美國
證券交易委員會
華盛頓特區20549
表格
(標記一)
根據1934年證券交易法第13或15(d)節的季度報告 |
季度期間 結束了
或者
根據1934年證券交易法第13或15(d)節的轉型報告書 |
過渡期從開始到結束
委託文件編號:001-39866
(依據其憲章指定的註冊名稱)
(該州或其他司法管轄區 公司成立或組織) |
(IRS僱主 |
,(主要行政辦公地址) |
(郵政編碼) |
公司電話號碼,包括區號:(
在法案第12(b)條的規定下注冊的證券:
每一類的名稱 |
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交易 符號: |
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在其上註冊的交易所的名稱 |
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The |
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可贖回的認股權證,每張認股權證可行使權利購買1/1,050股th普通股一股行使價爲12,075.00美元 |
|
REVBW |
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納斯達克證券交易所 LLC |
請在以下複選框中打勾,指示註冊人:(1)在前12個月(或註冊人被要求提交這些報告的更短期間內)已經提交了1934年證券交易法第13或15(d)條規定需要提交的所有報告;以及(2)在過去的90天內一直受到了此類文件提交要求的限制。
請在以下複選框中打勾,指示註冊人是否已經電子提交了根據Regulation S-T規則405條(本章節的§232.405條)需要提交的所有互動數據文件在過去的12個月內(或註冊人被要求提交這些文件的更短期間內)。
勾選以下選框,指示申報人是大型加速評估提交人、加速評估提交人、非加速評估提交人、小型報告公司或新興成長型公司。關於「大型加速評估提交人」、「加速評估提交人」、「小型報告公司」和「新興成長型公司」的定義,請參見《交易所法規》第12億.2條。
大型加速報告人 |
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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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較小的報告公司 |
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新興成長公司 |
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如果是新興成長型企業,請勾選複選標記,表明註冊者已選擇不使用延長過渡期來符合根據證券交易法第13(a)條規定提供的任何新財務會計準則。
請在以下空格內打勾,表示註冊人是不是外殼公司(按交易所法則120億.2條定義)。 是 ☐ 否
截至2024年11月4日,註冊人員已
目錄
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第一部分 |
1 |
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項目1。 |
1 |
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1 |
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2 |
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3 |
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4 |
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5 |
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事項二 |
22 |
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第3項。 |
30 |
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事項4。 |
30 |
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第二部分 |
30 |
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項目1。 |
30 |
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項目1A。 |
31 |
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事項二 |
32 |
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第3項。 |
32 |
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事項4。 |
32 |
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項目5。 |
32 |
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項目6。 |
32 |
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33 |
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第一部分——財務信息
項目1 控件m 1. 總資產負債表(未經審計)
REVELATION生物科技股份有限公司。
濃縮 合併資產負債表
(未經審計)
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九月三十日 |
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十二月 31, |
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資產 |
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流動資產: |
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現金和現金等價物 |
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$ |
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$ |
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延期發行成本 |
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預付費用和其他流動資產 |
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流動資產總額 |
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財產和設備,淨額 |
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總資產 |
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$ |
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$ |
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負債和股東權益 |
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流動負債: |
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應付賬款 |
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$ |
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$ |
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應計費用 |
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遞延承保佣金 |
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認股權證責任 |
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流動負債總額 |
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負債總額 |
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(註釋 4) |
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股東權益: |
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普通股,$ |
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額外的實收資本 |
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累計赤字 |
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股東權益總額 |
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負債和股東權益總額 |
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$ |
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$ |
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請參見簡明合併財務報表的附註。
1
REVELATION生物科技股份有限公司。
基本報表: 綜合結果表
(未經審計)
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三個月已結束 |
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九個月已結束 |
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2024 |
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2023 |
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2024 |
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2023 |
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運營費用: |
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研究和開發 |
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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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運營費用總額 |
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運營損失 |
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其他(支出)收入: |
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認股權證負債公允價值的變化 |
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其他(支出)收入,淨額 |
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其他(支出)收入總額,淨額 |
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( |
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( |
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淨(虧損)收益 |
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( |
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$ |
( |
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$ |
( |
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$ |
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基本每股淨(虧損)收益 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
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用於計算每股淨(虧損)收益的加權平均股票,基本 |
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攤薄後的每股淨(虧損)收益 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
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用於計算每股淨(虧損)收益的加權平均股票,攤薄後 |
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請參見簡明合併財務報表的附註。
2
REVELATION生物科技股份有限公司。
綜合簡明財務報表股東權益(赤字)變動表
(未經審計)
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A類 |
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普通股 |
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共計 |
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累積的 |
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總計 |
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股份 |
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金額 |
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股份 |
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金額 |
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資本 |
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赤字 |
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股權 |
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2022年12月31日結存餘額 |
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$ |
— |
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$ |
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$ |
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$ |
( |
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$ |
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贖回A系列優先股 |
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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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— |
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2023年2月公開發行普通股 |
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— |
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— |
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— |
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C類預先融資認股權行使 |
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— |
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— |
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— |
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C類普通股權證的替代無現金行使 |
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— |
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— |
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— |
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股票補償費用 |
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— |
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— |
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— |
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— |
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— |
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淨利潤 |
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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日的餘額 |
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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類預先擬定認股權證行使 |
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— |
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— |
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— |
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可替代非現金行使C類普通股認股權 |
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— |
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— |
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— |
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發放的RSU獎勵 |
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— |
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— |
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( |
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— |
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— |
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股票補償費用 |
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— |
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— |
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— |
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— |
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— |
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淨損失 |
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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日的餘額 |
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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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股票補償費用 |
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— |
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— |
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— |
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— |
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— |
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淨損失 |
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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9月30日的餘額 |
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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日結餘爲 |
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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月公開發行普通股 |
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— |
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— |
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— |
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D類可提前行使認股權證 |
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— |
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— |
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( |
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— |
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替代性無現金行使C類普通股權證 |
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— |
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— |
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— |
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股票補償費用 |
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— |
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— |
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— |
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— |
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— |
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淨損失 |
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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日的餘額 |
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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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因服務發行的普通股 |
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— |
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— |
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— |
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股票補償費用 |
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— |
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— |
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— |
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— |
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— |
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淨損失 |
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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日的餘額 |
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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級普通股認股權行使 |
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— |
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— |
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— |
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認股權誘因行使 |
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— |
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— |
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股票補償費用 |
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— |
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— |
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— |
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— |
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— |
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淨損失 |
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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9月30日餘額 |
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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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請參見簡明合併財務報表的附註。
3
REVELATION生物科技股份有限公司。
基本報表: 合併現金流量表
(未經審計)
|
|
九個月結束 |
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2024 |
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2023 |
|
||
經營活動現金流量: |
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淨(虧損)利潤 |
|
$ |
( |
) |
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調整以將淨(損失)收入調節爲經營活動中使用的淨現金流量: |
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股票補償費用 |
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以股票形式發放服務 |
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折舊費用 |
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權證賠償金額的變化 |
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( |
) |
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( |
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經營性資產和負債變動: |
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預付費用和其他流動資產 |
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( |
) |
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( |
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延遲募資成本 |
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應付賬款 |
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應計費用 |
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( |
) |
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經營活動使用的淨現金流量 |
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( |
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( |
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投資活動現金流量: |
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購置固定資產等資產支出 |
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( |
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投資活動產生的淨現金流出 |
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( |
) |
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籌集資金的現金流量: |
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2024年2月公開發行的款項淨額 |
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來自D類普通股權證行使的款項 |
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來自權證誘因行使的款項,淨額 |
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D類預付認股證行權所得款項 |
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贖回A系列優先股 |
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2023年2月公開發行的款項淨額 |
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C類預付認股證行權所得款項 |
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籌資活動產生的現金淨額 |
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現金及現金等價物淨增加額(減少額) |
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期初現金及現金等價物餘額 |
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期末現金及現金等價物 |
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非現金投資和籌資活動的補充披露: |
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與權證誘因相關的E類普通股權證的公允價值 |
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與權證誘因相關的D類普通股權證的增值 |
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權證誘因中包含的權益發行成本列入應付賬款 |
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2024年2月公開發行中與D類普通股權證相關的公允價值 |
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與2023年2月公開發行相關的C類普通股權證公允價值 |
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C類普通股權證的替代無現金行使 |
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請參見簡明合併財務報表的附註。
4
啓示生物科學公司
No基本報表的總彙編財務報表
1。組織和演示依據
Revelation Biosciences, Inc.(及其全資子公司,統稱爲 「我們」、「我們的」、「Revelation」 或 「公司」)是一家臨床階段的生物製藥公司,專注於開發或商業化 關於利用其專有配方Gemini利用經過訓練的免疫力來預防和治療疾病。我們有多個正在進行的評估Gemini的項目,包括作爲術後感染的預防、急性腎損傷的預防和慢性腎臟病的治療。 該公司於2019年11月20日在特拉華州註冊成立(原名Petra Acquisition, Inc.),總部位於加利福尼亞州聖地亞哥。
該公司的普通股和公開認股權證分別在納斯達克資本市場上市,代碼分別爲 「REVB」 和 「REVBW」。
反向股票分割
2024 年 1 月 25 日,公司 影響了批准的 反向拆分我們的普通股。 除非此處另有特別規定,否則本季度報告中隨後的股票和每股信息反映了反向股票拆分的影響。
納斯達克合
正如先前報道的那樣,2024年10月16日,公司收到了納斯達克股票市場有限責任公司(「納斯達克」)上市資格部門(「員工」)的退市信(「最低出價退市函」),通知該公司未遵守納斯達克上市規則5550(a)(2),該規則要求上市公司維持最低出價爲美元
通常,公司將有180個日曆日的時間來證明遵守了最低出價要求。但是,根據上市規則第5810 (c) (3) (A) (iv) 條,該公司沒有資格在《上市規則》第5810 (c) (3) (A) 條規定的任何合規期內進行過一次或多次反向股票分割,累計比率爲
除了先前披露的最低出價退市信外,公司於2024年8月14日收到了納斯達克工作人員的一封信(「股東權益要求缺陷信」 和最低出價退市信,即 「納斯達克信函」),通知公司未遵守納斯達克上市規則5550(b)(1),該規則要求公司維持最低限額爲美元
公司打算採取一切合理的措施,恢復納斯達克上市規則的合規性,並繼續在納斯達克上市。公司有權通過要求獨立小組舉行聽證會,對最低出價退市書提出上訴,該公司於2024年10月23日提交了聽證會。在聽證程序結束以及聽證會後小組批准的任何額外延期期到期之前,聽證請求暫停了任何暫停或除名行動。但是,無法保證該公司將獲得小組的任何延期,並最終恢復遵守繼續上市的所有適用要求。《納斯達克快報》和公司的違規行爲都不會對公司普通股或認股權證的上市或交易產生直接影響,這些普通股或認股權證將繼續在納斯達克資本市場上分別以 「REVB」 和 「REVBW」 的代碼進行交易。
5
流動性和資本資源
企業持續經營評估
公司自成立以來一直遭受着不斷的虧損,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日的未經審計的簡明綜合基本報表是基於公司將繼續作爲持續經營實體,不包括任何調整以反映資產的可收回性和分類以及可能由於公司無法繼續作爲持續經營實體而導致的負債的金額和分類。
報告範圍
附屬的基本報表是根據美國通用會計準則(「GAAP」)編制的。所有公司間交易和餘額在合併時已被消除。
6
2。重要會計政策摘要
未經審計的中期簡明合併財務報表
未經審計的中期簡明合併財務報表的編制基礎與截至2023年12月31日的已審計財務報表以及截至2023年12月31日的年度財務報表相同,管理層認爲,這些調整反映了公允列報公司財務狀況所必需的所有調整,僅包括正常的經常性調整。截至2024年9月30日的三個月和九個月的簡明合併財務報表附註中包含的財務數據和其他財務信息未經審計。截至2024年9月30日的三個月和九個月的經營業績不一定表示截至2024年12月31日的年度或任何其他未來年度或中期的預期業績。簡明合併財務報表及其附註應與2024年3月22日向美國證券交易委員會提交的10-k表中包含的截至2023年12月31日的公司經審計的財務報表及其附註一起閱讀。隨附的截至2023年12月31日的簡明合併資產負債表來自上述參考的10-k表中包含的截至2023年12月31日的經審計的資產負債表。
估算值的使用
根據公認會計原則編制簡明合併財務報表需要管理層進行估算es和有關未來事件的假設,這些事件會影響報告的資產和負債金額,或有資產和負債的披露以及報告的支出金額。這些估計和假設基於公司的最佳估計和判斷。公司定期使用歷史和行業經驗以及其他因素評估其估計和假設;但是,實際業績可能與這些估計存在重大差異,並可能對公司的簡明合併財務報表產生不利影響。
現金和現金等價物
公司將自購買之日起三個月或更短期限購買的所有高流動性投資視爲現金等價物。公司將現金存入支票和儲蓄帳戶。儲蓄帳戶中持有的現金產生的收入記作利息收入。公司儲蓄帳戶的賬面價值包含在現金中,近似於公允價值。
信用風險的集中度
可能使公司受到信用風險集中的金融工具主要包括現金和現金等價物。銀行存款由認可的金融機構持有,這些存款有時可能超過聯邦保險限額。該公司通過將現金和現金等價物存放在其認爲高質量的金融機構來限制與現金及現金等價物相關的信用風險。該公司的現金或現金等價物存款沒有遭受任何損失。
延期發行成本
在融資完成之前,公司將與正在進行的股權融資直接相關的某些法律、專業會計和其他第三方費用作爲延期發行成本進行資本化。股權融資完成後,這些成本記作發行所得收益的減少額。如果計劃中的股權融資被放棄,延期發行成本將立即記作簡報中的運營費用 合併運營報表。
財產和設備,淨額
財產和設備按成本減去累計折舊後列報。折舊是使用資產估計使用壽命的直線法計算的,即
7
租約
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.
研發費用
研發費用主要包括用於研發公司的產品候選藥物GEm-AKI,GEm-CKD,GEm-PSI和其他產品候選藥物的成本。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.
專利成本
與已批准專利和專利申請相關的法律費用按發生計入費用,因爲這些支出的收回性不確定。這些費用記錄在綜合財務和行政費用中 資產負債表的綜合經營結果中
2021年6月,公司採用了2021年員工、董事和顧問股權激勵計劃(「2021計劃」),並進行了修改,授權公司授予最多83,564股普通股。2022年,公司修改了2021計劃,並將計劃授權的股票總數增加至2,748,818股。2024年1月,公司採用了2024年員工、董事和顧問股權激勵計劃(「2024計劃」),授權公司授予最多3,900,000股普通股,加上2021計劃中剩餘的未授予或被放棄的股票。截至2024年3月31日,還有3,939,333股可供授予。公司的股票期權根據授予協議中的條款授予,通常按比例贈與。
公司承認與股票期權、第三方認股權證和受限制的員工股票單位(「 RSU」)授予有關的股票基礎補償費用,基於授予日股票基礎獎勵的估計公允價值。員工股票期權和第三方認股權的公允價值通常使用黑-斯科爾斯期權定價模型確定,使用各種輸入,包括歷史波動率、期限、無風險利率和未來股利估計。具有分級解鎖的股票基礎獎的授予日公允價值按每個股票基礎獎的必要服務期間的直線法識別,這通常是各自股票基礎獎的解鎖期。公司在出現棄權時予以確認。
所得稅
所得稅按照資產負債法覈算。根據這種方法,對由現有資產和負債的財務報表賬面金額與其相應稅基之間差異以及經營虧損和稅前抵免產生的未來稅後果予以確認。使用通過稅率計算的對臨時差異預計將實現的應稅所得進行衡量的遞延稅資產和負債。對稅率變更對遞延稅資產和負債的影響,在含有頒佈日期的期間中認可爲收入或損失。當必要時設立減少遞延稅資產至預計實現金額的準備金。與未確認稅收優惠相關的利息和罰款包括在所得稅提供中。迄今爲止,沒有可報告的稅前利益。
8
公正價值
公司的金融工具是根據活躍市場上的報價或基於其他可觀察到的輸入值進行估值的。貨幣市場基金被分類爲1級金融資產。存單、商業票據、市政債券、企業債務證券和美國政府機構證券屬於2級金融資產。2級資產的公正價值是基於使用當前可觀察安全的市場信息的定價模型進行估算的。公司的2級投資包括美國政府支持的證券和企業證券,這些證券是根據可觀察的輸入進行估值的,這些可觀察的輸入可能包括基準收益率、報告的交易、經紀/報價、發行人差價、兩側市場、基準證券、要約、報盤和參考數據,包括市場研究出版物。商業票據的公允價值是基於到期日和使用三個月國庫券利率進行折現。截至2024年6月30日,公司的2級投資的平均剩餘期限不足12個月,並且這些投資的評級爲S&P和Moody’s的AAA或AA-評級的證券和A1、A2、P1或P2評級的商業票據。
• 第1級—活躍市場上針對相同資產或負債的報價。
• 第2級—除第1級以外的可觀察輸入,可以是直接或間接可觀察到的,例如類似資產或負債的報價;在非活躍市場上的報價;或者是可觀察到的或者可以通過可觀察市場數據證實的其他輸入,在幾乎整個資產或負債期限內都是可觀察的。
• 第3級—不可觀察的輸入,幾乎沒有市場活動支持,並且對資產或負債的公允價值具有重要意義。
公司已經確定 Class C 普通股權證的公允價值衡量是一個第3級公允價值衡量,並使用蒙特卡洛模擬模型進行估值(參見注釋10)。
權證負債
公司審查債務工具、股權工具和其他融資安排的條款,以確定是否存在應拆分並單獨列報爲衍生金融工具的嵌入式衍生特徵,包括需要進行拆分的嵌入式轉換選擇權。此外,在發行融資工具的情況下,公司可能發行獨立的期權和認股權證。
公司根據ASC 480「區分負債和股本的準則」和ASC 815「衍生品和套期保值」處理其普通股認股權證。根據ASC 480和ASC 815的規定,如果認股權證不符合權益分類標準,公司將其視爲流動負債。初始將被視爲負債的普通股認股權證在授予日按公允價值記錄,並在每個資產負債表日重新計價,抵銷調整記錄在財務報表中的認股權證負債公允價值變動內。
公司使用蒙特卡洛模型對按流動負債分類的C類普通股認股權證進行估值。
每股基本及攤薄淨(虧損)收益
基本每股淨(虧損)收益是通過將淨收益(虧損)除以期間內流通的普通股加權平均股份數計算出來,不考慮潛在的普通股份。稀釋每股淨(虧損)收益是通過將淨收益(虧損)除以流通的普通股加權平均股份數加上潛在的普通股份數計算出來。按換股基礎計算的可轉換優先股,RSU獎勵,認股權證和期權均被視爲潛在的普通股份,並在計算稀釋每股淨(虧損)收益時使用庫藏股法,當其作用爲稀釋時。如果潛在的普通股份具有抗稀釋作用,將被排除在稀釋每股淨(虧損)收益的計算之外。截至2024年9月30日,共有
綜合(損失)收益
公司除了淨(損)收入之外,沒有綜合(損)收入的組成部分。因此,綜合(損)收益與淨(損)收入相同對於可能使公司集中面臨信貸風險的金融工具包括該帳戶,該帳戶是一個在某些時候可能會超過250,000美元的聯邦存款保險覆蓋的金融機構現金帳戶。截至2023年和2022年12月31日,公司未在該帳戶上經歷損失,管理層認爲公司沒有面臨任何顯著的風險。
9
《修訂和重新制定的2020年The Aaron's Company, Inc.股權和激勵計劃》,(參考到2024年5月16日提交給美國證券交易委員會的S-8表格附註4.3)。
經營部門被定義爲實體的組成部分,有關這些部分的單獨離散信息可供首席經營決策人或決策團隊評估,以便在評估績效並決定如何分配資源時做出決策。
公司在加利福尼亞州爲其辦公空間租賃了一個子租約,該租約於2023年11月開始,最初租約期至2026年1月。該租約替代了同一地址於2022年1月開始的租約,最初租約期至2024年1月(於2024年1月結束)。此外,該公司還租用其他租期少於十二個月的空間;因此,在資產負債表上不承認此租約爲營運租約。
最近的會計聲明
2023年11月,財務會計準則委員會(「FASB」)發佈了會計準則更新(「ASU」)2023-07, 報告部門披露的改進(「ASU 2023-07」)通過增強有關重要部門費用的披露,改進了關於報告部門披露要求,該指南對公司截至2024年12月31日的年度報告和2025財年的中期報告實行生效。允許提前採納。公司正在評估採納該指南對其合併財務報表的影響。 預計採納該指南不會對公司的財務報表產生實質影響。
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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$ |
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Other prepaid expenses & current assets |
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Total prepaid expenses & current assets |
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$ |
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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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( |
) |
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( |
) |
Total property and equipment, net |
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$ |
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$ |
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Depreciation expense was $
Accrued Expenses
Accrued expenses consisted of the following:
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September 30, |
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December 31, |
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Accrued payroll and related expenses |
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$ |
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$ |
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Accrued clinical study expenses |
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Accrued professional fees |
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Accrued clinical development costs |
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Total accrued expenses |
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$ |
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$ |
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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:
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September 30, |
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September 30, |
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Public Warrants (exercise price of $ |
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Class A Common Stock Warrants (exercise price of $ |
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Class A Placement Agent Common Stock Warrants (exercise price of $ |
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Class B Common Stock Warrants (exercise price of $ |
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Class B Placement Agent Common Stock Warrants (exercise price of $ |
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Class C Common Stock Warrants (exercise price of $ |
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Class D Common Stock Warrants (exercise price of $ |
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— |
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Class E Common Stock Warrants (exercise price of $ |
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— |
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Rollover Warrants (exercise price of $ |
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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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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:
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Shares |
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Weighted-average Exercise Price |
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Weighted-average Remaining Contractual Term (Years) |
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Outstanding at December 31, 2023 |
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$ |
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Granted |
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Exercised |
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— |
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— |
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Expired and forfeited |
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( |
) |
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Outstanding at September 30, 2024 |
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$ |
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Exercisable at September 30, 2024 |
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$ |
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For the nine months ended September 30, 2023, the weighted-average Black-Scholes value per stock option was $
Volatility |
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% |
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Expected term (years) |
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Risk-free interest rate |
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% |
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Expected dividend yield |
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% |
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:
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Three Months Ended |
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Nine Months Ended |
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2024 |
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2023 |
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2024 |
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2023 |
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General and administrative: |
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RSU awards |
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$ |
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$ |
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$ |
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$ |
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Stock Options |
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General and administrative stock-based compensation expense |
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Research and development: |
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RSU awards |
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Stock Options |
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Research and development stock-based compensation expense |
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Total stock-based compensation expense |
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$ |
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$ |
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$ |
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$ |
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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 |
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% |
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Expected term (years) |
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Risk-free interest rate |
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% |
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Expected dividend yield |
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% |
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 |
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% |
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Expected term (years) |
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Risk-free interest rate |
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% |
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Expected dividend yield |
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% |
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 |
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% |
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Expected term (years) |
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Risk-free interest rate |
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% |
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Expected dividend yield |
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% |
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 |
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% |
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Expected term (years) |
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Risk-free interest rate |
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% |
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Expected dividend yield |
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% |
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 |
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% |
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Expected term (years) |
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Risk-free interest rate |
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% |
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Expected dividend yield |
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% |
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 |
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% |
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Expected term (years) |
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Risk-free interest rate |
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% |
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Expected dividend yield |
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% |
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 |
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% |
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Expected term (years) |
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Risk-free interest rate |
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% |
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Expected dividend yield |
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% |
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
我們的一般和行政開支主要包括人員成本、外部專業服務費用,包括財務顧問、法律、人力資源、審計和會計服務以及諮詢費用。人員及相關成本包括董事、財務和其他行政職能人員的薪資、員工福利和基於股票的薪酬。我們預計我們的一般和行政開支將在可預見的未來增加,因爲我們需要擴大行政職能部門的規模,以支持業務增長和持續進行研發活動。我們還預計隨着我們繼續作爲一家上市公司運營,相關費用也將增加,包括與財務顧問服務、審計、法律、監管、投資者關係成本以及與維持交易所上市和SEC要求合規相關的董事和高管保險費用。
其他(費用)收益,淨額
其他(費用)收入主要包括認股權證債務公允價值變動、臨床試驗相關費用、外幣交易收益和損失、利息支出以及來自儲蓄帳戶中現金餘額的利息收入。
經營結果
下表總結了我們呈現的期間的經營結果:
|
|
三個月已結束 |
|
|
九個月已結束 |
|
||||||||||||||||||
|
|
2024 |
|
|
2023 |
|
|
改變 |
|
|
2024 |
|
|
2023 |
|
|
改變 |
|
||||||
運營費用: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
研究和開發 |
|
$ |
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 |
|
運營費用總額 |
|
|
1,796,686 |
|
|
|
2,777,897 |
|
|
|
(981,211 |
) |
|
|
6,221,221 |
|
|
|
6,330,774 |
|
|
|
(109,553 |
) |
運營損失 |
|
|
(1,796,686 |
) |
|
|
(2,777,897 |
) |
|
|
981,211 |
|
|
|
(6,221,221 |
) |
|
|
(6,330,774 |
) |
|
|
109,553 |
|
其他(支出)收入總額,淨額 |
|
|
(444,879 |
) |
|
|
149,521 |
|
|
|
(594,400 |
) |
|
|
(7,091,596 |
) |
|
|
8,413,423 |
|
|
|
(15,505,019 |
) |
淨(虧損)收益 |
|
$ |
(2,241,565 |
) |
|
$ |
(2,628,376 |
) |
|
$ |
386,811 |
|
|
$ |
(13,312,817 |
) |
|
$ |
2,082,649 |
|
|
$ |
(15,395,466 |
) |
24
研發費用
以下表格總結了我們所提供的研發費用期間。
|
|
三個月結束 |
|
|
九個月結束 |
|
||||||||||||||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
2024 |
|
|
2023 |
|
|
Change |
|
||||||
創業板-PSI和創業板-AKI臨床研究費用 |
|
$ |
246,801 |
|
|
$ |
66,721 |
|
|
$ |
180,080 |
|
|
$ |
1,511,435 |
|
|
$ |
66,721 |
|
|
$ |
1,444,714 |
|
製造業-半導體費用 |
|
|
263,225 |
|
|
|
183,253 |
|
|
|
79,972 |
|
|
|
299,393 |
|
|
|
693,759 |
|
|
|
(394,366 |
) |
其他項目支出 |
|
|
(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 |
) |
人員支出(包括股票補償) |
|
|
309,611 |
|
|
|
207,071 |
|
|
|
102,540 |
|
|
|
920,125 |
|
|
|
467,838 |
|
|
|
452,287 |
|
所有研發費用 |
|
$ |
830,981 |
|
|
$ |
1,651,367 |
|
|
$ |
(820,386 |
) |
|
$ |
2,943,492 |
|
|
$ |
3,085,918 |
|
|
$ |
(142,426 |
) |
研發費用從截至2023年9月30日的170萬美元減少了80萬美元,至截至2024年9月30日的80萬美元。 這一減少主要是由於其他項目費用減少了110萬美元,其中包括GEm-AKI和GEm-PSI相關的臨床研究費用增加了20萬美元,人員費用增加了10萬美元。其他項目費用包括主要用於GEm-AKI和GEm-PSI項目的臨床準備費用和臨床前成本。
研發費用從2023年9月30日結束的九個月的310萬美元下降了10萬美元,到2024年9月30日結束的九個月的290萬美元。此減少主要是由其他項目費用減少160萬美元和製造業費用減少40萬美元引起的,其中包括GEm-AKI和GEm-PSI臨床研究費用增加140萬美元以及人員費用增加50萬美元。其他項目費用包括主要用於GEm-AKI和GEm-PSI計劃的臨床研究前階段費用和臨床準備費用。
一般行政費用
以下表格總結了我們所列期間的一般和行政費用:
|
|
三個月結束 |
|
|
九個月結束 |
|
||||||||||||||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
2024 |
|
|
2023 |
|
|
Change |
|
||||||
人事費用(包括員工股份報酬) |
|
$ |
694,530 |
|
|
$ |
634,691 |
|
|
$ |
59,839 |
|
|
$ |
2,105,420 |
|
|
$ |
1,641,129 |
|
|
$ |
464,291 |
|
法律和專業費用(包括非員工股份報酬) |
|
|
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 |
|
總管理費用 |
|
$ |
965,705 |
|
|
$ |
1,126,530 |
|
|
$ |
(160,825 |
) |
|
$ |
3,277,729 |
|
|
$ |
3,244,856 |
|
|
$ |
32,873 |
|
2023年9月30日結束的三個月,管理和行政費用減少了20萬美元,從110萬美元減少到2024年9月30日結束的三個月的100萬美元。這一減少主要是由於法律和專業費用增加了20萬元。
截至2023年9月30日的九個月總務及行政支出增加不到10萬美元,從320萬美元增至2024年9月30日的九個月總務及行政支出330萬美元。增加主要是由於人員支出增加了50萬美元,而法律和專業費用減少了40萬美元。
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.
我們選擇使用這個延長的過渡期,以便我們遵守針對上市公司和非上市公司在不同有效日期的新或修訂會計準則,直至以下事件的較早發生日期:(i)我們不再是新興成長型公司;或(ii)我們積極且不可撤銷地選擇退出《作業機會法案》規定的延長過渡期。因此,我們的基本報表和我們的中期簡明基本報表可能與遵守新的或修訂的會計公告的公開公司的報表不可比。
29
事項3. 關於市場風險的定量和定性披露。
我們是根據交易所法規120億.2規定而被定義爲較小的報告公司,並且不需要根據該項要求提供其他信息。
事項4. 控制和程序。
披露控件和程序的評估
我們的管理層,在我們的首席執行官和我們的信安金融主管的參與下,截至本季度報告(表10-Q)涵蓋的期間結束時,評估了我們的披露控制和程序的有效性。根據對我們的披露控制和程序截至2024年9月30日的評估,我們的首席執行官和信安金融主管得出結論,認爲截至該日期的我們的披露控制和程序在合理保證水平上是有效的。術語「披露控制和程序」的定義見於1934年證券交易法(「交易所法」)13a-15(e)和15d-15(e)規則中,是指公司設計的用於確保公司在根據交易所法要求披露的信息被記錄、處理、總結和報告的控制和其他程序,其內容應在美國證券交易委員會規則和表格規定的時間期限內進行。披露控制和程序包括但不限於設計的控制和程序,以確保我們在根據交易所法要求披露的信息被積累並及時傳達給我們的管理層,包括我們的首席執行官和信安金融主管,以便及時作出有關要求披露的決策。管理層認識到,任何控制和程序,無論多麼設計和運營良好,都只能合理保證其目標的實現,我們的管理層必須在評估可能的控制和程序的成本效益關係時運用其判斷。
財務報告內部控制的變化
在我們最近的一個季度內,我們的內部財務報告控制沒有發生任何重大影響或可能重大影響我們的內部財務報告的變化。
第二部分-其他信息
第1項。法律訴訟。
2022年2月18日,LifeSci Capital LLC(「LifeSci」)在紐約南區聯邦地區法院對公司提起訴訟,要求支付約$530萬的未支付銀行和諮詢費用及利息。這些費用是根據在與Petra Acquisition(「Petra」)進行業務組合(「業務組合」)之前簽訂的合同產生的,公司聲稱LifeSci Capital LLC無權收取費用,因爲其違反了其責任,向Petra錯誤陳述了在業務組合後將可用的資金,如果沒有這些資金,Petra將不會簽訂業務組合協議。 此外,正如先前報道的,2023年12月1日,一名法官裁定支持LifeSci Capital LLC的摘要判決報告。於2024年8月1日,地方法院法官頒佈了一項採納法官的報告並支持摘要判決的命令,並頒佈了一項判決,含利息,總額爲$730萬。 判決書頒佈後,LifeSci提出了一項20萬美元的費用補償申請。判決書中的150萬美元是來自Petra首次公開發行的遞延承銷佣金,這筆款項先前記錄在財務報表中作爲流動負債,剩餘的580萬美元和20萬美元的費用補償已在截至2024年9月30日的簡明合併利潤表中計提。2024年8月12日,公司收到了一項解除令並全額支付了摘要判決,包括利息和律師費,總額爲750萬美元。一個滿意的判決書於2024年8月23日提交給法院。結果,對公司在判決書的事項或與判決書有關的事項不得采取進一步行動,並且公司已獲得免除任何和所有索賠,包括判決書。
2022年9月27日,A-IR臨床研究有限公司(「A-IR」)在英格蘭和威爾士的高等法院業務和財產法庭對公司提起訴訟,要求支付160萬英鎊的未付發票,以及利息和成本,涉及公司的病毒挑戰研究。公司對此提出異議,因爲許多發票涉及未執行的工作,A-IR曾虛報其執行合同工作的資質。2024年4月26日,雙方達成和解並與偏見撤銷訴訟程序。
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第1A項。風險因素。
我們的業務面臨各種風險,包括下文描述的風險以及我們於2023年12月31日結束的年度10-k表格的項目1A中描述的風險。
如果啓示錄不能遵守納斯達克適用的繼續上市要求或標準,納斯達克可能會將我們的普通股除牌。
公司的普通股和公開認股權證分別在納斯達克資本市場上以「REVB」和「REVBW」符號進行交易。
2024年10月16日,公司收到納斯達克工作人員發送的最低買盤價格退市函,通知公司未符合最低買盤價格要求。另外,公司還於2024年8月14日另行披露,收到納斯達克工作人員發送的股東權益要求缺失函,通知公司未符合股東權益要求,也未符合兩種備用上市標準之一,即上市證券的市場價值至少3500萬美元或最近完成的財政年度持續經營淨利潤至少500,000美元,或者在最近完成的三個財政年度中的兩個財政年度之一。基於公司在第三季度的融資活動,截至2024年9月30日,公司滿足了股東權益要求;但是,納斯達克可能要求公司展示其滿足股東權益要求的能力直至2025年12月31日。
公司打算採取一切合理措施,以恢復納斯達克上市規則並繼續在納斯達克上市。公司有權通過要求在獨立小組面前進行聽證會的方式對納斯達克函件提出上訴,該上訴已於2024年10月23日提交。聽證會請求暫停了任何停牌或除牌行動,直至聽證程序結束及小組在聽證後授予的任何額外延期期限到期。然而,並不能保證公司將獲得小組的延期,並最終符合所有持續上市的適用要求。如果納斯達克因未達到上市標準,如股東權益要求或最低買盤要求等,而將公司普通股或公開認股權證從其交易所除牌,我們和股東可能面臨重大負面後果,包括:
如果需要進行股票的逆向股票拆分以維持繼續在納斯達克上市的最低買盤要求,公司打算進行這樣的逆向股票拆分。即使進行了逆向股票拆分,也不能保證公司普通股的市場價格將維持最低買盤要求。我們的普通股市場價格將繼續部分基於我們的業績和其他與已發行股票數量無關的因素。
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第2項。未註冊的股權銷售和資金使用。
第3項。 對高級證券的拖欠。
不適用。
項目4. 礦業安全披露。
不適用。
第5項。其他信息。
項目6. 陳列品,財務報表附表。
提供Regulation S-k (§ 229.601 of this chapter)規定的展品。
展覽 |
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描述 |
31.1* |
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根據根據2002年《薩班斯-奧克斯利法案》第302條通過的《證券交易法》第13a_14 (a) 條和15 (d) -14 (a) 條對首席執行官進行認證 |
31.2* |
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根據根據2002年《薩班斯-奧克斯利法案》第302條通過的《證券交易法》第13a_14 (a) 條和15 (d) -14 (a) 條對首席財務官進行認證 |
32.1* |
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32.2* |
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101.INS* |
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XBRL 實例文檔 — 該實例文檔不出現在交互式數據文件中,因爲其 XBRL 標籤嵌入在內聯 XBRL 文檔中。 |
101.SCH* |
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內聯 XBRL 分類擴展架構文檔 |
101.CAL* |
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內聯 XBRL 分類擴展計算鏈接庫文檔 |
101.DEF* |
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內聯 XBRL 分類法擴展定義鏈接庫文檔 |
101.LAB* |
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內聯 XBRL 分類法擴展標籤 Linkbase 文檔 |
101.PRE* |
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內聯 XBRL 分類擴展演示鏈接庫文檔 |
104* |
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封面交互式數據文件(格式爲 Inline XBRL,包含在附錄 101 中) |
* |
隨此提交。 |
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簽名
根據1934年證券交易法第13或15(d)條的要求,發行人已經授意以下籤署的人員,據此授權,由其代表簽署了這份十分之一的季度報告表格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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首席執行官 |
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(首席執行官) |
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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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首席財務官 |
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姓名:Chee Hui Law(財務和會計主管) |
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