to an institutional investor to purchase up to
The fair value of the Class A Common Stock Warrants were estimated using the Black-Scholes option pricing model with the following assumptions:
Volatility |
|
|
% |
|
Expected term (years) |
|
|
|
|
Risk-free interest rate |
|
|
% |
|
Expected dividend yield |
|
|
% |
Class A Placement Agent Common Stock Warrants
In connection with the PIPE Investment, the Company issued warrants to Roth to purchase an aggregate of
The fair value of the Class A Placement Agent Common Stock Warrants were estimated using the Black-Scholes option pricing model with the following assumptions:
Volatility |
|
|
% |
|
Expected term (years) |
|
|
|
|
Risk-free interest rate |
|
|
% |
|
Expected dividend yield |
|
|
% |
Class B Common Stock Warrants
In connection with closing of a public offering on July 28, 2022 (“the July 2022 Public Offering”), the Company issued and has outstanding
The fair value of the Class B Common Stock Warrants were estimated using the Black-Scholes option pricing model with the following assumptions:
Volatility |
|
|
% |
|
Expected term (years) |
|
|
|
|
Risk-free interest rate |
|
|
% |
|
Expected dividend yield |
|
|
% |
18
Class B Placement Agent Common Stock Warrants
In connection with the July 2022 Public Offering, the Company issued warrants to the Placement Agent to purchase up to
The fair value of the Class B Placement Agent Common Stock Warrants were estimated using the Black-Scholes option pricing model with the following assumptions:
Volatility |
|
|
% |
|
Expected term (years) |
|
|
|
|
Risk-free interest rate |
|
|
% |
|
Expected dividend yield |
|
|
% |
Class C Pre-Funded Warrants
In connection with the February 2023 Public Offering, the Company issued pre-funded warrants to purchase up to
Class C Common Stock Warrants
In connection with the February 2023 Public Offering, the Company issued
The Company evaluated the Class C Common Stock Warrants under ASC 815-40 and concluded that they do not meet the criteria to be classified in stockholders’ equity and accounted for the Class C Common Stock Warrants as current liabilities.
The Company concluded that the multiplier of
At the date of issuance, the Company valued the Class C Common Stock Warrants using a Monte-Carlo simulation model with a fair value of $
As of September 30, 2024, the Company has received notices of alternative cashless exercises for
As of September 30, 2024, the Company re-valued
As part of the February 2024 Public Offering, the exercise price of the Class C Common Stock Warrants was reset from $
19
Class D Pre-Funded Warrants
In connection with the February 2024 Public Offering, the Company issued pre-funded warrants to purchase up to
Class D Common Stock Warrants
In connection with the February 2024 Public Offering, the Company issued and has outstanding
As part of a common stock issuance to a third party consultant on June 11, 2024 for services provided, the exercise price of the Class D Common Stock Warrants was reset from $
As of September 30, 2024 there were
The fair value of the Class D Common Stock Warrants were originally estimated using the Black-Scholes option pricing model with the following assumptions:
Volatility |
|
|
% |
|
Expected term (years) |
|
|
|
|
Risk-free interest rate |
|
|
% |
|
Expected dividend yield |
|
|
% |
Modification of the Class D Common Stock Warrants and Class E Common Stock Warrants
As part of the Warrant Inducement, the Class D Common Stock Existing Warrants to purchase up to
In connection with the Warrant Inducement, the Company issued Class E Common Stock Warrants to purchase up to
The fair value of the Class D Common Stock Existing Warrant modification and the Class E Common Stock Warrants were estimated using the Black-Scholes option pricing model with the following assumptions:
Volatility |
|
|
% |
|
Expected term (years) |
|
|
|
|
Risk-free interest rate |
|
|
% |
|
Expected dividend yield |
|
|
% |
11. Income Taxes
The quarterly provision for or benefit from income taxes is computed based upon the estimated annual effective tax rate and the year-to-date pre-tax (loss) income and other comprehensive (loss) income. The Company did
For the nine months ended September 30, 2024 and 2023, the Company recorded non-taxable income of $
20
12. Subsequent Event
NASDAQ Minimum Bid Price Delist Letter
October 16, 2024, the Company received the Minimum Bid Price Delist Letter from the Staff of Nasdaq, notifying the Company that it was not in compliance with the Minimum Bid Price Requirement. Pursuant to Listing Rule 5810(c)(3)(A)(iv) the Company is not eligible for any compliance period specified in Rule 5810(c)(3)(A) because the Company effected one or more reverse stock splits over the prior
The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. On October 23, 2024 the Company appealed the Minimum Bid Price Delist Letter by requesting a hearing with the Panel. The hearing request stayed any suspension or delisting action pending the conclusion of the hearing process. The Minimum Bid Price Delist Letter does not have an immediate effect on the listing or trading of the Company’s common stock or warrants, which will continue to trade on The Nasdaq Capital Market under the symbols “REVB” and “REVBW,” respectively. (see Note 1)
Deferred Underwriting Commissions Payment
On October 31, 2024 the Company entered into a release agreement with
21
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion of our financial condition and results of operations in conjunction with our unaudited financial statements and the notes included elsewhere in this Form 10-Q. The following discussion contains forward-looking statements that involve certain risks and uncertainties. Our actual results could differ materially from those discussed in these statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Form 10-Q or our Annual Report Form 10-K for the year ended December 31, 2023, particularly under the “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements and Risk Factors Summary” sections.
Overview
Revelation is a clinical-stage biopharmaceutical company focused on harnessing the power of trained immunity for the prevention and treatment of disease by developing and commercializing therapeutics that modulate the innate immune system. We are developing a pipeline of potential high-value products based on Gemini. Gemini is our proprietary formulation of PHAD an established TLR4 agonist that can stimulate the human body’s innate immune response to prevent and treat disease. Our current Gemini based programs consist of: GEM-AKI, which is being developed as a potential therapy for the prevention and treatment of acute kidney injury as a result of cardiac surgery; GEM-CKD, which is being developed as a potential therapy for the prevention and treatment of chronic kidney disease; and GEM-PSI, which is being developed for the prevention and treatment of post surgical infection.
Since our inception, we have devoted substantially all of our resources to organizing and staffing our Company, business planning, raising capital, and research and development of GEM-AKI, GEM-CKD and GEM-PSI, our product candidates.
We have funded our operations since our inception to September 30, 2024 through the issuance and sale of our capital stock, from which we have raised net proceeds of $53.0 million. Our current cash and cash equivalents balance will not be sufficient to complete all necessary product development or future commercialization efforts. We anticipate that our current cash and cash equivalents balance will not be sufficient to sustain operations within one-year after the date that our unaudited financial statements for September 30, 2024 were issued, which raises substantial doubt about our ability to continue as a going concern.
We plan to seek additional funding through public or private equity or debt financings. We may not be able to obtain financing on acceptable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of our stockholders. If we are unable to obtain funding we could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect our business operations.
We have incurred recurring losses since our inception, including a net loss of $13.3 million for the nine months ended September 30, 2024 and $2.1 million for the nine months ended September 30, 2023, respectively. As of September 30, 2024 we had an accumulated deficit of $38.8 million. We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future if and as we:
22
Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical studies and our expenditures on other research and development activities.
We have never generated revenue and do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for GEM-AKI, GEM-CKD, GEM-PSI or other product candidates, which we expect will not be for at least several years, if ever. Accordingly, until such time as we can generate significant revenue from sales of GEM-AKI, GEM-CKD, GEM-PSI or other product candidates, if ever, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Recent Developments
2024 Reverse Stock Split
On January 25, 2024, the Company effected a 1-for-30 reverse stock split of our outstanding shares of common stock, which had been approved at a special meeting of stockholders.
NASDAQ Compliance
As previously reported, on October 16, 2024, the Company received the Minimum Bid Price Delist Letter from the Staff of Nasdaq, notifying the Company that it was not in compliance with the Minimum Bid Price Requirement.
Normally, a company would be afforded a 180-calendar day period to demonstrate compliance with the Minimum Bid Price Requirement. However, pursuant to Listing Rule 5810(c)(3)(A)(iv) the Company is not eligible for any compliance period specified in Rule 5810(c)(3)(A) because the Company effected one or more reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one.
Separate from and in addition to the Minimum Bid Price Delist Letter, as previously disclosed, on August 14, 2024, the Company received the Stockholders’ Equity Requirement Deficiency Letter from the Staff of Nasdaq notifying the Company that it was not in compliance with the Stockholders’ Equity Requirement, nor is it in compliance with either of the alternative listing standards, market value of listed securities of at least $35 million or net income of $500,000 from continuing operations in the most recently completed fiscal year, or in two of the three most recently completed fiscal years. The Minimum Bid Price Delist Letter stated that the Company’s Stockholders’ Equity Requirement Deficiency serves as an additional basis per Nasdaq Listing Rule 5810(d)(2) for delisting the Company’s securities from The Nasdaq Stock Market and that at a hearing in connection with the Minimum Bid Price Requirement, the Panel will consider the Company’s Stockholders’ Equity Requirement Deficiency as well. By virtue of the Company’s financing activities during the third quarter, the Company satisfied the Stockholders’ Equity Requirement as of September 30, 2024.
The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. The Company has the right to appeal the Minimum Bid Price Delist Letter by requesting a hearing before an independent panel, which it filed on October 23, 2024. The hearing request stayed any suspension or delisting action pending the conclusion of the hearing process and the expiration of any additional extension period granted by the panel following the hearing. However, there can be no assurance that the Company will receive any extension by Panel and will ultimately regain compliance with all applicable requirements for continued listing. Neither the Nasdaq Letters nor the Company’s noncompliance have an immediate effect on the listing or trading of the Company’s common stock or warrants, which will continue to trade on The Nasdaq Capital Market under the symbols “REVB” and “REVBW,” respectively.
23
Research and Development
Research and development expenses consist primarily of costs incurred for the development of our product candidates GEM-AKI, GEM-CKD and GEM-PSI. Our research and development expenses consist primarily of external costs related to clinical development, costs related to contract research organizations, costs related to consultants, costs related to acquiring and manufacturing clinical study materials, costs related to contract manufacturing organizations and other vendors, costs related to the preparation of regulatory submissions, costs related to laboratory supplies and services, and personnel costs. Personnel and related costs consist of salaries, employee benefits and stock-based compensation for personnel involved in research and development efforts.
We expense all research and development expenses in the periods in which they are incurred. We accrue for costs incurred as the services are being provided by monitoring the status of specific activities and the invoices received from our external service providers. We adjust our accrual as actual costs become known.
We expect our research and development expenses to increase substantially for the foreseeable future as we continue the development of GEM-AKI, GEM-CKD and GEM-PSI and continue to invest in research and development activities. The process of conducting the necessary clinical research and product development to obtain regulatory approval is costly and time consuming, and the successful development of GEM-AKI, GEM-CKD and GEM-PSI and any future product candidates is highly uncertain. To the extent that our product candidates continue to advance into larger and later stage clinical studies, our expenses will increase substantially and may become more variable.
The actual probability of success for GEM-AKI, GEM-CKD and GEM-PSI or any future product candidate may be affected by a variety of factors, including the safety and efficacy of our product candidates, investment in our clinical programs, manufacturing capability and competition with other products. As a result, we are unable to determine the timing of initiation, duration and completion costs of our research and development efforts or when and to what extent we will generate revenue from the commercialization and sale of GEM-AKI, GEM-CKD and GEM-PSI or any future product candidate.
General and Administrative
我们的一般和行政开支主要包括人员成本、外部专业服务费用,包括财务顾问、法律、人力资源、审计和会计服务以及咨询费用。人员及相关成本包括董事、财务和其他行政职能人员的薪资、员工福利和基于股票的薪酬。我们预计我们的一般和行政开支将在可预见的未来增加,因为我们需要扩大行政职能部门的规模,以支持业务增长和持续进行研发活动。我们还预计随着我们继续作为一家上市公司运营,相关费用也将增加,包括与财务顾问服务、审计、法律、监管、投资者关系成本以及与维持交易所上市和SEC要求合规相关的董事和高管保险费用。
其他(费用)收益,净额
其他(费用)收入主要包括认股权证债务公允价值变动、临床试验相关费用、外币交易收益和损失、利息支出以及来自储蓄账户中现金余额的利息收入。
经营结果
下表总结了我们呈现的期间的经营结果:
|
|
三个月已结束 |
|
|
九个月已结束 |
|
||||||||||||||||||
|
|
2024 |
|
|
2023 |
|
|
改变 |
|
|
2024 |
|
|
2023 |
|
|
改变 |
|
||||||
运营费用: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
研究和开发 |
|
$ |
830,981 |
|
|
$ |
1,651,367 |
|
|
$ |
(820,386 |
) |
|
$ |
2,943,492 |
|
|
$ |
3,085,918 |
|
|
$ |
(142,426 |
) |
一般和行政 |
|
|
965,705 |
|
|
|
1,126,530 |
|
|
|
(160,825 |
) |
|
|
3,277,729 |
|
|
|
3,244,856 |
|
|
|
32,873 |
|
运营费用总额 |
|
|
1,796,686 |
|
|
|
2,777,897 |
|
|
|
(981,211 |
) |
|
|
6,221,221 |
|
|
|
6,330,774 |
|
|
|
(109,553 |
) |
运营损失 |
|
|
(1,796,686 |
) |
|
|
(2,777,897 |
) |
|
|
981,211 |
|
|
|
(6,221,221 |
) |
|
|
(6,330,774 |
) |
|
|
109,553 |
|
其他(支出)收入总额,净额 |
|
|
(444,879 |
) |
|
|
149,521 |
|
|
|
(594,400 |
) |
|
|
(7,091,596 |
) |
|
|
8,413,423 |
|
|
|
(15,505,019 |
) |
净(亏损)收益 |
|
$ |
(2,241,565 |
) |
|
$ |
(2,628,376 |
) |
|
$ |
386,811 |
|
|
$ |
(13,312,817 |
) |
|
$ |
2,082,649 |
|
|
$ |
(15,395,466 |
) |
24
研发费用
以下表格总结了我们所提供的研发费用期间。
|
|
三个月结束 |
|
|
九个月结束 |
|
||||||||||||||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
2024 |
|
|
2023 |
|
|
Change |
|
||||||
创业板-PSI和创业板-AKI临床研究费用 |
|
$ |
246,801 |
|
|
$ |
66,721 |
|
|
$ |
180,080 |
|
|
$ |
1,511,435 |
|
|
$ |
66,721 |
|
|
$ |
1,444,714 |
|
制造业-半导体费用 |
|
|
263,225 |
|
|
|
183,253 |
|
|
|
79,972 |
|
|
|
299,393 |
|
|
|
693,759 |
|
|
|
(394,366 |
) |
其他项目支出 |
|
|
(15,279 |
) |
|
|
1,108,558 |
|
|
|
(1,123,837 |
) |
|
|
86,189 |
|
|
|
1,651,297 |
|
|
|
(1,565,108 |
) |
其他支出 |
|
|
26,623 |
|
|
|
85,764 |
|
|
|
(59,141 |
) |
|
|
126,350 |
|
|
|
206,303 |
|
|
|
(79,953 |
) |
人员支出(包括股票补偿) |
|
|
309,611 |
|
|
|
207,071 |
|
|
|
102,540 |
|
|
|
920,125 |
|
|
|
467,838 |
|
|
|
452,287 |
|
所有研发费用 |
|
$ |
830,981 |
|
|
$ |
1,651,367 |
|
|
$ |
(820,386 |
) |
|
$ |
2,943,492 |
|
|
$ |
3,085,918 |
|
|
$ |
(142,426 |
) |
研发费用从截至2023年9月30日的170万美元减少了80万美元,至截至2024年9月30日的80万美元。 这一减少主要是由于其他项目费用减少了110万美元,其中包括GEm-AKI和GEm-PSI相关的临床研究费用增加了20万美元,人员费用增加了10万美元。其他项目费用包括主要用于GEm-AKI和GEm-PSI项目的临床准备费用和临床前成本。
研发费用从2023年9月30日结束的九个月的310万美元下降了10万美元,到2024年9月30日结束的九个月的290万美元。此减少主要是由其他项目费用减少160万美元和制造业费用减少40万美元引起的,其中包括GEm-AKI和GEm-PSI临床研究费用增加140万美元以及人员费用增加50万美元。其他项目费用包括主要用于GEm-AKI和GEm-PSI计划的临床研究前阶段费用和临床准备费用。
一般行政费用
以下表格总结了我们所列期间的一般和行政费用:
|
|
三个月结束 |
|
|
九个月结束 |
|
||||||||||||||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
2024 |
|
|
2023 |
|
|
Change |
|
||||||
人事费用(包括员工股份报酬) |
|
$ |
694,530 |
|
|
$ |
634,691 |
|
|
$ |
59,839 |
|
|
$ |
2,105,420 |
|
|
$ |
1,641,129 |
|
|
$ |
464,291 |
|
法律和专业费用(包括非员工股份报酬) |
|
|
206,049 |
|
|
|
411,715 |
|
|
|
(205,666 |
) |
|
|
900,245 |
|
|
|
1,344,650 |
|
|
|
(444,405 |
) |
其他支出 |
|
|
65,126 |
|
|
|
80,124 |
|
|
|
(14,998 |
) |
|
|
272,064 |
|
|
|
259,077 |
|
|
|
12,987 |
|
总管理费用 |
|
$ |
965,705 |
|
|
$ |
1,126,530 |
|
|
$ |
(160,825 |
) |
|
$ |
3,277,729 |
|
|
$ |
3,244,856 |
|
|
$ |
32,873 |
|
2023年9月30日结束的三个月,管理和行政费用减少了20万美元,从110万美元减少到2024年9月30日结束的三个月的100万美元。这一减少主要是由于法律和专业费用增加了20万元。
截至2023年9月30日的九个月总务及行政支出增加不到10万美元,从320万美元增至2024年9月30日的九个月总务及行政支出330万美元。增加主要是由于人员支出增加了50万美元,而法律和专业费用减少了40万美元。
25
Other (Expense) Income, Net
Other (expense) income, net was $149,521 for the three months ended September 30, 2023, related to the change in fair value of the warrant liability, foreign currency transaction gains and losses, and interest income from our cash balances in savings accounts. Other (expense) income, net was ($444,879) for the three months ended September 30, 2024, related to expense in connection with the deferred underwriting commissions, the change in fair value of the warrant liability, foreign currency transaction gains and losses, and interest income from our cash balances in savings accounts.
Other (expense) income, net was $8,413,423 for the nine months ended September 30, 2023, related to the change in fair value of the warrant liability, foreign currency transaction gains and losses, and interest income from our cash balances in savings accounts. Other (expense) income, net was ($7,091,596) for the nine months ended September 30, 2024, primarily related to the LifeSci judgment expense, reimbursement of costs, clinical trial related settlement expenses with A-IR (defined in Part II-Other Information, Item 1. Leegal Proceedings) and expense in connection with the deferred underwriting commissions, offset by interest income from our cash balances in savings accounts.
Liquidity and Capital Resources
Since our inception to September 30, 2024, we have funded our operations from the issuance and sale of our common stock, preferred stock and warrants, from which we have raised net proceeds of $53.0 million, of which $9.1 million was received during the nine months ended September 30, 2024. As of September 30, 2024, we had available cash and cash equivalents of $6.5 million and an accumulated deficit of $38.8 million.
Our use of cash is to fund operating expenses, which consist primarily of research and development expenditures related to our therapeutic product candidates, GEM-AKI, GEM-CKD and GEM-PSI. We plan to increase our research and development expenses substantially for the foreseeable future as we continue the clinical development of our current and future product candidates. At this time, due to the inherently unpredictable nature of product development, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval, and commercialize our current product candidate or any future product candidates. For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or any future license agreements which we may enter into or whether, or when, if ever, we may achieve profitability. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations. In addition, we cannot forecast the timing and amounts of milestone, royalty and other revenue from licensing activities, which future product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
We expect to continue to generate substantial operating losses for the foreseeable future as we expand our research and development activities. We will continue to fund our operations primarily through utilization of our current financial resources and through additional raises of capital.
To the extent that we raise additional capital through partnerships or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams or research programs or to grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of our then-existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our clinical studies or preclinical studies, research and development programs or commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Going Concern
We have incurred recurring losses since our inception, including a net loss of $13.3 million for the nine months ended September 30, 2024. As of September 30, 2024 we had an accumulated deficit of $38.8 million, a stockholders’ equity of $2.7 million and available cash and cash equivalents of $6.5 million. We expect to continue to incur significant operating and net losses, as well as negative cash flows from operations, for the foreseeable future as we continue to complete all necessary product development or future commercialization efforts. We have never generated revenue and do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for GEM-AKI, GEM-CKD, GEM-PSI or other product candidates, which we expect will not be for at least several years, if ever. We do not anticipate that our current cash and cash equivalents balance will be sufficient to sustain operations within one-year after the date that our unaudited financial statements for September 30, 2024 were issued, which raises substantial doubt about our ability to continue as a going concern.
26
To continue as a going concern, we will need, among other things, to raise additional capital resources. We plan to seek additional funding through public or private equity or debt financings. We may not be able to obtain financing on acceptable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of our stockholders. If we are unable to obtain funding we could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect our business operations.
The unaudited condensed consolidated financial statements for September 30, 2024, have been prepared on the basis that we will continue as a going concern, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability for us to continue as a going concern.
Cash Flows
The following table summarizes our cash flows for the periods presented:
|
|
Nine Months Ended |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Net cash used in operating activities |
|
$ |
(14,573,635 |
) |
|
$ |
(5,283,450 |
) |
Net cash used in investing activities |
|
|
(36,860 |
) |
|
|
- |
|
Net cash provided by financing activities |
|
|
9,159,846 |
|
|
|
14,025,008 |
|
Net (decrease) increase in cash and cash equivalents |
|
$ |
(5,450,649 |
) |
|
$ |
8,741,558 |
|
Net Cash Used in Operating Activities
During the nine months ended September 30, 2024, net cash used in operating activities was $14.6 million, which consisted of a net loss of $13.3 million and a net change of $1.3 million in our net operating assets and liabilities.
During the nine months ended September 30, 2023, net cash used in operating activities was $5.3 million, which consisted of a net income of $2.1 million, offset by a net change of $8.1 million comprised of the change in fair value of the warrant liability, stock-based compensation expense and depreciation expense.
Net Cash Used in Investing Activities
During the nine months ended September 30, 2024, net cash used in investing activities consisted of a purchase of lab equipment.
During the nine months ended September 30, 2023, there was no cash used in investing activities.
Net Cash Provided by Financing Activities
During the nine months ended September 30, 2024, net cash provided by financing activities was $9.2 million, from net proceeds of $5.4 million received in connection with the February 2024 Public Offering, $0.2 million received from exercises of the Class D Common Stock Warrants and net proceeds of $3.5 million received in connection with the Warrant Inducement.
During the nine months ended September 30, 2023, net cash provided by financing activities was $14.0 million, from the February 2023 Public Offering.
Contractual Obligations and Other Commitments
The following table summarizes our contractual obligations as of September 30, 2024 and the effects of such obligations are expected to have on our liquidity and cash flow in future periods:
|
|
Less than |
|
|
1 to 3 |
|
|
3 to 5 |
|
|
More than |
|
|
Total |
|
|||||
Operating lease obligations |
|
$ |
10,700 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
10,700 |
|
Total contractual obligations |
|
$ |
10,700 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
10,700 |
|
27
We have entered into an operating lease for laboratory space in San Diego, California. The table above includes future minimum lease payments under the non-cancelable lease arrangement.
We enter into contracts in the normal course of business with third party service providers and vendors. These contracts generally provide for termination on notice and, therefore, are cancellable contracts and not considered contractual obligations and commitments. We believe that our non-cancelable obligations under these agreements are not material.
Off-Balance Sheet Arrangements
As of September 30, 2024, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K.
Quantitative and Qualitative Disclosure about Market Risk
We are exposed to market risks in the ordinary course of our business.
Interest Rate Risk
Our cash and cash equivalents consist primarily of highly liquid investments in money market funds and cash on hand and have an original maturity date of 90 days or less. The fair value of our cash and cash equivalents would not be significantly affected by either an increase or decrease in interest rates due mainly to the short-term nature of these instruments.
Foreign Currency Risk
Our expenses are generally denominated in the currencies in which our operations are located, which is primarily in the United States, England and Australia. We make payments to vendors for research and development services with payments denominated in foreign currencies including Australian Dollars and British Pounds. We are subject to foreign currency transaction gains or losses on our payments denominated in foreign currencies. To date, foreign currency transaction gains and losses have not been material and we have not had a formal hedging program with respect to foreign currency; however, we may consider doing so in the future. A 10% increase or decrease in currency exchange rates would not have a material effect on our financial results.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with the U.S. generally accepted accounting principles (“GAAP”). The preparation of the condensed consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions about future events that affect the amounts of assets and liabilities reported, disclosures about contingent assets and liabilities, and reported amounts of revenue and expenses. These estimates and assumptions are based on management’s best estimates and judgment. Management regularly evaluates its estimates and assumptions using industry experience and other factors; however, actual results could differ materially from these estimates and could have an adverse effect on our condensed consolidated financial statements. While our significant accounting policies are more fully described in the notes to our condensed consolidated financial statements, we believe that the accounting policies discussed below are most critical to understanding and evaluating our historical and future performance.
28
Research and Development Expenditures
We record accrued expenses for estimated preclinical and clinical study and research expenses related to the services performed but not yet invoiced pursuant to contracts with research institutions, contract research organizations and clinical manufacturing organizations that conduct and manage preclinical studies, and clinical studies, and research services on our behalf. Payments for these services are based on the terms of individual agreements and payment timing may differ significantly from the period in which the services were performed. Our estimates are based on factors such as the work completed, including the level of patient enrollment. We monitor patient enrollment levels and related activity to the extent reasonably possible and make judgments and estimates in determining the accrued balance in each reporting period. Our estimates of accrued expenses are based on the facts and circumstances known at the time. If we underestimate or overestimate the level of services performed or the costs of these services, our actual expenses could differ from our estimates. As actual costs become known, we adjust our accrued expenses. To date, we have not experienced significant changes in our estimates of clinical study accruals.
Stock-based Compensation
We recognize the compensation expense related to stock options, third-party warrants, and RSU awards granted, based on the estimated fair value of the awards on the date of grant. The fair value of employee stock options and third-party warrants are generally determined using the Black-Scholes option-pricing model using various inputs, including estimates of historic volatility, term, risk-free rate, and future dividends. The grant date fair value of the stock-based awards, which have graded vesting, is recognized using the straight-line method over the requisite service period of each stock-based award, which is generally the vesting period of the respective stock-based awards. The Company recognizes forfeitures as they occur.
As of September 30, 2024, there were 94 Rollover RSU awards unvested and unissued and 946 stock options outstanding.
Determination of the Fair Value of Common Stock
Prior to the Business Combination, given the absence of a public trading market for our shares of common stock, our board of directors exercised its judgment and considered a number of objective and subjective factors to determine the best estimate of the fair value of our shares of common stock, including timely valuations of our shares of common stock prepared by an unrelated third-party valuation firm, important developments in our operations, sales of common stock and convertible preferred shares, actual operating results and financial performance, the conditions in the biotechnology industry and the economy in general, the stock price performance and volatility of comparable public companies, and the lack of liquidity of our shares of common stock, among other factors. After the Business Combination, the fair value of each share of common stock is based on the closing price of our shares of common stock as reported on the date of grant.
Recent Accounting Pronouncements
See Note 2 to our unaudited condensed consolidated financial statements for more information about recent accounting pronouncements, the timing of their adoption, and our assessment, to the extent we have made one yet, of their potential impact on our financial condition of results of operations.
JOBS Act Accounting Election
We are an “emerging growth company,” as defined in the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies.
我们选择使用这个延长的过渡期,以便我们遵守针对上市公司和非上市公司在不同有效日期的新或修订会计准则,直至以下事件的较早发生日期:(i)我们不再是新兴成长型公司;或(ii)我们积极且不可撤销地选择退出《作业机会法案》规定的延长过渡期。因此,我们的基本报表和我们的中期简明基本报表可能与遵守新的或修订的会计公告的公开公司的报表不可比。
29
事项3. 关于市场风险的定量和定性披露。
我们是根据交易所法规120亿.2规定而被定义为较小的报告公司,并且不需要根据该项要求提供其他信息。
事项4. 控制和程序。
披露控件和程序的评估
我们的管理层,在我们的首席执行官和我们的信安金融主管的参与下,截至本季度报告(表10-Q)涵盖的期间结束时,评估了我们的披露控制和程序的有效性。根据对我们的披露控制和程序截至2024年9月30日的评估,我们的首席执行官和信安金融主管得出结论,认为截至该日期的我们的披露控制和程序在合理保证水平上是有效的。术语“披露控制和程序”的定义见于1934年证券交易法(“交易所法”)13a-15(e)和15d-15(e)规则中,是指公司设计的用于确保公司在根据交易所法要求披露的信息被记录、处理、总结和报告的控制和其他程序,其内容应在美国证券交易委员会规则和表格规定的时间期限内进行。披露控制和程序包括但不限于设计的控制和程序,以确保我们在根据交易所法要求披露的信息被积累并及时传达给我们的管理层,包括我们的首席执行官和信安金融主管,以便及时作出有关要求披露的决策。管理层认识到,任何控制和程序,无论多么设计和运营良好,都只能合理保证其目标的实现,我们的管理层必须在评估可能的控制和程序的成本效益关系时运用其判断。
财务报告内部控制的变化
在我们最近的一个季度内,我们的内部财务报告控制没有发生任何重大影响或可能重大影响我们的内部财务报告的变化。
第二部分-其他信息
第1项。法律诉讼。
2022年2月18日,LifeSci Capital LLC(“LifeSci”)在纽约南区联邦地区法院对公司提起诉讼,要求支付约$530万的未支付银行和咨询费用及利息。这些费用是根据在与Petra Acquisition(“Petra”)进行业务组合(“业务组合”)之前签订的合同产生的,公司声称LifeSci Capital LLC无权收取费用,因为其违反了其责任,向Petra错误陈述了在业务组合后将可用的资金,如果没有这些资金,Petra将不会签订业务组合协议。 此外,正如先前报道的,2023年12月1日,一名法官裁定支持LifeSci Capital LLC的摘要判决报告。于2024年8月1日,地方法院法官颁布了一项采纳法官的报告并支持摘要判决的命令,并颁布了一项判决,含利息,总额为$730万。 判决书颁布后,LifeSci提出了一项20万美元的费用补偿申请。判决书中的150万美元是来自Petra首次公开发行的递延承销佣金,这笔款项先前记录在财务报表中作为流动负债,剩余的580万美元和20万美元的费用补偿已在截至2024年9月30日的简明合并利润表中计提。2024年8月12日,公司收到了一项解除令并全额支付了摘要判决,包括利息和律师费,总额为750万美元。一个满意的判决书于2024年8月23日提交给法院。结果,对公司在判决书的事项或与判决书有关的事项不得采取进一步行动,并且公司已获得免除任何和所有索赔,包括判决书。
2022年9月27日,A-IR临床研究有限公司(“A-IR”)在英格兰和威尔士的高等法院业务和财产法庭对公司提起诉讼,要求支付160万英镑的未付发票,以及利息和成本,涉及公司的病毒挑战研究。公司对此提出异议,因为许多发票涉及未执行的工作,A-IR曾虚报其执行合同工作的资质。2024年4月26日,双方达成和解并与偏见撤销诉讼程序。
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第1A项。风险因素。
我们的业务面临各种风险,包括下文描述的风险以及我们于2023年12月31日结束的年度10-k表格的项目1A中描述的风险。
如果启示录不能遵守纳斯达克适用的继续上市要求或标准,纳斯达克可能会将我们的普通股摘牌。
公司的普通股和公开认股权证分别在纳斯达克资本市场上以“REVB”和“REVBW”符号进行交易。
2024年10月16日,公司收到纳斯达克工作人员发送的最低买盘价格退市函,通知公司未符合最低买盘价格要求。另外,公司还于2024年8月14日另行披露,收到纳斯达克工作人员发送的股东权益要求缺失函,通知公司未符合股东权益要求,也未符合两种备用上市标准之一,即上市证券的市场价值至少3500万美元或最近完成的财政年度持续经营净利润至少500,000美元,或者在最近完成的三个财政年度中的两个财政年度之一。基于公司在第三季度的融资活动,截至2024年9月30日,公司满足了股东权益要求;但是,纳斯达克可能要求公司展示其满足股东权益要求的能力直至2025年12月31日。
公司打算采取一切合理措施,以恢复纳斯达克上市规则并继续在纳斯达克上市。公司有权通过要求在独立小组面前进行听证会的方式对纳斯达克函件提出上诉,该上诉已于2024年10月23日提交。听证会请求暂停了任何停牌或摘牌行动,直至听证程序结束及小组在听证后授予的任何额外延期期限到期。然而,并不能保证公司将获得小组的延期,并最终符合所有持续上市的适用要求。如果纳斯达克因未达到上市标准,如股东权益要求或最低买盘要求等,而将公司普通股或公开认股权证从其交易所摘牌,我们和股东可能面临重大负面后果,包括:
如果需要进行股票的逆向股票拆分以维持继续在纳斯达克上市的最低买盘要求,公司打算进行这样的逆向股票拆分。即使进行了逆向股票拆分,也不能保证公司普通股的市场价格将维持最低买盘要求。我们的普通股市场价格将继续部分基于我们的业绩和其他与已发行股票数量无关的因素。
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第2项。未注册的股权销售和资金使用。
第3项。 对高级证券的拖欠。
不适用。
项目4. 矿业安全披露。
不适用。
第5项。其他信息。
项目6. 陈列品,财务报表附表。
提供Regulation S-k (§ 229.601 of this chapter)规定的展品。
展览 |
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描述 |
31.1* |
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根据根据2002年《萨班斯-奥克斯利法案》第302条通过的《证券交易法》第13a_14 (a) 条和15 (d) -14 (a) 条对首席执行官进行认证 |
31.2* |
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根据根据2002年《萨班斯-奥克斯利法案》第302条通过的《证券交易法》第13a_14 (a) 条和15 (d) -14 (a) 条对首席财务官进行认证 |
32.1* |
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32.2* |
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101.INS* |
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XBRL 实例文档 — 该实例文档不出现在交互式数据文件中,因为其 XBRL 标签嵌入在内联 XBRL 文档中。 |
101.SCH* |
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内联 XBRL 分类扩展架构文档 |
101.CAL* |
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内联 XBRL 分类扩展计算链接库文档 |
101.DEF* |
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内联 XBRL 分类法扩展定义链接库文档 |
101.LAB* |
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内联 XBRL 分类法扩展标签 Linkbase 文档 |
101.PRE* |
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内联 XBRL 分类扩展演示链接库文档 |
104* |
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封面交互式数据文件(格式为 Inline XBRL,包含在附录 101 中) |
* |
随此提交。 |
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签名
根据1934年证券交易法第13或15(d)条的要求,发行人已经授意以下签署的人员,据此授权,由其代表签署了这份十分之一的季度报告表格10-Q。
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REVELATION生物科技股份有限公司。 |
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日期:2024年11月8日 |
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作者: |
/s/ James Rolke |
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James Rolke |
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首席执行官 |
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(首席执行官) |
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日期:2024年11月8日 |
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作者: |
/s/ Chester S. Zygmont, III |
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Chester S. Zygmont, III |
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首席财务官 |
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姓名:Chee Hui Law(财务和会计主管) |
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