美国
证券和交易委员会
华盛顿特区20549
表格
截至季度结束日期的财务报告
或者
过渡期从 至
委员会档案号
(根据其章程规定的准确名称)
Not Applicable | |
(设立或组织的其他管辖区域) | ( .) |
,(主要行政办公地址)
(
(注册人电话号码,包括区号)
在法案第12(b)条的规定下注册的证券:
每一类的名称 | 交易代码 | 在其上注册的交易所的名称 |
该 |
请用勾号勾选以下内容:(1)在过去的12个月内(或者c注册人所需要提交此类报告的更短期限内),c注册人已经提交了根据1934年证券交易法第13或第15(d)条规定需要提交的全部报告;和(2)c注册人在过去的90天内一直需要遵守此类提交要求。⌧
请通过勾选,指明注册人是否在过去12个月内(或者在注册人必须提交此类文件的较短时期内)提交了根据规则405的S-t条例(本章第232.405条)要求提交的每个互动数据文件。 ⌧
请通过勾选,指明注册人是大型加速报告者、加速报告者、非加速报告者、较小报告公司还是新兴成长公司。请参阅《交易所法》第120亿.2条中对“大型加速报告者”、“加速报告者”、“较小报告公司”和“新兴成长公司”的定义。
大型加速归档人◻ | 加速报告人◻ |
x | 小型报告公司 |
新兴成长公司 |
如果是新兴成长公司,请勾选注册人是否选择不使用根据交易所法第13(a)节规定的任何新的或修订的财务会计标准的延长过渡期。 ◻
请用勾号勾选以下内容:c注册人是否是一个空壳公司(根据证券交易法规则12b-2中的定义)。
截至2024年11月12日,注册公司的每股面值为£0.001的普通股未偿还数量为
基本信息
根据本表10-Q季度报告(“季度报告”),“Adaptimmune”,“集团”,“公司”,“我们”,“我们”和“我们”指的是Adaptimmune Therapeutics plc及其合并子公司,除非上下文另有要求。
关于前瞻性声明的信息
这款电动三轮车提供了卓越的舒适度和支撑作用,减轻了骑手的背部和关节的压力。它是寻求轻松骑行体验而不影响性能和效率的人的绝佳选择。后置电机可以在加减速时更好地控制和操纵,而前叉悬挂可最小化不平的路面对车辆的冲击。此三轮车还配备了5英寸液晶屏、EB 2.0照明系统、可折叠车把、胖胎、后差速器和停车刹车。此外,它还有一个拖车管,可以轻松地搬运大货物。还有一个适用于身材较矮的骑手的Mini版本。季度 报告包含涉及风险和不确定因素的前瞻性声明,以及假设,如果这些假设从未实现或被证明不正确,可能导致我们的结果与这些前瞻性声明所表达或暗示的结果大相径庭。我们根据1995年《私人证券诉讼改革法案》和其他联邦证券法的庇护规定作出这些前瞻性声明。本季度报告中除了历史事实陈述之外的所有陈述均为前瞻性声明。在某些情况下,您可以通过诸如 “相信”,“可能”,“将”,“估计”,“持续”,“预期”,“期待”等词来识别前瞻性声明 或这些词的否定形式或其他类似术语。
本季度报告中的任何前瞻性陈述反映了我们对未来事件或未来财务业绩的当前看法,涉及已知和未知风险、不确定性和其他因素,可能导致我们的实际结果、业绩或成就与这些前瞻性陈述中表达或暗示的任何未来结果、业绩或成就有实质差异。可能导致实际结果与当前预期有实质差异的因素包括,但不限于,我们在2023年12月31日止的年度10-K表格的第I部分第1A条“风险因素”中讨论的事项。规定在2024年3月6日向证券交易委员会(“SEC”)提交。鉴于这些不确定性,您不应过度依赖这些前瞻性陈述。除非法律要求,我们不承担因任何原因更新或修订这些前瞻性陈述的义务,即使将来有新信息可用。
本季度 本季度报告还包含有关我们行业、业务和某些疾病市场的估计、预测和其他信息,包括关于这些市场的估计规模、某些医疗状况的发病率和流行率的数据。基于估计、预测、投影、市场研究或类似方法的信息固有地受到不确定性的影响,实际事件或情况可能与此信息反映的事件和情况有实质差异。除非另有明确声明,我们获得此行业、业务、市场和其他数据的来源包括第三方准备的报告、研究调查、研究以及类似数据,行业、医疗和一般出版物、政府数据和类似来源。
3
第一部分 — 财务信息
项目1.基本报表。
ADAPTIMMUNE THERAPEUTICS PLC
未经审计的简明合并资产负债表
(单位:千美元,以股份数据为单位)
9月30日, | 十二月31日, | |||||
| 2024 |
| 2023 | |||
资产 | ||||||
流动资产 | ||||||
现金及现金等价物 | $ | | $ | | ||
可交易证券 - 可供出售的债务证券(摊余成本为$ | | | ||||
应收账款,减预期信贷损失后的净额为$ | | | ||||
存货净额 | | — | ||||
其他流动资产和预付费用 | | | ||||
总流动资产 | | | ||||
Restricted cash | | | ||||
其他非流动资产 | | — | ||||
运营租赁使用权资产,扣除累计摊销$ | | | ||||
不动产、厂房及设备,扣除累计折旧$ | | | ||||
无形资产净额(摊销数累计$89.5) | | | ||||
总资产 | $ | | $ | | ||
负债和股东权益 | ||||||
流动负债 | ||||||
应付账款 | $ | | $ | | ||
经营租赁负债,流动负债 | | | ||||
应计费用及其他流动负债 | | | ||||
递延收入,流动 | | | ||||
流动负债合计 | | | ||||
非流动经营租赁负债 | | | ||||
递延收入,非流动 | | | ||||
非流动借款 | | — | ||||
其他非流动负债 | | | ||||
总负债 | | | ||||
股东权益 | ||||||
普通股 - 普通股面值£ | | | ||||
股票认购应收款项。 | | | ||||
其他综合收益累计 | ( | ( | ||||
累积赤字 | ( | ( | ||||
股东权益合计 | | | ||||
负债和股东权益总额 | $ | | $ | |
请参见附注的未经审计的简明合并财务报表。
4
ADAPTIMMUNE THERAPEUTICS PLC
未经审计的摘要合并利润表
(单位:千美元,除每股数据外)
结束于三个月 |
| 截至九个月 | ||||||||||
9月30日, | 2023年9月30日 | |||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||||
营业收入 | $ | | $ | | $ | | $ | | ||||
营业费用 | ||||||||||||
研发 | ( | ( |
| ( |
| ( | ||||||
销售、总务和管理费用 | ( | ( |
| ( |
| ( | ||||||
总营业费用 | ( | ( | ( |
| ( | |||||||
营运(亏损)/利润 | ( | ( |
| |
| ( | ||||||
利息收入 | | |
| |
| | ||||||
利息支出 | ( | — | ( | — | ||||||||
减价收购利得 | — | ( |
| — |
| | ||||||
其他收入(费用),净额 | ( | ( |
| ( |
| ( | ||||||
所得税费用前的(亏损)/利润 | ( | ( |
| |
| ( | ||||||
所得税费用 | ( | ( |
| ( |
| ( | ||||||
归属于普通股东的净(损失)/利润 | $ | ( | $ | ( | $ | | $ | ( | ||||
每普通股的净(损失)/利润 | ||||||||||||
基本 | $ | ( | $ | ( | $ | | $ | ( | ||||
稀释 | $ | ( | $ | ( | $ | | $ | ( | ||||
加权平均股数: | ||||||||||||
基本 | | |
| |
| | ||||||
稀释 | | | | |
请参见附注的未经审计的简明合并财务报表。
5
ADAPTIMMUNE THERAPEUTICS PLC
未经审计的综合收益/损失简明综合汇报表
(以千为单位)
结束于三个月 | 截至九个月 | |||||||||||
2023年9月30日 | 九月30日 | |||||||||||
| 2024 |
| 2023 | 2024 | 2023 | |||||||
净亏损/利润 | $ | ( | $ | ( | $ | | $ | ( | ||||
其他综合损益(税后),净额 | ||||||||||||
外币翻译调整,净税后$ | ( | | ( | ( | ||||||||
长期投资性质的跨公司贷款货币兑换盈亏,税后净额为$ | | ( | | | ||||||||
可供出售债券的未实现持有收益(亏损),税后$ | | | | | ||||||||
可供出售债务证券的收益再分类调整,税后净损失中已包含$ | — | | — | | ||||||||
本期的综合(亏损)/利润总额 | $ | ( | $ | ( | $ | | $ | ( |
请参见附注的未经审计的简明合并财务报表。
6
ADAPTIMMUNE THERAPEUTICS PLC
未经审计的综合股东权益变动表
(单位:千美元,以股份数据为单位)
累计的 | |||||||||||||||||
其他 | |||||||||||||||||
全面 | 总计 | ||||||||||||||||
常见 | Common | 额外 | (亏损)。 | 积累的 | 股东权益 | ||||||||||||
| 股票 |
| 股票 |
| 资本溢价 |
| 收入 |
| 赤字 |
| 普通股及限制性股票单位进入 | ||||||
2024年1月1日的余额 | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
净损失 |
| — | — | — | — | ( | ( | ||||||||||
其他综合收益 | — | — | — | | — | | |||||||||||
股票期权行权发行的股票 |
| | | | — | — | | ||||||||||
根据市场销售协议发行股票,扣除佣金和费用 | | | | — | — | | |||||||||||
基于股份的薪酬费用 |
| — | — | | — | — | | ||||||||||
截至2024年3月31日的余额 |
| | $ | | $ | | $ | ( | $ | ( | $ | | |||||
净利润 |
| — | — | — | — | | | ||||||||||
其他综合损失 | — | — | — | ( | — | ( | |||||||||||
股票期权行权发行的股票 |
| | | — | — | — | | ||||||||||
根据市场销售协议发行股票,扣除佣金和费用 | — | — | | — | — | | |||||||||||
基于股份的薪酬费用 |
| — | — | | — | — | | ||||||||||
截至2024年6月30日的余额 |
| | $ | | $ | | $ | ( | $ | ( | $ | | |||||
净损失 |
| — | — | — | — | ( | ( | ||||||||||
其他综合损失 | — | — | — | ( | — | ( | |||||||||||
股票期权行使后股份发行 |
| | | — | — | — | | ||||||||||
基于股份的薪酬支出 |
| — | — | | — | — | | ||||||||||
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。
7
ADAPTIMMUNE THERAPEUTICS PLC
未经审计的简明合并权益变动表
(单位:千美元,以股份数据为单位)
累计的 | |||||||||||||||||
其他 | |||||||||||||||||
全面 | 总计 | ||||||||||||||||
常见 | Common | 额外 | (亏损)。 | Accumulated | 股东权益 | ||||||||||||
股票 |
| 股票 |
| 股本 |
| 收入 |
| 赤字 |
| 普通股及限制性股票单位进入 | |||||||
2023年1月1日余额 |
| | $ | | $ | | $ | ( | $ | ( | $ | | |||||
净利润 |
| — | — | — | — | | | ||||||||||
其他综合损失 | — | — | — | ( | — | ( | |||||||||||
股票期权行权发行的股票 |
| | | | — | — | | ||||||||||
公开发行完成后发行股份,扣除发行成本净额 | | | | — | — | | |||||||||||
基于股份的薪酬费用 |
| — | — | | — | — | | ||||||||||
截至2023年3月31日的余额 |
| | $ | | $ | | $ | ( | $ | ( | $ | | |||||
净损失 |
| — | — | — | — | ( | ( | ||||||||||
其他全面亏损 | — | — | — | ( | — | ( | |||||||||||
股票期权行权发行的股票 |
| | | | — | — | | ||||||||||
在收购TCR时发行股票2 | | | | — | — | | |||||||||||
基于股份的薪酬费用 |
| — | — | | — | — | | ||||||||||
截至2023年6月30日的余额 |
| | $ | | $ | | $ | ( | $ | ( | $ | | |||||
净损失 |
| — | — | — | — | ( | ( | ||||||||||
行使股票期权后发行股份 |
| — | — | — | | — | | ||||||||||
根据市场销售协议发行股票,减去佣金和费用 | | | | — | — | | |||||||||||
其他综合收益 | | | | — | — | | |||||||||||
基于股票的报酬支出 |
| — | — | | — | — | | ||||||||||
截至2023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。
8
ADAPTIMMUNE THAREUTICS
未经审计的简明合并现金流量表
(以千计)
九个月已经结束 | ||||||
九月三十日 | ||||||
| 2024 |
| 2023 | |||
经营活动产生的现金流 | ||||||
净利润/(亏损) | $ | | $ | ( | ||
为使净亏损与经营活动中使用的净现金相一致而进行的调整: | ||||||
折旧 | | | ||||
摊销 | | | ||||
特价购买的收益 | — | ( | ||||
基于股份的薪酬支出 | | | ||||
未实现的外汇损失 | | | ||||
可供出售债务证券的增加 | ( | ( | ||||
其他 | ( | | ||||
运营资产和负债的变化: | ||||||
应收账款和其他运营资产减少/(增加) | | ( | ||||
库存增加 | ( | — | ||||
应付账款和其他流动负债的增加/(减少) | | ( | ||||
非流动资产的增加 | ( | — | ||||
借款和其他非流动负债的增加 | | — | ||||
递延收入减少 | ( | ( | ||||
用于经营活动的净现金 | ( | ( | ||||
来自投资活动的现金流 | ||||||
购置财产、厂房和设备 | ( | ( | ||||
收购无形资产 | ( | ( | ||||
收购 TCR2 Therapeutics Inc. 产生的现金 | — | | ||||
有价证券的到期或赎回 | — | | ||||
投资有价证券 | ( | ( | ||||
其他 | | | ||||
净现金(用于)/由投资活动提供 | ( | | ||||
来自融资活动的现金流 | ||||||
发放借款所得的收益,扣除折扣 | | — | ||||
发行普通股的收益,扣除佣金和发行成本 | | | ||||
行使股票期权的收益 | | | ||||
融资活动提供的净现金 | | | ||||
货币汇率变动对现金、现金等价物和限制性现金的影响 | ( | | ||||
现金、现金等价物和限制性现金净减少 | ( | ( | ||||
期初的现金、现金等价物和限制性现金 | | | ||||
期末现金、现金等价物和限制性现金 | $ | | $ | |
见随附的未经审计的简明合并财务报表附注。
9
ADAPTIMMUNE THERAPEUTICS PLC
未经审计的缩编合并财务报表附注
注释1—概述
adaptimmune therapeutics plc在英格兰和威尔士注册。其注册办公地址位于英国牛津郡阿宾登密尔顿公园千禧大道60号,邮编OX14 4RX。adaptimmune therapeutics plc及其子公司(统称为“Adaptimmune”或“公司”)是一家主要致力于应用电芯疗法治疗实体肿瘤癌症的商业化生物制药公司。该公司独有的平台使其能够识别癌症靶点,找到并开发针对这些靶点有效的疗法候选者,并生产治疗候选者供患者使用。
公司面临着许多与其他生物制药公司在临床开发阶段类似的风险,包括但不限于:需要获得足够的额外资金、可能失败的临床前项目或临床项目、需要为其疗法获得上市批准、竞争对手正在开发新的技术创新、需要成功商业化并获得市场接受其疗法、需要开发可靠的商业化制造过程、需要商业化可能获得上市批准的任何疗法以及保护专有技术。如果公司无法成功商业化其任何疗法,将无法产生产品收入或实现盈利能力。截至2024年9月30日,公司累计赤字为 $
注2— 重大会计政策摘要
(a) 报告基础
Adaptimmune Therapeutics plc及其子公司的简明合并财务报表及本季度报告中包含的其他财务信息是未经审计的,并按照美国通用会计准则(“U.S. GAAP”)编制,以美元表示。所有公司和子公司之间的重要公司间账户和交易在合并时已予以消除。
本季度报告中提供的未经审计的简明合并财务报表应与公司2023年年度报告中包括的合并财务报表及附表一起阅读。截至2023年12月31日的资产负债表来源于包括在公司2023年年度报告中的经审计合并财务报表,但不包括U.S. GAAP要求的所有披露。公司的重要会计政策在那些合并财务报表的附注2中有所描述。
根据U.S. GAAP编制的财务报表通常包括的某些信息和脚注披露已在这些中期财务报表中进行了简化或省略。然而,这些中期财务报表包含了所有调整,仅包括在管理层看来必要的一般性回顾调整,以公正陈述中期期间的结果。中间结果未必预示全年业绩。
(b) 使用中期财务报表中的估计
依据U.S. GAAP及SEC规定编制中期财务报表要求管理层进行估计和假设,这些对中期财务报表报告的资产和负债的金额,披露中期财务报表日期的或附条件的资产和负债的金额以及报告期内收入和支出的金额产生影响。 在各个领域,包括递延税项的减值准备,收入确认,收购的资产的公允价值,承担的负债以及商业组合中转让的代价,并且对于营运租赁的增量借款利率的估计中进行了估计和假设。 如果实际结果与公司的估计有所不同,或者这些估计在未来期间进行调整,公司的运营结果可能受益,或者受到任何估计变化的不利影响。
10
(c) 公允价值计量
公司需披露所有以公允价值报告的资产和负债的信息,以便评估用于确定报告的公允价值的输入。公允价值层级根据这些输入的可观察性质对估值输入进行优先排序。该层级定义了三种估值输入的级别:
一级 - 在活跃市场上,相同资产或负债的报价
2级 - 除了包含在1级的报价价格之外,还可观察到的资产或负债的输入,无论是直接还是间接
3级 - 不可观察的输入,反映公司对市场参与者在定价资产或负债时将使用的假设的自身假设
公司的现金及现金等价物、限制性现金、应收账款、应付账款和应计费用的账面金额因这些工具的短期性质而接近公允价值。以公允价值计量的可交易证券的公允价值,每个报告期均有详细说明,请参见附注6,公允价值计量。
(d) 重大信用风险集中
截至2024年9月30日,公司持有现金及现金等价物$
公司
管理层分析当前和逾期账户,并根据收款经验、客户的信用评级以及其他相关信息确定是否需要计提信用损失准备。估计不可收回账款的过程涉及假设和判断,最终的不可收回应收款项金额可能超过所计提的金额。
(e) 新的会计准则
在当前期间采用
报告业务板块披露的改进
2023年11月,财务会计准则委员会发布了ASU 2023-07 - 分部报告(主题280)- 可报告分部披露的改进,该项改进优化了分部披露的要求,主要通过增强重要分部费用的披露要求。改进后的披露要求适用于所有需要报告分部信息的公众实体,包括仅有一个可报告分部的实体。
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在2024年3月,FASB发布了ASU 2024-02 - 编纂改进——修订以删除对概念声明的引用,包含了对编纂的修订,移除了对各种FASB概念声明的引用。该修订适用于受影响会计指导范围内的所有报告实体,并且对于在2024年12月15日之后开始的财政年度,公共商业实体必须遵守,允许所有实体提前采用。公司在2024年1月1日开始的财政年度中采用了该指导,该指导对公司的基本报表没有影响。
将在未来期间采用
所得税披露改进
在2023年12月,FASB发布了ASU 2023-09 – 所得税(主题740) – 所得税披露的改进,主要改进了与税率调解和已支付所得税信息相关的所得税披露。这包括使用百分比和报告货币金额的表格调解,涵盖各种税收和调解项目,以及对期间内已支付所得税的分项摘要。对于公共商业实体,该指导对于在2024年12月15日之后开始的年度期间生效,允许提前采用。公司计划在2025年1月1日开始的财政年度中采用该指导。公司目前正在评估该指导对其合并基本报表的影响。
(f) 贷款
公司仅认识以固定或可确定的日期到期的合同支付构成的贷款,这些贷款仅以现金等于其票面价值的形式发行,以票面价值入账,票面金额与发行时收到的收益之间的差额作为折扣或溢价列示。
这些票据随后采用利息法计量,利息总额是公司实际收到的现金金额与约定偿还的总金额之间的差额。某一期间的利息费用基于有效利率,该利率是根据合同现金流隐含的利率。票据的折扣或溢价在票据的生命周期内作为利息费用摊销,以产生恒定的利率。
(g) 存货
公司在获得监管批准或认为可能会获得批准后开始对存货进行资本化。在此之前,公司将所有相关成本当作研发费用支出。公司资本化在其商业产品生产中发生的材料成本、劳务和相关间接费用。
公司以成本或可实现净值中的较低者对存货进行计量,采用先进先出法。公司每个报告期审查存货的可回收性,以判断由于存货过剩、滞销或过时而导致的可实现净值的变化。如果可实现净值低于成本,则存货将被减记至可实现净值,并将在营业成本中确认减值费用。
可以用于临床或商业目的的存货初步分类为存货。随后指定用于临床试验并不再可用于商业产品的存货,自其专门用于临床用途时起,将作为研发支出进行费用化。
《营收确认,与客户的合同》注释3 — 营业收入
该公司通过与客户的合作协议产生开发营业收入。该公司在截至2024年9月30日的三个月和九个月内有
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自2023年3月6日起终止。基因泰克合作协议于2024年4月终止,随后于2024年9月23日生效。
营业收入包括以下类别(以千为单位):
截至三个月的时间 |
| 截至九个月的时间 | ||||||||||
| 2023年9月30日, | 2023年9月30日, | ||||||||||
| 2024 |
| 2023 | 2024 |
| 2023 | ||||||
开发营业收入 |
| $ | |
| $ | | $ | |
| $ | | |
| $ | |
| $ | | $ | |
| $ | |
递延收入减少了$
截至2024年9月30日,分配给根据协议未满足或部分满足的履行义务的交易价格的总金额为$
galapagos合作与独家许可协议
2024年5月30日,公司签署了galapagos合作协议,一项与galapagos的临床合作协议。该galapagos合作协议包括一个选项,允许galapagos独家许可在galapagos去中心化制造平台上生产的TCR电芯治疗候选药物uza-cel,用于头颈癌和未来潜在的实体瘤适应症。根据该galapagos合作协议,我们将进行临床概念验证试验(“POC试验”),评估在galapagos去中心化制造平台上生产的uza-cel在头颈癌患者中的安全性和有效性。
公司将收到初始支付$
公司确定galapagos是一个客户,并在ASC 606下对协议进行了会计处理。 Revenue from Contracts with Customers公司已识别出与完成POC试验所需的各种活动相关的履约义务,以及与专有许可选项相关的重大权利。
galapagos合作协议成立时的总体交易价格为$
总体交易价格根据履约义务的相对独立销售价格分配给履约义务。在确定相对独立销售价格的最佳估计时,公司考虑了其在谈判合同中使用的内部定价目标,以及有关预计成本和这些成本的标准利润的内部数据,用于完成POC试验。由于公司以前没有单独销售uza-cel,因此使用剩余法来评估与专有许可选项相关的重大权利,并且尚未为uza-cel确定价格。
13
公司预计会根据试验的完成情况,逐步履行POC试验义务,该完成基于对试验已发生成本占预期总成本的比例估算。分配给与独家许可期权相关的实质权益的营业收入将从期权行使并将控制权交给galapagos或期权过期的时间点开始确认。
2024年9月30日,分配给未实现或部分实现的履约义务的交易价格金额为$
Genentech合作与许可协议
2024年4月12日,公司宣布终止Genentech合作协议,该协议由公司全资子公司Adaptimmune Limited签署,涉及癌症靶向异基因T细胞疗法的研究、开发和商业化,原定自2024年10月7日生效。终止按累积回顾法会计处理。终止没有改变已确认的履约义务的性质,但导致交易价格减少,因为在2024年10月7日后本已应收的额外付款和变量考虑现在将不会收到。
公司最初预计将满足与初始的“现货”合作目标和个性化疗法相关的履约义务,并根据项目完成的百分比的估计来确认营业收入,该百分比是基于项目的成本占项目总预期成本的百分比确定的。公司预计将满足与指定额外“现货”合作目标的材料权利相关的履约义务,从期权可能会被行使的时间点开始,然后随着开发的进行,与最初的“现货”合作目标保持一致,或在权利到期时。公司预计将满足与延长研究期限的材料权利相关的履约义务,从期权可能会被行使的时间点开始,然后在延长期间内,或在权利到期时。
截至终止日期尚未确认的剩余交易价格为$
2024年9月23日,Adaptimmune有限公司与Genentech签署了一份相互解除和解决协议(“相互解除协议”)。该协议解决并释放双方与Genentech合作协议相关的任何历史、现在和未来的争端、索赔、要求和诉因,无论已知或未知。根据相互解除协议的条款,Genentech将向公司支付$
相互解除协议导致所有剩余履行义务已完全履行,剩余的待确认营收为
GSk终止和转让协议
2023年4月6日,公司与GSk签署了终止和转让协议,涉及返回包括PRAME和 NY-ESO细胞疗法项目在内的权利和材料。双方将共同努力确保维持作为 NY-ESO细胞疗法项目一部分的进行中的lete-cel临床试验的患者的持续性。
作为终止和转让协议的一部分,与NY-ESO细胞疗法项目相关的IGNYTE和长期随访(LTFU)试验的赞助和责任将转让给公司。作为回报,公司将获得一笔预付款£
14
公司确定葛兰素史克是客户,并已根据ASC 606考虑了终止和转让协议 与客户签订合同的收入。终止和转让协议作为一份独立于与 GsK 签订的原始合作和许可协议的合同进行核算。该协议于2022年10月终止,终止于2022年12月23日生效。公司已根据终止和转让协议确定了以下履约义务:(i)接管IGNYTE试验的赞助以及(ii)接管LTFU试验的赞助。
协议开始时的总交易价格为美元
公司预计,从赞助构成试验的活跃试验之日起,再到试验完成期间,根据在给定期末转诊且迄今仍在积极注册的患者人数与预计试验持续时间内的活跃患者入组总期相比,公司希望在一段时间内履行业绩义务。
该公司认为,这描述了根据终止和转移协议完成试验的进展情况,因为该试验中患者的状况不受公司可能做出的与自己开发NY-ESO细胞疗法计划有关的决定的直接影响。
截至2024年9月30日,分配给协议中未履行或部分履行的履约义务的交易价格金额为美元
安斯泰来合作协议
公司和环球电池共同同意自2023年3月6日(“终止日期”)起终止安斯泰来合作协议。与终止有关的是,根据安斯泰来合作协议授予任何一方的所有许可和分许可自终止之日起终止。没有与解雇相关的解雇处罚;但是,公司仍有权获得在终止之日起30天内开展的研发工作的报销。
终止是按累计补交计算的合同修改算作的。修改后未确定任何履约义务,因为公司没有提供更多的商品或服务,而且修改导致合作项下剩余未履行和部分履行的履约义务得到充分履行。合约修改的总交易价格为美元
注意事项 4 — 每股(亏损)/利润
下表协调了基本计算和摊薄(亏损)/每股利润(以千计)计算中的分子和分母:
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截至三个月的时间 | 截至九个月的时间 | |||||||||||
2023年9月30日, | 9月30日, | |||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||||
基本和稀释每股收益的分子 | ||||||||||||
归属于普通股东的净(亏损)/利润 |
| $ | ( |
| $ | ( |
| $ | |
| $ | ( |
归属于普通股股东的净利润/亏损,用于基本和稀释每股盈利/亏损 | ( | ( | | ( |
截至三个月的时间结束 | 截至九个月的时间结束 | |||||||
9月30日 | 9月30日, | |||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |
基本每股(亏损)/盈利的分母-加权平均股数 |
| |
| |
| |
| |
摊薄效应: | ||||||||
员工股票期权 |
| — |
| — |
| |
| — |
每股稀释(亏损)/利润的分母 |
| |
| |
| |
| |
The dilutive effect of
注意事项 5 — Accumulated other comprehensive (loss)/income
The Company reports foreign currency translation adjustments and the foreign exchange gain or losses arising on the revaluation of intercompany loans of a long-term investment nature within Other comprehensive (loss) income. Unrealized gains and losses on available-for-sale debt securities are also reported within Other comprehensive (loss) income until a gain or loss is realized, at which point they are reclassified to Other (expense) income, net in the Condensed Consolidated Statement of Operations.
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以下表格显示累积其他全面(亏损)收入的变化情况(以千为单位):
累计 | 累积 | 总计 | |||||||
外国的 | 未实现的 | 累积 | |||||||
货币翻译(b) | (亏损)盈利 on | 其他 | |||||||
| 翻译 |
| 可供出售 | 全面 | |||||
调整 | 债务证券 | (亏损)收入 | |||||||
2024年1月1日的余额 |
| $ | ( | $ | | $ | ( | ||
外币换算调整 | | — | | ||||||
长期投资性质的公司间贷款外币收益,税后净额为$ | ( | — | ( | ||||||
未实现的可供出售债务证券持有收益,税后金额为$ | — | ( | ( | ||||||
2024年3月31日结存余额 | $ | ( | $ | | $ | ( | |||
外币翻译调整 | ( | — | ( | ||||||
长期投资性质的公司间贷款外币收益,税后净额为$ | | — | | ||||||
可供出售债务证券的未实现持有收益,税后净额为 | — | ( | ( | ||||||
2024年6月30日余额 | $ | ( | $ | — | $ | ( | |||
外币翻译调整 | ( | — | ( | ||||||
长期投资性质公司间贷款的外币汇兑损失,扣税净额为$ | | — | | ||||||
可供出售债务证券未实现持有盈利,扣税净额为$ | — | | | ||||||
截至2024年9月30日的余额 | $ | ( | $ | | $ | ( | |||
累计 | 累计 | 总计 | |||||||
外国的 | 未实现的 | 已经累积 | |||||||
货币 | (亏损)在 | 其他 | |||||||
| 翻译 |
| 可供出售 | 综合 | |||||
调整 | 债务证券 | (损失) 收入 | |||||||
2023年1月1日的余额 |
| $ | | $ | ( | ( | |||
外币翻译调整 | ( | — | ( | ||||||
长期投资性质的跨公司贷款的外汇收益,税后净额为$ | | — | | ||||||
可供出售债务证券的未实现持有收益,税后开多$ | — | | | ||||||
2023年3月31日的余额 | $ | ( | $ | ( | $ | ( | |||
外币换算调整 | ( | — | ( | ||||||
长期投资性质的跨公司贷款外汇损失,税后净额为$ | | — | | ||||||
未实现的可供出售债务证券持有损失,税后金额为$ | — | | | ||||||
2023年6月30日的余额 | $ | ( | $ | ( | $ | ( | |||
外币翻译调整 | | — | | ||||||
长期投资性质的公司间贷款外币损失,税后净额为$ | ( | — | ( | ||||||
重新分类计入综合收益的可供出售债务证券收益,在税后净损失中净额。 $ | — | | | ||||||
可供出售债务证券的未实现持有收益,税后净额为$ | — | | | ||||||
2023年9月30日的余额 | $ | | $ | | $ | |
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注6 — 公允价值衡量
截至2024年9月30日,按第1级、第2级和第3级公允价值计量标准,经常性公允价值计量的资产和负债如下(以千计):
公允价值计量使用 | ||||||||||||
2023年9月30日, | 一级水平 | 2级 | 三级 | |||||||||
| 2024 |
|
|
| ||||||||
被归类为现金等价物的资产: | ||||||||||||
美国国债 | $ | | $ | — | $ | | $ | — | ||||
分类为可供出售债务证券的资产: | ||||||||||||
机构债券 | $ | | $ | — | $ | | $ | — | ||||
公司债务证券 | | | ||||||||||
美国国债证券 | | — | | — | ||||||||
| $ | | $ | |
| $ | |
| $ | — |
公司利用第三方估值服务来估算可供出售债务证券的公允价值,该服务每天使用来自第三方提供者的实际交易和指示性价格来估算公允价值。如果没有可观察的市场价格(例如短期到期且二级市场交易不频繁的证券),则使用最大化可观察输入的估值模型为这些证券定价,包括市场利率期货。
注释 7 — 可流通证券 – 可供出售的债务证券
截至2024年9月30日,公司在可流通证券方面的投资如下(单位:千元):
毛 | 毛总 | 汇总 | ||||||||||||
剩余 | 摊销 | 未实现的 | 未实现 | 预计 | ||||||||||
| 21. 分类合同到期 |
| 成本 |
| 收益 |
| 损失 |
| 公允价值 | |||||
现金及现金等价物: |
|
|
|
|
|
|
|
|
|
| ||||
美国国债证券 | 少于 | $ | | $ | — | $ | — | $ | | |||||
|
| $ | | $ | — | $ | — | $ | | |||||
可供出售的债务证券: |
|
|
|
|
|
|
|
|
|
| ||||
代理债券 |
| 少于 | $ | | $ | | $ | — | $ | | ||||
公司债务证券 | 少于 | | | ( | | |||||||||
美国国债 | 少于 | | | — | | |||||||||
机构债券 | | | — | | ||||||||||
企业债务证券 | | | — | | ||||||||||
美国国债 | | | — | | ||||||||||
|
| $ | | $ | | $ | ( | $ | |
18
截至2024年9月30日和2023年12月31日,公司持有的证券(包括现金等价物类别)处于未实现损失位置的总公允价值(以千计)和数量如下:
2024年9月30日 | 2023年12月31日 | |||||||||||||||||
| 未实现亏损头寸的投资公允市场价值 | 持有未实现损失头寸的投资数量 | 未实现损失 | 持有未实现损失头寸的投资的公允市场价值 | 持有未实现损失头寸的投资数量 | 未实现损失 | ||||||||||||
持续亏损不足12个月的可交易证券: | ||||||||||||||||||
企业债券 |
| $ | |
| | $ | — |
| $ | |
| |
| $ | ( | |||
| $ | |
| | $ | — |
| $ | |
| |
| $ | ( |
截至2024年9月30日,
Note 8 — 其他流动资产
其他流动资产如下(以千元为单位):
2023年9月30日, | 十二月31日, | |||||
| 2024 | 2023 | ||||
研发积分应收款 |
| $ | | $ | | |
预付款项 |
| | | |||
临床材料 |
| | | |||
增值税应收款项 | | — | ||||
其他流动资产 |
| | | |||
$ | | $ | |
2024年1月19日,从HMRC收到了一份有关研究与开发税收抵免的英镑收据
Note 9 — 经营租赁
公司在办公室、制造业和研发设施方面存在经营租赁。.
19
以下表格显示了截至2024年9月30日和2023年的九个月的租赁成本,以及2024年和2023年9月30日时的加权平均剩余租期和加权平均折扣率:
截至九个月 | |||||||
九月三十日, | |||||||
| 2024 |
| 2023 | ||||
租金成本: | |||||||
营运租赁成本 |
| $ | |
| $ | | |
短期租赁成本 |
| |
| | |||
| $ | |
| $ | | ||
九月三十日, | |||||||
2024 | 2023 | ||||||
加权平均剩余租期 - 经营租赁 | |||||||
经营租赁加权平均贴现率 |
2024年9月30日以及之后的营运租赁负债到期时间如下(以千元计算):
| 经营租约 | ||
2024 |
| $ | |
2025 |
| | |
2026 |
| | |
2027 |
| | |
2028 |
| | |
2028年后 |
| | |
总租赁付款 | | ||
减:推算利息 | ( | ||
租赁负债的现值 | $ | |
未启动终止期权的最长租赁期为至2041年。
解决方案框架于2023年9月6日生效,截至2024年1月31日,原始约33亿美元的解决方案责任和其他和解款项的大部分已经支付,详情请参阅会计报表附注10。 — 应计费用和其他当前负债
应计费用及其他流动负债包括以下项目(千元):
九月三十日 | 十二月三十一日 | |||||
| 2024 |
| 2023 | |||
累积的临床和研发支出 | $ | | $ | | ||
应付员工费用 | | | ||||
应付增值税 | — | | ||||
其他应计支出 | | | ||||
其他 |
| |
| | ||
$ | | $ | |
20
注意 11 — 以股份为基础的补偿
下表显示了未经审核的合并经营报表中包含的总以股份为基础的补偿费用(以千为单位):
截至三个月结束 | 截至九个月 | |||||||||||
九月三十日, | 九月三十日, | |||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||||
研究与开发 | $ | | $ | | $ | | $ | | ||||
销售、一般及行政 |
| |
| |
| | | |||||
$ | | $ | | $ | | $ | |
下表显示了有关期权和具有名义行使价格的期权(类似于限制性股票单位(RSUs))的资讯:
截至三个月 | 截至九个月 | |||||||||||
截至九月三十日 | 九月三十日, | |||||||||||
2024 |
| 2023 |
| 2024 |
| 2023 | ||||||
授予普通股的期权数量 | ||||||||||||
普通股期权的加权平均公平价值 | $ | $ | $ | $ | ||||||||
额外授予的名义行使价的期权数量 | ||||||||||||
期权的加权平均公允价值,名义行使价为 | $ | $ | $ | $ |
附注12 — 股东权益
在2022年4月8日,公司与Cowen签订了一份销售协议("销售协议"),根据该协议,我们可以不时通过Cowen以"市价"发行和出售美国预托股份(ADSs),总募集金额不超过$
注意 13 – 业务合并
在2023年3月6日,公司宣布进入一项最终协议,根据该协议将与TCR2 Therapeutics Inc.(“TCR2”)以全股交易的方式创建一家专注于治疗实体肿瘤的卓越电芯疗法公司。TCR2 是一家位于美国麻萨诸塞州的T细胞疗法公司,专注于治疗实体肿瘤,拥有进行临床试验的临床领域和前期管道。该组合为临床开发和产品交付提供了大量好处,并得到互补科技平台的支持。
该交易于2023年5月30日获得公司股东和TCR股东的批准,并于2023年6月1日生效。2 公司发行了
该公司被确定为收购方,TCR2 则为被收购方,2023年6月1日被确定为收购日期。
21
The consideration transferred for TCR2 includes the shares issued by the Company to former TCR2 shareholders, plus the fair value of replacement awards of the Company granted to TCR2 grantholders attributable to pre-combination vesting. The table below summarizes the consideration transferred and the amounts of the assets acquired and liabilities assumed recognized at the acquisition date:
Consideration transferred: | |||
Fair value of | $ | | |
Fair value of replacement options and RSU-style options granted attributable to pre-combination service: | | ||
Purchase consideration | $ | | |
Identifiable assets acquired and liabilities assumed: | |||
Assets acquired | |||
Cash and cash equivalents | $ | | |
Restricted cash | | ||
Marketable securities - available-for-sale debt securities | | ||
Other current assets and prepaid expenses | | ||
Property, plant and equipment | | ||
Operating lease right-of-use assets | | ||
Intangible assets | | ||
Total assets acquired | $ | | |
Liabilities assumed | |||
Accounts payable | ( | ||
Accrued expenses and other current liabilities | ( | ||
Operating lease liabilities, current | ( | ||
Operating lease liabilities, non-current | ( | ||
Total liabilities assumed | $ | ( | |
Net assets acquired and liabilities assumed | $ | |
The fair value of the
The assets acquired and liabilities assumed were measured based on management’s estimates of the fair value as of the acquisition date, excluding leases.
The lease contracts acquired by the Company relate to the rental of office and manufacturing spaces in which TCR2 was the lessee. The Company retained TCR2’s previous classification of acquired leases as operating leases as there were no lease modifications as a result of the combination, with the exception of leases with a remaining lease term of 12 months or less at the acquisition date, for which no assets or liabilities were recognized at the acquisition date. The lease liabilities were measured at the present value of the remaining lease payments as if the leases were a new lease as of June 1, 2023, discounted using the incremental borrowing rate. The right-of-use assets were measured at the same amount as the lease liabilities, with adjustments to reflect favorable or unfavorable terms compared to market terms.
The table below summarises the calculation for the gain on bargain purchase, recognized in the Gain on bargain purchase line in the Consolidated Statement of Operations:
Gain on bargain purchase | |||
Purchase consideration | $ | ( | |
Net assets acquired and liabilities assumed | | ||
Gain on bargain purchase | $ | |
22
The gain on bargain purchase above includes the impact of a $
The transaction resulted in a gain on bargain purchase as the purchase consideration included in the agreement on March 6, 2023 comprising Company ADSs was based on a fixed ratio of
The amount of revenue and earnings of the combined entity for the nine months ended September 30, 2023, had the acquisition date been January 1, 2022, would be as follows:
Nine months ended | |||
September 30, 2023 | |||
Revenue | $ | | |
Net loss | ( |
The supplemental pro forma earnings for the nine months ended September 30, 2023 were adjusted to exclude the $
TCR2 did not generate revenue in the period from January 1, 2023 to June 30, 2023, as it had no contracts with customers, so there was no impact on the revenue included in the Company’s Consolidated Statement of Operations or in the supplemental pro forma revenue and earnings presented above.
The Company incurred the following acquisition-related costs that were recognized as an expense in 2023:
Total | |||
acquisition-related | |||
costs | |||
Legal, professional and accounting fees | $ | | |
Bankers' fees | | ||
Total acquisition-related costs | $ | |
All acquisition-related costs that were recognized as an expense were recognized in General and administrative expenses in the Consolidated Statement of Operations.
Note 14 – Borrowings
On May 14, 2024 (the “Closing Date”), we entered into a Loan and Security Agreement (the “Loan Agreement”), with several banks and other financial institutions or entities and Hercules Capital, Inc. (“Hercules Capital”), for a term loan facility of up to $
23
The Term Loan attracts interest on the outstanding principal in the form of both cash and payment-in-kind (“PIK”) interest. The cash interest rate is the
The Term Loan matures on June 1, 2029 and payments are interest-only until the June 1, 2027 (the “Amortization Date”) after which the monthly payments include repayments of both principal and interest. The Amortization Date can be extended if certain criteria are met and the Company chooses to extend the date. The final Term Loan Maturity Date cannot be extended.
The Term Loan is secured by a lien on substantially all of Borrower’s existing or after-acquired assets, including intellectual property, subject to customary exceptions. In addition, the Loan Agreement contains customary closing and commitment fees, prepayment fees and provisions, events of default and representations, warranties and affirmative and negative covenants, including a financial covenant requiring the Company to maintain certain levels of cash in accounts subject to a control agreement in favor of Hercules Capital (the “Qualified Cash”) during the period commencing on January 1, 2025 (which initial commencement date is subject to adjustment if certain performance milestones are met) and at all times thereafter, provided that if the Company has achieved certain performance milestones, the amount of Qualified Cash is subject to certain reductions. The Loan Agreement also includes customary events of default, including payment defaults, breaches of covenants following any applicable cure period, the occurrence of certain events that could reasonably be expected to have a “material adverse effect” as set forth in the Loan Agreement, cross acceleration to third-party indebtedness and certain events relating to bankruptcy or insolvency.
Each loan tranche has been identified as a separate unit of account within the scope of ASC 835-30 Imputation of interest, with the Tranche 1 Advance constituting a debt instrument and the remaining tranches being loan commitments.
On May 14, 2024, the Company drew down the Tranche 1 Advance of $
At September 30, 2024, the fair value of the Term Loan is a Level 2 measurement considered to approximate its book value of $
The aggregate maturity of the term loan for the next five years from September 30, 2024 is as follows:
| Maturity | ||
2024 |
| $ | — |
2025 |
| — | |
2026 |
| — | |
2027 |
| | |
2028 |
| | |
2029 |
| | |
Total principal repayments | $ | | |
Composition of principal repayments | |||
Original principal | $ | | |
Capitalized PIK interest | | ||
Total principal repayments | $ | |
The payments included in the table include capitalized PIK interest, as this forms part of the principal balance to be repaid once incurred. Payments relating to cash interest and the End of Term Charge are excluded as they do not constitute repayments of the principal.
24
Note 15 – Segment reporting
The Company has
The Company’s Chief Operating Decision Maker (the “CODM”), its Chief Executive Officer and the senior leadership team (comprising the Executive Team members and three senior vice presidents), manages the Company’s operations on an integrated basis for the purposes of allocating resources. When evaluating the Company’s financial performance, the CODM regularly reviews total revenues, total expenses and expenses by function and the CODM makes decisions using this information on a global basis.
The table below is a summary of the segment profit or loss, including significant segment expenses (in thousands):
Three months ended | Nine months ended | ||||||||||
September 30, | September 30, | ||||||||||
2024 |
| 2023 | 2024 |
| 2023 | ||||||
Revenue | $ | | $ | | $ | | $ | | |||
Less: | |||||||||||
Research | ( | ( | ( | ( | |||||||
CMC and Quality | ( | ( | ( | ( | |||||||
Biomarkers | ( | ( | ( | ( | |||||||
Development and Compliance | ( | ( | ( | ( | |||||||
Infrastructure management and Facilities | ( | ( | ( | ( | |||||||
Commercial | ( | ( | ( | ( | |||||||
Support functions | ( | ( | ( | ( | |||||||
Other segment expenses(a) | ( | ( | ( | ( | |||||||
Total operating expenses | ( | ( | ( | ( | |||||||
Operating (loss)/profit | ( | ( | | ( | |||||||
Interest income | | | | | |||||||
Interest expense | ( | — | ( | — | |||||||
Gain on bargain purchase | — | ( | — | | |||||||
Other income (expense), net | ( | ( | ( | ( | |||||||
Income tax expense | ( | ( | ( | ( | |||||||
Segment and consolidated net (loss)/profit | $ | ( | $ | ( | $ | | $ | ( |
(a)Other segment expenses includes reimbursements receivable for research and development tax and expenditure credits, depreciation, amortization and share-based compensation expenses.
Note 16 – Inventories
On August 1, 2024, the Company received U.S. Food and Drug Administration (“FDA”) approval for TECELRA® (afamitresgene autoleucel) (“Tecelra”) for the treatment of advanced MAGE-A4+ synovial sarcoma in adults with certain HLA types who have received prior chemotherapy, and commenced capitalization of inventory from this date.
Prior to August 1, 2024, regulatory approval and subsequent commercialization of Tecelra, and thus the possibility of future economic benefits from Tecelra sales, were not considered probable and inventory-related costs were expensed as incurred; as such, the inventory recognized on the balance sheet does not included any pre-launch inventory. At September 30, 2024, the gross value of pre-launch inventory held but not recognized was $
25
The components of inventory are as follows:
September 30, | |||
| 2024 | ||
Raw materials | $ | | |
Work-in-progress | | ||
Finished goods |
| — | |
Total inventory, net | $ | |
In addition to the above, the Company recognized an asset of $
Note 17 – Subsequent events
On November 13, 2024 the Company announced a restructuring plan that aims to prioritize its commercial sarcoma franchise and certain research and development programs. As part of this restructuring, the Company is planning a
26
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited consolidated financial statements and related notes appearing elsewhere in this Quarterly Report and the audited consolidated financial statements and notes thereto and management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2023, included in our Annual Report on Form 10-K that was filed with the SEC on March 6, 2024. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report and our Annual Report on Form 10-K for the year ended December 31, 2023, our actual results could differ materially from the results described in, or implied by, these forward-looking statements.
Overview
We are a commercial-stage biopharmaceutical company working to redefine the treatment of solid tumor cancers with cell therapies. With the approval by the U.S. Food and Drug Administration (“FDA”) of our first biologics license application (“BLA”) for Tecelra® (afamitresgene autoleucel) (“Tecelra”), which is the first engineered cell therapy for a solid tumor cancer approved in the U.S., we are now focused on its launch and commercialization. Tecelra is a genetically modified autologous T-cell immunotherapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. This indication is approved under the FDA’s accelerated approval based on overall response rate (“ORR”) and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits from a confirmatory trial.
We are focussing on a strategic business plan and restructuring to prioritize our commercial sarcoma franchise and pre-clinical programs (PRAME and CD-70 programs) which we believe have the highest potential for return on invested capital and transformational benefit to patients. We remain commited to our collaboration with Galapagos for uza-cel. We are ceasing further investment in all non-core programs, including the SURPASS-3 trial in ovarian cancer. As a result of this re-focussing we are undertaking a reduction of headcount and expenses. We anticipate a reduction in headcount of approximately 33% with the majority of the headcount restructuring to be completed by the end of the first quarter of 2025.
Tecelra
We are focused on the launch and commercialization of Tecelra for the treatment of advanced synovial sarcoma and for which we received FDA approval on August 1, 2024. Nine Authorized Treatment Centers (“ATCs”) are available to initiate the treatment journey for our patients. The first patient has been apheresed and manufacture of Tecelra is underway. We are confident that the full network of approximately 30 ATCs will be active by the end of 2025, covering an estimated 80% of patients treated in sarcoma centers of excellence.
The approval of Tecelra was based on results of the SPEARHEAD-1 (Cohort 1) trial, which included 44 patients. The major efficacy outcome was ORR determined by independent review and supported by duration of response. Tecelra treatment resulted in an ORR of 43% with a complete response rate of 4.5%. The median duration of response was six months (95% CI: 4.6, not reached). Among patients who were responsive to the treatment, 39% had a duration of response of twelve months or longer.
Lete-cel
Lete-cel targets the NY-ESO antigen and has been in clinical trials (the IGNYTE-ESO trial) for people with synovial sarcoma and myxoid round cell liposarcoma (MRCLS). Final data for the IGNYTE-ESO trial were reported at the Connective Tissue Oncology Society Annual Meeting (“CTOS”) in November 2024 with an ORR of 42% across both synovial sarcoma and myxoid round cell liposarcoma (MRCLS) patients and with six patients having a complete response (6/64) as their best overall response. The median duration of response was just over a year. These data will form part of our planned rolling BLA submission for lete-cel, starting in 2025.
27
Clinical and Pre-clinical Pipeline
*Synovial sarcoma, Malignant Peripheral Nerve Sheath Tumor (MPNST), Neuroblastoma, Osteosarcoma, Temporary suspension of enrolment as per protocol in SPEARHEAD-3 trial
**uzatresgene autoleucel, formerly ADP-A2M4CD8; SURPASS Ph 1 and SURPASS-3 trials are no longer enrolling. Adaptimmune and Galapagos to conduct a clinical proof-of- concept trial to evaluate the safety and efficacy of uza-cel produced on Galapagos’ decentralized manufacturing platform in patients with
head & neck cancer
We have a pediatric trial ongoing in the US in tumors expressing the MAGE-A4 antigen. Enrollment in this trial has been temporarily suspended as per protocol. Enrollment in our other ongoing clinical trials has ceased or been closed including the SURPASS-3 Phase 2 Trial in ovarian cancer.
We are currently focusing our preclinical pipeline on the development of T-cell therapies directed to PRAME (ADP-600) and CD70 (ADP-520).
● | PRAME is highly expressed across a broad range of solid tumors including ovarian, endometrial, lung and breast cancers. We are developing TCR T-cells directed to PRAME, with the initial candidate (ADP-600) currently in preclinical testing and next-generation candidates being developed over the longer term. |
● | The CD70 program targets the CD70 antigen which is expressed across a range of hematological malignancies (acute myeloid leukemia and lymphoma) and solid tumors (renal cell carcinoma). We are using TRuC technology to develop a T-cell therapy (ADP-520) against CD70, with membrane bound IL-15 to enhance persistence. ADP-520 is currently in pre-clinical testing. |
Corporate News
On September 23, 2024, we announced the entry into the Mutual Release Agreement between Adaptimmune and Genentech Inc and F. Hoffmann-La Roche Ltd. This Agreement amongst other things resolves and releases each party from any and all past, present and future disputes, claims, demands and causes of action, whether known or unknown, related to the Genentech Collaboration Agreement in any way. Under the terms of the Mutual Release Agreement the Collaboration Agreement is terminated and Genentech will pay $12.5 million.
On May 14, 2024, we entered into the Loan Agreement with several banks and other financial institutions or entities and Hercules Capital for a Term Loan of up to $125.0 million. The Tranche 1 advance of $25.0 million was drawn on the closing date of the Loan Agreement. The Tranche 2 advance was received on August 13, 2024 following the receipt of FDA approval for Tecelra.
28
We are focussed on the prioritization of our commercial sarcoma franchise and certain research and development programs. As a result the Company is planning a 33% reduction in workforce. The planned reduction in workforce is subject to consultation with employee representatives in the UK regarding the plan. The Company anticipates that the majority of the reduction in workforce will be completed during the first quarter of 2025. The Company estimates that the pre-tax costs of such reduction in workforce relating to employee severance and other employee-related costs may be in the region of $9-11 million with the majority of such costs being incurred in the first quarter of 2025. It will provide further updates as it progresses through the restructuring process and once the costs and expenses of such restructuring are known.
Financial Operations Overview
Revenue
The Company had three customers in the three and nine months ended September 30, 2024, two customers in the three months ended September 30, 2023, and three customers in the nine months ended September 30, 2023: the Astellas Collaboration Agreement (until March 6, 2023), the Galapagos Collaboration Agreement (from May 30, 2024), the Genentech Collaboration Agreement and the GSK Termination and Transfer Agreement (from April 11, 2023).
The Astellas Collaboration Agreement
In January 2020, the Company entered into the Astellas Collaboration Agreement. The Company received $50.0 million as an upfront payment after entering into the Astellas Collaboration Agreement. Under the Astellas Collaboration Agreement the parties would agree on up to three targets and would co-develop T-cell therapies directed to those targets pursuant to an agreed research plan. For each target, Astellas would fund co-development up until completion of a Phase 1 trial for products directed to such target. In addition, Astellas was also granted the right to develop, independently of the Company, allogeneic T-cell therapy candidates directed to two targets selected by Astellas. Astellas would have sole rights to develop and commercialize products resulting from these two targets.
The Astellas Collaboration Agreement consisted of the following performance obligations: (i) research services and rights granted under the co-exclusive license for each of the three co-development targets and (ii) the rights granted for each of the two independent Astellas targets. The revenue allocated to the co-development targets was recognized as the development of products directed to the targets progressed up until completion of a Phase 1 trial. The revenue allocated to each of the research licenses for the targets being independently developed by Astellas was to be recognized when the associated license commenced, which was upon designation of a target by Astellas.
The Company and Universal Cells mutually agreed to terminate the Astellas Collaboration Agreement as of the Termination Date. In connection with the termination, all licenses and sublicenses granted to either party pursuant to the Collaboration Agreement ceased as of the Termination Date. There were no termination penalties in connection with the termination, however the Company was still entitled to receive reimbursement for research and development work performed up to and including a period of 30 days after the Termination Date.
The termination was accounted for as a contract modification and the modification resulted in the remaining unsatisfied and partially satisfied performance obligations under the collaboration becoming fully satisfied. The aggregate transaction price of the contract modification was $42.4 million, which was primarily comprised of deferred income relating to the third co-development target and the two independent targets, and was recognized in full in March 2023. No revenue was recognized for Astellas in 2024.
The Genentech Collaboration Agreement
On September 3, 2021, Adaptimmune Limited, a wholly-owned subsidiary of the Company, entered into the Genentech Collaboration Agreement. The collaboration has two components:
1) | development of allogeneic T-cell therapies for up to five shared cancer targets; and |
2) | development of personalized allogeneic T-cell therapies utilizing αβ T-cell receptors (TCRs) isolated from a patient, with such therapies being administered to the same patient. |
The parties would collaborate to perform a research program, initially during an eight-year period (which may be extended for up to two additional two-year terms at Genentech’s election upon payment of an extension fee for each two-year term), to develop the cell therapies, following which Genentech would determine whether to further develop and commercialize such therapies. The Company
29
received an upfront payment of $150 million in October 2021 and milestone payments of $20 million and $15 million in December 2022 and 2023, respectively.
The Company identified the following performance obligations under the Genentech Collaboration Agreement: (i) research services and rights granted under the licenses for each of the initial “off-the-shelf” collaboration targets, (ii) research services and rights granted under the licenses for the personalized therapies, (iii) material rights relating to the option to designate additional “off-the-shelf” collaboration targets and (iv) material rights relating to the two options to extend the research term. The revenue allocated to the initial “off-the-shelf” collaboration targets and the personalized therapies was recognized as development progressed. The revenue allocated to the material rights to designate additional ‘off-the-shelf’ collaboration targets would have been recognized from the point that the options were exercised and then as development progressed, in line with the initial “off-the-shelf” collaboration targets, or at the point in time that the rights expired. The revenue from the material rights to extend the research term would have been recognized from the point that the options were exercised and then over the period of the extension, or at the point in time that the options expired.
On April 12, 2024, we announced the termination of the Genentech Collaboration Agreement. The termination was accounted for as a contract modification on a cumulative catch-up basis. The termination did not change the nature the performance obligations identified but resulted in a reduction of the transaction price as the additional payments and variable consideration that would have been due in periods after October 7, 2024 will now never be received. The termination resulted in a cumulative catch-up adjustment to revenue recognized at the date of the termination of $101.3 million.
On September 23, 2024, Adaptimmune Limited entered into a Mutual Release Agreement with Genentech. The Mutual Release Agreement, among other things, resolved and released each party from any and all past, present and future disputes, claims, demands and causes of action, whether known or unknown, related to the Genentech Collaboration Agreement in any way. Under the terms of the Mutual Release Agreement, Genentech will pay $12.5 million, upon which the Genentech Collaboration Agreement will be terminated. The Mutual Release Agreement was effective immediately as of September 23, 2024. The Mutual Release Agreement resulted in all remaining performance obligations being fully satisfied and the remaining deferred revenue and the additional payment were both recognized as total revenue of $37.8 million in the third quarter of 2024.
The GSK Termination and Transfer Agreement
On April 11, 2023, the Company announced its entry into the Termination and Transfer Agreement with GSK regarding the return to the Company of rights and materials comprised within the PRAME and NY-ESO cell therapy programs. The parties will work collaboratively to ensure continuity for patients in ongoing lete-cel clinical trials forming part of the NY-ESO cell therapy program.
As part of the Termination and Transfer Agreement, sponsorship of the ongoing IGNYTE and LTFU trials relating to the NY-ESO cell therapy program will transfer to the Company. In return for this, the Company received an upfront payment of £7.5 million in June 2023 following the execution of the Termination and Transfer Agreement and further milestone payments of £3 million, £12 million, £6 million and £1.5 million to the Company in September and December 2023 and June and August 2024, respectively. No further payments are due from GSK under the Termination and Transfer Agreement.
The Company has identified the following performance obligations under the Termination and Transfer Agreement: (i) to take over sponsorship and complete the IGNYTE trial and (ii) to take over sponsorship and complete the LTFU trial. The revenue allocated to both obligations is recognized over time from the point that sponsorship of the active trials that make up the trial transfer, based on the number of patients transferred and still actively enrolled to date on the trial at a given period-end relative to the total estimated periods of active patient enrollment over the estimated duration of the trial.
The Galapagos Collaboration and Exclusive License Agreement
On May 30, 2024, the Company entered into a the Galapagos Collaboration Agreement. The Galapagos Collaboration Agreement includes an option for Galapagos to exclusively license the TCR T-cell therapy candidate uza-cel, manufactured on Galapagos’s decentralized manufacturing platform, in head and neck cancer and potential future solid tumor indications. Under the Galapagos Collaboration Agreement, we will conduct a clinical proof-of-concept trial to evaluate the safety and efficacy of uza-cel produced on Galapagos’ decentralized manufacturing platform in patients with head and neck cancer.
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The Company will receive initial payments of $100 million, comprising $70 million upfront and $30 million of research and development funding, option exercise fees of up to $100 million (the amount depending on the number of indications in relation to which the option is exercised), additional development and sales milestone payments of up to a maximum of $465 million, plus tiered royalties on net sales. The $70 million upfront payment and $15 million of upfront research and development funding was received in June 2024.
The Company has identified a performance obligation relating to the various activities required to complete the POC trial and a material right associated with the exclusive license option. The Company expects to satisfy the POC Trial obligation over time over the period that the trial is completed, based on an estimate of the percentage of completion of the trial determined based on the costs incurred on the trial as a percentage of the total expected costs. The revenue allocated to the material right associated with the exclusive licence option will be recognized from the point that the option is either exercised and control of the license has passed to Galapagos or the option lapses.
Research and Development Expenses
Research and development expenditures are expensed as incurred. Research and development expenses consist principally of the following:
● | salaries for research and development staff and related expenses, including benefits; |
● | costs for production of preclinical compounds and drug substances by contract manufacturers; |
● | fees and other costs paid to contract research organizations in connection with additional preclinical testing and the performance of clinical trials; |
● | costs associated with the development of a process to manufacture and supply our lentiviral vector and cell therapies for use in clinical trials; |
● | costs to develop manufacturing capability at our U.S. facility for manufacture of cell therapies for use in clinical trials; |
● | costs relating to facilities, materials and equipment used in research and development; |
● | costs of acquired or in-licensed research and development which does not have alternative future use; |
● | costs of developing assays and diagnostics; |
● | an allocation of indirect costs clearly related to research and development; |
● | amortization and depreciation of property, plant and equipment and intangible assets used to develop our cells therapies; and |
● | share-based compensation expenses. |
These expenses are partially offset by:
● | reimbursable tax and expenditure credits from the U.K. government. |
Research and development expenditure is presented net of reimbursements from reimbursable tax and expenditure credits from the U.K. government.
As a company that carries out extensive research and development activities, we benefit from the U.K. research and development tax credit regime for small and medium sized companies (“SME R&D Tax Credit Scheme”), whereby our principal research subsidiary company, Adaptimmune Limited, is able to surrender the trading losses that arise from its research and development activities for a payable tax credit of up to approximately 18.6% of eligible research and development expenditures. Qualifying expenditures largely comprise employment costs for research staff, consumables and certain internal overhead costs incurred as part of research projects for which we do not receive income. Subcontracted research expenditures are eligible for a cash rebate of up to approximately 12.1%. A large
31
proportion of costs in relation to our pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by Adaptimmune Limited, are eligible for inclusion within these tax credit cash rebate claims.
Expenditures incurred in conjunction with our collaboration agreements are not qualifying expenditures under the SME R&D Tax Credit Scheme but certain of these expenditures can be reimbursed through the U.K. research and development expenditure credit scheme (the “RDEC Scheme”). Under the RDEC Scheme tax relief is given at 20% of allowable research and development costs, which may result in a payable tax credit at an effective rate of approximately 15% of qualifying expenditure for the year ended December 31, 2024.
On July 18, 2023, the U.K. Government released draft legislation on proposed changes to the U.K. research and development regimes which was subsequently enacted on February 22, 2024. These changes include combining the current SME R&D Tax Credit Scheme and RDEC Schemes with a single 20% gross rate applying to all claims with an exception for R&D Intensive SMEs. For entities which qualify as R&D Intensive SMEs, a higher effective cash tax benefit of 27% will be available. The legislation also includes changes to other rules and types of qualifying expenditure, such as the treatment of subcontracted and overseas costs.
Our research and development expenses may vary substantially from period to period based on the timing of our research and development activities, which depends upon the timing of initiation of clinical trials and the rate of enrollment of patients in clinical trials. The duration, costs, and timing of clinical trials and development of our cell therapies will depend on a variety of factors, including:
● | the scope, rate of progress, and expense of our ongoing as well as any additional clinical trials and other research and development activities; |
● | uncertainties in clinical trial enrollment rates; |
● | future clinical trial results; |
● | significant and changing government regulation; |
● | the timing and receipt of any regulatory approvals; and |
● | supply and manufacture of lentiviral vector and cell therapies for clinical trials. |
A change in the outcome of any of these variables may significantly change the costs and timing associated with the development of that cell therapy. For example, if the FDA, or another regulatory authority, requires us to conduct clinical trials beyond those that we currently anticipate will be required for regulatory approval, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.
Selling, General and Administrative Expenses
Our general and administrative expenses consist principally of:
● | salaries for employees other than research and development staff, including benefits; |
● | business development expenses, including travel expenses; |
● | professional fees for auditors, lawyers and other consulting expenses; |
● | selling and other costs relating to our commercial product; |
● | costs of facilities, communication, and office expenses; |
● | cost of establishing commercial operations; |
● | information technology expenses; |
● | amortization and depreciation of property, plant and equipment and intangible assets not related to research and development activities; and |
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● | share-based compensation expenses. |
Interest Income
Interest income primarily comprises interest on cash, cash equivalents and marketable securities.
Interest Expense
Interest expense primarily comprises loan interest on the Hercules Capital loan facility.
Other Income (Expense), Net
Other income (expense), net primarily comprises foreign exchange gains (losses). We are exposed to foreign exchange rate risk because we currently operate facilities in the United Kingdom and United States. Our expenses are generally denominated in the currency in which our operations are located, which are the United Kingdom and United States. However, our U.K.-based subsidiary incurs significant research and development costs in U.S. dollars and, to a lesser extent, Euros. Our U.K. subsidiary has an intercompany loan balance in U.S. dollars payable to the Comapny. Since July 1, 2019, the intercompany loan has been considered as being a long-term investment as repayment is not planned or anticipated in the foreseeable future. It is the Company’s intent not to request payment of the intercompany loan for the foreseeable future. The foreign exchange gains or losses arising on the revaluation of intercompany loans of a long-term investment nature are reported within other comprehensive (loss) income, net of tax.
Our results of operations and cash flows will be subject to fluctuations due to changes in foreign currency exchange rates, which could harm our business in the future. We seek to minimize this exposure by maintaining currency cash balances at levels appropriate to meet forthcoming expenditure in U.S. dollars and pounds sterling. To date, we have not used hedging contracts to manage exchange rate exposure, although we may do so in the future.
In addition to currency fluctuations, adverse macroeconomic conditions, including inflation, slower growth or recession, new or increased tariffs, changes to fiscal and monetary policy, tighter credit, and higher interest rates, could materially adversely affect the Company by, for example, driving higher input costs and/or impacting the Company’s ability to raise future financing.
Taxation
We are subject to corporate taxation in the United Kingdom and the United States. We typically incur tax losses and tax credit carryforwards in the United Kingdom on an annual basis. No net deferred tax assets are recognized on our U.K. losses and tax credit carryforwards because there is currently no indication that we will make sufficient taxable profits to utilize these tax losses and tax credit carryforwards. The rate of U.K. corporation tax is 25% for the year ended December 31, 2024.
We benefit from reimbursable tax credits in the United Kingdom through the SME R&D Tax Credit Scheme as well as the RDEC Scheme which are presented as a deduction to research and development expenditure.
Our pre-existing subsidiary in the United States, Adaptimmune LLC, has generated taxable profits due to a Service Agreement between our U.S. and U.K. operating subsidiaries and is subject to U.S. federal corporate income tax of 21%. Due to its activity in the United States, and the sourcing of its revenue, the Adaptimmune LLC is not currently subject to any state or local income taxes. The Company also benefits from the U.S Research Tax Credit and Orphan Drug Credit.
TCR2 has incurred net losses since acquisition and generates research and development tax credits. TCR2’s operating loss and tax credit carryforwards and other tax attributes are reduced by a valuation allowance to the amount supported by reversing taxable temporary differences because there is currently no indication that we will make sufficient taxable profits to utilize these deferred tax assets.
In the future, if we generate taxable income in the United Kingdom, we may benefit from the United Kingdom’s “patent box” regime, which would allow certain profits attributable to revenues from patented products to be taxed at a rate of 10%. As we have many different patents covering our products, future upfront fees, milestone fees, product revenues, and royalties may be taxed at this favorably low tax rate.
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U.K. Value Added Tax (“VAT”) is charged on all qualifying goods and services by VAT-registered businesses. An amount of 20% of the value of the goods or services is added to all relevant sales invoices and is payable to the U.K. tax authorities. Similarly, VAT paid on purchase invoices paid by Adaptimmune Limited and the Company is reclaimable from the U.K. tax authorities.
Critical Accounting Policies and Significant Judgments and Estimates
The preparation of our unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities, and the revenues and expenses incurred during the reported periods. We base our estimates on historical experience and on various other factors that we believe are relevant under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The accounting policies considered to be critical to the judgments and estimates used in the preparation of our financial statements are disclosed in the Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our 2023 Annual Report.
In addition, the following estimate was considered to be critical to the judgements and estimates used in the preparation of our financial statements for the nine months ending September 30, 2024.
Allocation of transaction price using the relative standalone selling price
Upfront and other payments included in the transaction price of a contract are allocated between performance obligations using the Company’s best estimate of the relative standalone selling price of the performance obligation. The relative standalone selling price is estimated by determining the market values of development and license obligations. As these inputs are not directly observable, the estimate is determined considering all reasonably available information including internal pricing objectives used in negotiating the contract, together with internal data regarding the cost and margin of providing services for each deliverable, taking into account the different stage of development of each development program and consideration of adjusted-market data from comparable arrangements, where applicable and available. This assessment involves significant judgment and could have a significant impact on the amount and timing of revenue recognition.
An assessment of the allocation of transaction price using the relative standalone selling price was required in the nine months ending September 30, 2024 and 2023 for the Galapagos Collaboration Agreement and the GSK Termination and Transfer Agreement, respectively, although the assessment for the GSK Termination and Transfer Agreement in 2023 was not considered to be a significant estimate.
Results of Operations
Comparison of three months ended September 30, 2024 and 2023
The following table summarizes the results of our operations for the three months ended September 30, 2024 and 2023, together with the changes to those items (in thousands):
Three months ended |
| |||||||||||
September 30, |
|
| ||||||||||
| 2024 |
| 2023 |
| Increase/decrease |
| ||||||
Revenue | $ | 40,901 | $ | 7,319 | $ | 33,582 |
| 459 | % | |||
Research and development expenses |
| (34,304) |
| (37,788) |
| 3,484 |
| (9) | % | |||
Selling, general and administrative expenses |
| (21,277) |
| (16,164) |
| (5,113) |
| 32 | % | |||
Total operating expenses |
| (55,581) |
| (53,952) |
| (1,629) |
| 3 | % | |||
Operating loss |
| (14,680) |
| (46,633) |
| 31,953 |
| (69) | % | |||
Interest income |
| 2,096 |
| 2,149 |
| (53) |
| (2) | % | |||
Interest expense | (1,109) | — | (1,109) | — | % | |||||||
Gain on bargain purchase | — | (106) | 106 | (100) | % | |||||||
Other (expense) income, net |
| (3,093) |
| (324) |
| (2,769) |
| 855 | % | |||
Loss before income tax expense |
| (16,786) |
| (44,914) |
| 28,128 |
| (63) | % | |||
Income tax expense |
| (831) |
| (687) |
| (144) |
| 21 | % | |||
Loss for the period | $ | (17,617) | $ | (45,601) | $ | 27,984 |
| (61) | % |
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Revenue
Revenue increased by $33.6 million to $40.9 million for the three months ended September 30, 2024 compared to $7.3 million for the three months ended September 30, 2023. The increase is primarily due to the termination of the Genentech Collaboration Agreement in April 2024 and subsequent Mutual Release Agreement, resulting in the remaining deferred revenue of $25 million, representing deferred revenue at June 30, 2024, and $12.5 million payment, being recognized as revenue in the current quarter. The remaining revenue in the three months ended September 30, 2024 relates to the GSK and Galapagos agreements, whereas the revenue in the three months ended September 30, 2023 related to Genentech.
Research and Development Expenses
Research and development expenses decreased by 9% to $34.3 million for the three months ended September 30, 2024 from $37.8 million for the three months ended September 30, 2023.
Our research and development expenses comprise the following (in thousands):
Three months ended |
| |||||||||||
September 30, |
|
| ||||||||||
| 2024 |
| 2023 |
| Increase/decrease | |||||||
Salaries, materials, equipment, depreciation of property, plant and equipment and other employee-related costs(1) | $ | 23,245 | $ | 22,405 | $ | 840 | 4 | % | ||||
Subcontracted expenditure |
| 10,551 |
| 16,604 |
| (6,053) | (36) | % | ||||
Manufacturing facility expenditure |
| 2,025 |
| 2,049 |
| (24) | (1) | % | ||||
Share-based compensation expense |
| 1,070 |
| 789 |
| 281 | 36 | % | ||||
In-process research and development costs |
| 13 |
| 10 |
| 3 | 30 | % | ||||
Reimbursements receivable for research and development tax and expenditure credits |
| (2,600) |
| (4,069) |
| 1,469 | (36) | % | ||||
$ | 34,304 | $ | 37,788 | $ | (3,484) | (9) | % |
(1) | These costs are not analyzed by project since employees may be engaged in multiple projects simultaneously. |
The net decrease in our research and development expenses of $3.5 million for the three months ended September 30, 2024 compared to the same period in 2023 was primarily due to the following:
● | a decrease of $6.1 million in subcontracted expenditure due primarily to a decrease in clinical trial expenses relating to TCR2 as the TCR2 programs wind down, offset by an increase in vector manufacturing; offset by |
● | a decrease of $1.5 million in offsetting reimbursements receivable for research and development tax and expenditure credits due to decreases in the associated research and development costs for which the credits may be claimed. |
Our subcontracted costs for the three months ended September 30, 2024 were $10.6 million, compared to $16.6 million in the same period in 2023. This includes $8.7 million of costs directly associated with our afami-cel, lete-cel and uza-cel T-cells and $1.9 million of other development costs.
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Selling, General and Administrative Expenses
Selling, general and administrative expenses increased by 32% to $21.3 million for the three months ended September 30, 2024 from $16.2 million in the same period in 2023. Our selling, general and administrative expenses consist of the following (in thousands):
Three months ended |
| |||||||||||
September 30, |
|
| ||||||||||
| 2024 |
| 2023 |
| Increase/decrease | |||||||
Salaries, depreciation of property, plant and equipment and other employee-related costs | $ | 9,922 | $ | 8,237 | $ | 1,685 | 20 | % | ||||
Other corporate costs |
| 9,181 |
| 5,533 |
| 3,648 | 66 | % | ||||
Share-based compensation expense | 1,985 | 2,394 | (409) | (17) | % | |||||||
Commercial expenses | 189 | — | 189 | — | % | |||||||
$ | 21,277 | $ | 16,164 | $ | 5,113 | 32 | % |
The net increase in our selling, general and administrative expenses of $5.1 million for the three months ended September 30, 2024 compared to the same period in 2023 was largely due to an increase of:
● | $1.7 million in salaries, depreciation of property, plant and equipment and other employee-related costs, due primarily to increased travel and training costs, primarily due to commercialization-related activities; and |
● | $3.6 million in other corporate costs due to an increase in accounting, legal and professional fees, due to a combination of fees relating to business development work and fees relating to preparation for commercialization. |
Income Taxes
Income taxes arise in the United States due to Adaptimmune LLC generating taxable profits. We typically incur taxable losses in the United Kingdom on an annual basis and have incurred losses in TCR2 since the acquisition.
Comparison of nine months ended September 30, 2024 and 2023
The following table summarizes the results of our operations for the nine months ended September 30, 2024 and 2023, together with the changes to those items (in thousands):
Nine months ended |
| |||||||||||
September 30, |
|
| ||||||||||
| 2024 |
| 2023 |
| Increase/decrease |
| ||||||
Revenue | $ | 174,810 | $ | 60,050 | $ | 114,760 |
| 191 | % | |||
Research and development expenses |
| (109,959) |
| (93,301) |
| (16,658) |
| 18 | % | |||
Selling, general and administrative expenses |
| (60,092) |
| (56,634) |
| (3,458) |
| 6 | % | |||
Total operating expenses |
| (170,051) |
| (149,935) |
| (20,116) |
| 13 | % | |||
Operating profit/(loss) |
| 4,759 |
| (89,885) |
| 94,644 |
| (105) | % | |||
Interest income |
| 4,817 |
| 4,368 |
| 449 |
| 10 | % | |||
Interest expense | (1,635) | — | (1,635) | — | % | |||||||
Gain on bargain purchase | — | 22,049 | (22,049) | (100) | % | |||||||
Other (expense) income, net |
| (2,657) |
| (494) |
| (2,163) |
| 438 | % | |||
Profit/(loss) before income tax expense |
| 5,284 |
| (63,962) |
| 69,246 |
| (108) | % | |||
Income tax expense |
| (1,883) |
| (1,992) |
| 109 |
| (5) | % | |||
Profit/(loss) for the period | $ | 3,401 | $ | (65,954) | $ | 69,355 |
| (105) | % |
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Revenue
The revenue recognized in the nine months ended September 30, 2024 relates to development revenue under the Genentech Collaboration Agreement, the Galapagos Collaboration Agreement and the GSK Termination and Transfer Agreement whereas the revenue in the nine months ended September 30, 2024 relates to development revenue under the Genentech Collaboration Agreement and the Astellas Collaboration Agreement.
Revenue increased by $114.8 million to $174.8 million in the nine months ended September 30, 2024 compared to $60.1 million for the nine months ended September 30, 2023 primarily due to the termination of the Genentech Collaboration Agreement in April 2024, resulting in a cumulative catch-up adjustment of $101.3 million and the subsequent Mutual Release Agreement, resulting in the remaining deferred revenue and additional payment, being recognized as $37.8 million of revenue in the third quarter of 2024, compared to the termination of the Astellas Collaboration Agreement in the first quarter of 2023, which resulted in the remaining deferred revenue for the collaboration of $42.4 million being recognized as revenue in March 2023.
Total revenue from Genentech and GSK in the nine months ended September 30, 2024 was $163.9 million and $10.7 million respectively, compared to $16.1 million from Genentech and $44.0 million from Astellas in the nine months ended September 30, 2023. The revenue recognized in 2024 and 2023 for Genentech and Astellas, respectively, includes the impact of the events noted above, as well as revenue recognized as research and development work for the collaborations was performed.
Research and Development Expenses
Research and development expenses increased by 18% to $110.0 million for the nine months ended September 30, 2024 from $93.3 million for the nine months ended September 30, 2023.
Our research and development expenses comprise the following (in thousands):
Nine months ended |
| |||||||||||
September 30, |
|
| ||||||||||
| 2024 |
| 2023 |
| Increase/decrease | |||||||
Salaries, materials, equipment, depreciation of property, plant and equipment and other employee-related costs(1) | $ | 72,359 | 62,120 | $ | 10,239 | 16 | % | |||||
Subcontracted expenditure |
| 35,970 |
| 37,249 |
| (1,279) | (3) | % | ||||
Manufacturing facility expenditure |
| 7,197 |
| 5,441 |
| 1,756 | 32 | % | ||||
Share-based compensation expense |
| 2,878 |
| 2,190 |
| 688 | 31 | % | ||||
In-process research and development costs |
| 34 |
| (1,853) |
| 1,887 | (102) | % | ||||
Reimbursements receivable for research and development tax and expenditure credits |
| (8,479) |
| (11,846) |
| 3,367 | (28) | % | ||||
$ | 109,959 | $ | 93,301 | $ | 16,658 | 18 | % |
(1) | These costs are not analyzed by project since employees may be engaged in multiple projects simultaneously. |
The net increase in our research and development expenses of $16.7 million for the nine months ended September 30, 2024 compared to the same period in 2023 was primarily due to the following:
● | an increase of $10.2 million in salaries, materials, equipment, depreciation of property, plant and equipment and other employee-related costs, which is driven primarily by an increase in the average number of employees engaged in research |
37
and development following the acquisition of TCR2 in June 2023 and annual salary increases, and increased costs relating to property due to additional lease properties acquired following the acquisition of TCR2; |
● | an increase of $1.8 million in manufacturing facility expenditure due to the consumption of batches of clinical materials that had not previously been impaired, compared to 2023 where clinical materials consumed were primarily those that had been impaired to nil in previous years and therefore no corresponding expense was recognised; |
● | an increase of $1.9 million in in-process research and development costs due to a credit of $1.9 million in 2023 that was not repeated in 2024; and |
● | a decrease of $3.4 million in reimbursements receivable for research and development tax and expenditure credits due to decreases in the associated research and development costs for which the credits may be claimed and a reduction in the effective rate at which the tax credits can be claimed which was effective from April 1, 2023; offset by |
● | a decrease of $1.3 million on subcontracted expenditure primarily due to a reduction in outsourced research costs. |
Our subcontracted costs for the nine months ended September 30, 2024 were $36.0 million, compared to $37.2 million in the same period of 2023. This includes $26.7 million of costs directly associated with our afami-cel, lete-cel and uza-cel T-cells and $9.3 million of other development costs.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased by 6% to $60.1 million for the nine months ended September 30, 2024 from $56.6 million in the same period in 2023. Our selling, general and administrative expenses consist of the following (in thousands):
Nine months ended |
| |||||||||||
September 30, |
|
| ||||||||||
| 2024 |
| 2023 |
| Increase/decrease | |||||||
Salaries, depreciation of property, plant and equipment and other employee-related costs | $ | 29,930 | $ | 28,901 | $ | 1,029 | 4 | % | ||||
Restructuring charges | — | 1,703 | (1,703) | (100) | % | |||||||
Other corporate costs |
| 27,436 |
| 22,002 |
| 5,434 | 25 | % | ||||
Share-based compensation expense |
| 6,337 |
| 6,506 |
| (169) | (3) | % | ||||
Commercial expenses | 189 | — | 189 | — | % | |||||||
Reimbursements |
| (3,800) |
| (2,478) |
| (1,322) | 53 | % | ||||
$ | 60,092 | $ | 56,634 | $ | 3,458 | 6 | % |
The net decrease in our selling, general and administrative expenses of $3.5 million for the nine months ended September 30, 2024 compared to the same period in 2023 was largely due to:
● | a reduction in restructuring charges of $1.7 million, which related to the restructuring programme completed in the first quarter of 2023; offset by |
● | an increase of $5.4 million in other corporate costs due to an increase in accounting, legal and professional fees, due primarily to a combination of fees relating to business development work and fees relating to preparation for commercialization. |
Gain on Bargain Purchase
The gain on bargain purchase arose in June 2023 from the strategic combination with TCR2 on June 1, 2023.
38
Liquidity and Capital Resources
Sources of Funds
Since our inception, we have incurred significant net losses and negative cash flows from operations. We financed our operations primarily through sales of equity securities, cash receipts under our collaboration arrangements and research and development tax and expenditure credits. From inception through to September 30, 2024, we have raised:
● | $900.2 million, net of issuance costs, through the issuance of shares; |
● | $49.5 million, net of discount, drawn from the Hercules Capital loan facility; |
● | $533.3 million through collaborative arrangements with Galapagos, Genentech, GSK and Astellas; |
● | $141.3 million in the form of reimbursable U.K. research and development tax credits and receipts from the U.K. RDEC Scheme; and |
● | $45.3 million in cash and cash equivalents and restricted cash and $39.5 million of marketable securities acquired as part of the strategic combination with TCR2. |
We use a non-GAAP measure, Total Liquidity, which is defined as the total of cash and cash equivalents and marketable securities, to evaluate the funds available to us in the near-term. A description of Total Liquidity and reconciliation to cash and cash equivalents, the most directly comparable U.S. GAAP measure, are provided below under “Non-GAAP measures”.
As of September 30, 2024, we had cash and cash equivalents of $116.7 million and Total Liquidity of $186.1 million.
Cash Flows
The following table summarizes the results of our cash flows for the nine months ended September 30, 2024 and 2023 (in thousands):
| Nine months ended | |||||
September 30, | ||||||
| 2024 |
| 2023 | |||
Net cash used in operating activities | $ | (39,002) | $ | (126,204) | ||
Net cash (used in)/provided by investing activities |
| (67,119) |
| 108,341 | ||
Net cash provided by financing activities |
| 78,748 |
| 806 | ||
Cash, cash equivalents and restricted cash |
| 119,422 |
| 93,072 |
Operating Activities
Net cash used in operating activities was $39.0 million for the nine months ended September 30, 2024 compared to net cash used in operating activities of $126.2 million for the nine months ended September 30, 2023. Our activities typically result in net use of cash in operating activities. The net cash used in operating activities for the nine months ended September 30, 2024 decreased primarily due to the receipt of research and development credits of $30.8 million, an $85 million upfront payment from Galapagos and $9.7 million milestone payments from GSK which was offset by an increase in operating expenditures.
Net cash used in operating activities of $39.0 million for the nine months ended September 30, 2024 comprised a net profit of $3.4 million and a net cash outflow of $62.5 million from changes in operating assets and liabilities, offset by non-cash items of $20.1 million. The changes in operating assets and liabilities include the impact of a $21.5 million decrease in reimbursements receivable for research and development tax credits and the recognition of deferred revenue following the termination of the Genentech Collaboration
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Agreement. The non-cash items consisted primarily of depreciation expense on plant and equipment of $8.2 million, share-based compensation expense of $9.2 million, unrealized foreign exchange losses of $3.2 million and other items of $0.4 million.
Investing Activities
Net cash used in investing activities was $67.1 million for the nine months ended September 30, 2024 compared to $108.3 million provided investing activities for the nine months ended September 30, 2023. The net cash used in or provided by investing activities for the respective periods consisted primarily of:
● | purchases of property, plant and equipment of $0.7 million and $3.9 million for the nine months ended September 30, 2024 and 2023, respectively. Purchases of property, plant and equipment were higher in 2023 compared to 2024 due to the expansion of our manufacturing facilities, which was largely completed in 2022 and finalized in 2023; |
● | purchases of intangible assets of $0.9 million and $0.2 million for the nine months ended September 30, 2024 and 2023, respectively; |
● | investments in marketable securities of $65.7 million in the nine months ended September 30, 2024 compared to $73.0 million in the nine months ended September 30, 2023; and |
● | there were no cash inflows from maturity or redemption of marketable securities in the nine months ended September 30, 2024 compared to $139.2 million for the nine months ended September 30, 2023. |
The Company invests surplus cash and cash equivalents in marketable securities.
Financing Activities
Net cash provided by financing activities was $78.7 million and $0.8 million for the nine months ended September 30, 2024 and 2023, respectively. The net cash provided by financing activities in the nine months ended September 30, 2024 consisted of net proceeds of $29.2 million from shares issued in an ATM offering, net of commissions and issuance costs, and $49.5 million proceeds from the issuance of borrowings, net of discount. The net cash provided by financing activities in the nine months ended September 30, 2023 consisted primarily of net proceeds of $0.6 million from shares issued in an ATM offering, net of commissions and issuance costs.
Non-GAAP Measures
Total Liquidity
Total Liquidity (a non-GAAP financial measure) is the total of cash and cash equivalents and marketable securities. Each of these components appears in the condensed consolidated balance sheet. The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the condensed consolidated financial statements, which reconciles to Total Liquidity as follows (in thousands):
| September 30, |
| December 31, | |||
2024 | 2023 | |||||
Cash and cash equivalents | $ | 116,741 | $ | 143,991 | ||
Marketable securities - available-for-sale debt securities |
| 69,349 |
| 2,947 | ||
Total Liquidity | $ | 186,090 | $ | 146,938 |
We believe that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its management of overall solvency and liquidity, financial flexibility, capital position and leverage. The definition of Total Liquidity includes marketable securities, which are highly-liquid and available to use in our current operations.
Safe Harbor
See the section titled “Information Regarding Forward-Looking Statements” at the beginning of this Quarterly Report.
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Item 3. Quantitative and Qualitative Disclosures about Market Risk.
There have been no material changes to the Company’s market risk during the three and nine months ended September 30, 2024. For a discussion of the Company’s exposure to market risk, please refer to the Company’s market risk disclosures set forth in Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk” in our 2023 Annual Report.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) under the Securities and Exchange Act of 1934, as amended (“Exchange Act”) as of September 30, 2024.
Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective at September 30, 2024.
Changes in Internal Control over Financial Reporting
No changes in our internal control over financial reporting (as defined in Rules 13a-15(e) and 15d – 15(e)) under the Exchange Act) occurred during the quarter ended September 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
As of September 30, 2024 we were not a party to any material legal proceedings.
Item 1A. Risk Factors.
Our business has significant risks. You should carefully consider the risk factors set out in Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2023 and the disclosures and risk factors set out in this Quarterly Report, including our condensed consolidated financial statements and the related notes, before making an investment decision regarding our securities. The risks and uncertainties described are those material risk factors currently known and specific to us that we believe are relevant to our business, results of operations and financial condition. Additional risks and uncertainties not currently known to us or that we now deem immaterial may also impair our business, results of operations and financial condition.
As of and for the period ended September 30, 2024, save as provided below there have been no material changes from the risk factors previously disclosed by us in Part I, Item 1A. Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2023.
We may not be able to maintain compliance with the continued listing requirements of Nasdaq.
Our Americal Depository Shares (ADSs) are listed on Nasdaq. In order to maintain that listing, we must satisfy minimum financial and other requirements including, without limitation, a requirement that our closing bid price must not fall below $1.00 per ADS for 30 consecutive business days. On November 1, 2024, we received a notice from The Nasdaq Stock Market (“Nasdaq”) that the Company is not in compliance with Nasdaq’s Listing Rule 5450(a)(1), because the minimum bid price of the Company’s American Depositary Shares (“ADSs”) has been below $1.00 per share for 30 consecutive business days (the “Notice”). The Notice has no immediate effect on the listing or trading of the Company’s ADSs on The Nasdaq Global Select Market.
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 calendar days, or until April 30, 2025, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company’s ADSs must be at least
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$1.00 per ADS for a minimum of ten consecutive business days during this 180 calendar day grace period, unless Nasdaq exercises its discretion to extend this ten-day period. In the event the Company does not regain compliance with the minimum bid price requirement by April 30, 2025, the Company may be eligible for an additional 180 calendar day compliance period if it elects to ransfer to The Nasdaq Capital Market. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the minimum bid price requirement, and would need to provide written notice of its intention to cure the bid price deficiency during the second compliance period. However, if it appears to Nasdaq’s staff that the Company will not be able to cure the deficiency or if the Company is otherwise not eligible, Nasdaq would notify the Company that its securities would be subject to delisting. The Company may appeal any such determination to delist its securities, but there can be no assurance that any such appeal would be successful.
The Company intends to monitor the closing bid price of its ADSs and assess potential actions to regain compliance with Nasdaq’s Listing Rule 5450(a)(1). However, there can be no assurance that we will be able to regain compliance with the minimum bid price requirement or that we will otherwise maintain compliance with other Nasdaq listing requirements. If we fail to regain and maintain compliance with the minimum bid price requirement or to meet the other applicable continued listing requirements in the future and Nasdaq decides to delist our ADSs, the delisting could adversely affect the market price and liquidity of our ADSs, reduce our ability to raise additional capital and result in operational challenges and damage to investor relations and market reputation.
Although our financial statements have been prepared on a going concern basis, if we fail to obtain additional financing in the future, this may raise substantial doubt about our ability to continue as a going concern in future reporting periods
As of September 30, 2024, the Company had cash and cash equivalents of $116.7 million, marketable securities of $69.3 million, and stockholders’ equity of $80.0 million. During the nine months ended September 30, 2024, the Company incurred a net profit of $3.4 million, used cash of $39.0 million from its operating activities, and generated revenues of $174.8 million. The Company has incurred net losses in most periods since inception and it expects to incur operating losses in future periods.
We believe that our Total Liquidity will be sufficient to fund our operations for at least 12 months, based upon our currently anticipated research and development activities and planned restructuring of the company to reduce headcount and expenses. This belief is based on estimates that are subject to risks and uncertainties and may change if actual results, revenue from commercialisation of Tecelra or the currently anticipated costs and cost reductions (including those associated with the restructuring) differ from management’s estimates or do not occur within anticipated timeframes.
We must obtain additional capital to continue funding planned operations. There is no assurance that the Company will be able to obtain sufficient additional capital to continue funding its operations or, if we do, that it will be on terms that are favourable to our shareholders. Any future fundraising, if possible, is likely to be highly dilutive to our existing shareholders and may also divert our management from its day-to-day activities.
If the Company fails to obtain additional funding, it may be required to:
● | significantly reduce certain activities and operations of the business in order to reduce ongoing expenditure. Any such reduction could significantly delay the timelines under which we can bring new products to the market (including lete-cel) or our ability to commercialize Tecelra. |
● | conduct a restructuring of the company to further reduce headcount and expenditure which will in turn reduce the activities and operations of the business. |
● | repay all or part of the loan advances received under the Loan Agreement in accordance with the terms of the Loan Agreement (including any applicable repayment charges or costs). |
● | seek further third party alliances for existing assets, including Tecelra, on terms that are less favorable than might otherwise be available; |
● | seek an acquirer for all or part of the business on terms that are less favorable than might otherwise be available |
● | relinquish or license on unfavorable terms or rights to technologies, intellectual property or product candidates we would otherwise seek to develop or commercialize ourselves. |
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If we fail to obtain additional funding, or in the event that we significantly reduce our ongoing expenditures and operations (including the current restructuring), this may result in an inability to retain key individuals required for our ongoing business and may result in a need to delay or halt ongoing programs or change the nature and scope of such programs. As a result, our business financial condition and results of operations could be materially affected.
Our business is, in part, dependent on the successful commercialization of Tecelra in the United States.
Tecelra received FDA approval in August 2024. Tecelra is a genetically modified autologous T-cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic synovial sarcoma who have received prior systemic therapy, are positive for HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P, and negative for HLA-A*02:05P, and whose tumor expresses the MAGE-A4 antigen as detected by an FDA-approved test. The success of our business, including our ability to finance our company and generate any revenue in the future, will, at this point, depend on the successful commercialization of Tecelra in the U.S. Any failure to successfully commercialize Tecelra in the U.S. would have a material and adverse impact on our business.
The commercial success of Tecelra will depend on a number of factors, including the following:
● | our ability to obtain any additional required capital or equivalent sources of finance to support the commercialization on acceptable terms, or at all; |
● | our ability to consistently manufacture Tecelra on a timely basis and sufficient to meet demand; |
● | our ability to activate authorized treatment centres (ATC) capable of administering Tecelra and the timing of activation of those authorized treatment centres; |
● | the ability of our authorized treatment centres to facilitate treatments with Tecelra given Tecelra is a novel T-cell therapy requiring patient specific administration; |
● | the availability of the tests required to assess for the required HLA types and antigen presentation ahead of treatment with Tecelra and the ability of third party suppliers of such tests to make those tests available when required; |
● | the prevalence, duration and severity of potential side effects or other safety issues that patients may experience with Tecelra; |
● | achieving and maintaining, and, where applicable, ensuring that our third-party contractors (including those responsible for supply of Tecelra or any raw or intermediate materials required for such supply) achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to Tecelra; |
● | the willingness of physicians, operators of hospitals and clinics and patients to adopt and administer Tecelra; |
● | the availability of coverage and adequate reimbursement from managed care plans, private insurers, government payors (such as Medicare and Medicaid and similar foreign authorities) and other third-party payors for Tecelra; |
● | patients’ ability and willingness to pay out-of-pocket for Tecelra in the absence of coverage and/or adequate reimbursement from third-party payors; |
● | patient demand for Tecelra; |
● | the identification of patients eligible for treatment by the authorized treatment centres (including by referral from other hospitals and treatment centres) and the ability of the authorized treatment centres to progress such patients through to treatment; |
● | prevalence of the required HLA types and antigen within the synovial sarcoma population and the ability of the tests for HLA and antigen to function as expected; |
● | our ability to avoid third-party patent interference, intellectual property challenges or intellectual property infringement claims; and |
● | our ability to comply with any post marketing requirements and obligations including those imposed by the FDA as part of the authorization for Tecelra. |
These factors, many of which are beyond our control, could cause us to experience significant delays or an inability to obtain regulatory approvals or commercialize Tecelra. While we have obtained regulatory approval of Tecelra in the United States, we may never be able to successfully commercialize Tecelra in the United States or receive regulatory approval of Tecelra outside the United States. Accordingly, we cannot provide assurances as to the revenue obtainable through the sale of Tecelra.
Tecelra is approved under accelerated approval in the United States, and additional confirmatory work is required in order to maintain that approval. Inability to maintain approval or to otherwise meet the requirements imposed by the FDA will have a significant impact on our ability to commercialize Tecelra.
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Tecelra is approved under accelerated approval in the U.S. based on overall response rate and duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. Our ability to obtain traditional approval for Tecelra may require the conduction of additional studies and will require ongoing discussions with the FDA. Any additional work required to satisfy the conditions of accelerated approval will require additional finances, and any ability to obtain any additional required capital or equivalent sources of finance may delay or prevent our ability to maintain approval for Tecelra.
As part of the approval of Tecelra, certain post approval requirements apply which, if not satisfied, could impact continued approval of Tecelra.
Tecelra is subject to continuing regulation by the FDA Failure to meet any of these requirements may result in negative consequences including adverse publicity, judicial or administrative enforcement, warning letters from the FDA, mandated corrective advertising or communications with doctors, and civil or criminal penalties.
These requirements include submissions of safety and other postmarketing information and reports, registration and listing, as well as continued compliance with cGMPs and cGCPs for any clinical trials that we conduct post-approval. In addition, the FDA and other regulatory authorities may impose additional restrictions or require amendments to our product label after marketing approval in the event of additional adverse events with our cell therapy or of other adverse events seen with similar cell therapy products.
As part of the approval of Teclera, the FDA has imposed certain Postmarketing Commitments (“PMCs”) and Postmarketing Requirements (“PMRs”), including certain requirements to conduct additional studies under proscribed timelines. Failure to conduct these PMCs and PMRs in a timely manner could result in enforcement action from the FDA.
We and our contract manufacturers will be subject to periodic unannounced inspections by the FDA to monitor and ensure compliance with cGMPs. We must also comply with requirements concerning advertising and promotion for any cell therapies for which we obtain marketing approval. Promotional communications with respect to prescription drugs, including biologics, are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved labeling. Thus, we will not be able to promote any cell therapies we develop for indications or uses for which they are not approved.
The approval of Tecelra is limited to adult patients with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P, and negative for HLA-A*02:05P, and whose tumor expresses the MAGE-A4 antigen.
As is common for initial approval of cancer therapies, Tecelra has been approved by the FDA for use in a limited patient population, who have unresectable or metastatic synovial sarcoma and who have already received prior systemic therapy. As a result, our ability to market Tecelra is generally limited to that patient population.
The use of prior therapies or treatment for synovial sarcoma may reduce the effectiveness of our cell therapies.
This is the first time we as an organization are marketing a product and we have limited experience as a commercial company and have never generated revenue from product sales.
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Tecelra is the first product for which we have obtained FDA approval. As a company we have not yet launched any approved products for commercial sale and have not previously generated any revenue from product sales. Accordingly, we will need to continue to transition from a company with a research and development focus to a company capable of supporting commercial activities. We may not be successful in such a transition. We have recruited experienced commercial and medical affairs teams and we will need to continue to develop those teams and the associated support network in order to supply Tecelra on a commercial basis.
We will have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train, and retain suitably skilled and experienced marketing and sales personnel. This process may result in additional delays in bringing our cell therapies to market or in certain cases require us to enter into alliances with third parties in order to do so. However, there can be no assurance that we will be able to establish or maintain such collaborative arrangements, or even if we are able to do so, that they will result in effective sales forces. Any revenue we receive will depend upon the efforts of such third parties, which may not be successful. We may have little or no control over the efforts of such third parties, and our revenue from cell therapy sales may be lower than if we had commercialized our cell therapies ourselves.
For Tecelra, we are using certain third parties to supplement the internal commercial facing teams. We are also using a third party distributor to supply Tecelra and third parties to provide some of the systems required to supply Tecelra and support patients prescribed with Tecelra. We are reliant on those third parties to provide the services we require in accordance with our planned timelines. If any critical third party supplier fails to provide the services as required that may result in a delay to the commercialization of Tecelra. Any inability on our part to develop inhouse sales and commercial distribution capabilities or to establish and maintain relationships with third-party collaborators that can successfully commercialize any cell therapy in the U.S. or elsewhere will have a materially adverse effect on our business and results of operations.
As a novel cell therapy, Tecelra may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community, including referral centers.
The use of engineered T-cells and cell therapies more generally as a potential cancer treatment is a recent development and may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers and others in the medical community. For example, the product labelling and prescribing information for Tecelra describe certain limitations of use, adverse events, and warnings and precautions, including a boxed warning related to Cytokine Release Syndrome (CRS), which may be severe or life threatening and which occurred in patients receiving Tecelra in clinical trials. Additional factors will influence whether Tecelra is accepted in the market, including:
● | physicians, hospitals, cancer treatment centers and patients considering Tecelra as a safe and effective treatment; |
● | the potential and perceived advantages of Tecelra over alternative treatments; |
● | the prevalence and severity of any side effects; |
● | willingness of treating centers to test for the required HLA types and MAGE A4 antigen using the FDA approved tests; |
● | our product labeling and prescribing information describe certain limitations of use, adverse events, and warnings and precautions; |
● | the cost of Tecelra in relation to alternative treatments; |
● | the willingness of referral centers and awareness of referral centers to refer patients to our authorized treatment centers; |
● | the availability of coverage, adequate reimbursement and pricing by third-party payors and government authorities; |
● | the willingness of patients to pay for Tecelra on an out-of-pocket basis in the absence of coverage by third-party payors and government authorities; |
● | relative convenience and ease of administration as compared to alternative treatments and competitive therapies; and |
● | the effectiveness of our sales and marketing efforts. |
The product labelling and prescribing information for Tecelra includes a boxed warning for CRS as well as other warnings and precautions. As Tecelra is used commercially, the rate and nature of adverse reactions may increase and as afamitresgene autoleucel (afami-cel) is studied in additional indications and populations, toxicities may further limit its development and use.
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Coverage, price flexibility, and reimbursement may be limited or unavailable in certain market segments for Tecelra.
Successful sales of Tecelra may depend on the availability of coverage and adequate reimbursement from third-party payors. In addition, because Tecelra represents a new approach to the treatment of synovial sarcoma, we cannot accurately estimate the potential revenue from Tecelra.
Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Obtaining coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drugs and treatments they will cover and the amount of reimbursement. Reimbursement by a third-party payor may depend upon a number of factors, including, but not limited to, the third-party payor’s determination that use of a product is:
● | a covered benefit under its health plan; |
● | safe, effective and medically necessary; |
● | appropriate for the specific patient; and |
● | cost-effective. |
Obtaining coverage and reimbursement approval of Tecelra from a government or other third-party payor is a time consuming and costly process which could require us to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our products. Even if we obtain coverage for Tecelra, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Patients are unlikely to use Tecelra unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of Tecelra.
In the U.S., no uniform policy of coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our cell therapies to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained.
There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, national and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare, including the Affordable Care Act (“ACA”) or provisions of the Inflation Reduction Act (“IRA”). Such regulatory changes may bring prescription drug pricing reform or healthcare affordability programs that, for example, seek to lower prescription drug costs by allowing governmental healthcare programs to negotiate prices with drug companies, put an inflation cap on drug prices, and lower out-of-pocket expenses for recipients of governmental healthcare programs. We cannot predict the initiatives that may be adopted in the future.
Tecelra represents a novel approach to treatment of synovial sarcoma that could result in heightened regulatory scrutiny.
Use of Tecelra to treat a patient involves genetically engineering a patient’s T-cells. This is a relatively novel treatment approach that carries inherent development risks including the following, any of which can result in delays to our ability to provide confirmatory evidence of Tecelra’s effectiveness:
● | Further development, characterization and evaluation may be required if post-marketing or clinical data suggest any potential safety risk for patients. The need to develop further assays, or to modify in any way the protocols related to Tecelra to improve safety or effectiveness, may delay the commercialization and further clinical development; |
● | End users and medical personnel require a substantial amount of education and training in their administration of Tecelra either to engage in confirmatory clinical trials and recruit patients or ultimately to provide Tecelra to patients. |
● | Regulatory requirements governing gene and cell therapy products have changed frequently and may continue to change in the future. |
● | There is the potential for delayed adverse events following exposure to gene therapy products due to persistent biological activity of the genetic material or other components of products used to carry the genetic material. In part for this reason, the FDA recommends a 15-year follow-up observation period for all surviving patients who receive treatment using gene therapies in clinical trials. |
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● | Negative results seen in third party clinical trials utilizing gene therapy products may result in regulators halting development and commercialization of our cell therapies, including Tecelra, or in requiring additional data or requirements prior to our cell therapies progressing to the next stage of development. |
Manufacturing and supply of cell therapies is complex, and if we encounter any difficulties in manufacture or supply of Tecelra or our ability to provide supply for confirmatory clinical trials commercial supply of Tecelra could be delayed or stopped.
The process of manufacturing and administering Tecelra is complex and highly regulated. Manufacture requires the harvesting of white blood cells from the patient, isolating certain T-cells from these white blood cells, combining patient T-cells with our lentiviral delivery vector through a process known as transduction, expanding the transduced T-cells to obtain the desired dose, and ultimately infusing the modified T-cells back into the patient. As a result of the complexities, our manufacturing and supply costs are likely to be higher than those at more traditional manufacturing processes and the manufacturing process is less reliable and more difficult to reproduce.
Delays or failures in the manufacture of Tecelra (whether by us, any collaborator or our third party contract manufacturers) may result in a patient being unable to receive Tecelra or a requirement to re-manufacture which itself then causes delays in manufacture for other patients. Any delay or failure or inability to manufacture on a timely basis can adversely affect a patient’s outcomes and delay the timelines for our confirmatory clinical trials and commercialization. With a commercial product delays or failure to manufacture could additionally lead to claims by patients for reimbursement or damages. Such delays or failure or inability to manufacture can result from:
● | a failure in the manufacturing process itself for example, by an error in manufacturing process (whether by us or our third party contract manufacturing organization), equipment or reagent failure, failure in any step of the manufacturing process, failure to maintain a GMP environment, failure in quality systems applicable to manufacture, sterility failures, contamination during process; |
● | variations in patient starting material or apheresis product resulting in less product than expected or product which is not viable, or which cannot be used to successfully manufacture a cell therapy; |
● | product loss or failure due to logistical issues including issues associated with the differences between patients’ white blood cells or characteristics, interruptions to process, contamination, failure to supply patient apheresis material within required timescales (for example, as a result of an import or export hold-up) or supplier error; |
● | inability to have enough manufacturing slots to manufacture cell therapies for patients as and when those patients require manufacture; |
● | inability to procure components, consumables, ingredients, or starting materials, or to manufacture starting materials (including at our U.K. vector facility), as a result of supply chain issues; |
● | loss of or close-down of any manufacturing facility used in the manufacture of our cell therapies. For example, we will be manufacturing Tecelra at our Navy Yard manufacturing facility. Should there be a contamination event at the facility resulting in the close-down of that facility, it would not be possible to find alternative manufacturing capability for Tecelra within the timescales required for patient supply including for commercial supply. |
● | loss or contamination of patient starting material, requiring the starting material to be obtained again from the patient or the manufacturing process to be re-started. In the context of commercial supply, this could result in cancellation of order for the commercial cell therapy or a claim from the patient; |
● | a requirement to modify or make changes to any manufacturing process. Such changes may additionally require comparability testing which then may reduce the amount of manufacturing slots available for manufacture of Tecelra. Delays in our ability to make the required modifications or perform any required comparability testing within currently anticipated timeframes or that such modifications or comparability testing, when made, will obtain regulatory approval or that the new processes or modified processes will successfully be transferred to the third party contract suppliers within currently anticipated timeframes can also impact timelines for manufacture; |
● | reduction or loss of the staff resources required to manufacture our cell therapies at our facilities or those of our CMOs; |
● | allocation of the resources, materials, and services of any collaborator or our third party contract manufacturers away from our cell therapy programs; |
● | reduction in available workforce to perform manufacturing processes, for example, as a result of a COVID-19 outbreak or workforce exhibiting potential COVID-19 symptoms, and pending receipt of test results for COVID-19 infection; |
● | changes in the manufacturing and supply process. Any changes to the manufacturing process may require amendments to be made to regulatory applications or comparability tests to be conducted which can further delay timeframes. If Tecelra |
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manufactured under the new process has a worse safety or efficacy profile than the prior product or the process is less reproducible than the previous process, we may need to re-evaluate the use of that manufacturing process, which could significantly delay or even result in the halting of our confirmatory clinical trials and commercialization. |
We will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense as well as significant penalties if we fail to comply with regulatory requirements or experience unanticipated problems with Tecelra.
FDA approval is accompanied by requirements to conduct surveillance to monitor the safety and efficacy of Tecelra.
Later discovery of previously unknown problems with Tecelra, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:
● | restrictions on our ability to conduct further clinical trials, including full or partial clinical holds on ongoing or planned trials; |
● | restrictions on Tecelra’s manufacturing processes; |
● | restrictions on the marketing of Tecelra; |
● | restrictions on product distribution; |
● | requirements to conduct additional post-marketing clinical trials; |
● | untitled or warning letters; |
● | withdrawal of Tecelra from the market; |
● | refusal to approve pending supplements to the Tecelra that we submit; |
● | recall of products; |
● | fines, restitution or disgorgement of profits or revenue; |
● | suspension or withdrawal of regulatory approvals; |
● | refusal to permit the import or export of our products; |
● | product seizure; |
● | injunctions; |
● | imposition of civil penalties; or |
● | criminal prosecution |
The FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could adversely impact the approval of Tecelra. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the U.S. or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose marketing approval and we may not achieve or sustain profitability.
In addition, FDA has required us to conduct a confirmatory trial to verify the clinical benefit of Tecelra. The results from the confirmatory trial or trials may not support the clinical benefit, which could result in the approval being withdrawn.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
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项目 5. 其他信息。
于2024年9月30日结束的三个月内,我们的任何董事或高级管理人员
条款6. 附件。
本季度报告表10-Q已提供以下展品,或已纳入参考:
附件 数量 |
| 展览说明 | ||
10.1**† | Adaptimmune Therapeutics有限公司、Genentech, Inc.和F. Hoffmann-La Roche Ltd.之间的机密保密协议及和解协议日期为2024年9月23日。 | |||
31.1** | 根据1934年证券交易法第13a-14(a)条及第15d-14(a)条,信安金融主要执行官依据2002年沙宾斯-豪利法案第302条进行认证。. | |||
31.2** | 信安金融主管凭借第1934年证券交易法案第13a-14(a)条款和第15d-14(a)条款的要求进行证明,该法案根据2002年萨班斯-豪利法案第302条颁布. | |||
32.1*** | ||||
32.2*** | ||||
101** | 以下为adaptimmune therapeutics plc截至2024年9月30日季度结束的第10-Q表格中以iXBRL(内嵌可扩展商业报告语言)格式化的财务信息:(i) 2024年9月30日和2023年12月31日的未经审计简明综合账簿;(ii) 截至2024年9月30日和2023年的三个月和九个月的未经审计简明综合损益表;(iii) 截至2024年9月30日和2023年的三个月和九个月的未经审计简明综合损益表; (iv) 截至2024年9月30日和2023年的三个月和九个月的未经审计简明资本变动表;(v) 截至2024年9月30日和2023年九个月的未经审计简明现金流量表;和(vi) 未经审计简明综合财务报表附注。 | |||
104** | 互动日期档案封面(采用内联XBRL格式,包含于展示101中)。 |
** 连同本文件一并申报。
*** 一并提供。
† | 根据S-k条例第601(b)(10)条,某些私人或机密资讯(如所示)已被删除。 |
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