美國
證券交易委員會
華盛頓特區20549
表格
截至季度結束
或
從 至過渡期間
委員會檔案編號:
(依憑章程所載的完整登記名稱)
(依據所在地或其他管轄區) 的註冊地或組織地點) |
(國稅局雇主 識別號碼) |
(總部辦公地址) |
(郵遞區號) |
註冊人的電話號碼,包括區號:(
根據《1934年證券交易法》第12(b)條,註冊的證券:
每種類別的名稱 |
交易標的(s) |
每個註冊交易所的名稱 |
請在核對標記上打勾,確認申報人(1)已在前12個月(或申報人被要求提交此類申報的縮短期間)內提交證券交易所法案第13條或第15(d)條要求申報的所有報告,以及(2)過去90天一直處於此類申報要求的範圍內。
請打勾號表明註冊人是否根據《S-t條例405條規定(本章節232.405號)的規定,在過去12個月內(或註冊人需要提交此類文件的更短期限內),已提交每個交互數據文件。
請勾選指示登記者是否為大型快速提交人、快速提交人、非快速提交人、較小的報告公司或新興成長型公司。請參閱交易所法規120億2條,了解「大型快速提交人」、「快速提交人」、「較小的報告公司」和「新興成長型公司」的定義。
大型加速歸檔人 |
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加速歸檔人 |
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☒ |
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小型報告公司 |
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新興成長型企業 |
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如果一家新興成長型公司,請用勾選標記表示該申報人已選擇不使用根據證交所法案13(a)條款提供的任何新的或修訂過的財務會計準則的延長過渡期。 ☐
請勾選是否屬於外殼公司(根據交易所法案第120億2條的定義)。是
截至二零二四年十一月十二日,註冊人有
vaccinex inc.
表格10-Q
目錄
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頁面 |
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項目1. |
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3 |
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3 |
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4 |
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5 |
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6 |
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7 |
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項目 2。 |
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25 |
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項目 3。 |
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37 |
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項目 4。 |
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项目1A。 |
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第6項。 |
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41 |
2
第一部分——財務所有信息
項目1。 基本報表
Vaccinex,醫療公司。
簡明 資產負債表(未經審計)
(以千計,除分享和每分享數據外)
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截至 |
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截至 |
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資產 |
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流動資產: |
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現金及現金等價物 |
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$ |
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$ |
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應收賬款 |
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預付費用及其他流動資產 |
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衍生工具資產 |
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- |
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總流動資產 |
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物業和設備,淨值 |
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經營租賃資產使用權 |
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資產總計 |
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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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遞延收入 |
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長期債務的流動部分 |
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經營租賃負債 |
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認股權責任 |
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總流動負債 |
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長期債務 |
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- |
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負債合計 |
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股東權益(赤字): |
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可轉換優先股(A系列),面值爲$ |
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-每股--股份數已於2023年7月31日和2024年4月30日授權; |
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追加實收資本 |
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即期收購庫藏股;截至2022年9月25日,共計157,773股,截至2022年6月26日,共計157,087股。 |
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累積赤字 |
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( |
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股東權益總額/(赤字) |
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( |
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( |
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負債和股東權益總計 |
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$ |
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$ |
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附註是這份基本報表的一個組成部分。
3
VACCINEX, INC.
股東權益(遞減)簡版(未經審計)損益及綜合損失表(未經審計)
(以千計,股票和每股數據除外)
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截至9月30日的三個月 |
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截至9月30日的九個月 |
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2024 |
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2023 |
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2024 |
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2023 |
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收入 |
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$ |
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$ |
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$ |
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$ |
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成本和費用: |
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研發 |
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一般和行政 |
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總成本和費用 |
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營業損失 |
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利息支出 |
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- |
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- |
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- |
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( |
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warrants的結算損失 |
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( |
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- |
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- |
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融資成本 - warrant負債 |
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- |
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- |
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- |
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權證負債公允價值變動 |
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- |
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- |
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公允價值變動損益(衍生工具) |
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- |
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- |
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其他收入(費用),淨額 |
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稅前虧損 |
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所得稅準備金 |
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歸屬於Vaccinex, Inc.普通股股東的淨虧損 |
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$ |
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$ |
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$ |
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全面損失 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
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歸屬於Vaccinex, Inc.普通股的每股淨虧損 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
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計算每股淨虧損時使用的加權平均股份 |
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附註是這份基本報表的一個組成部分。
4
Vaccinex,醫療公司。
基本報表 股東權益(赤字)(未經審計)
(以千爲單位,除股票數據外)
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優先股 |
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普通股 |
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庫藏股 |
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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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額外的 |
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普通 |
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金額 |
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累計 |
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總計 |
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2023年1月1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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普通股發行 |
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- |
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- |
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- |
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- |
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- |
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- |
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基於股票的補償 |
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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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淨虧損 |
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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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( |
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截至2023年3月31日的餘額 |
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發行普通股 |
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- |
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基於股票的補償 |
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- |
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- |
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- |
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淨虧損 |
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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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( |
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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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發行普通股 |
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- |
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基於股票的補償 |
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- |
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淨虧損 |
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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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優先股 |
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普通股 |
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庫藏股 |
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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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額外的 |
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普通 |
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金額 |
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累計 |
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總計 |
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截至2024年1月1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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普通股發行 |
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- |
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- |
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- |
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- |
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基於股票的補償 |
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- |
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- |
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- |
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在定向增發中發行普通股票和預先融資權證 |
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在定向增發中發行權證 |
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權證發行 |
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優先股發行 |
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- |
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- |
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- |
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公共warrants的再分類,經修訂 |
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定向增發warrants的再分類,經修訂 |
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淨虧損 |
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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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( |
) |
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( |
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截至2024年3月31日的餘額 |
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( |
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基於股票的補償 |
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- |
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- |
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- |
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- |
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優先股折扣的攤銷 |
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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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- |
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發行限制股 |
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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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- |
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- |
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|
淨虧損 |
|
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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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( |
) |
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( |
) |
截至2024年6月30日的餘額 |
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( |
) |
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( |
) |
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( |
) |
||||||
基於股票的補償 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
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|
- |
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- |
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||
優先股折扣的攤銷 |
|
|
- |
|
|
|
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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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- |
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執行期權 |
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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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|||
權證發行 |
|
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- |
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- |
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- |
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- |
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|
|
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- |
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- |
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- |
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淨虧損 |
|
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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2024年9月30日的餘額 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
附註是這份基本報表的一個組成部分。
5
Vaccinex,醫療公司。
股東權益(遞減)簡版(未經審計)現金流量表(未經審計)
(以千爲單位)
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截至9月30日的九個月 |
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|||||
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2024 |
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2023 |
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經營活動產生的現金流量: |
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淨虧損 |
|
$ |
( |
) |
|
$ |
( |
) |
調整爲淨損失到經營活動現金流量淨使用: |
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折舊費 |
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基於股票的補償 |
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權證責任公允價值變動 |
|
|
( |
) |
|
|
- |
|
公允價值變動損益(衍生工具) |
|
|
|
|
|
- |
|
|
warrants的結算損失 |
|
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- |
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|
運營資產和負債的變化: |
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||
應收賬款 |
|
|
( |
) |
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|
( |
) |
預付費用及其他流動資產 |
|
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應付賬款 |
|
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應計費用 |
|
|
( |
) |
|
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遞延收入 |
|
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( |
) |
|
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- |
|
用於經營活動的淨現金 |
|
|
( |
) |
|
|
( |
) |
投資活動產生的現金流量: |
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|
||
購置固定資產等資產支出 |
|
|
( |
) |
|
|
( |
) |
投資活動中使用的淨現金 |
|
|
( |
) |
|
|
( |
) |
籌資活動產生的現金流量: |
|
|
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|
||
普通股發行所得,及 |
|
|
|
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- |
|
|
行使認股權收到的款項 |
|
|
|
|
|
- |
|
|
在定向增發中發行的warrants所得 |
|
|
|
|
|
- |
|
|
普通股定向增發的收益 |
|
|
- |
|
|
|
|
|
開多期債務償還 |
|
|
( |
) |
|
|
( |
) |
優先股及相關warrants的發行收益 |
|
|
|
|
|
- |
|
|
普通股的發行收益,以及 |
|
|
|
|
|
- |
|
|
普通股發行收入 |
|
|
- |
|
|
|
|
|
融資活動提供的淨現金 |
|
|
|
|
|
|
||
現金及現金等價物的淨增加/(減少) |
|
|
|
|
|
( |
) |
|
現金及現金等價物–期初 |
|
|
|
|
|
|
||
現金及現金等價物–期末 |
|
$ |
|
|
$ |
|
||
非現金投資和 |
|
|
|
|
|
|
||
warrant 激勵(產生但未支付的交易費用) |
|
$ |
|
|
|
|
附註是這份基本報表的一個組成部分。
6
Vaccinex,醫療公司。
財務報表說明d經審核的基本報表(未經審計)
附註1. 公司及業務性質
Vaccinex,Inc.(以下簡稱「公司」)成立於2001年4月,總部位於紐約羅切斯特。公司是一家處於臨床階段的生物技術公司,致力於發現和開發用於治療嚴重疾病和未滿足醫療需求的靶向生物治療藥物,包括神經退行性疾病、癌症和自身免疫疾病。自成立以來,公司幾乎所有的努力都投入到產品研究、製造和臨床開發以及籌集資本方面。
公司面臨一系列與其他早期生物技術公司普遍存在的風險和不確定性,包括但不限於對產品候選者的成功開發和商業化的依賴性、快速技術變革和競爭、對關鍵人員和合作夥伴的依賴、專利技術和專利保護的不確定性、臨床試驗的不確定性、營運業績和財務表現的波動性、獲取額外資金的需求、符合政府監管、技術和醫療風險、公司成長管理和營銷效果的有效性。如果公司無法成功將任何產品候選者商業化或達成合作,將無法產生產品收入或實現盈利能力。
持續經營
這些簡明財務報表是根據適用於持續經營的公認會計原則編制的,預計在正常業務過程中實現資產和滿足負債。
公司自成立以來一直遭受巨額虧損和經營活動現金流出,並預計將在能夠通過產品候選者的商業化產生重大收入之前繼續出現虧損。公司報告截至2024年9月30日的九個月中經營活動中使用的現金爲$
作爲對這些情況的回應,管理層目前正在評估不同的策略,以獲得未來運營所需的資金。融資策略可能包括但不限於公開或私人出售股權、債務融資或來自其他資本來源的資金,例如政府資金、合作、戰略聯盟、出售非核心資產或與第三方達成許可協議。無法保證公司將能夠獲得額外融資,或者如有融資,是否足以滿足其需求或具有優惠條款。由於管理層的計劃尚未最終確定且不在公司的控制範圍內,因此無法認爲這些計劃的實施是可能的。因此,公司得出結論,管理層的計劃無法消除對公司繼續作爲持續經營單位的重大懷疑。
簡明財務報表未包括與資產金額的收回能力和分類,或者可能由於這種不確定性的結果而導致的負債金額和分類相關的任何調整。
7
注意事項 2.重要會計政策摘要
列報和合並的基礎
隨附的未經審計的簡明財務報表反映了公司的賬目和業務,是根據美利堅合衆國普遍接受的中期財務信息會計原則(「GAAP」)編制的(「會計準則編纂」(「ASC」)270, 臨時報告)以及10-Q表格和第S-X條例第8條的說明。因此,這些財務報表不包括按照公認會計原則全面列報財務狀況、經營業績和現金流所需的所有信息。管理層認爲,簡明財務報表反映了爲公允列報公司在所報告期間的業績而認爲必要的所有調整(包括正常的經常性調整)。
這些簡明財務報表應與公司於2024年4月25日向美國證券交易委員會提交的截至2023年12月31日止年度的10-K/A表年度報告中包含的公司經審計的財務報表和相關附註一起閱讀。
普通股反向拆分
2023 年 9 月 25 日,
估算值的使用
這些簡明財務報表是根據美國公認會計原則編制的。根據美國公認會計原則編制財務報表要求管理層做出估算和假設,以影響截至簡明財務報表之日報告的資產負債金額、或有資產負債的披露以及報告期內報告的支出金額。此類管理估計包括與股票期權獎勵估值、認股權證負債估值、衍生資產估值以及遞延所得稅資產估值補貼中使用的假設有關的估計。實際結果可能與這些估計有所不同。
可轉換優先股
2024年3月,公司發行了新指定的可轉換優先股系列的股票(見附註9)。可轉換優先股包含嵌入式贖回功能,除了可轉換優先股的主持工具外,還需要進行分叉和單獨覈算。根據ASC主題815,公司將嵌入式贖回功能的公允價值作爲衍生資產記錄在公司的資產負債表上, 衍生品和套期保值。有關衍生資產公允價值衡量中使用的關鍵輸入,請參閱附註4。
金融工具的公允價值
金融工具包括現金、應收賬款、衍生資產、應付賬款、應計負債、長期債務、權證負債和可轉換優先股。現金、應收賬款、應付賬款、應計負債、債務和可轉換優先股均按其賬面價值列報,賬面價值近似於公允價值,因爲此類金額的預計收到或付款日期很短。認股權證負債和衍生資產按公允價值定期計量,假設見附註4。
8
信用風險、其他風險和不確定性集中
公司面臨多種風險,包括但不限於資本不足;可能會從納斯達克退市;臨床前測試或臨床試驗可能失敗;無法獲得產品候選人的監管批准;競爭對手開發新技術創新;製造和商業供應操作的潛在中斷;專有藥物候選人的商業化策略和啓動計劃不成功;訴訟中固有的風險,包括所謂的集體訴訟;市場對公司產品的接受度;以及對專有技術的保護。
可能使公司面臨信用風險集中情況的金融工具主要包括現金及現金等價物。現金等價物存放在有息貨幣市場帳戶中。儘管公司將現金存放在多個金融機構中,現金餘額有時可能超過聯邦存款保險公司所保險金額。管理層認爲,與這些餘額相關的金融風險是最低的,迄今爲止沒有經歷任何損失。
公司歷史上通過與投資者的交易來籌集資金,投資者中包括董事會成員和由某些董事會成員控制的實體。因此,公司的董事直接或間接地控制着公司的顯著持股比例。公司無法保證未來融資會以充足的金額或可接受的條款可用,或其董事或由某些董事會成員控制的實體會願意或能夠參與公司未來的資本籌集。
公司依靠第三方製造商製造藥物成分和用於臨床試驗的藥物產品。公司還依賴於某些第三方供應鏈。與這些第三方製造商的爭議或來自第三方供應商的商品或服務短缺可能會延遲公司產品候選人的製造,並對其運營結果產生不利影響。
最近發佈的會計聲明
2023年12月,FASB發佈了ASU 2023-09,所得稅 (話題740) 改進所得稅披露。 ASU 2023-09要求在稅率調節表中披露有關聯邦、州和外國所得稅的額外信息類別,並且如果項目滿足量化閾值,還需要提供某些類別的調節項目的更多細節。該ASU要求實體在年度期間披露支付的所得稅,扣除退款後,按聯邦(國家)、州和外國稅種進行分列,並根據量化閾值對信息按管轄區進行分列。該指導原則對披露要求進行了其他幾項更改。ASU要求前瞻性地應用,並可選擇追溯適用。該ASU適用於2024年12月15日後開始的財政年度。公司目前正在評估採納該指導原則對其基本報表和披露的影響。
2023年11月,FASB發佈了ASU 2023-07,分部報告 (主題280): 對可報告 сегмент 披露的改進。 ASU 2023-07改善了可報告業務部門的披露要求,主要是通過增強對重要業務部門費用的披露。此外,ASU增強了中期披露要求,澄清了實體可以披露多項利潤或虧損的業務部門指標的情況,幷包含其他披露要求。ASU並未改變實體如何識別其經營部門、聚合這些經營部門,或應用定量閾值以確定其可報告部門。ASU要求對財務報表中呈現的所有期間進行追溯應用。ASU自2023年12月15日之後開始的財政年度生效,並適用於2024年12月15日之後開始的財政年度中的中期期間。公司目前正在評估採納該指南對其基本報表和披露的影響。
9
注意 3. 資產負債表元件
資產和設備
固定資產和設備包括以下項目(以千爲單位):
|
|
截至 |
|
|
截至 |
|
||
租賃改良 |
|
$ |
|
|
$ |
|
||
研究設備 |
|
|
|
|
|
|
||
傢俱和固定裝置 |
|
|
|
|
|
|
||
計算機設備 |
|
|
|
|
|
|
||
234,036 |
|
|
|
|
|
|
||
減:累計折舊與攤銷 |
|
|
( |
) |
|
|
( |
) |
物業和設備,淨值 |
|
$ |
|
|
$ |
|
與固定資產和設備相關的折舊費用爲$,分別爲2023年12月31日和2022年底的三個月,其中$列入商品成本,$列入一般和行政費用。有關固定資產和設備的折舊費用爲$,分別爲2023年6月30日和2022年底的六個月,其中$列入一般和行政費用。
應計費用
應計費用包括以下內容(以千爲單位):
|
|
截至 |
|
|
截至 |
|
||
|
|
|
|
|
|
|
||
已計提的臨床試驗成本 |
|
$ |
|
|
$ |
|
||
應計的工資和相關福利 |
|
|
|
|
|
|
||
已計提的諮詢和法律費用 |
|
|
|
|
|
|
||
應計其他 |
|
|
|
|
|
|
||
應計費用 |
|
$ |
|
|
$ |
|
第4條 金融資產的公允價值衡量
以非重複計量方式計量的資產和負債
在簡明的資產負債表中以非經常性方式記錄的資產和負債根據用於衡量其公允價值的輸入所涉及的判斷水平進行分類。金融工具包括現金、應收賬款、應付賬款、應計負債和長期債務。現金、應收賬款、應付賬款、應計負債和債務均按其賬面價值計量,由於這些金額的預計收款或支付日期較短,其賬面價值近似於公允價值。
以公允價值計量的資產和負債的重複計量
公允價值衡量標準還適用於定期(每個報告期)以公允價值衡量的某些金融資產和金融負債。對於公司而言,這些金融資產和金融負債包括存放在貨幣市場基金中的現金等價物、認股權證負債和衍生資產。公司沒有任何以定期以公允價值衡量的非金融資產或負債。
資產或負債在公允價值層次結構內的公允價值衡量水平是基於任何對公允價值衡量有重要作用的輸入的最低水平。
10
以下表格詳細列出了公司按照公允價值層次(以千爲單位)劃分的金融資產和負債的公允價值。
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截至2024年9月30日 |
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公允價值 |
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一級 |
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二級 |
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三級 |
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財務資產: |
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貨幣型基金 |
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$ |
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$ |
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$ |
- |
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$ |
- |
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||
衍生工具資產 |
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- |
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- |
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所有資產合計 |
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$ |
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$ |
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$ |
- |
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$ |
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|
截至2023年12月31日 |
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公允價值 |
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一級 |
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二級 |
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三級 |
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財務資產: |
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||||
貨幣型基金 |
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$ |
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$ |
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$ |
- |
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$ |
- |
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||
所有資產合計 |
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$ |
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$ |
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$ |
- |
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$ |
- |
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|
截至2024年9月30日 |
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公允價值 |
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一級 |
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二級 |
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三級 |
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財務負債: |
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||||
認股權負債-公開認股權 |
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$ |
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$ |
- |
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$ |
- |
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$ |
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||
認股權負債-定向增發認股權 |
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- |
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- |
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||
全部金融負債 |
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$ |
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|
$ |
- |
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|
$ |
- |
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|
$ |
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|
截至2023年12月31日 |
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公允價值 |
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一級 |
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二級 |
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三級 |
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||||
財務負債: |
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||||
Warrant liabilities - public warrants |
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$ |
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$ |
- |
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$ |
- |
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$ |
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||
Warrant liabilities - private placement warrants |
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|
|
|
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- |
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|
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- |
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|
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||
全部金融負債 |
|
$ |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
|
公司在2024年3月31日和2023年3月31日結束的三個月內都沒有記錄任何所得稅支出。公司已爲所有報表期的淨運營虧損記錄了完整的減值準備,並未在隨附的簡明財務報表中反映任何此類淨運營虧損的盈餘。
權證負債的公允價值衡量
公司使用Black-Scholes定價模型,採用三級輸入來確定其權證負債的公允價值。用於確定權證負債估計公允價值的輸入包括評估日的基礎股票公允價值、權證期限以及基礎股票的預期波動率。在權證負債的公允價值衡量中使用的重要不可觀察輸入是權證的估計期限。
2024年9月30日,用於估計權證負債公允價值的各自估值模型的關鍵輸入如下:
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公開warrants |
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私募認股權證 |
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低 |
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高 |
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低 |
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高 |
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無風險利率 |
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% |
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% |
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% |
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% |
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波動率 |
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% |
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% |
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% |
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% |
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股息收益率 |
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% |
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% |
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% |
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% |
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預期期限(年) |
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股價 |
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$ |
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|
$ |
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$ |
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|
$ |
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用於估算2023年12月31日認股權證負債公允價值的各自估值模型的關鍵輸入如下:
11
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公開warrants |
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私募認股權證 |
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低 |
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高 |
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低 |
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高 |
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||||
無風險利率 |
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% |
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% |
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% |
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% |
||||
波動率 |
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% |
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% |
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% |
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% |
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股息收益率 |
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% |
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% |
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% |
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% |
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預期期限(年) |
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股價 |
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$ |
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$ |
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$ |
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$ |
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下表總結了公司認可的權證負債的公允價值變動,這些變動反映在截至2024年9月30日的經營活動和全面損益各報表中(以千爲單位):
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公開warrants |
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私募認股權證 |
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總計 |
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2024年1月1日的權證負債 |
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$ |
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$ |
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$ |
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|||
權證發行 |
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- |
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||
重新分類爲股本 |
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( |
) |
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( |
) |
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( |
) |
取消認股權證 |
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
執行期權 |
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|
( |
) |
|
|
( |
) |
|
|
( |
) |
公允價值變動 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
2024年9月30日認股權證負債 |
|
$ |
|
|
$ |
|
|
$ |
|
截至2023年7月31日,續借貸款協議下未償還的借款額爲
衍生資產的公允價值測量
衍生資產的公允價值是通過使用二叉樹格倫模型(BLM)來確定的。應用BLM方法需要使用多個輸入和一些重要的不可觀察到的假設,包括波動率。在確定公司衍生資產的預期波動率時需要做出重要判斷。
以下表格提供了用於估計「Level 3資產」公允價值的測量輸入的定量信息:
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2024年9月30日 |
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無風險利率 |
|
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% |
|
預期波動率 |
|
|
% |
|
預期期限(以年爲單位) |
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|
|
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每股行使價格 |
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$ |
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股份數量 |
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|
|
以下表格顯示了截至九個月結束時衍生資產的變化 2024年9月30日(以千爲單位):
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|
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2024年1月1日的衍生資產 |
|
$ |
- |
|
可轉換優先股的發行 |
|
|
|
|
公允價值變動 |
|
|
( |
) |
2024年9月30日的衍生資產 |
|
$ |
|
12
備註 5. 合作協議
surface oncology, Inc.
在2017年11月,公司與surface oncology, Inc.(「surface」)簽訂了一項研究合作和許可期權協議,以識別和選擇針對
根據研究合作和許可期權協議,surface支付了一筆前期科技接入費用爲$
註釋6. 承諾和或有事項
納斯達克違規通知書
2024年4月11日,公司收到納斯達克上市資格工作人員的通知函,告知公司根據其2023年12月31日截止年度的10-K表格中的基本報表, 不再符合納斯達克上市規則5550(b)(1)的要求,需保持至少$
在2024年6月5日,納斯達克通知公司,給予其延期,要求在2024年9月30日或之前恢復並證明符合股本標準。截至2024年9月30日,我們的股東權益爲負數 $
13
時。 然而,並不能保證聽證會將批准公司提出的繼續上市請求,或者公司能夠在聽證會可能授予的任何額外合規期內展示符合於權益標準或其他替代標準。
取消認股權證
某些我們要求取消的認股權證持有人通知公司,他們認爲自己持有的認股權證仍然有效。這些被取消的認股權證代表的股份數量約佔公司2024年9月30日未發行基礎上的總流通股的
其他預期情況
公司業務正常運營中可能需要面對索賠和評估。當公司相信已經可能發生一項負債,並且金額可以合理估計時,公司會記錄負債準備金。確定概率和估計金額都需要做出重大判斷。
在業務正常運行中,公司可能捲入法律訴訟。當公司認爲可能已經發生一項負債並且金額可以合理估計時,將爲此類事項計提負債準備金。當只能確定一定範圍內的可能損失時,會計提取最有可能的範圍內的金額。如果該範圍內沒有任何一個金額比該範圍內的其他任何一個金額更好的估計,則選擇該範圍內的最低金額進行計提。對訴訟損失或風險的計提可能包括例如潛在損害賠償金、外部法律費用和預計會發生的其他直接相關成本的估計。截至2024年9月30日和2023年12月31日,公司未涉及任何重大法律訴訟。
注7. 租賃
公司向1895管理有限公司租賃其設施,該公司由與公司董事關聯的實體控制,租賃爲不可取消的經營租賃。租賃協議要求每月租金支付$
公司根據ASC 842覈算其租賃 租賃 具有12個月或更短初始期限的租賃不會在簡式資產負債表上記錄。公司在租賃開始時確定安排是否爲租賃。使用權資產代表公司在租賃期間使用基礎資產的權利,而租賃負債代表公司因租賃產生的租金支付義務。經營租賃的使用權資產和租賃負債是基於租賃期限內租金支付的現值確認的。
截至2024年9月30日,未來最低經營租賃付款總額爲$
截至2024年和2023年9月30日的三個月和九個月期間,因經營租賃而產生的租賃費用爲$
14
Note 8. 長期債務
2020年5月8日,公司根據小型企業管理局的薪資保護計劃("PPP貸款")獲得了一筆貸款,金額爲$
附註 9. 可轉換優先股
2024年3月28日,公司與阿爾茨海默氏病藥物研發基金會簽署了一份證券購買協議,根據該協議,公司出售了一系列新指定的可轉換優先股,即A系列優先股,以及購買最多的warrants
此外,系列A優先股的清算優先權等於以下兩者中的較大者:(i) $
公司也同意,只要系列A優先股未贖回,公司在未經持有者書面同意的情況下將不進行,
公司有權在披露相對於安慰劑組患者的pepinemab治療患者增加的公共公告後的任何時間,以原始股價每股的價格贖回系列A優先股,該公告的統計顯著性具有不大於或等於的p值。
15
A系列優先股具有 「利率上升證券」 的特徵,如美國證券交易委員會工作人員會計公告主題5Q 「增息優先股」 所述。因此,A系列優先股的折扣被視爲未申報的股息成本,使用實際利息法在永久股息開始之前的一段時間內攤銷,方法是從留存收益中扣除估算的股息成本,或者在沒有留存收益的情況下額外支付資本,將A系列優先股的賬面金額增加相應金額,以在預期贖回日將初始確認價值增加到預期結算價值。每個時期的攤銷額是指與該期間規定的股息相比使A系列優先股賬面金額的有效成本率保持不變的金額。
A系列優先股的每股都包含贖回功能,允許在發生自願或非自願清算、解散、公司清盤或認定清算事件(「清算事件」)中定義的情況下贖回A系列優先股。此類合格清算事件發生後,A系列優先股持有人有權獲得公司的現金或資產,然後才能向普通股持有人進行或分派任何款項,A系列優先股的每股金額等於或大於(i)美元
嵌入式贖回功能要求公司在發生某些符合條件的清算事件時以清算優先金額結算A系列優先股。當過去三個交易日的普通股成交量加權平均價格大於美元時,持有人行使嵌入式轉換功能
根據ASC 815,符合衍生品會計定義的某些合同條款必須與嵌入衍生品的金融工具分開計算(注2)。公司得出的結論是,當過去三個交易日的普通股成交量加權平均價格大於美元時,贖回功能和持有人可以選擇進行轉換
如果發生任何清算或被視爲清算事件(如指定證書所定義),在向普通股持有人進行任何分配或付款或爲其分期付款之前,A系列優先股持有人有權從公司獲得等於美元的資產
首次發行時,公司記錄了嵌入式衍生品的公允價值,金額爲美元
因此,根據發行之日工具的相對公允價值,公司分配了大約 $
Note 10。認股權證
公開warrants
在
16
到 最多購買
如果進行基本面交易,則公開認股權證要求公司根據Black-Scholes定價模型估值進行付款,使用特定輸入,根據ASC 815,這些工具不被視爲與公司自有股票掛鉤。公開認股權證還包含某些條款,這些條款規定根據特定事件的發生或不發生進行調整,該事件與標準估值模型中的隱含假設不一致,標準估值模型也排除了根據ASC 815將這些工具視爲與公司股票掛鉤的情況。因此, 發行時, 公司將公開認股權證列爲負債, 在發行日的公允價值約爲 $
2024年3月,公司與大約持有人簽訂了認股權證修訂協議
私募認股權證
2023年11月,根據與某些投資者簽訂的證券購買協議,公司發行並出售了私募認股權證進行購買
17
開啓
2024年3月,公司與認股權證的持有人簽訂了認股權證修訂協議
2024年3月27日,公司簽訂了證券購買協議,根據該協議,公司發行和出售
公司對2024年3月的私募認股權證進行了評估,得出的結論是,這些認股權證符合在額外實收資本範圍內歸類爲股東權益的標準。這些私募認股權證之所以被歸類爲股權,是因爲它們(1)是獨立的金融工具,可以合法地與普通股分開行使,(2)可以立即行使,(3)不體現公司回購股票的義務,(4)允許持有人在行使時獲得固定數量的普通股,(5)與公司普通股掛鉤以及(6)滿足股票分類標準。
18
因此,公司分配了大約$
公共warrants和定向增發warrants的看漲
在2024年8月,公司根據warrants的條款呼籲取消公共warrants和定向增發warrants,允許公司在宣佈在公司的SIGNAL-AD試驗中獲得阿爾茨海默病治療的pepinemab時,FDG-PEt信號在患者中顯著增加後呼叫warrants進行取消。之後,所有未根據誘導函協議行使的公共warrants和定向增發warrants於2024年9月被取消。至2024年9月30日,
誘導交易
在2024年9月17日,公司與現有warrants的持有者(「持有者」)簽訂了誘導函協議(「誘導函協議」),以購買總計高達
現有warrants的行使導致公司發行了
公司通過行使現有warrants和銷售新warrants所獲得的總收入約爲$
ADDF warrants
與阿爾茨海默病藥物發現基金的證券購買協議相關,公司出售了ADDF warrants,最多可購買
公司評估了ADDF權證,並得出結論認爲它們符合分類爲股東權益的標準,屬於額外的實收資本。ADDF權證被分類爲股權,因爲它們(1) 是獨立的金融工具,法律上可以與普通股分開行使並單獨行使,(2)
19
可立即行使,(3)不構成公司回購股票的義務,(4)允許持有人在行使時獲得固定數量的普通股,(5)與公司普通股掛鉤,(6)符合股票分類標準。
截至2024年9月30日,所有ADDF認股權證均未執行。
預先融資認股權證
在2024年9月的激勵交易中行使現有認股權證方面,公司預先提供了資金
與2024年2月的SPA有關,公司出售了可行使的預先注資的認股權證
公司對預先注資的認股權證進行了評估,得出的結論是,這些認股權證符合在額外實收資本範圍內歸類爲股東權益的標準。預先注資的認股權證之所以歸類爲股權,是因爲它們(1)是獨立的金融工具,可以合法地與普通股分開行使,(2)可以立即行使,(3)不體現公司回購股票的義務,(4)允許持有人在行使時獲得固定數量的普通股,(5)與公司普通股掛鉤以及(6)滿足股票分類標準。
因此,公司分配了大約 $
截至2024年9月30日,與2024年9月激勵交易相關的所有2024年2月SPA預先注資認股權證和預先籌資的股票均已流通。
注11. 爲發行而保留的普通股
普通股已爲以下潛在未來發行而保留:
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註釋12. 股票基礎薪酬
2011員工股權計劃
隨着公司在2018年8月通過的2018年綜合激勵計劃的採用,公司停止在2011年員工股權計劃(「2011計劃」)下授予期權。然而,2011計劃將繼續管理之前授予的未償還期權的條款和條件。任何由於到期、沒收、取消或以其他方式未發行的與2011計劃相關的獎勵的股票將可以在2018年綜合激勵計劃下發放。在2011計劃下授予的期權將在五年內到期,
2018年綜合激勵計劃
在2018年8月,公司的董事會通過並獲得股東批准的2018年綜合激勵計劃,允許向員工、顧問和諮詢師授予限制性股票、期權和股票增值權獎勵。
2018年6月22日,公司的董事會通過了2018年綜合激勵計劃的第一次修正案,需經股東批准,以(i) 增加2018計劃下可發行普通股的一次性自動增加,(ii) 增加每年2018計劃下可發行普通股的自動增加百分比,以及(iii) 將2018計劃的期限延長至2034年3月21日。2024年5月9日,公司的股東批准了2018年綜合激勵計劃的第一次修正案。
根據2018年綜合激勵計劃(「2018計劃」)授予的股票期權,可以是激勵股票期權或非法定股票期權。激勵股票期權可授予員工、顧問和諮詢師,行使價格不得低於授予日期普通股的公允價值。如果在授予時,期權持有者擁有代表超過
公司最初保留了
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525,948股
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2024年9月30日結束的九個月內,授予員工和董事的股票期權的加權平均授予日期公允價值爲 $
股票期權的內在價值是基於截至2024年9月30日和2013年12月31日公司普通股的行使價格和公允價值之間的差異計算的。已行使股票期權的內在價值是基於行使日期時基礎普通股的公允價值與行使價格之間的差異
截至2024年9月30日和2013年12月31日,授予員工的股票期權相關的未確認補償成本總額爲$
員工期權的授予日公允價值是使用Black-Scholes期權定價模型以以下加權平均假設估計的:
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在損益表和綜合損益表中確認的總股票補償費用如下(以千爲單位):
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註釋 13. 稅收
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公司評估稅務立場的確認標準爲更可能實現的標準,並且符合確認條件的稅務立場按稅收利益的最大金額計量,該金額超過50%的可能性。據2024年9月30日和2023年12月31日,公司已經
第14條。歸屬於普通股股東的每股淨虧損
以下加權平均普通股等價物被排除在攤薄每股淨虧損的計算之外,因爲它們產生了抗稀釋效應:
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注意事項 15.區段和地理信息
該公司的首席運營決策者兼首席執行官對經營業績進行彙總審查,以分配資源和評估財務業績。該公司有
Note 16. RELATED PARTY TRANSACTIONS
As discussed in Note 7, the Company leases its facility from 1895 Management, Ltd., a New York corporation controlled by an entity affiliated with the Company’s chairman and major stockholder of the Company. Lease expense incurred under the operating lease for each of the three-month and nine-month periods ended September 30, 2024 and 2023 was $
On
On
23
placement warrant, for aggregate gross proceeds of approximately $
On
On September 17, 2024, the Company entered into the Inducement Letter Agreements as described in Note 10 above. FCMI and Vaccinex (Rochester), L.L.C. participated in the transactions contemplated by the Inducement Letter Agreements.
Note 17. SUBSEQUENT EVENTS
On
The Pre-Funded Warrants have an initial exercise price of $
24
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
References in this Quarterly Report on Form 10-Q, or this Report, to the “Company,” “we,” “our,” or “us” mean Vaccinex, Inc. and its subsidiaries except where the context otherwise requires You should read the following discussion and analysis of financial condition and results of operations together with our condensed financial statements and related notes included elsewhere in this Report, as well as the audited financial statements, related notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations and other disclosures included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, or the Annual Report.
Cautionary Note Regarding Forward-Looking Statements
The following discussion and other parts of this Report contain forward-looking statements that involve risk and uncertainties, such as statements of our plans, objectives, expectations, and intentions. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “expects,” “plans,” “anticipate,” “believes,” “estimates,” “potential,” or “continue,” or the negative of these terms or other comparable terminology. Forward-looking statements include, but are not limited to, statements about:
25
Although we believe that the expectations reflected in the forward-looking statements contained herein are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. These statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the risk factors identified in the “Risk Factors” section of this Report, and in Part I, Item 1A of the Annual Report on Form 10-K, as well as in our other filings with the Securities and Exchange Commission, or SEC. The forward-looking statements speak only as of the date they were made. Except as required by law, after the date of this Report, we are under no duty to update or revise any of the forward-looking statements, whether as a result of new information, future events or otherwise. We qualify all of our forward-looking statements by the foregoing cautionary statements.
Common Stock Reverse Splits
On September 25, 2023, the Company effected a 1-for-15 reverse stock split of its issued shares of common stock. On February 19, 2024, the Company effected a second reverse split of shares of the Company's common stock on a 1-for-14 basis. All per share amounts, common shares outstanding, warrants, and stock-based compensation amounts for all periods presented have been retroactively adjusted to reflect these reverse stock splits. The shares of common stock retain a par value of $0.0001 per share.
Company Overview
We are a clinical-stage biotechnology company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs, including neurodegenerative diseases, cancer, and autoimmune disorders. We believe we are the leader in the field of semaphorin 4D, or SEMA4D, biology and that we are the only company targeting SEMA4D as a potential treatment for neurodegenerative diseases, cancer, and autoimmune disorders. SEMA4D is an extracellular signaling molecule that regulates the activity of immune and inflammatory cells at sites of injury, cancer, or infection. We are leveraging our SEMA4D antibody platform and our extensive knowledge of SEMA4D biology to develop our lead product candidate, pepinemab, an antibody that we believe utilizes novel mechanisms of action. We are focused on developing pepinemab for the treatment of Alzheimer’s disease, Huntington’s disease, head and neck cancer, and pancreatic cancer. Additionally, third party investigators are studying pepinemab in clinical trials in breast cancer, as well as in “window of opportunity” studies in other indications, including head and neck cancer, and melanoma. We have developed multiple proprietary platform technologies and are developing product candidates to address serious diseases or conditions that have a substantial impact on day-to-day functioning and for which treatment is not addressed adequately by available therapies. We employ our proprietary platform technologies, including through our work with our academic collaborators, to identify potential product candidates for sustained expansion of our internal product pipeline and to facilitate strategic development and commercial partnerships.
Our lead platform technologies include our SEMA4D antibody platform and our ActivMAb antibody discovery platform. Our lead product candidate, pepinemab, is currently in clinical development for the treatment of Alzheimer’s disease, head and neck, pancreatic and breast cancer, through our efforts or through investigator-sponsored trials. Our additional product candidates, VX5 (CXCL13 Mab) and CXCR5 Mab are in earlier stages of development and were selected using our ActivMAb platform. We believe our multiple platform technologies position us well for continued pipeline expansion and partnership opportunities going forward.
We have generated a limited amount of service revenue from collaboration agreements but have not generated any revenue from sales of our product candidates to date. We continue to incur significant development and other expenses related to our ongoing operations. As a result, we are not and have never been profitable and have incurred losses in each period since our inception, resulting in substantial doubt in our ability to continue as a going concern. We reported a net loss of $5.7 million and $4.9 million for the three months ended September 30, 2024 and 2023, respectively, and a net loss of $15.3 million and $16.9 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, and December 31, 2023, we had cash and cash equivalents of $2.9 million and $1.5 million, respectively. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, our product candidates. We may also encounter unforeseen expenses, difficulties, complications,
26
delays, and other unknown factors which may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues, if any.
Our recurring net losses and negative cash flows from operations raised substantial doubt regarding our ability to continue as a going concern within one year after the issuance of our condensed financial statements for the three and nine months ended September 30, 2024. Until we can generate sufficient revenue from the commercialization of our product candidates, we expect to finance our operations through the public or private sale of equity, debt financing or other capital sources, such as government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. To date, we have relied on equity and debt financing to fund its operations, in addition to capital contributions from noncontrolling interests and a limited amount of service revenue from collaboration agreements.
In August 2024, we called for cancellation the public warrants and the private placement warrants pursuant to terms of the warrants permitting us to call the warrants for cancellation following the announcement of a statistically significant increase in FDG-PET signal in patients in our SIGNAL-AD trial of pepinemab for the treatment of Alzheimer’s disease. All of the public warrants and private placement warrants not exercised pursuant to the Inducement Letter Agreements were thereafter canceled in September 2024. As of September 30, 2024, none of the private placement warrants or the public warrants were outstanding. A holder of certain of the warrants that we called for cancellation has notified us that it believes that the warrants it held are still outstanding. The number of shares represented by these canceled warrants represents approximately 8% of our outstanding shares as of September 30, 2024, on a pre-issuance basis. Should this misunderstanding continue and a resolution be required and reached, there could be adverse impacts to the Company, including the payment of damages or the issuance of additional shares of common stock.
On September 17, 2024, we entered into the Inducement Letter Agreements with the Holders of the Existing Warrants. Pursuant to the Inducement Letter Agreements, the Holders agreed to exercise for cash the Existing Warrants at a reduced exercise price of $5.636 per share in consideration of our agreement to issue the New Warrants to purchase up to 1,601,238 shares of common stock, which were issued and sold in a private placement at a price of $0.125 per New Warrant. Each New Warrant had an initial exercise price equal to $5.636 per share, was immediately exercisable, and expires September 18, 2029. The gross proceeds to us from the exercise of the Existing Warrants and the sale of the New Warrants were approximately $6.2 million, prior to deducting financial advisory fees and estimated transaction expenses. FCMI Parent Co. (“FCMI”), which is controlled by Albert D. Friedberg, the chairman of our board of directors, and Vaccinex (Rochester) L.L.C., which is majority owned and controlled by Dr. Maurice Zauderer, our President, Chief Executive Officer, and a member of our board of directors, participated in the transactions contemplated by the Inducement Letter Agreements.
On March 28, 2024, we entered into a securities purchase agreement with Alzheimer’s Drug Discovery Foundation pursuant to which we sold shares of a newly designated series of convertible preferred stock, our Series A Preferred Stock, and warrants to purchase up to 229,057 shares of our common stock for an aggregate purchase price of $1.75 million.
On March 27, 2024, we entered into a securities purchase agreement pursuant to which we issued and sold 193,000 shares of our common stock in a public offering together with warrants to purchase up to 193,000 shares of common stock in a concurrent private placement at a combined price of $7.77 per share and accompanying warrant for an aggregate purchase price of approximately $1.5 million. Separately on March 27, 2024, we entered into a securities purchase agreement in a different form pursuant to which we sold 159,683 shares of common stock and warrants to purchase up to 159,683 shares of common stock in a private placement at a combined price of $7.77 per share and accompanying warrant for an aggregate purchase price of approximately $1.25 million. FCMI and Vaccinex (Rochester) L.L.C. purchased shares of our common stock and accompanying warrants in the latter transaction.
On February 6, 2024, we entered into a securities purchase agreement pursuant to which we issued and sold 274,182 shares of our common stock together with warrants to purchase up to 274,182 shares of common stock at a combined price of $10.15 per share and accompanying warrant and (ii) pre-funded warrants to purchase up to 90,363 shares of common stock together with warrants to purchase up to 90,363 shares of our common stock at a combined price of $10.1486 per pre-funded warrant and accompanying warrant, for aggregate gross proceeds of
27
approximately $3.7 million. FCMI and Vaccinex (Rochester) L.L.C. purchased 118,227 and 29,557 shares of our common stock and accompanying warrants, respectively, in the February 2024 offering for an aggregate purchase price of $1.5 million.
Our cash and cash equivalents were $2.9 million and total current assets were $4.8 million at September 30, 2024, which will be insufficient to fund our planned operations through one year of the date that these condensed financial statements are available for issuance. See Note 1 of our unaudited condensed financial statements. There can be no assurances that we will be able to secure additional financing when needed, or if available, that it will be sufficient to meet our needs or on favorable terms.
Nasdaq Deficiency Notice
On April 11, 2024, the Company received a letter from the Listing Qualifications staff of Nasdaq notifying the Company that based on the financial statements contained in its Form 10-K for the year-ended December 31, 2023, it no longer complies with the requirement under Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders’ equity for continued listing on the Nasdaq Capital Market (the “Equity Standard”) or the alternative requirements of having a market value of listed securities of $35.0 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years (the “Alternative Standards”) , and may be subject to delisting. The notification letter had no immediate effect on the Company’s listing on the Nasdaq Capital Market and the Company timely submitted a plan to regain compliance with the Equity Standard.
On June 5, 2024, Nasdaq notified the Company that it has been provided an extension to regain and evidence compliance with the Equity Standard on or before September 30, 2024. As of September 30, 2024, we had a stockholders' deficit of $1.3 million. On October 7, 2024, the Company received a letter from the Nasdaq Listing Staff stating that the Company had not regained compliance with the Equity Standard or the Alternatives Standards and that, as a result, unless the Company timely requested an appeal of this determination to a Nasdaq Hearings Panel, Nasdaq would move to suspend trading of the Company’s common stock and to have the Company’s securities delisted from the Nasdaq Capital Market. The Company timely appealed the determination, which automatically stayed any suspension or delisting action pending the Hearings Panel’s decision and the expiration of any additional extension period granted by the Hearings Panel following the hearing set for December 5, 2024. As a result, the Company’s common stock is expected to remain listed on the Nasdaq Capital Market through at least that time. However, there can be no assurance that the Hearings Panel will grant the Company’s request for continued listing or that the Company will be able to demonstrate compliance with the Equity Standard or the Alternative Standards within any additional compliance period that may be granted by the Hearings Panel.
Clinical Update
Alzheimer's Disease
The Company initiated a randomized, placebo-controlled, multi-center phase 1/2a clinical study of pepinemab in AD, or the SIGNAL-AD trial, in 2021. On March 28, 2024, we entered into a second agreement with Alzheimer’s Drug Discovery Foundation pursuant to which we sold shares of a newly designated series of convertible preferred stock, our Series A Preferred Stock, and warrants to purchase up to 229,057 shares of our common stock for an aggregate purchase price of $1.75 million. This trial is based on evidence from the SIGNAL clinical trial in HD that showed treatment with pepinemab reduced cognitive decline and induced a sharp increase in glucose metabolism in the brain during HD disease progression as detected by conventional FDG-PET imaging. Previous studies in AD have shown that decline in glucose metabolism correlates with cognitive decline. In April 2023, we reached our enrollment target for the Phase 1b/2 SIGNAL-AD study evaluating pepinemab as a potential treatment for people with Mild Cognitive Impairment (MCI) or mild dementia due to AD. On April 25, the Company provided an update regarding plans for analysis of biomarkers and clinical outcome measures during a presentation at 12th Annual Alzheimer’s & Parkinson’s Drug Development Summit. All 50 participants have completed 12-months of treatment on June 30, 2024, and SIGNAL-AD topline data was reported by Eric Siemers, MD, Principal Investigator of the SIGNAL-AD trial at the Alzheimer's Association International Conference in Philadelphia on July 31, 2024. Additional efficacy data for SIGNAL-AD was reported by Elizabeth Evans, PhD, Senior VP Discovery and
28
Translational Research and Chief Operating Officer on October 31, 2024, at the Clinical Trials on Alzheimer’s Disease Conference in Madrid, Spain.
An important secondary endpoint of the study was to determine whether pepinemab prevents decline in brain metabolic activity consistent with blocking astrocyte reactivity as evidenced by an increase in FDG-PET imaging signal in a major brain region known to be affected by disease progression. This was determined over the course of 12-months of treatment with pepinemab relative to placebo. Pepinemab treatment resulted in a statistically significant increase (p=0.0297) in FDG-PET signal in the medial temporal cortex of patients with Mild Cognitive Impairment (MCI) due to AD. The medial temporal region of brain includes hippocampus and entorhinal cortex, known to be affected during early disease progression in many patients with MCI. A similar significant result of pepinemab treatment on brain metabolic activity was previously shown in our phase 2 study of HD, which we believe highlights mechanistic similarities in the pathology of these two neurodegenerative diseases.
Although the present study was not sufficiently powered to detect cognitive effects or changes in some additional secondary endpoints with statistical significance, we previously reported that, in a larger study that enrolled approximately 90 HD patients/arm with early symptoms of cognitive deficits, seemingly similar to MCI in AD, pepinemab treatment improved performance on key cognitive and psychological measures.
We believe that results of the SIGNAL-AD study demonstrate that pepinemab has a similar effect in Alzheimer’s to those we previously described for a key outcome in Huntington’s disease, preventing the characteristic disease-related decline of brain metabolic activity in a brain region known to be affected early in disease progression. This positive data release suggests that pepinemab has the potential to benefit patients with MCI due to AD. AD and HD share important pathological features and clinical symptoms, and we believe that our approach of confirming similar treatment effects of pepinemab in these two different neurodegenerative diseases is strongly supportive of pepinemab as a potentially well-tolerated and effective treatment for both Alzheimer’s and Huntington’s disease.
Our study indicates that pepinemab may be most effective in patients with early stage symptoms, e.g., Mild Cognitive Impairment (MCI) or Mild Dementia due to AD. This suggests that a promising treatment strategy would be to identify people with MCI as early as possible and to treat with pepinemab to keep them from progressing for as long as possible. We believe that, to date, no disease modifying therapy has been shown to be effective in later stages of AD dementia.
The Alzheimer’s Association estimates that 12% to 18% of people age 60 or older are living with MCI due to AD and that about one-third of these patients will develop dementia within five years. A drug that can slow progression of MCI could significantly extend a rewarding and productive life for people at risk.
Pepinemab has been well-tolerated in clinical trials that enrolled a total of more than 600 patients primarily in neurological indications, AD, HD, and MS. Current concerns about the limitations of treatment with approved anti-Aβ amyloid antibodies such as Leqembi™ (Eisai and Biogen) and Kisunla™ (Eli Lilly) might make pepinemab, if approved, attractive as either an alternative for patients at high risk for adverse events related to treatment with Leqembi or Kisunla, and could also be a complementary treatment to enhance benefit of such anti-Aβ antibodies to patients.
Cancer
As prespecified in the study protocol, the Company analyzed interim data from the first 36 patients in the open-label, single-arm, Phase 2 KEYNOTE B-84 study (NCT04815720) evaluating pepinemab and KEYTRUDA™ in immunotherapy naïve patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The study was based on preclinical and clinical studies demonstrating that antibody blockade of semaphorin 4D (SEMA4D) in combination with immune checkpoint inhibitors (ICI) promotes infiltration of CD8+ cytotoxic T cells and inhibits the recruitment and function of myeloid derived suppressor cells (MDSC) in tumors, enabling enhanced ICI efficacy. The study results showed that pepinemab in combination with KEYTRUDA™ resulted in an approximately 2X increase in objective responses (ORR) and median progression free survival (PFS) in patients with hard-to-treat PD-L1-low tumors, those with combined positive score <20 (CPS<20), compared to historical response rates for ICI monotherapy in this population. ORR for the CPS<20 population was 21.1% with median PFS
29
of 5.79 months, which is almost 2X that of historical response to checkpoint monotherapy in this population, ORR 11.9% and PFS 2.2 months. In contrast, patients in the CPS>20 subgroup (n=17) responded similarly to historical ICI monotherapy data. Biopsy data suggest that treatment-induced formation of highly organized lymphoid aggregates, tertiary lymphoid structures (TLS), correlate with disease control. TLS are characterized by a high density of B cells, antigen-presenting dendritic cells and activated T cells including stem-like TCF-1+, PD-1+, CD8+ T cells whose expansion and differentiation has previously been shown to be central for response to checkpoint inhibitors. The safety of pepinemab in combination with KEYTRUDA is regularly reviewed by an independent safety committee and has to date been found to be well tolerated.
In January and March 2024, the Company and its collaborators presented posters at the ASCO Gastrointestinal Cancers Symposium and the Society for Surgical Oncology Annual Meeting, respectively:
Financial Overview
Revenue
To date, we have not generated any revenue from sales of our product candidates. The Company recorded service revenue of $52,000 and $20,000 during the three months ended September 30, 2024 and 2023, respectively. The Company recorded service revenue of $388,000 and $70,000 during the nine months ended September 30, 2024 and 2023, respectively, and $500,000 in revenue related to the achievement of a contractual milestone during the nine months ended September 30, 2023 from our collaboration agreement with Surface Oncology.
Our ability to generate revenue and become profitable depends on our ability to successfully obtain marketing approval of and commercialize our product candidates. We do not expect to generate product revenue in the foreseeable future as we continue our development of, and seek regulatory approvals for, our product candidates, and potentially commercialize approved products, if any.
Operating Expenses
Research and Development. Research and development expenses consist primarily of costs for our clinical trials and activities related to regulatory filings, employee compensation-related costs, supply expenses, equipment depreciation and amortization, consulting, and other miscellaneous costs. The following table sets forth the components of our research and development expenses and the amount as a percentage of total research and development expenses for the periods indicated.
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||||||||||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||||||||||||||||||
|
|
(in thousands) |
|
|
% |
|
|
(in thousands) |
|
|
% |
|
|
(in thousands) |
|
|
% |
|
|
(in thousands) |
|
|
% |
|
||||||||
Clinical trial costs |
|
$ |
1,578 |
|
|
|
50 |
% |
|
$ |
2,728 |
|
|
|
63 |
% |
|
$ |
5,173 |
|
|
|
50 |
% |
|
$ |
8,206 |
|
|
|
62 |
% |
Wages, benefits, and related costs |
|
|
1,184 |
|
|
|
37 |
% |
|
|
1,158 |
|
|
|
27 |
% |
|
|
3,586 |
|
|
|
34 |
% |
|
|
3,609 |
|
|
|
27 |
% |
Preclinical supplies and equipment depreciation |
|
|
318 |
|
|
|
10 |
% |
|
|
365 |
|
|
|
8 |
% |
|
|
1,203 |
|
|
|
12 |
% |
|
|
1,105 |
|
|
|
9 |
% |
Consulting, non-clinical trial services, and other |
|
|
84 |
|
|
|
3 |
% |
|
|
104 |
|
|
|
2 |
% |
|
|
449 |
|
|
|
4 |
% |
|
|
297 |
|
|
|
2 |
% |
Total research and development expenses |
|
$ |
3,165 |
|
|
|
|
|
$ |
4,355 |
|
|
|
|
|
$ |
10,412 |
|
|
|
|
|
$ |
13,217 |
|
|
|
|
30
We expense research and development costs as incurred. We record costs for certain development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment. We do not allocate employee-related costs, depreciation, rental and other indirect costs to specific research and development programs because these costs are deployed across multiple product programs under research and development.
Our current research and development activities primarily relate to clinical development in the following indications:
31
Results of Operations
The following table set forth our results of operations for the periods presented (in thousands):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Revenue |
|
$ |
52 |
|
|
$ |
20 |
|
|
$ |
388 |
|
|
$ |
570 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
3,165 |
|
|
|
4,355 |
|
|
|
10,412 |
|
|
|
13,217 |
|
General and administrative |
|
|
1,439 |
|
|
|
1,499 |
|
|
|
5,324 |
|
|
|
5,250 |
|
Total costs and expenses |
|
|
4,604 |
|
|
|
5,854 |
|
|
|
15,736 |
|
|
|
18,467 |
|
Loss from operations |
|
|
(4,552 |
) |
|
|
(5,834 |
) |
|
|
(15,348 |
) |
|
|
(17,897 |
) |
Interest expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1 |
) |
Loss on settlement of warrants |
|
|
(1,106 |
) |
|
|
- |
|
|
|
(1,106 |
) |
|
|
- |
|
Financing costs - warrant liabilities |
|
|
- |
|
|
|
- |
|
|
|
(28 |
) |
|
|
- |
|
Change in fair value of warrant liabilities |
|
|
(71 |
) |
|
|
- |
|
|
|
1,291 |
|
|
|
- |
|
Change in fair value of derivative asset |
|
|
- |
|
|
|
- |
|
|
|
(81 |
) |
|
|
- |
|
Other (expense) income, net |
|
|
(3 |
) |
|
|
922 |
|
|
|
12 |
|
|
|
964 |
|
Loss before provision for income taxes |
|
|
(5,732 |
) |
|
|
(4,912 |
) |
|
|
(15,260 |
) |
|
|
(16,934 |
) |
Provision for income taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net loss attributable to Vaccinex, Inc. |
|
$ |
(5,732 |
) |
|
$ |
(4,912 |
) |
|
$ |
(15,260 |
) |
|
$ |
(16,934 |
) |
Comparison of the Three Months Ended September 30, 2024 and 2023
Revenue
The Company recorded service revenue of $52,000 and $20,000 during the three months ended September 30, 2024 and 2023, respectively.
Operating Expenses
|
|
Three Months Ended September 30, |
|
|||||||||||||
|
|
2024 |
|
|
2023 |
|
|
$ Change |
|
|
% Change |
|
||||
|
|
(in thousands) |
|
|
|
|
||||||||||
Research and development |
|
$ |
3,165 |
|
|
$ |
4,355 |
|
|
$ |
(1,190 |
) |
|
|
(27 |
)% |
General and administrative |
|
|
1,439 |
|
|
|
1,499 |
|
|
|
(60 |
) |
|
|
(4 |
)% |
Total operating expenses |
|
$ |
4,604 |
|
|
$ |
5,854 |
|
|
$ |
(1,250 |
) |
|
|
(21 |
)% |
Research and Development. Research and development expenses in the three months ended September 30, 2024 decreased by $1.2 million, or 27%, compared to the three months ended September 30, 2023. The decrease was primarily attributable to the winding down of the SIGNAL-AD trial, a pause in enrollment for the head and neck cancer trial, and less drug manufacturing costs.
General and Administrative. General and administrative expenses consist primarily of the necessary costs associated with maintaining the Company’s daily operations and administration of the Company’s business. General and administrative expenses in the three months ended September 30, 2024 were essentially the same when compared to the three months ended September 30, 2023.
32
Comparison of the Nine Months Ended September 30, 2024 and 2023
Revenue
The Company recorded service revenue of $388,000 and $70,000 during the nine months ended September 30, 2024 and 2023, respectively, and $500,000 in revenue during the nine months ended September 30, 2023 from our collaboration agreement with Surface Oncology.
Operating Expenses
|
|
Nine Months Ended September 30, |
|
|||||||||||||
|
|
2024 |
|
|
2023 |
|
|
$ Change |
|
|
% Change |
|
||||
|
|
(in thousands) |
|
|
|
|
||||||||||
Research and development |
|
$ |
10,412 |
|
|
$ |
13,217 |
|
|
$ |
(2,805 |
) |
|
|
(21 |
)% |
General and administrative |
|
|
5,324 |
|
|
|
5,250 |
|
|
|
74 |
|
|
|
1 |
% |
Total operating expenses |
|
$ |
15,736 |
|
|
$ |
18,467 |
|
|
$ |
(2,731 |
) |
|
|
(15 |
)% |
Research and Development. Research and development expenses in the nine months ended September 30, 2024 decreased by $2.8 million, or 21%, compared to the nine months ended September 30, 2023. The decrease was primarily attributable to the winding down of the SIGNAL-AD trial, a pause in enrollment for the head and neck cancer trial, and less drug manufacturing costs.
General and Administrative. General and administrative expenses consist primarily of the necessary costs associated with maintaining the Company’s daily operations and administration of the Company’s business. General and administrative expenses in the nine months ended September 30, 2024 were essentially the same when compared to the nine months ended September 30, 2023.
Liquidity and Capital Resources
To date, we have not generated any revenue from sales of our product candidates. Our recurring net losses and negative cash flows from operations raised substantial doubt regarding our ability to continue as a going concern within one year after the issuance of our unaudited condensed financial statements. During the nine months ended September 30, 2024 and the year-ended December 31, 2023, we have generated a limited amount of revenue through the achievement of contractually stated milestones as well as grants, and the performance of services from collaboration agreements, including through our ActivMAb platform. See Note 1 of our unaudited condensed financial statements. Since our inception in 2001, we have relied on public and private sales of equity and debt financing to fund our operations, in addition to capital contributions from noncontrolling interests and limited-service revenue from collaboration agreements.
During the nine months ended September 30, 2024, the Company sold 208 shares of the Company’s common stock at a weighted average price per share of $10.30 through the Open Market Sale Agreement, for net proceeds of $2,077, respectively.
Additionally, during the nine months ended September 30, 2024 the Company received aggregate gross proceeds of approximately $14.1 million from (i) private placements of 433,865 shares of common stock, 90,363 pre-funded warrants and 717,228 warrants to purchase shares of common stock (ii) a public offering of 193,000 shares of common stock (iii) sale of 10 shares of our Series A Preferred Stock, and warrants to purchase up to 229,057 shares of our common stock, and (iv) exercise of warrants.
Series A Preferred Stock
On March 28, 2024, we sold shares of a newly designated series of our preferred stock, the Series A Preferred Stock. Our Series A Preferred Stock is convertible at the election of the holder at any time after the public announcement by the Company of top-line data from its SIGNAL-AD Alzheimer’s disease study (the “Data Release”) into shares of common stock at a conversion price equal to the greater of (a) $7.77 per share of common
33
stock and (b)(i) the volume weighted average price of the common stock for the last three trading days prior to delivery of the conversion notice if the common stock is traded on a trading market or if its prices are reported on OTCQB or OTCQX, (ii) the most recent bid price of the common stock if it is then traded on The Pink Open Market, or (iii) in all other cases the fair market value of the common stock as determined by an independent appraiser, which conversion right is subject to termination on the last full day preceding the proposed effective date for exercise of the Company’s redemption right or the date fixed for redemption upon a Deemed Liquidation Event (generally defined to include certain fundamental transactions involving the company including a merger or sale of substantially all of the Company’s assets) or on a liquidation, dissolution or winding up of the Company.
The Series A Preferred Stock is non-voting, has no mandatory redemption, and carries an annual 5% cumulative dividend, increasing by 2% each year, which dividend rate shall not exceed 12%. The Series A Preferred Stock will also participate on an as-converted basis in any regular or special dividends paid to holders of our common stock.
In addition, the Series A Preferred Stock has a liquidation preference equal to the greater of (i) $175,000 per share, subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series A Preferred Stock (the “Original Share Price”), plus any accrued but unpaid dividends thereon, whether or not declared, together with any other dividends declared but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series A Preferred Stock been converted into common stock immediately prior to such liquidation, dissolution, winding up or Deemed Liquidation Event.
The Company also agreed that so long as the Series A Preferred Stock is outstanding, the Company will not, without the written consent of the holders of 50.1% of the Series A Preferred Stock, (i) amend, alter, or repeal any provision of the Company’s certificate of incorporation or bylaws in a manner adverse to the Series A Preferred Stock or (ii) until March 29, 2026, incur any indebtedness for borrowed money in excess of $1.0 million.
The Company has the right to redeem the Series A Preferred Stock at a price equal to the Original Share Price per share at any time after a public announcement of an increase in pepinemab-treated patients relative to placebo-treated patients, with statistical significance having a p-value of less than or equal to 0.05, in the change of the FDG-PET standard uptake value ratio for brain metabolism between baseline and month 12 as assessed by [18F]fluorodeoxyglucose (FDG)-PET in the resting state following administration of 40 mg/kg pepinemab or placebo, as applicable, as described in the protocol for the Company’s SIGNAL-AD Alzheimer’s disease study and the associated Statistical Analysis Plan, provided that (i) the holder is not in possession of any material nonpublic information that was provided by the Company or any of its directors, directors, employees, agents, or affiliates and (ii) there is an effective resale registration statement on file covering the underlying common stock.
The holders of outstanding shares of Series A Preferred Stock have no voting rights with respect to such shares of Series A Preferred Stock on any matter presented to the Company’s stockholders, except as required by law or as specifically set forth in the Certificate of Designation of Series A Preferred Stock.
Operating Capital Requirements
Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, third-party research services and amounts due to vendors for research supplies. As of September 30, 2024 and December 31, 2023, our principal source of liquidity was cash and cash equivalents in the amount of $2.9 million and $1.5 million, respectively. Given our projected operating requirements, our existing cash and cash equivalents and marketable securities, we will seek to complete an additional financing transaction or transactions in order to continue operations.
Since our inception in 2001, we have incurred significant net losses and negative cash flows from operations. For the nine months ended September 30, 2024 and 2023, we reported a net loss of $15.3 million and $16.9 million, respectively. For the nine months ended September 30, 2024 and 2023, we reported cash used in operations of $12.3 million and $13.6 million, respectively. As of September 30, 2024 and December 31, 2023, we had an accumulated deficit of $355.2 million and $339.9 million, respectively. We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates. We are subject to risks associated with the development of new
34
biopharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors, which may adversely affect our business.
Our recurring net losses and negative cash flows from operations, as well as forecast of continued losses and negative cash flows from operations, raised substantial doubt regarding our ability to continue as a going concern within one year after the issuance of our financial statements for the year ended December 31, 2023. Until we can generate a sufficient amount of revenue from the commercialization of our product candidates, we expect to finance our operations through the public or private sale of equity, debt financing, or other capital sources, such as government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. Our cash and cash equivalents were $2.9 million and total current assets were $4.8 million at September 30, 2024, which the Company is projecting will be insufficient to sustain its operations through one year following the date that the financial statements are issued.
Financing strategies we may pursue include, but are not limited to, the public or private sale of equity, debt financing or funds from other capital sources, such as government funding, collaborations, strategic alliances, or licensing arrangements with third parties. There can be no assurances additional capital will be available to secure additional financing, or if available, that it will be sufficient to meet our needs on favorable terms. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development of one or more of our product candidates. If we raise additional funds through the public or private sale of equity or debt financing, it could result in dilution to our existing stockholders or increased fixed payment obligations and these securities may have rights senior to those of our common stock and could contain covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license our intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition, and prospects.
Cash Flows
The following table summarizes our cash flows for the periods presented:
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
|
|
(in thousands) |
|
|||||
Cash used in operating activities |
|
$ |
(12,254 |
) |
|
$ |
(13,642 |
) |
Cash used in investing activities |
|
|
(22 |
) |
|
|
(67 |
) |
Cash provided by financing activities |
|
|
13,647 |
|
|
|
7,445 |
|
Operating Activities. We have historically experienced negative cash flows as we have developed our product candidates and continued to expand our business. Our net cash used in operating activities primarily results from our net loss adjusted for non-cash expenses and changes in working capital components as we have continued our research and development and is influenced by the timing of cash payments for research related expenses. Our primary uses of cash from operating activities are compensation and related expenses, employee-related expenditures, third-party research services and amounts due to vendors for research supplies. Our cash flows from operating activities will continue to be affected principally by the extent to which we increase spending on personnel, research and development and other operating activities as our business grows.
During the nine months ended September 30, 2024 and 2023, operating activities used $12.3 million and $13.6 million, respectively, in cash, primarily as a result of our continued efforts of discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs without any product revenue, resulting in a net loss of $15.3 million and $16.9 million, respectively.
Investing Activities. The investing activities during the nine months ended September 30, 2024 and 2023, were due to purchases of property and equipment.
Financing Activities. During the nine months ended September 30, 2024, financing activities provided $14.1 million, from the private placement of common stock and pre-funded warrants, with accompanying warrants, the
35
public offering of common stock and private placement of accompanying warrants, the sale of Series A Preferred Stock and accompanying warrants, and the exercise of warrants. During the nine months ended September 30, 2023, financing activities provided a net of $7.4 million, of which $6.3 million was due to private placements of common stock, $1.0 million through an award from the Alzheimer’s Drug Discovery Foundation in the form of an investment in our common stock and $0.2 million was due to the issuance of the Company’s common stock pursuant to the Open Market Sale Agreement.
Critical Accounting Policies and Estimates
Our unaudited condensed financial statements are prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosures. We evaluate our estimates and assumptions on an ongoing basis. Our estimates are based on historical experience and various other assumptions that we believe to be reasonable under the circumstances. Our actual results could differ from these estimates.
There have been no material changes to our critical accounting policies and significant judgments during the nine months ended September 30, 2024, other than those discussed in Note 2 of our unaudited condensed financial statements as of and for the nine months ended September 30, 2024, included elsewhere in this quarterly report on Form 10-Q.
Impact of Recent Accounting Pronouncements
For a discussion on the impact of recent accounting pronouncements on our business, see Note 2 to our unaudited condensed financial statements.
36
Item 3. Quantitative and Qualitative Disclosures about Market Risk
As a smaller reporting company, we are not required to provide the information required by this item.
Item 4. Controls and Procedures
Evaluation of disclosure controls and procedures
Our Chief Executive Officer (our principal executive officer) and Chief Financial Officer (our principal financial officer), with the participation of our management evaluated the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as of September 30, 2024, the end of the period covered by this Form 10-Q. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of September 30, 2024, our disclosure controls and procedures were effective.
Changes in internal control over financial reporting
There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended September 30, 2024 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
37
Part II - OTHER INFORMATION
Item 1A. Risk Factors
An investment in our stock involves a high degree of risk. You should carefully consider the risks set forth in this section, and in Part I, Item 1A of the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the "Annual Report"), and all of the other information set forth in this Report, the Annual Report, and in the other reports we file with the SEC. If any of the risks contained in those reports actually occur, our business, results of operation, financial condition, and liquidity could be harmed, the value of our securities could decline, and you could lose all or part of your investment. Except as set forth below, there have been no material changes from risk factors disclosed in the Annual Report on Form 10-K. See the discussion of the Company’s risk factors under Part I, Item 1A. of the Annual Report.
We are currently not in compliance with the continued listing standards of the Nasdaq Capital Market, and if we are unable to regain compliance, our common stock will be delisted from the exchange.
Our common stock is currently listed for trading on the Nasdaq Capital Market under the symbol “VCNX." The continued listing of our common stock on Nasdaq is subject to our compliance with a number of listing standards, including Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders’ equity (the “Equity Standard”) or the alternative requirements of having a market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years (the “Alternative Standards”). On April 11, 2024, Nasdaq informed us that based on the financial statements contained in our Form 10-K for the year-ended December 31, 2023, the Company is no longer in compliance with the Equity Standard or the Alternative Standards and we may be subject to delisting. The notification letter had no immediate effect on the Company’s listing on the Nasdaq Capital Market and the Company timely submitted a plan to regain compliance with the Equity Standard.
On June 5, 2024, Nasdaq notified the Company that it has been provided an extension to regain and evidence compliance with the Equity Standard on or before September 30, 2024. As of September 30, 2024, we had a stockholders' deficit of $1.3 million. On October 7, 2024, the Company received a letter from the Nasdaq Listing Staff stating that the Company had not regained compliance with the Equity Standard or the Alternatives Standards and that, as a result, unless the Company timely requested an appeal of this determination to a Nasdaq Hearings Panel, Nasdaq would move to suspend trading of the Company’s common stock and to have the Company’s securities delisted from the Nasdaq Capital Market. The Company timely appealed the determination, which automatically stayed any suspension or delisting action pending the Hearings Panel’s decision and the expiration of any additional extension period granted by the Hearings Panel following the hearing set for December 5, 2024. As a result, the Company’s common stock is expected to remain listed on the Nasdaq Capital Market through at least that time. However, there can be no assurance that the Hearings Panel will grant the Company’s request for continued listing or that the Company will be able to demonstrate compliance with the Equity Standard or the Alternative Standards within any additional compliance period that may be granted by the Hearings Panel.
A delisting or even notification of failure to comply with such requirements would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In addition, the delisting of our common stock could lead to a number of other negative implications such as a loss of media and analyst coverage, a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and likely result in a reduced level of trading activity in the secondary trading market for our securities, and materially adversely impact our ability to raise capital on acceptable terms or at all. Delisting from Nasdaq could also have other negative results, including the potential loss of confidence by our current or prospective third-party providers and collaboration partners, the loss of institutional investor interest, and fewer licensing and partnering opportunities. In the event of a delisting, we would take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.
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If our common stock were no longer listed on Nasdaq, investors might only be able to trade on one of the over-the-counter markets, if at all. There is no assurance that prices for our common stock would be quoted on one of these other trading systems or that an active trading market for our common stock would exist, which would materially and adversely impact the market value of our common stock and your ability to sell our common stock.
The Series A Preferred Stock ranks senior to the Company’s common stock with respect to rights on the distribution of assets upon liquidation, dissolution and winding up.
The Series A Preferred Stock has a liquidation preference before our common stockholders equal to the greater of (i) $175,000 per share for a total of $1.75 million, subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series A Preferred Stock (the “Original Share Price”), plus any accrued but unpaid dividends thereon, whether or not declared, together with any other dividends declared but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series A Preferred Stock been converted into common stock immediately prior to such liquidation, dissolution, winding up or Deemed Liquidation Event. As of September 30, 2024, the holder of the shares of Series A preferred stock were entitled to a liquidation preference of $1.75 million, in the event of any liquidation, dissolution or winding up of the Company. Further, upon the occurrence of Deemed Liquidation Event (generally defined to include certain fundamental transactions involving the Company including a merger or sale of substantially all of the Company’s assets) or other liquidation of the Company, the holders of the Series A Preferred Stock will receive a distribution of the Company’s assets per their liquidation preference before any holders of common stock receive a distribution. As a result, in the event of a liquidation of the Company the proceeds received by the common stockholder may be reduced.
Shares of common stock issuable upon conversion of our Series A Preferred Stock will be dilutive to our existing shareholders upon conversion and adversely affect the market price of our common stock.
As of September 30, 2024, we had outstanding 10 shares of Series A Preferred Stock with an aggregate liquidation preference of $1.75 million. No shares of the outstanding Series A Preferred Stock are convertible before the public announcement by the Company of top-line data from its study “SEMA4D Blockade Safety and Brain Metabolic Activity in Alzheimer’s Disease (AD)” (the “Data Release”). The Data Release was made on July 31, 2024, but no shares of Series A Preferred Stock have to date been converted into shares of common stock. The issuance of common stock upon conversion of the Series A Preferred Stock would result in immediate dilution to existing holders of our common stock.
The Alzheimer’s Drug Discovery Foundation may be able to sell shares of our common stock in the public market, which may cause the market price of our common stock to decrease, and therefore make it more difficult to raise equity financing or issue equity as consideration in an acquisition.
Our registration rights agreement with the Alzheimer’s Drug Discovery Foundation requires us to register all shares of common stock held by the Alzheimer’s Drug Discovery Foundation issuable upon conversion of the Series A Preferred Stock and upon the exercise of certain warrants issued in connection with the Series A Preferred Stock under the Securities Act of 1933, as amended. The registration rights for the Alzheimer’s Drug Discovery Foundation allows it to sell its shares without compliance with the volume and manner of sale limitations under Rule 144 promulgated under the Securities Act and facilitates the resale of such securities into the public market. The market value of our common stock could decline as a result of sales by the Alzheimer’s Drug Discovery Foundation from time to time. In particular, the future sale of a substantial number of the shares of our common stock by the Alzheimer’s Drug Discovery Foundation within a short period of time, or the perception that such sale might occur, could cause our stock price to decrease, make it more difficult for us to raise funds through future offerings of our common stock or acquire other businesses in the future using our common stock as consideration for the purchase price.
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Item 6. Exhibits
INDEX TO EXHIBITS
Exhibit No. |
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Description |
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4.1 |
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10.1 |
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31.1* |
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Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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31.2* |
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Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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32.1** |
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101.INS |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
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101.SCH |
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Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents
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104 |
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The cover page for the Company’s Quarterly Report on Form 10-Q has been formatted in Inline XBRL and contained in Exhibit 101 |
* Filed herewith.
** Furnished herewith.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Vaccinex, Inc. |
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(Registrant) |
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November 14, 2024 |
By: |
/s/ Maurice Zauderer |
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Maurice Zauderer, Ph.D. |
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President & Chief Executive Officer |
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(Principal Executive Officer) |
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November 14, 2024 |
By: |
/s/ Jill Sanchez |
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Jill Sanchez, CPA |
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Chief Financial Officer |
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(Principal Financial Officer) |
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