美国
证券交易委员会
华盛顿，特区。20549
表格
截至季度结束
或
在从___________到____________的过渡期内
委员会
文件编号：
（公司章程中指定的准确公司名称）
（住所的州或其他司法辖区 文件号码） |
（税务局雇主 (主要 执行人员之地址) |
（总部地址）（邮政编码）
根据交易所法规（17 CFR 240.14a-12）第14a-12规定的招股材料
(公司更名、更改地址和更改财年情况的以往名称、以前地址和以前财年，如与上次报告有所改变)
根据法案第12(b)节注册的证券:
| 每一类别的名称 | 交易标的 | 在每个交易所注册的名称 | ||
请勾选标记以指示注册者是否（1）在过去12个月内（或注册者需要提交这些报告的更短时间内）已提交证券交易所法案第13或15（d）节要求提交的所有报告，及 （2）是否已被提交要求过去90天的提交要求所制约。
通过勾选圆圈表明注册者是否在过去12个月内(或注册者需要提交这些文件的较短期限内)已经递交规章S-T(本章第232.405条)规定的每个交互式数据文件。
在勾选标记处表示注册人是大型加速提交人、加速提交人、非加速提交人、小型报告公司还是新兴增长公司。请参阅证券交易法120亿条规则中“大型加速提交人”、“加速提交人”、“小型报告公司”和“新兴增长公司”的定义。
| 大型加速归档者 ☐ | 加速归档者 ☐ |
| 较小的报告公司 | |
| 新兴成长公司 |
如果是新兴成长公司，请勾选，如果注册人已选择不使用根据交易所法案第13(a)条提供的任何新的或修改的财务会计准则的延长过渡期，请勾选。
请勾选注册人是否为壳公司（如在交易所法第120亿.2条中定义）。 是 ☐ 否
截至2024年11月14日，公司发行和流通的普通股数量为 .
凯罗斯制药有限公司。
目录
| 第一部分 基本报表 | 3 | ||
| 项目1. | 财务报表 | 3 | |
| 2024年9月30日和2023年12月31日未经审计的简明合并资产负债表 | 3 | ||
| 2024年9月30日和2023年三个月及九个月结束的未经审计简明综合损益表 | 4 | ||
| 2024年和2023年9月30日三个月和九个月结束时未经审计的股东权益（赤字）的简明综合报表 | 5 | ||
| 2024年9月30日和2023年未经审计的简明合并现金流量表 | 6 | ||
| 简明联合财务报表附注(未经审计) | 7 | ||
| 项目 2. | 管理层对财务状况和经营成果的讨论与分析 | 19 | |
| 项目 3 | 关于市场风险的定量和定性披露 | 29 | |
| 项目 4. | 控制和程序 | 29 | |
| 第二部分-其他信息 | 30 | ||
| 项目 1 | 法律诉讼 | 30 | |
| 项目 1A | 风险因素。 | 30 | |
| 项目 2. | 未登记的股票销售及使用所得款项 | 30 | |
| 项目 3. | 触及到高级证券的违约情况 | 30 | |
| 项目 4. | 矿山安全披露 | 30 | |
| 项目5。 | 其他信息 | 30 | |
| 项目 6. | 展示资料 | 31 | |
| 签名 | 32 | ||
| 2 |
第一节金融信息
项目 基本报表。
Kairos 医药有限公司。
简明合并资产负债表
(以千为单位，除每股金额和面值数据外)
| 九月 30， | 2024年12月31日， | |||||||
| 2024 | 2023 | |||||||
| (未经审计) | ||||||||
| 资产 | ||||||||
| 流动资产 | ||||||||
| 现金 | $ | $ | ||||||
| 供应商预付款 | ||||||||
| 预付款及其他流动资产 | ||||||||
| 总流动资产 | ||||||||
| 延迟募资成本 | ||||||||
| 无形资产-净额 | ||||||||
| 其他资产合计 | ||||||||
| 总资产 | $ | $ | ||||||
| 负债和股东权益（赤字） | ||||||||
| 流动负债 | ||||||||
| 应付账款及应计费用 | $ | $ | ||||||
| 应付关联方 | ||||||||
| 应付票据 - 高管 | ||||||||
| 总计 流动负债 | ||||||||
| 可转换票据应付,
减去债务折扣 $ | ||||||||
| 总负债 | ||||||||
| 承诺和或有事项 - 注释 7 | ||||||||
| 股东权益 (赤字) | ||||||||
| 优先股，面值$, 授权股份; 股份 已发行和流通，分别; | ||||||||
| 普通股，每股面值 $，授权股数：百万股；发行股数：分别为2024年6月30日和2023年12月31日：百万股；流通股数：分别为2024年6月30日和2023年12月31日：百万股, 股份 授权; 和 股份已发行和流通，分别; | ||||||||
| 其他资本公积 | ||||||||
| 累积赤字 | ( | ) | ( | ) | ||||
| 总 股东权益（赤字） | ( | ) | ||||||
| 总 负债和股东权益（赤字） | $ | $ | ||||||
附注是这些精简合并财务报表的一部分。
| 3 |
Kairos 医药有限公司。
简化合并利润表
(以千为单位，除分享金额和每股数据外)
| 三个月 | 九个月 结束 | |||||||||||||||
| 九月 30， | 九月 30日, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (未经审计) | （未经审计） | |||||||||||||||
| 收入 | $ | $ | $ | $ | ||||||||||||
| 营业费用： | ||||||||||||||||
| 研发 | ||||||||||||||||
| 总务及行政费用 | ||||||||||||||||
| 总营业费用 | ||||||||||||||||
| 运营损失 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 其他费用: | ||||||||||||||||
| 利息支出 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 融资成本 | ( | ) | ( | ) | ||||||||||||
| 债务贴现摊销 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 其他支出总额 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 净损失 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 基本和摊薄每股亏损 | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| 加权平均每股优先股 | ||||||||||||||||
| 基本和摊薄 | ||||||||||||||||
附注是这些精简合并财务报表的一部分。
| 4 |
Kairos 医药有限公司。
缩略版 合并股东权益（赤字）表（未经审计）
(以千为单位，除了分享金额)
| 普通 股票 | 追加 已付资本 | 累计 | ||||||||||||||||||
| 股份 | 金额 | 资本 | 亏损 | 总计 | ||||||||||||||||
| 2024年6月30日余额（未经审计） | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| 初次公开发行结束时发行普通股，减去发行费用 | ||||||||||||||||||||
| 在可转换应付款项和应计利息转换后发行普通股 | ||||||||||||||||||||
| 在应付款项转换后发行普通股 | ||||||||||||||||||||
| 在与关联方到期款项转换后发行普通股 | ||||||||||||||||||||
| 与可转换应付款项相关发行权证的公允价值 | - | |||||||||||||||||||
| 发放的已获股票单元的公允价值 | - | |||||||||||||||||||
| 净损失 | - | ( | ) | ( | ) | |||||||||||||||
| 2024年9月30日余额（未经审计） | $ | $ | $ | ( | ) | $ | ||||||||||||||
| 2023年12月31日的余额 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| 发行普通股以抵消首次公开发行的成本 | ||||||||||||||||||||
| 发行普通股以转换应付可转换票据和应计利息 | ||||||||||||||||||||
| 发行普通股以转换应付账款 | ||||||||||||||||||||
| 发行普通股以转换对关联方的应付款项 | ||||||||||||||||||||
| 与应付可转换票据相关的权证的公允价值 | - | |||||||||||||||||||
| 已获批准的限制性股票单位的公允价值 | - | |||||||||||||||||||
| 净损失 | - | ( | ) | ( | ) | |||||||||||||||
| 2024年9月底余额（未经审计） | $ | $ | $ | ( | ) | $ | ||||||||||||||
| 2023年6月30日余额（未经审计） | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| 净损失 | - | ( | ) | ( | ) | |||||||||||||||
| 2023年9月余额（未经审计） | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| 2022年12月31日的余额 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| 净损失 | - | ( | ) | ( | ) | |||||||||||||||
| 2023年9月余额（未经审计） | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
附注是这些精简合并财务报表的一部分。
| 5 |
Kairos 医药有限公司。
简明合并现金流量表。
（以千为单位）
| 九个月 结束 | ||||||||
| 九月 30， | ||||||||
| 2024 | 2023 | |||||||
| (未经审计) | ||||||||
| 经营活动产生的现金流量 | ||||||||
| 净损失 | $ | ( | ) | $ | ( | ) | ||
| 摊销费用 | ||||||||
| 债务折扣摊销 | ||||||||
| 与应付账款转换相关的普通股发行的公允价值 | ||||||||
| 限制性股票单位的公允价值 | ||||||||
| 与可转换应付票据相关的warrants发行的公允价值 | ||||||||
| 运营资产和负债的变化： | ||||||||
| 供应商预付款 | ( | ) | ||||||
| 预付款及其他流动资产 | ( | ) | ( | ) | ||||
| 应付账款和应计费用 | ||||||||
| 净现金流量（经营活动） | ( | ) | ||||||
| 筹资活动现金流量 | ||||||||
| 与首次公开发行结束相关的发行普通股以获取现金的收益 | ||||||||
| 应付款项筹资净额-执行官 | ||||||||
| 支付递延发行费用 | ( | ) | ( | ) | ||||
| 融资活动提供的（使用的）净现金 | ( | ) | ||||||
| 现金净增加（减少） | ( | ) | ||||||
| 期初现金余额 | ||||||||
| 期末现金余额 | $ | $ | ||||||
| 补充现金流披露： | ||||||||
| 已支付利息 | $ | $ | ||||||
| 已缴纳的税款 | $ | $ | ||||||
| 补充非现金融资披露： | ||||||||
| 将递延发行成本重新分类至股东权益 | $ | $ | ||||||
| 将可转换票据应付款项及应计利息转为股东权益 | $ | $ | ||||||
| 将应付账款转为股东权益 | $ | $ | ||||||
| 将应支付给关联方款项转为股东权益 | $ | $ | ||||||
附注是这些精简合并财务报表的一部分。
| 6 |
凯罗斯制药有限公司。
基本报表附注（未经审计）
2024年和2023年截至2024年9月30日的九个月
(以千为单位，除了分享金额和每股数据)
注意 1 - 提供的基础
Cell Source, Inc.（“Cell Source”、“CSI”或“公司”）是一家于2012年6月6日成立 的内华达州公司，是Cell Source Limited（“CSL”）的母公司，CSL是一家在2011年在以色列成立的全资子公司，旨在商业化若干个涉 及某些癌症治疗的发明。公司专注于开发基于免疫耐受治疗方法的细胞疗法治疗，其主要潜在产品是其 拥有专利的Veto Cell免疫系统管理技术，这是一种免疫耐受性生物技术，可以选择性地阻止 免疫反应。CSL的Veto Cell免疫系统管理技术是基于由以色列公司Yeda Research and Development Company Limited （“Yeda”）拥有、持有和许可的专利技术所基于的（见注释8）。公司旨在治疗的疾病包括：淋巴瘤、白血病和多发性骨髓瘤，通过促进 更安全、更易接受的干细胞（例如骨髓）移植的接受、通过改善器官移植（扩大供体库， 减少对术后抗排异治疗的依赖）来治疗晚期肾脏疾病和其他非恶性器官疾病，从而最终治疗各种癌症 和非恶性疾病。
Kairos Pharma, Ltd.（"公司"或"Kairos"）于2013年6月17日在加利福尼亚州法律下注册为NanoGB13, Inc.。公司于2016年7月15日更名为Kairos Pharma, Ltd.，并于2023年5月10日根据相同名称转换为特拉华州公司Kairos Pharm, Ltd.。该公司是一家早期阶段的生物技术公司，专注于开发用于肿瘤学的免疫疗法和电芯疗法治疗。
未经审计的财务信息的呈现基础
本公司附带的未经审计的简明合并基本报表是根据美国公认会计原则为临时财务信息而编制，并遵循Form 10-Q的指示及S-X条例第10-01条。因此，它们未包括公认会计原则对完整基本报表所要求的所有信息和附注。管理层认为，为了公平呈现，所有常规的必要调整均已包括在内。截止2024年9月30日的九个月经营结果未必能反映2024年12月31日结束的年度可能预期的结果。
流动性和资本资源
附带的简明合并财务报表已根据持续经营原则编制，预期资产的实现和负债以及承诺的清偿将在正常业务过程中进行。
截至2023年12月31日，公司录得净损失$
截至2024年9月30日的九个月里，公司完成了其首次公开发行（“IPO”），收到了$
作为一个持续经营的能力，取决于公司在未来实现并维持盈利业务，主要通过筹集额外资本来满足其义务，并在正常业务运营中到期时偿还债务。自成立以来，公司主要通过股本和债务融资来投资其业务，并预计在未来继续依赖这些资本来源，直到能够产生收入。
无法保证将来会有可获得的融资，即使有也可能未必符合公司的要求。即使公司能获得额外的融资，这种融资可能对我们的运营施加过度限制（在债务融资的情况下），或导致股东股权的大幅稀释（在股权融资的情况下）.
反向 股票拆分
在2023年5月10日，公司进行了
| 7 |
重新注册
公司的公司注册证明于2023年5月10日提交至特拉华州，跟随公司从加利福尼亚公司转变为特拉华公司，授权公司发行最多 股，包括 普通股，面值$ 。 每股股票价格为 每股。附带的简化合并基本报表及其说明对所有呈现的期间给予追溯效力。
附注2-重要会计政策摘要
合并财务报表的基础
附带的简明综合基本报表及相关附注已按照美国通用会计准则（"U.S. GAAP"）编制。附带的综合基本报表包括公司及其全资子公司Enviro Therapeutics, Inc.的账户。所有公司间余额及交易在合并时已予以消除。
使用估计值
编制符合GAAP的合并基本报表需要管理层做出估计和假设，这些估计和假设影响合并基本报表日期的资产和负债的报告金额以及或有资产和负债的披露，以及报告期内收入和费用的报告金额。公司定期评估这些估计和假设。公司基于当前事实、历史经验和其他各种其认为在具体情况下合理的因素来做出估计和假设，这些结果为判断资产和负债的账面价值以及未从其他来源明显显现的费用和支出进行确认提供了依据。公司实际经验的结果可能与公司的估计存在重大且不利的差异。在估计和实际结果之间存在重大差异的情况下，未来的经营结果将受到影响。随附的合并基本报表中的重要估计包括递延税资产的估值准备，以及无形资产的减值分析和使用寿命。
现金
在现金流量表的目的下，现金包括与银行和金融机构的货币。
信贷风险集中
金融工具可能导致公司面临信用风险集中，主要包括现金存款。每家金融机构的账户都由联邦存款保险公司（“FDIC”）在一定限额内保险。
无形资产
公司的无形资产按获取日期的公允价值列示，减去累计摊销额。摊销额基于资产的预计使用寿命计算，这些寿命已被确定为
| 8 |
us-gaap:SalesRevenueNetMember
公司的无形资产按照预计可用生命周期进行摊销，其摊销分别如下：物业、厂房和设备针对长期资产减值的财务会计和报告。持有并使用的长期资产应在出现事件或情况变化时进行可收回性测试，表明资产组的账面价值可能无法收回，无论此类账面价值是否为零或负数。如果估计的未打折未来现金流小于账面价值，则需要进行减值决定。在该事件中，将基于账面金额超过长期资产公允价值的金额确认损失。
每股净亏损是根据ASC主题260计算的， 每股收益每股基本收益（“EPS”）是基于普通股加权平均股数计算的。 摊薄后每股收益是基于所有可摊薄证券被转换的假设。 当期权或warrants存在时，稀释是通过应用财库股票法计算的。 根据此方法，假设在期初（或在发行时，如果更晚）行使期权和warrants，因而获得的资金被假设用于在期间的平均市场价格购入普通股。 截至2023年和2024年9月30日的九个月，基本和摊薄的流通股数是相同的，因为潜在的可稀释股被认为具有反稀释特性。 和 截至2024年9月30日，可能的可稀释证券包括普通股购买warrants的行使而可发行的普通股，分别为 截至2024年9月30日，尚未归属的限制性股票单位（“RSUs”）在归属时可发行的股份为
推迟销售费用
公司将某些直接与进行中的股权发行相关的法律、专业、会计及其他第三方费用资本化为递延发行费用，直到该股权发行完成。在股权发行完成后，这些费用将作为资本化金额的减少记录。如果股权发行被延迟或放弃，递延发行费用将立即作为营业费用在运营报表中计入费用。截至2023年12月31日和2024年9月30日，公司已产生$
截至2024年9月30日的九个月期间，共记录了$ 的递延发行成本，作为从IPO获得的净收益的抵消。
公允价值衡量
公司根据美元交易价格确定其资产和负债的公允价值，该价格是在资产卖出或负债转让（退出价格）方面，会在资产或负债的主要或最有利市场上，市场参与者之间于计量日期进行交易的有序交易。用于衡量公允价值的估值技术最大化使用可观察输入并最小化使用不可观察输入。公司使用三个层次的公允价值层次结构，其中前两个被认为是可观察的，最后一个是不可观察的，以衡量公允价值：
| ● | 第一层次—基于未经调整的报价活跃市场上的价值，而公司有能力获取可转让相同的资产或负债。不适用估值调整和块折扣。由于估值是基于报价价格进行的，这些价格在活跃市场上是容易获得的，因此对这些证券的估值不涉及重要程度的判断。 在活跃市场中报价的相同资产或负债。 | |
| ● | 第二层次—根据直接或间接可观察到的市场数据进行定价，但数据并非来自活跃市场的报价。 除了一级之外的可观察到的输入，直接或间接，如类似资产或负债的报价；在非活跃市场中的报价；或其他可观察到的或可由可观察到的市场数据证实的输入，用于资产或负债的整个期限。 | |
| ● | 3级 - 不可观测的输入，几乎没有市场活动支持，并且对资产或负债的公允价值具有重大影响。 |
财务工具的资产账面价值，如现金、应付账款和应计负债，由于这些工具的短期到期，近似于相关的公允价值。公司可转换应付票据和来自高管的应付票据的资产账面价值与其公允价值相近，因为票据利率基于现行市场利率。
| 9 |
所得税
收入税前利润。递延税资产和负债是根据预期税收因素对资产和负债的税基和报告金额之间的暂时差异予以确认的。计提准备金以将递延税资产减少到更有可能实现的金额。公司记录
这个
公司使用两步法来识别和衡量不确定的税收状况，以考虑所得税的不确定性。这个
第一步是评估税收状况以供认定，确定现有证据的权重是否表明税收状况更大
该职位很可能会在审计中得以维持，包括相关上诉或诉讼程序的解决（如果有）。
第二步是将税收优惠作为结算时可能实现的超过50％的最大金额来衡量。
在公司预期付款的范围内，公司将未确认的税收优惠负债归类为流动负债（或
一年内收到）现金。与不确定税收状况相关的利息和罚款在收入准备金中确认
税。曾经有
专利 和专利申请费用
尽管公司认为其专利和基础技术具有持续价值，但未来从专利中获得的收益金额是不确定的。因此，专利成本在发生时确认为费用，并包括在附表中的综合损益表的一般和管理费用中。专利费用为$
研发成本
公司将其研发成本列为已发生的费用。截至2024年9月30日和2023年的九个月的研发成本为$
基于股票的薪酬
公司对所有期权和其他基于股票的奖励进行测量，根据授予的奖励在授予日的公允价值，并在相应奖励的必要服务期内（一般为相应奖励的获准期）确认这些奖励的补偿费用。公司已选择在发生时确认弃权。对于因未能满足服务或绩效条件而被放弃的奖励，已经认可的补偿费用的反转在放弃期间进行确认。通常，公司仅对基于服务的归属条件发放期权，并使用直线法在必要服务期内记录这些奖励的费用。
公司对基于股票的补偿费用进行分类，方式与奖励接收方的工资成本或奖励接收方的服务支付分类的方式相同，在其经营报表中显示。
该公司是一家私人公司，直到2024年9月17日其IPO完成。公司通过采用美国注册会计师协会技术实践援助框架中的合适估值方法，估算普通股的公允价值。每种估值方法都包括需要该公司判断的估算和假设。这些估算和假设包括多个客观和主观因素，包括外部市场情况、指导上市公司信息，公司将普通股以公允交易价格出售给第三方的价格，公司普通股高于公司普通股的证券的权利和偏好，以及实现诸如首次公开招股或出售之类的流动性事件的可能性。在估值中使用的假设发生重大变化可能导致每个估值日期的期权的不同公允价值。
每个股票期权或warrants授予的公允价值是根据Black-Scholes期权定价模型估算的。公司是一家私营公司，缺乏公司特定的历史和隐含波动性信息。因此，它根据与公司特征相似的一组公开交易的同行公司在生物技术行业的历史波动性，估算其预期股票波动性。公司的股票期权的预期期限是利用“简化”方法确定的，该方法适用于符合“普通”期权或warrants的奖励。授予非员工的股票期权或warrants的预期期限等同于期权授予的合同期限。无风险利率是参考以授予奖励时的美国国债收益率曲线来确定的，时间段大致等于奖励的预期期限。预计的分红派息收益率为零，这是基于公司从未支付现金分红，并且在可预见的未来不会支付任何现金分红的事实。
最近的会计准则
在2023年11月，财务会计准则委员会（"FASB"）发布了ASU 2023-07，分段报告（主题280）：可报告分段披露的改进，旨在改善可报告分段的披露要求，主要通过增强关于定期提供给首席运营决策maker的重大分段费用类别的披露，并包括在每个报告的分段利润或亏损指标中。该更新还要求在中期提供所有关于可报告分段利润或亏损和资产的年度披露，对于只有一个可报告分段的实体，需提供ASC 280所要求的所有披露，包括重大分段费用的披露。公司自2024年1月1日起采用ASU 2023-07。公司认为新指南及相关的编码改进对其财务状况、运营结果和现金流量没有重大影响。
其他 最近由FASB发布的会计声明，包括其新兴议题特别委员会、美国注册会计师协会和证券交易委员会，并未或管理层相信不会对公司的当前或未来合并基本报表产生重大影响。
注意 3 – 来自关联方的贷款
截至2021年12月31日，公司的股东以及一家主要股东也是公司的股东向公司提前了
| 10 |
截至2024年9月30日的三个月期间，管理人员同意在首次公开募股交易关闭时自动将本金转换为公司的普通股。 在首次公开募股交易关闭时，所有本金自动转换为
由于
这些官员收到了 额外的股份，基于
注意 4 –应付账款 - 官方
截至2024年9月30日的九个月内，公司与三名高管签订了总金额为$的票据支付协议。
2024年9月30日后，债券已偿还， 公司普通股股票已发行给高管（见注释8）。
截至2024年9月30日结束的三个月内，公司与首席财务官道格拉斯·塞缪尔森（Douglas Samuelson）达成协议，塞缪尔森先生同意将其应付账款的$
注意 5 – 可转换票据应付款项
截至2022年12月31日的财年，公司与某些投资者签订了几份可转换票据协议，总金额为$
在截至2023年12月31日的一年期间，该票据上未进行本金或利息支付，而票据应计利息为$
公司占据了$的公司账户
| 11 |
截至2023年12月31日，总未摊销余额为$
在公司的首次公开募股（IPO）结束时，$的本金金额
注意 6 – 股东权益
普通股
已授权股份
公司的公司注册证明于2023年5月10日提交至特拉华州，跟随公司从加利福尼亚公司转变为特拉华公司，授权公司发行最多 股，包括 普通股，面值$ 。 每股股票价格为 每股。普通股的持有者拥有完全的投票权，每持有一股就有一票。股东有权根据董事会所声明的由合法可用的所有基金类型所发放的分红派息，并在清算时与其他股东按比例分享任何分配。股东没有转换权、优先权或认购权。所有流通的普通股均已完全支付且不可评估。截止2024年9月30日和2023年12月31日，共有 和 已发行和流通的普通股数量，分别是，并且 优先股的发行量分别为。
公司IPO完成后以现金发行普通股
2024年9月16日，公司完成了普通股的首次公开募股，发行并出售了 股普通股，公开发行价格为$ 每股，IPO的总募集资金净额为$
根据承销协议，公司于2024年9月17日发行了两份普通股认购权证给承销商，每份股票售价为 股普通股，行权价为
应付账款转换
在截至2024年9月30日的三个月期间，公司与西达斯-西奈医疗中心（“西达斯”）签署了一项协议，西达斯同意将$
| 12 |
2023年股权激励计划的采纳
在 2023年7月，公司董事会和股东通过了2023年股权激励计划（“2023 计划”）。根据2023计划，公司可以授予员工激励股权期权，包括任何母公司或子公司的员工，以及非法定股权期权、股票增值权、限制性股票奖励、RSU奖励、业绩奖励和其他形式的股票奖励给员工、董事和顾问，包括公司的附属机构的员工和顾问。经批准，最初预留了总共 用于2023计划发行的普通股数量为 截至2023年12月31日，已根据2023计划发行了 截至2024年9月30日，共发行了 截至2024年9月30日， 根据2023计划可供授予的股份为
限制性股票授予
下表总结了截至2024年9月30日的九个月内限制性普通股活动：
数量 限制股 股份 | 公平价值 价值 | 加权平均授予日期公允价值 | ||||||||||
| 未取得的股份，2023年12月31日 | $ | $ | ||||||||||
| 已授予 | ||||||||||||
| 归属 | ( | ) | ( | ) | ||||||||
| 被取消 | ||||||||||||
| 2024年9月30日，未归属 | $ | $ | ||||||||||
在2024年9月23日，公司与Belair Capital Advisors Inc.（“BCA”）签订了一份战略顾问协议（“战略顾问协议”）。在战略顾问协议的一年期限内，作为服务的交换，公司向BCA发行了
RSU，这些RSU将在发行后六个月结束时归属。授予时股票的公允价值为$
在公司首次公开募股完成时，公司与其三名独立董事签署了董事协议。
这些协议规定年度现金补偿为$
在2024年9月30日结束的三个月和九个月内，共计$股票报酬被记录，用于无条件普通股和 的公允价值归属截至2024年9月30日，剩余$未摊销的报酬。
| 13 |
股票 认股权证
以下表格总结了公司截至2024年9月30日九个月的权证活动：
| 认股权证股份数量 | 行使 价格 范围 每股 | 加权 平均行权价格 | ||||||||||
| 2023年12月31日余额 | $ | $ | ||||||||||
| 已授予 | – | |||||||||||
| 取消 | ||||||||||||
| 已行权 | ||||||||||||
| 被剥夺/过期 | ||||||||||||
| 余额，2024年9月30日 | $ | – | $ | |||||||||
| 截至2024年9月30日，已授予和行使的股票期权 | $ | – | $ | |||||||||
以下表格总结了截至2024年9月30日的未到期和可行使的warrants的信息：
| 此外，有待行使的权证 | 待行使的权证 | |||||||||||||||||||||||||
| 区间 行使价格 | 数量 尚未行使 | 平均 剩余合同期限 （）年内 | 加权 平均行权价格 | 数量 可行使 | 平均 剩余合同期限 （）年内 | 加权 平均行权价格 | ||||||||||||||||||||
| $ | $ | $ | ||||||||||||||||||||||||
- | ||||||||||||||||||||||||||
| $ | – | $ | $ | |||||||||||||||||||||||
在
2024年9月17日，IPO完成时，公司向参与的承销商发行了两个股票warrants，每个warrants用于购买
在2024年9月17日，首次公开募股（IPO）结束时，公司向承销商发行了一份认股权证，用于购买 认股权证行使价格为$开多的募股价值，每股普通股的价格为$
截至2022年12月31日的年度内，公司与一名个人签署了一份可转换债券协议，金额为$
有 2024年9月30日截至，认股权证股份的内在价值。
注7 - 股东赤字承诺和 contingencies
Kairos 与Prevail Infoworks，Inc.达成协议。
2024年8月，公司与Prevail Infoworks, Inc.（“Prevail”）签署了一项主服务和技术协议，根据协议，Prevail同意向公司提供某些临床研究服务。作为协议的一部分，公司必须在Prevail开始提供服务之前向其支付预付款$
| 14 |
凯罗斯 与PreCheck健康服务公司的协议。
在2024年9月20日，公司与位于佛罗里达州的PreCheck Health Services, Inc.（“PreCheck”）签订了一份生物测定服务协议（“生物测定服务协议”）。根据该协议，PreCheck将为公司的正在进行的carotuximab（ENV105）临床试验提供某些生物标志物筛查服务，以协助公司识别适合进行肺癌患者的第一阶段临床试验和雄激素抵抗前列腺癌患者的第二阶段试验的患者。为了识别用于患者筛查和治疗监测的生物标志物，PreCheck将利用其SolidTumorCheck+平台对来自肺癌和前列腺癌患者的活检组织样本进行体细胞基因表达分析，这是公司正在进行的临床试验的一部分。为了进一步推进这些工作，PreCheck将开发一个伴随诊断，以支持其识别此类患者，采用三基因PCR分析或其他遗传分析，该诊断测试将被开发并提交给食品和药物管理局（“FDA”），用于雄激素抵抗前列腺癌患者和正在接受Tagrisso治疗的肺癌患者。作为对PreCheck服务的交换，并根据生物测定服务协议的条款，公司支付了$
凯罗斯 与首席执行官.CA科技有限公司的协议。
2024年9月23日，公司与加拿大公司CEO.CA Technologies Ltd.签订了一份咨询服务协议（“CEO.CA协议”），根据该协议，CEO.CA将提供为期一年的特定基于互联网的金融信息和通信服务，服务费为$
Kairos 与贝莱尔资本顾问公司的协议。
开启
2024 年 9 月 23 日，公司与 Belair 签订了战略咨询协议（“战略咨询协议”）
资本顾问公司（“BCA”）。风险投资和企业融资咨询公司BCA一直是长期投资者
也是公司的顾问，经常与早期制药公司合作。战略咨询服务包括
制药行业的企业战略、市场定位和长期增长计划、数字营销和参与，
市场研究分析和业务发展援助等.在战略咨询的一年期内
协议，以换取其服务，公司将向BCA支付一美元
公司根据协议生效日的收盘股价对其进行了评估 股，每股售价为$
| 15 |
Kairos 与医疗中心辛尼医学中心（辛尼）签订独家许可协议
公司已与Cedars签订了四份独家许可协议，授予公司对Cedars拥有的某些专利权的许可权如下：
| 1. | 方法 用于结合NFkB的RelA的化合物的使用； | |
| 2. | 组成 及治疗纤维化的方法； | |
| 3. | 组成 及治疗癌症和自身免疫疾病的方法；以及 | |
| 4. | 方法 生成用于癌症治疗的活化T细胞。 |
对于项目1、2和3中的每个独占许可协议，公司需要支付初始许可费$
| ● | $ | |
| ● | $ | |
| ● | $ | |
| ● | $ |
For
the exclusive license agreement listed in item 4, the Company is required to pay an initial license fee of $
| ● | $ | |
| ● | $ | |
| ● | $ | |
| ● | $ |
Enviro Therapeutics
On June 2, 2021, the Company’s wholly owned subsidiary, Enviro Therapeutics, Inc. (Enviro), entered into two Exclusive License Agreements with Cedars, which granted Enviro exclusive licensing rights (which include the right to sublicense) with respect to certain patent rights owned by Cedars, as follows:
| ● | an Exclusive License Agreement (the “Enviro-Cedars License Agreement (Mitochondrial DNA)”) for Enviro to develop, manufacture, use and sell products utilized or derived from patent rights worldwide related to the “Compositions and Methods for Treating Diseases and Conditions by Depletion of Mitochondrial DNA from Circulation and for Detection of Mitochondrial DNA” invented by Dr. Neil Bhowmick and others; and | |
| ● | an Exclusive License Agreement, (the “Enviro-Cedars License Agreement (Endoglin Antagonism)” and, collectively with the Enviro-Cedars License Agreement (Mitochondrial DNA), the “Enviro-Cedars License Agreements”) for Enviro to develop, manufacture, use and sell products utilized or derived from the patent rights and technical information worldwide related to the “Sensitization of Tumors to Therapies Through Endoglin Antagonism” invented by Dr. Neil Bhowmick and others. |
In exchange for each of the licenses, Enviro is required to pay an upfront license fee in the mid four-figures and low-five figures, respectively. Enviro is also required to reimburse Cedars for the costs in the mid-to-high six figures incurred in the prosecution of the patent rights subject to the Enviro-Cedars License Agreements prior to the date of execution of such agreements, and certain costs and fees then outstanding aggregating in the low-six figures owed by Kairos pursuant to the Kairos-Cedars License Agreements. Pursuant to the Enviro-Cedars License Agreements, Cedars shall also receive royalty payments of a mid-single-digit percentage of net sales of products associated with the licensed patent right and less than one percent of net sales of other products derived from Cedars’ technical information, with a minimum annual royalty fee in the low five-digits due beginning on the third anniversary of the effective date of the Enviro-Cedars License Agreements. To the extent Enviro derives non-royalty sublicensing revenues, a high single-digit to low double-digit percentage of such revenues would be due and payable to Cedars, with the actual percentage of such revenues dependent on the stage of FDA authorization at the time the sublicense revenue is generated.
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Enviro
is also required to pay Cedars in connection with achieving the following Payment Milestones relating to products derived from the patent
rights: successful completion of a Phase I clinical trial; successful completion of a Phase II clinical trial, receipt of FDA approval,
and approval for a Phase III clinical trial; FDA approval of an NDA or BLA; cumulative net sales exceeding $
Pursuant
to the Enviro-Cedars License Agreements, Enviro is obligated to meet the following Commercialization Milestones. Pursuant to the Enviro-Cedars
License Agreement (Endoglin Antagonism), Enviro is obligated to
The Enviro-Cedars License Agreements will, unless sooner terminated, continue in effect on a country-by-country basis until the last of the patents covering the patent rights or future patent rights expires. Under the terms of the Enviro-Cedars License Agreements, unless waived by Cedars, the agreements would automatically terminate: (a) if Enviro ceases, dissolves or winds up its business operations; (b) if performance by either party jeopardizes the licensure, accreditation or tax exempt status of Cedars or the agreement is deemed illegal by a governmental body; (c) within 30 days for non-payment of royalties or if Enviro fails to undertake commercially reasonable efforts to exploit the patent rights or future patent rights; (d) within 60 days of Cedars’ failure to cure any breach or default of a material obligation under the agreements; (e) within 90 days of Enviro’s failure to cure any breach or default of a material obligation under the agreements; or (f) upon mutual written agreement of the parties.
On March 7, 2024, the Company and Enviro
entered into a conversion agreement with Cedars pursuant to which Cedars agreed to convert $
License Agreement with Tracon Pharmaceutical, Inc.
On May 21, 2021, Enviro entered into a License Agreement with Tracon Pharmaceutical, Inc. (“Tracon”). Pursuant to the Tracon License Agreement, Tracon granted Enviro access to inactive IND filings for “TRC105” in the United States; ownership of “TRC105” stored vials of drug product manufactured to GMP standards stored at Fisher Clinical or their designee; and assignment of Tracon’s patent rights to its “CD105 technologies” (all as defined or described in the Tracon License Agreement).
Pursuant
to the Tracon License Agreement, Enviro paid Tracon an upfront fee of $
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Agreement with former Chief Financial Officer
The
Company has an agreement with its former Chief Financial Officer that requires the Company to pay $
NOTE 8 – SUBSEQUENT EVENTS
Notes Payable from Officers
As
of September 30, 2024, the Company owed $
Kairos Agreement with Prevail
In
August 2024, the Company entered into a master service and technology agreement with Prevail pursuant to which Prevail
agreed to provide certain clinical research services to the Company (see Note 7). As part of the agreement, the Company must make an
advance payment of $
Kairos Agreement with Cross Current Capital LLC
On
October 1, 2024, the Company entered into a consulting agreement (the “Consulting Agreement”) with Cross Current Capital
LLC, a limited liability company organized under the laws of Puerto Rico (“Cross Current”), and Alan Masley (the “Advisor”),
pursuant to which Cross Current agreed to provide certain financial and business consulting services to the Company including, but not
limited, to (a) help drafting a public company competitive overview, (b) help preparing and/or reviewing a valuation analysis, (c) help
in drafting marketing materials and presentations, (d) reviewing the Company’s business requirements and discuss financing and
businesses opportunities, (e) investor marketing, (f) investor relations introductions, (g) legal counsel introductions, (h) auditor
introductions, (i) investment banking and research introductions, (j) M&A canvassing and ways to grow the business organically, and
(k) stand by capital markets advisory services. For the services rendered thereunder, the Company agreed to pay Cross Current $
Settlement Agreement
On
October 17, 2024, the Company entered into a Settlement Agreement with the Company’s former legal counsel. In connection with
the agreement, the law firm agreed to settle the amount the Company owed them, which totaled $
Common Share Issuances
On October 4, the Company’s board of directors approved the grant of shares of its common stock to the Company’s CFO.
Employment Agreements
On November 11, 2024, the Company entered into an agreement with each of its four executive officers under which each agreed to delay receipt of compensation under their agreements from the IPO effective date to January 1, 2025.
Agreement with Helena Global Investment Opportunities
On November 12, 2024, the Company entered into an agreement with Helena
Global Investment Opportunities I LTD (“Helena”) pursuant to which the Company will have the right to issue and sell to the
Helena, from time to time, and Helena shall purchase from the Company, up to $
Conversion of Accounts Payable
On November 13, 2024, the Company
entered into an agreement with Cedars-Sinai Medical Center (“Cedars”) under which Cedars agreed to convert $
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
(in thousands, except for share amounts and per share data)
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited consolidated financial statements and related notes appearing in Part I, Item 1 of this Quarterly Report on Form 10-Q (the “Quarterly Report”), and with our audited financial statements and notes thereto for the year ended December 31, 2023, included in our prospectus dated September 16, 2024 (File Number: 333-274805)(the “Prospectus”).
Special Note Regarding Forward-Looking Statements
In addition to historical information, some of the statements 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, constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). We have based these forward-looking statements on our current expectations and any projections about future events. The following information and any forward-looking statements should be considered in light of factors discussed elsewhere in this Quarterly Report, along with the risks identified in the Prospectus under the title “Risk Factors” and in our other filings with the Securities Exchange Commission (the “SEC”).
We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report. Statements made herein are as of the date of the filing of this Quarterly Report with the SEC and should not be relied upon as of any subsequent date. Even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this Quarterly Report, they may not be predictive of results or developments in future periods. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Overview
We are a clinical-stage biopharmaceutical company advancing therapeutics for cancer patients that are designed to overcome key hurdles in immune suppression and drug resistance.
Our mission is to advance our portfolio of innovative therapeutics to reverse key mechanisms of therapeutic resistance and immune suppression and transform the way cancer is treated. We have leveraged molecular insights of the mechanisms of therapeutic resistance and immune suppression to develop a new class of novel drugs that we expect will target drug resistance and checkpoints of immune suppression. As of the date of this Quarterly Report, our product candidates have not been approved as safe or effective by the Food and Drug Administration (“FDA”) or any other comparable foreign regulator.
Since inception, our operations have focused on organizing and staffing our company, business planning, raising capital, acquiring and developing our technology, establishing our intellectual property portfolio, identifying potential product candidates and undertaking preclinical and clinical studies and manufacturing. We do not have any products approved for sale and have not generated any revenue from product sales.
Since inception, we have incurred significant operating losses. Our net losses were $1,623 and $1,812 for the nine months ended September 30, 2024 and for the year ended December 31, 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $7,835. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our current and future product candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel and operate as a public company.
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We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates. In addition, if we obtain regulatory approval for our product candidates and do not enter into a third-party commercialization partnership, we will likely incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing, and distribution activities.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all. Our failure to raise capital or enter into such agreements as, and when needed, could have a material adverse effect on our business, results of operations and financial condition.
The report of our independent registered public accounting firm on our financial statements for the years ended December 31, 2022 and 2023 included an explanatory paragraph indicating that there was substantial doubt about our ability to continue as a going concern. See Note 1 to our annual financial statements appearing at the Prospectus for additional information on our assessment.
At September 30, 2024, the Company had cash on hand in the amount of $3,217. The ability to continue as a going concern is dependent on the Company attaining and maintaining profitable operations in the future and raising additional capital to meet its obligations and repay its liabilities arising from normal business operations when they come due. Since inception, the Company has funded its operations primarily through equity and debt financings and it expects to continue to rely on these sources of capital in the future.
No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in case of equity financing.
Critical Accounting Policies and Significant Judgments and Estimates
This Management’s Discussion and Analysis of Financial Condition and Results of Operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the date of the balance sheets and the reported amounts of expenses during the reporting periods. In accordance with GAAP, we base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances at the time such estimates are made. Actual results may differ materially from our estimates and judgments under different assumptions or conditions. We periodically review our estimates in light of changes in circumstances, facts and experience. The effects of material revisions in estimates are reflected in our financial statements prospectively from the date of the change in estimate.
We define our critical accounting policies as those accounting principles that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. While our significant accounting policies are more fully described in Note 2 to our unaudited financial statements appearing elsewhere in this Quartey Report, we believe the following are the critical accounting policies used in the preparation of our financial statements that require significant estimates and judgments.
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Research and Development Expenses
Research and development expenses consist primarily of costs incurred in connection with the development of our product candidates. We expense research and development costs as incurred.
At the end of each reporting period, we compare payments made to third-party service providers to the estimated progress toward completion of the applicable research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that we estimate has been made as a result of the service provided, we may record net prepaid or accrued expenses relating to these costs. As of December 31, 2023, and September 30, 2024, we have not made any material adjustments to our prior estimates of accrued research and development expenses.
Stock-Based Compensation
The Company measures all stock options and other stock-based awards granted based on the fair value of the award on the date of the grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award. The Company has elected to recognize forfeitures as they occur. The reversal of compensation cost previously recognized for an award that is forfeited because of a failure to satisfy a service or performance condition is recognized in the period of the forfeiture. Generally, the Company issues stock options with only service-based vesting conditions and records the expense for these awards using the straight-line method over the requisite service period.
The Company classifies stock-based compensation expense in its statements of operations in the same manner in which the award recipient’s payroll costs are classified or in which the award recipients’ service payments are classified.
The Company was a private company until the completion of its IPO on September 17, 2024. The Company estimates the fair value of common stock using an appropriate valuation methodology, in accordance with the framework of the American Institute of Certified Public Accountants’ Technical Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation. Each valuation methodology includes estimates and assumptions that require the Company’s judgment. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, guideline public company information, the prices at which the Company sold its common stock to third parties in arms’ length transactions, the rights and preferences of securities senior to the Company’s common stock at the time, and the likelihood of achieving a liquidity event such as an initial public offering or sale. Significant changes to the assumptions used in the valuations could result in different fair values of stock options or warrants at each valuation date, as applicable.
The fair value of each stock option or warrant grant is estimated using the Black-Scholes option-pricing model. The Company was a private company and lacked company-specific historical and implied volatility information. Therefore, it estimated its expected stock volatility based on the historical volatility of a publicly traded set of peer companies within the biotechnology industry with characteristics similar to the Company. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to non-employees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is zero, based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.
Off-Balance Sheet Arrangements
During the years ended December 31, 2022 and 2023, and the nine months ended September 30, 2024, we did not have, and we do not currently have, any off-balance sheet arrangements (as defined under SEC rules).
Recent Accounting Pronouncements
For a description of recently issued accounting standards that may have a material impact on our financial statements or will otherwise apply to our operations, please see Note 2 to our unaudited financial statements appearing elsewhere in this Quartey Report.
Emerging Growth Company Status
As an “emerging growth company,” the Jumpstart Our Business Startups Act of 2012 permits us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have irrevocably elected to “opt out” of this provision and, as a result, we will comply with new or revised accounting standards when they are required to be adopted by public companies that are not emerging growth companies.
Components of Results of Operations
Net Sales
We have not generated any sales to date. There was no revenue recorded from any sources during the year ended December 31, 2023, and the nine months ended September 30, 2024.
Operating Expenses
Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.
Research and Development Expenses
Dr. Ramachandran Murali is our Vice President of Research and Development. Dr. Murali is a doctor and scientist at Cedars-Sinai Medical Center, and is the inventor, with others, of three of the patent technologies that are subject to the Kairos-Cedars license agreements.
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We are engaged in rolling out Phase 1 and Phase 2 clinical trials for ENV-105 and a Phase 1 trial for KROS-201. In addition, we are continuously performing preclinical research including animal models of disease, medicinal chemistry laboratory studies, formulation, and toxicology and biodistribution studies. Our clinical development costs may vary significantly based on factors such as: per patient trial costs; the number of trials required for approval; the number of sites included in the trials; the location where the trials are conducted; the length of time required to enroll eligible patients; the number of patients that participate in the trials; the number of doses that patients receive; the drop-out or discontinuation rates of patients; potential additional safety monitoring requested by regulatory agencies; the duration of patient participation in the trials and follow-up; the cost and timing of manufacturing our product candidates; the phase of development of our product candidates; and the efficacy and safety profile of our product candidates.
The successful development and commercialization of product candidates is highly uncertain. This is due to the numerous risks and uncertainties associated with product development and commercialization, including the following: the timing and progress of nonclinical and clinical development activities; the number and scope of nonclinical and clinical programs we decide to pursue; raising necessary additional funds; the progress of the development efforts of parties with whom we may enter into collaboration arrangements; our ability to maintain our current development program and to establish new ones; our ability to establish new licensing or collaboration arrangements; the successful initiation and completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority; the receipt and related terms of regulatory approvals from applicable regulatory authorities; the availability of drug substance and drug product for use in production of our product candidate; establishing and maintaining agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if our product candidates are approved; our ability to obtain and maintain patents, trade secret protection and regulatory exclusivity, both in the United States and internationally; our ability to protect our rights in our intellectual property portfolio; the commercialization of our product candidates, if and when approved; obtaining and maintaining third-party insurance coverage and adequate reimbursement; the acceptance of our product candidate, if approved, by patients, the medical community and third-party payors; competition with other products; the impact of any business interruptions to our operations, including the timing and enrollment of patients in our planned clinical trials, or to those of our manufacturers, suppliers, or other vendors resulting from the COVID-19 pandemic or similar public health crisis; and a continued acceptable safety profile of our therapies following approval.
A change in the outcome of any of these variables with respect to the development of our product candidates could significantly change the costs and timing associated with the development of that product candidate. We may never succeed in obtaining regulatory approval for any of our product candidates.
General and administrative expenses
General and administrative expenses consist primarily of salaries and related costs for personnel in executive, finance, corporate and business development, as well as administrative functions. General and administrative expenses also include legal fees relating to patent, corporate, IPO-related matters, and reporting matters; professional fees for accounting, auditing, tax and administrative consulting services; insurance costs; administrative travel expenses; marketing expenses and other operating costs.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our business operations. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs, as well as investor and public relations expenses associated with being a public company.
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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 (in thousands), respectively:
| 运营 费用： | 九月 2024 年 30 日 | 九月 2023 年 30 日 | ||||||
| 研究和 发展 | $ | 14 | $ | 33 | ||||
| 普通的 和行政 | 369 | 254 | ||||||
| 运营费用总额 | 383 | 287 | ||||||
| 运营损失 | (383 | ) | (287 | ) | ||||
| 其他费用： | ||||||||
| 利息支出 | (12 | ) | (15 | ) | ||||
| 融资成本 | (537 | ) | - | |||||
| 债务 折扣摊销 | (115 | ) | (10 | ) | ||||
| 其他支出总额 | (664 | ) | (25 | ) | ||||
| 净亏损 | $ | (1,047 | ) | $ | (312 | ) | ||
研究与开发支出
下表总结了截至2024年9月30日和2023年9月30日的三个月内我们的研发费用（以千元计）：
| 研发费用： | 2024年9月 30日 | 2023年9月30日 | ||||||
| 临床及相关费用 | $ | 14 | $ | 33 | ||||
| 总研发费用 | $ | 14 | $ | 33 | ||||
研发费用分别为2024年和2023年截至9月30日的三个月分别为14美元和33美元。 期间没有显着变化。
一般和行政费用
下表总结了截至2024年9月30日和2023年的三个月我们的一般和行政费用（按千计）。
| 一般和行政费用： | 2024年9月 30日 | 2023年9月30日 | ||||||
| 专利相关费用 | $ | 114 | $ | 109 | ||||
| 保修准备金 | 34 | - | ||||||
| 会计费用 | 30 | 47 | ||||||
| 其他专业费用 | 93 | 11 | ||||||
| 与许可协议相关的费用 | 29 | 30 | ||||||
| 保险费用 | 12 | 5 | ||||||
| 摊销费用 | 40 | 40 | ||||||
| 其他开支 | 17 | 12 | ||||||
| 总行政与管理费用 | $ | 369 | $ | 254 | ||||
General and administrative expenses were $369 and $254 for the three months ended September 30, 2024 and 2023, respectively. There were no significant changes between periods.
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Other Expenses
Other expenses were $664 and $25 for the three months ended September 30, 2024 and 2023, respectively. The increase in 2024 was due to financing costs recorded during 2024 of $537 and the increase in debt discount amortization in 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 (in thousands), respectively:
| Operating Expenses: | September 30, 2024 | September 30, 2023 | ||||||
| Research and development | $ | 242 | $ | 75 | ||||
| General and administrative | 655 | 550 | ||||||
| Total operating expenses | 897 | 625 | ||||||
| Loss from operations | (897 | ) | (625 | ) | ||||
| Other expenses: | ||||||||
| Interest expense | (35 | ) | (39 | ) | ||||
| Financing costs | (537 | ) | - | |||||
| Debt discount amortization | (154 | ) | (30 | ) | ||||
| Total other expenses | (726 | ) | (69 | ) | ||||
| Net loss | $ | (1,623 | ) | $ | (694 | ) | ||
Research and Development Expenses
The table below summarizes our research and development expenses for the nine months ended September 30, 2024 and 2023 (in thousands), respectively:
| Research and Development Expenses: | September 30, 2024 | September 30, 2023 | ||||||
| Clinical and related expenses | $ | 242 | $ | 75 | ||||
| Total research and development expenses | $ | 242 | $ | 75 | ||||
Research and development expenses were $242 and $75 for the nine months ended September 30, 2024 and 2023, respectively. The increase in 2024 primarily resulted from expenses relating to the beginning of our Phase 2 clinical trial for our lead product candidate ENV 105.
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一般和行政费用
下表总结了截至2024年9月30日和2023年9月30日的九个月的管理及行政费用（以千计）：
| General and Administrative Expenses: | September 30, 2024 | September 30, 2023 | ||||||
| Patent related expenses | $ | 123 | $ | 130 | ||||
| Legal fees | 2 | - | ||||||
| Stock compensation | 34 | - | ||||||
| Accounting fees | 102 | 145 | ||||||
| Other professional fees | 125 | 33 | ||||||
| Fees relating to license agreements | 93 | 88 | ||||||
| Insurance expense | 33 | 11 | ||||||
| Amortization expense | 120 | 120 | ||||||
| Other expenses | 23 | 23 | ||||||
| Total general and administrative expenses | $ | 655 | $ | 550 | ||||
General and administrative expenses were $655 and $550 for the nine months ended September 30, 2024 and 2023, respectively. There were no significant changes between periods.
Other Expenses
Other expenses were $726 and $69 for the nine months ended September 30, 2024 and 2023, respectively. The increase in 2024 was due to financing costs recorded during 2024 of $537 and the increase in debt discount amortization in 2024.
Liquidity and Capital Resources
During the year ended December 31, 2023, the Company incurred a net loss of $1,812 and had a shareholders’ deficit of $2,078 as of December 31, 2023. As reflected in the accompanying condensed consolidated financial statements, during the nine months ended September 30, 2024, the Company incurred a net loss of $1,623 and used cash in operations of $2,152.
During the nine months ended September 30, 2024, the Company closed its initial public offering (“IPO”) and received $5,524 of net proceeds from this offering, before deducting deferred offering costs. Due to the funds received through this offering, and the conversion of convertible notes payable and certain accounts payable upon the closing of the IPO, the Company had shareholders’ equity of $3,332 at September 30, 2024. The Company now expects its cash, totaling $3,217 at September 30, 2024, to last into the fourth quarter of 2025.
The ability to continue as a going concern is dependent on the Company attaining and maintaining profitable operations in the future and raising additional capital to meet its obligations and repay its liabilities arising from normal business operations when they come due. Since inception, the Company has funded its operations primarily through equity and debt financings and it expects to continue to rely on these sources of capital in the future.
No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.
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Cash Flows for the Nine Months Ended September 30, 2024 and 2023
The table below summarizes our cash flow activities for the nine months ended September 30, 2024 and 2023 (in thousands), respectively:
| Nine months Ended September 30, | ||||||||
| Net cash provided by (used in): | 2024 | 2023 | ||||||
| Operating activities | $ | (2,152 | ) | $ | 15 | |||
| Investing activities | - | - | ||||||
| Financing activities | 5,276 | (353 | ) | |||||
| Net increase (decrease) in cash | $ | 3,124 | $ | (338 | ) | |||
Operating Activities
During the nine months ended September 30, 2023, we provided cash from operating activities of $15, compared to $2,152 used during the nine months ended September 30, 2024. During the nine months ended September 30, 2024, we incurred a net loss of $1,623 and had non-cash expenses of $845, compared to a net loss of $694 and non-cash expenses of $150 during the nine months ended September 30, 2023. The primary non-cash expense incurred during both periods was amortization expense, totaling $120 during the nine months ended September 30, 2024 and 2023, respectively. The net change in assets and liabilities during the nine months ended September 30, 2023 provided cash of $559, compared to $1,374 used during the nine months ended September 30, 2024. The primary source of cash relating to the change in assets and liabilities for the nine months ended September 30, 2024 and 2023 was the increase in accounts payable and accrued expenses. The primary use of cash was the increase in vendor advances.
Investing Activities
There was no cash used in investing activities for the nine months ended September 30, 2024 and 2023.
Financing Activities
Net cash (used in) provided by financing activities for the nine months ended September 30, 2024 and 2023 was 5,276 and $(353), respectively. For the nine months ended September 30, 2024 and 2023, cash used in financing activities consisted of payments of deferred offering costs of $390 and $353, respectively. For the nine months ended September 30, 2024, cash provided by financing activities consisted of $5,524 of proceeds from common stock issued in connection with the IPO and $142 from notes payable – officers.
Debt Agreements
Advances from Related Parties
During the year ended December 31, 2021, shareholders of the Company, and a company whose principal stockholder is also a stockholder of the Company, advanced the Company $14, all of which was outstanding at December 31, 2021. The advances accrue no interest, are unsecured and are due on demand. As of December 31, 2021, $14 was owed on the advances. During the year ended December 31, 2022, the Company repaid $10 of the advances, and as of December 31, 2022 and 2023, and September 30, 2024, a total of $4 remained outstanding.
Convertible Notes Payable
During the year ended December 31, 2022, the Company entered into several convertible note payable agreements with certain investors. The convertible notes accrue interest at 6% per annum, are unsecured and are due by April 2025. If the Company does not close an IPO transaction within 12 months following the date of issuance of the notes, the Company will have the choice of paying off the principal plus all accrued and unpaid interest, or the note’s principal balance will increase to 110% of its original balance. The notes are convertible at the option of the noteholders into shares of the Company’s common stock at a price per share as defined in the agreement or will automatically be converted into shares of the Company’s common stock at 60% of the IPO price per share upon the closing of the IPO. The convertible note offerings were completed pursuant to an exemption from registration under Rule 506(b) of the Securities Act. Boustead Securities, LLC acted as placement agent in each of the June and September 2022 private placements and received five-year warrants to purchase shares of common stock equal to 7.0% of the number of the conversion shares at an exercise price equal to the conversion price.
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As of September 30, 2024, $792 of principal was outstanding on the notes and $92 of accrued and unpaid interest, which automatically converted into 368,371 shares of the Company’s common stock upon the closing of the Company’s IPO.
Notes Payable - Officers
During the nine months ended September 30, 2024, the Company borrowed $142 from three of its officers. The loans accrue interest at 7.5% per annum, are unsecured and are due one year from the issuance date, with the due dates ranging from April 2025 to August 2025.
Subsequent to September 30, 2024, the loans were repaid and the officers were granted 36,269 shares of the Company’s common stock.
Conversion of Accounts Payable
Subsequent to December 31, 2023, we entered into agreements with Cedars-Sinai Medical Center (“Cedars”) under which Cedars agreed to convert $750 of the $988 total accounts payable due to them into 312,500 shares of our common stock, with such conversion to occur upon the closing of the Company’s IPO. The conversion price of the shares will be equal to 60% of the per share IPO price. Upon the closing of the Company’s IPO, the 312,500 shares were issued to Cedars and the $750 of debt was forgiven.
Conversion of Amounts Due to Related Parties
Subsequent to December 31, 2023, two officers and shareholders agreed to convert the $4 due to them into 1,664 shares of the Company’s common stock, effective upon the closing of the Company’s IPO. The conversion price of the shares was equal to 60% of the per share IPO purchase price. During the three months ended September 30, 2024, the debt converted, and the 1,664 shares were issued.
As of September 30, 2024, an officer converted $172 of accounts payable owed primarily for past services into 51,610 shares of the Company’s common stock, effective upon the closing of the Company’s IPO. The conversion price of the shares was equal to the IPO per share purchase price times a multiple of 1.2, as per the officer’s employment agreement.
Funding Requirements
We expect our expenses to increase substantially in connection with our ongoing research activities, particularly as we pursue the advancement of our product candidates through clinical trials. In addition, we expect to incur additional costs associated with operating as a public company. The timing and amount of our operating expenditures will depend on numerous variables, including: the initiation, progress, timing, costs and results of the clinical trials for our product candidates or any future product candidates we may develop; the initiation, progress, timing, costs and results of nonclinical studies for our product candidates or any future product candidates we may develop; our ability to maintain our relationships with key collaborators; the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more nonclinical studies or clinical trials than those that we currently expect or change their requirements on studies that had previously been agreed to; the cost to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing any patents or other intellectual property rights; the effect of competing technological and market developments; the costs of continuing to grow our business, including hiring key personnel and maintain or acquiring operating space; market acceptance of any approved product candidates, including product pricing, as well as product coverage and the adequacy of reimbursement by third-party payors; the cost of acquiring, licensing or investing in additional businesses, products, product candidates and technologies; the cost and timing of selecting, auditing and potentially validating a manufacturing site for commercial-scale manufacturing; the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval and that we determine to commercialize; and our need to implement additional internal systems and infrastructure, including financial and reporting systems.
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We believe that our existing cash, plus the net proceeds from the IPO, will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. We expect that we will require additional funding to complete the clinical development and commercialize our product candidates, if we receive regulatory approval, and pursue in-licenses or acquisitions of other product candidates. If we receive regulatory approval for our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize ourselves.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity and debt financings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements with third parties. To the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interest may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect the rights of our current common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specified actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Contractual Obligations and Commitments
Kairos Agreement with Prevail Infoworks, Inc.
In August 2024, the Company entered into a master service and technology agreement with Prevail Infoworks, Inc. (“Prevail”), pursuant to which Prevail agreed to provide certain clinical research services to the Company. As part of the agreement, the Company must make an advance payment of $900 to Prevail before they begin their services and, at such time as we notify Prevail to engage their services related to the relevant clinical trial, or six months from the date of the agreement, pay approximately $80 per month during the time Prevail performs clinical research services for the Company’s Phase 2 ENV 105 prostate and Phase 1 ENV 105 lung clinical trials. The agreement with Prevail is subject to cancellation at any time upon 30 days’ written notice to the other party. The Company made the advance payment to Prevail in October 2024.
Kairos Agreement with PreCheck Health Services, Inc.
On September 20, 2024, the Company entered into a bioassay services agreement (the “Bioassay Services Agreement”) with PreCheck Health Services, Inc., a Florida-based corporation (“PreCheck”). Pursuant to the Bioassay Services Agreement, PreCheck will provide certain biomarker screening services for the Company’s ongoing carotuximab (ENV105) clinical trials in order to assist the Company in identifying lung and prostate cancer patients suitable to the Company’s ongoing Phase 1 clinical trials for lung cancer patients and Phase 2 trials for patients with castrate resistant prostate cancer. In order to identify biomarkers for patient screening and therapy monitoring using carotuximab (ENV105), PreCheck will utilize its SolidTumorCheck+ platform for the somatic gene expression analysis of biopsy tissue samples derived from patients with lung and prostate cancer, as part of the Company’s ongoing clinical trials. In furtherance of these efforts, PreCheck will develop a companion diagnostic to support its identification of such patients with a three gene PCR analysis or other genetic analysis, which diagnostic test will then be developed and submitted to the FDA for castrate-resistant prostate cancer patients and for lung cancer patients on Tagrisso. In exchange for PreCheck’s services, and according to the terms of the Bioassay Services Agreement, the Company paid $900 to PreCheck as an advance for the future laboratory services to be performed. The payment of $900 is included in vendor advances on the accompanying balance sheet as of September 30, 2024. The term of the agreement is one year from the effective date.
Kairos Agreement with CEO.CA Technologies Ltd.
On September 23, 2024, the Company entered into an advisory and consulting services agreement (the “CEO.CA Agreement”) with CEO.CA Technologies Ltd., a Canadian company (“CEO.CA”), pursuant to which CEO.CA will provide certain internet-based financial information and communications services for a period of one year for a services fee of $250. The service fee is an advance on future services to be performed. The CEO.CA Agreement includes such services as strategic news placement, news releases, interviews, monthly analytics and a video launch. The CEO.CA Agreement contains other customary clauses, including representations and warranties, indemnification clauses and governing law clauses. The payment of $250 is included in vendor advances on the accompanying balance sheet as of September 30, 2024.
Kairos Agreement with Belair Capital Advisors Inc.
On September 23, 2024, the Company entered into a strategic advisory agreement (the “Strategic Advisory Agreement”) with Belair Capital Advisors Inc. (“BCA”). BCA, a venture capital and corporate finance advisory firm, has been a long-term investor and advisor to the Company and frequently works with early-stage pharmaceutical companies. The strategic advisory services consist of corporate strategy, market positioning and long-term growth plans within the pharmaceutical sector, digital marketing and engagement, market research analysis and business development assistance, among other things. During the one-year term of the Strategic Advisory Agreement, in exchange for its services, the Company will pay BCA a $365 fee and will issue BCA 50,000 RSUs, which will vest at the end of six months. The payment of $365 is included in vendor advances on the accompanying balance sheet as of September 30, 2024.
The Company valued the 50,000 shares of common stock at $100 based on the Company’s closing stock price on the effective date of the agreement. The fair value will be amortized over the one-year term of the agreement.
Kairos Agreement with Cross Current Capital LLC
On October 1, 2024, the Company entered into a consulting agreement (the “Consulting Agreement”) with Cross Current Capital LLC, a limited liability company organized under the laws of Puerto Rico (“Cross Current”), and Alan Masley (the “Advisor”), pursuant to which Cross Current agreed to provide certain financial and business consulting services to the Company including, but not limited, to (a) help drafting a public company competitive overview, (b) help preparing and/or reviewing a valuation analysis, (c) help in drafting marketing materials and presentations, (d) reviewing the Company’s business requirements and discuss financing and businesses opportunities, (e) investor marketing, (f) investor relations introductions, (g) legal counsel introductions, (h) auditor introductions, (i) investment banking and research introductions, (j) M&A canvassing and ways to grow the business organically, and (k) stand by capital markets advisory services. For the services rendered thereunder, the Company agreed to pay Cross Current $200,000 in cash and agreed to issue to the Advisor restricted shares of the Company’s common stock, issuable under the Company’s 2023 Equity Inventive Plan, in an amount equal to $500,000 (the “Shares”), which Shares shall vest at the end of six months after issuance. The term of the Consulting Agreement is 24 months and can be extended for another 12 months upon the written consent of both parties. The Company made the $200 payment in October 2024.
Exclusive License Agreements with Cedars
We have entered into four Exclusive License Agreements with Cedars which grants us licensing rights with respect to certain patent rights owned by Cedars as follows:
| 1. | Methods of use of compounds that bind to RelA of NFkB; | |
| 2. | Composition and methods for treating fibrosis; | |
| 3. | Compositions and methods for treating cancer and autoimmune diseases; and | |
| 4. | Method of generating activated T cells for cancer therapy. |
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On June 2, 2021, our wholly owned subsidiary, Enviro, entered into two Exclusive License Agreements with Cedars, which granted Enviro exclusive licensing rights (which include the right to sublicense) with respect to certain patent rights owned by Cedars, as follows:
| ● | an Exclusive License Agreement (the “Enviro-Cedars License Agreement (Mitochondrial DNA)”) for Enviro to develop, manufacture, use and sell products utilized or derived from patent rights worldwide related to the “Compositions and Methods for Treating Diseases and Conditions by Depletion of Mitochondrial DNA from Circulation and for Detection of Mitochondrial DNA” invented by Dr. Neil Bhowmick and others; and | |
| ● | an Exclusive License Agreement, (the “Enviro-Cedars License Agreement (Endoglin Antagonism)” and, collectively with the Enviro-Cedars License Agreement (Mitochondrial DNA), the “Enviro-Cedars License Agreements”) for Enviro to develop, manufacture, use and sell products utilized or derived from the patent rights and technical information worldwide related to the “Sensitization of Tumors to Therapies Through Endoglin Antagonism” invented by Dr. Neil Bhowmick and others. |
Agreement with former Chief Financial Officer
We have an agreement with our former Chief Financial Officer that requires us to pay $50 upon the completion of raising more than $900 in a debt or an equity financing. No amount was owed at December 31, 2022 or 2023, but $50 was owed as of September 30, 2024. In addition, on September 27, 2023, we entered into an employment agreement with our current Chief Financial Officer, which became effective upon completion of the Company’s IPO.
Item 3. Quantitative and Qualitative Disclosures about Market Risks.
As a “smaller reporting company,” we are not required to provide the information required by this Item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow for timely decisions regarding required disclosure. Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of September 30, 2024. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective at a reasonable assurance level as of September 30, 2024.
In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) or 15d-15(f) of the Exchange Act) that occurred during the period covered by this Quarterly Report that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II — OTHER INFORMATION
项目1. 法律诉讼
我们目前并未参与任何待处理或其他威胁的法律诉讼或索赔，我们相信这些诉讼将对我们的业务、财务状况或经营业绩产生重大不利影响，尽管我们可能不时会在业务常规过程中卷入诉讼。根据业务性质、历史经验和行业标准，我们保持了我们认为足够的保险金额以及涵盖范围和免赔额。
项目1A. 风险因素
作为一家较小的报告公司，我们不必提供本项目要求的信息。
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无。
项目3. 对高级证券的违约。
不适用。
项目 4. 矿业安全披露。
不适用。
项目5. 其他信息。
截至2024年9月30日的期间内，我们的所有董事或执行官均没有
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项目 6. 附件。
随附提交。
**随此呈交。
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签名
根据1934年证券交易法的要求，注册名义人已授权下列人员代表该人签署本报告。
日期： 2024年11月14日
| KAIROS PHARMA, LTD. | ||
| By: | /s/ John S. Yu | |
John S. Yu Chief Executive Officer and Chairman of the Board of Directors (principal executive officer) |
||
| By: | /s/ Douglas Samuelson | |
| Douglas Samuelson | ||
| Chief Financial Officer | ||
| (Principal Financial and Accounting Officer) | ||
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