錯誤 Q3 --12-31 0001829247 0001829247 2024-01-01 2024-09-30 0001829247 US-GAAP:普通股成員 2024-01-01 2024-09-30 0001829247 BFRG:可交易認股權成員 2024-01-01 2024-09-30 0001829247 2024-11-04 0001829247 2024-09-30 0001829247 2023-12-31 0001829247 BFRG:A系列可轉換優先股會員 2024-09-30 0001829247 BFRG: A系可轉換優先股成員 2023-12-31 0001829247 2024-07-01 2024-09-30 0001829247 2023-07-01 2023-09-30 0001829247 2023-01-01 2023-09-30 0001829247 美國通用會計準則:優先股成員 us-gaap:SeriesAPreferredStockMember 2022-12-31 0001829247 US-GAAP:普通股成員 2022-12-31 0001829247 美元指數: 應付股本會員 2022-12-31 0001829247 us-gaap:留存收益成員 2022-12-31 0001829247 2022-12-31 0001829247 美國通用會計準則:優先股成員 us-gaap:SeriesAPreferredStockMember 2023-03-31 0001829247 US-GAAP:普通股成員 2023-03-31 0001829247 美元指數: 應付股本會員 2023-03-31 0001829247 us-gaap:留存收益成員 2023-03-31 0001829247 2023-03-31 0001829247 美國通用會計準則:優先股成員 us-gaap:SeriesAPreferredStockMember 2023-06-30 0001829247 US-GAAP:普通股成員 2023-06-30 0001829247 美元指數: 應付股本會員 2023-06-30 0001829247 us-gaap:留存收益成員 2023-06-30 0001829247 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美國

證券交易委員會 及交易所

華盛頓特區,20549

 

 

 

表單 10-Q

 

 

 

根據1934年證券交易法的第13或15(d)條款,季報。

 

截至年度季度結束 九月三十日, 2024

 

 

根據1934年證券交易法第13或15(d)條的過渡報告

 

在 從____________到的過渡期間

 

委員會 檔案編號 001-41600

 

 

 

牛蛙 人工智能控股有限公司。

(根據公司章程所述的註冊人的正確名稱)

 

 

 

內華達州   84-4786155

(註冊地點或其他管轄區的州份

註冊或組織)

 

(聯邦國稅局雇主身分識別號碼)

識別號碼)

 

325 埃靈頓大道。, 317單位

蓋瑟斯堡, MD 20878

(主要執行辦公室地址) (郵政編碼)

 

申報人的電話號碼,包括區號: (240) 658-6710

 

勾選表示公司已按照證券交易法第13或15(d)條款的規定,在過去12個月(或公司需要提交此類報告的較短期限內)提交了所有所需的報告;並且公司在過去90天內一直受到此類提交報告的要求。 否 ☒

 

標示 勾選該項,表示申報人於過去12個月(或更短期間,申報人必須申報此類檔案的期間)內已按照法規S-t第405條(本章節第232.405條)要求遞交每一個互動式資料檔案。 否 ☒

 

請勾選以下選項,指明掛牌者是否為大型快速申報掛牌者、快速申報掛牌者、非快速申報掛牌者、較小型的報告公司或新興成長型公司。關於Exchange Act第1202條中「大型快速申報掛牌者」、「快速申報掛牌者」、「較小型報告公司」和「新興成長型公司」的定義,請參閱。

 

大型及加速提交者   加速彙報者
非加速提交者   較小的報告公司
      新興成長型公司

 

如為新興成長企業,則應打勾選項表示申報人已選擇不使用交易所法第13(a)條所提供的任何新或修訂財務會計準則延長過渡期遵守。

 

通過勾選選項表示,是否登記的公司是一家殼公司(如交易所法案第1202條所定義) 是 ☐ 否

 

根據該法案第12(b)條紀錄的證券:

 

每個類別的標題   交易標的   在哪個交易所上市的名字
每股面值$0.00001的普通股   BFRG   納斯達克
可交易 權證   BFRGW   納斯達克 股票市場有限責任公司(納斯達克資本市場)

 

截至2024年11月4日,發行並流通中的登記公司普通股數量為 8,713,152.

 

 

 

 

 

 

牛蛙 人工智能控股有限公司。

 

十、 表 對於 10-Q 表

 

第一部分。 財務資訊  
     
項目 1 財務報表  
  總賬表總表(未經審核)。 2
  綜合綜合損益表(未經審核)。 3
  綜合股東權益變動綜合報表(未經審核)。 4
  綜合現金流量綜合報表(未經審核)。 5
  附註 至精簡合併財務報表(未經審核) 6
項目 2. 管理層對財務狀況和經營成果的討論與分析 15
項目 3. 關於市場風險的定量和質量披露 20
項目 4. 控制項和程序 21
     
第二部分。 其他資料 21
     
項目 1 法律訴訟 21
項目 1A 風險因素 21
項目 2. 未登記股權證券的銷售和使用收益 21
項目 3. 高級證券的違約 21
項目 4. 礦山安全披露 22
項目 5. 其他資訊 22
項目 6. 展品 22
     
  簽名 23

 

i

 

 

前瞻 陳述

 

這份報告中包含根據1933年證券法第27條或「證券法」以及1934年證券交易法第21條或「交易所法案」的前瞻性陳述。這些前瞻性陳述受到某些風險和不確定性的影響,可能導致實際結果與歷史結果或預期結果有顯著差異。

 

在某些情況下,您可以通過諸如"可能","打算","可能","將","應該","可以","會","預期","相信","預期","估計","預測","潛在"或這些術語的否定形式來識別前瞻性聲明。這些術語和類似表達旨在識別前瞻性聲明。本報告中的前瞻性聲明基於管理層目前的期望和信念,管理層認爲這是合理的。此外,我們無法評估每個因素對我們業務的影響,或者任何因素或多個因素的程度,或者我們不知道的因素會導致實際結果與任何前瞻性聲明中包含的結果有實質性差異。請注意,不要過分依賴任何前瞻性聲明。這些聲明僅代表我們的估計和假設,截至本報告日期。除非根據聯邦證券法的要求,否則我們不承擔更新任何前瞻性聲明以反映本日期之後的事件或情況,或反映未預料到的事件。

 

您應該意識到,由於許多因素,實際結果可能與前瞻性聲明中所包含的結果有很大不同,這些因素包括:

 

我們未來的財務表現,包括我們的營業收入、營業成本、營業費用和盈利能力;
   
我們的現金及現金等價物足以滿足我們的流動性需求;
   
我們對專有開發、數字轉型科技和生物健康業務以及它們各自的市場趨勢的預測;
   
我們在所有業務板塊吸引和保留客戶以購買我們的產品和服務的能力;
   
像我們這樣的小型上市公司融資的可用性;
   
在我們的三個主要業務市場以及新市場和行業垂直領域成功擴張的能力;和
   
有效管理我們的增長和未來費用的能力。

 

其他風險和不確定性包括市場對我們的產品和服務的接受度和需求、定價、不斷變化的監管環境、我們會計政策的影響、行業趨勢、我們財務資源的充足性以執行我們的業務計劃、吸引、留住和激勵關鍵人員的能力,以及我們不時在美國證券交易委員會(SEC)提交的定期和即時報告中描述的其他風險。您應該仔細考慮該報告下的聲明,其中涉及可能導致我們實際結果與前瞻性聲明中列出的不同,並可能對我們的業務、運營結果和財務狀況產生重大不利影響的其他因素。我們或代表我們行事的人發表的所有隨後的書面或口頭前瞻性聲明,均完全受到相應警告性聲明的限制。

 

1

 

 

第1部分 1. 財務信息

 

項目 1. 基本報表

 

牛蛙 人工智能控股有限公司

簡明合併資產負債表

(未經審計)

 

   2024年9月30日  2023年12月31日
       
資產          
流動資產          
現金及現金等價物  $4,238,988   $2,624,730 
預付費用   358,537    145,882 
總計 當前資產   4,597,525    2,770,612 
           
不動產、機器及設備,淨值   4,681    5,974 
總資產  $4,602,206   $2,776,586 
           
負債和股東權益          
流動負債          
應付賬款  $91,374   $103,656 
應計費用   515,658    80,694 
開空 期保險融資   172,005    - 
流動負債合計   779,037    184,350 
總負債   779,037    184,350 
           
股東權益          
A系列可轉換優先股,$0.00001每股面值,5,500,000 股份已獲授權; 73,449 股份截至2024年9月30日和2023年12月31日發行並流通。   1    1 
普通股,$0.00001每股面值,100,000,000 股份已獲授權; 7,850,550 and 6,094,644 2024年9月30日和2023年12月31日分別發行和流通的股份。   79    61 
外加實收資本   18,873,691    12,347,098 
累計虧損   (15,050,602)   (9,754,924)
總股東權益   3,823,169    2,592,236 
負債和股東權益總計  $4,602,206   $2,776,586 

 

請參見附註的未經審計簡明合併財務報表。

 

2

 

 

牛蛙 人工智能控股有限公司

簡化合並利潤表

(未經審計)

 

                 
   三個月結束   九個月結束 
   9月30日,   9月30日, 
   2024   2023   2024   2023 
營業收入                
營業收入  $-   $65,000   $-   $65,000 
總收入   -    65,000    -    65,000 
                     
營業成本                    
營業成本   -    5,200    -    5,200 
營業成本合計   -    5,200    -    5,200 
                     
毛利潤   -    59,800    -    59,800 
                     
營業費用                    
研發費用   566,584    380,015    1,632,409    1,023,619 
一般行政   1,253,357    983,929    3,835,213    3,067,940 
營業費用總計   1,819,941    1,363,944    5,467,622    4,091,559 
                     
經營虧損   (1,819,941)   (1,304,144)   (5,467,622)   (4,031,759)
                     
其他收入(費用)淨額                    
利息費用,淨額   (4,978)   (5,758)   (16,150)   (76,880)
換股債券轉換損失   -    -    -    (92,959)
其他收入,淨額   61,455    56,924    204,868    142,675 
總其他收入(費用),淨額   56,477    51,166    188,718    (27,164)
Net loss   (1,763,464)   (1,252,978)   (5,278,904)   (4,058,923)
與權證行權價格調整有關的視爲股利   -    -    (16,774)   - 
歸屬於普通股股東的淨虧損  $(1,763,464)  $(1,252,978)  $(5,295,678)  $(4,058,923)
                     
每股基本和稀釋後可歸屬於普通股股東的淨虧損  $(0.22)  $(0.21)  $(0.67)  $(0.72)
加權平均股本-基本和稀釋   8,124,834    6,094,644    7,880,288    5,667,997 

 

 

請參見附註的未經審計簡明合併財務報表。

 

3

 

 

牛蛙 人工智能控股有限公司

股東權益變動簡明合併財務報表

(未經審計)

 

                      
   A系列     額外的     總計
   優先股  普通股  實收資本  累積的  股東的
   股份  金額  股份  金額  資本  赤字  股權
2022年12月31日結存餘額   73,449   $1    4,021,935   $40   $1,341,662   $(4,399,055)  $(3,057,352)
基於股票的補償   -    -    -    -    127,450    -    127,450 
普通股票和認股權證的發行淨額 扣除發行成本   -    -    1,297,318    13    7,293,638    -    7,293,651 
以股票形式發放服務   -    -    7,692    1    49,999    -    50,000 
可轉換債務轉換爲普通股   -    -    331,166    3    1,535,612    -    1,535,615 
Net loss   -    -    -    -    -    (1,325,547)   (1,325,547)
2023年3月31日的餘額   73,449    1    5,658,111    57    10,348,361    (5,724,602)   4,623,817 
基於股票的補償   -    -    -    -    262,267    -    262,267 
根據認股證的發行發行普通股 練習   -    -    436,533    4    1,494,654    -    1,494,658 
Net loss   -    -    -    -    -    (1,480,398)   (1,480,398)
2023年6月30日的餘額   73,449    1    6,094,644    61    12,105,282    (7,205,000)   4,900,344 
基於股票的補償   -    -    -    -    121,460    -    121,460 
Net loss   -    -    -    -    -    (1,252,978)   (1,252,978)
截至2023年9月30日的餘額   73,449   $1    6,094,644   $61   $12,226,742   $(8,457,978)  $3,768,826 
                                    
2023年12月31日結餘爲   73,449   $1    6,094,644   $61   $12,347,098   $(9,754,924)  $2,592,236 
基於股票的補償   -    -    -    -    335,417    -    335,417 
普通股和權證發行,扣除發行成本   -    -    1,247,092    13    5,674,638    -    5,674,651 
根據認股權證發行普通股 行權   -    -    508,814    5    105,811    -    105,816 
因認股權證價格調整而視同股息   -    -    -    -    16,774    (16,774)   - 
Net loss   -    -    -    -    -    (1,903,794)   (1,903,794)
2024年3月31日結存餘額   73,449    1    7,850,550    79    18,479,738    (11,675,492)   6,804,326 
基於股票的補償   -    -    -    -    192,382    -    192,382 
Net loss   -    -    -    -    -    (1,611,646)   (1,611,646)
2024年6月30日餘額   73,449    1    7,850,550    79    18,672,120    (13,287,138)   5,385,062 
基於股票的補償   -    -    -    -    201,571    -    201,571 
Net loss   -    -    -    -    -    (1,763,464)   (1,763,464)
2024年9月餘額 30日   73,449   $1    7,850,550   $79   $18,873,691   $(15,050,602)  $3,823,169 

 

請參見附註的未經審計簡明合併財務報表。

 

4

 

 

牛蛙 人工智能控股有限公司

濃縮 合併現金流量表

(未經審計)

 

       
   截至9月30日的九個月。
   2024  2023
經營活動產生的現金流量:          
淨虧損  $(5,278,904)  $(4,058,923)
調整爲將淨損失調節爲經營活動中使用的淨現金流的項目:          
折舊   1,293    1,293 
股權獎勵    729,370    511,177 
股份 用於務工發行   -    50,000 
虧損 轉換債券   -    92,959 
債務折扣的攤銷   -    20,000 
經營性資產和負債的變動:          
預付費用   (212,655)   (337,433)
應付賬款   (12,282)   (433,490)
應計費用   434,964    (796,865)
遞延營收   -    (32,000)
經營活動中的淨現金流出   (4,338,214)   (4,983,282)
           
投資活動現金流量:          
購置固定資產和其他資產   -    - 
投資活動使用的淨現金   -    - 
           
籌資活動現金流量:          
普通股和認股權證發行收入淨額,扣除發行成本   5,674,651    7,293,651 
認股權證行使收入   105,816    1,494,658 
應付票據的收益   -    100,000 
應付票據支付   -    (319,950)
短期保險融資收入   561,885    697,534 
保險融資短期支付   (389,880)   (484,244)
籌資活動提供的淨現金流量   5,952,472    8,781,649 
           
現金及現金等價物淨增加額   1,614,258    3,798,367 
           
期初現金及現金等價物餘額   2,624,730    57,670 
期末現金及現金等價物餘額  $4,238,988   $3,856,037 
           
補充現金流量信息:          
支付利息的現金  $16,150   $93,916 
支付的稅費現金  $-   $- 
           
非現金活動的補充          
普通股發行款項轉換  $-   $1,535,615 

 

請參見附註的未經審計簡明合併財務報表。

 

5

 

 

牛蛙 人工智能控股有限公司

注意事項 至簡明合併財務報表(未經審計)

 

 

1. Organization and Nature of Business

 

業務描述

 

Bullfrog AI控股公司(「我們」,「我們的」或「公司」)於2020年2月在內華達州成立。Bullfrog AI控股公司是Bullfrog AI, Inc.和Bullfrog AI Management, LLC的母公司,這兩家公司分別於2017年和2021年在特拉華州和馬里蘭州成立。我們所有的業務目前都是通過Bullfrog AI控股公司進行的,該公司於2020年2月開始運營。我們是一家專注於醫學和醫療保健中複雜數據集的高級人工智能和機器學習(AI/ML)驅動分析的公司。我們的目標是利用我們的平台,通過外部合作和有選擇性的內部開發,實現對藥物資產的精準醫學方法。

 

大多數新的治療方法在臨床前或臨床開發的某個階段都會失敗。這些失敗是開發新治療方法成本高昂的主要原因。開發新治療方法的困難之一是有效整合在開發的每個階段產生的複雜和高度維度的數據,以降低後續開發過程的風險。人工智能和機器學習(AI/ML)已經成爲解決這一問題的數字解決方案。

 

我們使用人工智能和機器學習來推動內部和外部項目的藥物研發。大多數目前的人工智能和機器學習平台仍然在將不同、高維數據綜合爲可操作見解方面表現不足。我們的分析平台由一組最先進的機器學習和人工智能模型組成。我們的核心平台技術,命名爲bfLEAP™,是由約翰斯·霍普金斯大學應用物理實驗室(JHU-APL)開發的分析型人工智能和機器學習平台,能夠克服目前阻礙研究人員和臨床醫生的可擴展性和靈活性挑戰,通過提供對數據更精確、多維的理解。我們正在部署我們的分析平台,包括bfLEAP™,用於內部項目開發的若干關鍵階段,以及通過戰略伙伴關係和合作來簡化治療開發中的數據分析,通過降低新療法失敗率來降低整體開發成本,並影響無數患者的生活,讓他們獲得否則無法獲得的療法。

 

專有的分析平台同時利用了監督式和無監督式機器學習。因此,它能夠揭示數據中真實而有意義的關聯,無需先驗假設。平台中使用的算法旨在處理高度不平衡的數據集,併成功識別與感興趣結果相關的因素組合。我們的平台利用了同時使用相關性和因果關係的機器學習和人工智能方法,提供了綜合的預測分析方法,預計將帶來意義深遠的見解,包括疾病的分子驅動因素。在這方面,藉助於我們對專有數據集(如與利伯腦發育研究所的戰略數據和商業化協議)的訪問,我們增加了在目標發現方面的內部努力。

 

我們的目標是在所有階段改善臨床前和臨床療法開發的成功幾率,包括內部項目以及我們的戰略合作伙伴和合作者。我們的業務模式包括支持正在進行中臨床試驗的成功並拯救晚期失敗的藥物(即,第2或第3期臨床試驗失敗),將其內部開發以便最終出售;儘管我們也考慮進入早期階段藥物的合作。我們通過利用在JHU-APL初始開發的強大且經過驗證的bfLEAP™人工智能/機器學習平台來推進我們的藥物資產增值業務。我們相信bfLEAP™分析平台可能是一種潛在的顛覆性工具,用於分析臨床前和/或臨床數據集,例如在翻譯性研發和臨床試驗環境中生成的健壯的臨床前和臨床試驗數據集。

 

流動性和繼續經營

 

公司自成立以來一直存在經營性現金流爲負並處於淨虧損狀態。2023年第一季度,我們完成了首次公開募股(「IPO」)。2024年2月,我們從一次承銷的普通股和認股權證公募增發中收到了約$5.7百萬的淨收益。截至2024年9月30日,公司的現金餘額約爲$4.2百萬。2024年10月,我們從普通股和預先融資認股權證的註冊直接發行以及同時進行的定向增發普通股和認股權證中獲得了約$2.7百萬的淨收益,並且同時進行了普通股和認股權證的非公開配售。在2024年和2025年沒有獲得重大收入的情況下,公司認爲其資本資源足以支撐計劃中的運營直至2025年第四季度。

 

6

 

 

因此,我們將需要額外的資本來繼續執行我們的策略。我們預計通過各種途徑籌集這些額外資本,包括股權證券銷售、債務交易、許可協議和合作安排。儘管管理層相信這樣的資金來源將會可獲得,但不能保證任何此類安排將達成以在我們需要時提供足夠的資本來繼續我們的業務,或者如果有條件的話,符合我們的接受標準。如果我們無法及時籌集到足夠資金,我們可能被迫推遲、減少或淘汰部分或全部的研究和產品開發項目或我們的資本支出,或以不利的條件達成安排。目前,我們沒有從任何來源獲得未來資金的承諾。

 

附帶的合併財務報表已經假設公司將繼續作爲一個持續經營的實體,這涉及業務的連續性,資產的實現以及在正常業務過程中清償債務。因此,我們的合併財務報表不包括可能因此不確定性結果而產生的任何調整。

 

2. 重要會計政策之摘要

 

表述基礎

 

附表中的簡明綜合財務報表包括Bullfrog 人工智能 控股有限公司及其全資子公司的帳戶,並按照美國通用會計準則(「GAAP」)編制了中期財務信息。所有公司間帳戶和交易在合併中已予以消除。

 

這份未經審計的精簡綜合報表應與我們於2024年3月29日向證券交易委員會提交的《基本報表在10-k表格中的2023年年度報告》中包含的綜合財務報表和相關注解一起閱讀。這些未經審計的精簡綜合財務報表是根據在10-k表格中包含的年度審計綜合財務報表保持一致的基礎編制的,並且在管理層的意見中,包括所有正常經常性調整,以公平陳述我們的財務狀況、經營業績和現金流量。

 

2024年9月30日結束的九個月的結果未必代表截至2024年12月31日或其他未來時期的預期營業結果。

 

2023年2月,我們 完成了普通股1股合併爲7股的反向拆分。股東權益及附屬未經審計的簡明合併財務報表中所有股份和每股金額的參考數據已經調整,以反映所有期間的股票反向拆分。

 

營業收入 確認

 

公司根據以下五步模型確認營業收入:

 

與客戶簽訂合同的辨別
  本步驟概述了與客戶簽訂供應貨物或服務的合同時必須滿足的標準。
識別合同中的履約義務
  本步驟描述瞭如何處理合同中的獨立履約義務。
確定交易價格
  這一步驟概述了建立交易價格時必須考慮的因素,即企業期望通過向客戶轉移商品或服務而收到的金額。
在合同中將交易價格分配給履約義務的分配
  這一步驟概述了跨合同的各個履約義務分配交易價格的指導方針,也是客戶同意爲商品或服務支付的內容。
識別出現時,公司履行履約義務時達到營業收入。
  當業務滿足每個履約義務時,營業收入可以被確認。這一步驟指明瞭應該如何發生。

 

7

 

 

合同 服務

 

公司預計,未來大部分營業收入將來自於發現和變現新藥靶點以及知識產權,通過專注於分析豐富專有數據集的數據使用合作伙伴關係。變現的目標市場主要是尋求打造新藥靶點流水線的中型到大型生物製藥機構。第二營業渠道是與生物製藥公司和所有規模的其他組織合作的服務費合作伙伴關係,這些公司在整個藥物開發過程中分析數據面臨挑戰。公司利用公司的專有人工智能/機器學習平台爲客戶分析大型複雜數據集。該平台旨在預測感興趣的目標、模式、關係、異常以及疾病的分子驅動因素。公司認爲將會有伴侶方的額外工作請求;因此,服務模式採用主服務協議,發出用於在藥物研發的發現、臨床前或臨床階段執行的離散分析的工作或任務訂單。公司收取現金費用,有時還可能獲得分析生成的新知識產權的權利。一旦數據分析和分析報告完成,公司將分析結果交付給客戶,並在那個時間點確認收入。

 

重要會計政策

 

在公司審計的基本報表中討論的重要會計政策以及年度10-K表格中包括的附註中,沒有發生新的重大變化。

 

最近發佈的會計準則的影響

 

公司已評估尚未採用的會計準則更新(“ASU”),並認爲這些準則的採納不會對其合併基本報表產生重大影響。

 

3. 可轉換債券

 

八月 2021年筆記

 

2021年8月,公司與一家無關方簽訂了一項可轉換貸款協議,承諾最高額度爲$195,000 ,帶有 5%原始發行折扣和 9%利率。該貸款已於2023年2月全部償還。

 

2021年12月 2021年筆記

 

2021年12月,公司與一家無關聯方簽訂了一項貸款協議,貸款本金爲$25,000, a 10原始發行折扣率爲% ,利率爲 6%。與公司於2023年2月IPO結束同時,根據其條款,該票據轉換爲 6,939 股普通股。轉換過程中未確認任何收益或損失。

 

可轉換 橋樑債券

 

2022年,公司從幾次發行可轉換橋式票據中獲得了約$991,000 的總收益。與公司於2023年2月的IPO收盤同時,所有可轉換橋式票據根據其條款轉換爲 269,513 普通股。這些轉換沒有確認任何盈虧。

 

4. 可轉換債券 - 關聯方

 

安全 協議

 

2021年7月,公司與關聯方簽訂了未來股權簡易協議(SAFE),購買價格爲$150,000。2023年2月,SAFE終止並按照其條款轉換爲 32,967 股普通股,按照公司首次公開發行(IPO)的規定。轉換被視爲會計目的上的贖回,因此公司確認了$63,626轉換損失。

 

8

 

 

八月 2021年筆記

 

2021年8月,公司與關聯方簽訂了一項可轉換貸款協議,金額爲$99,900。2023年2月,關聯方選擇按照條款將可轉換貸款轉換爲 21,747 股普通股,在公司IPO完成後。此次轉換被視爲贖回,會計處理上,因此公司確認了$29,333的轉換損失。

 

5. 應付票據

 

2023年1月,公司與一家開空期票簽訂了一份,本金餘額爲$100,000,原始發行折扣率爲20%,利率爲 9%。該票據在2023年2月全部償還。

 

2023年2月,公司達成協議,爲其董事和高管保險的部分保費提供融資。該協議規定融資額爲$697,534 保費的 10個相等的月供分期付款$71,485 每月直至2023年12月 ,並計提 6.5%的利息。融資已於2023年償還。

 

2024年2月,公司再次達成協議,爲其董事和高級管理人員保險的一部分保費提供融資。 該協議規定了對保費的融資金額爲$561,885分10個相等月付還款$58,005 ,每月直至2024年12月 及應計利息 6.99%.

 

6. 股東權益

 

優先股

 

普通股股份爲$的10,000,000 授權發行$實值的優先股股份0.00001以及5,500,000 被指定爲A系可轉換優先股。在A系可轉換優先股的授權股份中, 5,500,000 股份已發行並流通於2024年9月30日。每股A系可轉換優先股可隨時轉換爲 73,449 股公司普通股。A系優先股在經濟上等同於普通股,但沒有投票權,並受到 10 阻礙人的限制,如果將其轉換爲普通股會導致投資者在該時擁有超過公司 4.99的流通普通股超過%的股份。

 

普通股

 

普通股股份爲$的100,000,000 普通股授權數量爲$ 的面值0.00001.

 

2023年2月,公司完成了首次公開發行,出售了 1,297,318 單位(每個統稱爲一個「單位」) 以每單位$6.50 單位,共計約$8.4 百萬美元的總募集資金。 每個單位包括公司普通股一份,一張可交易權證(每張統稱爲「可交易權證」),行使價格爲$7.80,和 一張不可交易權證(每張統稱爲「不可交易權證」;與可交易權證一同,共稱爲「權證」),行使價格爲每股$8.125.

 

在 與其首次公開募股完成相關的情況下,公司發行了總計 331,166 普通股的股份,作爲某些未償還可轉換債務的轉換股份(見註釋3和註釋4)。

 

在 與首次公開募股有關的事宜中,公司於2023年2月 完成了1比7的反向拆股股東權益 以及所有關於股份和每股金額的引用在附帶的未經審計的壓縮合並基本報表中已被 追溯調整,以反映所有呈現期間的反向拆股。

 

在 2023年2月,公司發行了 7,692 普通股以換取諮詢服務,並確認$50,000 與這些股份相關的補償費用 爲$

 

9

 

 

在 2024 年 2 月,公司收到了大約 $6.5 出售的總收益爲百萬美元 1,247,092 普通股股份, 478,429 預先注資的認股權證和 1,725,521 認股權證(統稱 “單位”)。這些商品的售價爲 $3.782 還有銷售 是通過承銷的二次公開募股完成的,包括承銷商行使其總配股權的行使。 認股權證的行使價爲美元4.16 並在發行後五年內到期。預先注資的認股權證的行使價爲 $0.001 並於2024年第一季度全部行使。

 

稀釋性證券在其效果爲反稀釋時被排除在每股稀釋收益計算之外。截至2024年9月30日, 73,449 優先股的股份, 5,307,444 認股權證和 849,427 普通股的期權被排除在每股淨虧損的計算之外。截至2023年9月30日, 73,449 優先股的股份, 3,796,164 認股權證和 507,717 普通股的期權被排除在每股淨虧損的計算之外。

 

2022 股權激勵計劃

 

在 2022年11月,公司董事會通過了其股東批准的2022年股權激勵計劃(“計劃”)。 該計劃提供了向員工、董事和顧問授予基於股權的獎勵。該計劃提供的基於股權的 獎勵包括激勵股權期權、非合格股權期權、股票增值權、績效股票獎勵、現金獎勵 以及其他基於股權的獎勵。獎勵的最大期限限制爲 10 年,任何行使價格不得低於授予日一個普通股的公允市場價值的100%。

 

Stock Options

 

The following tables summarizes the stock option activity for the nine months ended September 30, 2024:

  

   Number of Shares  Weighted-Average Exercise Price  Weighted-Average Remaining Contractual Term (Years)  Aggregate
Intrinsic Value
Outstanding at December 31, 2023   527,717   $4.17    9.00   $112,141 
Granted   368,000   $3.71           
Exercised   -   $          -           
Forfeited / canceled   (46,290)  $3.95           
Outstanding at September 30, 2024   849,427   $3.98    8.72   $25,652 
Vested at September 30, 2024   449,434   $4.06    8.27   $16,837 

 

   Number of Shares  Weighted-Average Exercise Price  Weighted-Average Remaining Contractual Term (Years)  Aggregate
Intrinsic Value
Outstanding at December 31, 2022   69,217   $3.06    7.08   $117,669 
Granted   438,500   $4.41           
Exercised   -   $-           
Forfeited / canceled   -   $           -           
Outstanding at September 30, 2023   507,717   $4.23    9.17   $102,441 
Vested at September 30, 2023   215,623   $3.97    8.64   $52,644 

 

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The fair value of options granted during the nine months ended September 30, 2024 and 2023 was estimated using the Black-Scholes option pricing model based on the assumptions in the table below:

  

     九個月截至9月30日  
     2024      2023  
預期 股息收益率    0%      0%  
預期波動率    92% - 97%      87% - 92%  
無風險 利率    3.5% - 4.4%      3.4% - 4.1%  
預期 壽命(年)    5.3 - 6.0      5.0 - 6.0  

 

股息 收益率 - 公司預計在可預見的未來不會支付股息。
波動性 - 交易波動性是通過計算公司的對等集團的波動性來確定的。
無風險 利率 - 這是美國國庫利率,其期限與股票期權的預期存續期相當。
期權的預期存續期 - 員工獲得的期權的預期存續期是使用簡化方法確定的。

 

截至2024年9月30日和2023年9月30日的九個月內授予的期權的加權平均授予日期公允價值爲$2.833.20

 

在截至2024年9月30日的三個月和九個月期間,公司確認了$201,571726,363,分別與期權相關的薪酬費用。在截至2023年9月30日的三個月和九個月期間,公司確認了$116,410475,465,分別與期權相關的薪酬費用。

 

截至2024年9月30日,與未歸屬期權相關的未確認薪酬費用總計約爲$1,084,000,公司預計將在大約加權平均期間內確認 1.5 年。

 

認股權證

 

以下表格提供截至2024年9月30日公司未償還warrants的詳細信息:

  

行使價格  到期日  認股證數目
$0.0007  2030   274,286 
$2.10 - $2.66  2026 - 2032   446,160 
$3.36 - $4.27  2028 - 2029   1,933,226 
$6.51 - $7.80  2026 - 2032   1,484,829 
$8.125  2027 - 2028   1,443,227 
       5,581,728 

 

與交易並行發行的權證

 

截至2023年12月31日止,公司作爲2023年2月IPO的一部分發行了以下認股權證:

 

276,452向某些債權人發行的附條件權證,行權價爲$4.27 ,截止日期爲 5 年發行的截至2024年9月30日,已有 204,033 份權證行權,尚有 72,419 份權證尚未行權。由於2024年2月的公募增發交易,權證行權價降至$3.782 ,根據權證中包含的防稀釋條款。價格變動的效果被確認爲特別股東可得的$5,794 的虛擬股息,使截至2024年9月30日止九個月的普通股股東可獲得的淨損失增加。
18,000作爲對公司承銷商的一種費用,發行價格爲$的有條件權證8.125 並於發行日起年到期 4 從發行日起舉例爲2024年9月30日,這些權證中沒有一個被行使。由於2024年2月的公募增發交易,權證的行使價格降至$3.782 根據權證中包含的反稀釋條款,行使價格調整爲$。價格變動的效應被確認爲$的應分配股利10,980 ,從截至2024年9月30日的九個月的角度來看,這增加了可供普通股股東使用的淨虧損。

 

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1,297,318 可交易的warrants,行使價格爲$7.80 ,到期日期爲 5 的年限。 截至2024年9月30日, 100 warrants已被行使。
1,297,318 不可交易的warrants,行使價格爲$8.125 ,到期日期爲 5 自發行之日起的年數。截止到2024年9月30日, 7,500 這些warrants已被行使, 1,289,818仍然未被行使。
153,409根據超額配售期權向我們的承銷商提供可交易的warrants,行使價格爲$7.80 ,到期日期爲 5 自發行之日起的年數。截止到2024年9月30日,沒有這些warrants被行使。
153,409 根據超額分配期權向我們的承銷商提供不可交易的warrants,行使價格爲$8.125 和到期日爲 5 發行後幾年。從2024年9月30日開始,尚未行使上述任何warrants。

 

在截至2024年9月30日的九個月期間,公司發行了以下warrants 作爲公司公募增發的一部分:

 

1,507,139warrants 購買公司普通股的權利,行權價爲$4.16每股,到期日 5 年自發行日起。此外,公司另外發行了 218,382 認股權證行使價為$4.16 ,到期日 5 年自發行日起根據承銷商的超額配股選擇權。截至2024年9月30日,其中 16,000 這些認股權證中已經有 1,709,521 還未行使。
478,429 以每 share $ 預先資金支持權證0.001。截至2024年9月30日,所有這些 預先資金支持權證均已行使。
90,428 每股 $ 行權價的權證4.16 和到期日爲 5 年,面向我們的承銷商。這些權證的價值約爲 $263,000截至2024年9月30日,這些認股權證尚未行使。

 

Warrants Issued as Consideration for Services

 

以下表格總結了截至2024年9月30日的九個月和截至2023年12月31日的年度,作爲服務對價發行的warrants的活動:

   

   Number of Warrants  Weighted-Average Exercise Price  Weighted-Average Remaining Contractual Term (Years)  Aggregate
Intrinsic Value
Outstanding at December 31, 2022   678,176   $1.57    7.6   $2,131,123 
Granted   -   $       -           
Exercised   -   $-           
Forfeited / canceled   -   $-           
Outstanding at December 31, 2023   678,176   $1.57    6.6   $1,209,136 
Granted   -   $-           
Exercised   (14,285)  $2.66           
Forfeited / canceled   -   $-           
Outstanding at September 30, 2024   663,891   $1.55    5.8   $964,513 
Vested at September 30, 2024   663,891   $1.55    5.8   $964,513 

 

During the three and nine months ended September 30, 2024, the Company recognized $0 and $3,007, respectively, of compensation expense related to certain warrants. During the three and nine months ended September 30, 2023, the Company recognized $5,050 and $35,712, respectively, of compensation expense related to certain warrants.

 

As of September 30, 2024, there was no unrecognized compensation expense related to unvested warrants.

 

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7. Income Taxes

 

The Company has not recorded any tax provision or benefit for the nine months ended September 30, 2024 and 2023. The Company has provided a valuation allowance for the full amount of its net deferred tax assets since realization of any future benefits from deductible temporary differences, net operating loss carryforwards, and research and development credits are not more-likely-than-not to be realized at September 30, 2024 and December 31, 2023.

 

8. Material Agreements

 

JHU-APL Technology License

 

在 2018年2月,公司簽訂了JHU-APL的全球獨家特許權使用許可。該許可證涵蓋三 (3) 已頒發的專利、一(1)份新的臨時專利申請、算法專有庫和其他貿易的非專利權 祕密,以及修改和改進。2021 年 10 月,公司對原始改進許可證進行了修訂 以及新的高級分析功能。考慮到根據許可協議授予公司的權利,JHU收到了 等於百分之五的認股權證 (5公司當時全面攤薄後的股本基礎的百分比),該股權基礎在公司收盤後進行了稀釋 首次公開募股。根據許可協議的條款,JHU將有權獲得百分之八(8%) 服務淨銷售額的特許權使用費 由公司提供以及百分之五十(50佔公司通過服務和分許可獲得的所有分許可收入的百分比 其中使用了JHU許可的技術。此外,公司需要向JHU支付年度維護費 $1,500。 最低年度特許權使用費爲 $20,000 對於2022年,美元80,000 2023 年,以及 $300,000 2024 年及以後每年一次。如果每年累計 特許權使用費未達到這些水平,JHU爲達到年度最低金額而應支付的金額應在以下日期的1月1日之前支付 年。根據協議,未支付年度特許權使用費被視爲重大違約行爲,JHU收到有關材料的通知後 違規行爲,公司應有60天的時間來糾正重大違規行爲。2022年7月,公司在全球範圍內簽訂了獨家協議 JHU-APL爲增強bFleap™ 平台而開發的額外技術提供了特許權使用許可。新許可證提供 其他知識產權,包括專利、版權和專有技術,將在公司的 bFleap™ 下使用 分析型人工智能/機器學習平台。該許可證取代了以前的許可證。考慮到新的許可證,公司頒發了 39,879 普通股歸JHU。根據新許可協議的條款,JHU將有權獲得百分之八(8%) 佔淨銷售額 用於公司向其他各方提供的服務,百分之三(3%) 用於內部開發的藥物項目,其中 使用了 JHU 許可證。新許可證還包含分層次許可費,起價爲 50% 並減少到 25% 基於收入。 此外,根據新的許可協議,最低年度特許權使用費爲 $30,000 對於2022年,美元80,000 2023 年,以及 $300,000 2024 年及以後每年一次。

 

在 2023 年 5 月,公司和 JHU-APL 簽訂了 2022 年 7 月許可協議第 1 號修正案,公司據此獲得了訪問權限 進行某些改進,包括額外的專利和專有技術,以換取總額爲美元的一系列付款275,000。第一個 這些款項的金額爲 $75,000 已於 2023 年 7 月支付,剩餘款項爲 $75,000, $75,000,和 $50,000 將於 2025 年、2026 年到期, 分別是 2027 年和 2027 年。該修正案還將2023年的最低年度特許權使用費減少至美元60,000,所有其他財務條款保持不變 一樣。截至 2024 年 9 月 30 日,我們已經累積了 $225,000 2024 年的最低年度特許權使用費支付。

 

喬治·華盛頓大學 - 貝塔2-光譜蛋白siRNA許可

 

2022年1月,公司與喬治華盛頓大學(GWU)達成了一項獨家、全球範圍的、以特許權爲基礎的許可協議,獲得了應用siRNA靶向Beta2-pectrin治療人類疾病(包括肝細胞癌)的權利。該許可涵蓋了三項美國和全球專利申請中所要求的方法,並且還包括利用這種方法治療肥胖、非酒精性脂肪肝病和非酒精性脂肪肝炎。

 

考慮到根據許可協議授予公司的權利,公司向GWU支付了$20,000 許可啓動費。 根據許可協議的條款,GWU將有權獲得淨銷售額的3%(3%)特許權使用費,受季度最低限額的限制 一旦首次銷售在監管批准後發生,作爲子許可或轉讓費用,如果公司將其使用科技的權利進行子許可 或轉讓。公司還將報銷GWU之前發生的和正在進行的專利費用。 隨着公司推進許可科技的臨床開發,子許可和轉讓費用的金額會下降。許可 協議還包含了通過NDA審批和商業化的臨床開發的里程碑付款。截止至2024年9月30日,尚未產生 no 特許權使用費的應計,因爲我們尚未開始產生可適用的營業收入。公司評估了該許可證是否應資本化,並確定該許可項目處於早期階段,因此可能無法收回; 公司將許可費用記入費用,並將在商業可行性可能確定之前將開發成本記入費用。

 

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Johns Hopkins University – Mebendazole License

 

In February 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from Johns Hopkins University (JHU) for the use of an improved formulation of Mebendazole for the treatment of any human cancer or neoplastic disease. This formulation shows potent activity in animal models with different types of cancer and has been evaluated in a Phase I clinical trial in patients with high-grade glioma (NCT01729260). The trial, an open-label dose-escalation study, assessed the safety and efficacy of the improved formulation with adjuvant temozolomide in 24 patients with newly diagnosed gliomas. Investigators observed no dose-limiting toxicity in patients receiving all but the highest tested dose (200mg/kg/day). Four of the 15 patients receiving the maximum tested dose of 200mg/kg/day experienced dose-limiting toxicity, all of which were reversed by decreasing or eliminating the dose given. There were no serious adverse events attributed to Mebendazole at any dose during the trial. 41.7% of patients who received Mebendazole were alive at two years after enrollment, and 25% were alive at four years (Gallia et al., 2021).

 

The license covers six (6) issued patents and one (1) pending application. In consideration of the rights granted to the Company under the License Agreement, JHU will receive a staggered Upfront License Fee of $250,000. The Company initially paid $50,000 and the remaining balance of $200,000 was paid after the Company completed its IPO. The Company will also reimburse JHU for previously incurred and ongoing patent costs. Under the terms of the License Agreement, JHU will be entitled to three and one-half percent (3.5%) royalty on net sales by the Company in which the JHU license was utilized. In addition, the Company is required to pay JHU minimum annual royalty payments of $5,000 for 2022, $10,000 for 2023, $20,000 for 2024, $30,000 for 2025, and $50,000 for 2026 and each year after until the first commercial sale, after which, the annual minimum royalty shall be $250,000. The license agreement also contains milestone payments for clinical development steps through the approval of an NDA and commercialization. As of September 30, 2024 and December 31, 2023, the balance of accrued expense related to this license agreement was $15,000 and $10,000, respectively. The Company assessed whether the license should be capitalized and determined that the licensed program is in the early stage and therefore may not be recoverable; the Company expensed the license fee and will expense development costs until commercial viability is likely.

 

Johns Hopkins University – Prodrug License

 

In October 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU and the Institute of Organic Chemistry and Biochemistry (IOCB) of the Czech Academy of Sciences for rights to commercialize N-substituted prodrugs of Mebendazole that demonstrate improved solubility and bioavailability. The license covers prodrug compositions and use for treating disease as claimed in multiple US and worldwide patent applications. In consideration for the rights granted to the Company under the License Agreement, JHU and IOCB will receive a staggered upfront license fee of $100,000. The Company will also reimburse JHU and IOCB for previously incurred patent costs. Under the terms of the License Agreement, JHU and IOCB will be entitled to four percent (4.0%) royalty on net sales by the Company in which the JHU and IOCB license was utilized. In addition, the Company is required to pay JHU and IOCB minimum annual royalty payments of $5,000 for 2026, $10,000 for 2027, $20,000 for 2028, $30,000 for 2029, and $50,000 for 2030 and each year after until the first commercial sale, after which, the annual minimum royalty shall be $150,000. The license agreement also contains milestone payments for patent grants, clinical development steps through the approval of an NDA and commercialization. No expenses have been accrued as of any of the periods presented. The Company assessed whether the license should be capitalized and determined that the licensed program is in the early stage and therefore may not be recoverable; the Company expensed the license fee and will expense development costs until commercial viability is likely.

 

9. Subsequent Events

 

The Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the unaudited condensed consolidated financial statements are issued.

 

Other than as disclosed in this Note 9 and as may be disclosed elsewhere in the notes to the accompanying unaudited condensed consolidated financial statements, there have been no subsequent events that require adjustment or disclosure in the accompanying unaudited condensed consolidated financial statements.

 

On October 18, 2024, the Company entered into a securities purchase agreement with certain institutional investors (the “Purchasers”), pursuant to which the Company agreed to issue to the Purchasers, in a registered direct offering, (i) 862,602 shares of the Company’s common stock (the “Shares”), par value $0.00001 per share (“Common Stock”), pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 702,398 shares of Common Stock (the “Pre-funded Warrants Shares”) with an exercise price of $0.0001 per share, at a purchase price of $2.00 per share of Common Stock and a purchase price of $1.9999 per Pre-Funded Warrant, and (ii) in a concurrent private placement, warrants (the “Common Warrants”) to purchase an aggregate of 1,565,000 shares of Common Stock (the “Common Warrant Shares”) with an exercise price of $2.00 per share, which are exercisable after six (6) months from the date of issuance for a five-year period from the initial exercise date. The transaction closed on October 21, 2024, with the Company earning gross proceeds of approximately $3.13 million, and net proceeds of approximately $2.7 million. Concurrently with the securities purchase agreement, on October 18, 2024, the Company also entered into a placement agency agreement with WallachBeth Capital, LLC, as the placement agent (the “Placement Agent”), pursuant to which the Company agreed to pay the Placement Agent an aggregate cash fee of 8.0% of the gross proceeds from the sale of securities in the transaction, reimburse for certain out-of-pocket expenses, and issue to the Placement Agent (or its designees) warrants to purchase an aggregate of 62,600 shares of Common Stock, equal to 4% of the aggregate number of shares of Common Stock and/or Pre-Funded Warrants sold in the registered direct offering, at an exercise price per share equal to $2.00, which is equal to the exercise price of the Common Warrants. The placement agent warrants are exercisable six (6) months from the date of issuance and expire on the five-year anniversary of initial exercise date.

 

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Item 2. Management’s Discussion and Analysis of Financial Conditions and Results of Operations

 

References in this Management’s Discussion and Analysis of Financial Condition and Results of Operations to “us”, “we”, “our” and similar terms refer to the Company. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with (1) our consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q, and (2) our consolidated financial statements, related notes and management’s discussion and analysis of financial condition and results of operations in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on March 29, 2024. This Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These statements are often identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “will,” “would” or the negative or plural of these words or similar expressions or variations. Such forward-looking statements are subject to a number of risks, uncertainties, assumptions, and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein. You should not rely upon forward-looking statements as predictions of future events. Furthermore, such forward-looking statements speak only as of the date of this report. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

 

Overview

 

Bullfrog AI Holdings, Inc. was incorporated in the State of Nevada in February 2020. Bullfrog AI Holdings, Inc. is the parent company of Bullfrog AI, Inc. and Bullfrog AI Management, LLC, which were incorporated in Delaware and Maryland, in 2017 and 2021, respectively. Operations are currently conducted through Bullfrog AI Holdings, Inc., which began operations on February 6, 2020. We are a company focused specifically on advanced Artificial Intelligence / Machine Learning (AI/ML) analysis of complex data in the advancement of medicine. Our founding AI/ML platform (trade name: bfLEAP™) was created from technology originally developed at The Johns Hopkins University Applied Physics Laboratory (JHU-APL). Subsequently, we have developed new tools and capabilities composed of an ensemble of machine learning and artificial intelligence models.

 

In February 2018, Bullfrog AI Holdings secured the original exclusive, worldwide, royalty-bearing license from JHU-APL. The license covers three (3) issued patents, one (1) new provisional patent application, non-patent rights to proprietary libraries of algorithms and other trade secrets including modifications and improvements. Our objective is to utilize our AI/ML platform with a precision medicine approach toward drug development with biopharmaceutical collaborators, as well as for our own internal clinical development programs. We believe the bfLEAP™ platform is ideally suited for evaluating pre-clinical and clinical trial data generated in translational research and clinical trial settings that lead to faster, less expensive drug approvals.

 

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Our aim is to improve the odds of success in each stage of developing medicine, ranging from early pre-clinical through late-stage clinical development. Our ultimate objective is to utilize bfLEAP™ to enable the success of ongoing clinical trials or rescue late-stage failed drugs (i.e., Phase 2 or Phase 3 clinical trial failures) for in-house development and divestiture; although, we also consider entering collaborations for earlier stage drugs.

 

In September 2020 and October 2021, the Company executed amendments to the original February 2018 license which represents improvements and new advanced analytics capabilities. In consideration of the rights granted to the Company under the original License Agreement, the Company granted JHU 178,571 warrants exercisable to purchase shares of common stock at $2.10 per share.

 

In July 2022, the Company entered into an exclusive, worldwide, royalty-bearing license from JHU-APL that provides additional intellectual property rights including patents, copyrights, and knowhow to be utilized under the Company’s bfLEAP™ analytical AI/ML platform. In consideration for the new license, the Company issued to JHU-APL 39,879 shares of common stock. Under the terms of the new License Agreement, JHU will be entitled to eight (8%) percent of net sales for the services provided by the Company to other parties and three (3%) percent for internally developed drug projects in which the JHU license was utilized. The new license also contains tiered sub licensing fees that start at fifty (50%) percent and reduce to twenty-five (25%) percent based on revenues. The Company and JHU-APL entered into Amendment number 1 of the July 2022 License Agreement whereby the Company gained access to certain improvements including additional patents and knowhow in exchange for a series of payments totaling $275,000. The first of these payments for $75,000 was paid in July 2023 and the remaining payments of $75,000, $75,000 and $50,000 are due in years 2025, 2026 and 2027, respectively. The amendment also reduced the 2023 minimum annual royalty payment to $60,000, all other financial terms remain the same. As a result of this Amendment, the minimum annual payments were $30,000 for 2022 and $60,000 for 2023, and the minimum annual payments will be $300,000 for 2024 and beyond, all of which are creditable by royalties. As of September 30, 2024, we have accrued $225,000 of the 2024 minimum annual royalty payments.

 

We intend to continue to evolve and improve bfLEAP™, either in-house or with development partners like JHU-APL. We plan to leverage our proprietary AI/ML platform, developed over several years at one of the top innovation institutions in the world which has already been successfully applied in multiple sectors.

 

We have staffed our business using funds from our initial public offering and have entered into partnerships and relationships and recently completed our first commercial service contract with a leading rare disease non-profit organization for AI/ML analysis of late-stage clinical data. We have also acquired the rights to a series of preclinical and early clinical drug assets from universities, as well as a strategic collaboration with a world-renowned research institution to create a HSV1 viral therapeutic platform to engineer immunotherapies for a variety of diseases. We have signed exclusive worldwide License Agreements with JHU for a cancer drug that targets glioblastoma (brain cancer), pancreatic cancer, and others. We have also signed an exclusive worldwide license from George Washington University for another cancer drug that targets hepatocellular carcinoma (liver cancer) and other liver diseases. In addition, we have signed three-year strategic data and commercialization agreements with the Lieber Institute for Brain Development (“LIBD”) whom we believe has a repository of the largest collection of postmortem brains in the world including molecular, clinical, and other data. The objective of this partnership is for the Company to analyze these rich data sets using its proprietary AI/ML tools and models and then go to market with the discoveries with the ultimate goal of securing revenue generating strategic partnership deals with biopharmaceutical companies. We intend to secure the rights to other proprietary data sets and repeat this strategy. Additionally, we intend to gain access to later-stage clinical assets through partnerships or the acquisition of rights to failed therapeutic candidates for drug rescue. In certain circumstances, we intend to conduct late-stage clinical trials in an effort to rescue therapeutic assets that previously failed. In these cases, there will be a requirement for drug supply and regulatory services to conduct clinical trials. The success of our clinical development programs will require finding partners to support the clinical development, adequate availability of raw materials and/or drug product for our R&D and clinical trials, and, in some cases, may also require establishment of third-party arrangements to obtain finished drug product that is manufactured appropriately under Good Manufacturing Practices, and packaged for clinical use or sale. Since we are a company focused on using our AI technology to advance medicines, any clinical development programs will also require, in all cases, partners and the establishment of third-party relationships for execution and completion of clinical trials.

 

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Since completing our IPO in February 2023, aided by the receipt of the IPO proceeds in addition to the proceeds from our February 2024 and October 2024 offerings, we have implemented several initiatives: investor relations and marketing to promote and raise awareness of the company in the financial and business sectors, research and development, collaboration with the J Craig Venter Institute and initiated preclinical studies with our in-licensed drug programs. The Company is actively engaged in developing and pursuing new intellectual property as it strives to continuously evolve its AI/ML platform.

 

Internally, the Company has added incremental staff to accelerate execution, and the development of processes and custom scripts for use in performing new drug target discovery and analytical services for customers, while also launching initiatives targeting large public health data sources and seeking access to proprietary health data sources, such as our agreement with the Lieber Institute for Brain Development. We also transitioned our accounting and financial reporting systems and processes to enhance our internal control environment as a public company. Capital from the IPO was also used to retire two notes that were sold to fund the Company through the IPO that did not convert into common stock as well as other debts accrued over time to our staff, employees and consultants as well as obligations related to the acquisition of our licensed drug programs.

 

The Company has had negative cash flows from operations and operated at a net loss since inception. In the first quarter of 2023, we completed our initial public offering (“IPO”). In February 2024, we received net proceeds of approximately $5.7 million from an underwritten secondary public offering of common stock and warrants. As of September 30, 2024, the Company has a cash balance of approximately $4.2 million. In October 2024, we received net proceeds of approximately $2.7 million from a registered direct offering of common stock and pre-funded warrants, and concurrent private placement of common stock warrants. In the absence of significant revenues in 2024 and 2025, the Company believes that its capital resources are sufficient to fund planned operations into the fourth quarter of 2025.

 

Accordingly, we will require additional capital to continue to execute our strategy. We anticipate raising this additional capital through various avenues including sales of equity securities, debt transactions, licensing agreements and collaborative arrangements. Although management believes that such funding sources will be available, there can be no assurance that any such arrangements will be consummated to provide sufficient capital when needed to allow us to continue our operations, or if available, on terms acceptable to us. If we do not raise sufficient funds in a timely manner, among other things, we may be forced to delay, scale back or eliminate some or all our research and product development programs and/or our capital expenditures or to enter into arrangements on unfavorable terms. We currently do not have commitments for future funding from any source.

 

Our Strategy

 

The Company has a unique strategy designed to reduce risk and increase the frequency of cash flow. The first part of the strategy is to generate revenues through strategic relationships with biopharma companies. These relationships will be structured as a combination of fees and intellectual property based on the specific scope of the engagement. The objective of these engagements will be to uncover valuable insights to reduce the risk and/or increase the speed of the drug development process which can be achieved through manual or automated integration into the client’s workflow or analysis of discrete data sets.

 

In the future, the second part of our strategy involves acquiring the rights to drugs at various stages of development, using our proprietary AI/ML technology to advance the development and make discoveries, with the objective of creating near term value and then exiting and monetizing as quickly as possible, preferably within approximately 30 months.

 

Critical Accounting Policies and Estimates

 

Our financial statements are prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, as well as related disclosures. We evaluate our estimates and assumptions on an ongoing basis. Our estimates are based on historical experience and various other assumptions that we believe to be reasonable under the circumstances. Our actual results could differ from these estimates. There have been no material changes to our critical accounting policies and estimates as those described in our Form 10-K for the fiscal year ended December 31, 2023.

 

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Financial Operations Overview

 

Revenue

 

While we generated our first revenues in late 2022 from our services provided to a pharmaceutical customer, we completed our first commercial service contract and recognized revenue in the amount of $65,000 in the third quarter of 2023. We did not generate any revenue during the nine months ended September 30, 2024.

 

Research and Development Costs and Expenses

 

Research and development expenses consist primarily of costs related to the acquisition of licensed technology, annual minimum royalty fees payable until commercialization, fees paid to external service providers and internal costs for personnel working on research and development activities, including work on our proprietary platform which utilizes bfLEAP™ and an ensemble of AI/ML tools and models.

 

Research and development costs are expensed as incurred. Estimates are used in determining the expense liability of certain costs where services have been performed but not yet invoiced.

 

We anticipate our research and development costs continuing to increase as we execute on our business plan and begin conducting preclinical research and development activities directed at securing development partners and filing an Investigational New Drug application for our licensed drug development programs described in this filing, as well as under strategic partnerships and for other drug development programs we may pursue. Further, we anticipate our research and development costs will increase as we add additional staff and perform analytical work aimed at target discovery on proprietary data sets through our partnering efforts as well as with prospective customers.

 

General and Administrative Expenses

 

General and administrative expenses consist primarily of personnel related costs, including non-cash stock-based compensation, as well as accounting and consulting services, insurance expense, and legal fees relating to corporate matters. We anticipate that our general and administrative expenses will increase in the future to support our target discovery efforts, service offerings, and clinical and pre-clinical research and development activities associated with strategic partnering and collaborations.

 

Results of Operations - Comparison of Three Months Ended September 30, 2024 and 2023

 

   September 30,   Net Change 
   2024   2023     
Operating expenses:               
Research and development  $566,584   $380,015   $186,569 
General and administrative   1,253,357    983,929    269,428 
Total operating expenses  $1,819,941   $1,363,944   $455,997 

 

Research and Development

 

Our research and development expenses for the three months ended September 30, 2024 increased, compared to the same period ended September 30, 2023, primarily due to increased personnel costs related to the hiring of several additional technical staff as well as our Chief Science Officer. In addition, in the first quarter of 2024, we engaged disease experts as area consultants, we expanded our target discovery efforts, and we also initiated a preclinical obesity study related to siRNA program. We expect our R&D expenses to increase as we begin the validation process on potential targets identified in our target discovery program.

 

General and Administrative

 

Our general and administrative expenses for the three months ended September 30, 2024 increased, compared to the same period ended September 30, 2023, primarily due to increased personnel costs related to the hiring of several additional staff, as well as associated increases in equity compensation costs and recruiting fees as we work to expand our technical staff and capabilities.

 

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Other Income (Expense), Net

 

Interest income generated from cash held in an overnight sweep account increased by $4,531 for the three months ended September 30, 2024, compared to the same period ended September 30, 2023.

 

Results of Operations - Comparison of Nine Months Ended September 30, 2024 and 2023

 

   September 30,   Net Change 
   2024   2023     
Operating expenses:               
Research and development  $1,632,409   $1,023,619   $608,790 
General and administrative   3,835,213    3,067,940    767,273 
Total operating expenses  $5,467,622   $4,091,559   $1,376,063 

 

Research and Development

 

Our research and development expenses for the nine months ended September 30, 2024 increased, compared to the same period ended September 30, 2023, primarily due to increased personnel costs related to the hiring of several additional technical staff as well as our Chief Science Officer. In addition, in the first quarter of 2024, we engaged disease experts as area consultants, we expanded our target discovery efforts, and we also initiated a preclinical obesity study related to siRNA program. We expect our R&D expenses to increase as we begin the validation process on potential targets identified in our target discovery program.

 

General and Administrative

 

Our general and administrative expenses for the nine months ended September 30, 2024 increased, compared to the same period ended September 30, 2023, primarily due to increased personnel costs related to the hiring of several additional staff, as well as associated increases in equity compensation costs and recruiting fees as we work to expand our technical staff and capabilities.

 

Other Income (Expense), Net

 

Interest expense decreased $60,730 for the nine months ended September 30, 2024, compared to the same period ended September 30, 2023, due to the majority of our debt converting or being paid off in the first quarter of 2023. Interest income generated from cash held in an overnight sweep account increased by $62,193 for the nine months ended September 30, 2024, compared to the same period ended September 30, 2023, due to an increase in our average cash balances.

 

Results of Operations

 

Liquidity and Capital Resources

 

In 2022, the Company received net proceeds from the sale of Convertible Bridge Notes of approximately $1,016,000 and repaid unsecured promissory notes sold in 2021 in the amount of $49,000. The Company sold one additional promissory note and received net proceeds of $100,000 in January 2023.

 

Through September 30, 2024, the Company has an accumulated deficit of approximately $15.1 million and has funded its operations through the sale of common stock and debt. We anticipate that our expenses will increase in the future to support our target discovery activities, service offerings, clinical and pre-clinical research and development activities associated with strategic partnering and collaborations, as well as acquired product candidates and the increased costs of operating as a public company.

 

The Company’s current entities include Bullfrog AI, Inc. and Bullfrog Management, LLC, which are wholly owned subsidiaries of Bullfrog AI Holdings, Inc., which is a holding company that depends upon the sale of its securities and cash generated through its subsidiaries to fund consolidated operations.

 

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On February 16, 2023, the Company completed its IPO of 1,297,318 units (each, a “Unit,” collectively, the “Units”) at a price of $6.50 per unit for a total of approximately $8.4 million of gross proceeds to the Company. Each Unit consists of one share of the Company’s common stock, one tradeable warrant (each, a “Tradeable Warrant,” collectively, the “Tradeable Warrants”) to purchase one share of common stock at an exercise price of $7.80 per share, and one non-tradeable warrant (each, a “Non-tradeable Warrant,” collectively, the “Non-tradeable Warrants”; together with the Tradeable Warrants, each, a “Warrant,” collectively, the “Warrants”) to purchase one share of the Company’s common stock at an exercise price of $8.125. In connection with the IPO, the Company also completed a 1-for-7 reverse stock split of our common stock.

 

In connection with the IPO, a SAFE and convertible loan agreement held by a related party converted into 55,787 shares of common stock. Additionally, all outstanding convertible bridge notes and accrued interest through November 30, 2022 were converted into 276,289 shares of common stock and 276,289 warrants to purchase common stock and were issued to the Convertible Bridge Note holders at conversion. The convertible bridge note conversions and the warrant exercise pricing were determined using a $25 million company valuation immediately before the IPO.

 

In April 2023, the holders of warrants exercised 436,533 warrants for common stock at various exercise prices and the Company received proceeds of approximately $1,495,000.

 

In February 2024, we completed an underwritten secondary offering of common stock and warrants generating approximately $5.7 million of net proceeds.

 

In the first quarter of 2024, holders exercised warrants (including prefunded warrants from the secondary offering) to purchase 508,814 shares of common stock generating proceeds of approximately $106,000.

 

In October 2024, we completed a registered direct offering of common stock and pre-funded warrants, and concurrent private placement of common stock warrants generating approximately $2.7 million of net proceeds.

 

In the absence of significant revenues in 2024 and 2025, management believes the Company’s capital resources are sufficient to fund planned operations into the fourth quarter of 2025. Accordingly, we will seek additional capital to continue to execute our strategy as discussed above.

 

Consolidated Cash Flow Data

 

   Nine Months Ended September 30,    
   2024   2023   Change 
Net cash (used in) provided by               
Operating activities  $(4,338,214)  $(4,983,282)  $645,068 
Investing activities   -    -    - 
Financing activities   5,952,472    8,781,649    (2,829,177)
Net increase in cash and cash equivalents  $1,614,258   $3,798,367   $(2,184,109)

 

Cash Flows Used in Operating Activities

 

Net cash used in operating activities for the nine months ended September 30, 2024 decreased compared to the same period ended September 30, 2023 primarily due to paying down payables and accrued expenses for technology access, consultants, and compensation in 2023, partially offset by increased operating costs in 2024.

 

Cash Flows Used in Investing Activities

 

There was no cash used in investing activities during the nine months ended September 30, 2024 or 2023.

 

Cash Flows Provided by Financing Activities

 

Net cash provided by financing activities for the nine months ended September 30, 2024 decreased compared to the same period ended September 30, 2023 primarily due to proceeds from our Initial Public Offering in February 2023 exceeding the proceeds from our secondary offering in February 2024.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

As a smaller reporting company, this disclosure is not required.

 

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Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

We are required to maintain “disclosure controls and procedures” as such term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934. In designing and evaluating our disclosure controls and procedures, our management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of disclosure controls and procedures are met. The design of any disclosure controls and procedures also is 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. 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 as of the end of the reporting period covered in this Quarterly Report on Form 10-Q, as a result of the material weaknesses in our internal control over financial reporting described below. Notwithstanding the identified material weaknesses, our management has concluded that the unaudited condensed consolidated financial statements in this quarterly filing on Form 10-Q, and the audited consolidated financial statements contained in our Form 10-K for the year ended December 31, 2023, fairly present, in all material respects, our financial position, results of operations and cash flows as of and for the periods presented in conformity with GAAP.

 

Changes in Internal Control Over Financial Reporting

 

Management has identified material weaknesses in its internal controls over financial reporting at December 31, 2023. Specifically, Management noted the Company did not properly document, implement or operate a system of effective internal controls over financial reporting.

 

Ongoing Remediation Efforts

 

Management is in the process of implementing improvements to its internal controls over financial reporting. Namely the Company has and is continuing to:

 

  transitioned its day-to-day accounting processes to a new external firm including automating its vendor payments;
  initiated the transfer of the overall accounting process to an enterprise type accounting platform;
  periodically review the design and effectiveness of our controls including the creation of an annual risk assessment and ongoing monitoring activities; and
  evaluate all internal and external resources to ensure they are appropriate for the level and complexity of our current operations. This includes the recent hiring of a Corporate Controller.

 

While we believe that these efforts will improve our internal control over financial reporting, the implementation of these measures is ongoing and will require validation and testing of the design and operating effectiveness of internal controls over a sustained period of financial reporting cycles. We will continue to monitor and evaluate the effectiveness of our internal control over financial reporting on an ongoing basis and are committed to taking further action and implementing additional enhancements or improvements, as necessary and as funds allow. We cannot assure you that the measures we have taken to date, or that we may take in the future, will be sufficient to remediate the material weaknesses we have identified or avoid potential future material weaknesses. Accordingly, there could continue to be a reasonable possibility that a material misstatement of our financial statements would not be prevented or detected on a timely basis.

 

PART II. OTHER INFORMATION

 

Item 1 Legal Proceedings.

 

To our best knowledge, we are currently not a party to any legal proceedings that, individually or in the aggregate, are deemed to be material to our financial condition or results of operations.

 

Item 1A Risk Factors.

 

Smaller reporting companies are not required to provide the information required by this item.

 

Item 2 Unregistered Sales of Equity Securities and Use of Proceeds.

 

There were no unregistered sales of equity securities during the nine months ended September 30, 2024.

 

Item 3 Defaults Upon Senior Securities.

 

None.

 

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Item 4 Mine Safety Disclosures.

 

Not applicable.

 

Item 5 Other Information.

 

(c) Insider Trading Arrangements

 

Trading Plans

 

On June 6, 2023, Vininder Singh, the Chief Executive Officer and Director of the Company, entered into a 10b5-1 sales plan (the “10b-5 Sales Plan”) intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act. The 10b5 Sales Plan provides for the sale of up to 1,000,000 shares of common stock and will remain in effect until the earlier of (1) September 30, 2024; or (2) the date on which an aggregate of 1,000,000 shares of common stock have been sold under the 10b5 Sales Plan. Pursuant to the 10b5 Sales Plan, 50,000 shares were sold under the plan in September 2023, 100,000 shares were sold under the plan in the first quarter of 2024, and 50,000 shares were sold under the plan in each of the second and third quarters of 2024. In May 2024, the 10b-5 Sales Plan was extended until August 31, 2025, no other adjustments were made to the plan.

 

No other directors or executive officers of the Company adopted, modified or terminated any contract, instruction or written plan for the purchase or sale of the Company’s securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any non-Rule 10b5 trading arrangement, (as defined in Item 408(c) of Regulation S-K) during the quarterly period covered by this report.

 

Item 6. EXHIBITS

 

Exhibit

No.

  Description
31.1 *   Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a).
     
31.2 *   Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a).
     
32.1 *   Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
32.2 *   Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
101.INS *   Inline XBRL Instance Document.
     
101.SCH *   Inline XBRL Taxonomy Extension Schema Document.
     
101.CAL *   Inline XBRL Taxonomy Extension Calculation Linkbase Document.
     
101.DEF *   Inline XBRL Taxonomy Extension Definition Linkbase Document.
     
101.LAB *   Inline XBRL Taxonomy Extension Label Linkbase Document.
     
101.PRE *   Inline XBRL Taxonomy Extension Presentation Linkbase Document.
     
104   The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, formatted in Inline XBRL (included in Exhibit 101).

 

* Filed herewith.

 

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SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

      Bullfrog AI Holdings, Inc.
       
 Date: November 8, 2024   By: /s/ Vininder Singh
      Vininder Singh
      Chief Executive Officer
       
 Date: November 8, 2024   By: /s/ Dane Saglio
      Dane Saglio
      Chief Financial Officer

 

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