美國
證券交易委員會
華盛頓，特區。20549
表格
截至季度結束
或
在從___________到____________的過渡期內
委員會
文件編號：
（公司章程中指定的準確公司名稱）
（住所的州或其他司法轄區 文件號碼） |
（稅務局僱主 (主要 執行人員之地址) |
（總部地址）（郵政編碼）
根據交易所法規（17 CFR 240.14a-12）第14a-12規定的招股材料
(公司更名、更改地址和更改財年情況的以往名稱、以前地址和以前財年，如與上次報告有所改變)
根據法案第12(b)節註冊的證券:
| 每一類別的名稱 | 交易標的 | 在每個交易所註冊的名稱 | ||
指示
用複選標記註冊人（1）是否已提交證券交易所第13條或第15（d）條要求提交的所有報告
在過去的12個月內（或註冊人必須提交此類報告的較短期限）的1934年法案，以及（2）
在過去的90天中一直受到此類申報要求的約束。
通過勾選圓圈表明註冊者是否在過去12個月內(或註冊者需要提交這些文件的較短期限內)已經遞交規章S-T(本章第232.405條)規定的每個交互式數據文件。
在勾選標記處表示註冊人是大型加速提交人、加速提交人、非加速提交人、小型報告公司還是新興增長公司。請參閱證券交易法120億條規則中「大型加速提交人」、「加速提交人」、「小型報告公司」和「新興增長公司」的定義。
| 大型加速歸檔者 ☐ | 加速歸檔者 ☐ |
| 較小的報告公司 | |
| 新興成長公司 |
如果
一家新興成長型公司，用勾號表示註冊人是否選擇不使用延長的過渡期來遵守規定
以及根據《交易法》第13（a）條規定的任何新的或修訂的財務會計準則。
請勾選註冊人是否爲殼公司（如在交易所法第120億.2條中定義）。 是 ☐ 否
截至2024年11月14日，公司發行和流通的普通股數量爲 .
凱羅斯製藥有限公司。
目錄
| 第一部分 基本報表 | 3 | ||
| 項目1. | 財務報表 | 3 | |
| 2024年9月30日和2023年12月31日未經審計的簡明合併資產負債表 | 3 | ||
| 2024年9月30日和2023年三個月及九個月結束的未經審計簡明綜合損益表 | 4 | ||
| 2024年和2023年9月30日三個月和九個月結束時未經審計的股東權益（赤字）的簡明綜合報表 | 5 | ||
| 2024年9月30日和2023年未經審計的簡明合併現金流量表 | 6 | ||
| 簡明聯合財務報表附註(未經審計) | 7 | ||
| 項目 2. | 管理層對財務狀況和經營成果的討論與分析 | 19 | |
| 項目 3 | 關於市場風險的定量和定性披露 | 29 | |
| 項目 4. | 控制和程序 | 29 | |
| 第二部分-其他信息 | 30 | ||
| 項目 1 | 法律訴訟 | 30 | |
| 項目 1A | 風險因素。 | 30 | |
| 項目 2. | 未登記的股票銷售及使用所得款項 | 30 | |
| 項目 3. | 觸及到高級證券的違約情況 | 30 | |
| 項目 4. | 礦山安全披露 | 30 | |
| 項目5。 | 其他信息 | 30 | |
| 項目 6. | 展示資料 | 31 | |
| 簽名 | 32 | ||
| 2 |
第一節金融信息
項目 基本報表。
Kairos 醫藥有限公司。
簡明合併資產負債表
(以千爲單位，除每股金額和麪值數據外)
| 九月 30， | 2024年12月31日， | |||||||
| 2024 | 2023 | |||||||
| (未經審計) | ||||||||
| 資產 | ||||||||
| 流動資產 | ||||||||
| 現金 | $ | $ | ||||||
| 供應商預付款 | ||||||||
| 預付款及其他流動資產 | ||||||||
| 總流動資產 | ||||||||
| 延遲募資成本 | ||||||||
| 無形資產-淨額 | ||||||||
| 其他資產合計 | ||||||||
| 總資產 | $ | $ | ||||||
| 負債和股東權益（赤字） | ||||||||
| 流動負債 | ||||||||
| 應付賬款及應計費用 | $ | $ | ||||||
| 應付關聯方 | ||||||||
| 應付票據 - 高管 | ||||||||
| 總計 流動負債 | ||||||||
| 可轉換票據應付,
減去債務折扣 $ | ||||||||
| 總負債 | ||||||||
| 承諾和或有事項 - 註釋 7 | ||||||||
| 股東權益 (赤字) | ||||||||
| 優先股，面值$, 授權股份; 股份 已發行和流通，分別; | ||||||||
| 普通股，每股面值 $，授權股數：百萬股；發行股數：分別爲2024年6月30日和2023年12月31日：百萬股；流通股數：分別爲2024年6月30日和2023年12月31日：百萬股, 股份 授權; 和 股份已發行和流通，分別; | ||||||||
| 其他資本公積 | ||||||||
| 累積赤字 | ( | ) | ( | ) | ||||
| 總 股東權益（赤字） | ( | ) | ||||||
| 總 負債和股東權益（赤字） | $ | $ | ||||||
附註是這些精簡合併財務報表的一部分。
| 3 |
Kairos 醫藥有限公司。
簡化合並利潤表
(以千爲單位，除分享金額和每股數據外)
| 三個月 | 九個月 結束 | |||||||||||||||
| 九月 30， | 九月 30日, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (未經審計) | （未經審計） | |||||||||||||||
| 收入 | $ | $ | $ | $ | ||||||||||||
| 營業費用： | ||||||||||||||||
| 研發 | ||||||||||||||||
| 總務及行政費用 | ||||||||||||||||
| 總營業費用 | ||||||||||||||||
| 運營損失 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 其他費用: | ||||||||||||||||
| 利息支出 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 融資成本 | ( | ) | ( | ) | ||||||||||||
| 債務貼現攤銷 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 其他支出總額 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 淨損失 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 基本和攤薄每股虧損 | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| 加權平均每股優先股 | ||||||||||||||||
| 基本和攤薄 | ||||||||||||||||
附註是這些精簡合併財務報表的一部分。
| 4 |
Kairos 製藥有限公司
縮略版 合併股東權益（赤字）表（未經審計）
(以千爲單位，除了分享金額)
| 普通 股票 | 追加 已付資本 | 累計 | ||||||||||||||||||
| 股份 | 金額 | 資本 | 虧損 | 總計 | ||||||||||||||||
| 2024年6月30日餘額（未經審計） | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| 初次公開發行結束時發行普通股，減去發行費用 | ||||||||||||||||||||
| 在可轉換應付款項和應計利息轉換後發行普通股 | ||||||||||||||||||||
| 在應付款項轉換後發行普通股 | ||||||||||||||||||||
| 在與關聯方到期款項轉換後發行普通股 | ||||||||||||||||||||
| 與可轉換應付款項相關發行權證的公允價值 | - | |||||||||||||||||||
| 發放的已獲股票單元的公允價值 | - | |||||||||||||||||||
| 淨損失 | - | ( | ) | ( | ) | |||||||||||||||
| 2024年9月30日餘額（未經審計） | $ | $ | $ | ( | ) | $ | ||||||||||||||
| 2023年12月31日的餘額 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| 發行普通股以抵消首次公開發行的成本 | ||||||||||||||||||||
| 發行普通股以轉換應付可轉換票據和應計利息 | ||||||||||||||||||||
| 發行普通股以轉換應付賬款 | ||||||||||||||||||||
| 發行普通股以轉換對關聯方的應付款項 | ||||||||||||||||||||
| 與應付可轉換票據相關的權證的公允價值 | - | |||||||||||||||||||
| 已獲批准的限制性股票單位的公允價值 | - | |||||||||||||||||||
| 淨損失 | - | ( | ) | ( | ) | |||||||||||||||
| 2024年9月底餘額（未經審計） | $ | $ | $ | ( | ) | $ | ||||||||||||||
| 2023年6月30日餘額（未經審計） | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| 淨損失 | - | ( | ) | ( | ) | |||||||||||||||
| 2023年9月餘額（未經審計） | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| 2022年12月31日的餘額 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| 淨損失 | - | ( | ) | ( | ) | |||||||||||||||
| 2023年9月餘額（未經審計） | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
附註是這些精簡合併財務報表的一部分。
| 5 |
Kairos 醫藥有限公司。
簡明合併現金流量表。
（以千爲單位）
| 九個月 結束 | ||||||||
| 九月 30， | ||||||||
| 2024 | 2023 | |||||||
| (未經審計) | ||||||||
| 經營活動產生的現金流量 | ||||||||
| 淨損失 | $ | ( | ) | $ | ( | ) | ||
| 攤銷費用 | ||||||||
| 債務折扣攤銷 | ||||||||
| 與應付賬款轉換相關的普通股發行的公允價值 | ||||||||
| 限制性股票單位的公允價值 | ||||||||
| 與可轉換應付票據相關的warrants發行的公允價值 | ||||||||
| 運營資產和負債的變化： | ||||||||
| 供應商預付款 | ( | ) | ||||||
| 預付款及其他流動資產 | ( | ) | ( | ) | ||||
| 應付賬款和應計費用 | ||||||||
| 淨現金流量（經營活動） | ( | ) | ||||||
| 籌資活動現金流量 | ||||||||
| 與首次公開發行結束相關的發行普通股以獲取現金的收益 | ||||||||
| 應付款項籌資淨額-執行官 | ||||||||
| 支付遞延發行費用 | ( | ) | ( | ) | ||||
| 融資活動提供的（使用的）淨現金 | ( | ) | ||||||
| 現金淨增加（減少） | ( | ) | ||||||
| 期初現金餘額 | ||||||||
| 期末現金餘額 | $ | $ | ||||||
| 補充現金流披露： | ||||||||
| 已支付利息 | $ | $ | ||||||
| 已繳納的稅款 | $ | $ | ||||||
| 補充非現金融資披露： | ||||||||
| 將遞延發行成本重新分類至股東權益 | $ | $ | ||||||
| 將可轉換票據應付款項及應計利息轉爲股東權益 | $ | $ | ||||||
| 將應付賬款轉爲股東權益 | $ | $ | ||||||
| 將應支付給關聯方款項轉爲股東權益 | $ | $ | ||||||
附註是這些精簡合併財務報表的一部分。
| 6 |
凱羅斯製藥有限公司。
基本報表附註（未經審計）
2024年和2023年截至2024年9月30日的九個月
(以千爲單位，除了分享金額和每股數據)
注意 1 - 提供的基礎
Cell Source, Inc.（「Cell Source」、「CSI」或「公司」）是一家於2012年6月6日成立 的內華達州公司，是Cell Source Limited（「CSL」）的母公司，CSL是一家在2011年在以色列成立的全資子公司，旨在商業化若干個涉 及某些癌症治療的發明。公司專注於開發基於免疫耐受治療方法的細胞療法治療，其主要潛在產品是其 擁有專利的Veto Cell免疫系統管理技術，這是一種免疫耐受性生物技術，可以選擇性地阻止 免疫反應。CSL的Veto Cell免疫系統管理技術是基於由以色列公司Yeda Research and Development Company Limited （「Yeda」）擁有、持有和許可的專利技術所基於的（見註釋8）。公司旨在治療的疾病包括：淋巴瘤、白血病和多發性骨髓瘤，通過促進 更安全、更易接受的幹細胞（例如骨髓）移植的接受、通過改善器官移植（擴大供體庫， 減少對術後抗排異治療的依賴）來治療晚期腎臟疾病和其他非惡性器官疾病，從而最終治療各種癌症 和非惡性疾病。
Kairos Pharma, Ltd.（"公司"或"Kairos"）於2013年6月17日在加利福尼亞州法律下注冊爲NanoGB13, Inc.。公司於2016年7月15日更名爲Kairos Pharma, Ltd.，並於2023年5月10日根據相同名稱轉換爲特拉華州公司Kairos Pharm, Ltd.。該公司是一家早期階段的生物技術公司，專注於開發用於腫瘤學的免疫療法和電芯療法治療。
未經審計的財務信息的呈現基礎
本公司附帶的未經審計的簡明合併基本報表是根據美國公認會計原則爲臨時財務信息而編制，並遵循Form 10-Q的指示及S-X條例第10-01條。因此，它們未包括公認會計原則對完整基本報表所要求的所有信息和附註。管理層認爲，爲了公平呈現，所有常規的必要調整均已包括在內。截止2024年9月30日的九個月經營結果未必能反映2024年12月31日結束的年度可能預期的結果。
流動性和資本資源
附帶的簡明合併財務報表已根據持續經營原則編制，預期資產的實現和負債以及承諾的清償將在正常業務過程中進行。
截至2023年12月31日，公司錄得淨損失$
截至2024年9月30日的九個月裏，公司完成了其首次公開發行（「IPO」），收到了$
作爲一個持續經營的能力，取決於公司在未來實現並維持盈利業務，主要通過籌集額外資本來滿足其義務，並在正常業務運營中到期時償還債務。自成立以來，公司主要通過股本和債務融資來投資其業務，並預計在未來繼續依賴這些資本來源，直到能夠產生收入。
無法保證將來會有可獲得的融資，即使有也可能未必符合公司的要求。即使公司能獲得額外的融資，這種融資可能對我們的運營施加過度限制（在債務融資的情況下），或導致股東股權的大幅稀釋（在股權融資的情況下）.
反向 股票拆分
在2023年5月10日，公司進行了
| 7 |
重組
公司的公司註冊證明於2023年5月10日提交至特拉華州，跟隨公司從加利福尼亞公司轉變爲特拉華公司，授權公司發行最多 股，包括 普通股，面值$ 。 每股股票價格爲 每股。附帶的簡化合並基本報表及其說明對所有呈現的期間給予追溯效力。
附註2-重要會計政策摘要
合併財務報表的基礎
附帶的簡明綜合基本報表及相關附註已按照美國通用會計準則（"U.S. GAAP"）編制。附帶的綜合基本報表包括公司及其全資子公司Enviro Therapeutics, Inc.的帳戶。所有公司間餘額及交易在合併時已予以消除。
使用估計值
編制符合GAAP的合併基本報表需要管理層做出估計和假設，這些估計和假設影響合併基本報表日期的資產和負債的報告金額以及或有資產和負債的披露，以及報告期內收入和費用的報告金額。公司定期評估這些估計和假設。公司基於當前事實、歷史經驗和其他各種其認爲在具體情況下合理的因素來做出估計和假設，這些結果爲判斷資產和負債的賬面價值以及未從其他來源明顯顯現的費用和支出進行確認提供了依據。公司實際經驗的結果可能與公司的估計存在重大且不利的差異。在估計和實際結果之間存在重大差異的情況下，未來的經營結果將受到影響。隨附的合併基本報表中的重要估計包括遞延稅資產的估值準備，以及無形資產的減值分析和使用壽命。
現金
在現金流量表的目的下，現金包括與銀行和金融機構的貨幣。
信貸風險集中
金融工具可能導致公司面臨信用風險集中，主要包括現金存款。每家金融機構的帳戶都由聯邦存款保險公司（「FDIC」）在一定限額內保險。
無形資產
公司的無形資產按獲取日期的公允價值列示，減去累計攤銷額。攤銷額基於資產的預計使用壽命計算，這些壽命已被確定爲
| 8 |
us-gaap:SalesRevenueNetMember
公司的無形資產按照預計可用生命週期進行攤銷，其攤銷分別如下：物業、廠房和設備針對長期資產減值的財務會計和報告。持有並使用的長期資產應在出現事件或情況變化時進行可收回性測試，表明資產組的賬面價值可能無法收回，無論此類賬面價值是否爲零或負數。如果估計的未打折未來現金流小於賬面價值，則需要進行減值決定。在該事件中，將基於賬面金額超過長期資產公允價值的金額確認損失。
每股淨虧損是根據ASC主題260計算的， 每股收益每股基本收益（「EPS」）是基於普通股加權平均股數計算的。 攤薄後每股收益是基於所有可攤薄證券被轉換的假設。 當期權或warrants存在時，稀釋是通過應用財庫股票法計算的。 根據此方法，假設在期初（或在發行時，如果更晚）行使期權和warrants，因而獲得的資金被假設用於在期間的平均市場價格購入普通股。 截至2023年和2024年9月30日的九個月，基本和攤薄的流通股數是相同的，因爲潛在的可稀釋股被認爲具有反稀釋特性。 和 截至2024年9月30日，可能的可稀釋證券包括普通股購買warrants的行使而可發行的普通股，分別爲 截至2024年9月30日，尚未歸屬的限制性股票單位（「RSUs」）在歸屬時可發行的股份爲
推遲銷售費用
公司將某些直接與進行中的股權發行相關的法律、專業、會計及其他第三方費用資本化爲遞延發行費用，直到該股權發行完成。在股權發行完成後，這些費用將作爲資本化金額的減少記錄。如果股權發行被延遲或放棄，遞延發行費用將立即作爲營業費用在運營報表中計入費用。截至2023年12月31日和2024年9月30日，公司已產生$
截至2024年9月30日的九個月期間，共記錄了$ 的遞延發行成本，作爲從IPO獲得的淨收益的抵消。
公允價值衡量
公司根據美元交易價格確定其資產和負債的公允價值，該價格是在資產賣出或負債轉讓（退出價格）方面，會在資產或負債的主要或最有利市場上，市場參與者之間於計量日期進行交易的有序交易。用於衡量公允價值的估值技術最大化使用可觀察輸入並最小化使用不可觀察輸入。公司使用三個層次的公允價值層次結構，其中前兩個被認爲是可觀察的，最後一個是不可觀察的，以衡量公允價值：
| ● | 第一層次—基於未經調整的報價活躍市場上的價值，而公司有能力獲取可轉讓相同的資產或負債。不適用估值調整和塊折扣。由於估值是基於報價價格進行的，這些價格在活躍市場上是容易獲得的，因此對這些證券的估值不涉及重要程度的判斷。 在活躍市場中報價的相同資產或負債。 | |
| ● | 第二層次—根據直接或間接可觀察到的市場數據進行定價，但數據並非來自活躍市場的報價。 除了一級之外的可觀察到的輸入，直接或間接，如類似資產或負債的報價；在非活躍市場中的報價；或其他可觀察到的或可由可觀察到的市場數據證實的輸入，用於資產或負債的整個期限。 | |
| ● | 3級 - 不可觀測的輸入，幾乎沒有市場活動支持，並且對資產或負債的公允價值具有重大影響。 |
財務工具的資產賬面價值，如現金、應付賬款和應計負債，由於這些工具的短期到期，近似於相關的公允價值。公司可轉換應付票據和來自高管的應付票據的資產賬面價值與其公允價值相近，因爲票據利率基於現行市場利率。
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所得稅
收入稅前利潤。遞延稅資產和負債是根據預期稅收因素對資產和負債的稅基和報告金額之間的暫時差異予以確認的。計提準備金以將遞延稅資產減少到更有可能實現的金額。公司記錄
這個
公司使用兩步法來識別和衡量不確定的稅收狀況，以考慮所得稅的不確定性。這個
第一步是評估稅收狀況以供認定，確定現有證據的權重是否表明稅收狀況更大
該職位很可能會在審計中得以維持，包括相關上訴或訴訟程序的解決（如果有）。
第二步是將稅收優惠作爲結算時可能實現的超過50％的最大金額來衡量。
在公司預期付款的範圍內，公司將未確認的稅收優惠負債歸類爲流動負債（或
一年內收到）現金。與不確定稅收狀況相關的利息和罰款在收入準備金中確認
稅。曾經有
專利 和專利申請費用
儘管公司認爲其專利和基礎技術具有持續價值，但未來從專利中獲得的收益金額是不確定的。因此，專利成本在發生時確認爲費用，幷包括在附表中的綜合損益表的一般和管理費用中。專利費用爲$
研發成本
公司將其研發成本列爲已發生的費用。截至2024年9月30日和2023年的九個月的研發成本爲$
基於股票的薪酬
公司對所有期權和其他基於股票的獎勵進行測量，根據授予的獎勵在授予日的公允價值，並在相應獎勵的必要服務期內（一般爲相應獎勵的獲准期）確認這些獎勵的補償費用。公司已選擇在發生時確認棄權。對於因未能滿足服務或績效條件而被放棄的獎勵，已經認可的補償費用的反轉在放棄期間進行確認。通常，公司僅對基於服務的歸屬條件發放期權，並使用直線法在必要服務期內記錄這些獎勵的費用。
公司對基於股票的補償費用進行分類，方式與獎勵接收方的工資成本或獎勵接收方的服務支付分類的方式相同，在其經營報表中顯示。
該公司是一傢俬人公司，直到2024年9月17日其IPO完成。公司通過採用美國註冊會計師協會技術實踐援助框架中的合適估值方法，估算普通股的公允價值。每種估值方法都包括需要該公司判斷的估算和假設。這些估算和假設包括多個客觀和主觀因素，包括外部市場情況、指導上市公司信息，公司將普通股以公允交易價格出售給第三方的價格，公司普通股高於公司普通股的證券的權利和偏好，以及實現諸如首次公開招股或出售之類的流動性事件的可能性。在估值中使用的假設發生重大變化可能導致每個估值日期的期權的不同公允價值。
每個股票期權或warrants授予的公允價值是根據Black-Scholes期權定價模型估算的。公司是一傢俬營公司，缺乏公司特定的歷史和隱含波動性信息。因此，它根據與公司特徵相似的一組公開交易的同行公司在生物技術行業的歷史波動性，估算其預期股票波動性。公司的股票期權的預期期限是利用「簡化」方法確定的，該方法適用於符合「普通」期權或warrants的獎勵。授予非員工的股票期權或warrants的預期期限等同於期權授予的合同期限。無風險利率是參考以授予獎勵時的美國國債收益率曲線來確定的，時間段大致等於獎勵的預期期限。預計的分紅派息收益率爲零，這是基於公司從未支付現金分紅，並且在可預見的未來不會支付任何現金分紅的事實。
最近的會計準則
在2023年11月，財務會計準則委員會（"FASB"）發佈了ASU 2023-07，分段報告（主題280）：可報告分段披露的改進，旨在改善可報告分段的披露要求，主要通過增強關於定期提供給首席運營決策maker的重大分段費用類別的披露，幷包括在每個報告的分段利潤或虧損指標中。該更新還要求在中期提供所有關於可報告分段利潤或虧損和資產的年度披露，對於只有一個可報告分段的實體，需提供ASC 280所要求的所有披露，包括重大分段費用的披露。公司自2024年1月1日起採用ASU 2023-07。公司認爲新指南及相關的編碼改進對其財務狀況、運營結果和現金流量沒有重大影響。
其他 最近由FASB發佈的會計聲明，包括其新興議題特別委員會、美國註冊會計師協會和證券交易委員會，並未或管理層相信不會對公司的當前或未來合併基本報表產生重大影響。
注意 3 – 來自關聯方的貸款
截至2021年12月31日，公司的股東以及一家主要股東也是公司的股東向公司提前了
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截至2024年9月30日的三個月期間，管理人員同意在首次公開募股交易關閉時自動將本金轉換爲公司的普通股。 在首次公開募股交易關閉時，所有本金自動轉換爲
由於
這些官員收到了 額外的股份，基於
注意 4 –應付賬款 - 官方
截至2024年9月30日的九個月內，公司與三名高管簽訂了總金額爲$的票據支付協議。
2024年9月30日後，債券已償還， 公司普通股股票已發行給高管（見註釋8）。
截至2024年9月30日結束的三個月內，公司與首席財務官道格拉斯·塞繆爾森（Douglas Samuelson）達成協議，塞繆爾森先生同意將其應付賬款的$
注意 5 – 可轉換票據應付款項
截至2022年12月31日的財年，公司與某些投資者簽訂了幾份可轉換票據協議，總金額爲$
在截至2023年12月31日的一年期間，該票據上未進行本金或利息支付，而票據應計利息爲$
公司佔據了$的公司帳戶
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截至2023年12月31日，總未攤銷餘額爲$
在公司的首次公開募股（IPO）結束時，$的本金金額
注意 6 – 股東權益
普通股
已授權股份
公司的公司註冊證明於2023年5月10日提交至特拉華州，跟隨公司從加利福尼亞公司轉變爲特拉華公司，授權公司發行最多 股，包括 普通股，面值$ 。 每股股票價格爲 每股。普通股的持有者擁有完全的投票權，每持有一股就有一票。股東有權根據董事會所聲明的由合法可用的所有基金類型所發放的分紅派息，並在清算時與其他股東按比例分享任何分配。股東沒有轉換權、優先權或認購權。所有流通的普通股均已完全支付且不可評估。截止2024年9月30日和2023年12月31日，共有 和 已發行和流通的普通股數量，分別是，並且 優先股的發行量分別爲。
公司IPO完成後以現金髮行普通股
2024年9月16日，公司完成了普通股的首次公開募股，發行並出售了 股普通股，公開發行價格爲$ 每股，IPO的總募集資金淨額爲$
根據承銷協議，公司於2024年9月17日發行了兩份普通股認購權證給承銷商，每份股票售價爲 股普通股，行權價爲
應付賬款轉換
在截至2024年9月30日的三個月期間，公司與西達斯-西奈醫療中心（「西達斯」）簽署了一項協議，西達斯同意將$
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2023年股權激勵計劃的採納
在 2023年7月，公司董事會和股東通過了2023年股權激勵計劃（「2023 計劃」）。根據2023計劃，公司可以授予員工激勵股權期權，包括任何母公司或子公司的員工，以及非法定股權期權、股票增值權、限制性股票獎勵、RSU獎勵、業績獎勵和其他形式的股票獎勵給員工、董事和顧問，包括公司的附屬機構的員工和顧問。經批准，最初預留了總共 用於2023計劃發行的普通股數量爲 截至2023年12月31日，已根據2023計劃發行了 截至2024年9月30日，共發行了 截至2024年9月30日， 根據2023計劃可供授予的股份爲
限制性股票授予
下表總結了截至2024年9月30日的九個月內限制性普通股活動：
數量 限制股 股份 | 公平價值 價值 | 加權平均授予日期公允價值 | ||||||||||
| 未取得的股份，2023年12月31日 | $ | $ | ||||||||||
| 已授予 | ||||||||||||
| 歸屬 | ( | ) | ( | ) | ||||||||
| 被取消 | ||||||||||||
| 2024年9月30日，未歸屬 | $ | $ | ||||||||||
在2024年9月23日，公司與Belair Capital Advisors Inc.（「BCA」）簽訂了一份戰略顧問協議（「戰略顧問協議」）。在戰略顧問協議的一年期限內，作爲服務的交換，公司向BCA發行了
RSU，這些RSU將在發行後六個月結束時歸屬。授予時股票的公允價值爲$
在公司首次公開募股完成時，公司與其三名獨立董事簽署了董事協議。
這些協議規定年度現金補償爲$
在2024年9月30日結束的三個月和九個月內，共計$股票報酬被記錄，用於無條件普通股和 的公允價值歸屬截至2024年9月30日，剩餘$未攤銷的報酬。
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股票 認股權證
以下表格總結了公司截至2024年9月30日九個月的權證活動：
| 認股權證股份數量 | 行使 價格 範圍 每股 | 加權 平均行權價格 | ||||||||||
| 2023年12月31日餘額 | $ | $ | ||||||||||
| 已授予 | – | |||||||||||
| 取消 | ||||||||||||
| 已行權 | ||||||||||||
| 被剝奪/過期 | ||||||||||||
| 餘額，2024年9月30日 | $ | – | $ | |||||||||
| 截至2024年9月30日，已授予和行使的股票期權 | $ | – | $ | |||||||||
以下表格總結了截至2024年9月30日的未到期和可行使的warrants的信息：
| 此外，有待行使的權證 | 待行使的權證 | |||||||||||||||||||||||||
| 區間 行使價格 | 數量 尚未行使 | 平均 剩餘合同期限 （）年內 | 加權 平均行權價格 | 數量 可行使 | 平均 剩餘合同期限 （）年內 | 加權 平均行權價格 | ||||||||||||||||||||
| $ | $ | $ | ||||||||||||||||||||||||
- | ||||||||||||||||||||||||||
| $ | – | $ | $ | |||||||||||||||||||||||
在
2024年9月17日，IPO完成時，公司向參與的承銷商發行了兩個股票warrants，每個warrants用於購買
在2024年9月17日，首次公開募股（IPO）結束時，公司向承銷商發行了一份認股權證，用於購買 認股權證行使價格爲$開多的募股價值，每股普通股的價格爲$
截至2022年12月31日的年度內，公司與一名個人簽署了一份可轉換債券協議，金額爲$
有 2024年9月30日截至，認股權證股份的內在價值。
注7 - 股東赤字承諾和 contingencies
Kairos 與Prevail Infoworks，Inc.達成協議。
2024年8月，公司與Prevail Infoworks, Inc.（「Prevail」）簽署了一項主服務和技術協議，根據協議，Prevail同意向公司提供某些臨床研究服務。作爲協議的一部分，公司必須在Prevail開始提供服務之前向其支付預付款$
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凱羅斯 與PreCheck健康服務公司的協議。
在2024年9月20日，公司與位於佛羅里達州的PreCheck Health Services, Inc.（「PreCheck」）簽訂了一份生物測定服務協議（「生物測定服務協議」）。根據該協議，PreCheck將爲公司的正在進行的carotuximab（ENV105）臨床試驗提供某些生物標誌物篩查服務，以協助公司識別適合進行肺癌患者的第一階段臨床試驗和雄激素抵抗前列腺癌患者的第二階段試驗的患者。爲了識別用於患者篩查和治療監測的生物標誌物，PreCheck將利用其SolidTumorCheck+平台對來自肺癌和前列腺癌患者的活檢組織樣本進行體細胞基因表達分析，這是公司正在進行的臨床試驗的一部分。爲了進一步推進這些工作，PreCheck將開發一個伴隨診斷，以支持其識別此類患者，採用三基因PCR分析或其他遺傳分析，該診斷測試將被開發並提交給食品和藥物管理局（「FDA」），用於雄激素抵抗前列腺癌患者和正在接受Tagrisso治療的肺癌患者。作爲對PreCheck服務的交換，並根據生物測定服務協議的條款，公司支付了$
凱羅斯 與首席執行官.CA科技有限公司的協議。
2024年9月23日，公司與加拿大公司CEO.CA Technologies Ltd.簽訂了一份諮詢服務協議（「CEO.CA協議」），根據該協議，CEO.CA將提供爲期一年的特定基於互聯網的金融信息和通信服務，服務費爲$
Kairos 與貝萊爾資本顧問公司的協議。
開啓
2024 年 9 月 23 日，公司與 Belair 簽訂了戰略諮詢協議（「戰略諮詢協議」）
資本顧問公司（「BCA」）。風險投資和企業融資諮詢公司BCA一直是長期投資者
也是公司的顧問，經常與早期製藥公司合作。戰略諮詢服務包括
製藥行業的企業戰略、市場定位和長期增長計劃、數字營銷和參與，
市場研究分析和業務發展援助等.在戰略諮詢的一年期內
協議，以換取其服務，公司將向BCA支付一美元
公司根據協議生效日的收盤股價對其進行了評估 股，每股售價爲$
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Kairos 與醫療中心辛尼醫學中心（辛尼）簽訂獨家許可協議
公司已與Cedars簽訂了四份獨家許可協議，授予公司對Cedars擁有的某些專利權的許可權如下：
| 1. | 方法 用於結合NFkB的RelA的化合物的使用； | |
| 2. | 組成 及治療纖維化的方法； | |
| 3. | 組成 及治療癌症和自身免疫疾病的方法；以及 | |
| 4. | 方法 生成用於癌症治療的活化T細胞。 |
對於項目1、2和3中的每個獨佔許可協議，公司需要支付初始許可費$
| ● | $ | |
| ● | $ | |
| ● | $ | |
| ● | $ |
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:
| 運營 費用： | 九月 2024 年 30 日 | 九月 2023 年 30 日 | ||||||
| 研究和 發展 | $ | 14 | $ | 33 | ||||
| 普通的 和行政 | 369 | 254 | ||||||
| 運營費用總額 | 383 | 287 | ||||||
| 運營損失 | (383 | ) | (287 | ) | ||||
| 其他費用： | ||||||||
| 利息支出 | (12 | ) | (15 | ) | ||||
| 融資成本 | (537 | ) | - | |||||
| 債務 折扣攤銷 | (115 | ) | (10 | ) | ||||
| 其他支出總額 | (664 | ) | (25 | ) | ||||
| 淨虧損 | $ | (1,047 | ) | $ | (312 | ) | ||
研究與開發支出
下表總結了截至2024年9月30日和2023年9月30日的三個月內我們的研發費用（以千元計）：
| 研發費用： | 2024年9月 30日 | 2023年9月30日 | ||||||
| 臨床及相關費用 | $ | 14 | $ | 33 | ||||
| 總研發費用 | $ | 14 | $ | 33 | ||||
研發費用分別爲2024年和2023年截至9月30日的三個月分別爲14美元和33美元。 期間沒有顯着變化。
一般和行政費用
下表總結了截至2024年9月30日和2023年的三個月我們的一般和行政費用（按千計）。
| 一般和行政費用： | 2024年9月 30日 | 2023年9月30日 | ||||||
| 專利相關費用 | $ | 114 | $ | 109 | ||||
| 保修準備金 | 34 | - | ||||||
| 會計費用 | 30 | 47 | ||||||
| 其他專業費用 | 93 | 11 | ||||||
| 與許可協議相關的費用 | 29 | 30 | ||||||
| 保險費用 | 12 | 5 | ||||||
| 攤銷費用 | 40 | 40 | ||||||
| 其他開支 | 17 | 12 | ||||||
| 總行政與管理費用 | $ | 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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一般和行政費用
下表總結了截至2024年9月30日和2023年9月30日的九個月的管理及行政費用（以千計）：
| 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
項目1. 法律訴訟
我們目前並未參與任何待處理或其他威脅的法律訴訟或索賠，我們相信這些訴訟將對我們的業務、財務狀況或經營業績產生重大不利影響，儘管我們可能不時會在業務常規過程中捲入訴訟。根據業務性質、歷史經驗和行業標準，我們保持了我們認爲足夠的保險金額以及涵蓋範圍和免賠額。
項目1A. 風險因素
作爲一家較小的報告公司，我們不必提供本項目要求的信息。
如果您還未使用您的moomoo帳戶，請使用它查看該功能。
無。
項目3. 對高級證券的違約。
不適用。
項目 4. 礦業安全披露。
不適用。
項目5. 其他信息。
截至2024年9月30日的期間內，我們的所有董事或執行官均沒有
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項目 6. 附件。
隨附提交。
**隨此呈交。
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簽名
根據1934年證券交易法的要求，註冊名義人已授權下列人員代表該人簽署本報告。
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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