美国
证券交易委员会
华盛顿特区20549
Form
截至季度结束日期的财务报告
or
过渡期从到
委托文件编号：001-39866
(公司章程中指定的)完整注册名称
|
||
（国家或其他管辖区的 公司成立或组织） |
|
（IRS雇主 唯一识别号码） |
（总部地址，包括邮政编码）
注册人的电话号码，包括区号：
(
根据证券交易法案第12(b)条规定注册或将要注册的证券。
每一类的名称 |
交易标的 |
在其上注册的交易所的名称 |
股市 |
请在以下方框内打勾，以指示注册人是否（1）已在过去12个月内（或在注册人需要提交此类报告的较短期间内）提交了交易所法案第13或15（d）条规定的所有要求提交的报告，并且（2）在过去90天内一直需要遵守提交要求。
☑ 否 ☐
请在勾选标志处表示注册人是否已经在过去12个月内（或者在注册人要求提交这些文件的较短时期内）按照规则405 of协议S-T（本章节的§232.405）提交了每个交互式数据文件。 ☒ 没有 ☐
勾选以下选框，指示申报人是大型加速评估提交人、加速评估提交人、非加速评估提交人、小型报告公司或新兴成长型公司。关于“大型加速评估提交人”、“加速评估提交人”、“小型报告公司”和“新兴成长型公司”的定义，请参见《交易所法规》第12亿.2条。
大型加速报告人 |
|
☐ |
|
|
☒ |
|
非加速文件提交人 |
|
☐ |
|
较小的报告公司 |
|
|
|
|
|
|
新兴成长公司 |
|
如果是新兴成长型企业，请勾选复选标记，表明注册者已选择不使用延长过渡期来符合根据证券交易法第13(a)条规定提供的任何新财务会计准则。 ☐
请在检查标记处说明申报人是否为外壳公司 (见交易所法案 Rule 12b-2 定义)。 是☐ 没有
2024年11月8日，发行人普通股的流通股数量：
Agenus公司。
2024年9月30日止九个月
目录
|
|
|
|
页 |
第一部分 |
|
|
||
项目 1。 |
|
|
2 |
|
|
|
|
2 |
|
|
|
|
3 |
|
|
|
|
4 |
|
|
|
|
6 |
|
|
|
|
7 |
|
ITEm 2. |
|
|
20 |
|
控件3。 |
|
|
26 |
|
控件4。 |
|
|
26 |
|
|
|
|
||
第II部分 |
|
|
||
项目 1。 |
|
|
28 |
|
项目1A. |
|
|
28 |
|
第5项 |
|
|
28 |
|
项目6。 |
|
|
29 |
|
|
|
|
30 |
|
第一部分 - 财务信息
项目1。 基本报表
艾吉纳斯公司及其子公司
压缩的综合资产负债表TED资产负债表
（除每股股价和每股收益之外的所有金额均以千为单位）
|
|
2024年9月30日 |
|
|
2023年12月31日 |
|
||
资产 |
|
|
|
|
|
|
||
现金及现金等价物 |
|
$ |
|
|
$ |
|
||
应收账款 |
|
|
|
|
|
|
||
预付费用 |
|
|
|
|
|
|
||
其他流动资产 |
|
|
|
|
|
|
||
总流动资产 |
|
|
|
|
|
|
||
物业、厂房及设备净值，减去累计摊销和折旧 |
|
|
|
|
|
|
||
经营租赁使用权资产 |
|
|
|
|
|
|
||
商誉 |
|
|
|
|
|
|
||
购买的无形资产，减去累计摊销$ |
|
|
|
|
|
|
||
其他长期资产 |
|
|
|
|
|
|
||
总资产 |
|
$ |
|
|
$ |
|
||
负债和股东赤字 |
|
|
|
|
|
|
||
长期负债的流动部分 |
|
$ |
|
|
$ |
|
||
与未来版税和里程碑出售相关的负债的流动部分 |
|
|
|
|
|
|
||
短期部分，递延营收 |
|
|
|
|
|
|
||
短期部分，经营租赁负债 |
|
|
|
|
|
|
||
应付账款 |
|
|
|
|
|
|
||
应计负债 |
|
|
|
|
|
|
||
其他流动负债 |
|
|
|
|
|
|
||
流动负债合计 |
|
|
|
|
|
|
||
开多期债务，净电流部分 |
|
|
|
|
|
|
||
与未来版税和里程碑销售有关的负债，减去短期部分净额 |
|
|
|
|
|
|
||
递延收入，减去当前部分净额 |
|
|
|
|
|
|
||
经营租赁负债，净值超过流动资产 |
|
|
|
|
|
|
||
其他长期负债 |
|
|
|
|
|
|
||
|
|
|
|
|
|
|||
股东权益亏损 |
|
|
|
|
|
|
||
A-1系列可转换优先股； |
|
|
|
|
|
|
||
普通股，每股面值 $，授权股数：百万股；发行股数：分别为2024年6月30日和2023年12月31日：百万股；流通股数：分别为2024年6月30日和2023年12月31日：百万股 |
|
|
|
|
|
|
||
额外实收资本 |
|
|
|
|
|
|
||
累计其他综合损失 |
|
|
( |
) |
|
|
( |
) |
累积赤字 |
|
|
( |
) |
|
|
( |
) |
Agenus Inc.归属于股东的总股东赤字 |
|
|
( |
) |
|
|
( |
) |
非控制权益 |
|
|
|
|
|
|
||
股东赤字总额 |
|
|
( |
) |
|
|
( |
) |
负债总额和股东权益亏损总额 |
|
$ |
|
|
$ |
|
||
请参见附注的未经审计的简明合并财务报表。
2
艾吉纳斯公司及其子公司
简明综合损益表合并财务报表F经营和综合损失
(未经审计)
（金额为千元，除每股金额外）
|
|
截至9月30日的三个月 |
|
|
截至9月30日的九个月 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
营业收入： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
研发 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
服务收入 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
与未来特许权出售相关的非现金版税收入 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
总收入 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
营业费用： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
服务成本 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
研发 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
总务和行政 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
公允价值调整 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating loss |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
其他收入（费用）： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
营业外收入 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
利息费用，净额 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
净损失 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
A-1可转换优先股股息 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
减：归属于非控股权益的净亏损 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
归属Agenus Inc.普通股股东的净亏损 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
每股普通股数据： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Agenus Inc.普通股股东的基本和稀释每股净亏损 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Agenus Inc.普通股平均流通股数： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
基本和稀释 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
其他全面损失： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
外币汇兑损失 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
其他综合损失 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
综合损失 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
请参见附注的未经审计的简明合并财务报表。
3
艾吉纳斯公司及其子公司
（未经审计）
（以千为单位）
|
|
A-1系列 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
|
|
可转换证券 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
|
|
优先股 |
|
|
普通股 |
|
|
|
|
|
库藏股 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||
|
|
数量 |
|
|
Par |
|
|
数量 |
|
|
Par |
|
|
其他 |
|
|
数字 |
|
|
金额 |
|
|
累计 |
|
|
非控制股东 |
|
|
累计 |
|
|
合计 |
|
|||||||||||
2023年12月31日的余额 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
|
( |
) |
||||||
净损失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
其他综合损失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
基于股份的补偿 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
股票在市场上出售 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
通过股票支付CEO的薪酬 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
未投资股份的归属权 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
行使股票期权和员工购买股份 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||||
2024年3月31日结存余额 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||
净损失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
其他综合收益 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
基于股份的补偿 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
股票在市场上出售 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
发行认股权证，减去费用 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
非受限股份的释放 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
通过股票支付CEO的薪资 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
MiNk定向增发股票出售 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
执行股票期权 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||||
2024年6月30日余额 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||
净损失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
其他综合损失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
基于股份的补偿 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
市场上出售股份 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
以股份支付CEO工资 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
非质押股份的解锁 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
行使股票期权和员工购买股份 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||||
2024年9月30日的余额 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||
请参见附注的未经审计的简明合并财务报表。
4
艾吉纳斯公司及其子公司
（未经审计）
（以千为单位）
|
|
A-1系列 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
|
|
可转换证券 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
|
|
优先股 |
|
|
普通股 |
|
|
|
|
|
库藏股 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||
|
|
数量 |
|
|
Par |
|
|
数量 |
|
|
面值 |
|
|
其他 |
|
|
数字 |
|
|
金额 |
|
|
累计 |
|
|
非控制股东 |
|
|
累积 |
|
|
合计 |
|
|||||||||||
2022年12月31日的余额 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||||||
净损失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
其他综合收益 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
基于股份的补偿 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
市场上出售的股票 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
董事延期股份发行 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
发行股份以换取服务 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
行使股票期权和员工购股 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||||
发行子公司股份作为员工奖金 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
发行股份作为员工奖金 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
回购库藏股份 |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
2023年3月31日的余额 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||||||
净损失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
其他综合损失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
基于股票的补偿 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
市场上出售的股份 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
MiNk股息 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
MiNk股票购买 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
发行子公司股份作为员工奖金 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
发行股份作为员工奖金 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
自家股份的养老 |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
2023年6月30日的余额 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||
净损失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
其他全面损失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
基于股份的薪酬 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
在市场上出售的股份 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
以股份支付CEO工资 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
MiNk股票购买 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
发行股份换取服务 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
未投资股份的归属权 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
员工购买股份 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||||
2023年9月30日财务状况表 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||
请参考财务报表的相关说明.
5
艾吉纳斯公司及其子公司
简明合并财务报表现金流量表
(未经审计)
（金额为千元，除每股金额外）
|
|
截至9月30日的九个月 |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
经营活动现金流量： |
|
|
|
|
|
|
||
净损失 |
|
$ |
( |
) |
|
$ |
( |
) |
调整为净损失到经营活动现金流量净使用： |
|
|
|
|
|
|
||
折旧与摊销 |
|
|
|
|
|
|
||
基于股份的补偿 |
|
|
|
|
|
|
||
非现金版税收入 |
|
|
( |
) |
|
|
( |
) |
非现金利息费用 |
|
|
|
|
|
|
||
用于计算每股普通股股东净收益的加权平均股数： |
|
|
|
|
|
|
||
租赁终止的收益 |
|
|
( |
) |
|
|
— |
|
其他，净额 |
|
|
( |
) |
|
|
|
|
经营性资产和负债变动: |
|
|
|
|
|
|
||
应收账款 |
|
|
|
|
|
|
||
预付费用 |
|
|
|
|
|
( |
) |
|
应付账款 |
|
|
( |
) |
|
|
|
|
递延营业收入 |
|
|
( |
) |
|
|
( |
) |
应计的负债和其他流动负债 |
|
|
|
|
|
|
||
其他营运资产和负债 |
|
|
( |
) |
|
|
( |
) |
经营活动使用的净现金流量 |
|
|
( |
) |
|
|
( |
) |
投资活动现金流量： |
|
|
|
|
|
|
||
购买固定资产 |
|
|
( |
) |
|
|
( |
) |
出售厂房和设备的收益 |
|
|
|
|
|
|
||
购买长期投资 |
|
|
— |
|
|
|
( |
) |
出售长期投资的收益 |
|
|
|
|
|
— |
|
|
可供出售证券购买 |
|
|
— |
|
|
|
( |
) |
可供出售证券的出售收益 |
|
|
— |
|
|
|
|
|
投资活动提供的净现金流量 |
|
|
|
|
|
|
||
筹集资金的现金流量： |
|
|
|
|
|
|
||
股权出售所得净额 |
|
|
|
|
|
|
||
定向增发中子公司股份出售所得净额 |
|
|
|
|
|
— |
|
|
利根购买协议所得款项，扣除费用后净额 |
|
|
|
|
|
— |
|
|
员工购买股票和期权行权所得款项 |
|
|
|
|
|
|
||
购买公司库存股以支付税款 |
|
|
— |
|
|
|
( |
) |
购买子公司股份 |
|
|
— |
|
|
|
( |
) |
支付融资租赁债务 |
|
|
( |
) |
|
|
( |
) |
筹资活动产生的现金净额 |
|
|
|
|
|
|
||
汇率变动对现金的影响 |
|
|
( |
) |
|
|
( |
) |
现金、现金等价物和受限制现金净减少额 |
|
|
( |
) |
|
|
( |
) |
期初现金、现金等价物及受限制的现金 |
|
|
|
|
|
|
||
期末现金、现金等价物及受限制的现金 |
|
$ |
|
|
$ |
|
||
补充现金流量信息： |
|
|
|
|
|
|
||
支付的利息现金 |
|
$ |
|
|
$ |
|
||
其他信息披露 - 非现金活动： |
|
|
|
|
|
|
||
普通股发行，$ |
|
$ |
— |
|
|
$ |
|
|
保险融资协议 |
|
|
|
|
|
|
||
发放股票期权以支付一定员工奖金 |
|
|
|
|
|
— |
|
|
普通股发行，$ |
|
|
— |
|
|
|
|
|
发行子公司期权，以支付某些员工奖金 |
|
|
|
|
|
— |
|
|
发行子公司股票，以支付某些员工奖金 |
|
|
— |
|
|
|
|
|
出租权，以换取新的经营租赁负债 |
|
|
|
|
|
|
||
长期使用权资产，以换取新的融资租赁负债 |
|
|
|
|
|
|
||
请参见附注的未经审计的简明合并财务报表。
6
艾吉纳斯公司及其子公司
未经审计的简明基本财务报表附注基本报表
2024年9月30日
附注A——业务、流动性和列报基础
Agenus Inc.（包括其子公司，统称为 “Agenus”、“公司”、“我们” 和 “我们的”）是一家领先的临床阶段生物技术公司，通过强大的免疫药物管道开发针对癌症的疗法。我们的使命是通过组合方法，使用广泛的抗体疗法、过继细胞疗法（通过我们的子公司MinK Therapeutics, Inc.（“MinK”））和疫苗佐剂（通过我们的子公司SaponiqX，Inc.（“SaponiQX”））来扩大受益于癌症免疫疗法的患者群体。我们相信，联合疗法和对每位患者癌症的深入了解将显著扩大受益于免疫肿瘤学（“I-O”）治疗的患者群体。
除了多样化的产品线外，我们还建立了全面整合的能力，包括新靶标发现、抗体生成、细胞系开发和当前的良好生产规范（“cGMP”）制造。我们相信，与行业标准相比，这些综合能力使我们能够在更短的时间内开发新候选药物，并在获得批准后将其商业化。通过独立开发和战略伙伴关系，我们利用我们的科学专长和能力来推动人工智能领域的创新。
我们的I-O产品组合由多个平台和计划驱动，我们计划单独使用或组合使用这些平台和计划：
我们的业务活动包括产品研究、临床前和临床开发、知识产权申请、制造、监管和临床事务、企业融资和开发活动以及对我们合作的支持。我们的候选产品需要成功的临床试验和监管机构的批准，并获得市场的认可。我们战略的一部分是通过继续与学术和企业合作者和被许可方的现有安排以及开展新的合作，开发和商业化我们的一些候选产品。
截至2024年9月30日，我们的现金和现金等价物为 $
截至2024年9月30日，我们的累计赤字为 $
根据我们目前的计划和预测，我们认为我们的现金资源是 $
目前，我们正在与包括生物技术和制药合作伙伴在内的多个实体进行讨论，以及专门的医疗保健基金，通过我们计划提交的botensilimab/balstilimab的生物制剂许可证申请或上市许可，为我们的运营提供必要的资金。但是，由于此类交易的完成并不完全在我们的控制范围内，根据会计指导，我们必须披露，自提交本10-Q表季度报告之日起，我们是否有能力继续经营一年。财务报表是在假设Agenus将继续作为持续经营企业的基础上编制的，并考虑在正常业务过程中变现资产和偿还负债和承诺。
管理层继续满足公司的流动性需求，并继续调整支出以保持流动性。2023 年 8 月，我们对资源进行了优先排序和集中，以加快主要资产的开发、注册和商业化，推迟了所有临床前和其他临床项目，并裁减了大约员工
7
当前 包括与多方签署许可和/或合作机会、额外第三方协议、资产销售、更多版权货币化、项目融资和/或股票出售有关的合作。
随附的未经审计的中期简明合并财务报表已按照美国通用会计准则（"U.S. GAAP"）和《S-X条例第10条的规定编制。因此，它们不包括美国通用会计准则对于完整年度合并财务报表所需的所有信息和附注。经管理层的意见，这些简明合并财务报表包括为公正展示我们的财务状况和运营结果而认为必要的一切正常和重复调整。所有重大公司内交易和账户已在合并中消除。截至2024年9月30日的九个月运营结果未必反映2024年12月31日结束的财年预期结果。有关更多信息，请参阅包括在我们提交给证券交易委员会（"SEC"）的2023年12月31日年度报告中的合并财务报表和附注。
按照美国通用会计准则编制合并财务报表要求管理层进行可影响报告资产和负债的金额以及披露财务报表日期财产和负债的估计和假设，以及在报告期间报告收入和支出的金额。管理层基于历史经验和认为在情况下合理的各种假设进行估计。实际结果可能与这些估计有实质性差异。
对于我们的外国子公司，当地货币是功能货币。外国子公司的资产和负债使用资产负债表日期的汇率转换为美元，而收入和支出使用期间的平均汇率转换为美元。由于汇率变动导致的累积翻译调整作为综合收益（亏损）的累积组成部分包括在合并资产负债表中的股东权益总逆差。
在2024年4月4日，我们对我们已发行和流通的普通股进行了一次反向股票拆分，面值$
在截至2024年9月30日的九个月中，我们对某些外国子公司进行了脱离合并，并分别确认了约$的收益，包括在我们的摘要综合损益表的“其他收入（费用）”中。
基本每股普通股净损失是通过将归属于普通股股东的净损失除以普通股的加权平均股数来计算的（包括我们修订和重设的董事延期补偿计划（简称“DDCP”）下可发行的普通股）。稀释普通股每股净损失是通过将归属于普通股股东的损失除以普通股的加权平均股数（包括我们DDCP下可发行的普通股）加上发行的工具的稀释效应计算的，例如权证、股票期权、未实现的股份和可转换优先股。由于我们报告了所有期间归属于普通股股东的净损失，稀释每股普通股净损失与基本每股普通股净损失相同，因为使用全稀释股数将会降低每股普通股的净损失。
|
|
截至9月30日的三个月和九个月 |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
warrants |
|
|
|
|
|
|
||
股票期权 |
|
|
|
|
|
|
||
未获授股份 |
|
|
|
|
|
|
||
A-1系列可转换优先股 |
|
|
|
|
|
|
||
8
附注C – 投资
截至日期，现金等价物包括以下内容 2024年9月30日和2023年12月31日（单位：千美元）：
|
|
2024年9月30日 |
|
|
2023年12月31日 |
|
||||||||||
|
|
成本 |
|
|
估计 |
|
|
成本 |
|
|
估计 |
|
||||
机构货币市场基金 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
合计 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
由于这些投资的短期性质，截至2024年9月30日和2023年的三个和九个月，未实现的持有增值或减值很少。
截至2024年9月30日和2023年12月31日，上述所有投资在我们的简明综合资产负债表中均被分类为等价物。
备注D – 商誉和取得的无形资产
以下表格说明了截至2024年9月30日的商誉账面金额变化 截至2024年9月30日的九个月变动情况（以千为单位）：
2023年12月31日的余额 |
|
$ |
|
|
外汇影响 |
|
|
( |
) |
2024年9月30日资产负债表 |
|
$ |
|
取得的无形资产截至 2024年9月30日和2023年12月31日（单位：千美元）：
|
|
截至2024年9月30日 |
|
|||||||||||
|
|
摊销 |
|
毛额携带 |
|
|
累积 |
|
|
净账面价值 |
|
|||
知识产权 |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
商标 |
|
|
|
|
|
|
( |
) |
|
|
|
|||
其他 |
|
|
|
|
|
|
( |
) |
|
|
|
|||
研发中的项目 |
|
不确定 |
|
|
|
|
|
— |
|
|
|
|
||
合计 |
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
|
|
截至2023年12月31日 |
|
|||||||||||
|
|
摊销 |
|
毛账载 |
|
|
累积 |
|
|
净账面价值 |
|
|||
知识产权 |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
商标 |
|
|
|
|
|
|
( |
) |
|
|
|
|||
其他 |
|
|
|
|
|
|
( |
) |
|
|
|
|||
研发中的项目 |
|
不确定 |
|
|
|
|
|
— |
|
|
|
|
||
合计 |
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
我们有限生命周期无形资产的加权平均摊销期为
9
附注 E – 债务
债务工具 |
|
期末余额 |
|
|
流动部分: |
|
|
|
|
无抵押可转换债券 |
|
$ |
|
|
2015年次级票据 |
|
|
|
|
其他 |
|
|
|
|
合计 |
|
$ |
|
|
债务工具 |
|
期末余额 |
|
|
流动部分: |
|
|
|
|
无抵押可转换债券 |
|
$ |
|
|
长期部分： |
|
|
|
|
2015年次级票据 |
|
|
|
|
合计 |
|
$ |
|
|
截至2024年9月30日和2023年12月31日，我们未偿还债务余额的本金金额为$
备注F – 与未来专利和里程碑销售相关的责任
下表显示了截至2024年9月30日的负债账户内的活动 2024年9月30日止九个月内的活动情况（以千为单位）：
|
|
Period from |
|
|
与未来专利和里程碑销售相关的责任 - 期初余额 |
|
$ |
|
|
未来专利和里程碑销售款项 |
|
|
|
|
非现金版税收入 |
|
|
( |
) |
确认的非现金利息费用 |
|
|
|
|
与未来版税和里程碑销售相关的负债 - 期末余额 |
|
|
|
|
减：未摊销交易成本 |
|
|
( |
) |
与未来版税和里程碑销售相关的负债，净值 |
|
$ |
|
|
医疗保健版税合作伙伴
2018年1月，我们通过全资子公司Antigenics，LLC（"Antigenics"）与医疗保健版税合作伙伴III号有限合伙及其某些关联公司（统称"HCR"）签署了一份版税购买协议（"HCR版税购买协议"）。根据HCR版税购买协议的条款，我们向HCR出售了Antigenics在全球范围内从葛兰素史克（"GSK"）销售含有我们的STIMULON QS-21佐剂疫苗的版税的权利的百分之
2024年9月30日结束的九个月内，我们确认了相关收入$
10
由于版税将从GSk汇入HCR，已记录的负债余额将在HCR版税购买协议的有效期内得以偿还。为了确定已记录负债的摊销，我们需要估计HCR将收到的未来版税总额。这些金额之和减去我们收到的$
ligand pharmaceuticals
于2024年5月，我们及特定的全资子公司与ligand pharmaceuticals incorporated（“ligand”）签订了一份购买与销售协议（“ligand购买协议”）。根据ligand购买协议的条款，ligand将收到（i）
向ligand支付的总金额须根据%的退还难关进行调整
作为出售购买资产的考虑，我们在交割日收到了总额为$的毛收益
与已购资产的出售相结合，我们向Ligand发行了一份购股证（"Ligand Warrant"），以购买
从2023年12月31日至2024年3月31日，净合同资产增加$
与未来版税和里程碑销售有关的负债 |
|
$ |
|
|
Ligand购股证 |
|
|
|
|
购买者增加选项 |
|
|
|
|
ligand pharmaceuticals总购买协议的总收益 |
|
$ |
|
由于我们对购买资产现金流生成的重大持续参与，我们被要求将来自该交易的$的收入视为负债，该负债将根据支付给ligand用于ligand购买协议估计寿命内的特许权和里程碑支付，按比例确认为营业收入。
购买者增加选项被视为独立的财务工具，因为它可以分开行使并且可以从ligand购买协议中合法转让。因此，它被视为按公允价值计入负债，并在每个资产负债表日按照公允价值重新衡量，公允价值变动记录在收入中。2024年9月30日购买者增加选项的公允价值为$
ligand warrants被认为是独立的财务工具，因为它可以分开行使并且可以从ligand购买协议中合法转让，根据ASC 815的规定，被划分为股本类别。
为分配收益，购买者增加选项负债和被划分为股本类别的ligand warrants被确认为其公允价值，并将余下部分分配给与未来特许权和里程碑销售相关的负债，在我们的资产负债表中确认。
截至2024年9月30日的九个月内，我们记录了$
随着我们收到的版税、从购买资产赚取的里程碑和销售额，记录的负债余额将在Ligand购买协议的有效偿还期内得到偿还。为了判断记录的负债的摊销，我们需要估计Ligand在Ligand购买协议下有权获得的未来支付总额。这些金额之和减去已分配给与未来版税和里程碑销售相关的负债的$
11
负债和利息支出的相关确认。截至2024年9月30日，我们估计协议期内的有效年利率为
附注G-应计及其他流动负债
截至目前，应计负债包括以下内容 2024年9月30日和2023年12月31日（单位：千美元）：
|
|
2024年9月30日 |
|
|
2023年12月31日 |
|
||
薪资 |
|
$ |
|
|
$ |
|
||
专业费用 |
|
|
|
|
|
|
||
合同制造业-半导体成本 |
|
|
|
|
|
|
||
研究服务 |
|
|
|
|
|
|
||
其他 |
|
|
|
|
|
|
||
合计 |
|
$ |
|
|
$ |
|
||
其他流动负债截至 2024年9月30日和2023年12月31日（单位：千美元）：
|
|
2024年9月30日 |
|
|
2023年12月31日 |
|
||
融资租赁负债 |
|
$ |
|
|
$ |
|
||
购买方增加选择权 (注释 F) |
|
|
|
|
|
— |
|
|
其他 |
|
|
|
|
|
|
||
合计 |
|
$ |
|
|
$ |
|
||
我们的一个融资租赁协议条款包括维持特定最低现金余额的要求。截至2024年9月30日，我们的现金余额低于此门槛。尽管如此，我们仍在协议项下及时支付所有租金。虽然金融机构有权采取补救措施，包括可能收回已租赁的资产，但我们正在积极应对这一局面，并希望恢复合规。截至2024年9月30日，在此租赁项下欠款的剩余金额约为$
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
22
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
23
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.
24
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.
26
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.
27
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. |
|
Description |
|
|
|
31.1 |
|
|
|
|
|
31.2 |
|
|
|
|
|
32.1 |
|
|
|
|
|
101.INS |
|
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) |
|
|
|
101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document |
|
|
|
101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
|
101.DEF |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document |
|
|
|
101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
|
|
|
101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
|
|
|
104 |
|
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: |
|
November 12, 2024 |
|
AGENUS INC. |
|
|
|
|
|
|
|
|
|
/s/ CHRISTINE M. KLASKIN |
|
|
|
|
Christine M. Klaskin VP, Finance, Principal Financial Officer, Principal Accounting Officer |
30