美國
證券交易委員會
華盛頓特區20549
表格
（標記一）
根據1934年證券交易法第13或15(d)節的季度報告 |
截至季度結束日期的財務報告
或者
根據1934年證券交易法第13或15(d)節的轉型報告書 |
過渡期從_______________到_______________
委託文件編號：001-39866
（依據其憲章指定的註冊名稱）
（國家或其他管轄區的 公司成立或組織） |
（IRS僱主 |
，（主要行政辦公地址） |
(郵政編碼) |
公司電話，包括區號：
在法案第12(b)條的規定下注冊的證券：
每一類的名稱 |
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交易 符號: |
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在其上註冊的交易所的名稱 |
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請在以下複選框中打勾，指示註冊人：(1)在前12個月(或註冊人被要求提交這些報告的更短期間內)已經提交了1934年證券交易法第13或15(d)條規定需要提交的所有報告；以及(2)在過去的90天內一直受到了此類文件提交要求的限制。
請在以下複選框中打勾，指示註冊人是否已經電子提交了根據Regulation S-T規則405條(本章節的§232.405條)需要提交的所有互動數據文件在過去的12個月內(或註冊人被要求提交這些文件的更短期間內)。
勾選以下選框，指示申報人是大型加速評估提交人、加速評估提交人、非加速評估提交人、小型報告公司或新興成長型公司。關於「大型加速評估提交人」、「加速評估提交人」、「小型報告公司」和「新興成長型公司」的定義，請參見《交易所法規》第12億.2條。
大型加速報告人 |
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☐ |
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加速文件提交人 |
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☐ |
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☒ |
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較小的報告公司 |
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新興成長公司 |
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如果是新興成長型企業，請勾選複選標記，表明註冊者已選擇不使用延長過渡期來符合根據證券交易法第13(a)條規定提供的任何新財務會計準則。
請勾選「是」，如果報告人是外殼公司（定義見證券交易法規則12b-2）。是 ☐ 沒有
截至2024年11月6日，登記人持有
目錄
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第I部分 |
1 |
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項目1。 |
1 |
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1 |
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2 |
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3 |
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5 |
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6 |
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事項二 |
16 |
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第3項。 |
24 |
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事項4。 |
24 |
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第二部分 |
26 |
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項目1。 |
26 |
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項目1A。 |
26 |
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事項二 |
26 |
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第3項。 |
26 |
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事項4。 |
26 |
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項目5。 |
26 |
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項目6。 |
27 |
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28 |
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i
第一部分——財務信息
項目1 控件1. 基本報表。
Boundless Bio, Inc.
精簡資產負債表資產負債表簡表
（以千爲單位，除股票和麪值數據外）
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九月30日, |
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12月31日, |
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(未經審計) |
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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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短期投資 |
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預付費用和其他流動資產 |
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總流動資產 |
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資產和設備，淨值 |
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淨使用權資產 |
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受限現金 |
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其他 |
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資產總額 |
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$ |
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$ |
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負債、可轉換優先股和股東權益/(赤字) |
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流動負債 |
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應付賬款及應計費用 |
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$ |
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$ |
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應計的薪資 |
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租賃負債，短期部分 |
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流動負債合計 |
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可轉換優先股，每股面值$ |
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授權的和 |
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優先股，$0.0001 |
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普通股，每股面值爲 $0.0001； |
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股本溢價 |
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累計其他綜合收益 |
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累積赤字 |
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( |
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( |
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股東權益總額/(赤字) |
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( |
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總負債、優先轉股股票和股東權益/(赤字) |
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$ |
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$ |
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附註是這份基本報表的一個組成部分。
1
Boundless Bio, Inc.
合併綜合損益表及綜合虧損的詳細說明
(未經審計)
(以千爲單位，除每股數據外)
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三個月結束 |
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九個月結束 |
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2024 |
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2023 |
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2024 |
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2023 |
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營業費用： |
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研發 |
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$ |
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$ |
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$ |
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$ |
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一般行政 |
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營業費用總計 |
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經營虧損 |
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( |
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( |
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( |
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( |
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其他收入，淨額： |
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利息收入 |
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其他收入，淨額 |
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其他收入淨額 |
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淨損失 |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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綜合虧損： |
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淨損失 |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
短期投資未實現收益 |
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綜合損失 |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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基本和稀釋每股淨虧損 |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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用於計算的股份 |
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附註是這份基本報表的一個組成部分。
2
Boundless Bio, Inc.
可轉換優先股和股東權益/（赤字）壓縮報表)
(未經審計)
(以千爲單位，除股票數據外)
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可轉換優先股票 |
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普通股 |
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額外的 |
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累積的 |
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累積的 |
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總計 |
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股份 |
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數量 |
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股份 |
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數量 |
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資本 |
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收入/（損失） |
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虧損 |
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（赤字） |
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2023年12月31日結餘爲 |
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$ |
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$ |
— |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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早期行使的股票期權的分配 |
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— |
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— |
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— |
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— |
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— |
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行使股票期權 |
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— |
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— |
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— |
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— |
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— |
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股票補償 |
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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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短期投資未實現損失 |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
淨損失 |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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2024年3月31日結存餘額 |
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$ |
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$ |
— |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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首次公開發行普通股，扣除$其他 |
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— |
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— |
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— |
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— |
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首次公開發行時，可轉換優先股轉換爲普通股 |
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( |
) |
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( |
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— |
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— |
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早期行使的股票期權的分配 |
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— |
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— |
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— |
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— |
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— |
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行使股票期權 |
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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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— |
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股票補償 |
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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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短期投資未實現損失 |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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淨損失 |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
2024年6月30日餘額 |
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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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$ |
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早期行使的股票期權的分配 |
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— |
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— |
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— |
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— |
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— |
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股票補償 |
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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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短期投資未實現收益 |
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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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淨損失 |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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2024年9月30日的餘額 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
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附註是這份基本報表的一個組成部分。
3
Boundless Bio, Inc.
可轉換優先股和股東權益/(逆差)的簡明報表 - 繼續
(未經審計)
（以千計，共享數據除外）
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可轉換優先股票 |
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普通股 |
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額外的 |
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累積的 |
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累積的 |
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總計 |
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股份 |
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數量 |
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股份 |
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數量 |
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資本 |
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收入/（損失） |
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虧損 |
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虧損 |
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2022年12月31日結存餘額 |
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$ |
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$ |
— |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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( |
) |
||||
早期行使的股票期權的分配 |
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— |
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— |
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— |
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— |
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— |
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行使股票期權 |
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— |
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— |
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— |
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— |
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— |
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股票補償 |
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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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短期投資未實現收益 |
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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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淨損失 |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
2023年3月31日的餘額 |
|
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$ |
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$ |
— |
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$ |
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$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
||||
發行C轉換優先股淨額$ |
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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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早期行使的股票期權的分配 |
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— |
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— |
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— |
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— |
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— |
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行使股票期權 |
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— |
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— |
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— |
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— |
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— |
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股票補償 |
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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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短期投資未實現損失 |
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— |
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— |
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— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
淨損失 |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
截至2023年6月30日的餘額 |
|
|
|
|
$ |
|
|
|
|
|
|
$ |
— |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
||||
早期行使的股票期權的分配 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
行使股票期權 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
股票補償 |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
短期投資未實現收益 |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
淨損失 |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
截至2023年9月30日的餘額 |
|
|
|
|
$ |
|
|
|
|
|
|
$ |
— |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
||||
附註是這份基本報表的一個組成部分。
4
Boundless Bio, Inc.
康泰公司現金流量表附註
（未經審計）
（以千爲單位）
|
|
九個月結束 |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
經營活動現金流 |
|
|
|
|
|
|
||
淨損失 |
|
$ |
( |
) |
|
$ |
( |
) |
調整爲淨損失到經營活動現金流量淨使用： |
|
|
|
|
|
|
||
股票補償 |
|
|
|
|
|
|
||
折舊和攤銷 |
|
|
|
|
|
|
||
投資的累積增值淨額 |
|
|
( |
) |
|
|
( |
) |
非現金租賃費用 |
|
|
|
|
|
|
||
其他 |
|
|
— |
|
|
|
|
|
經營性資產和負債變動: |
|
|
|
|
|
|
||
預付款項和其他資產 |
|
|
( |
) |
|
|
( |
) |
應付賬款及應計費用 |
|
|
|
|
|
|
||
經營租賃負債 |
|
|
( |
) |
|
|
( |
) |
經營活動使用的淨現金流量 |
|
|
( |
) |
|
|
( |
) |
投資活動現金流量 |
|
|
|
|
|
|
||
投資購買 |
|
|
( |
) |
|
|
( |
) |
投資到期日 |
|
|
|
|
|
|
||
購買固定資產 |
|
|
( |
) |
|
|
( |
) |
投資活動產生的淨現金流出 |
|
|
( |
) |
|
|
( |
) |
籌資活動現金流量 |
|
|
|
|
|
|
||
首次公開發行普通股淨額，扣除折扣 |
|
|
|
|
|
— |
|
|
支付普通股發行成本 |
|
|
( |
) |
|
|
( |
) |
發行可轉換優先股所得款項 |
|
|
— |
|
|
|
|
|
可換股優先股發行成本 |
|
|
— |
|
|
|
( |
) |
行使期權所得款項 |
|
|
|
|
|
|
||
籌資活動產生的現金淨額 |
|
|
|
|
|
|
||
現金及現金等價物淨增加額 |
|
|
|
|
|
|
||
期初現金、現金等價物和受限制的現金餘額 |
|
|
|
|
|
|
||
期末現金、現金等價物和受限制的現金餘額 |
|
$ |
|
|
$ |
|
||
現金及現金等價物的組成部分及受限現金 |
|
|
|
|
|
|
||
現金及現金等價物 |
|
$ |
|
|
$ |
|
||
受限現金 |
|
|
|
|
|
|
||
期末現金、現金等價物和受限制的現金餘額 |
|
$ |
|
|
$ |
|
||
非現金投融資活動 |
|
|
|
|
|
|
||
未支付普通股發行費用的變動 |
|
$ |
( |
) |
|
$ |
|
|
ROU資產的增加 |
|
$ |
— |
|
|
$ |
|
|
由於再度計量租賃義務而導致ROU資產的增加 |
|
$ |
— |
|
|
$ |
|
|
早期行使的股票期權的分配 |
|
$ |
|
|
$ |
|
||
未付的房地產和設備購買費用 |
|
$ |
|
|
$ |
|
||
附註是這份基本報表的一個組成部分。
5
Boundless Bio, Inc.
No轉換爲簡明財務報表（未經審計）
業務描述
Boundless Bio, Inc.（以下簡稱 「公司」）是一家臨床階段的精準腫瘤學公司，致力於開啓癌症治療的新模式，通過靶向染色體外DNA（ecDNA）來滿足癌基因擴增腫瘤患者尚未滿足的巨大需求。該公司專注於設計和開發名爲ecDNA定向治療候選藥物（eCDTx）的小分子藥物。該公司在美國註冊成立
首次公開募股
2024 年 4 月 2 日，公司完成了首次公開募股 (IPO)，並據此出售
在2024年4月2日完成首次公開募股時，對公司的註冊證書進行了修訂和重申，以授權
反向股票分割
流動性
自公司於2018年開始運營以來，它已將幾乎所有的精力和資源用於組織和人員配備、業務規劃、籌集資金、建立其專有的Spyglass平台、發現其eCDTx、開發其ecDNA候選診斷、建立其知識產權組合、開展研究、臨床前研究和臨床試驗、與第三方建立eCDTx和相關原材料的製造安排，以及提供其他一般和行政支持用於這些操作。
自成立以來，該公司在運營中蒙受了巨額營業虧損和負現金流，並預計在可預見的將來，公司將繼續這樣做，繼續發展，尋求監管部門批准並可能將其任何eCDTx商業化，尋求發現和開發更多eCDTx，利用第三方製造其eCDTx和相關原材料，尋求開發其ecDNA候選診斷，僱用更多人員，以及擴展和保護其知識產權。如果公司獲得任何eCDTx的監管批准，預計將產生與產品銷售、營銷、製造和分銷相關的巨額商業化費用。截至2024年9月30日，該公司的累計赤字爲美元
演示基礎
隨附的財務報表是根據美國公認會計原則（U.S. GAAP）和美國證券交易委員會（SEC）對中期報告的要求編制的。在這些規則允許的情況下，可以壓縮或省略美國公認會計原則通常要求的某些腳註或其他財務信息。財務報表以美元列報。這些附註中提及的適用指南均指財務會計準則委員會（FASB）頒佈的《會計準則編纂（ASC）和會計準則更新》（ASU）中的美國公認會計原則。
6
無界生物公司
摘要的財務報表附註（未經審計）
未經審計的簡明中期財務信息
截至2024年9月30日的簡明資產負債表、截至2024年和2023年9月30日結束的三個月和九個月的簡明運營和綜合虧損報表，以及截至2024年和2023年9月30日結束的三個月和九個月的可轉換優先股和股東權益/（赤字）簡明報表，以及截至2024年和2023年9月30日結束的九個月的簡明現金流量表均爲未經審計。這些未經審計的簡明財務報表是按照公司的年度財務報表的相同基礎編制的，並且在管理層的意見中，反映了所有的調整，僅包括爲公正地呈現公司的財務狀況、運營結果和所示期間的現金流所必需的正常經常性調整。與2024年和2023年9月30日結束的三個月和九個月相關的這些簡明財務報表附註中包含的財務數據和其他財務信息也爲未經審計。2024年9月30日結束的三個月和九個月的運營結果不一定預示着預計2024年12月31日結束的年度或任何其他未來年度或中期的結果。
此處包含的截至2023年12月31日的簡明資產負債表是根據該日期的審計財務報表得出的。這些未經審計的簡明財務報表應與公司經審計的財務報表結合閱讀，這些財務報表包含在公司於2024年3月27日發佈的招股說明書（招股說明書）中，相關於根據1933年證券法規則424(b)(4)提交給SEC的首次公開募股，提交日期爲2024年3月28日。
估計的使用
按照美國通用會計準則編制財務報表要求管理層做出估計和假設，這些估計和假設會影響資產、負債、營業收入和費用的報告金額，以及在公司財務報表及其附註中披露的或有資產和負債。儘管這些估計是基於公司對當前事件的認識和未來可能採取的行動，但實際結果可能與這些估計和假設有重大差異。
管理層持續評估其估計，主要涉及基於股票的薪酬、投資和普通股的公允價值以及應計的研發成本。這些估計基於歷史數據和經驗，以及管理層認爲在當前情況下合理的各種其他因素，其結果構成了對資產和負債的賬面價值進行判斷的基礎，而這些賬面價值在其他來源中並不明顯。公司的期權估計涉及選擇適當的估值方法和模型，並在評估假設和財務輸入的範圍時進行重大判斷。
現金、現金等價物和受限現金
公司將購買時原始到期日在三個月或更短時間內的所有高度流動性投資視爲現金等價物。現金及現金等價物包括隨時可用的支票和貨幣市場帳戶中的現金。
在這些基本報表中反映的受限現金餘額代表一個存入資金帳戶，作爲擔保抵押品以確保在公司的一處租賃設施上的備用信用證所需的安全存款。公司已將受限現金歸類爲截至2024年9月30日和2023年12月31日的資產負債表上的非流動資產。
信用風險集中度
金融工具可能使公司面臨信用風險集中，主要由現金、現金等價物和投資組成。公司在聯邦保險的金融機構中維持的存入資金超過了聯邦保險限額，金額爲$
公允價值計量
某些資產和負債根據美國通用會計準則按公允價值計量。公允價值被定義爲退出價格，表示在市場參與者之間進行有序交易時，出售資產所獲得的金額或轉移負債所支付的金額。因此，公允價值是基於市場參與者在給資產定價時使用的假設確定的市場基礎測量。
7
無界生物公司
摘要的財務報表附註（未經審計）
或負債。按照公允價值計量的金融資產和負債被分類並披露在以下三個公允價值層級中的一個，其中前兩個被視爲可觀察的，最後一個被視爲不可觀察的：
第一級—在活躍市場中對相同資產或負債的報價價格。
第二級—在活躍市場中對相似資產和負債的報價價格，在不活躍市場中的報價價格，或直接或間接可觀察的輸入，這些輸入適用於幾乎整個資產或負債的期限。
第三級—不易觀察的輸入，市場活動很少或沒有，且對確定資產或負債的公允價值至關重要，包括定價模型、折現現金流方法論和類似技術。
現金、現金等價物和短期投資按公允價值計量，依據上述描述的公允價值層級進行確定。由於這些資產和負債的短期性質，公司預付費用、應付款和應計費用的賬面價值接近其公允價值。公司的任何非金融資產或負債均未按非經常性基礎以公允價值記錄。
遞延發行成本和普通股發行成本
公司將某些法律、專業、會計及其他與正在進行的股權融資直接相關的第三方費用記錄爲遞延發行成本，直到這些融資完成。股權融資完成後，這些費用被記錄在股東權益（赤字）中，作爲因發行而產生的收益的減少。截至2024年9月30日和2023年12月31日，遞延發行成本分別爲$
分部
運營部門被定義爲企業的元件，關於這些元件有離散的財務信息可供首席運營決策者在做出資源配置和績效評估決策時進行評估。公司將其業務視爲
可轉換優先股
截至2023年12月31日，公司可轉換優先股在隨附的資產負債表中被歸類爲臨時權益，並且從股東權益/（赤字）中排除，因爲該股的潛在贖回超出了公司的控制範圍，並且需要贖回當時未贖回的可轉換優先股。除非在公司清算、解散或終止時，否則可轉換優先股不可贖回。與可轉換優先股發行相關的費用被記錄爲發行毛收益的減少。由於在2023年12月31日時這些事件的發生被視爲不太可能，因此公司沒有將可轉換優先股的賬面價值累積到贖回價值。2024年4月2日IPO關閉前，公司現有的可轉換優先股自動轉換爲
每股淨損失
歸屬於普通股股東的基本每普通股淨虧損是通過將淨虧損除以期間內已發行普通股的加權平均股數來計算的，而不考慮可能的稀釋證券。歸屬於普通股股東的稀釋每股淨虧損是通過將淨虧損除以期間內已發行的普通股及可能的稀釋證券的加權平均股數來計算的。公司的可能稀釋證券，包括購買普通股的期權、與未歸屬限制性股票及提前行權的期權相關的普通股回購，以及截至2024年4月2日的可轉換優先股，已被排除在稀釋每股淨虧損的計算之外，因爲這會降低每股淨虧損。因此，用於計算基本和稀釋每股淨虧損的已發行普通股的加權平均股數是相同的。
最近採用的會計準則
如 截至2024年9月30日，FASB發佈了幾個新的會計公告，未來將會有采用日期。公司將按照要求於規定日期前採納所有適用的會計公告。管理層正在審查其影響。
8
無界生物公司
摘要的財務報表附註（未經審計）
採納所有待決的會計公告，但尚未能判斷其對公司的基本報表及相關附註的影響。 採納所有待決的會計公告，但尚未能判斷其對公司的基本報表及相關附註的影響。
下表彙總了公司按公允價值定期計量的金融資產及其依據上述第2條說明的公允價值層級的相應輸入水平（以千爲單位）：
|
|
|
|
|
公允價值計量使用 |
|
||||||||||
截至2024年9月30日 |
|
金額 |
|
|
第一級 |
|
|
第二級 |
|
|
第三級 |
|
||||
資產 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
貨幣市場基金 (1) |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
美國政府債務 (2) |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
企業債務證券 (2) |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
資產的總公允價值 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|||
|
|
|
|
|
公允價值計量使用 |
|
||||||||||
截至2023年12月31日 |
|
金額 |
|
|
第一級 |
|
|
第二級 |
|
|
第三級 |
|
||||
資產 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
貨幣市場所有基金類型 (1) |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
美國政府債務 (2) |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
企業債務證券 (2) |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
資產的總公允價值 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|||
公司的貨幣市場基金被歸類爲一級，因爲它們是使用活躍市場中相同資產的報價市場價格進行估值的。公司的投資由可供出售證券組成，並被歸類爲二級，因爲其價值基於使用來自可觀察市場數據的顯著輸入的評估。
總共有
下表總結了按可供出售證券入賬的投資（以千爲單位）：
|
|
截至2024年9月30日 |
|
|||||||||||||
|
|
收購 |
|
|
未實現的 |
|
|
未實現的 |
|
|
估計公平價值 |
|
||||
所有基金類型 |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
美國政府債務 |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
企業債務證券 |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
現金等價物和投資總額 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
分類爲： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
現金等價物 |
|
|
|
|
|
|
|
|
|
|
$ |
|
||||
短期投資 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
現金等價物和投資總額 |
|
|
|
|
|
|
|
|
|
|
$ |
|
||||
9
無界生物公司
摘要的財務報表附註（未經審計）
|
|
截至2023年12月31日 |
|
|||||||||||||
|
|
收購 |
|
|
未實現的 |
|
|
未實現的 |
|
|
估計的公平價值 |
|
||||
所有基金類型 |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
美國政府債務 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
企業債務證券 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
現金等價物和總投資 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
分類爲： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
現金等價物 |
|
|
|
|
|
|
|
|
|
|
$ |
|
||||
短期投資 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
現金及現金等價物和投資總額 |
|
|
|
|
|
|
|
|
|
|
$ |
|
||||
截至2024年9月30日和2023年12月31日，公司所有可供出售投資的剩餘合同到期時間均少於12個月。截至2024年9月30日和2023年12月31日，公司尚未爲其任何可供出售證券設立信用損失準備金。
截至2024年9月30日，
物業和設備，淨值包括以下內容（單位：千）:
|
|
9月30日 |
|
|
2023年12月31日, |
|
||
|
|
2024 |
|
|
2023 |
|
||
實驗室設備 |
|
$ |
|
|
$ |
|
||
計算機和軟件 |
|
|
|
|
|
|
||
租賃改良 |
|
|
|
|
|
|
||
傢俱及裝置 |
|
|
|
|
|
|
||
總的物業和設備 |
|
|
|
|
|
|
||
較少的累計折舊和攤銷 |
|
|
|
|
|
|
||
物業和設備，淨值 |
|
$ |
|
|
$ |
|
||
與物業和設備相關的折舊和攤銷費用爲$
應付賬款和應計負債包括以下內容（單位：千）:
|
|
9月30日 |
|
|
2023年12月31日, |
|
||
應付賬款 |
|
$ |
|
|
$ |
|
||
應計研發成本 |
|
|
|
|
|
|
||
其他應計負債 |
|
|
|
|
|
|
||
應付賬款和應計負債合計 |
|
$ |
|
|
$ |
|
||
10
無界生物公司
摘要的財務報表附註（未經審計）
2022租賃
2021年3月，公司與位於加利福尼亞州聖地亞哥的一處設施簽訂了一項不可取消的運營租賃，該租賃於2021年11月進行修訂（經修訂後爲2022租賃）。2022租賃的初始期限在2024年5月結束，經過修訂後，該期限現在在2024租賃的租賃開始日期之後的第 ",
公司支付了$
2024年租賃
在2021年12月，公司簽訂了一份不可取消的設施租賃，租賃約爲
截至2024年9月30日，儘管2024年租賃下的物業施工已在進行中，但2024年租賃的開始日期尚未確定。2024年租賃的期限爲自租賃開始日期起120個月，租賃付款在爲期六個月的免租期後開始，並持續到租賃期結束。截止到2024年9月30日，房東已通知公司該物業預計將在2024年11月可供使用。有關更多信息，請參見第13條。2024年租賃包括總計$
公司在2024年租約下進行了$的預付款，
合約數
公司在正常的業務過程中與各種第三方簽訂合同，以進行臨床前研究、臨床試驗、測試、製造業-半導體和其他服務。這些合同通常規定在通知後終止，且可在沒有重大罰款或支付的情況下取消，並且不包含任何最低採購承諾。
賠償協議
在正常的業務過程中，公司可能會爲供應商、出租方、業務合作伙伴和其他各方提供不同範圍和條款的賠償，涉及的事項包括但不限於因違反協議或第三方提出的知識產權侵權索賠而產生的損失。此外，公司還與高級職員及其董事會成員簽訂了賠償協議，要求公司在其他事項中賠償他們因其擔任職員或董事的身份或服務可能產生的某些責任。公司可能需要根據這些賠償安排進行的最大潛在未來支付在很多情況下是不受限制的。到目前爲止，公司未因這些賠償而產生任何重大成本。公司未對此類賠償累計任何負債。
11
無界生物公司
摘要的財務報表附註（未經審計）
截至2024年9月30日或2023年12月31日的基本報表中的此類賠償安排，因爲公司判斷根據此類安排產生支付義務的可能性不大。
訴訟
因索賠、評估、訴訟、罰款、處罰和其他來源而產生的損失或有爭議的負債在有很大可能性產生負債且金額可以合理估計時予以記錄。當前沒有任何未決事項已計提負債。公司在截至2024年9月30日的九個月或截至2023年12月31年的期間內不曾作爲任何訴訟的被告。
系列A億和C可轉換優先股
公司在一系列交易中發行了之前未發行的可轉換優先股，如下所示：
普通股用於可轉換優先股的轉換
在2024年4月2日首次公開募股（IPO）關閉之前，公司未償還的可轉換優先股自動轉換爲
可轉換優先股的權利、偏好和特權
以前未償還的可轉換優先股的權利、偏好和特權詳見招股說明書中基本報表附註9的內容。
普通股權利
12
無界生物公司
摘要的財務報表附註（未經審計）
未來發行的普通股
未來發行的普通股包括以下內容：
|
|
截至9月30日， |
|
|
截至12月31日, |
|
||
|
|
2024 |
|
|
2023 |
|
||
轉換現有的可轉換優先股 |
|
|
— |
|
|
|
|
|
已發行和流通的普通股期權 |
|
|
|
|
|
|
||
可供未來發行的股權獎勵 |
|
|
|
|
|
|
||
根據員工股票購買計劃可購買的股份 |
|
|
|
|
|
— |
|
|
總計 |
|
|
|
|
|
|
||
Equity Incentive Plan
在2024年3月，公司董事會採用了2024年激勵獎項計劃（該計劃），並獲得了公司的股東批准，該計劃在首次公開募股過程中生效，期限爲
在採納本計劃之前，公司已根據2018年股權激勵計劃（已修訂，前任計劃）授予普通股期權。根據計劃的條款，2024年3月27日（計劃的生效日期）時已發行的前任計劃的授予標的股份，若隨後被取消或沒收，將可以根據本計劃發放，並將增加可根據計劃發行的股份數量。
重新定價現有期權
在2024年8月，公司董事會的薪酬委員會作爲計劃和前任計劃的管理者，批准了期權重定價，重定價於2024年8月19日生效（生效日期）。該重定價適用於購買公司普通股的期權，數量總計不超過
此次重新定價導致非現金股票基礎補償費用總計增加了$
13
無界生物公司
摘要的財務報表附註（未經審計）
公司。 如果保費結束日期發生在重新定價選項的剩餘歸屬期結束之前，則增量成本將在剩餘歸屬期內按直線法攤銷。
在截至2024年9月30日的三個月和九個月期間，公司確認了與重新定價相關的增量股票補償費用，總計$
期權
計劃下的股票期權活動及其他相關信息如下：
|
|
編號 |
|
|
加權- |
|
|
加權- |
|
|
總計- |
|
||||
截至2023年12月31日的餘額 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
授予 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
行使 |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
被取消和過期 |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
截至2024年9月30日的餘額 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
截至2024年9月30日已歸屬和預計歸屬的權益 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
自2024年9月30日起可行使 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
上述表格中的總內在價值是指公司普通股截至2024年9月30日或2023年12月31日的估計公允價值與行使價格低於該價值的股票期權的行使價格之間的差額。對於重新定價的期權，上述表格中加權平均價格和內在價值信息的計算是基於重新定價生效日期前的每股行使價格，需滿足所需服務要求。
截至2024年9月30日的三個月和九個月內行使的期權的內在價值約爲$
基於股票的薪酬費用
基於股票的補償費用如下（以千爲單位）：
|
|
截至三個月 |
|
|
九個月結束 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
研究和開發費用 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
一般及行政費用 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
總股票薪酬 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
截至2024年9月30日，與未確認的時間型期權相關的補償成本爲$
不考慮期權重新定價的影響，在表中列示的期間內，使用Black-Scholes期權定價模型判斷授予股票期權公允價值的加權平均假設如下：
|
|
截至三個月 |
|
|
九個月結束 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
預期期權人生（以年爲單位） |
|
|
|
|
|
|
|
|
|
|
|
|
||||
假設波動率 |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
||||
假設無風險利率 |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
||||
預期股息收益率 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
14
Boundless Bio, Inc.
Notes to Condensed Financial Statements (Unaudited)
Excluding any effect due to the option repricing, the weighted-average grant date per share fair value of options granted during the three months ended September 30, 2024 and 2023 was $
Employee Stock Purchase Plan
In March 2024, the Company’s board of directors adopted, and the Company’s stockholders approved, the Company’s 2024 Employee Stock Purchase Plan (the ESPP), which became effective in connection with the IPO. The ESPP permits participants to contribute up to a specified percentage of their eligible compensation during a series of offering periods of
The following table summarizes the calculation of basic and diluted net loss per common share attributable to common stockholders (in thousands, except per share data):
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Weighted-average shares of common stock used in |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
The Company excluded the following potential shares of its common stock, presented based on amounts outstanding at each period end, from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
|
|
September 30, |
|
|
|||||
|
|
2024 |
|
|
2023 |
|
|
||
Conversion of outstanding convertible preferred stock |
|
|
|
|
|
|
|
||
Options to purchase common stock |
|
|
|
|
|
|
|
||
Options early exercised subject to future vesting |
|
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
|
||
In November 2024, the 2024 Lease commenced and the Company recorded an ROU asset of $
15
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis and the unaudited interim financial statements included in this Quarterly Report on Form 10-Q should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2023 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in the Prospectus dated March 27, 2024 filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended (Securities Act), with the Securities and Exchange Commission (SEC) on March 28, 2024 (the Prospectus).
Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design, and conduct of our ongoing and planned clinical trials and preclinical studies for our extrachromosomal DNA (ecDNA) directed therapeutic candidates (ecDTx), ecDNA diagnostic candidate, our other discovery program, the timing of expected data readouts, the potential safety and therapeutic benefits of our ecDTx, the timing and likelihood of regulatory filings and approvals for our ecDTx, our ability to commercialize our ecDTx, if approved, the pricing and reimbursement of our ecDTx, if approved, the potential to develop future ecDTx, the potential benefits of strategic collaborations and our intent to enter into any strategic arrangements, the timing and likelihood of success, plans, and objectives of management for future operations, future results of anticipated ecDTx development efforts, and the sufficiency of our cash position to fund operations and achievement of milestones, including initial clinical proof-of-concept data readouts.
In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” or “will” or the negative of these terms or other similar expressions. Our forward-looking statements are only predictions. We have based our forward-looking statements largely on our current expectations and projections about future events and financial and other trends that we believe may affect our business, financial condition, and results of operations. The forward-looking statements in this Quarterly Report speak only as of the date of the filing of this Quarterly Report with the SEC and are subject to a number of known and unknown risks, uncertainties, and assumptions, including, without limitation, the risk factors described in Part II, Item 1A, “Risk Factors” of our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024, filed with the SEC on May 13, 2024, which are incorporated herein by reference. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and our actual results, performance, or achievements could differ materially from those expressed or implied by our forward-looking statements. Given these uncertainties, you should not place undue reliance on any forward-looking statement. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Overview
We are a clinical-stage oncology company dedicated to unlocking a new paradigm in cancer therapeutics that addresses the significant unmet need in patients with oncogene amplified tumors by targeting ecDNA, a root cause of oncogene amplification observed in more than 14% of cancer patients. Using our proprietary Spyglass platform, we identify targets essential for ecDNA functionality in cancer cells, then design and develop ecDTx to inhibit those targets with the aim to prevent cancer cells from using ecDNA to grow, adapt, and become resistant to existing therapies. Instead of directly targeting the proteins produced by amplified oncogenes, like the approach of traditional targeted therapies, our ecDTx are intended to be synthetic lethal in tumor cells reliant on ecDNA. They are designed to disrupt the underlying cellular machinery that enables ecDNA to function properly, such as proteins essential for ecDNA replication, transcription, assembly, repair, and segregation.
Our lead ecDTx, BBI-355, is a novel, oral, selective small molecule inhibitor of checkpoint kinase 1 (CHK1) being studied in the ongoing first-in-human, Phase 1/2 POTENTIATE clinical trial in patients with oncogene amplified cancers (clinicaltrials.gov identifier NCT05827614). As of September 30, 2024, no new safety signals have been observed. Based on current projections, we expect to have preliminary clinical proof-of-concept safety and antitumor activity data from the POTENTIATE trial in the second half of 2025.
Our second ecDTx, BBI-825, is a novel, oral, selective small molecule inhibitor of ribonucleotide reductase (RNR) being studied in the ongoing first-in-human, Phase 1/2 STARMAP clinical trial in colorectal cancer patients with BRAFV600E or KRASG12C mutations and resistance oncogene amplifications (clinicaltrials.gov identifier NCT06299761). Multiple dose levels have been completed in the single-agent, dose-escalation portion of the trial and, to date, BBI-825 has demonstrated oral bioavailability and has been generally well-tolerated. We expect to have preliminary clinical proof-of-concept safety and antitumor data from the STARMAP trial in the second half of 2025.
Our third ecDTx program, in the drug discovery stage, is directed at a previously undrugged kinesin target essential for ecDNA segregation and inheritance during cell division. We are advancing this program through drug discovery to candidate identification and expect to submit an Investigational New Drug application (IND) in the first half of 2026.
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Through our Spyglass platform, we are able to identify and preclinically validate additional ecDNA-essential targets. In addition to our three ecDTx programs described above, we have preclinically validated multiple additional ecDNA targets and have initiated ecDTx drug discovery efforts to identify candidates against such targets. To date, all of our ecDTx have been discovered internally, and we retain global rights for all of our programs.
To assist in identifying patients that may benefit from our ecDTx, we have developed an ecDNA diagnostic test, internally called ECHO (ecDNA Harboring Oncogenes), to detect ecDNA in patient tumor samples via routine next generation sequencing (NGS) assays. In partnership with an in vitro diagnostic company, we developed and analytically validated the ecDNA diagnostic test for use as a clinical trial assay in the PONTENTIATE trial. The U.S. Food and Drug Administration (FDA) has determined that the ecDNA diagnostic is a non-significant risk device when used in patient selection for the POTENTIATE trial, meaning that FDA approval of an investigational device exemption is not required for the use of the ecDNA diagnostic in this trial. We have received institutional review board approval for use of the ecDNA diagnostic as a clinical trial assay in the POTENTIATE trial.
Since we commenced operations in 2018, we have devoted substantially all of our efforts and resources to organizing and staffing our company, business planning, raising capital, building our proprietary Spyglass platform, discovering our ecDTx, developing our ecDNA diagnostic candidate, establishing our intellectual property portfolio, conducting research, preclinical studies, and clinical trials, establishing arrangements with third parties for the manufacture of our ecDTx and related raw materials, and providing general and administrative support for these operations.
We have incurred significant operating losses since our inception and, as of September 30, 2024, we had an accumulated deficit of $185.0 million. We expect to continue to incur losses for the foreseeable future, and anticipate these losses will increase substantially as we continue our development of, seek regulatory approval for, and potentially commercialize any of our ecDTx, seek to discover and develop additional ecDTx, develop our ecDNA diagnostic, conduct our ongoing and planned clinical trials and preclinical studies, continue our research and development activities, utilize third parties to manufacture our ecDTx and related raw materials, hire additional personnel, seek to expand and protect our intellectual property, as well as incur additional costs associated with being a public company. If we obtain regulatory approval for any of our ecDTx, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials, preclinical studies, and our other research and development activities and capital expenditures.
In April 2024, we completed our initial public offering (IPO) pursuant to which we sold 6,250,000 shares of our common stock for gross proceeds of $100.0 million. Through September 30, 2024, we have raised a total of $353.6 million to fund our operations primarily from the gross proceeds from the sale and issuance of our convertible preferred stock and from our IPO. As of September 30, 2024, we had cash, cash equivalents, and short-term investments of $167.1 million. In August 2024, we announced our intention to scale back our early discovery efforts, including a modest reduction in workforce, to extend our operating runway and had implemented these planned cost reduction measures as of September 30, 2024. Based upon our current operating plans, we believe that our existing cash, cash equivalents, and short-term investments will be sufficient to fund our operations into the fourth quarter of 2026.
We do not have any products approved for sale and have not generated any revenue to date. We do not expect to generate any revenue from product sales until we successfully complete development and obtain regulatory approval for one or more of our ecDTx, which we expect will take a number of years and which may never occur. We will need substantial additional funding to support our continuing operations and pursue our long-term business plan, including to complete the development and commercialization of our ecDTx, if approved. Accordingly, until such time as we can generate significant revenue from sales of our ecDTx, if ever, we expect to finance our cash needs through equity offerings, debt financings, or other capital sources, including potential collaborations, licenses, and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce, or terminate our research and development programs or other operations, or grant rights to develop and market ecDTx that we would otherwise prefer to develop and market ourselves.
We do not own or operate, and currently have no plans to establish, any manufacturing facilities. We rely, and expect to continue to rely, on third parties for the manufacture of our ecDTx for preclinical and clinical testing, as well as for commercial manufacture if any of our ecDTx obtain marketing approval. We are working with our current manufacturers to ensure that we will be able to scale up our manufacturing capabilities to support our clinical plans. In addition, we rely on third parties to package, label, store, and distribute our ecDTx, and we intend to rely on third parties for our commercial products if marketing approval is obtained. We believe that this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment, and personnel while also enabling us to focus our expertise and resources on the discovery and development of our ecDTx.
Components of Our Results of Operations
Revenue
To date, we have not generated any revenue from the sale of products. We do not expect to generate any such revenue unless and until such time that our ecDTx have advanced through clinical development and regulatory approval, if ever. If we fail to complete
17
preclinical and clinical development of ecDTx or obtain regulatory approval for them, our ability to generate future revenues, and our results of operations and financial position would be adversely affected.
Operating Expenses
Our operating expenses consist of research and development expenses and general and administrative expenses.
Research and Development
Our research and development (R&D) expenses have related primarily to the building of our Spyglass platform, our ecDTx discovery efforts, our preclinical and clinical development activities, and the development of an ecDNA diagnostic test. Our R&D expenses consist of:
R&D expenses are recognized as incurred, and payments made prior to the receipt of goods or services to be used in R&D are capitalized until the goods or services are received. We use internal resources primarily to conduct our research and discovery activities, as well as for managing our preclinical development, process development, manufacturing, and clinical development activities. We track direct costs on a development program specific basis. Indirect costs are not included in program costs, as these costs are general in nature and benefit all of our discovery efforts and development programs.
Although R&D activities are central to our business model, the successful development of our ecDTx is highly uncertain. There are numerous factors associated with the successful development of any ecDTx, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. In addition, future regulatory factors beyond our control may impact our clinical development programs. Product candidates in later stages of development generally have higher development costs than those in earlier stages of development. As a result, we expect that our R&D expenses will increase substantially for the foreseeable future as we continue to conduct our ongoing R&D activities, advance preclinical research programs toward clinical development, conduct clinical trials, hire additional personnel, and maintain, expand, protect, and enforce our intellectual property portfolio.
Our future R&D expenses may vary significantly based on a wide variety of factors such as:
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A change in the outcome of any of these variables with respect to development of any of our ecDTx could significantly change the costs and timing associated with the development of that ecDTx.
The process of conducting the necessary preclinical and clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for our current ecDTx or any future ecDTx may be affected by a variety of factors. We may never succeed in achieving regulatory approval for any of our ecDTx. Preclinical and clinical development timelines, the probability of success, and total development costs can differ materially from expectations. We anticipate that we will make determinations as to which ecDTx to pursue and how much funding to direct to each ecDTx on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments, and our ongoing assessments as to each ecDTx’s commercial potential. We will need to raise substantial additional capital in the future. In addition, we cannot forecast which ecDTx may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
General and Administrative
General and administrative (G&A) expenses consist primarily of personnel-related costs, including salaries, bonuses, benefits, travel, and stock-based compensation expenses for employees in executive, accounting and finance, business development, legal, and other administrative functions. Other significant costs include allocated facility-related costs, legal fees relating to intellectual property and corporate matters, professional fees for accounting and consulting services, insurance costs, and business development expenses.
We expect that our G&A expenses will increase substantially for the foreseeable future as we continue to increase our G&A headcount to support our continued R&D activities and, if any ecDTx receive marketing approval, commercialization activities, as well as to support our operations generally. We also expect to incur increased expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with securities exchange listing and SEC requirements, director and officer insurance premiums, and investor relations costs associated with operating as a public company.
Other Income (Expense), Net
Other income (expense), net consists primarily of interest income earned on our cash, cash equivalents, and investments.
19
Results of Operations
Comparison of the Three Months Ended September 30, 2024 and 2023
The following table summarizes our results of operations for each of the periods indicated (in thousands):
|
|
Three Months Ended |
|
|
|
|
||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
14,089 |
|
|
$ |
11,645 |
|
|
$ |
2,444 |
|
General and administrative |
|
|
4,626 |
|
|
|
3,308 |
|
|
|
1,318 |
|
Total operating expenses |
|
|
18,715 |
|
|
|
14,953 |
|
|
|
3,762 |
|
Loss from operations |
|
|
(18,715 |
) |
|
|
(14,953 |
) |
|
|
(3,762 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
|
|||
Interest income |
|
|
2,174 |
|
|
|
1,748 |
|
|
|
426 |
|
Other income, net |
|
|
32 |
|
|
|
32 |
|
|
|
- |
|
Total other income, net |
|
|
2,206 |
|
|
|
1,780 |
|
|
|
426 |
|
Net loss |
|
$ |
(16,509 |
) |
|
$ |
(13,173 |
) |
|
$ |
(3,336 |
) |
Research and Development Expenses
The following table summarizes our R&D expenses for each of the periods indicated (in thousands):
|
|
Three Months Ended |
|
|
|
|
||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Direct program costs: |
|
|
|
|
|
|
|
|
||||
BBI-355 |
|
$ |
2,354 |
|
|
$ |
1,802 |
|
|
$ |
552 |
|
BBI-825 |
|
|
3,246 |
|
|
|
2,093 |
|
|
|
1,153 |
|
Other development programs |
|
|
1,640 |
|
|
|
1,490 |
|
|
|
150 |
|
Total direct program costs: |
|
|
7,240 |
|
|
|
5,385 |
|
|
|
1,855 |
|
Indirect program costs |
|
|
|
|
|
|
|
|
||||
Personnel-related (including stock compensation) |
|
|
4,485 |
|
|
|
3,572 |
|
|
|
913 |
|
Outside services and consulting |
|
|
735 |
|
|
|
917 |
|
|
|
(182 |
) |
Lab and pharmacology supplies |
|
|
439 |
|
|
|
760 |
|
|
|
(321 |
) |
Facilities-related (including depreciation) |
|
|
708 |
|
|
|
692 |
|
|
|
16 |
|
Other indirect program costs |
|
|
482 |
|
|
|
319 |
|
|
|
163 |
|
Total indirect program costs: |
|
|
6,849 |
|
|
|
6,260 |
|
|
|
589 |
|
Total R&D expenses |
|
$ |
14,089 |
|
|
$ |
11,645 |
|
|
$ |
2,444 |
|
R&D expenses were $14.1 million for the three months ended September 30, 2024, compared to $11.6 million for the same period in 2023. The increase in R&D expenses was primarily due to a $1.9 million increase in direct program costs for our BBI-355, BBI-825, and other development programs, a $0.5 million increase in personnel-related costs due to an increase in personnel and annual salary increases, and $0.4 million of additional stock-based compensation, partially offset by a $0.5 million decrease in third-party services and other miscellaneous R&D costs.
General and Administrative Expenses
G&A expenses were $4.6 million for the three months ended September 30, 2024, compared to $3.3 million for the same period in 2023. The increase in G&A expenses was due to a $0.4 million increase in personnel-related costs resulting from an increase in personnel and annual salary increases, $0.7 million of additional stock-based compensation, and a $0.5 million increase in other G&A costs; partially offset by a decrease in professional service fees of $0.3 million.
Other Income, Net
Other income, net was $2.2 million and $1.8 million for the three months ended September 30, 2024 and 2023, respectively. The $0.4 million increase resulted from the additional interest income generated by our available-for-sale investment securities portfolio due to the net proceeds from the sale of our common stock in our IPO in April 2024, as well as the increase in market yields available for such investment securities in comparison to the prior year period.
20
Comparison of the Nine Months Ended September 30, 2024 and 2023
The following table summarizes our results of operations for each of the periods indicated (in thousands):
|
|
Nine Months Ended |
|
|
|
|
||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
41,953 |
|
|
$ |
32,223 |
|
|
$ |
9,730 |
|
General and administrative |
|
|
13,036 |
|
|
|
8,777 |
|
|
|
4,259 |
|
Total operating expenses |
|
|
54,989 |
|
|
|
41,000 |
|
|
|
13,989 |
|
Loss from operations |
|
|
(54,989 |
) |
|
|
(41,000 |
) |
|
|
(13,989 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
|
|||
Interest income |
|
|
5,977 |
|
|
|
3,662 |
|
|
|
2,315 |
|
Other income, net |
|
|
97 |
|
|
|
48 |
|
|
|
49 |
|
Total other income, net |
|
|
6,074 |
|
|
|
3,710 |
|
|
|
2,364 |
|
Net loss |
|
$ |
(48,915 |
) |
|
$ |
(37,290 |
) |
|
$ |
(11,625 |
) |
Research and Development Expenses
The following table summarizes our R&D expenses for each of the periods indicated (in thousands):
|
|
Nine Months Ended |
|
|
|
|
||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Direct program costs: |
|
|
|
|
|
|
|
|
||||
BBI-355 |
|
$ |
7,347 |
|
|
$ |
5,697 |
|
|
$ |
1,650 |
|
BBI-825 |
|
|
8,707 |
|
|
|
4,464 |
|
|
|
4,243 |
|
Other development programs |
|
|
4,093 |
|
|
|
3,555 |
|
|
|
538 |
|
Total direct program costs: |
|
|
20,147 |
|
|
|
13,716 |
|
|
|
6,431 |
|
Indirect program costs |
|
|
|
|
|
|
|
|
||||
Personnel-related (including stock compensation) |
|
|
13,071 |
|
|
|
10,084 |
|
|
|
2,987 |
|
Outside services and consulting |
|
|
3,600 |
|
|
|
2,939 |
|
|
|
661 |
|
Lab and pharmacology supplies |
|
|
1,639 |
|
|
|
2,401 |
|
|
|
(762 |
) |
Facilities-related (including depreciation) |
|
|
2,125 |
|
|
|
2,133 |
|
|
|
(8 |
) |
Other indirect program costs |
|
|
1,371 |
|
|
|
950 |
|
|
|
421 |
|
Total indirect program costs: |
|
|
21,806 |
|
|
|
18,507 |
|
|
|
3,299 |
|
Total R&D expenses |
|
$ |
41,953 |
|
|
$ |
32,223 |
|
|
$ |
9,730 |
|
R&D expenses were $42.0 million for the nine months ended September 30, 2024, compared to $32.2 million for the same period in 2023. The increase in R&D expenses was primarily due to a $6.4 million increase in the direct program costs for our BBI-355, BBI-825, and other development programs, a $1.8 million increase in personnel-related costs resulting from an increase in headcount and salary increases, $1.2 million of additional stock-based compensation, and a $0.4 million increase in third-party services and other miscellaneous R&D costs.
General and Administrative Expenses
G&A expenses were $13.0 million for the nine months ended September 30, 2024, compared to $8.8 million for the same period in 2023. The increase in G&A expenses was primarily due to a $1.1 million increase in personnel-related costs due to an increase in headcount and salary increases, $1.9 million of additional stock-based compensation, an increase in professional service fees of $0.4 million, and a $0.8 million increase in other G&A costs.
Other Income, Net
Other income, net was $6.1 million and $3.7 million for the nine months ended September 30, 2024 and 2023, respectively. The $2.4 million increase resulted from the additional interest income generated by our available-for-sale investment securities portfolio due to the net proceeds from the sale of our common stock in our IPO in April 2024, as well as the increase in market yields available for such investment securities in comparison to the prior year period.
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Liquidity and Capital Resources
Sources of Liquidity
Through September 30, 2024, we have raised a total of $353.6 million to fund our operations primarily from the gross proceeds from the sale and issuance of our convertible preferred stock and the sale and issuance of 6,250,000 shares of our common stock in our IPO in April 2024 for gross proceeds of $100.0 million.
Future Funding Requirements
As of September 30, 2024, we had cash, cash equivalents, and short-term investments of $167.1 million. Based upon our current operating plans, we believe that our existing cash, cash equivalents, and short-term investments will be sufficient to fund our operations into the fourth quarter of 2026. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of conducting preclinical studies, manufacturing ecDTx, developing our ecDNA diagnostic, and testing ecDTx in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain.
We have incurred significant operating losses since our inception and, as of September 30, 2024, we had an accumulated deficit of $185.0 million. We expect to continue to incur losses for the foreseeable future, and we anticipate these losses will increase substantially as we continue our development of, seek regulatory approval for, and potentially commercialize any of our ecDTx, seek to discover and develop additional ecDTx, develop our ecDNA diagnostic, conduct our ongoing and planned clinical trials and preclinical studies, continue our research and development activities, utilize third parties to manufacture our ecDTx and related raw materials, hire additional personnel, seek to expand and protect our intellectual property, as well as incur additional costs associated with being a public company. If we obtain regulatory approval for any of our ecDTx, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials, preclinical studies, and our other research and development activities and capital expenditures.
Our future capital requirements are difficult to predict and depend on many factors, including but not limited to:
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We have no committed sources of capital. Until we can generate sufficient product revenue to finance our cash requirements, if ever, we expect to finance our future cash needs primarily through equity offerings, debt financings, or other capital sources, including potential collaborations, licenses, and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise additional funds through other collaborations or licensing arrangements with third parties, we may have to relinquish valuable rights to our future revenue streams, ecDTx, research programs, intellectual property or proprietary technology, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce, or terminate our R&D programs or other operations, or grant rights to develop and market ecDTx to third parties that we would otherwise prefer to develop and market ourselves, or on less favorable terms than we would otherwise choose.
Cash Flows
The following table summarizes our cash flows for each of the periods indicated:
|
|
Nine Months Ended |
|
|
|
|
||||||
|
|
September 30, |
|
|
|
|
||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Net cash used in operating activities |
|
$ |
(45,278 |
) |
|
$ |
(35,169 |
) |
|
$ |
(10,109 |
) |
Net cash used in investing activities |
|
|
(27,924 |
) |
|
|
(54,072 |
) |
|
|
26,148 |
|
Net cash provided by financing activities |
|
|
89,710 |
|
|
|
99,281 |
|
|
|
(9,571 |
) |
Net increase in cash, cash equivalents, and |
|
$ |
16,508 |
|
|
$ |
10,040 |
|
|
$ |
6,468 |
|
Operating Activities
Net cash used in operating activities was $45.3 million and $35.2 million for the nine months ended September 30, 2024 and 2023, respectively. The net cash used in operating activities during the nine months ended September 30, 2024 was primarily due to our reported net loss of $48.9 million, net of noncash charges (including stock-based compensation expense, depreciation, and right-of-use asset amortization) totaling $4.2 million and a $0.6 million increase of our net operating assets. The net cash used in operating activities during the nine months ended September 30, 2023 was primarily due to our reported net loss of $37.3 million and a $0.6 million increase in our net operating assets, adjusted for noncash charges (including stock-based compensation expense, depreciation) totaling $2.7 million. The increase in cash used in operations during the nine months ended September 30, 2024 in comparison to the nine months ended September 30, 2024 was primarily attributable to higher personnel-related costs and an increase in third-party spending associated with our discovery, development, and clinical activities.
Investing Activities
Investing activities consist primarily of the cash flows of purchases and maturities of investment securities and the cash outflow associated with purchases of property and equipment. Such activities resulted in a net outflow of funds of approximately $27.9 million and $54.1 million during the nine months ended September 30, 2024 and 2023, respectively, primarily from the net purchases of our available-for-sale securities portfolio.
Financing Activities
Our financing activities consist of the proceeds from sales of our common and convertible preferred stock and, to a lesser extent, the exercise of common stock options by our employees and consultants. Net cash provided by financing activities was $89.7 million and $99.3 million during the nine months ended September 30, 2024 and 2023, respectively. The increase in cash provided by financing activities for the first nine months of 2024 was primarily due to the net proceeds from our IPO. The increase in cash provided by financing activities for the first nine months of 2023 was primarily the result of the net proceeds from the sale of our Series C convertible preferred stock.
Contractual Obligations and Other Commitments
We lease office and lab space under lease agreements with varying expiration dates through 2034. As of September 30, 2024, total future aggregate operating lease commitments was $72.3 million, which is exclusive of variable lease payments for common area maintenance and property taxes under the 2024 Lease. During the normal course of our business, we enter into contracts for research
23
and professional services, and for the purchase of lab supplies used in our research activities. These contracts generally provide for termination after a notice period, and, therefore, are cancelable contracts and not separately presented.
Off-Balance Sheet Arrangements
Since our inception, we have not had, and we do not currently have, any off-balance sheet arrangements as defined under rules and regulations of the SEC.
Critical Accounting Policies and Significant Estimates and Judgments
Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation. We base our estimates on historical experience, known trends and events, and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no material changes to our critical accounting policies and estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Significant Estimates and Judgments” included in the Prospectus, except that from the effectiveness date of our registration statement on Form S-1 (File No. 333-277696), we have a publicly traded stock price and no longer require common stock valuations.
Emerging Growth Company and Smaller Reporting Company Status
As an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the JOBS Act), we can take advantage of an extended transition period for complying with new or revised accounting standards. This period allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this exemption from new or revised accounting standards and, therefore, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates. We also intend to rely on other exemptions provided by the JOBS Act, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of Sarbanes-Oxley for so long as we are exempt from doing so.
We will remain an emerging growth company until the earliest of (i) December 31, 2029, which is the last day of the fiscal year following the fifth anniversary of the consummation of our IPO; (ii) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion; (iii) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year; or (iv) the date on which we have issued more than $1.0 billion in nonconvertible debt securities during the prior three-year period.
We are also a smaller reporting company as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company, as defined by Rule 12b-2 under the Exchange Act and in Item 10(f)(1) of Regulation S-K, and are not required to provide the information under this item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation and supervision of our principal executive officer and our principal financial and accounting officer, have evaluated our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the
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Exchange Act. Based on that evaluation, our principal executive officer and our principal financial and accounting officer have concluded that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial and accounting officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
Due to a transition period established by SEC rules applicable to newly public companies, our management is not required to evaluate the effectiveness of our internal control over financial reporting until after the filing of our Annual Report on Form 10-K for the year ending December 31, 2025. As a result, this Quarterly Report on Form 10-Q does not address whether there have been any changes in our internal control over financial reporting.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
There currently is no material pending legal proceeding to which we are a party or to which any of our property is subject, and our management is not aware of any contemplated proceeding by any governmental authority against us. From time to time, we may become involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources, negative publicity, reputational harm, and other factors and there can be no assurances that favorable outcomes will be obtained.
Item 1A. Risk Factors.
Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described in Part II, Item 1A, “Risk Factors” of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, together with all of the information in this Quarterly Report and the Prospectus, before making an investment decision to purchase or sell shares of our common stock. If any of those risks are realized, our business, financial condition, results of operations, and prospects could be materially and adversely affected. In that event, the trading price of our common stock could decline, and you could lose part or all of your investment. There have been no material changes to the risk factors disclosed in Part II, Item 1A, “Risk Factors” of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
On March 27, 2024, our registration statement on Form S-1 (File No. 333-277696), as amended, was declared effective by the SEC for our IPO. There has been no material change in the planned use of proceeds from the IPO from that described in the Prospectus.
Not applicable.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Rule 10b5-1 Trading Arrangements
From time to time, our officers (as defined in Rule 16a-1(f) of the Exchange Act) and directors may enter into or terminate Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements (as each such term is defined in Item 408 of Regulation S-K). During the three months ended September 30, 2024,
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Item 6. Exhibits.
Exhibit |
|
|
Incorporated by Reference |
Filed |
||
Number |
|
Description |
Form |
Date |
Number |
Herewith |
3.1 |
|
8-K |
4/2/24 |
3.1 |
|
|
3.2 |
|
8-K |
4/2/24 |
3.2 |
|
|
4.1 |
|
Specimen stock certificate evidencing the shares of common stock |
S-1/A |
3/21/24 |
4.1 |
|
4.2 |
|
S-1 |
3/6/24 |
4.2 |
|
|
10.1# |
|
|
|
|
X |
|
31.1 |
|
|
|
|
X |
|
31.2 |
|
|
|
|
X |
|
32.1* |
|
|
|
|
X |
|
101.INS |
|
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
|
|
|
X |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
|
|
|
X |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
|
|
|
X |
# Indicates management contract or compensatory plan.
* These certifications are deemed not filed for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall they be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
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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.
|
|
Boundless Bio, Inc. |
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|
|
|
|
Date: November 7, 2024 |
|
By: |
/s/ Zachary D. Hornby |
|
|
|
Zachary D. Hornby |
|
|
|
President and Chief Executive Officer |
|
|
|
(Principal Executive Officer) |
|
|
|
|
Date: November 7, 2024 |
|
By: |
/s/ David Hinkle |
|
|
|
David Hinkle |
|
|
|
Senior Vice President, Finance, Controller and Treasurer |
|
|
|
(Principal Financial and Accounting Officer) |
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