美国
证券交易委员会 及交易所
华盛顿特区，20549
表单
（马克 一）
截至年度季度结束
或
在 从__________到__________的过渡期间
委员会
档案编号
(根据公司章程所述的注册人的正确名称)
(成立州或其他管辖区) 成立或组织证明文件) |
(国税局雇主 识别号码) | |
| （总执行办公室地址） | （邮政编码） |
申报人的电话号码，包括区号：
证券 根据本法第 12 (b) 条注册：
| 每个类别的标题 | 交易 标的 |
在哪个交易所上市的名字 | ||
请勾选以下选项，以指示公司是否：（1）已在过去12个月内（或对于公司被要求提交此类报告的较短期间）提交了《证券交易法》第13条或第15(d)条所要求提交的所有报告；以及（2）在过去90天内是否需要遵守此等提交要求。
请勾选，指出在过去12个月内（或更短时间并应提供此类文件的情况下），申报人是否已依据Regulation S-t（本章节之§232.405号）提交每一个所需提交的互动式数据文件。
指出 通过勾选注册人是否是大型加速文件，加速文件，非加速文件，更小的报告 公司，或一家新兴的成长公司。请参阅「大型加速档案」、「加速档案」的定义 《交易法》第 120 亿条第 2 条中，「较小的报告公司」和「新兴增长公司」。
| 大型加速归档人 | ☐ | 加速归档人 | ☐ |
| ☒ | 小型报告公司 | ||
| 新兴成长型企业 |
如为新兴成长企业，则应打勾选项表示申报人已选择不使用交易所法第13(a)条所提供的任何新或修订财务会计准则延长过渡期遵守。
请勾选是否登记人为空壳公司（根据《交易所法》第120亿2条的定义）。 是☐
否
截至2024年11月15日，总共有 公司普通股股份，面值为$，每股。在打印的总能资末瘫有的股份中， 的普通股，已发行并流通。
目 录
| 页面 | |
| 第一部分－基本报表 | 1 |
| 项目一 基本报表（未经审核） | 1 |
| 项目2. 管理层对财务状况和营运结果的讨论与分析。 | 17 |
| 项目3. 关于市场风险的定量和定性披露。 | 31 |
| 项目4. 控制项和程序。 | 31 |
| 第二部分－其他资讯 | 32 |
| 项目1. 法律诉讼。 | 32 |
| 项目 1A. 风险因素。 | 32 |
| 项目 5. 其他资讯。 | 32 |
| 项目 6. 附件。 | 34 |
| 签名 | 34 |
| i |
第一部分 - 财务信息
项目 1. 基本报表（未经核数）
Tevogen 生物控股有限公司。
未经审计 合并资产负债表
| 九月 30, | 12月31日, | |||||||
| 2024 | 2023 | |||||||
| 资产 | ||||||||
| 流动资产: | ||||||||
| 现金 | $ | $ | ||||||
| 预付费用及其他 资产 | ||||||||
| 应收 来自关联方 | ||||||||
| 流动资产总额 | ||||||||
| 不动产及设备，净额 | ||||||||
| 租赁财产 − 经营租赁 | ||||||||
| 递延交易成本 | ||||||||
| 其他资产 | ||||||||
| 总资产 | $ | $ | ||||||
| 负债及股东 赤字 | ||||||||
| 流动负债： | ||||||||
| 应付账款 | $ | $ | ||||||
| 应计费用及其他 负债 | ||||||||
| 租赁负债 | ||||||||
| 应付款项 | ||||||||
| 可转换的票据 债券 | ||||||||
| 贷款协议 | ||||||||
| 应付 关联方 | ||||||||
| 流动负债总额 | ||||||||
| 可转换票据 | ||||||||
| 租赁负债 | ||||||||
| 衍生权证负债 | ||||||||
| 书面看涨期权衍生品 负债 | ||||||||
| 总负债 | ||||||||
| 股东赤字 | ||||||||
| A系列优先股，$ 面值; 授权的股份； 截至2024年9月30日已发行及流通的股份数量 | ||||||||
| C系列优先股，$ 面值; 授权的股份； 截至2024年9月30日已发行及流通的股份数量 | ||||||||
| 0.01 面值； 授权股份； 和 于2024年9月30日和2023年12月31日发行并流通的股份 | ||||||||
| 资本公积额额外增资 | ||||||||
| 累积亏损 | ( | ) | ( | ) | ||||
| 股东总净资产的 总负债 | ( | ) | ( | ) | ||||
| 总负债及 股东总净资产的负债 | $ | $ | ||||||
请参阅未经审核的合并基本报表附注。
| 1 |
TEVOGEN生物控股公司
未经审核 综合损益表
三个月结束 九月 30, | 九个月结束 九月 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| 营运费用： | ||||||||||||||||
| 研发 | $ | $ | $ | $ | ||||||||||||
| 总务及管理 | $ | |||||||||||||||
| 营业费用总额 | ||||||||||||||||
| 营运损失 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 利息费用，净额 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 并购交易成本 | ( | ) | ||||||||||||||
| 认股权证变动公允价值之变动 | ||||||||||||||||
| 可换股票应付票据公允价值变动 | ( | ) | ( | ) | ||||||||||||
| 认股权证衍生负债公允价值变动 | ( | ) | ||||||||||||||
| 承诺股份发行损失 | ( | ) | ||||||||||||||
| 净亏损 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 归属普通股股东的净损，基本 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 归属普通股股东的净损，稀释 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 每股归属普通股股东的净损，基本 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 每股归属普通股股东的净损，稀释 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 加权平均普通股股本，基本 | ||||||||||||||||
| 加权平均普通股股本，稀释 | ||||||||||||||||
参见 附注以了解未经审核的综合基本报表。
| 2 |
Tevogen 生物控股有限公司。
未经审计 股东资本赤字变动综合报表
| Series A优先股 | Series B优先股 | Series C 首选股 | 普通 股 | 追加 实收 | 累积的 | |||||||||||||||||||||||||||||||||||||||
| 股份 | 金额 | 股份 | 金额 | 股份 | 金额 | 股份 | 金额 | 资本 | 赤字 | 总计 | ||||||||||||||||||||||||||||||||||
| 2024年1月1日的余额 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||||||||||||||
| 发行A系列优先股 | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| 不可退款的预付款项，用于预期的A-1系列优先股发行 | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||
| 发行b类优先股 | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| 将可转让约定票据换股为普通股，与合并相关 | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| 合并，扣除赎回金额和交易成本后的净额 | — | — | — | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||
| 发行受限制的普通股 | — | — | — | ( | ) | |||||||||||||||||||||||||||||||||||||||
| 发行普通股以支付赞助顾问服务费 | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| 基于股票的薪酬 | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||
| 净收入 | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||
| 截至2024年3月31日的余额 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||||||
| 发行承诺股份 与无抵押股权授信设施相关 | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| 发行普通股 与极地应付票据相关 | — | — | — | ( | ) | |||||||||||||||||||||||||||||||||||||||
| 发行普通股 以支付已发行限制股票单位 | — | — | — | ( | ) | |||||||||||||||||||||||||||||||||||||||
| 不可退还预付款项 用于预期发行A-1首选股本 | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||
| 来自关联方的出资 | — | ( | ) | $ | ( | ) | — | — | ||||||||||||||||||||||||||||||||||||
| 基于股票的薪酬 | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||
| 净 损失 | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||
| 2024年6月30日结余 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||||||||||||||
| 发行C系列优先股 | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| 以已发行之有限制股份单位为基础发行普通股 | — | — | — | ( | ) | |||||||||||||||||||||||||||||||||||||||
| 基于股票的薪酬 | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||
| 净 损失 | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||
| 2024年9月30日结余 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||||||||||||||
| Series A优先股 | Series B优先股 | Series C 首选股 | 普通 股 | 实收 | 累积的 | |||||||||||||||||||||||||||||||||||||||
| 股份 | 金额 | 股份 | 金额 | 股份 | 金额 | 股份 | 金额 | 资本 | 赤字 | 总计 | ||||||||||||||||||||||||||||||||||
| 2023年1月1日结余 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||||||
| 净 损失 | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||
| 截至2023年3月31日的余额 2023 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||||||||||||||
| 净 损失 | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||
| 2023年6月30日结余 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||||||
| 净亏损 | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||
| 截至2023年9月30日的余额 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||||||
参见 附注以了解未经审核的综合基本报表。
| 3 |
Tevogen 生物控股有限公司。
未经审计 合并现金流量表
| 截至九个月结束于九月三十日的报告 | ||||||||
| 2024 | 2023 | |||||||
| 营业活动之现金流量： | ||||||||
| 净亏损 | $ | ( | ) | $ | ( | ) | ||
| 调整以协调净亏损与营运活动使用之净现金： | ||||||||
| 折旧费用 | ||||||||
| 基于股票的补偿 开支 | ||||||||
| 非现金利息费用 | ||||||||
| 并购交易成本 | ||||||||
| 可转换承诺票据的公允价值变动 | ( | ) | ||||||
| A系列优先股发行的损失 | ||||||||
| 承诺股份发行损失 | ||||||||
| 权证公允价值的变化 | ( | ) | ||||||
| 已写入看涨期权衍生负债的公允价值变动 | ||||||||
| 使用权的摊销 | ||||||||
| 营运资产及负债之变动： | ||||||||
| 预付费用及其他 资产 | ( | ) | ||||||
| 其他资产 | ( | ) | ||||||
| 应付账款 | ||||||||
| 应计费用及其他 负债 | ( | ) | ( | ) | ||||
| 营运 租赁负债 | ( | ) | ( | ) | ||||
| 持续营运活动所使用的净现金流量 | ( | ) | ( | ) | ||||
| 投资活动产生的现金流量 | ||||||||
| 购置固定资产及设备 | ( | ) | ||||||
| 投资活动中使用的净现金 | ( | ) | ||||||
| 来自融资的现金流量 活动： | ||||||||
| 与反向资本重组有关的现金获得 | ||||||||
| 发行A系列优先股所获得的收益 | ||||||||
| 发行C系列优先股所获得的收益 | ||||||||
| 非可退款的预付收益 用于预期的A-1系列优先股发行 | ||||||||
| 贷款协议所获得的收益 | ||||||||
| 延迟交易成本的支付 | ( | ) | ||||||
| 发行可转换本票所获得的收益 | ||||||||
| 融资活动流入净额 | ||||||||
| 现金流量净增加（减少） | ( | ) | ||||||
| 现金 – 期间开始 | ||||||||
| 现金 – 期间结束 | $ | $ | ||||||
| 补充披露 非现金投资及融资活动： | ||||||||
| 去-SPAC交易费用 包含在应计费用及其他负债中 | ||||||||
| 可转换票据转换为普通股 与合并有关 | ||||||||
| 回购B系列 特别股 | ||||||||
| 发行普通股 用于反向资本重组的净负债，扣除交易成本 | ( | ) | ||||||
参见 附注以了解未经审核的综合基本报表。
| 4 |
TEVOGEN生物控股公司
附注 至未经审核的合并基本报表
注意 1. 业务性质
Tevogen生物控股有限公司，一家特拉华州企业（以下简称“公司”），是一家临床专业免疫治疗公司，利用CD8+细胞毒性T淋巴球的潜力开发离架、精准的T细胞治疗产品，用于治疗传染性疾病和癌症。公司的精准T细胞技术ExacTcell是一套过程和方法论，用于开发、丰富和扩展单一人类白细胞抗原受限的CTL疗法，并选择性地确定目标。公司已完成了ExacTcell的首个临床产品TVGN 489的Phase 1概念验证试验，用于治疗行动力强、高风险的成年COVID-19患者，并且在其产品管线中还有其他候选产品。
于2024年2月14日（「结束日期」），根据于2023年6月28日签署的合并协议和计划（「合并协议」），Semper Paratus Acquisition Corporation（「Semper Paratus」）、Semper Merger Sub, Inc. （Semper Paratus的全资子公司）SSVk Associates, LLC（「赞助商」） Tevogen Bio Inc（现称Tevogen Bio Inc.）（「Tevogen Bio」）及以卖方代表身份的Ryan Saadi 博士，Merger Sub 合并并纳入Tevogen Bio，使Tevogen Bio成为生存公司，并成为该公司的全资子公司（「合并」，以及根据合并协议规定的其他交易一同进行的「业务组合」），并将Semper Paratus更名为Tevogen Bio Holdings Inc。
在业务合并（“完成”）结束之际，Tevogen Bio的所有普通股被按照约等比率转换为公司的普通股。 每股Tevogen Bio普通股可换取股公司普通股股份（“交换比率”）。有关业务合并的更多信息请参见附注4。
如第4号附注所述，此次合并被视为一项反向资本重组，根据此，合并前公司的历史基本报表为Tevogen Bio的基本报表。所有与Tevogen Bio在成交前的普通股相关的信息，以及在合并的基本报表及其附注中呈现的内容，已经追溯调整以反映交易所比例。
在合并后，Tevogen Bio的前股权持有者和可转换票据持有者持有
注意 2。 发展阶段风险与流动性
自成立以来，该公司一直出现亏损和负的营运现金流。该公司预计在能从目前开发中的产品候选项中产生显著销售之前，将继续出现额外的亏损。管理层认为，截至2024年9月30日，以及在2024年6月签订的贷款协议（如第7条所定义），使该公司能够进行400万美元的分期贷款，每月分期160000美元，总计1600万美元，将使该公司在未经审计的合并财务报表发布之后的至少下一年中营运获得足够的现金和财务资源。该公司不打算在获得额外资金之前启动临床试验。
管理层 定期评估不同的策略，以获得运营的资金，用于后续期间。这些策略可能包括但不限于私募发行证券、许可及/或行销安排、与其他药品或生物技术公司的合作伙伴关系，以及公开发售证券。公司可能无法以可接受的条件获得融资，且公司可能无法以有利的条件进入战略联盟或其他安排。任何融资的条件可能对公司的股东的持股或权利产生不利影响。如果公司无法获得足够的资金，公司可能需要延迟、减少或取消研究和开发计划、产品组合扩展或未来的商业化努力，这可能会对其业务前景造成不利影响。
自成立以来，公司的运营主要包括组织公司、筹集资金、开发授权技术、进行研究、执行临床前研究和临床试验，以及追求并完成业务合并。该公司面临与任何专业生物技术公司相关的风险，这些公司需要大量开支进行研究和开发。 公司的研究和开发项目可能不会成功，开发的产品可能无法获得必要的监管批准，而且任何获得批准的产品可能无法具备商业可行性。此外，该公司在快速技术变革的环境中运营，并在很大程度上依赖其员工和顾问的服务。
| 5 |
Tevogen Bio Holdings Inc.
附注 至未经审核的合并基本报表
备注 3。 重要会计政策摘要
可在公司于2024年4月29日提交给证券交易委员会的8-K/A表格中的附件99.1中找到的年度基本报表中包含的重大会计政策摘要，未有实质变动，除下列情况外：
报表说明基础
公司的附注未经审核的综合财务报表系按照美国公认会计原则（“GAAP”）呈现，适用于中期财务资讯，并根据美国证券交易委员会的规则和法规展示。在这些附注中，对适用准则的提及是指GAAP，即会计准则法典(“ASC”) 和财务会计准则委员会(“FASB”) 的会计准则更新(“ASU”)。管理层认为，附注的未经审核的综合财务报表包括所有调整事项，主要由常规性重复性的事项（主要包括应计项目、估计和对综合财务报表有影响的假设）组成，这些调整对于公平呈现所述期间的财务状况、营运结果和现金流量是必要的。附注的未经审核的综合财务报表应与Tevogen Bio的财务报表及管理层关于财务状况和营业结果的讨论一并阅读，该讨论作为提交的8-k表格附件99.1和99.2。所呈现的期间内的中期结果未必代表截至2024年12月31日结束之年度的预期结果，或任何未来中期期间的结果。
使用估计值
在遵循GAAP准则准备未经审核的合并基本报表时，管理层需要进行影响资产和负债报告金额、条件性资产和负债披露以及费用报告金额的估计和假设。实际结果可能与这些估计不同。估计和假设定期审核，并且对修订的影响会在确定有必要时反映在未经审核的合并基本报表中。
重要的 需要管理层估算的领域包括合并前普通股和可转换票据的公允价值、系列A优先股、系列B优先股和系列C优先股的公允价值、根据贷款协议的购买期权的公允价值、以股本为基础的补偿假设、财产和设备的预估使用寿命以及应计的研究和开发费用。
自由挂牌 和嵌入式普通股购买期权
与公司债务协议相关的股权连动购买期权根据ASC 815进行评估，以判断它们是否为独立存在或与母体工具内嵌。 企业在自有股本中的衍生品和避险合同(“ASC 815”)。每种类型的购买期权在ASC 815下进行股权或负债分类的评估。 公司的内嵌和独立存在的购买期权被判定为负债分类的衍生工具，并在发行日和每个后续资产负债表日进行公平价值衡量，公允价值变动记录在综合损益表和综合现金流量表中的‘撰写看涨期权衍生负债的公平价值变动’中。
信用风险的集中
财务 工具可能使公司面临显著的信贷风险集中，主要包括现金。公司在联邦保险的金融机构中持有超过联邦保险限额的存款。公司在这些账户中未经历过任何损失，并相信其现金不面临显著风险。
分部报告
营运
分 Segment定义为一个实体的元件，该元件的具体财务资讯是可得的，并且经常由其首席营运决策者或决策小组进行审查。公司以其业务进行运营和管理
| 6 |
Tevogen 生物控股有限公司。
附注 至未经审核的合并基本报表
认股权证
由于合并的结果，公司按照ASC 815和ASC 480的规定，对最初作为Semper Paratus首次公开募股（“IPO”）一部分出售的warrants进行会计处理， 区分负债和权益 （“ASC 480”）。此评估考虑warrants是否为独立的金融工具，并根据ASC 480的定义满足负债的条件，以及是否符合ASC 815下的所有股权分类条件，包括warrants是否以公司的普通股为指数，还有其他条件。这项评估需要专业判断，并在warrant发行的时候及之后每个季度结算日进行，当warrants仍然有效时。对于符合所有股权分类条件的已发行或修改的warrants，必须在发行时作为额外已付资本的组成部分进行记录。对于不符合所有股权分类条件的已发行或修改的warrants，必须在发行日以其初始公允价值进行记录，并在随后的每个资产负债表日保持至结算。warrants的公允价值变动将作为非现金损失在综合收益表中确认。在这些标准下，公司在IPO时出售的定向增发warrants不符合股权分类的标准，必须记录为负债，而在IPO相关的公共warrants则符合股权分类标准，必须记录为股权。
公平 值量测
根据GAAP，某些资产和负债是按公允值列报。公允值定义为在计量日期当中，在资产或负债的主要或最有利市场进行有秩序交易的市场参与者可能接收的价格（资产）或支付的价格（负债，离市价）。公司使用的评估技术最大限度地利用可观测的输入，尽可能减少不可观测的输入。在公允值衡量时考虑市场参与者假设时，以下公允值阶层区分可观测和不可观测输入，这些输入分类为以下水平之一:
| 等级 1 | 未调整的 在活跃市场中对相同资产或负债的报价。 |
| 等级 2 | 可观察的 除了第1级价格之外的输入，例如在活跃市场中对类似但不相同的资产或负债的报价； 在不活跃市场中对相同或类似的资产或负债的报价；或者其他可以观察的输入 或者可以由可观察的市场数据进行证明的输入； |
| 等级 3 | 不可观察的 输入中几乎没有或没有市场数据可用，并且需要公司自行开发市场参与者在为资产或负债定价时将使用的假设。 |
财务 在资产负债表上以历史金额确认的金融工具包括应付帐款和应付票据。公司相信，由于这些工具的短期性质，应付帐款和应付票据的账面价值大致接近其公平价值。
公司的重复公允价值测量包括合并前的可转换本票，该公司选择了公允价值选项以减少会计复杂性，以及合并后的私人warrants。这些公允价值测量属于第3级输入。以下表格提供了公司可转换本票的总体公允价值的滚动变化。
| 2024年1月1日的余额 | $ | |||
| 应计利息费用 | ||||
| 公平价值变动 | ( | ) | ||
| 因转换可转换票据而撤销确认 | ( | ) | ||
| 2024年9月30日结余 | $ | |||
| 2023年1月1日结余 | $ | |||
| 发行时的初始公允价值 | ||||
| 应计利息费用 | ||||
| 公允价值变动 | ||||
| 截至2023年9月30日的余额 | $ |
公司使用概率加权预期回报法来判断可转换本票在合并前的公允价值。用于判断可转换本票在合并前公允价值的重要假设和范围包括波动率 (
截至2024年和2023年9月30日结束的九个月期间，各层级之间没有转移。
| 7 |
特沃根 生物控股有限公司
附注 至未经审核的合并基本报表
收盘后，公司取得了私人认股权证，其公允价值下降了$
衍生品 认股权证 负债 | 已写入的 看涨期权 衍生金融工具 负债 | |||||||
| 2024年2月15日余额 | $ | $ | ||||||
| 发行时的初始公允 价值 | ||||||||
| 公允价值变动 | ( | ) | ( | ) | ||||
| 2024年9月30日结余 | $ | $ | ||||||
以下表格显示了截至2024年9月30日，该公司以重复性基准衡量的资产和负债的信息，并且指出了公司用来判断此等公平价值的评估输入的公平价值层级。
| 级别 | 引用的
价格于 活跃市场 (一级) | 重大
其他 可观察的输入 (二级) | 重大
其他 不可观察 (第三层级)观察价格输入栏 | |||||||||||
| 负债： | ||||||||||||||
| 衍生权证负债 | 3 | $ | $ | $ | | |||||||||
| 已发出看涨期权衍生负债 | 3 | $ | $ | $ | ||||||||||
该公司的非经常性公允价值测量包括A系列优先股。该等公允价值测量属于第3级输入。
公司使用蒙特卡罗模拟（“MCS”）来确定A系列优先股的公允价值。MCS中用于估算A系列优先股公允价值的关键输入包括波动率的区间，介于
公司使用了一种MCS评估方法来确定独立的$的公平价值。
公司通过将净亏损除以期内加权平均流通普通股数来计算基本每股净亏损。公司确定每股流通的优先股和限制性普通股将参与可分配给普通股股东的收益，但不会参与亏损。公司通过将净亏损除以期内加权平均普通股数量的总和，并加上任何潜在的稀释效果，来计算稀释每股净亏损。
最近 发布的会计标准
于2020年8月，FASB发布了ASU No. 2020-06，《Debt - 债务转换和其他期权（Subtopic 470-20）及Derivatives and Hedging - 实体自家资本中的合同（Subtopic 815-40）：关于可转换工具和实体自家资本中的合同之会计》（“ASU 2020-06”），该准则通过减少可转换工具的会计模型数量，简化可转换工具的会计处理。ASU 2020-06也取消了计算可转换工具稀释每股盈利的库藏股票法，并要求使用已转换法。公司于2024年1月1日生效采用了ASU 2020-06，且该采用对其合并财务报表和相关披露没有产生影响。 （2020-06）》用于简化可转换工具的会计处理，减少可转换债务工具可选用的会计模型数量。ASU 2020-06也取消了利用库藏股票法计算可转换工具稀释每股盈利，并要求使用已转换方法。自2024年1月1日起，公司采用了ASU 2020-06，该准则的采用对其合并财务报表和相关披露没有产生影响。 （“ASU 2020-06”）简化了可转换工具的会计处理，通过减少可转换债务工具可选的会计模型数量。ASU 2020-06也取消了用库藏股票法计算可转换工具稀释每股盈利，并要求使用转换后法。截至2024年1月1日，公司适用了ASU 2020-06，该采用对其合并基本报表和相关披露没有影响。
| 8 |
Tevogen 生物控股有限公司。
附注 至未经审核的合并基本报表
在 2023年11月，FASB 发布了 ASU 第2023-07号， 分部报告（主题280）：改善可报告分部披露 （“ASU 2023-07”）。ASU 2023-07通过要求披露重要部门支出、首席营运决策者资讯和具有单一可报告部门的实体所需的披露等方式增强了可报告部门披露。此外，修订增加了中期披露要求，澄清了实体可以在何种情况下披露多个部门损益指标，并包含其他披露要求。ASU 2023-07将于2023年12月15日后开始的财政年度起生效，并适用于2024年12月15日后开始的财政年度内的中期期间。公司预计采用ASU 2023-07对其合并财务报表和相关披露不会产生实质影响。
注意 4. 业务合并
在结案日，公司完成了第1条所描述的业务组合。由于Tevogen Bio被视为根据Merger条款和其他因素，包括Merger后，Tevogen Bio的前股东和持有可转换应收票据约占公司的％（i），董事构成公司董事会的多数（七人中的六人）（ii），以及管理阶层拥有公司所有关键管理职位（iii）的会计并表，Merger被视为根据GAAP进行的逆向资本重组。因此，Merger被视为Tevogen Bio发行股票以收购Semper Paratus的净资产的等同行为。由于Merger，Semper Paratus的净负债按其收购当日的公允价值记录在合并财务报表中，Merger之前报告的营运结果为Tevogen Bio的营运结果。经过Merger后，公司的普通股总共有
下表显示了并购中获得的净负债：
| 二月
14， 2024 | ||||
| 现金 | $ | |||
| 账户应收赞助商款项 | ||||
| 预付费用及其他资产 | ||||
| 应付账款 | ( | ) | ||
| 应计费用 | ( | ) | ||
| 应付款项 | ( | ) | ||
| 衍生权证负债 | ( | ) | ||
| 总净负债取得 | ( | ) | ||
| 加：合并交易 成本限于现金取得 | ( | ) | ||
| 总净负债 取得加上交易成本 | $ | ( | ) | |
总交易成本为$
Tevogen Bio普通股的前持有人和赞助商有资格合计最多收取一定数量的股票 如果公司普通股的成交量加权平均价（"VWAP"）在收盘日期起算的三年期间达到指定阈值水平，则将获得普通股股份（"Earnout Shares"）。详情请参阅备注5，Earnout Shares，有关earnout安排的更多细节。
就并购而言，公司发行B系列优先股给赞助方，以换取赞助方承担的$
在收购完成之后，Tevogen Bio的前持有人最多可获得 分享。 在每个 级的交易中，可能会以每 级发行利润股。 , ， 以及（除了被视为已提供且未提交的部分之外的部分）；和 每 级分别以公司普通股的成交价格高于或等于$ 发行。, $，和 $分别在收购完成后的三年期间的 任何十五个交易日内，当公司的普通股每股成交价高于或等于美元时，可以发行第一、第二和第三级股票。
赞助商获得以上条款相同的赢利股份权利，不过赞助商的三个赢利分配阶段各自为 股普通股，总计 股普通股在整个赞助商赢利中。赢利股份对于Tevogen Bio普通股的持有人来说是一种股息，而赞助商可赚取的赢利股份在反向资本重组中被视为有条件对价。根据ASC 815，赢利股份被认为是与公司的普通股相关的，并被归类为永久权益。
| 9 |
Tevogen 生物控股有限公司。
附注 至未经审核的合并基本报表
注意 6。 应计费用及其他负债
应计费用及其他负债包括以下内容:
| 九月 30, | 十二月， 31 | |||||||
| 2024 | 2023 | |||||||
| 专业服务 | $ | $ | ||||||
| 其他 | ||||||||
| 总计 | $ | $ | ||||||
备注 7。 债务
贷款协议
在2024年6月，本公司与The Patel Family, LLP（「贷方」）签订了一份贷款协议（「贷款协议」），
该贷方是本公司的关联方，提供了一项无担保的信用额度（「贷款额度」），以用于最高初始总额的定期贷款$
该
贷款协议包括一项购买选择权，贷方有权选择购买高达$ 的普通股股份，购买价格等于 %的滚动VWAP每股（"$ 百万购买选择权"）。该$ 百万购买选择权在滚动VWAP达到$ 百万或$
该 贷款协议还包括一项购买选择权（“额外金额购买选择权”），其内容与$ 百万 购买选择权相同，不过该选择权可行使的金额上限为当时贷款协议下尚未提取的定期贷款金额，当时的滞后VWAP达到$ 每股。额外金额购买选择权被认定为书面贷款承诺中的一种嵌入衍生工具，根据ASC 815需要进行拆分，因此其以公允价值计量，公允价值的变动记录在合并业绩报表和合并现金流量表中的书面看涨选择权衍生负债的公允价值变动中。
这一授权费用被记入递延营业收入，并在合同履行义务期限内确认，公司认为在合同缔结后12个月。
贷款协议是一份书面贷款承诺，不符合ASC 825下的公允价值选择， 金融工具然而，管理层打算选择在此承诺下的公允价值选择，并因此已将与贷款协议相关的所有发行成本记入费用，这些成本包括 发给贷方的普通股股份的公允价值，以及发行日公允价值的$
应付票据
因合并的关系，公司承担了由Polar Multi-Strategy Master Fund（「Polar」）持有的应付票据，该票据的收益将用于Semper Paratus的营运资金，未偿还余额为$
| 10 |
Tevogen 生物控股有限公司。
附注 至未经审核的合并基本报表
有关本次交易，公司采纳了Tevogen Bio Holdings Inc. 2024全权激励计划（“2024计划”），并不再根据2020股权激励计划（“2020计划”）发放奖励。根据2020计划授予但截至交易日期时尚未实现的每一个限制性股票单位（“RSU”）奖励均自动取消并转换为2024计划下的一项奖励，涉及该公司的普通股（“转入RSU”）。此类转入RSU仍受到在交易之前适用的奖励协议中所列条款和条件的约束。
除了涵盖延续受限股单位（Rollover RSUs）外，根据2024计划，公司被授权授予总计奖励至 普通股的股份。2024计划规定授予期权、股票增值权、受限股票、受限股票单位及其他基于股权的奖励。截至2024年9月30日，尚有奖励数量可供根据2024计划授予。 股份仍可根据2024计划授予。
公司已发行受限公司股股份，受制于服务层面的控制项或服务层面和绩效层面的控制项。服务层面的受限公司股的补偿费用将根据奖励的控制期间以直线方式认列。服务层面和绩效层面的受限公司股（「绩效型受限公司股」）的补偿费用将在绩效控制项达成的条件，基于满足流动性事件条件，被认为有可能实现时认列。
在 交割日，该公司发行了总计的 根据2024计划向公司的首席执行官 瑞安·萨迪博士（“特别RSU奖励”）发放的RSU。这些RSU立即转换为受限普通股（“受限 股票”），其限制在2031年2月14日开始的四个相等的年度分期中解除（“归属期”）。 根据特别RSU奖励的条款，萨迪博士将有权对受限股票进行投票，但这些股票不得被出售、 转让、转移、质押、抵押或以其他方式设置负担，这可能会导致丧失。若萨迪博士离开公司，所有未归属的 受限股票将自动被没收。特别RSU奖励的每股公允价值被定为$ 每 股，相当于该公司在交割日的股价，导致总授予日公允价值为$。 根据ASC 718， 薪酬 - 股票补偿 （“ASC 718”）该公司将从交割日起直线认列薪酬费用，直至归属期结束。
限制性股票 股票和RSU的活动如下：
| 服务型 限制性股票和RSUs | 绩效型 RSUs | |||||||||||||||
| 股份 | 加权 平均 授予日期 公允 价值 | 股份 | 加权 平均 授予日期 公允价值 | |||||||||||||
| 截至2024年1月1日尚未归属 | $ | $ | | |||||||||||||
| 已授予 | ||||||||||||||||
| 已归属 | ( | ) | ( | ) | ||||||||||||
| 放弃 | ||||||||||||||||
| 2024年9月30日为止不存在未发放的股份。 | $ | $ | ||||||||||||||
由于合并，流动性事件届满，因此已完成控制项报酬成本共计$截至2024年9月30日三个月以来为$，截至2024年9月30日九个月为$，已被识别为基于绩效的受限制股票单位，其中分股票在2024年9月30日当日已发行和流通，另外 分股票将于2024年9月30日后发行。截至2024年9月30日基于服务的受限制股票和受限制股票单位尚未识别的报酬成本共计$
| 11 |
Tevogen 生物控股有限公司。
附注 至未经审核的合并基本报表
| 三个月 截至 | 九个月 结束 | |||||||
九月 30, 2024 | 九月 30, 2024 | |||||||
| 研发 | $ | $ | ||||||
| 一般及行政费用 | ||||||||
| 总计 | $ | $ | ||||||
截至2023年9月30日的九个月内，确认了以股票为基础的薪酬费用。
备注 9. 股东资本赤字
普通 股票
截至2024年2月15日，公司的普通股和warrants开始在纳斯达克证券交易所进行交易，代码分别为「TVGN」和「TVGNW」。
截至2024年9月30日，该公司拥有 普通股发行并流通中。就每股盈利相关的会计目的而言，只有完全授予或不受回购限制的股份被视为发行并流通中。
以下是已发行和持有的普通股份对账：
| 九月 30, | ||||
| 2024 | ||||
| 普通股份的总发行量及流通量 | ||||
| 再加：待发行股份： | ||||
| 尚未合法兑现为普通股的已授予 RSUs（限制性股票单位）（a） | ||||
| 减去：未来将会合法兑现的股份： | ||||
| 颁发受限制的普通股并受到没收的规定（b） | ( | ) | ||
| 已发行并流通的总股份 | ||||
| (a) | ||
| (b) |
合并之前，Tevogen Bio拥有投票和非投票普通股。合并完成后，Tevogen Bio的普通股股东将根据交易比率分配一定数量的公司普通股，详见附注1。
优先股
公司授权发行最多的是 每股股票价格为 。
A类优先股;
在
2024年3月，公司授权并发行了 和 股的A系列优先股（“系列A”）
以每股$ 作为原始发行价格（“系列A原始发行价格”），总收益为$
分红派息
系列A的持有人有权按固定利率每日累积获得分红派息，
| 12 |
Tevogen生物控股公司。
非经审计的合并财务报表附注
清算
系列A在清算优先权上优于普通股和系列C优先股。如果公司发生清算， 或某些被视为清算事件，系列A可以按价格赎回，价格等于系列A原始发行价加上所有截至赎回日期未支付的系列A累积分红派息，或在发生清算或被视为清算事件之前，如果系列A转换为普通股应支付的金额。
投票
A轮投资没有任何投票权。
赎回
A系列股东不享有在公司清算或视为清算事件发生之外赎回其股份的权利。公司有权以等于A系列原始发行价加上任何累积未付的A系列应计分红派息的价格赎回该A系列，如果公司普通股的成交量加权平均价超过$ per share for
转换
系列A的持有人可以选择将系列A转换为普通股，转换比例等于系列A原始发行价格除以系列A转换价格，初始为$ 每股，并且该价格会受到标准反稀释调整的影响。
A-1系列优先股
在2024年3月27日，公司与A轮投资者签署了一份经修订和重订的证券购买协议，涵盖了发行 股A-1优先股，总购买价格为$
Series B优先股
就交易结束而言，公司与赞助商达成协议，发行b系列股份，以换取赞助商承担Semper Paratus和Tevogen Bio的某些债务和义务。2024年3月， 发行b系列股份，以换取承担的担保债务。b系列股份的发行日期公允价值确定为$
2024年6月15日，公司与赞助商签订了优先股回购协议，根据该协议，公司回购了所有未偿系列b股，并释放赞助商免除与承担债务相关的义务，但没有现金作为补偿。回购被记录为关联方出资，并记录为股本溢价。截至2024年6月30日，有股系列b未偿。 在2024年8月9日时，尚有股系列b待清算，在同日公司提交了一份淘汰证明书以清除系列b。尽管公司尚未被债权人合法解除，但公司已向承担债务支付，并截至2024年9月30日，公司资产负债表上尚有约万美元。
Series C优先股
在
2024年8月21日，公司与一位投资者签署了一项证券购买协议（“C系列协议”），根据该协议，投资者购买了 股份的C系列优先股（“C系列”）以每股的价格（“C系列原始发行价格”），总收入为
系列C包含一个看涨权利，允许公司在发行日期的第五个周年之后的任何时间召回股票。公司还同意，只要系列C仍在流通，未经持有50.1%系列C股东的书面同意，公司将不修改、变更或废除公司章程或章程细则中对系列C不利的任何条款。根据ASC 480和ASC 815中的会计指导，考虑到系列C未注册且没有强制赎回特征，系列C在2024年9月30日按发行面值分类为权益。
| 13 |
蒂伏根生物控股有限公司
非经审计的合并财务报表附注
分红派息
该
C系列具有年利率为
清算
系列C在清算优先权中低于系列A和系列A-1优先股，高于普通股。在公司清算或某些视为清算事件的情况下，系列C可以按其原始发行价加上在赎回日期未支付的所有系列C累计分红的金额进行赎回，或按系列C在清算或视为清算事件发生前立即转换为普通股时应支付的资产金额进行赎回。
投票
系列C没有任何投票权。
赎回
系列C的持有者无权在公司的清算之外或者发生被视为清算事件时赎回其股份。公司有权以系列C的原始发行价格加上任何未支付的系列C累积分红派息的价格赎回该系列C，具体取决于下面描述的转换权。
转换
系列C的股份将根据持有者的选择，在发行日期六个月后可转换为普通股股份，转换价格等于在行使持有者转换选项之前30个交易日普通股的成交量加权平均价格，最低价格为$.
认购权证
在结束时，
公共认股权证
该
公开认购权证的行使价格为$
定向增发认购权证
每一份定向增发权证与公开认购权证相同，唯一区别在于定向增发权证只要由首发购买者或其允许的受让人持有，(i) 将不受公司的赎回限制，(ii) 可以由持有人以无现金方式行使。截至2024年9月30日，
请参阅 注释3以获取有关公司的认购权证券会计政策的更多信息。
| 14 |
Tevogen Bio控股公司。
非经审计的合并财务报表附注
注10 关联交易
赞助商交易
根据合并协议，公司产生了$
截至2024年9月30日，赞助方欠公司$
请参见第9条，获取有关向赞助商发行的B系列的更多信息。
股份支付
在
2023年1月，公司发行了 基于业绩的限制性股票单位(RSU)授予公司董事长和首席执行官的妻子，以
作为对公司提供顾问服务的补偿，并 基于业绩的限制性股票单位(RSU)授予Mehtaphoric Consulting Inc，这是一家由公司首席财务官的女儿控制的公司，作为对公司提供信息技术服务的补偿。在与
交易相关的情况下，业绩控件达成，因此补偿成本为$
贷款协议
请参见
第7条以获取关于贷款协议的更多信息，该协议提供了一个无担保的定期贷款信用额度，初始金额高达$
| 15 |
Tevogen 生物控股公司。
非经审计的合并财务报表附注
公司通过在期间内普通股的加权平均数除以净损失来计算基本每股净损失。公司通过在期间内普通股的加权平均数加上可能的稀释效应，计算每股稀释净损失，如果有的话，还包括未获授予的普通股和可转换的可赎回票据按转换基础计算的项目。鉴于公司的净损失，未获授予的普通股和可转换的可赎回票据对基本和稀释每股净损失的影响是抵消的，截至2024年和2023年9月30日三个和九个月的基本和稀释每股净损失是相同的。
公司在计算每股摊薄净亏损时排除了以下潜在股份，因为将它们包含在内会产生反稀释效果：
| 九月 30日, | ||||||||
| 2024 | 2023 | |||||||
| 优秀的限制性股票单位 (a) | ||||||||
| 受限股 | ||||||||
| 公开股权证 | ||||||||
| 私人认股证 | ||||||||
| 可转换的应付票据 (b) | ||||||||
| 业绩股数 | ||||||||
| 总计 | ||||||||
| (a) | |
| (b) |
上述表格排除了由于$百万购买选项和额外金额购买选项（见注释7）可能产生的任何反稀释股份。这些被排除是因为可发行股份的数量无法确定，直到满足发行条件并在行权时知道股价。
备注12。后续事件
公司已评估截至2024年11月19日这些基本报表发布日之后可能需要确认或披露的后续事项和交易，并未发现除下文所示之外需要披露的任何额外项目。
Series C优先股
在
2024年10月25日，公司收到$
| 16 |
项目2。分销计划
在本季度报告表格10-Q（以下称“报告”）中，“我们”、“我们的”、“我们”、“Tevogen”、“公司”以及类似的术语指的是Tevogen Bio Holdings Inc.及其子公司，除非上下文另有说明。所有季度信息均未经审计。本管理层讨论与分析中对我们经营成果及流动性和资本资源的讨论与分析应与我们声称的未经审计的合并财务报表及本报告其余部分相关的附注共同阅读，以及审计的财务信息和相关附注，以及包含在我们截至2023年12月31日的年度报告表格10-K（以下称“年度报告”）中的财务状况和经营成果的管理层讨论与分析及其他披露信息，并附录99.1和99.2列在我们于2024年4月29日发布的当前报告表格8-K/A（以下称“表格8-K”）中。
前瞻性声明
本 报告包含旨在受1934年证券交易法第21E条中有关前瞻性声明的安全港条款保护的前瞻性声明。我们可能会使用诸如“相信”、“预期”、“计划”、“期望”、“估计”、“打算”、“应该”、“会”、“能够”、“潜在”、“将”或“可能”等词语，或其他传达未来事件、条件、情况或结果的词语或表达来识别这些前瞻性声明。本报告中的前瞻性声明包括但不限于关于：
| ● | 我们产品候选药物在治疗传染病和癌症方面的发展、潜在的好处以及患者的获取，包括用于治疗COVID-19和长期COVID的TVGN 489； | |
| ● | 我们开发其他产品候选药物的能力，包括通过使用我们的ExacTcellTM 科技； | |
| ● | ExacTcell的预期好处； | |
| ● | 我们 对未来临床试验的预期； | |
| ● | 我们的 制造业-半导体计划； | |
| ● | 我们 未来产生营业收入的能力； | |
| ● | 我们 管理、发展和多元化我们的业务以及执行我们的业务主动和策略的能力； | |
| ● | 对医疗和生物制药行业的预期; | |
| ● | 我们证券的潜在流动性和交易; | |
| ● | 我们公司的未来业务、运营和财务表现。 |
前瞻性声明基于我们对未来业绩的信念、假设和期望，考虑到我们目前掌握的信息，并不代表未来结果的保证。许多重要因素可能导致实际结果与这些前瞻性声明所预期的结果大不相同，包括但不限于与以下风险和不确定性相关的因素：
| ● | 最近Semper Paratus Acquisition公司（现更名为Tevogen Bio Holdings Inc.）和Tevogen Bio Inc（现更名为Tevogen Bio Inc.）的业务合并（如下所定义）对我们的业务关系、运营结果和业务普遍产生的影响； | |
| ● | 可能针对我们与业务合并相关的任何法律诉讼的结果； | |
| ● | 我们竞争的市场发生的变化，包括其竞争格局、科技演进或监管变化； | |
| ● | 国内和全球一般经济状况的变化； | |
| ● | 我们执行增长战略或管理增长和扩大业务的能力; |
| 17 |
| ● | 欧元千，除百分比外 | |
| ● | 与业务组合相关的成本 ，以及我们实现业务组合预期收益的能力； | |
| ● | 我们 可能无法实现商业化和发展计划，并确定并实现 其他机遇，这可能受到影响，包括竞争和我们 实现经济增长并雇佣和留住关键员工的能力； | |
| ● | 与我们开发、许可或获取新疗法的风险 相关； | |
| ● | 我们筹集资金的能力可能并非按可接受的条件提供，无法完全执行我们的业务计划并及时履行义务； | |
| ● | 涉及我们业务的监管诉讼或诉讼风险； | |
| ● | 执行、成本和完成临床前研究和临床试验中固有的不确定性； | |
| ● | 与监管审查和批准以及商业发展相关的风险； | |
| ● | 与知识产权保护相关的风险; | |
| ● | 我们有限的营业历史; | |
| ● | 我们能够继续符合纳斯达克证券交易所（“纳斯达克”）的持续上市要求; 和 | |
| ● | 我们未能及时向美国证券交易委员会（“SEC”）提交某些定期报告，并未来能否及时提交这些报告。 |
前瞻性 声明应考虑这些因素以及本报告中其他地方描述的因素，包括在“风险 因素”部分，在我们的年度报告的“风险因素”部分，以及在我们与SEC的各种文件中。重要的是，您应阅读这些因素以及在本报告中所做的其他警示性声明，认为它们适用于本报告中出现的所有相关前瞻性 声明。如果其中任何因素发生，或者任何基本假设证明不正确，我们的实际结果、表现或成就可能与任何未来结果、表现或成就有重大差异，这些都由这些前瞻性声明表达或暗示。考虑前瞻性声明时，您还应阅读我们年度报告中对我们业务的更详细描述。我们提醒读者不应对本报告中的任何前瞻性声明过度依赖，因为这些声明仅在本报告的日期有效。除非法律要求，否则我们不承担公开更新任何前瞻性声明的义务。
概览
我们是一家临床阶段的专业免疫疗法公司，利用自然界中最强大的免疫武器之一——CD8+细胞毒性T淋巴细胞（“CD8+ CTLs”），开发现成的、精准的T细胞治疗药物，以治疗传染病和癌症，旨在满足广大患者群体的重大未满足需求。我们相信，在即将到来的医学时代，持续性和商业成功将依赖于通过先进的科学、创新的商业模式以及在开发生命周期和医疗系统中的参与，确保患者的可达性。我们认为，T细胞疗法的全部潜力仍然大部分未被开发，期待成为第一家提供在商业上具有吸引力、经济上可行且具有成本效益的个性化T细胞疗法的生物技术公司。
我们 相信我们的同种异体精准T细胞技术ExacTcell是有资格参加FORTITUDE-OLE代表了一项重大的科学突破，具有将细胞疗法主流化的潜力，采用新类别的即用型、制造和存储的T细胞疗法，能够广泛应用于病毒学、肿瘤学和神经学。ExacTcell是一套开发、富集和扩展单个人类白细胞抗原（“HLA”）限制的CTL疗法的流程和方法，采用主动选择、精确定义的靶点。 HLA分子是对免疫系统识别“自我”和“外部”非常重要的蛋白质。HLA类型因人而异。CD8+ CTL，即杀伤性T细胞，是白血球的一种，属于免疫系统的一部分，能够摧毁感染、恶性或受损细胞。我们专注于使用ExacTcell开发同种异体治疗，意味着这些治疗是计划输注给非原始供体的患者。
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ExacTcell 疗法基于仔细选择的、自然存在的CTL，能够识别来自身体的天然T细胞受体池中的靶点，不同于基因工程的T细胞疗法。ExacTcell-based产品中的CD8+ CTL针对多个独特的抗原，旨在规避病毒和癌细胞中的突变对现有治疗效果的影响。 ExacTcell旨在最大化我们产品的免疫特异性，以便消灭恶性和病毒感染的细胞，同时让健康细胞保持完整。我们相信这种高特异性有潜力显著降低交叉反应或对健康细胞的不良影响的风险。我们对ExacTcell的信心在于我们的研发管线，这些管线经过精心调整以解决大量面临生命威胁的病毒疾病、病毒和非病毒引发的癌症以及多发性硬化症等神经障碍患者的未满足需求。通过我们的Tevogen.AI人工智能计划，我们正在探索利用人工智能推动目标检测，以进一步加快我们的产品开发进度，或者与人工智能领域的领先实体合作，例如通过我们最近宣布的加入微软初创企业项目。
The first clinical product of ExacTcell, TVGN 489, is being developed to fill a critical gap in COVID-19 therapeutics for the immunocompromised and the high-risk elderly, with potential applications in both treatment and prevention of chronic lingering symptoms of the disease (“Long COVID”). Viruses, including COVID-19, hijack cellular machinery to transform infected cells into virus production plants. Elimination of infected cells is necessary to allow them to be replaced by healthy, uninfected counterparts. TVGN 489 consists of CTLs active against multiple precise, well defined, and well characterized targets across the SARS-CoV-2 genome. The product progressed from pre-discovery to the clinic in less than 18 months, and in January 2023, we completed the Phase 1 proof-of-concept clinical trial of TVGN 489 for the treatment of ambulatory, high-risk adult COVID-19 patients. No dose-limiting toxicities or significant treatment-related adverse events were observed in the treatment arm. Secondary endpoints showing a rapid reduction of viral load and that infusion of TVGN 489 did not prevent development of the patients’ own t cell-related (cellular) or antibody-related (humoral) anti-COVID-19 immunity were also met. None of the patients who participated in the trial reported progression of infection, reinfection, or the development of Long COVID during the six-month follow-up period. These clinical observations were mirrored by laboratory evidence of the persistence of TVGN 489 cells for at least six months after treatment. The results of the trial were submitted for peer-review and were published in Blood Advances in June 2024. We believe these findings validate our initiative to develop off-the-shelf t cell therapies for outpatient administration, targeting diseases that affect large patient populations – for the very first time. We plan to launch a pivotal trial of TVGN 489 in COVID-19 patients with b cell malignancies, with studies of other highly vulnerable populations thereafter. TVGN 489 is also in pre-clinical development for treatment and prevention of Long COVID, and we have other product candidates in our pipeline for other indications.
我们的商业成功在某种程度上依赖于我们获得和维持专利及其他对我们专有知识产权的保护，以保障已开发的产品和科学方法，保护我们的商业秘密的机密性，确保在不侵犯、窃取或以其他方式违反他人有效、可强制执行的专有权利的情况下运营，并防止他人侵犯、窃取或以其他方式违反我们的专有权利。我们阻止第三方不当制造、使用、销售、提议销售或进口无权进行的产品的能力可能取决于我们在有效且可强制执行的专利或商业秘密下所拥有的权利的范围，这些权利覆盖这些活动。
我们继续构建我们的知识产权组合，并通过申请专利等方式寻求保护我们的专有地位。我们的专利组合包括与我们的产品候选者、使用方法及产品候选者的制备方法相关的专利和专利申请。迄今为止，我们的美国知识产权组合包括三项与治疗COVID-19的TVGN 489相关的美国专利，九项待审的美国专利申请，包括两项与治疗COVID-19相关的专利申请、五项与治疗其他病毒或癌症相关的专利申请，以及两项与人工智能驱动的t细胞靶向识别和受体结合相关的专利申请。我们的组合还包括十一项美国以外的专利申请，包括在澳大利亚、加拿大、欧洲、日本、卡塔尔和阿拉伯联合酋长国的申请，涉及病毒特异性t细胞、治疗和预防病毒感染的方法，以及开发对多种病毒表位的CD3+CD+细胞以治疗病毒感染的方法，预计到期日为2042年7月29日。
在美国，我们的三项已授予的实用专利，所有专利于2040年12月9日到期，分别是：覆盖使用COVID-19肽特异性CTLs治疗COVID-19感染的方法的美国专利号11,191,827；覆盖COVID-19肽特异性CTLs的美国专利号11,207,401；以及覆盖制造COVID-19肽特异性CTLs的方法的美国专利号11,219,684。美国的一项待审实用专利申请，针对病毒特异性t细胞及治疗和预防病毒感染的方法，预计于2041年12月9日到期。此外，我们已向美国专利商标局申请“Tevogen Bio”（及设计）、“ExacTcell”和“Tevogen AI”的注册商标保护。
我们根据个案情况确定专利索赔范围的战略，考虑到法律顾问的建议和我们的商业模式。我们提交包含对我们自有技术及任何产品候选者有益应用保护的索赔的专利申请，包括我们为现有技术和产品候选者发现的新应用或用途，基于对其战略价值的评估。我们持续重新评估专利申请的数量和类型，以及我们的待审和已发专利索赔，以确保针对我们的过程和组合获得最大覆盖和价值，考虑到现有的专利局规则和规定。
由于上述专利是内部开发的，与其开发相关的历史支出均按照美国普遍公认会计原则（“GAAP”）按发生时费用化。我们认为这些专利作为我们产品管道的基础具有重大价值。我们对管道的持续投资突显了我们对这些产品未来商业可行性的信心。
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2024年2月14日（“结束日期”），根据2023年6月28日签订的《合并协议和计划》（“合并协议”），Semper Paratus、Semper Merger子公司、Semper Paratus全资子公司（“合并子公司”）、SSVk Associates, LLC、Tevogen Bio和Ryan Saadi博士（作为卖方代表）之间进行合并，并且合并子公司与Tevogen Bio合并，Tevogen Bio成为存续公司，同时也是Semper Paratus的全资子公司（“合并”，以及合并协议拟定的其他交易，称为“业务组合”），Semper Paratus更名为Tevogen Bio Holdings Inc.（“结束”）。有关通过合并获取的净资产的更多信息，请参阅我们的本季度未经审计的合并财务报表附注4。由于公司被确定为会计收购方，合并按照GAAP标准被视为反向重组。
自2020年6月开始运营以来，我们已经将几乎所有的精力和财力投入到建立公司治理、招募基本人员、建立研发能力（包括获得实验室空间和设备）、进行科学研究、获得与我们的药物候选产品和ExacTcell相关的发明的知识产权、进行药物发现（包括临床前研究和我们TVGN 489的一期临床试验）、筹集资金以及追求业务合并。
截至目前，我们尚未产生任何营业收入。我们截至2024年和2023年9月30日的三个月净亏损分别为590万和390万美金。2024年9月30日的三个月净亏损主要归因于610万的运营亏损。我们截至2024年和2023年9月30日的九个月净亏损分别为430万和5680万美金。2024年9月30日的九个月净亏损主要归因于4420万的运营亏损，主要是由于在某些股票奖励中与流动性事件控件相关的非现金股权补偿费用被确认，该控件在业务组合关闭时得以满足，以及与业务组合相关的750万美金的交易成本，部分被4850万的可转换票据公允价值变化抵消。截至2024年9月30日，我们的现金为230万美金。
2024年2月14日，我们与Patel Family LLP（“Patel Family”）签订了一份证券购买协议，根据该协议，Patel Family购买了我们500股A轮优先股，总购买价为200万美元。2024年3月27日，我们与Patel Family签订了修订后的证券购买协议，根据该协议，我们修改并重订了原协议，Patel Family同意购买我们600股A-1轮优先股，总购买价为600万美元，其中截至2024年11月19日，已收到300万美元。2024年8月21日，我们与Patel Family签订了一份证券购买协议，投资者购买了我们600股C轮优先股，总购买价为600万美元。
如详述于“流动性与资本资源 - 融资需求”下，我们于2024年6月6日与Patel家族签订了贷款协议（“贷款协议”），提供(i) 无担保信用额度（“额度”），根据该额度，Patel家族同意每月借给我们最高初始金额为3600万美元（“最高贷款金额”）的定期贷款，以100万美元的增量，在为期三十六个月的提款期内，以及(ii) Patel家族在未来私募中购买至少1400万美元的我们普通股（面值$0.0001每股）（“普通股”）的附带选项（“可选PIPE”）。贷款协议还包含Patel家族在普通股的十天移动加权平均价格（“移动VWAP”）达到每股10美元时，在未来私募中购买至少1400万美元的普通股加上额度下当时剩余可用金额的附带选项。根据贷款协议的条款，公司还向Patel家族发行了1,000,000股普通股作为承诺费用（“承诺股份”），如Patel家族未能(i) 按时在额度下进行存款或(ii) 在阈值价格通知日期（如贷款协议中定义）后30天内支付可选PIPE的购买价格，则Patel家族需放弃承诺股份或等量的普通股。
根据本报告日期的现金情况，以及2024年10月出售系列C优先股收到的200万美元，和我们的贷款协议，我们得出结论，认为我们有足够的现金为我们的运营提供至少12个月的资金，自发行未经审计的合并财务报表之日起。
我们预计在获得市场批准或其他授权，并成功商业化TVGN 489或其他产品候选之前，不会产生产品收入。我们预计将产生与扩展研发能力、建设制造基础设施（包括通过收购）和开发商业化组织（包括报销、市场营销、受管市场和分销功能，以及培训和部署专业医学科学联络团队）相关的费用。
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近期发展
纳斯达克 最低出价合规
2024年6月14日，我们收到了纳斯达克上市资格部门（“工作人员”）的信函，通知我们 根据我们普通股在过去35个连续交易日的收盘出价，未再满足纳斯达克继续上市的每股1.00美元最低出价要求（“最低出价要求”）。该信函对我们普通股的上市及持有的可公开认购普通股的权利没有立即影响，且我们在收到信函后获得了180个日历天的初步合规期，即截至2024年12月11日，以重新达到最低出价要求。 2024年10月28日，我们接到了工作人员的信函，通知我们已满足最低出价要求。 信函确认，从2024年10月14日至2024年10月25日，我们普通股的收盘出价已达到每股1.00美元或更高，因此我们已重新满足最低出价要求，该事项已结案。
我们经营的业务在一个可报告的业务部门内进行，这与我们的管理层审查业务、做出投资和资源分配决策以及评估业绩的方式一致。
收入
截至目前，我们尚未产生任何收入，且除非我们获得市场营销批准或其他授权，并商业化TVGN 489或其他候选产品，否则我们预计不会从产品销售中产生任何收入。
运营 费用
研究与开发支出
研发费用主要包括我们为研究活动而发生的费用，包括员工、发现努力、临床前研究和TVGN 489的临床开发，以及其他产品候选者的临床前研究，包括：
| ● | 采购 供应和设备以及租赁实验室空间； | |
| ● | 为了进行美国食品和药物管理局要求的必要临床前研究而产生的费用 以获得进行我们TVGN 489临床试验所需的监管批准； | |
| ● | 为从事研发工作的人员支付的薪水、 福利和其他相关费用； | |
| ● | 第三方进行研究的资金成本，包括与合同研究组织（“CROs”）的协议所产生的费用，以及开展我们的前临床研究和临床试验的调查站点成本； | |
| ● | 制造成本，包括与合同制造组织（“CMOs”）下的协议产生的费用，包括制造扩大生产费用，以及获取和制造前临床研究和临床试验材料的成本； | |
| ● | 外部顾问的费用，包括他们的费用、基于股票的补偿和相关的差旅费用； | |
| ● | 实验室供应和为前临床研究和临床试验采购材料的成本； | |
| ● | 与设施相关的 费用，包括设备的直接折旧成本，以及设施的租金、维护和其他运营费用。 |
Research and development activities are central to the biotechnology business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased study sizes, which also leads generally to longer patient enrollment times in later-stage clinical trials. We expect our research and development expenses to increase over the next several years as we increase manufacturing, shipping, and storage of clinical batches required for clinical trials, personnel costs, including stock-based compensation, conduct planned clinical trials for TVGN 489 and other clinical and pre-clinical activities for other product candidates, and prepare regulatory filings for any of our product candidates.
The successful development of our current or future product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing, and costs of the efforts that will be necessary to complete the development of any product candidates. The success of TVGN 489 and our other product candidates will depend on several factors, including the following:
| ● | with respect to products other than TVGN 489, successfully completing pre-clinical studies; | |
| ● | successfully initiating future clinical trials; | |
| ● | successfully enrolling patients in and completing clinical trials; | |
| ● | applying for and receiving marketing approvals from applicable regulatory authorities; |
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| ● | obtaining and maintaining intellectual property protection and regulatory exclusivity for TVGN 489 and any other product candidates we are developing or may develop in the future and enforcing, defending, and protecting these rights; | |
| ● | making arrangements with third-party manufacturers, or establishing adequate commercial manufacturing capabilities; | |
| ● | establishing sales, marketing, and distribution capabilities and launching sales of our products, if and when approved, whether alone or in collaboration with others; | |
| ● | market adoption of TVGN 489 and any other product candidates, if and when approved, by patients and the medical community; | |
| ● | competing effectively with potential therapeutic alternatives in our target disease areas; and | |
| ● | adequate reimbursement by private and public payors including health technology appraisal entities in non-U.S. countries. |
A change in the outcome of any of these variables concerning the development, manufacturing, or commercialization activities of a product candidate could result in a change in the costs and timing associated with the development of that product candidate. For example, if we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive, if there are safety concerns or if we determine that the observed safety or efficacy profile would not be competitive in the marketplace, we could be required to expend significant additional financial resources and time on the completion of clinical development. We anticipate that product commercialization may take several years, and we expect to spend a significant amount in development costs.
General and Administrative Expenses
General and administrative expenses primarily consist of personnel expenses, which include salaries, benefits, and stock-based long term incentive compensation for employees. These expenses also encompass corporate facility costs such as rent, utilities, depreciation, and maintenance, as well as costs not classified under research and development expenses. Legal fees pertaining to intellectual property and corporate matters, as well as fees for accounting and consulting services, are also included in general and administrative expenses.
We expect that our general and administrative expenses will increase in the future to support our continued research and development activities, potential commercialization efforts, and increased costs of operating as a public company. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside consultants, lawyers, accountants, and recruitment firms, among other expenses. Increased costs associated with being a public company will also include expenses related to services associated with maintaining compliance with SEC and Nasdaq Stock Market requirements, insurance, and investor relations costs. If any of our current or future product candidates obtains marketing approval, we expect that we would incur significantly increased expenses associated with sales and marketing efforts.
Interest Expense, Net
Interest expense, net consists primarily of interest on our convertible promissory notes and loan agreement, partially offset by interest earned on bank deposits. (See “—Sources of Liquidity” below).
Merger Transaction Costs
Transaction costs we incurred in relation to the Merger were initially capitalized as deferred transaction costs up through the Closing Date, at which time such costs were charged to expense in our statements of operations less the amount of cash received in the Merger.
Change in Fair Value of Convertible Promissory Notes
U.S. accounting standards provide entities with an option to measure many financial instruments and certain other items at fair value. As a result of us electing this option, we recorded all convertible promissory notes at fair value with changes in fair value reported in our statements of operations at each balance sheet date through the settlement of the convertible promissory notes in connection with the Closing, at which time the convertible promissory notes were converted into our Common Stock.
Change in Fair Value of Written Call Option Derivative Liabilities
Equity-linked purchase options issued in connection with our debt agreements are assessed to determine whether they are freestanding or embedded with the host instrument under ASC 815. Our embedded and freestanding purchase options were determined to be liability-classified derivative instruments and are measured at fair value both on the date of issuance and at each subsequent balance sheet date, with changes in fair value recorded to “Change in fair value of written call option derivative liabilities” within the consolidated statements of operations and consolidated statements of cash flows.
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Loss on Issuance of Commitment Shares
Our other expenses consist of losses on the issuance of the Commitment Shares during the nine months ended September 30, 2024 associated with the Loan Agreement. Since we intend to elect the fair value option for future draws under the Loan Agreement, we expense all issuance costs associated with the Loan Agreement, which are comprised of the fair value of the Commitment Shares as well as the issuance date fair value of the $14 million Purchase Option and Additional Amount Purchase Option. For more information about the Loan Agreement, see “—Liquidity and Capital Resources—Funding Requirements” below.
Results of Operations
Comparison of the three months ended September 30, 2024 and 2023
The following table summarizes our results of operations for the three months ended September 30, 2024 and 2023:
| Three months ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 3,260,938 | $ | 1,116,911 | ||||
| General and administrative | 2,824,589 | 1,208,097 | ||||||
| Total operating expenses | 6,085,527 | 2,325,008 | ||||||
| Loss from operations | (6,085,527 | ) | (2,325,008 | ) | ||||
| Interest expense, net | (12,459 | ) | (299,887 | ) | ||||
| Change in fair value of warrants | 7,613 | — | ||||||
| Change in fair value of convertible promissory notes | — | (1,280,000 | ) | |||||
| Change in fair value of written call option derivative liabilities | 206,150 | — | ||||||
| Loss on issuance of commitment shares | — | — | ||||||
| Net loss | (5,884,223 | ) | (3,904,951 | ) | ||||
Research and Development Expenses
We do not track our internal research and development costs on a program-by-program basis. The following table summarizes our research and development expenses for the three months ended September 30, 2024 and 2023:
| Three months ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Personnel costs | 675,976 | $ | 573,832 | |||||
| Stock-based compensation | 2,185,958 | — | ||||||
| Other clinical and pre-clinical development expenses | 148,145 | 513,843 | ||||||
| Facilities and other expenses | 250,859 | 29,236 | ||||||
| Total research and development expenses | $ | 3,260,938 | $ | 1,116,911 | ||||
Research and development expenses for the three months ended September 30, 2024 were $3.3 million, compared to $1.1 million for the three months ended September 30, 2023. The increase was primarily attributable to an increase in stock-based compensation due to stock compensation expense related to the RSUs granted to Dr. Saadi.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the three months ended September 30, 2024 and 2023:
| Three months ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Personnel costs | $ | 343,129 | $ | 256,840 | ||||
| Stock-based compensation | 1,141,693 | — | ||||||
| Legal and professional fees | 1,272,181 | 753,813 | ||||||
| Facilities and other expenses | 67,586 | 197,444 | ||||||
| Total general and administrative expenses | $ | 2,824,589 | $ | 1,208,097 | ||||
General and administrative expenses for the three months ended September 30, 2024 were $2.8 million compared to $1.2 million for the three months ended September 30, 2023. The $0.5 million increase in legal and professional fees was primarily attributable to additional services incurred as a result of the Merger. The $1.1 million in stock-based compensation was due to stock compensation expense related to the RSUs granted to Dr. Saadi.
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Interest Expense, Net
We recognized $0.0 million and $0.3 million in interest expense for the three months ended September 30, 2024 and 2023, respectively. Interest expense for the three months ended September 30, 2023 was attributable primarily to the outstanding principal balance associated with our convertible promissory notes which converted into Common Stock in connection with the Closing.
Change in Fair Value of Convertible Promissory Notes
We recognized a non-cash charge of $1.3 million for the change in fair value of the convertible promissory notes for the three months ended September 30, 2023. The change in fair value of the convertible promissory notes was primarily a result of the increase in the underlying estimated fair value of our Common Stock during the three months ended September 30, 2023. The convertible promissory notes were converted into shares of Common Stock in connection with the Closing.
Change in Fair Value of Written Call Option Derivative Liabilities
We recognized a non-cash charge of $0.2 million for the fair value of our written call option derivative liabilities associated with our Loan Agreement for the three months ended September 30, 2024.
Comparison of the nine months ended September 30, 2024 and 2023
The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023:
| Nine months ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 28,196,970 | $ | 3,495,477 | ||||
| General and administrative | 16,004,308 | 3,338,279 | ||||||
| Total operating expenses | 44,201,278 | 6,833,756 | ||||||
| Loss from operations | (44,201,278 | ) | (6,833,756 | ) | ||||
| Interest expense, net | (168,239 | ) | (888,827 | ) | ||||
| Merger transaction costs | (7,499,353 | ) | — | |||||
| Change in fair value of warrants | 14,428 | — | ||||||
| Change in fair value of convertible promissory notes | 48,468,678 | (49,122,865 | ) | |||||
| Change in fair value of written call option derivative liabilities | (7,064 | ) | — | |||||
| Loss on issuance of commitment shares | (890,000 | ) | — | |||||
| Net loss | $ | (4,282,828 | ) | $ | (56,845,448 | ) | ||
Research and Development Expenses
We do not track our internal research and development costs on a program-by-program basis. The following table summarizes our research and development expenses for the nine months ended September 30, 2024 and 2023:
| Nine months ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Personnel costs | $ | 1,892,839 | $ | 1,526,871 | ||||
| Stock-based compensation | 24,932,798 | — | ||||||
| Other clinical and pre-clinical development expenses | 636,402 | 1,677,644 | ||||||
| Facilities and other expenses | 734,931 | 290,962 | ||||||
| Total research and development expenses | $ | 28,196,970 | $ | 3,495,477 | ||||
Research and development expenses for the nine months ended September 30, 2024 were $28.2 million, compared to $3.5 million for the nine months ended September 30, 2023. The increase was primarily attributable to an increase in stock-based compensation due to a non-cash stock-based compensation expense of $20.5 million recognized from certain stock-based awards that continue to vest through satisfaction of service conditions subsequent to the satisfaction of the liquidity condition upon the Closing.
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General and Administrative Expenses
The following table summarizes our general and administrative expenses for the nine months ended September 30, 2024 and 2023:
| Nine months ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Personnel costs | $ | 2,031,536 | $ | 819,209 | ||||
| Stock-based compensation | 8,810,322 | — | ||||||
| Legal and professional fees | 4,683,607 | 1,953,748 | ||||||
| Facilities and other expenses | 418,843 | 565,322 | ||||||
| Total general and administrative expenses | $ | 16,004,308 | $ | 3,338,279 | ||||
General and administrative expenses for the nine months ended September 30, 2024 were $16.0 million compared to $3.3 million for the nine months ended September 30, 2023. The increase was primarily attributable to stock-based compensation expense of $8.9 million, of which $6.7 million was recognized as a non-cash stock-based compensation expense from certain stock-based awards that continue to vest through satisfaction of service conditions subsequent to the satisfaction of the liquidity condition upon the Closing, and $2.2 million was recognized as restricted stock compensation expense related to the RSUs granted. The increase of $1.2 million in personnel costs was primarily attributable to an increase in headcount and an increase in premium for the Company’s director and officer insurance policy, and $0.8 million was recognized as a loss from the issuance of Series A Preferred Stock. The increase of $2.7 million in legal and professional fees was primarily attributable to the additional services incurred as a result of the Merger.
Interest Expense, Net
We recognized $0.2 million and $0.9 million in interest expense for the nine months ended September 30, 2024 and 2023, respectively, which was attributable primarily to the outstanding principal balance associated with our convertible promissory notes that converted into Common Stock in connection with the Closing.
Merger Transaction Costs
Merger transaction costs in excess of cash received from the Merger of $7.5 million were recognized as period expenses for the nine months ended September 30, 2024.
Change in Fair Value of Convertible Promissory Notes
We recognized a non-cash gain of $48.5 million and a non-cash loss of $49.1 million for the change in fair value of the convertible promissory notes for the nine months ended September 30, 2024 and 2023, respectively. The change was primarily a result of the increase in the underlying estimated fair value of our Common Stock during the nine months ended September 30, 2023 compared to a decrease in the underlying estimated fair value of our Common Stock from January 1, 2024 to the settlement of the convertible promissory notes upon the Closing.
Loss on issuance of Commitment Shares
We incurred losses on the issuance of Commitment Shares during the nine months ended September 30, 2024, associated with the Loan Agreement.
Liquidity and Capital Resources
Sources of Liquidity
As of September 30, 2024, we had $2.3 million in cash, as compared to $1.1 million in cash as of December 31, 2023. To date, we have not yet commercialized any products or generated any revenue from product sales and have financed our operations primarily with proceeds from the sale of convertible promissory notes and preferred stock, funds drawn on the Loan Agreement, and research tax credits. Since January 2021, we have raised aggregate gross proceeds of $24.0 million from the sale of convertible promissory notes, $2.0 million from the sale of our Series A Preferred Stock, $3.0 million from deposits related to the future sale of our Series A-1 Preferred Stock, and $6.0 million from the sale of our Series C Preferred Stock. In June 2024, we entered into the Loan Agreement, which provided up to $36.0 million of term loans that can be drawn in $1.0 million increments each month over thirty-six months, as described below. As of September 30, 2024, we have drawn an aggregate of $1.0 million under the Loan Agreement.
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Cash Flows
The following table summarizes our cash flows for the nine months ended September 30, 2024 and 2023:
For the nine months ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Cash provided by (used in) | ||||||||
| Operating activities | $ | (8,981,044 | ) | $ | (6,194,646 | ) | ||
| Investing activities | — | (133,000 | ) | |||||
| Financing activities | 10,229,328 | 3,450,000 | ||||||
| Net change in cash | $ | 1,278,284 | $ | (2,877,646 | ) | |||
Cash Flows from Operating Activities
During the nine months ended September 30, 2024, we used $9.0 million of net cash in operating activities. Cash used in operating activities reflected $9.7 million of net loss, non-cash charges related to the change in the fair value of the convertible promissory notes, stock-based compensation expense, Merger transaction costs, loss on the issuance of Series A Preferred Stock, loss on issuance of the Commitment Shares, depreciation expense, reductions in the operating right of use (“ROU”) assets, and non-cash interest on the convertible promissory notes, partially offset by a $0.7 million net change in our operating assets and liabilities attributable to the timing of our payments to our vendors for research and development activities.
During the nine months ended September 30, 2023, we used $6.2 million of net cash in operating activities. Cash used in operating activities reflected our net loss of $56.9 million offset by $49.1 million of non-cash charges related to the change in the fair value of the convertible promissory notes, depreciation expense, and reductions in the operating ROU assets, offset by a $0.4 million net change in our operating assets and liabilities attributable to the timing of our payments to our vendors for research and development activities.
Cash Flows from Investing Activities
During the nine months ended September 30, 2023, we purchased $0.1 million of property and equipment. There was no investing activities during the nine months ended September 30, 2024.
Cash Flows from Financing Activities
During the nine months ended September 30, 2024, we received $10.2 million of net cash from financing activities attributable to $2.0 million in proceeds from the sale of Series A Preferred Stock, $4.0 million in proceeds from the sale of Series C Preferred Stock, $3.0 million of non-refundable prepaid proceeds towards the anticipated issuance of Series A-1 Preferred Stock, $1.0 million drawn under the Loan Agreement, and $0.2 million of cash in connection with the Merger.
During the nine months ended September 30, 2023, we received $3.7 million of net cash from financing activities attributable to the proceeds from the convertible promissory notes, partially offset by $0.2 million in payment of deferred transaction costs.
Funding Requirements
Our primary sources of funds to meet our near-term liquidity and capital requirements include cash on hand, including the funding we have received from the sale of our Series A and Series C Preferred Stock and the funding we expect to receive from the sale of our Series A-1 Preferred Stock, and our access to an unsecured line of credit (limited to a $1.0 million monthly draw) under the Loan Agreement described below. On February 14, 2024, we entered into a securities purchase agreement with an investor pursuant to which the investor agreed to purchase shares of our Series A Preferred Stock for an aggregate purchase price of $8.0 million. On March 27, 2024, we entered into an agreement pursuant to which that amount was reduced to $2.0 million and the investor agreed to purchase shares of our Series A-1 Preferred Stock for an aggregate purchase price of $6.0 million. We have not yet received $3.0 million of the $6.0 million purchase price for the Series A-1 Preferred Stock. Even if we receive such proceeds, we will still need additional capital to fully implement our business, operating, and development plans. On August 21, 2024, we entered into a securities purchase agreement with an investor pursuant to which the investor agreed to purchase shares of our Series C Preferred Stock for an aggregate purchase price of $6.0 million.
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On June 6, 2024, we entered into the Loan Agreement, pursuant to which the Lender agreed to provide to the Company up to the Maximum Loan Amount of $36.0 million under the Facility. The Lender is also the investor in our Series A, Series A-1, and Series C Preferred Stock. The Facility permits us to borrow up to $1.0 million monthly in a single monthly draw over a period of up to three years. Draws will accrue interest at a fixed annual rate of the lower of (i) the daily secured overnight financing rate, measured on the date we receive the draw (the “Deposit Date”), plus 2.00% and (ii) 7.00%, accruing quarterly beginning on the Deposit Date and payable quarterly beginning on the three-month anniversary of the Deposit Date. Interest will be payable in shares of Common Stock with an effective purchase price of $1.50 per share, and each draw will mature 48 months after the Deposit Date. Prepayment will be permitted without penalty. The Company may repay or prepay any amount of outstanding principal balance under the Facility at the Company’s election in cash or in shares of Common Stock with an effective purchase price of the greater of $1.50 per share and the 10-day trailing volume weighted average price of the Common Stock (the “Trailing VWAP”) as of the trading day prior to payment, subject to certain requirements related to resale registration. Pursuant to the Loan Agreement, we also agreed to provide the Lender an option to purchase $14.0 million of shares of our Common Stock plus an additional amount up to the total then-remaining available and undrawn portion of the Maximum Loan Amount (which amount would thereafter no longer be available under the Facility). The Optional PIPE would be priced at a 30% discount to the Trailing VWAP on the date such price first reaches at least $10.00 per share (the “Threshold Price Date”) and will be exercisable by the Lender by written notice within three business days after the Company has notified the Lender of the Threshold Price Date (the date of such notice, the “Threshold Price Notice Date”). Pursuant to the terms of the Loan Agreement, we issued to the Lender the Commitment Shares, subject to forfeiture by the Lender of the Commitment Shares or an equal number of shares of Common Stock in the event the Lender fails to (i) make a deposit under the Facility when due or (ii) pay the purchase price for the Optional PIPE within 30 days after the Threshold Price Notice Date in the event the Company has satisfied all applicable closing conditions. There is no assurance as to the amount of proceeds we will ultimately receive under the Loan Agreement. As of September 30, 2024, we have drawn an aggregate of $1.0 million under the Loan Agreement
We expect to devote considerable financial resources to our ongoing and planned activities, particularly as we conduct our planned clinical trials of TVGN 489 and other product candidates.
Identifying potential product candidates and conducting pre-clinical testing and clinical trials is a time-consuming, expensive, and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success.
We expect our expenses to increase in connection with our ongoing activities, particularly as we advance our pre-clinical studies and clinical trials. In addition, if we obtain marketing approval for TVGN 489 in any indication or for any other product candidate we are developing or develop in the future, we expect to incur commercialization expenses related to product manufacturing, sales, marketing, and distribution. Furthermore, we expect to continue to incur increased costs associated with operating as a public company. Accordingly, we will need additional funding to fully implement our business plans.
Our future capital requirements will depend on many factors, including:
| ● | the progress, costs, and results of our planned clinical trials of TVGN 489 and other planned and future clinical trials; | |
| ● | the scope, progress, costs and results of our pre-clinical testing and clinical trials of TVGN 489 for additional combinations, targets, and indications; | |
| ● | the number of and development requirements for additional indications for TVGN 489 or for any other product candidates; | |
| ● | our ability to scale up our manufacturing processes and capabilities to support clinical trials of TVGN 489 and other product candidates we are developing and may develop in the future; | |
| ● | the costs, timing, and outcome of regulatory review of TVGN 489 and other product candidates we are developing and may develop in the future; | |
| ● | potential changes in the regulatory environment and enforcement rules; | |
| ● | our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such arrangements; | |
| ● | the costs and timing of future commercialization activities, including product manufacturing, sales, marketing, and distribution, for TVGN 489 and other product candidates we are developing and may develop in the future for which we may receive marketing approval; | |
| ● | our ability to obtain and maintain acceptance of any approved products by patients, the medical community, and third-party payors; | |
| ● | the amount and timing of revenue, if any, received from commercial sales of TVGN 489 and any other product candidates we are developing or develop in the future for which we receive marketing approval; |
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| ● | potential changes in pharmaceutical pricing and reimbursement infrastructure; | |
| ● | the availability of raw materials for use in production of our product candidates; and | |
| ● | the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights, and defending any intellectual property-related claims. |
As of September 30, 2024, we had cash of $2.3 million. Our cash balance, the $2.0 million received from the sale of Series C Preferred Shares, and the Loan Agreement, which allows us to draw down term loans of $1.0 million per month over thirty-six months, will allow us to have adequate cash and financial resources, to operate for at least the next 12 months from the date of issuance of our unaudited consolidated financial statements included in this Report.
We regularly evaluate different strategies to obtain funding for operations for subsequent periods. These strategies may include but are not limited to private placements of securities, licensing and/or marketing arrangements, partnerships with other pharmaceutical or biotechnology companies, and public offerings of securities. We may not be able to obtain financing on acceptable terms and may not be able to enter into strategic alliances or other arrangements on favorable terms. The terms of any financing may adversely affect the holdings or the rights of our stockholders. If we are unable to obtain sufficient funding, we could be required to delay, reduce or eliminate research and development programs, product portfolio expansion, or future commercialization efforts, which could adversely affect our business prospects.
Contractual Obligations and Commitments
The following table summarizes our contractual obligations and commitments as of September 30, 2024:
| Total | Less than 1 Year | 1 to 3 Years | 3+ Years | |||||||||||||
| Contractual obligations: | ||||||||||||||||
| Operating lease commitments (1) | $ | 391,067 | $ | 146,621 | $ | 244,446 | $ | 0 | ||||||||
| Line of Credit repayment (2)(3) | $ | 1,012,466 | $ | 0 | $ | 0 | $ | 1,012,466 | ||||||||
| Total contractual obligations | $ | 1,403,533 | $ | 146,621 | $ | 244,446 | $ | 1,012,466 | ||||||||
| (1) | Reflects obligations pursuant to our office and laboratory leases in Philadelphia, Pennsylvania and Warren, New Jersey. |
| (2) | Reflects obligations to settle outstanding balances on our Line of Credit, if paid in cash at time of settlement. |
| (3) | Reflects balance of loans drawn on line of credit and accrued interest. |
The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including fixed or minimum services to be used, fixed, minimum, or variable price provisions, and the approximate timing of the actions under the contracts. Our contracts with CROs, CMOs, and other third parties for the manufacture of our product candidates and to support pre-clinical research studies and clinical testing are generally cancelable by us upon prior notice and do not contain any minimum purchase commitments. Payments due upon cancellation consisting only of payments for services provided or expenses incurred, including non-cancelable obligations of our service providers, up to the date of cancellation are not included in the table above as the amount and timing of such payments are not known.
Critical Accounting Policies and Estimates
This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with GAAP. The preparation of the financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, the fair value of our Common Stock, the fair value of our convertible promissory notes, and stock-based compensation. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions, including those factors set out in the “Risk Factors” section of our Annual Report. See also the section entitled “–Forward-Looking Statements” above.
While our significant accounting policies are described in more detail in Note 3 to our financial statements contained in this Report and Note 3 to the audited financial statements included as Exhibit 99.1 to the Form 8-K, we believe the following accounting policies are the most critical to the judgments and estimates used in the preparation of our financial statements or involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition or results of operation.
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Research and Development Expenses
Research and development activities are expensed as incurred. As part of the process of preparing our financial statements, we are required to estimate our accrued research and development expenses, including those related to clinical trials and product candidate manufacturing. This process involves reviewing open contracts and purchase orders, communicating with our applicable personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the services when we have not yet been invoiced or otherwise notified of actual costs. Our service providers invoice us in arrears or require prepayments for services performed, as well as on a pre-determined schedule or when contractual milestones are met. We make estimates of our accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of the estimates with the service providers and make adjustments if necessary. Examples of estimated accrued research and development expenses include fees paid to:
| ● | vendors in connection with pre-clinical and clinical development activities; | |
| ● | CROs in connection with clinical trials; and | |
| ● | CMOs in connection with the process development and scale-up activities and the production of pre-clinical and clinical trial materials. |
Costs for clinical trials and manufacturing activities are recognized based on an evaluation of our vendors’ progress towards completion of specific tasks, using data such as participant enrollment, clinical site activations, or information provided to us by our vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services were performed. We determine accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the progress or state of completion of studies, or the services completed. Our estimates of accrued expenses as of each balance sheet date are based on the facts and circumstances known at the time. Costs that are paid in advance of performance are deferred as a prepaid expense and amortized over the service period as the services are provided.
Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses. However, due to the nature of estimates, we cannot assure that we will not make changes to our estimates in the future as we become aware of additional information about the status or conduct of our clinical trials and other research activities.
Stock-Based Compensation
Awards under our compensation plans are accounted for in accordance with ASC 718. Compensation cost is measured at the grant date fair value of the award and is recognized over the vesting period of the award. We use the straight-line method to record compensation expense of awards with service-based vesting conditions. We account for forfeitures of stock-based awards as they occur. We recognize share-based compensation expense for awards with performance conditions when it is probable that the condition will be met, and the award will vest. Prior to the Merger, we estimated the fair value of our Common Stock in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation.
Estimating the fair value of Common Stock
Prior to the Closing, we were required to estimate the fair value of shares of our Common Stock underlying our stock-based awards and in connection with valuing our convertible promissory notes. Because our Common Stock was not publicly traded prior to February 15, 2024, the fair value of our Common Stock prior to such date had been estimated on each grant date by our board of directors, with input from our management, considering third-party valuations of our Common Stock.
Our board of directors considered various objective and subjective factors to estimate the estimated fair value of our Common Stock, including:
| ● | the estimated value of all classes of securities outstanding; | |
| ● | the anticipated capital structure that will directly impact the value of the currently outstanding securities; | |
| ● | our results of operations and financial position; | |
| ● | the status of our research and development efforts; |
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| ● | the composition of, and changes to, our management team and board of directors; | |
| ● | the lack of liquidity of our Common Stock as a private company; | |
| ● | our stage of development and business strategy and the material risks related to our business and industry; | |
| ● | external market conditions affecting the life sciences and biotechnology industry sectors; | |
| ● | the likelihood of achieving a liquidity event for the holders of our Common Stock, such as an initial public offering, or a sale of the company, given the prevailing market conditions; and | |
| ● | the market value and volatility of comparable companies. |
Fair Value Measurements
Our recurring fair value measurements primarily consist of the convertible promissory notes prior to the Merger, for which we elected the fair value option, the freestanding $14 million purchase option under the Loan Agreement, and the bifurcated purchase option that is embedded within the loan commitment under the Loan Agreement.
We used the Probability Weighted Expected Return Method (“PWERM”) valuation methodology to determine the fair value of the convertible promissory notes prior to the Merger for all the periods presented. The PWERM is a scenario-based methodology that estimates the fair value based upon an analysis of future values for the company, assuming various outcomes. The value is based on the probability-weighted present value of expected future investment returns considering each of the possible outcomes available. The future value under each outcome is discounted back to the valuation date at an appropriate risk-adjusted discount rate and probability weighted to arrive at an indication of value. Significant assumptions used in determining the fair value of convertible promissory notes include volatility, discount rate, and probability of a future liquidity event. In February 2024, concurrent with the Merger, we converted our outstanding convertible promissory notes into 10,337,419 shares of Common Stock.
We used a Monte Carlo Simulation (“MCS”) valuation methodology to determine the fair value of the freestanding $14 million purchase option and embedded purchase option associated with the Loan Agreement at inception and as of September 30, 2024. The MCS methodology simulates the Company’s future stock price to estimate if and when the Trailing VWAP will reach $10.00 per share, and discounts the resulting payoff back to each valuation date using a present value factor. Significant assumptions used in determining the fair value of these options include volatility and discount rate.
Recent Accounting Pronouncements
See Note 3 to our unaudited consolidated financial statements found in this Report for a description of recent accounting pronouncements applicable to our financial statements.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk.
The Company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information under this Item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we have evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this report. Based upon the evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were not effective at the reasonable assurance level as of the end of the period covered by this report due to the material weaknesses in our internal control over financial reporting.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the period covered by this Report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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Part II – Other Information
Item 1. Legal Proceedings.
In the ordinary conduct of our business, we may be subject from time to time to legal proceedings. We currently have no material legal proceedings pending.
Item 1A. Risk Factors.
投资我们的普通股涉及高度风险。您应仔细考虑我们年度报告中“风险因素”部分列出的风险、该报告中列出的其他信息，以及我们向SEC提交的其他报告中的附加信息。如果这些报告中包含的任何风险发生，我们的业务、运营结果、财务状况和流动性可能会受到影响，证券的价值可能会下降，您可能会失去全部或部分投资。
除下文所述外，我们在年度报告Form 10-k中披露的风险因素没有发生重大变化，截至2023年12月31日的财政年度。
纳斯达克未能满足持续上市要求可能导致我们普通股的摘牌，以及我们未行使的公开认购权证。
我们的 普通股和我们已发行的可公开购买普通股的warrants（我们的“warrants”）在纳斯达克上市。我们需要满足特定的财务和其他要求以维持该上市，包括要求我们的普通股收盘买盘价格保持在1.00美元以上。
2024年6月14日，我们收到了纳斯达克上市资格部门（简称“工作人员”）的一封信，通知我们我们已经不再符合纳斯达克继续上市的1.00美元每股最低买盘价格要求（简称“最低买盘价格要求”），根据我们普通股在前35个连续营业日的收盘买盘价格。2024年10月28日，我们收到了主管部门的一封通知信，通知我们从2024年10月14日至2024年10月25日，我们的普通股收盘买盘价为1.00美元或更高，并且，我们已符合了最低买盘价格要求，该事项已结案。然而，并不能保证我们将能够继续符合最低买盘价格要求或其他纳斯达克的上市标准。
如果我们未能符合纳斯达克的持续上市要求，纳斯达克可能会采取除牌我们证券的步骤。这种除牌可能会对我们证券价格产生负面影响，并会影响您在希望这样做时卖出或购买证券的能力。在除牌的情况下，我们无法保证我们采取的任何恢复符合上市要求的行动能够使我们的证券再次上市，稳定市场价格或改善我们证券的流动性，或防止将来违反上市要求。此外，如果我们的证券因任何原因未在纳斯达克上市或被除牌，并在OTC挂牌在场外交易所，这是一种用于股票的经纪商自动报价系统，而不是国家证券交易所，我们的证券的流动性和价格可能会比如果我们的证券在纳斯达克或其他国家证券交易所上市或被挂牌时更受限制。除非能建立或维护市场，否则您可能无法卖出您的证券。
我们先前未能及时向证监会提交某些定期报告。未来可能在提交报告给证监会方面出现延迟会对我们的业务带来重大风险，并可能对我们的财务状况和运营结果产生重大不利影响。
我们 没有及时提交截至2023年12月31日的财政年度的10-K表格年度报告，或截至2024年3月31日的季度期的10-Q表格，错过了截至2024年9月30日季度期的10-Q表格的首次提交截止日期。 虽然我们现在已在交易法下及时提交了定期报告，但无法保证我们将来报告的提交总是及时的。任何定期报告的迟交可能会影响我们获得融资的能力。例如，直到我们及时提交交易法下要求的所有定期报告至少十二个月及其前一个月的所有部分，我们才能够以简式注册声明（Form S-3）注册我们的证券的发行和销售。此外，如果未来我们的定期报告提交被延迟，我们可能会对业务增长能力产生重大不利影响。
未来如果未能及时向美国证券交易委员会（SEC）提交定期报告，可能会导致我们受到SEC的执法行动和股东诉讼，并 可能导致我们的普通股和warrants在纳斯达克被摘牌，SEC的监管制裁，或未来任何信贷设施的契约违约，或我们可能在未来发行的任何优先股或债务证券的违约，这些都可能对我们的运营、您在我们的普通股和warrants上的投资以及我们为自己或安防-半导体持有者的利益在SEC注册公开发行证券的能力产生重大不利影响。此外，任何潜在的未能及时提交未来定期报告的情况，可能导致投资者无法获得有关我们业务和运营的最新或及时信息，从而做出投资决策。
项目 5. 其他信息。
内幕交易安排
在2024年9月30日结束的三个月内，我们的董事或高管（定义在《证券交易所法规16a-1(f)》中）中没有人
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物品 6. 附件。
展品目录
| 展览 | 描述 | |
| 2.1† | 合并协议及计划，日期为2023年6月28日，由公司、Semper Merger Sub, Inc.、SSVk Associates, LLC、Tevogen Bio Inc及Ryan Saadi以卖方代表身份签署（根据2023年6月29日向美国证券交易委员会提交的8-k表格的附件2.1引用） | |
| 3.1 | 公司系列b优先股的注销证明（根据2024年8月14日向美国证券交易委员会提交的10-Q表格的附件3.1引用） | |
| 3.2 | Tevogen Bio Holdings Inc.系列C优先股的指定证明（根据2024年8月23日向美国证券交易委员会提交的8-k表格的附件3.1引用） | |
| 10.1 | 证券购买协议，日期为2024年8月21日，由Tevogen Bio Holdings Inc.与The Patel Family, LLP之间签署（根据2024年8月23日向美国证券交易委员会提交的8-k表格的附件10.1引用） | |
| 31.1* | 首席执行官根据1934年证券交易法第13a-14(a)条规则所作的证明，依据2002年萨班斯-奥克斯利法第302条 | |
| 31.2* | 首席财务官根据1934年证券交易法第13a-14(a)条规则所作的证明，依据2002年萨班斯-奥克斯利法第302条 | |
| 32.1** | 根据《美国法典》第18编第1350条的首席执行官认证，依据2002年《修订豪利法》第906条的采用 | |
| 32.2** | 根据《美国法典》第18编第1350条的致富金融(临时代码)认证，依据2002年《修订豪利法》第906条的采用 | |
| EX-101.INS* | 内联XBRL实例文档——该实例文档不出现在交互数据文件中，因为它的XBRL标记嵌入在内联XBRL文档中 | |
| EX-101.SCH* | 内联XBRL分类扩展模式文档 | |
| EX-101.CAL* | 内联XBRL分类扩展计算链路库文档 | |
| EX-101.DEF* | 内联XBRL分类扩展定义链路库文档 | |
| EX-101.LAB* | 内联XBRL分类扩展标签链路库文档 | |
| EX-101.PRE* | 内联XBRL分类扩展演示链路库文档 | |
| 104.1* | 内嵌于Inline XBRL文件内的封面交互式数据文件 |
| * | 随本申报文件提交。 |
| ** | 随信附上 |
| † | 本展品中省略了根据Regulation S-k第601(a)(5)项目的计划和展品。发行人同意根据要求向证券交易委员会补充提供任何省略的计划或展品的副本。 |
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签名
根据1934年证券交易法的要求，注册者已经授权下面的签字人代表其签署了本报告。
蒂伏根生物控股有限公司 | |||
| 日期： | 十一月 2024年19日 | 由： | /s/ Ryan Saadi |
| Ryan Saadi | |||
首席执行官 (Duly Authorized Officer and Principal Executive Officer) | |||
| 日期： | 十一月 2024年19日 | 由： | Kirti Desai |
| Kirti Desai | |||
首席财务官 /s/ Maria Stan | |||
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