美國
證券交易委員會
華盛頓特區20549
Form
截至季度結束日期的財務報告
or
過渡期從到
委託文件編號：001-39866
(公司章程中指定的)完整註冊名稱
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（國家或其他管轄區的 公司成立或組織） |
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（IRS僱主 唯一識別號碼） |
（總部地址，包括郵政編碼）
註冊人的電話號碼，包括區號：
(
根據證券交易法案第12(b)條規定註冊或將要註冊的證券。
每一類的名稱 |
交易標的 |
在其上註冊的交易所的名稱 |
股市 |
請在以下方框內打勾，以指示註冊人是否（1）已在過去12個月內（或在註冊人需要提交此類報告的較短期間內）提交了交易所法案第13或15（d）條規定的所有要求提交的報告，並且（2）在過去90天內一直需要遵守提交要求。
☑ 否 ☐
請在勾選標誌處表示註冊人是否已經在過去12個月內（或者在註冊人要求提交這些文件的較短時期內）按照規則405 of協議S-T（本章節的§232.405）提交了每個交互式數據文件。 ☒ 沒有 ☐
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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非加速文件提交人 |
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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。 ☐
用複選標記表明註冊人是否爲空殼公司（定義見《交易法》第12b-2條）。是的 ☐ 沒有
2024年11月8日，發行人普通股的流通股數量：
Agenus公司。
2024年9月30日止九個月
目錄
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第一部分 |
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項目 1。 |
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2 |
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ITEm 2. |
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控件3。 |
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控件4。 |
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第II部分 |
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項目 1。 |
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項目1A. |
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第5項 |
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項目6。 |
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第一部分 - 財務信息
項目1。 基本報表
艾吉納斯公司及其子公司
壓縮的綜合資產負債表TED資產負債表
（除每股股價和每股收益之外的所有金額均以千爲單位）
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2024年9月30日 |
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2023年12月31日 |
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資產 |
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現金及現金等價物 |
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應收賬款 |
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預付費用 |
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其他流動資產 |
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總流動資產 |
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物業、廠房及設備淨值，減去累計攤銷和折舊 |
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經營租賃使用權資產 |
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商譽 |
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購買的無形資產，減去累計攤銷$ |
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其他長期資產 |
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總資產 |
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$ |
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負債和股東赤字 |
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長期負債的流動部分 |
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$ |
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$ |
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與未來版稅和里程碑出售相關的負債的流動部分 |
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短期部分，遞延營收 |
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短期部分，經營租賃負債 |
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應付賬款 |
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應計負債 |
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其他流動負債 |
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流動負債合計 |
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開多期債務，淨電流部分 |
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與未來版稅和里程碑銷售有關的負債，減去短期部分淨額 |
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遞延收入，減去當前部分淨額 |
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經營租賃負債，淨值超過流動資產 |
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其他長期負債 |
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股東權益虧損 |
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A-1系列可轉換優先股； |
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普通股，每股面值 $，授權股數：百萬股；發行股數：分別爲2024年6月30日和2023年12月31日：百萬股；流通股數：分別爲2024年6月30日和2023年12月31日：百萬股 |
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額外實收資本 |
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累計其他綜合損失 |
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累積赤字 |
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Agenus Inc.歸屬於股東的總股東赤字 |
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非控制權益 |
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股東赤字總額 |
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負債總額和股東權益虧損總額 |
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$ |
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$ |
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請參見附註的未經審計的簡明合併財務報表。
2
艾吉納斯公司及其子公司
簡明綜合損益表合併財務報表F經營和綜合損失
(未經審計)
（金額爲千元，除每股金額外）
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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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營業收入： |
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研發 |
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$ |
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$ |
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$ |
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服務收入 |
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與未來特許權出售相關的非現金版稅收入 |
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總收入 |
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營業費用： |
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服務成本 |
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研發 |
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總務和行政 |
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公允價值調整 |
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Operating loss |
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其他收入（費用）： |
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營業外收入 |
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利息費用，淨額 |
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淨損失 |
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A-1可轉換優先股股息 |
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減：歸屬於非控股權益的淨虧損 |
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歸屬Agenus 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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$ |
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每股普通股數據： |
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Agenus Inc.普通股股東的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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Agenus Inc.普通股平均流通股數： |
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基本和稀釋 |
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其他全面損失： |
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外幣匯兌損失 |
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$ |
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其他綜合損失 |
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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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請參見附註的未經審計的簡明合併財務報表。
3
艾吉納斯公司及其子公司
可轉換優先股和股東赤字的簡明合併報表
（未經審計）
（以千爲單位）
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A-1系列 |
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可轉換證券 |
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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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數量 |
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Par |
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數量 |
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Par |
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其他 |
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數字 |
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金額 |
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累計 |
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非控制股東 |
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累計 |
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合計 |
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2023年12月31日的餘額 |
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$ |
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$ |
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$ |
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— |
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$ |
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$ |
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$ |
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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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其他綜合損失 |
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— |
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— |
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— |
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基於股份的補償 |
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— |
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— |
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— |
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— |
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— |
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股票在市場上出售 |
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— |
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通過股票支付CEO的薪酬 |
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未投資股份的歸屬權 |
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行使股票期權和員工購買股份 |
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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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淨損失 |
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— |
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其他綜合收益 |
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— |
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基於股份的補償 |
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股票在市場上出售 |
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發行認股權證，減去費用 |
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非受限股份的釋放 |
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通過股票支付CEO的薪資 |
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MiNk定向增發股票出售 |
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— |
|
|
|
|
||
執行股票期權 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||||
2024年6月30日餘額 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||
淨損失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
其他綜合損失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
基於股份的補償 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
市場上出售股份 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
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|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
以股份支付CEO工資 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
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|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
非質押股份的解鎖 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
行使股票期權和員工購買股份 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||||
2024年9月30日的餘額 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||
請參見附註的未經審計的簡明合併財務報表。
4
艾吉納斯公司及其子公司
可轉換優先股和股東赤字的簡明合併報表
（未經審計）
（以千爲單位）
|
|
A-1系列 |
|
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||||||||||||||
|
|
可轉換證券 |
|
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|
||||||||||||||
|
|
優先股 |
|
|
普通股 |
|
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|
|
庫藏股 |
|
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|
||||||||||||||||||||
|
|
數量 |
|
|
Par |
|
|
數量 |
|
|
面值 |
|
|
其他 |
|
|
數字 |
|
|
金額 |
|
|
累計 |
|
|
非控制股東 |
|
|
累積 |
|
|
合計 |
|
|||||||||||
2022年12月31日的餘額 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||||||
淨損失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
其他綜合收益 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
基於股份的補償 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
市場上出售的股票 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
董事延期股份發行 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
發行股份以換取服務 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
行使股票期權和員工購股 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||||
發行子公司股份作爲員工獎金 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
發行股份作爲員工獎金 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
回購庫藏股份 |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
2023年3月31日的餘額 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||||||
淨損失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
其他綜合損失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
基於股票的補償 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
市場上出售的股份 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
MiNk股息 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
MiNk股票購買 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
發行子公司股份作爲員工獎金 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
發行股份作爲員工獎金 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
自家股份的養老 |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
2023年6月30日的餘額 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||
淨損失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
其他全面損失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
基於股份的薪酬 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
在市場上出售的股份 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
以股份支付CEO工資 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
MiNk股票購買 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
發行股份換取服務 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
未投資股份的歸屬權 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
員工購買股份 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||||
2023年9月30日財務狀況表 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||
請參考財務報表的相關說明.
5
AGENUS INC.和子公司
簡明合併財務報表現金流量表
(未經審計)
（金額爲千元，除每股金額外）
|
|
截至9月30日的九個月 |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
經營活動現金流量： |
|
|
|
|
|
|
||
淨損失 |
|
$ |
( |
) |
|
$ |
( |
) |
調整爲淨損失到經營活動現金流量淨使用： |
|
|
|
|
|
|
||
折舊與攤銷 |
|
|
|
|
|
|
||
基於股份的補償 |
|
|
|
|
|
|
||
非現金版稅收入 |
|
|
( |
) |
|
|
( |
) |
非現金利息費用 |
|
|
|
|
|
|
||
用於計算每股普通股股東淨收益的加權平均股數： |
|
|
|
|
|
|
||
租賃終止的收益 |
|
|
( |
) |
|
|
— |
|
其他，淨額 |
|
|
( |
) |
|
|
|
|
經營性資產和負債變動: |
|
|
|
|
|
|
||
應收賬款 |
|
|
|
|
|
|
||
預付費用 |
|
|
|
|
|
( |
) |
|
應付賬款 |
|
|
( |
) |
|
|
|
|
遞延營業收入 |
|
|
( |
) |
|
|
( |
) |
應計的負債和其他流動負債 |
|
|
|
|
|
|
||
其他營運資產和負債 |
|
|
( |
) |
|
|
( |
) |
經營活動使用的淨現金流量 |
|
|
( |
) |
|
|
( |
) |
投資活動現金流量： |
|
|
|
|
|
|
||
購買固定資產 |
|
|
( |
) |
|
|
( |
) |
出售廠房和設備的收益 |
|
|
|
|
|
|
||
購買長期投資 |
|
|
— |
|
|
|
( |
) |
出售長期投資的收益 |
|
|
|
|
|
— |
|
|
可供出售證券購買 |
|
|
— |
|
|
|
( |
) |
可供出售證券的出售收益 |
|
|
— |
|
|
|
|
|
投資活動提供的淨現金流量 |
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籌集資金的現金流量： |
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股權出售所得淨額 |
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定向增發中子公司股份出售所得淨額 |
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— |
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利根購買協議所得款項，扣除費用後淨額 |
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— |
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員工購買股票和期權行權所得款項 |
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||
購買公司庫存股以支付稅款 |
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— |
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( |
) |
購買子公司股份 |
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— |
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( |
) |
支付融資租賃債務 |
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( |
) |
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( |
) |
籌資活動產生的現金淨額 |
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匯率變動對現金的影響 |
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( |
) |
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( |
) |
現金、現金等價物和受限制現金淨減少額 |
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( |
) |
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( |
) |
期初現金、現金等價物及受限制的現金 |
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期末現金、現金等價物及受限制的現金 |
|
$ |
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$ |
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||
補充現金流量信息： |
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支付的利息現金 |
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$ |
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$ |
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||
其他信息披露 - 非現金活動： |
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||
普通股發行，$ |
|
$ |
— |
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|
$ |
|
|
保險融資協議 |
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||
發放股票期權以支付一定員工獎金 |
|
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— |
|
|
普通股發行，$ |
|
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— |
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發行子公司期權，以支付某些員工獎金 |
|
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— |
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發行子公司股票，以支付某些員工獎金 |
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— |
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出租權，以換取新的經營租賃負債 |
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長期使用權資產，以換取新的融資租賃負債 |
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||
請參見附註的未經審計的簡明合併財務報表。
6
艾吉納斯公司及其子公司
未經審計的簡明基本財務報表附註基本報表
2024年9月30日
附註A——業務、流動性和列報基礎
Agenus Inc.（包括其子公司，統稱爲 「Agenus」、「公司」、「我們」 和 「我們的」）是一家領先的臨床階段生物技術公司，通過強大的免疫藥物管道開發針對癌症的療法。我們的使命是通過組合方法，使用廣泛的抗體療法、過繼細胞療法（通過我們的子公司MinK Therapeutics, Inc.（「MinK」））和疫苗佐劑（通過我們的子公司SaponiqX，Inc.（「SaponiQX」））來擴大受益於癌症免疫療法的患者群體。我們相信，聯合療法和對每位患者癌症的深入了解將顯著擴大受益於免疫腫瘤學（「I-O」）治療的患者群體。
除了多樣化的產品線外，我們還建立了全面整合的能力，包括新靶標發現、抗體生成、細胞系開發和當前的良好生產規範（「cGMP」）製造。我們相信，與行業標準相比，這些綜合能力使我們能夠在更短的時間內開發新候選藥物，並在獲得批准後將其商業化。通過獨立開發和戰略伙伴關係，我們利用我們的科學專長和能力來推動人工智能領域的創新。
我們的I-O產品組合由多個平台和計劃驅動，我們計劃單獨使用或組合使用這些平台和計劃：
我們的業務活動包括產品研究、臨床前和臨床開發、知識產權申請、製造、監管和臨床事務、企業融資和開發活動以及對我們合作的支持。我們的候選產品需要成功的臨床試驗和監管機構的批准，並獲得市場的認可。我們戰略的一部分是通過繼續與學術和企業合作者和被許可方的現有安排以及開展新的合作，開發和商業化我們的一些候選產品。
截至2024年9月30日，我們的現金和現金等價物爲 $
截至2024年9月30日，我們的累計赤字爲 $
根據我們目前的計劃和預測，我們認爲我們的現金資源是 $
目前，我們正在與包括生物技術和製藥合作伙伴在內的多個實體進行討論，以及專門的醫療保健基金，通過我們計劃提交的botensilimab/balstilimab的生物製劑許可證申請或上市許可，爲我們的運營提供必要的資金。但是，由於此類交易的完成並不完全在我們的控制範圍內，根據會計指導，我們必須披露，自提交本10-Q表季度報告之日起，我們是否有能力繼續經營一年。財務報表是在假設Agenus將繼續作爲持續經營企業的基礎上編制的，並考慮在正常業務過程中變現資產和償還負債和承諾。
管理層繼續滿足公司的流動性需求，並繼續調整支出以保持流動性。2023 年 8 月，我們對資源進行了優先排序和集中，以加快主要資產的開發、註冊和商業化，推遲了所有臨床前和其他臨床項目，並裁減了大約員工
7
當前 包括與多方簽署許可和/或合作機會、額外第三方協議、資產銷售、更多版權貨幣化、項目融資和/或股票出售有關的合作。
隨附的未經審計的中期簡明合併財務報表已按照美國通用會計準則（"U.S. GAAP"）和《S-X條例第10條的規定編制。因此，它們不包括美國通用會計準則對於完整年度合併財務報表所需的所有信息和附註。經管理層的意見，這些簡明合併財務報表包括爲公正展示我們的財務狀況和運營結果而認爲必要的一切正常和重複調整。所有重大公司內交易和帳戶已在合併中消除。截至2024年9月30日的九個月運營結果未必反映2024年12月31日結束的財年預期結果。有關更多信息，請參閱包括在我們提交給證券交易委員會（"SEC"）的2023年12月31日年度報告中的合併財務報表和附註。
按照美國通用會計準則編制合併財務報表要求管理層進行可影響報告資產和負債的金額以及披露財務報表日期財產和負債的估計和假設，以及在報告期間報告收入和支出的金額。管理層基於歷史經驗和認爲在情況下合理的各種假設進行估計。實際結果可能與這些估計有實質性差異。
對於我們的外國子公司，當地貨幣是功能貨幣。外國子公司的資產和負債使用資產負債表日期的匯率轉換爲美元，而收入和支出使用期間的平均匯率轉換爲美元。由於匯率變動導致的累積翻譯調整作爲綜合收益（虧損）的累積組成部分包括在合併資產負債表中的股東權益總逆差。
在2024年4月4日，我們對我們已發行和流通的普通股進行了一次反向股票拆分，面值$
在截至2024年9月30日的九個月中，我們對某些外國子公司進行了脫離合並，並分別確認了約$的收益，包括在我們的摘要綜合損益表的「其他收入（費用）」中。
基本每股普通股淨損失是通過將歸屬於普通股股東的淨損失除以普通股的加權平均股數來計算的（包括我們修訂和重設的董事延期補償計劃（簡稱「DDCP」）下可發行的普通股）。稀釋普通股每股淨損失是通過將歸屬於普通股股東的損失除以普通股的加權平均股數（包括我們DDCP下可發行的普通股）加上發行的工具的稀釋效應計算的，例如權證、股票期權、未實現的股份和可轉換優先股。由於我們報告了所有期間歸屬於普通股股東的淨損失，稀釋每股普通股淨損失與基本每股普通股淨損失相同，因爲使用全稀釋股數將會降低每股普通股的淨損失。
|
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截至9月30日的三個月和九個月 |
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|||||
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2024 |
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2023 |
|
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warrants |
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股票期權 |
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未獲授股份 |
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A-1系列可轉換優先股 |
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8
附註C – 投資
截至日期，現金等價物包括以下內容 2024年9月30日和2023年12月31日（單位：千美元）：
|
|
2024年9月30日 |
|
|
2023年12月31日 |
|
||||||||||
|
|
成本 |
|
|
估計 |
|
|
成本 |
|
|
估計 |
|
||||
機構貨幣市場基金 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
合計 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
由於這些投資的短期性質，截至2024年9月30日和2023年的三個和九個月，未實現的持有增值或減值很少。
截至2024年9月30日和2023年12月31日，上述所有投資在我們的簡明綜合資產負債表中均被分類爲等價物。
備註D – 商譽和取得的無形資產
以下表格說明了截至2024年9月30日的商譽賬面金額變化 截至2024年9月30日的九個月變動情況（以千爲單位）：
2023年12月31日的餘額 |
|
$ |
|
|
外匯影響 |
|
|
( |
) |
2024年9月30日資產負債表 |
|
$ |
|
取得的無形資產截至 2024年9月30日和2023年12月31日（單位：千美元）：
|
|
截至2024年9月30日 |
|
|||||||||||
|
|
攤銷 |
|
毛額攜帶 |
|
|
累積 |
|
|
淨賬面價值 |
|
|||
知識產權 |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
商標 |
|
|
|
|
|
|
( |
) |
|
|
|
|||
其他 |
|
|
|
|
|
|
( |
) |
|
|
|
|||
研發中的項目 |
|
不確定 |
|
|
|
|
|
— |
|
|
|
|
||
合計 |
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
|
|
截至2023年12月31日 |
|
|||||||||||
|
|
攤銷 |
|
毛賬載 |
|
|
累積 |
|
|
淨賬面價值 |
|
|||
知識產權 |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
商標 |
|
|
|
|
|
|
( |
) |
|
|
|
|||
其他 |
|
|
|
|
|
|
( |
) |
|
|
|
|||
研發中的項目 |
|
不確定 |
|
|
|
|
|
— |
|
|
|
|
||
合計 |
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
我們有限生命週期無形資產的加權平均攤銷期爲
9
附註 E – 債務
債務工具 |
|
期末餘額 |
|
|
流動部分: |
|
|
|
|
無抵押可轉換債券 |
|
$ |
|
|
2015年次級票據 |
|
|
|
|
其他 |
|
|
|
|
合計 |
|
$ |
|
|
債務工具 |
|
期末餘額 |
|
|
流動部分: |
|
|
|
|
無抵押可轉換債券 |
|
$ |
|
|
長期部分： |
|
|
|
|
2015年次級票據 |
|
|
|
|
合計 |
|
$ |
|
|
截至2024年9月30日和2023年12月31日，我們未償還債務餘額的本金金額爲$
備註F – 與未來專利和里程碑銷售相關的責任
下表顯示了截至2024年9月30日的負債帳戶內的活動 2024年9月30日止九個月內的活動情況（以千爲單位）：
|
|
Period from |
|
|
與未來專利和里程碑銷售相關的責任 - 期初餘額 |
|
$ |
|
|
未來專利和里程碑銷售款項 |
|
|
|
|
非現金版稅收入 |
|
|
( |
) |
確認的非現金利息費用 |
|
|
|
|
與未來版稅和里程碑銷售相關的負債 - 期末餘額 |
|
|
|
|
減：未攤銷交易成本 |
|
|
( |
) |
與未來版稅和里程碑銷售相關的負債，淨值 |
|
$ |
|
|
醫療保健版稅合作伙伴
2018年1月，我們通過全資子公司Antigenics，LLC（"Antigenics"）與醫療保健版稅合作伙伴III號有限合夥及其某些關聯公司（統稱"HCR"）簽署了一份版稅購買協議（"HCR版稅購買協議"）。根據HCR版稅購買協議的條款，我們向HCR出售了Antigenics在全球範圍內從葛蘭素史克（"GSK"）銷售含有我們的STIMULON QS-21佐劑疫苗的版稅的權利的百分之
2024年9月30日結束的九個月內，我們確認了相關收入$
10
由於版稅將從GSk匯入HCR，已記錄的負債餘額將在HCR版稅購買協議的有效期內得以償還。爲了確定已記錄負債的攤銷，我們需要估計HCR將收到的未來版稅總額。這些金額之和減去我們收到的$
ligand pharmaceuticals
於2024年5月，我們及特定的全資子公司與ligand pharmaceuticals incorporated（「ligand」）簽訂了一份購買與銷售協議（「ligand購買協議」）。根據ligand購買協議的條款，ligand將收到（i）
向ligand支付的總金額須根據%的退還難關進行調整
作爲出售購買資產的考慮，我們在交割日收到了總額爲$的毛收益
與已購資產的出售相結合，我們向Ligand發行了一份購股證（"Ligand Warrant"），以購買
從2023年12月31日至2024年3月31日，淨合同資產增加$
與未來版稅和里程碑銷售有關的負債 |
|
$ |
|
|
Ligand購股證 |
|
|
|
|
購買者增加選項 |
|
|
|
|
ligand pharmaceuticals總購買協議的總收益 |
|
$ |
|
由於我們對購買資產現金流生成的重大持續參與，我們被要求將來自該交易的$的收入視爲負債，該負債將根據支付給ligand用於ligand購買協議估計壽命內的特許權和里程碑支付，按比例確認爲營業收入。
購買者增加選項被視爲獨立的財務工具，因爲它可以分開行使並且可以從ligand購買協議中合法轉讓。因此，它被視爲按公允價值計入負債，並在每個資產負債表日按照公允價值重新衡量，公允價值變動記錄在收入中。2024年9月30日購買者增加選項的公允價值爲$
ligand warrants被認爲是獨立的財務工具，因爲它可以分開行使並且可以從ligand購買協議中合法轉讓，根據ASC 815的規定，被劃分爲股本類別。
爲分配收益，購買者增加選項負債和被劃分爲股本類別的ligand warrants被確認爲其公允價值，並將餘下部分分配給與未來特許權和里程碑銷售相關的負債，在我們的資產負債表中確認。
截至2024年9月30日的九個月內，我們記錄了$
隨着我們收到的版稅、從購買資產賺取的里程碑和銷售額，記錄的負債餘額將在Ligand購買協議的有效償還期內得到償還。爲了判斷記錄的負債的攤銷，我們需要估計Ligand在Ligand購買協議下有權獲得的未來支付總額。這些金額之和減去已分配給與未來版稅和里程碑銷售相關的負債的$
11
負債和利息支出的相關確認。截至2024年9月30日，我們估計協議期內的有效年利率爲
附註G-應計及其他流動負債
截至目前，應計負債包括以下內容 2024年9月30日和2023年12月31日（單位：千美元）：
|
|
2024年9月30日 |
|
|
2023年12月31日 |
|
||
薪資 |
|
$ |
|
|
$ |
|
||
專業費用 |
|
|
|
|
|
|
||
合同製造業-半導體成本 |
|
|
|
|
|
|
||
研究服務 |
|
|
|
|
|
|
||
其他 |
|
|
|
|
|
|
||
合計 |
|
$ |
|
|
$ |
|
||
其他流動負債截至 2024年9月30日和2023年12月31日（單位：千美元）：
|
|
2024年9月30日 |
|
|
2023年12月31日 |
|
||
融資租賃負債 |
|
$ |
|
|
$ |
|
||
購買方增加選擇權 (註釋 F) |
|
|
|
|
|
— |
|
|
其他 |
|
|
|
|
|
|
||
合計 |
|
$ |
|
|
$ |
|
||
我們的一個融資租賃協議條款包括維持特定最低現金餘額的要求。截至2024年9月30日，我們的現金餘額低於此門檻。儘管如此，我們仍在協議項下及時支付所有租金。雖然金融機構有權採取補救措施，包括可能收回已租賃的資產，但我們正在積極應對這一局面，並希望恢復合規。截至2024年9月30日，在此租賃項下欠款的剩餘金額約爲$
12
Note H – Fair Value Measurements
Assets and liabilities measured at fair value are summarized below (in thousands):
Description |
|
September 30, 2024 |
|
|
Quoted Prices in |
|
|
Significant |
|
|
Significant |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents (Note C) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Long-term investments |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Purchaser Upsize Option (Note F) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Contingent purchase price considerations |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Description |
|
December 31, 2023 |
|
|
Quoted Prices in |
|
|
Significant |
|
|
Significant |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents (Note C) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Long-term investments |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Contingent purchase price consideration |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Long-term investments are included in "Other long-term assets" in our condensed consolidated balance sheets.
We are required to measure the Purchaser Upsize Option issued under the Ligand Purchase Agreement at fair value. The $
We measure our contingent purchase price considerations at fair value. The fair values of our contingent purchase price considerations at both September 30, 2024 and December 31, 2023, of $
Note I – Revenue from Contracts with Customers
Gilead Collaboration Agreement
On December 20, 2018, we entered into a series of agreements with Gilead Sciences, Inc. (“Gilead”) focused on the development and commercialization of up to five novel immuno-oncology therapies. Pursuant to the terms of the license agreement, the option and license agreements and the stock purchase agreement we entered into with Gilead (collectively, the “Gilead
13
Collaboration Agreements”), at the closing of the transaction on January 23, 2019, we received an upfront cash payment from Gilead of $
Collaboration Revenue
Disaggregation of Revenue
The following table presents revenue (in thousands) for the three and nine months ended September 30, 2024 and 2023, disaggregated by geographic region and revenue type. Revenue by geographic region is allocated based on the domicile of our respective business operations.
|
|
Three months ended September 30, 2024 |
|
|||||||||
|
|
United States |
|
|
Rest of World |
|
|
Total |
|
|||
Revenue Type |
|
|
|
|
|
|
|
|
|
|||
Other services |
|
$ |
— |
|
|
$ |
|
|
$ |
|
||
Non-cash royalties |
|
|
|
|
|
— |
|
|
|
|
||
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
|
|
|
|
|
|
|
|
|
|
|||
|
|
Three months ended September 30, 2023 |
|
|||||||||
Revenue Type |
|
|
|
|
|
|
|
|
|
|||
Research and development services |
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
Other services |
|
|
— |
|
|
|
|
|
|
|
||
Clinical product revenue |
|
|
|
|
|
— |
|
|
|
|
||
Recognition of deferred revenue |
|
|
|
|
|
— |
|
|
|
|
||
Non-cash royalties |
|
|
|
|
|
— |
|
|
|
|
||
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
|
|
Nine months ended September 30, 2024 |
|
|||||||||
|
|
United States |
|
|
Rest of World |
|
|
Total |
|
|||
Revenue Type |
|
|
|
|
|
|
|
|
|
|||
Clinical product revenue |
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
Other services |
|
|
— |
|
|
|
|
|
|
|
||
Non-cash royalties |
|
|
|
|
|
— |
|
|
|
|
||
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
|
|
|
|
|
|
|
|
|
|
|||
|
|
Nine months ended September 30, 2023 |
|
|||||||||
Revenue Type |
|
|
|
|
|
|
|
|
|
|||
Research and development services |
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
Other services |
|
|
— |
|
|
|
|
|
|
|
||
Clinical product revenue |
|
|
|
|
|
— |
|
|
|
|
||
Recognition of deferred revenue |
|
|
|
|
|
— |
|
|
|
|
||
Non-cash royalties |
|
|
|
|
|
— |
|
|
|
|
||
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
Contract Balances
Contract assets primarily relate to our rights to consideration for work completed in relation to our research and development services performed but not billed at the reporting date. The contract assets are transferred to receivables when the rights become unconditional. Currently, we do not have any contract assets which have not transferred to a receivable. We had
14
development services or licenses bundled with other promises is a contract liability until the underlying performance obligations are transferred to the customer.
The following table provides information about contract liabilities from contracts with customers (in thousands):
Nine months ended September 30, 2024 |
|
Balance at beginning of period |
|
|
Additions |
|
|
Deductions |
|
|
Balance at end of period |
|
||||
Contract liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Deferred revenue |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
During the nine months ended September 30, 2024, we did not recognize any revenue from amounts included in the contract asset or the contract liability balances from performance obligations satisfied in previous periods.
In June 2024, our stockholders approved an amendment to our Amended and Restated 2019 Equity Incentive Plan (the "2019 EIP") that increased the maximum number of shares of our common stock available for issuance under our 2019 EIP by
We primarily use the Black-Scholes option pricing model to value stock options granted to employees and non-employees, including stock options granted to members of our Board of Directors. However, the fair value of stock option market-based awards is calculated based on a Monte Carlo simulation as of the date of issuance. All stock options have
A summary of option activity for the nine months ended September 30, 2024 is presented below:
|
|
Options |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
Outstanding at December 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Forfeited |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Expired |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding at September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested or expected to vest at September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable at September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
— |
|
|||
The weighted average grant-date fair values of stock options granted during the nine months ended September 30, 2024 and 2023 were $
During the nine months ended September 30, 2024, all options were granted with exercise prices equal to the market value of the underlying shares of common stock on the grant date other than certain awards dated January 16, 2024 and January 17, 2024. In January 2024, our Board of Directors approved certain awards subject to forfeiture in the event stockholder approval was not obtained for an amendment to our 2019 EIP. This approval was obtained in June 2024. Accordingly, these awards have a grant date of June 2024, with an exercise price as of the date the Board of Director's approved the awards in January 2024.
As of September 30, 2024, there was approximately $
Certain employees and consultants have been granted non-vested stock. The fair value of non-vested market-based awards is calculated based on a Monte Carlo simulation as of the date of issuance. The fair value of other non-vested stock is calculated based on the closing sale price of our common stock on the date of issuance.
15
A summary of non-vested stock activity for the nine months ended September 30, 2024 is presented below:
|
|
Non-vested |
|
|
Weighted |
|
||
Outstanding at December 31, 2023 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Vested |
|
|
( |
) |
|
|
|
|
Forfeited |
|
|
( |
) |
|
|
|
|
Outstanding at September 30, 2024 |
|
|
|
|
$ |
|
||
As of September 30, 2024, there was approximately $
During the nine months ended September 30, 2024,
The impact on our results of operations from share-based compensation for the three and nine months ended September 30, 2024 and 2023, was as follows (in thousands):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total share-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Note K – Restricted Cash
As of September 30, 2024, and December 31, 2023, we maintained non-current restricted cash of $
The following table provides a reconciliation of cash, cash equivalents and restricted cash that sums to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands):
|
|
Nine Months Ended September 30, 2024 |
|
|
Nine Months Ended September 30, 2023 |
|
||||||||||
|
|
Beginning of Period |
|
|
End of Period |
|
|
Beginning of Period |
|
|
End of Period |
|
||||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Restricted cash |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash, cash equivalents and restricted cash |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Note L – Equity
On March 14, 2024, we filed a Post-effective Amendment to an Automatic Shelf Registration Statement on Form POSASR (file no. 333-272911) and a Post-Effective Amendments for Registration Statement on Form POS AM (file no. 333-272911) (together, the “Registration Statement”). The Registration Statement included both a base prospectus that covered the potential offering, issuance and sale from time to time of up to $
16
During the three and nine months ended September 30, 2024, we received net proceeds of approximately $
On April 3, 2024, our stockholders approved a proposal to amend our Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), to effect a reverse stock split of our issued and outstanding common stock at a ratio of
All common share, per share and related information included in the accompanying financial statements and footnote disclosures have been adjusted retroactively, where applicable, to reflect the Reverse Stock Split.
In connection with the Purchase Agreement described in Note F, on May 6, 2024, we issued to Ligand a warrant to purchase
Note M – Non-controlling Interest
Non-controlling interest recorded in our condensed consolidated financial statements as of September 30, 2024 and December 31, 2023, relates to the following approximate interests in certain consolidated subsidiaries, which we do not own.
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
||
MiNK Therapeutics, Inc. |
|
|
% |
|
|
% |
||
SaponiQx, Inc. |
|
|
% |
|
|
% |
||
Changes in non-controlling interest for the periods ended September 30, 2024 and December 31, 2023, were as follows (in thousands):
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
||
Beginning balance |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Net loss attributable to non-controlling interest |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Other items: |
|
|
|
|
|
|
||
Sale of subsidiary shares in private placement |
|
|
|
|
|
— |
|
|
Distribution of subsidiary shares to Agenus stockholders |
|
|
— |
|
|
|
|
|
Purchase of subsidiary shares |
|
|
— |
|
|
|
( |
) |
Issuance of subsidiary shares for employee bonus |
|
|
— |
|
|
|
|
|
Issuance of subsidiary shares for employee stock purchase plan and exercise of options |
|
|
|
|
|
|
||
Subsidiary share-based compensation |
|
|
|
|
|
|
||
Total other items |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Ending balance |
|
$ |
|
|
$ |
|
||
Sale of subsidiary shares in private placement
On May 13, 2024, MiNK entered into a Stock Purchase Agreement with a certain investor (the “Purchaser”), pursuant to which MiNK issued and sold an aggregate of
Distribution of subsidiary shares to Agenus stockholders
17
On
On
Purchase of subsidiary shares
During the year ended December 31, 2023, we purchased
Note N – Related Party Transactions
In 2023, our Audit and Finance Committee approved a contract between Avillion Life Sciences LTD ("Avillion") and Agenus for the performance of up to $
In June 2024, Dr. Jennifer Buell was appointed to our Board of Directors. Dr. Buell's spouse is a partner in the law firm of Wolf, Greenfield & Sachs, P.C. (“Wolf Greenfield”), which provides us legal services. For the three and nine months ended September 30, 2024, we expensed Wolf Greenfield fees totaling approximately $
Note O – Contingencies
In September 2024, a putative securities class action lawsuit was commenced in the U.S. District Court for the District of Massachusetts naming as defendants Agenus and three current officers. The complaint alleges that the defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions of material fact related to the efficacy and commercial prospects of botensilimab and balstilimab. The plaintiff seeks to represent all persons who purchased or otherwise acquired Agenus securities between January 23, 2023, and July 17, 2024. The plaintiff seeks damages and interest, and an award of costs, including attorneys’ fees. We are unable to estimate a range of loss, if any, that could result were there to be an adverse final decision in this action.
Note P – Recent Accounting Pronouncements
Recently Issued, Not Yet Adopted
In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 requires incremental annual and quarterly disclosures about segment measures of profit or loss as well as significant segment expenditures. It also requires public entities with a single reportable segment to provide all segment disclosures required by the amendments and all existing segment disclosures in Topic 280. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. As we have a single reportable segment, we expect the adoption of this standard to result in increased disclosures in the notes to our consolidated financial statements.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 requires incremental annual disclosures around income tax rate reconciliations, income taxes paid and other related disclosures. For public business entities, ASU 2023-09 is effective for fiscal years beginning after December 15, 2024. Early adoption is permitted for any annual periods for which financial statements have not been issued or made available for issuance. We are currently evaluating the impact that ASU 2023-09 will have on the notes to our consolidated financial statements.
No other new accounting pronouncement issued or effective during the nine months ended September 30, 2024 had or is expected to have a material impact on our consolidated financial statements or disclosures.
18
Note Q – Subsequent Events
At the Market Offerings
During the period of October 1, 2024 through November 8, 2024, we sold
19
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Forward Looking Statements
This Quarterly Report on Form 10-Q and other written and oral statements we make from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). You can identify these forward-looking statements by the fact they use words such as “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will,” “potential,” “opportunity,” “future” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. You can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements relate to, among other things, our business strategy, our research and development, our product development efforts, our ability to commercialize our product candidates, the activities of our licensees, our prospects for initiating partnerships or collaborations, the timing of the introduction of products, the effect of new accounting pronouncements, uncertainty regarding our future operating results and our profitability, anticipated sources of funds as well as our plans, objectives, expectations, and intentions.
More detailed descriptions of these risks and uncertainties and other risks and uncertainties applicable to our business that we believe could cause actual results to differ materially from any forward-looking statements are included in in Part I-Item 1A “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in Part II-Item 1A “Risk Factors” of our Quarterly Report on Form 10-Q for the period ended June 30, 2024. We encourage you to read those descriptions carefully. Although we believe we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved. We caution investors not to place significant reliance on forward-looking statements contained in this document; such statements need to be evaluated in light of all the information contained in this document. Furthermore, the statements speak only as of the date of this document, and we undertake no obligation to update or revise these statements.
ASV®, Agenus™, MiNK™, Prophage™, Retrocyte Display™ and STIMULON™ are trademarks of Agenus Inc. and its subsidiaries. All rights reserved.
Overview
We are a leading clinical-stage biotechnology company developing therapies targeting cancer with a robust pipeline of immunological agents. Our mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through our subsidiary MiNK Therapeutics, Inc. (“MiNK”)), and vaccine adjuvants (through our subsidiary SaponiQx, Inc. (“SaponiQx”)). We believe that combination therapies and a deep understanding of each patient’s cancer will significantly expand the patient population benefiting from immuno-oncology (“I-O”) treatments.
In addition to our diverse pipeline, we have established fully integrated capabilities encompassing novel target discovery, antibody generation, cell line development, and current good manufacturing practice ("cGMP") manufacturing. We believe these integrated capabilities enable us to develop and, if approved, commercialize novel candidates on accelerated timelines compared to industry standards. Through independent development and strategic partnerships, we leverage our scientific expertise and capabilities to drive innovation in the I-O field.
Our I-O portfolio is driven by several platforms and programs, which we plan to utilize individually and in combination:
We regularly evaluate development, commercialization, and partnering strategies for each product candidate based on various factors, including pre-clinical and clinical trial results, competitive positioning, funding requirements, and available resources. Our
20
lead program, botensilimab (AGEN1181), is progressing through multiple clinical programs designed to support accelerated development as a monotherapy and in combination with balstilimab. In April 2023, botensilimab in combination with balstilimab received Fast Track designation from the U.S. Food and Drug Administration ("FDA") for the treatment of patients with not-microsatellite instability-high ("MSI-H")/deficient mismatch repair ("dMMR") metastatic colorectal cancer with no active liver involvement. Patients targeted with this designation are heavily pretreated with standard of care chemotherapy, anti-VEGF and anti-EGFR if RAS wild type. We completed enrollment of patients with refractory MSS mCRC non-active liver metastases ("NLM") in a Phase 1 trial (n~150) and randomized Phase 2 trial (n~230) in October 2023. We are likely not to pursue accelerated approval pathways and intend to initiate a Phase 3 study with plans to ensure continued funding via partnering activities.
We have entered into collaborations with several companies, including Bristol-Myers Squibb Company (“BMS”), Betta Pharmaceuticals Co., Ltd. (“Betta”), UroGen Pharma Ltd. ("UroGen"), Gilead Sciences, Inc. (“Gilead”), Incyte Corporation (“Incyte”), and Merck Sharpe & Dohme (“Merck”). These collaborations, along with our internal programs, have resulted in over a dozen antibody pre-clinical or clinical development programs.
Pursuant to our collaboration agreement with Incyte, we have exclusively licensed to Incyte monospecific antibodies targeting GITR, OX40, TIM-3 and LAG-3, which Incyte is currently advancing in various clinical trials, as well as an additional undisclosed target that Incyte is advancing in preclinical studies. Under the terms of our agreement, Incyte is responsible for all future development expenses, and we are eligible to receive up to an additional $315.0 million in potential milestone payments plus royalties on any future sales. Incyte has terminated the OX40 program, effective October 2023, and both the GITR program and undisclosed program, effective May 2024. Upon termination, the rights to the OX40, GITR, and undisclosed programs reverted back to us. On July 30, 2024, Incyte announced that it would discontinue further development of the LAG-3 and TIM-3 monoclonal antibodies.
Pursuant to our collaboration and license agreement with Merck, we exclusively licensed to Merck a monospecific antibody targeting ILT4 (MK-4830), which Merck advanced in a Phase 2 clinical trial. Merck is responsible for all future development expenses, and we are eligible to receive up to an additional $85.0 million in potential milestone payments, as well as royalties on future sales. In 2024 Merck notified us that the further clinical development of MK-4830 will be limited to a neoadjuvant ovarian study of MK-4830 in combination with pembrolizumab and chemotherapy with or without bevacizumab that is ongoing.
In September 2018, we, through our wholly-owned subsidiary, Agenus Royalty Fund, LLC, entered into a royalty purchase agreement (the “XOMA Royalty Purchase Agreement”) with XOMA (US) LLC (“XOMA”). Pursuant to the terms of the XOMA Royalty Purchase Agreement, XOMA purchased 33% of all future royalties and 10% of all future milestone payments that we are entitled to receive from Incyte and Merck, net of certain of our obligations to a third party.
In December 2018, we entered into collaboration agreements with Gilead for the development and commercialization of up to five novel I-O therapies (the “Gilead Collaboration Agreements”). Gilead received worldwide exclusive rights to our bispecific antibody, AGEN1423, and the exclusive option to license AGEN1223, a bispecific antibody, and AGEN2373, a monospecific antibody. Gilead elected to return AGEN1423 to us in November 2020 and terminated the license agreement. We ceased development of AGEN1223 in the third quarter of 2021, and the option and license agreement for AGEN1223 were formally terminated in October 2021. On August 5, 2024, Gilead elected not to exercise the option to license AGEN2373 and the option and license agreement was formally terminated.
In November 2019, we entered into a license agreement with UroGen, granting them an exclusive, worldwide license (not including Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions) to develop, manufacture, and commercialize zalifrelimab for the treatment of cancers of the urinary tract via intravesical delivery. We received an upfront payment of $10.0 million and are eligible to receive up to $200.0 million in milestone payments, as well as royalties on future sales.
In June 2020, we entered into a license and collaboration agreement (the “Betta License Agreement”) with Betta, pursuant to which we granted Betta an exclusive license to develop, manufacture and commercialize balstilimab and zalifrelimab in Republic of China, Hong Kong, Macau and Taiwan (“Greater China”). Under the terms of the Betta License Agreement, we received $15.0 million upfront and are eligible to receive up to $100.0 million in milestone payments plus royalties on any future sales in Greater China.
In May 2021, we entered into a License, Development, and Commercialization Agreement with BMS for our pre-clinical anti-TIGIT bispecific antibody program, AGEN1777. BMS received an exclusive worldwide license to develop, manufacture, and commercialize AGEN1777 and its derivatives. We received a non-refundable upfront cash payment of $200.0 million. In October 2021, we achieved a $20.0 million milestone upon the dosing of the first patient in the AGEN1777 Phase 1 clinical trial and in December 2023, we announced that the first patient was dosed in an AGEN1777 Phase 2 clinical trial, triggering the achievement of a
21
$25.0 million milestone. We received this milestone in January 2024. On July 30, 2024, we received notice from BMS that it is returning AGEN1777 back to us and voluntarily terminating the BMS License Agreement, effective as of January 26, 2025.
In May 2024, we, and certain wholly-owned subsidiaries, entered into a Purchase and Sale Agreement (the “Ligand Purchase Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”) for the sale to Ligand of (i) 31.875% of the development, regulatory and commercial milestone payments we were then eligible to receive under our agreements with BMS, UroGen, Gilead, Merck and Incyte, (the “Covered License Agreements”) (ii) 18.75% of the royalties we receive under the Covered License Agreements; and (iii) a 2.625% synthetic royalty on worldwide net sales of botensilimab and balstilimab (collectively the “Purchased Assets”). The total amounts payable to Ligand are subject to a 50% reduction in the event total payments to Ligand exceed a specified return hurdle. The synthetic royalty is subject to a reduction if annual worldwide net sales exceed a specified level, and a cap on annual worldwide net sales if annual worldwide net sales exceed a higher specified level. The synthetic royalty can increase by 1% based on the occurrence of certain future events. After taking into account our obligations under the Ligand Purchase Agreement, XOMA Royalty Purchase Agreement and the recent status of our collaboration agreements, we remain eligible to receive up to approximately $136.3 million, $49.4 million and $183.1 million in potential development, regulatory, and commercial milestones from UroGen, Merck and Incyte, respectively.
In September 2021, we launched SaponiQx to lead innovation in novel adjuvant discovery and vaccine design, focusing on our saponin-based adjuvants. We are particularly dedicated to the development of the next-generation cultured plant cell QS-21. To support this initiative, we partnered with Ginkgo Bioworks, Inc. to develop SaponiQx’s saponin products from sustainably sourced raw materials. Our goal is to meet the demands of the vaccine industry, especially for pandemic vaccines.
Our bark extract QS-21 adjuvant is partnered with GSK and plays a vital role in multiple GSK vaccine programs. These programs are at various stages, including GSK’s approved shingles and RSV vaccines, SHINGRIX and AREXVY, which received FDA approval in the United States in October 2017 and May 2023, respectively.
In January 2018, we entered into a Royalty Purchase Agreement with Healthcare Royalty Partners III, L.P. and its affiliates (“HCR”). HCR purchased our worldwide rights to receive royalties from GSK on GSK’s sales of vaccines containing our QS-21 adjuvant. We do not incur clinical development costs for products partnered with GSK.
Under the agreement with HCR, we were entitled to receive milestone payments based on GSK’s vaccine sales. These milestones include $15.1 million upon GSK reaching $2.0 billion in last-twelve-months net sales prior to 2024 (the “First HCR Milestone”) and $25.25 million upon GSK reaching $2.75 billion in last-twelve-months net sales prior to 2026 (the “Second HCR Milestone”). We received the First HCR Milestone after GSK’s net sales of SHINGRIX for the twelve months ended December 31, 2019, exceeded $2.0 billion, and we received the Second HCR Milestone after GSK’s net sales of SHINGRIX for the twelve months ended June 30, 2022, exceeded $2.75 billion.
Our business activities include product research and preclinical and clinical development, intellectual property prosecution, manufacturing, regulatory and clinical affairs, corporate finance and development activities, and support of our collaborations. Our product candidates require successful clinical trials and approvals from regulatory agencies, as well as acceptance in the marketplace. Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing arrangements with academic and corporate collaborators and licensees and by entering into new collaborations.
In October 2021, we completed the initial public offering (“IPO”) of MiNK, which trades on the Nasdaq Capital Market under the ticker symbol “INKT”. MiNK is a clinical stage biopharmaceutical company focused on developing allogeneic invariant natural killer T (“iNKT”) cell therapies to treat cancer and other life-threatening immune diseases. MiNK’s most advanced product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy. MiNK is currently expanding its clinical programs, with a notable externally funded Phase 2 trial in second-line gastric cancer actively enrolling at Memorial Sloan Kettering Cancer Center. Additionally, MiNK is evaluating agenT-797 as a variant-agnostic therapy for patients with viral acute respiratory distress syndrome (“ARDS”) in planning for a randomized phase 2 study through a predominantly externally financed program. Recently, MiNK secured a $5.8 million private placement financing at a 25% premium, led by GKCC, LLC. This funding will propel the clinical development of MiNK-215, its leading allogeneic CAR-iNKT cell therapy targeting fibroblast activation protein (“FAP”) in solid tumors, which is scheduled to enter clinical trials in early 2025. In addition to its lead clinical program, MiNK has announced a collaboration with ImmunoScape, Inc. (“ImmunoScape”) to discover and develop next-generation T-cell receptor therapies targeting novel solid tumor antigens. This partnership leverages MiNK's proprietary library of T-cell antigens and ImmunoScape’s platform for rapid discovery of novel T-cell receptors.
Historical Results of Operations
Three months ended September 30, 2024 compared to the three months ended September 30, 2023
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Research and development revenue
We did not recognize any research and development revenue in the three months ended September 30, 2024, but recognized research and development revenue of approximately $3.4 million during the three months ended September 30, 2023. Research and development revenues in the third quarter of 2023 primarily consisted of $2.9 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements.
Non-cash royalty revenue related to the sale of future royalties
In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant to HCR. As described in Note F to our Condensed Consolidated Financial Statements, this transaction has been recorded as a liability that amortizes over the estimated life of our Royalty Purchase Agreement with HCR. As a result of this liability accounting, even though the royalties are remitted directly to HCR, we record these royalties from GSK as revenue. Non-cash royalty revenue related to our agreement with GSK increased $4.3 million, to approximately $24.7 million for the three months ended September 30, 2024, from $20.4 million for the three months ended September 30, 2023, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant, including net sales of AREXVY, that GSK launched in the third quarter of 2023.
Research and development expense
Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of consultants, and administrative costs. Research and development expense decreased 20% to $41.1 million for the three months ended September 30, 2024 from $51.4 million for the three months ended September 30, 2023. Decreased expenses in the three months ended September 30, 2024 primarily relate to a $4.2 million decrease in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs, a $2.9 million decrease in personnel related expenses, mainly due to a decrease in headcount, and a $4.1 million decrease in expenses attributable to the activities of our subsidiaries. These decreases were partially offset by a $0.8 million increase in other research and development expenses.
General and administrative expense
General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 9% to $17.3 million for the three months ended September 30, 2024 from $18.9 million for the three months ended September 30, 2023. Decreased expenses in the three months ended September 30, 2024 primarily relate to a $1.0 million decrease in personnel related expenses, mainly due to decreased share based compensation expense, a $0.7 million decrease in professional fees and a $0.5 million decrease in expenses attributable to the activities of our subsidiaries. These decreases were partially offset by a $0.7 million increase in other general and administrative expenses.
Interest expense, net
Interest expense, net increased to approximately $35.7 million for the three months ended September 30, 2024 from $18.6 million for the three months ended September 30, 2023, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR and the addition of non-cash interest expense recorded in connection with our Ligand Purchase Agreement.
Nine months ended September 30, 2024 compared to the nine months ended September 30, 2023
Research and development revenue
We recognized research and development revenue of approximately $0.3 million and $8.5 million during the nine months ended September 30, 2024 and 2023, respectively. Research and development revenues in the first nine months of 2023 primarily consisted of $7.2 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements.
Non-cash royalty revenue related to the sale of future royalties
In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant to HCR. As described in Note F to our Condensed Consolidated Financial Statements, this transaction has been recorded as a liability that amortizes over the estimated life of our Royalty Purchase Agreement with HCR. As a result of this liability accounting, even though the royalties are remitted directly to HCR, we record these royalties from GSK as revenue. Non-cash royalty revenue related to our agreement with GSK increased $13.5 million, to approximately $75.0 million for the nine months ended September 30, 2024, from $61.5 million for the nine months ended September 30, 2023, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant, including net sales of AREXVY, that GSK launched in the third quarter of 2023.
Research and development expense
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Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of consultants, and administrative costs. Research and development expense decreased 27% to $121.8 million for the nine months ended September 30, 2024 from $167.8 million for the nine months ended September 30, 2023. Decreased expenses in the nine months ended September 30, 2024 primarily relate to a $25.9 million decrease in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs, a $8.9 million decrease in personnel related expenses, mainly due to a decrease in headcount, and a $14.7 million decrease in expenses attributable to the activities of our subsidiaries. These decreases were partially offset by a $3.3 million increase in other research and development expenses.
General and administrative expense
General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 11% to $50.9 million for the nine months ended September 30, 2024 from $57.6 million for the nine months ended September 30, 2023. Decreased expenses in the nine months ended September 30, 2024 primarily relate to a $3.2 million decrease in personnel related expenses, mainly due to decreased share based compensation expense, a $1.5 million decrease in professional fees and a $2.9 million decrease in expenses attributable to the activities of our subsidiaries. These decreases were partially offset by a $1.0 million increase in other general and administrative expenses.
Non-operating income (expense)
Non-operating income increased $5.8 million for the nine months ended September 30, 2024, from income of $0.2 million for the nine months ended September 30, 2023 to income of $6.1 million for the nine months ended September 30, 2024, primarily due to the recognition of a $5.3 million gain on the early termination of two operating leases and the recognition of R&D tax credits in the UK in the nine months ended September 30, 2024, compared to de minimis activity in the nine months ended September 30, 2023.
Interest expense, net
Interest expense, net increased to approximately $96.9 million for the nine months ended September 30, 2024 from $53.7 million for the nine months ended September 30, 2023, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR and the addition of non-cash interest expense recorded in connection with our Ligand Purchase Agreement.
Research and Development Programs
For the nine months ended September 30, 2024, our research and development programs consisted largely of our antibody programs as indicated in the following table (in thousands).
|
|
|
|
Nine Months Ended September 30, |
|
|
Year Ended December 31, |
|
||||||||||
Research and |
|
Product |
|
2024 |
|
|
2023 |
|
|
2022 |
|
|
2021 |
|
||||
Antibody programs |
|
Various |
|
$ |
89,359 |
|
|
$ |
178,445 |
|
|
$ |
133,108 |
|
|
$ |
141,266 |
|
Vaccine adjuvant |
|
STIMULON cpcQS-21 |
|
|
1,765 |
|
|
|
10,296 |
|
|
|
10,789 |
|
|
|
5,912 |
|
Cell therapies |
|
Various |
|
|
5,314 |
|
|
|
16,283 |
|
|
|
24,300 |
|
|
|
15,507 |
|
Other research and development programs |
|
Various |
|
|
25,315 |
|
|
|
29,545 |
|
|
|
18,494 |
|
|
|
15,923 |
|
Total research and development expenses |
|
|
|
$ |
121,753 |
|
|
$ |
234,569 |
|
|
$ |
186,691 |
|
|
$ |
178,608 |
|
Research and development program costs include compensation and other direct costs plus an allocation of indirect costs, based on certain assumptions and our review of the status of each program. Our product candidates are in various stages of development and significant additional expenditures will be required if we start new clinical trials, encounter delays in our programs, apply for regulatory approvals, continue development of our technologies, expand our operations, and/or bring our product candidates to market. The total cost of any particular clinical trial is dependent on a number of factors such as trial design, length of the trial, number of clinical sites, number of patients, and trial sponsorship. The process of obtaining and maintaining regulatory approvals for new therapeutic products is lengthy, expensive, and uncertain. Because of the current stage of our product candidates, among other factors, we are unable to reliably estimate the cost of completing our research and development programs or the timing for bringing such programs to various markets or substantial partnering or out-licensing arrangements, and, therefore, when, if ever, material cash inflows are likely to commence.
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Liquidity and Capital Resources
We have incurred annual operating losses since inception, and we had an accumulated deficit of $2.1 billion as of September 30, 2024. We expect to incur significant losses over the next several years as we continue development of our technologies and product candidates, manage our regulatory processes, initiate and continue clinical trials, and prepare for potential commercialization of products. To date, we have financed our operations primarily through corporate partnerships, advance royalty sales and the issuance of equity. From our inception through September 30, 2024, we have raised aggregate net proceeds of approximately $2.0 billion through the sale of common and preferred stock, the exercise of stock options and warrants, proceeds from our Employee Stock Purchase Plan, royalty monetization transactions, and the issuance of convertible and other notes.
We maintain an effective registration statement (the “Registration Statement”) covering up to $300.0 million of common stock, preferred stock, warrants, debt securities and units. The Registration Statement includes prospectuses covering the offer, issuance and sale of up to 20.6 million shares of our common stock from time to time in “at-the-market offerings” pursuant to an At Market Issuance Sales Agreement (the “Sales Agreement”) with B. Riley Securities, Inc. as our sales agent. We sold approximately 1.9 million and 1.8 million shares of our common stock pursuant to the Sales Agreement during the nine months ended September 30, 2024 and the period of October 1, 2024 through November 8, 2024, respectively, and received aggregate net proceeds totaling $33.0 million. As of November 8, 2024, approximately 18.1 million shares remained available for sale under the Sales Agreement.
We have funded our operations largely from cash received from partners, royalty financing transactions and equity offerings. We transact at-the-market sales from time to time in order to manage our cash balances. We execute at-the-market offerings based on market conditions and our stock price. We do not have in place a program whereby at-the-market offerings are executed automatically based on our trading volume.
As of September 30, 2024, we had debt outstanding of $13.0 million in principal due February 2025.
Our cash and cash equivalents at September 30, 2024 were $44.8 million, a decrease of $31.3 million from December 31, 2023. Cash and cash equivalents of our subsidiary, MiNK, at June 30, 2024, were $9.3 million. MiNK cash can only be accessed by Agenus through a declaration of a dividend by the MiNK Board of Directors or through settlement of intercompany balances.
Since our founding we have financed our operations principally through income and revenues generated from corporate partnerships, advance royalty sales and proceeds from equity issuances. Based on our current plans and projections, we believe that our cash resources of $44.8 million as of September 30, 2024, will be sufficient to satisfy our critical liquidity requirements through the end of the year and into 2025. To support operations further, meet our subordinated notes obligation, and to execute on our business plans, we require additional funding.
Currently we are in discussions with several entities including biotechnology and pharmaceutical partners, as well as dedicated healthcare funds to provide the funding necessary to support our operations through our planned biologics license application, or marketing authorization, submission for botensilimab/balstilimab. However, because the completion of such transactions is not entirely within our control, in accordance with accounting guidance we are required to disclose that substantial doubt exists about our ability to continue as a going concern for a period of one year after the date of filing of this Quarterly Report on Form 10-Q. The financial statements have been prepared on a basis that assumes Agenus will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
Management continues to address the Company’s liquidity needs and has continued to adjust spending in order to preserve liquidity. In August 2023, we prioritized and focused our resources to accelerate the development, registration, and commercialization of our lead asset postponing all preclinical and other clinical programs and reducing our workforce by approximately 25%. Our CEO, Dr. Garo Armen has elected to receive his base salary and any potential bonus payments in stock rather than cash. We continuously evaluate the likelihood of success of our programs. As such, our decisions to continue to fund or eliminate funding of each of our programs are predicated on these determinations, on an ongoing basis. We expect our sources of funding to include payments from current collaborations which include out-licensing and/or partnering opportunities for our portfolio programs and product candidates with multiple parties; additional third-party agreements; asset sales; further royalty monetization; project financing, and/or sales of equity securities.
Our future cash requirements include, but are not limited to, supporting clinical trial and regulatory efforts and continuing our other research and development programs. Since inception, we have entered into various agreements with contract manufacturers, institutions, and clinical research organizations (collectively “third party providers”) to perform pre-clinical activities and to conduct and monitor our clinical studies and trials. Under these agreements, subject to the enrollment of patients and performance by the applicable third-party provider, we have estimated our total payments to be $660.4 million over the term of the related activities. Through September 30, 2024, we have expensed $598.1 million as research and development expenses and $562.4 million has been
25
paid under these agreements. The timing of expense recognition and future payments related to these agreements is subject to the enrollment of patients and performance by the applicable third-party provider. We plan to enter into additional agreements with third party providers and we anticipate significant additional expenditures will be required to initiate and advance our various programs.
Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing collaboration arrangements with academic and collaboration partners and licensees and by entering into new collaborations. As a result of our collaboration agreements, we will not completely control the efforts to attempt to bring those product candidates to market.
Net cash used in operating activities for the nine months ended September 30, 2024 and 2023 was $129.7 million and $183.8 million, respectively. Our future ability to generate cash from operations will depend on achieving regulatory approval and market acceptance of our product candidates, achieving benchmarks as defined in existing collaboration agreements, and our ability to enter into new collaborations. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Forward Looking Statements” in Part I, Item 2 of this Quarterly Report on Form 10-Q and the risks highlighted in Part I, Item 1A "Risk Factors" of our 2023 Form 10-K, Part II and Item 1A "Risk Factors" of our Q2 2024 Form 10-Q.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our primary market risk exposure is foreign currency exchange rate risk. International revenues and expenses are generally transacted by our foreign subsidiaries and are denominated in local currency. Approximately 0.6% and 1.0% of our cash used in operations for the nine months ended September 30, 2024 and the year ended December 31, 2023, respectively, was from our foreign subsidiaries. We are exposed to foreign currency exchange rate fluctuation risk related to our transactions denominated in foreign currencies. We do not currently employ specific strategies, such as the use of derivative instruments or hedging, to manage these exposures. Our currency exposures vary but are primarily concentrated in the British Pound and Swiss Franc, in large part due to our subsidiaries, Agenus UK Limited and AgenTus Therapeutics Limited, both with operations in England, and Antigenics SA, a company with operations in Switzerland.
We had cash and cash equivalents at September 30, 2024 of $44.8 million, which are exposed to the impact of interest rate changes, and our interest income fluctuates as interest rates change. Additionally, in the normal course of business, we are exposed to fluctuations in interest rates as we seek debt financing and invest excess cash. Due to the short-term nature of our investments in money market funds, our carrying value approximates the fair value of these investments at September 30, 2024.
There has been no material change to our interest rate exposure and our approach toward interest rate and foreign currency exchange rate exposures, as described in our Annual Report on Form 10-K for the year ended December 31, 2023.
We invest our cash and cash equivalents in accordance with our investment policy. The primary objectives of our investment policy are to preserve principal, maintain proper liquidity to meet operating needs, and maximize yields. We review our investment policy periodically and amend it as deemed necessary. Currently, the investment policy prohibits investing in any structured investment vehicles and asset-backed commercial paper. Although our investments are subject to credit risk, our investment policy specifies credit quality standards for our investments and limits the amount of credit exposure from any single issue, issuer, or type of investment. We do not invest in derivative financial instruments. Accordingly, we do not believe that there is currently any material market risk exposure with respect to derivatives or other financial instruments that would require disclosure under this item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our Principal Executive Officer and Principal Financial Officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) and Rule 15d-15(e) promulgated under the Exchange Act. Based on this evaluation, our Principal Executive Officer and our Principal Financial Officer 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 and were designed to ensure that information we are required to disclose in the reports that we file or submit under the Exchange Act is accumulated and communicated to management, including our Principal Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure, and is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms. It should be noted that any system of controls is designed to provide reasonable, but not absolute, assurances that the system will achieve its stated goals under all reasonably foreseeable circumstances. Our Principal Executive Officer and Principal Financial Officer have each concluded that our disclosure controls and procedures as of the end of the period covered by this report are effective at a level that provides such reasonable assurances.
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Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the three months ended September 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II - OTHER INFORMATION
Item 1. Legal Proceedings
In September 2024, a putative securities class action lawsuit was commenced in the U.S. District Court for the District of Massachusetts naming as defendants Agenus and three current officers. The complaint alleges that the defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions of material fact related to the efficacy and commercial prospects of botensilimab and balstilimab. The plaintiff seeks to represent all persons who purchased or otherwise acquired Agenus securities between January 23, 2023, and July 17, 2024. The plaintiff seeks damages and interest, and an award of costs, including attorneys’ fees. We have not recorded any accrual for a contingent liability associated with these legal proceedings.
In September 2024, we received a subpoena from the Boston Regional Office of the U.S. Securities and Exchange Commission seeking records relating to certain of our product candidates, correspondence with the FDA, public disclosure, and other matters. We have produced records pursuant to the subpoena.
We are not currently a party to any other material legal proceedings. From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Regardless of the outcome, litigation can have a material adverse effect on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors
Our results of operations and financial condition are subject to numerous risks and uncertainties described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. There have been no material changes to the risk factors described in Part I, Item 1A "Risk Factors" of our 2023 Form 10-K and Part II, Item 1A "Risk Factors" of our Q2 2024 Form 10-Q.
Item 5. Other Information
Trading Plans of Our Directors and Officers
During the quarter ended September 30, 2024, none of our directors or executive officers
28
Item 6. Exhibits
Exhibit No. |
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Description |
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31.1 |
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31.2 |
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32.1 |
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101.INS |
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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 Document |
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101.CAL |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF |
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Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB |
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Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101) |
29
AGENUS INC.
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.
Date: |
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November 12, 2024 |
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AGENUS INC. |
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/s/ CHRISTINE M. KLASKIN |
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Christine M. Klaskin VP, Finance, Principal Financial Officer, Principal Accounting Officer |
30