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2023-01-01 2023-09-30 0000946644 us-gaap:測量輸入股價成員 AIM : A類權證成員 2024-09-30 0000946644 us-gaap:測量輸入股價成員 AIM : A類權證成員 2023-12-31 0000946644 us-gaap:測量輸入執行價格成員 AIM : A類權證成員 2024-09-30 0000946644 us-gaap:測量輸入執行價格成員 AIM : A類權證成員 2023-12-31 0000946644 us-gaap:測量輸入無風險利率成員 目標 : A類認股權證成員 2024-09-30 0000946644 us-gaap:測量輸入無風險利率成員 目標 : A類認股權證成員 2023-12-31 0000946644 us-gaap:測量輸入預期期間成員 目標 : A類認股權證成員 2024-09-30 0000946644 us-gaap: 測量輸入價格波動成員 目標 : A類認股權證成員 2024-09-30 0000946644 us-gaap: 測量輸入價格波動成員 AIM : A類認股權證成員 2023-12-31 0000946644 us-gaap:測量輸入預期股息率成員 AIM : A類認股權證成員 2024-09-30 0000946644 us-gaap:測量輸入預期股息率成員 AIM : A類認股權證成員 2023-12-31 0000946644 us-gaap:測量輸入股價成員 AIM : B類認股權證成員 2024-09-30 0000946644 us-gaap:測量輸入股價成員 AIM : B類認購權證成員 2023-12-31 0000946644 us-gaap:測量輸入執行價格成員 AIM : B類認購權證成員 2024-09-30 0000946644 us-gaap:測量輸入執行價格成員 AIM : B類認購權證成員 2023-12-31 0000946644 us-gaap:測量輸入無風險利率成員 AIM : B類認購權證成員 2024-09-30 0000946644 us-gaap:測量輸入無風險利率成員 AIM : B類權證成員 2023-12-31 0000946644 us-gaap:測量輸入預期期間成員 AIM : B類權證成員 2024-09-30 0000946644 us-gaap: 測量輸入價格波動成員 AIM : B類權證成員 2024-09-30 0000946644 us-gaap: 測量輸入價格波動成員 AIM : B類權證成員 2023-12-31 0000946644 us-gaap:測量輸入預期股息率成員 AIM : B類認股權證成員 2024-09-30 0000946644 us-gaap:測量輸入預期股息率成員 AIM : B類認股權證成員 2023-12-31 0000946644 us-gaap：重大揭示成員 2024-09-30 0000946644 美元指數：一級公允價值輸入成員 us-gaap：重大揭示成員 2024-09-30 0000946644 美元指數:公平價值輸入層次2成員 us-gaap：重大揭示成員 2024-09-30 0000946644 美元指數:公平價值輸入層次3成員 us-gaap：重大揭示成員 2024-09-30 0000946644 us-gaap：重大揭示成員 2023-12-31 0000946644 美元指數：一級公允價值輸入成員 us-gaap：重大揭示成員 2023-12-31 0000946644 美元指數:公平價值輸入層次2成員 us-gaap：重大揭示成員 2023-12-31 0000946644 美元指數:公平價值輸入層次3成員 us-gaap：重大揭示成員 2023-12-31 0000946644 srt : Minimum Member 2024-01-01 2024-09-30 0000946644 srt : Maximum Member 2024-01-01 2024-09-30 0000946644 美元指數：研究和發展費用成員 2024-01-01 2024-09-30 0000946644 美元指數：研究和發展費用成員 2023-01-01 2023-09-30 0000946644 us-gaap:GeneralAndAdministrativeExpenseMember 2024-01-01 2024-09-30 0000946644 us-gaap:GeneralAndAdministrativeExpenseMember 2023-01-01 2023-09-30 0000946644 AIM : 臨床研究成員 2024-07-01 2024-09-30 0000946644 AIM : 製造與工程成員 2024-07-01 2024-09-30 0000946644 AIM : 質量控制成員 2024-07-01 2024-09-30 0000946644 AIM : 監管成員 2024-07-01 2024-09-30 0000946644 AIM : 臨床研究成員 2023-07-01 2023-09-30 0000946644 AIM : 製造與工程成員 2023-07-01 2023-09-30 0000946644 AIM : 質量控制成員 2023-07-01 2023-09-30 0000946644 AIM : 監管成員 2023-07-01 2023-09-30 0000946644 目標：臨床研究成員 2024-01-01 2024-09-30 0000946644 目標：製造與工程成員 2024-01-01 2024-09-30 0000946644 目標：品質控制成員 2024-01-01 2024-09-30 0000946644 目標：法規成員 2024-01-01 2024-09-30 0000946644 目標：臨床研究成員 2023-01-01 2023-09-30 0000946644 目標：製造與工程成員 2023-01-01 2023-09-30 0000946644 目標：品質控制成員 2023-01-01 2023-09-30 0000946644 目標：法規成員 2023-01-01 2023-09-30 0000946644 AIM : Amarex臨床研究有限責任公司成員 2024-07-01 2024-09-30 0000946644 AIM : Amarex臨床研究有限責任公司成員 2023-07-01 2023-09-30 0000946644 AIM : Amarex臨床研究有限責任公司成員 2024-01-01 2024-09-30 0000946644 AIM : Amarex臨床研究有限責任公司成員 2023-01-01 2023-09-30 0000946644 AIM : Amarex臨床研究有限責任公司成員 2022-04-01 2022-04-30 0000946644 AIM : Amarex臨床研究有限責任公司成員 AIM : 高級胰臟癌研究協議成員 2024-07-01 2024-09-30 0000946644 AIM : Amarex臨床研究有限責任公司成員 AIM : 先進的胰臟癌研究協議成員 2023-07-01 2023-09-30 0000946644 AIM : Amarex臨床研究有限責任公司成員 AIM : 先進的胰臟癌研究協議成員 2024-01-01 2024-09-30 0000946644 AIM : Amarex臨床研究有限責任公司成員 AIM : 先進的胰臟癌研究協議成員 2023-01-01 2023-09-30 0000946644 AIM : Amarex臨床研究有限責任公司成員 2022-09-01 2022-09-30 0000946644 AIM : Amarex臨床研究有限責任公司成員 2023-01-01 2023-12-31 0000946644 AIM : Amarex臨床研究有限責任公司成員 AIM : COVID後研究協議成員 2024-07-01 2024-09-30 0000946644 AIM : Amarex臨床研究有限責任公司成員 AIM : COVID後研究協議成員 2023-07-01 2023-09-30 0000946644 AIM : Amarex臨床研究有限責任公司成員 AIM : COVID後研究協議成員 2024-01-01 2024-09-30 0000946644 AIM : Amarex臨床研究有限責任公司成員 AIM : COVID後研究協議成員 2023-01-01 2023-09-30 0000946644 AIM : Jubilant Hollister Stier成員 2017-01-01 2017-12-31 0000946644 目標：Jubilant Hollister Stier成員 2023-01-01 2023-12-31 0000946644 目標：Jubilant Hollister Stier成員 目標：Ampligen製造協議成員 2024-07-01 2024-09-30 0000946644 目標：Jubilant Hollister Stier成員 目標：Ampligen製造協議成員 2023-07-01 2023-09-30 0000946644 目標：Jubilant Hollister Stier成員 目標：Ampligen製造協議成員 2024-01-01 2024-09-30 0000946644 目標：Jubilant Hollister Stier成員 AIM : Ampligen生產協議成員 2023-01-01 2023-09-30 0000946644 AIM : Sterling Pharma Solutions成員 AIM : 總服務協議與質量協議成員 2024-07-01 2024-09-30 0000946644 AIM : Sterling Pharma Solutions成員 AIM : 總服務協議與質量協議成員 2023-07-01 2023-09-30 0000946644 AIM : Sterling Pharma Solutions成員 AIM : 總服務協議與質量協議成員 2024-01-01 2024-09-30 0000946644 AIM : Sterling Pharma Solutions成員 目標：主服務協議及質量協議成員 2023-01-01 2023-09-30 0000946644 目標：埃拉斯姆斯大學醫療中心成員 目標：聯合臨床研究協議成員 2023-04-01 2023-04-30 0000946644 目標：埃拉斯姆斯大學醫療中心成員 目標：聯合臨床研究協議成員 2024-07-01 2024-09-30 0000946644 目標：埃拉斯姆斯大學醫療中心成員 目標：聯合臨床研究協議成員 2023-07-01 2023-09-30 0000946644 目標：埃拉斯姆斯大學醫療中心成員 目的：聯合臨床研究協議成員 2024-01-01 2024-09-30 0000946644 目的：伊拉斯謨斯大學醫療中心成員 目的：聯合臨床研究協議成員 2023-01-01 2023-09-30 0000946644 目的：Azenova LLC成員 目的：諮詢協議成員 2023-10-31 0000946644 目的：Azenova LLC成員 目的：諮詢協議成員 2024-08-01 2024-08-31 0000946644 目的：Azenova LLC成員 AIM : 諮詢協議成員 2024-07-01 2024-09-30 0000946644 AIM : Azenova LLC成員 AIM : 諮詢協議成員 2023-07-01 2023-09-30 0000946644 AIM : Azenova LLC成員 AIM : 諮詢協議成員 2024-01-01 2024-09-30 0000946644 AIM : Azenova LLC成員 AIM : 諮詢協議成員 2023-01-01 2023-09-30 0000946644 AIM : Alcami Corporation成員 2023-09-01 2023-09-30 0000946644 目標：Alcami Corporation成員 2023-07-01 2023-09-30 0000946644 目標：Alcami Corporation成員 2024-01-01 2024-09-30 0000946644 目標：Alcami Corporation成員 2023-01-01 2023-09-30 0000946644 目標：證券購買協議成員 us-gaap：普通股票成員 美國通用會計原則:後續事件成員 2024-10-01 2024-10-01 0000946644 目標：證券購買協議成員 us-gaap：普通股票成員 美國通用會計原則:後續事件成員 2024-10-01 0000946644 AIM : 證券購買協議成員 AIM : C類普通認股權證成員 美國通用會計原則:後續事件成員 2024-10-01 2024-10-01 0000946644 AIM : 證券購買協議成員 AIM : C類普通認股權證成員 美國通用會計原則:後續事件成員 2024-10-01 0000946644 AIM : 證券購買協議成員 AIM : 第D類普通認股權證成員 美國通用會計原則:後續事件成員 2024-10-01 2024-10-01 0000946644 AIM : 證券購買協議成員 AIM : 第D類普通認股權證成員 美國通用會計原則:後續事件成員 2024-10-01 0000946644 美國通用會計原則:後續事件成員 2024-10-01 2024-10-01 iso4217:美元指數 xbrli:股份 iso4217:美元指數 xbrli:股份 純種成員 AIM:整數

 

 

 

美國

證券交易委員會 及交易所

華盛頓, 哥倫比亞特區 20549

 

表單 10-Q

 

☒ 根據第13條或15(d)條要求提交的季度報告

1934年證券交易所法案的一部分。

 

☐ 根據第13或15(d)條的過渡報告

1934年證券交易所法案

 

截至季度結束 9月30日， 2024

 

委員會 檔案號碼： 001-27072

 

AIM 免疫科技公司。

(根據公司章程所述的註冊人的正確名稱)

 

德拉瓦   52-0845822
（州或其他管轄區   （美國國稅局雇主識別號碼）
註冊或組織）   識別號碼）

 

2117 SW Highway 484, 奧卡拉 佛羅里達州 34473

(主要執行辦公室地址) (郵政編碼)

 

(352) 448-7797

（申報人的電話號碼，包括區號）

 

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
普通股，每股面值$0.001   aim   紐交所 美國

 

請勾選以下選項，表示現行登記人在過去12個月內（或登記人需根據法院強制命令披露資訊的短時間內），已提交參照證券交易所1934年法案第13條或第15(d)條規定的所有報告；在過去90天內，登記人一直受到此等申報要求的約束。

☒ Yes ☐ 不

 

請用勾選標記指出登記人是否在過去 12 個月內（或登記人被要求提交和發帖此類文件的較短期間內）根據規則 405 的要求，電子提交了每一個互動數據文件（第 232.405 節）。

☒ Yes ☐ 不是

 

請用勾選表示，公司是否為大型加速發行商、加速發行商、非加速發行商、較小的報告公司或新興成長公司。請參見《交易所法》1202條對「大型加速發行商」、「加速發行商」、「較小的報告公司」和「新興成長公司」的定義。

 

☐ 大型加速申報者 ☐ 加速申報者
☒ 非加速歸檔人 ☒ 較小型報告公司
  ☐ 新興成長公司

 

若為新興成長公司，請勾選表示登記人已選擇不使用交易法第13(a)條規定的延長過渡期來遵守任何新的或修訂的財務會計準則。☐

 

請標示 以勾選是否登記人是空殼公司（根據交易法第120億2條的定義）。 ☐ 是 ☒ 不

 

63,706,446 普通股股份未拋售。 截至2024年11月11日，並無優先B系列股份未出售。

 

 

 

 
 

 

部分 一- 財務資訊

項目 1: 基本報表

 

AIM IMMUNOTECH INC.及其附屬公司

縮短的 合併資產負債表

(以千為單位，除了股份和每股金額)

(未經審核 2024年9月30日及已審核的2023年12月31日)

 

           
   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  $915   $5,439 
可市場證券   6,287    7,631 
來自新澤西州的淨營運虧損應收款項   —    1,184 
預付費用及其他流動資產   368    302 
流動資產總額   7,570    14,556 
不動產及設備，淨額   117    127 
使用權資產，淨值   653    697 
專利及商標權，淨值   2,532    2,313 
其他資產   2,716    1,688 
總資產  $13,588   $19,381 
負債及股東權益          
流動負債：          
應付賬款  $6,264   $6,443 
應計費用   1,011    1,986 
營業租賃負債流動部分   232    223 
應付票據的流動部分，淨額   2,593    — 
流動負債總額   10,100    8,652 
長期負債：          
營業租賃負債   437    495 
應付票據，淨額   139    — 
總負債   10,676    9,147 
承諾及或有事項（附註13及14）   -      
           
股東權益：          
A系列初級可參與優先股票，$0.001 面值， 4,000,000 和 250,000 截至2024年9月30日及2023年12月31日共授權的分享數量：已發行及流通 – 無   —    — 
B系列可轉換優先股，面值$1,000 每股， 10,000 授權的股份； no 截至2024年9月30日和 689 截至2023年12月31日已發行及流通   —    689 
普通股，每股面值$0.001 面值，授權股份 - 350,000,000；發行和流通股份 58,668,647 和 49,102,484 截至2024年9月30日和2023年12月31日的流通股份數   59    49 
資本公積額額外增資   423,714    419,004 
累積虧損   (420,861)   (409,508)
股東權益總額   2,912    10,234 
負債和股東權益總額  $13,588   $19,381 

 

請參見 附帶的合併財務報表註釋。

 

2
 

 

AIM IMMUNOTECH INC. 及其子公司

合併 綜合損益表

(以千爲單位，除股份和每股數據外)

(未經審計)

 

                     
   截至9月30日的三個月   截至9月30日的九個月 
   2024   2023   2024   2023 
營業收入：                
臨牀治療程序 - 美國  $35   $46   $125   $137 
總收入   35    46    125    137 
成本及費用：                    
生產成本   8    30    24    30 
研究和開發   1,437    2,734    4,533    7,739 
一般管理費用   3,079    5,439    9,485    10,280 
總成本與費用   4,524    8,203    14,042    18,049 
運營損失   (4,489)   (8,157)   (13,917)   (17,912)
投資收益（損失）   273    (310)   96    (201)
利息及其他收入   718    294    3,379    811 
利息支出及其他金融成本   (202)   —    (453)   — 
固定資產出售收益   —    39    —    16 
認股權證發行損失   —    —    (458)   — 
出售所得的收入稅經營虧損的收益   —    318    —    900 
                     
淨虧損  $(3,700)  $(7,816)  $(11,353)  $(16,386)
基本和稀釋後的每股虧損  $(0.06)  $(0.16)  $

 (0.21

)  $(0.34)
基本和稀釋後加權平均流通股   57,677,016    48,635,165    53,351,467    48,483,802 

 

請參見 附帶的合併財務報表註釋。

 

3
 

 

AIM IMMUNOTECH INC. 及其子公司

合併 股東權益變動表

截至2024年和2023年9月30日的九個月數據

(以千爲單位，不包括分享數據)

(未經審計)

 

                                    
  

B輪
優先股

股份

   普通
股票
股份		   普通
股票 .001
面值		   附加
已支付的
資本		  

累計其他

綜合
收入（損失）

   累積
赤字		  

總計
股東的

股權

 
截至2023年12月31日的餘額  $689   49,102,484   $49   $419,004   $—   $(409,508)  $          10,234 
普通股發行，扣除成本   —    807,577    1    328    —    —    329 
無現金行使Warrants   —    3,272    —    —    —    —    — 
基於股權的薪酬   —    —    —    80    —    —    80 
已承諾股份   —    338,600    —    —    —    —    — 
淨綜合損失   —    —    —    —    —    (5,817)   (5,817)
餘額截至2024年3月31日  $689    50,251,933   $50   $419,412   $—   $(415,325)  $4,826 
普通股發行，扣除成本   —    6,884,747    7    525    —    —    532 
發行權益證   —    —    —    2,500    —    —    2,500 
基於股權的薪酬   —    —    —    80    —    —    80 
B系列優先股已過期   (689)   —    —    689    —    —    — 
淨綜合損失   —    —    —    —    —    (1,836)   (1,836)
餘額截至2024年6月30日  $—    57,136,680   $57   $423,206   $—   $(417,161)  $6,102 
普通股發行，扣除成本   —    653,430    1    179    —    —    180 
發行權益證   —    —    —    —    —    —    — 
基於股權的薪酬   —    878,537    1    329    —    —    330 
B系列優先股到期   —    —    —    —    —    —    — 
淨綜合損失   —    —    —    —    —    (3,700)   (3,700)
2024年9月30日餘額  $—    58,668,647   $59   $423,714   $—   $(420,861)  $2,912 

 

  

B輪
優先股

股份

   普通
股票
股份		   普通
股票 .001
面值		   附加
已支付的
資本		   累計其他
綜合
收入（損失）		   累積
赤字		  

總計
股東權益

股權

 
截至2022年12月31日的餘額  $696   48,084,287   $48   $418,270   $—  $(380,546)  $         38,468 
普通股發行，扣除成本   —    322,583    —    100    —    —    100 
基於股權的薪酬   —    —    —    82    —    —    82 
B系列優先股轉換爲普通股   (4)   456    —    4    —    —    — 
淨綜合損失   —    —    —    —    —    (3,661)   (3,661)
餘額截至2023年3月31日  $692    48,407,326   $48   $418,456    —   $(384,207)  $34,989 
普通股發行，扣除成本   —    11,937    —    5    —    —    5 
基於股權的薪酬   —    —    —    50    —    —    50 
B系列優先股轉換爲普通股   (2)   228    —    2    —    —    — 
淨綜合虧損   —    —    —    —    —    (4,909)   (4,909)
餘額截至2023年6月30日  $690    48,419,491   $48   $418,513   $—   $(389,116)  $30,135 
普通股發行，淨額扣除成本   —    377,959    —    233    —    —    233 
基於股權的薪酬   —    —    —    50    —    —    50 
B系列優先股轉換爲普通股   —    —    —    —    —    —    — 
淨綜合虧損   —    —    —    —    —    (7,816)   (7,816)
截止2023年9月30日的餘額  $690    48,797,450   $48   $418,796   $—   $(396,932)  $22,602 

 

請參見 附帶的合併財務報表註釋。

 

4
 

 

AIM IMMUNOTECH INC. 及其子公司

綜合 現金流量表

截至2024年和2023年9月30日的九個月數據

(單位：千)

(未經審計)

 

           
   2024   2023 
經營活動產生的現金流：          
淨損失  $(11,353)  $(16,386)
調整淨虧損與經營活動使用的現金的折算：          
財產和設備的折舊   28    30 
放棄專利和商標權   46    14 
專利、商標權的攤銷   154    150 
使用權資產的變更   226    151 
出售所得的收入稅經營虧損的收益   —    (900)
基於股權的薪酬   490    182 
(收益)出售可交易證券的損失   (95)   201 
發行Warrants的損失   458    — 
金融義務的攤銷   232    — 
資產和負債的變化：          
其他應收款   —    (9)
來自新澤西州淨經營損失的所有基金類型應收款   1,181    1,676 
預付費用和其他流動資產以及其他非流動資產   (63)   192 
租賃負債   (231)   (136)
其他資產   (1,028)   — 
應付賬款   (179)   2,411 
應付費用   (799)   915 
淨現金流出活動   (10,933)   (11,509)
投資活動的現金流：          
出售有價證券的收益   1,597    924 
購買可交易的證券   (158)   (1,155)
(購買) 資產和設備   (18)   (10)
購買專利和商標權   (419)   (377)
投資活動提供的（使用的）淨現金   1,002    (618)
融資活動產生的現金流:          
出售股票的收入，扣除發行費用   860    338 
應付款項的收入，扣除發行費用   2,500    — 
發行Warrants的收入   2,047    — 
融資活動提供的淨現金   5,407    338 
現金及現金等價物淨減少   (4,524)   (11,789)
期初的現金及現金等價物   5,439    27,053 
期末現金及現金等價物  $915   $15,264 
非現金投資和融資現金流信息的補充披露：          
經營租賃-使用權資產  $(3)  $49 
市場證券的未實現收益（損失）  $373   $(71)
B系列優先股的轉換  $—   $6 
將應付票據利息轉換爲股份  $175   $— 

 

請參見 附帶的合併財務報表註釋。

 

5
 

 

AIM IMMUNOTECH INC. 及其子公司

未審計的簡明合併基本報表附註

 

備註 1： 業務和呈現基礎

 

AIM ImmunoTech Inc.及其子公司（統稱「AIM」、「公司」、「我們」或「我們公司」）是一家位於佛羅里達州奧卡拉的免疫藥物公司，專注於研究和開發治療多種癌症、病毒疾病和免疫缺陷疾病的療法。我們在開發核酸和天然干擾素方面建立了堅實的實驗室、臨牀前和臨牀數據基礎，以增強人體的自然抗病毒防禦系統，並幫助開發用於治療某些癌症和慢性疾病的治療產品。

 

AIM的 旗艦產品是Ampligen（rintatolimod）和Alferon N注射液（干擾素ALFA）。Ampligen是一種雙鏈RNA（「dsRNA」）分子，正在開發用於全球重要的癌症、病毒性疾病和免疫系統的疾病。Ampligen尚未獲得FDA批准或在美國銷售，但在阿根廷共和國已獲批准用於銷售，用於治療嚴重的慢性疲勞綜合症（「CFS」）。

 

該 公司目前主要在四個方面進行：

 

●進行臨牀試驗，以評估Ampligen在胰腺癌治療中的療效和安全性。
●評估Ampligen在多種癌症中的潛在療效，作爲調節腫瘤微環境的治療，旨在增強對檢查點抑制劑的抗腫瘤反應。
●探索Ampligen的抗病毒活性及其作爲預防或治療現有病毒、新病毒及其變異病毒的潛在用途。
●評估Ampligen作爲慢性疲勞綜合徵/慢性疲勞綜合徵（「ME/CFS」）和疲勞和/或疲勞的新型冠狀病毒後遺症治療。

 

公司正在優先考慮與發展階段相關的活動，其中胰腺癌、ME/CFS和後新冠狀況等臨牀活動優先於抗病毒實驗。公司計劃在FDA或歐洲藥品管理局（「EMA」）授權的臨牀試驗中進行優先臨牀工作，這些試驗支持未來可能的NDA。然而，AIM的抗病毒實驗旨在積累更多的初步數據，以支持他們的假設，即Ampligen是一種強效的廣譜預防藥物和早期治療藥物，可能增強免疫力並提供交叉保護。因此，AIM將在最容易獲得且能夠生成有效概念驗證數據的場所開展抗病毒項目，包括外國場所。

 

AIM的 業務計劃需要一個或多個合同製造組織（「CMO」）來生產Ampligen及其活性藥品 成分（API）。這包括利用Jubilant HollisterStier和Sterling分別製造Ampligen和我們的Poly I和Poly C12U多核苷酸。

 

在管理層看來，所有爲公正呈現其合併基本報表所需的調整均已包含。 這些調整由正常的經常性項目組成。中期業績不一定代表全年的業績。

 

根據證券交易委員會（「SEC」）的許可， 中期合併基本報表及其附註已按規定呈報， 並不包含將在公司年度合併基本報表及其附註中包括的某些信息。

 

這些 合併基本報表應與公司截至2023年12月31日及2022年12月31日的合併基本報表一起閱讀，這些報表包含在公司截至2023年12月31日的年度報告Form 10-k中， 並於2024年4月1日提交。

 

估算的使用

 

在符合美國公認會計原則的情況下編制基本報表，管理層需要做出估計和假設，這些估計和假設會影響資產和負債的報告金額以及在基本報表日期披露的或有資產和負債（「GAAP」），以及報告期間的收入和費用的報告金額。實際結果可能與這些估計有所不同，而這些差異可能是重大的。需要使用重大估計的賬戶包括對證券的暫時性損失的判斷、遞延稅款的估值、專利和商標的估值、基於股票的補償計算、Warrants的公允價值以及或有負債的計提。

 

6
 

 

流動性 和持續經營

 

附帶的未經審計的簡明合併基本報表已假設公司將繼續作爲持續經營的單位。 持續經營的呈報基礎假設公司將在這些基本報表發佈之日起的一年後繼續運營，並能夠在正常的業務過程中實現其資產並償還其負債和承諾。

 

根據財務會計準則委員會（「FASB」）的會計標準編纂（「ASC」）第205-40章，關於實體持續經營能力的不確定性披露，管理層必須評估是否存在在整體上被認爲對公司在這些基本報表發佈之日起的一年內能否繼續作爲一個持續經營實體引發重大懷疑的條件或事件。此評估不考慮管理層尚未完全實施或在基本報表發佈之日不在公司控制範圍內的計劃可能產生的緩解效果。當對公司持續經營能力存在重大懷疑時，管理層評估其計劃的緩解效果是否足以緩解重大懷疑。然而，只有在 (1) 計劃在基本報表發佈之日起的一年內很可能有效實施，以及 (2) 計劃實施後，很可能在基本報表發佈之日起的一年內緩解引發對公司能否繼續作爲一個持續經營實體的重大懷疑的相關條件或事件時，管理層的計劃的緩解效果才會被考慮。

 

公司的主要流動資金來源是其現金及現金等價物、可交易證券和融資活動的收益，以提供必要的資金，以滿足我們的義務。一年來，該公司在截至2024年9月30日的九個月期間內從運營中遭受了損失，使用的淨現金用於運營活動，並且截至2024年9月30日的營運資本出現赤字。此外，該公司的股東權益低於紐約證券交易所美國（「紐交所美國」）持續上市的最低要求。這些控制項對公司在從未審計的簡明合併基本報表發行之日起至少一年的持續經營能力產生了重大懷疑。管理層評估了這些控制項的相關性及其對公司履行義務的能力的重要性，並確定赤字的主要原因與該公司目前正在與供應商進行談判的某些應付賬款有關。這些談判仍在進行中，可能導致 significant amounts，部分緩解負面的營運資本。這些努力的時間或結果沒有保證。如果公司無法採取足夠的減輕措施，可能被迫限制其業務活動或無法繼續作爲一個持續經營者，這將對其運營結果和財務狀況產生重大不利影響。

 

注意 2: 現金及現金等價物

 

現金 包括在多個金融機構保持的銀行存款。公司將原始到期日爲三個月或更短的高度流動性工具視爲現金等價物。在截至2024年9月30日的九個月中，某些賬戶在不同時間段內在金融機構的餘額超過了聯邦保險的限額$250,000。公司在這些賬戶上沒有經歷任何損失，並認爲信用風險很小。

 

註釋 3: 可交易證券

 

可交易資產由共同基金組成。截至2024年9月30日和2023年12月31日，確定沒有可交易資產出現超過臨時減值。截至2024年9月30日和2023年12月31日，所有證券均按公允價值計量標準的第一級工具進行計量（見附註12：公允價值）。截至2024年9月30日和2023年12月31日，公司的持有額爲$6,287,000和$7,631,000 分別在共同基金中。

 

分類爲可供出售的共同基金總額爲$6,287,000 截至2024年9月30日。 截至2024年9月30日的三個月期間內，確認的股票證券的淨收益爲273,000美元。在2024年9月30日結束的三個月期間內出售的股票證券確認的淨損失爲（59,000）美元。截至2024年9月30日的三個月期間內，仍持有的股票證券確認的未實現收益爲332,000美元。截至2024年9月30日的九個月期間內，確認的股票證券的淨收益爲96,000美元。在2024年9月30日結束的九個月期間內出售的股票證券確認的淨損失爲（277,000）美元。截至2024年9月30日的九個月期間內，仍持有的股票證券確認的未實現收益爲373,000美元。

 

按可供出售分類的共同基金總額爲$7,631,000 截至2023年12月31日。 截至2023年9月30日的三個月期間，權益證券確認的淨損失爲（$309,000）。在此期間出售的權益證券確認的淨損失爲（$42,000）。截至2023年9月30日的三個月期間，仍持有的權益證券確認的未實現損失爲（$267,000）。截至2023年9月30日的九個月期間，權益證券確認的淨損失爲（$201,000）。在此期間出售的權益證券確認的淨損失爲（$130,000）。截至2023年9月30日的九個月期間，仍持有的權益證券確認的未實現損失爲（$71,000）。

 

7
 

 

注意 4: 淨資產和設備

 

           
   (以千爲單位) 
   2024年9月30日   2023年12月31日 
傢具、裝置和設備   1,466    1,448 
減：累計折舊   (1,349)   (1,321)
物業及設備（淨額）  $117   $127 

 

物業 和設備以成本記錄。折舊和攤銷採用直線法，基於各自資產的預計使用壽命計算，範圍從 三 至 十年截至2024年9月30日和2023年9月30日的九個月折舊費用爲$28,000 和 $30,000，分別爲。

 

注意 5: 專利和商標權，淨額

 

專利 和商標權包含以下內容（以千爲單位）：

Schedule of Patent and Trademark Rights

 

   2024年9月30日   2023年12月31日 
   總攜帶價值   累計攤銷   淨賬面價值   總攜帶價值   累計攤銷   淨賬面價值 
專利  $3,315   $(887)  $2,428   $2,947   $(750)  $2,197 
商標   232    (128)   104    229    (113)   116 
淨可攤銷專利和商標權  $3,547   $(1,015)  $2,532   $3,176   $(863)  $2,313 

 

專利 和商標權的獲取、放棄和攤銷：

Schedule of Changes in Patents, Trademark Rights

 

2023年12月31日  $2,313 
收購   419 
放棄和過期   (46)
攤銷   (154)
2024年9月30日  $2,532 

 

8
 

 

專利 和商標按照成本（主要是法律費用）列示，並採用直線法在預計的使用壽命內進行攤銷 17年 用於專利， 10年 用於商標。加權剩餘平均攤銷期大約爲 12年 用於專利， 6年 分別用於商標。公司將與其商標和專利相關的年金費用計入支出。

 

專利和商標的攤銷 未來五年及以後如下（以千計）：

Schedule of Amortization of Patents and Trademarks

 

截至12月31日的年度    
2024  $72 
2025   268 
2026   265 
2027   239 
2028   219 
之後   1,469 
總計  $2,532 

 

注意 6： 應計費用

 

應計 費用包括以下內容：

Schedule of Accrued Expenses

 

           
   (以千爲單位) 
   2024年9月30日   2023年12月31日 
補償  $1   $414 
專業費用   790    1,352 
臨牀試驗費用   132   184 
利息   51    — 
其他費用   37    36 
總計  $1,011   $1,986 

 

注意 7: 無擔保本票

 

在2024年2月16日，公司（「借款人」）與Streeterville Capital LLC（「Streeterville」或「貸方」）簽署了一份票據購買協議。根據協議條款，Streeterville向公司支付了$2,500,000以換取一份無擔保的 promissory Note，原始發行折扣爲$781,250。公司將支付$3,301,250，包括票據的本金金額、原始發行折扣和$20,000的貸方交易費用，最遲不超過2026年2月16日。該票據的規定利率爲 10%.。截至2023年12月31日，存在 無 的債務。

 

     
截至2024年9月30日的債務安排（單位：千）   
長期債務  $3,301 
未攤銷的原始發行折扣   (555)
未攤銷的融資費用   (14)
未攤銷的折扣和債務發行費用   2,732 
減去長期債務的當前部分，淨額    (2,593)
      
長期債務，淨額   $139 

 

與長期債務相關的利息支出爲$226,000 在2024年9月30日。與長期債務相關的攤銷費用爲$232,000 在2024年9月30日。這包括$226,000 的原始發行折扣和$6,000 的貸款費用攤銷。2024年9月30日的長期債務的未來到期爲$750,000 對於截至2024年12月31日的財政年度和$2,551,000 對於截至2025年12月31日的財政年度。

 

(1)Current portion of long-term debt of approximately $3,000,000 is net of the current portion of debt discount of approximately $397,000 and the current portion of debt origination costs of approximately $10,000 as of September 30, 2024.

 

(2)Long-term portion of debt of approximately $301,000 is net of the long-term portion of debt discount of approximately $159,000 and the unamortized debt origination costs of approximately $3,000 as of September 30, 2024.

 

9
 

 

截至2024年9月30日，目前的長期債務部分約爲$3,000,000 減去約$的當前債務折扣部分397,000 以及約$的當前債務來源成本部分10,000 截至2024年9月30日。

 

長期債務部分約爲$301,000 是扣除長期債務折扣部分約爲$159,000 和未攤銷的債務發行費用約爲$3,000 截至2024年9月30日。

 

協議允許貸款人從2024年8月開始，向借款人提供書面通知後，每個日歷月贖回高達250,000美元。本票進一步包含觸發事件，貸款人要求借款人糾正觸發事件的情況可以得到補救，增加未償餘額，應用觸發效果，或者使本票立即到期並應償還。

 

注意 8: 基於股權的補償

 

2018年權益激勵計劃於2018年9月12日生效，並於2019年8月19日修訂和重述（「2018年權益激勵計劃」）授權授予（i）激勵股票期權，（ii）非法定股票期權，（iii）股票增值權，（iv）限制性股票獎勵，（v）限制性股票單位獎勵，（vi）績效股票獎勵，（vii）績效現金獎勵，以及（viii）其他股票獎勵。在考慮到 44:1反向股票拆分 該拆分於2019年6月實施，最初，最多有 230,390共計股份被保留，以供根據2018年權益激勵計劃授予潛在發放。計劃修訂和重述時，額外 250,000股份被保留，以供根據2018年權益激勵計劃授予潛在發放。根據2023年7月1日每個日歷年的年度增加，公司可供授予和發行的普通股數量每年增加 685,012股份， 956,660股份， 960,976股份， 968,389 和 1,142,733 股票，分別。因此，根據2018年計劃的常青條款，最多有 5,167,160 截至2024年9月30日，最多有股票保留用於根據2018年股權激勵計劃頒發的潛在獎勵。除非提前終止，否則2018年股權激勵計劃將繼續有效，時間爲 10 年的有效期。從2018年12月31日結束的財年期間，董事會發行了 1,189,284 期權給每位員工、官員和董事，行使價格爲$9.68 將在 10 年到期 (27,028期權在反向拆分後)在截至2019年12月31日的財年期間， 1,727,756 向這些官員發放了期權，行使價格爲$9.68 爲期 十年 具有一年的歸屬期， （39,266個期權，經過反向拆分後）。 在截至2020年12月31日的財年期間， 1,025,000 向這些官員和董事發放了期權，行使價格區間爲$2.77 到 $3.07 爲期 十 年 爲期一年的歸屬期。在截至2021年12月31日的財年中， 613,512 期權被髮放給高管、董事和顧問，行使價格區間爲 $1.11 到 $1.71 爲期 十 年 擁有一年的歸屬期。在截至2022年12月31日的財年期間， 850,000 期權發放給了官員、董事和顧問，行權價格區間爲$0.31 到$0.71 爲期 十年 擁有一年的歸屬期。在截至2023年12月31日的財年期間， 400,000 期權發放給了官員，行權價格爲$0.47 爲期 十 年 具有一年的歸屬期。在截至2024年9月30日的九個月內，有 無 發行的期權。

 

10
 

 

每個期權和股權認購權獎勵的公允價值是在授予日使用Black-Scholes-Merton期權定價估值模型估算的。預期波動率基於公司的股票歷史波動率。無風險利率基於與期權和股權認購權預期壽命相等的美國國債發行。公司使用歷史數據來估算預期股息收益率、預期壽命和遺失率。在截至2024年9月30日和2023年9月30日的九個月期間， 無 共授予了期權。

 

截至2024年9月30日的三個月內，股票 期權活動如下：

 

員工的股票期權活動：

 

   數量
期權		   加權
平均
行使
價格		   加權
平均
剩餘
合同
條款
（年）		   彙總
內在價值
價值		 
截至2024年6月30日的業績   2,407,775   $2.50    8.70   $— 
授予   —    —    —    — 
被註銷   —    —    —    — 
已到期   (95)   —    —    — 
截至2024年9月30日的未償還期權   2,407,680   $2.44    8.70   $— 
已歸屬及預計於2024年9月30日歸屬   2,407,680   $2.44    8.70   $— 
可行使於2024年9月30日   2,341,014   $1.66    7.17   $— 

 

員工未歸屬 股票期權活動：

 

   數量
選項		   加權
平均
執行
價格		   加權
平均
剩餘
合同
條款
（年）		   彙總
內在價值
價值		 
未歸屬 2024年6月30日   166,666   $4.11    18.87   $— 
授予   —    —    —    — 
已到期   (95)   —    —    — 
Vested   (99,905)   0.47    7.17    — 
未歸屬至2024年9月30日   66,666   $9.61    36.22   $— 

 

11
 

 

非員工的股票期權活動：

 

   Number of
Options		   Weighted
Average
Exercise
Price		   Weighted
Average
Remaining
Contractual
Term (Years)		   Aggregate
Intrinsic
Value		 
Outstanding June 30, 2024   885,055   $2.02    9.23   $— 
Granted   —    —    —    — 
Forfeited   —    —    —    — 
Expired   (95)   —    —    — 
Outstanding September 30, 2024   884,960   $1.88    9.23   $— 
Vested and expected to vest September 30, 2024   884,960   $1.88    9.23   $— 
Exercisable September 30, 2024   729,960   $1.87    10.06   $— 

 

Unvested stock option activity for non-employees:

 

   數量
選項		   加權
平均
行使
價格		   加權
平均
剩餘
合同
條款
（年）		   彙總
內在價值
價值		 
未歸屬 2024年6月30日   155,001   $3.42    11.30   $— 
授予   —    —    —    — 
已到期   (95)   —    —    — 
Vested   95    0.46    10.18    — 
未歸屬 2024年9月30日   155,001   $3.42    11.31   $— 

 

基於股票的 薪酬費用大約爲$80,000 和 $50,000 在截至2024年9月30日和2023年9月30日的三個月中，分別導致一般和行政費用的增加。

 

截至2024年9月30日的九個月內，員工 股票期權活動情況如下：

 

員工的股票期權活動：

 

   數量
期權		   加權
平均
行使
價格		   加權
平均
剩餘
合同
期限
（年）		   彙總
內在
價值		 
2024年1月1日的傑出表現   2,408,438   $2.50    8.70   $— 
授予   —    —    —    — 
被註銷   —    —    —    — 
已到期   (758)   —    —    — 
截至2024年9月30日的未償還期權   2,407,680   $2.44    8.70   $— 
已歸屬及預計於2024年9月30日歸屬   2,407,680   $2.44    8.70   $— 
可行使於2024年9月30日   2,341,014   $1.66    7.17   $— 

 

12
 

 

Unvested stock option activity for employees:

 

   數量
選項		   加權
平均
行使
價格		   加權
平均
剩餘
合同的
條款
（年）		   彙總
內在價值
價值		 
未歸屬的2024年1月1日   366,666   $2.13    12.44   $— 
授予   —    —    —    — 
已到期   (758)   —    —    — 
Vested   (299,242)   0.47    7.17    — 
未歸屬 2024年9月30日   66,666   $9.61    36.22   $— 

 

非員工的股票期權活動：

 

   數量
期權		   加權
平均
行使
價格		   加權
平均
剩餘
合同
期限（年）		   合計
內在的
價值		 
2024年1月1日的傑出表現   885,055   $2.02    9.23   $— 
授予   —    —    —    — 
被註銷   —    —    —    — 
已到期   (95)   —    —    — 
截至2024年9月30日的未償還期權   884,960   $1.88    9.23   $— 
已歸屬及預計於2024年9月30日歸屬   884,960   $1.88    9.23   $— 
可行使於2024年9月30日   729,960   $1.87    10.06   $— 

 

Unvested stock option activity for non-employees:

 

   數量
選項		   加權
平均
行使
價格		   加權
平均
剩餘
合同
條款
（年）		   彙總
內在
價值		 
未歸屬 2024年1月1日   335,001   $1.83    10.70   $— 
授予   —    —    —    — 
已到期   (95)   —    —    — 
Vested   (179,905)   0.46    10.18    — 
未歸屬 2024年9月30日   155,001   $3.42    11.31   $— 

 

基於股票的 薪酬費用大約爲$490,000 和 $182,000 )和$

 

作爲公司現金節約策略的一部分，公司向部分高管發行普通股作爲現金薪資的替代品。截止到2024年9月30日的三個月和九個月中，作爲薪資發行的股票總額爲$250,000這筆股本已計入整體股權基礎補償費用。截止到2023年9月30日的三個月和九個月中並沒有作爲薪資發行的股票。

 

在2024年和2023年9月30日，分別有大約$53,400 和多少35,000 與根據股權激勵計劃授予的期權相關的未確認股權基礎補償成本。

 

13
 

 

注意 9: 股東權益

 

(a) 優先股

 

該 公司被授權發行 5,000,000 股數爲$0.01 具有董事會可能決定的各種名稱、權利和優先權的面值優先股。我們授權的優先股中， 4,000,000 已被指定爲A系列初級參與優先股， 10,000 已被指定爲B系列可轉換優先股。

 

系列 一類參與型優先股

 

在2023年5月10日，公司在特拉華州提交了增加證書，將指定爲A系列優先參與股票的數量增加至 4,000,000 來自 250,000 股。截至2024年9月30日，沒有未發行的A系列優先參與股票。

 

系列 b 可轉換優先股

 

公司已指定 10,000 其優先股的股份爲B系列可轉換優先股（「優先股」）。 每股優先股的面值爲$0.01 每股$1,000 （「已說明價值」）。 優先股的股份最初應以賬面登記形式的證券發行並保持，存託信託公司或其指定人（「DTC」）應最初爲優先股的唯一註冊持有人。

 

每一 股優先股可在自原始發行日期起的任何時間和不時地，由持有人選擇進行轉換，或者在自原始發行日期的第二個週年紀念日起的任何時間和不時地，由公司選擇進行轉換，轉換爲相應數量的普通股（每種情況下需遵循通過將該優先股的面值除以轉換價格所確定的限制）。優先股的轉換價格應等於$0.20， 根據此處的調整（「轉換價格」）。

 

根據美國證券交易委員會於2019年2月14日宣佈生效的與權利發行（「權利發行」）相關的註冊聲明，AIm於2019年2月14日向其普通股股東及某些期權和可贖回Warrants持有者免費分發了每持有或視爲持有的普通股一股的一項不可轉讓的認購權。每項權利使持有者有權以每單位$的認購價格購買一個單位，1,000 由一股面值爲$的B系列可轉換優先股和1,000 （並立即按假定轉換價格$轉換爲普通股）8.80和114 以$的假定行使價格的Warrants。可贖回Warrants在發行日期後可行使五年。8.80從權利發行中獲得的淨收益約爲$4,700,000截至2024年9月30日， 689 B系列可轉換優先股的股份在到期之前已到期，且沒有任何股份在到期前轉換。

 

(b) 普通股和股權融資

 

公司已授權的股份數量爲 350,000,000 ，對使用這些股份有具體的限制和要求。 8,000,000 的 350,000,000已授權的股份。 截至2024年9月30日和2023年12月31日，分別發行並流通的普通股股份爲 58,668,647 和 49,102,484，分別爲

 

員工 股票購買計劃（不是股權補償）

 

在 2020年7月7日，董事會批准了一項計劃，根據該計劃，所有董事、高級職員和員工可以從公司購買總計高達 $ 的股份，按市場價格購買（包括後續計劃，"員工股票購買計劃"）。500,000 根據紐交所美國的規則，該計劃在紐交所美國批准公司的補充上市申請之日起有效，持續六十天。計劃到期後，公司創建了後續的新計劃。最新的計劃於2024年10月21日由董事會批准，並於2024年12月到期。

 

截至2024年9月30日的三個月期間，公司沒有 無作爲員工股票購買計劃的一部分，未發行任何普通股。

 

截至2024年9月30日的九個月內，公司共發行了 335,603 股普通股，價格範圍爲$0.33 到 $0.41 總收益約爲$120,000 作爲員工股票購買計劃的一部分。

 

在截至2023年9月30日的三個月期間，公司共發行了 62,841 股普通股，價格範圍爲$0.44 到 $0.67 總收益約爲$35,500 作爲員工股票購買計劃的一部分。

  

在截至2023年9月30日的九個月內，公司總共發行了 385,424 股普通股，價格範圍爲$0.31 到$0.67 總收益約爲$135,000 作爲員工股票購買計劃的一部分。

  

14
 

 

權利 計劃

 

在 2023年5月12日，公司修訂並重新表述了其2017年11月14日的權利計劃，委任美國股票轉倉與Trust公司作爲 權利代理人（"權利計劃"）。

 

權證 （權利發行）

 

在2019年9月27日，公司完成了一項由A.G.P./Alliance Global Partners, LLC承銷的公開發行（「發行」） 1,740,550 普通股的份額；(ii) 可轉換爲普通股的預先資金認股權證 7,148,310 （「預先資金認股權證」），以及(iii) 購買總計的普通股的認股權證 8,888,860 （「認股權證」）。 與發行相關，我們發行了一個代表性認股權證，以購買總計的 266,665 普通股份額（「代表性認股權證」）。普通股和認股權證的銷售價格合計爲 $0.90，減去承銷折扣和佣金。每個與普通股一起出售的認股權證代表購買一股普通股的權利，行使價格爲 $0.99 每股。預資助認股權證和認股權證的銷售組合價格爲$0.899減去承銷折扣和 佣金。預資助認股權證出售給購買普通股的投資者，若該購買將導致投資者及其關聯方和某些相關方有益擁有超過 4.99%的公司 在發行完成後立即未償還的普通股。每份預資助認股權證代表以$的行權價格購買一股普通股的權利。0.001 預資助認股權證可以立即行使，可以在任何時間行使，直到預資助認股權證被完全行使。與此次發行相關的S-1表格的註冊聲明已提交給SEC，並於2019年9月25日獲得有效，淨收益約爲7,200,000。截至 12月31日, 2020, 1,870,000 預資助認股權證 已被行使，並且 8,873,960 認股權證被行使。 此外，在2020年3月25日，代表的Warrants進行了修訂， 允許從2020年3月30日開始行使該Warrants。這些Warrants在2020年3月31日行使，合計 266,665 分享在行使該Warrant時發行，預計總收入約爲$264,000 和一個 $46,000 Warrant 修改的費用。

 

期間 在截至2024年9月30日的三個月，有 不 已行使的認股權證以及 15,000 認股權證未行使到期。在第九場比賽中 截至 2024 年 9 月 30 日的月份， 205,000 認股權證已行使，以及 5,830,028 認股權證未行使到期。截至9月 2024 年 30 日有 不 未償還的認股權證，2023 年 12 月 31 日有 152,160 分裂後 分別未履行的認股權證。

 

股權 分配協議

 

開啓 2023年4月19日，公司與Maxim Group LLC（「Maxim」）簽訂了股權分配協議（「EDA」）， 根據該協議，公司可以不時出售總髮行價不超過$的普通股8,500,000 通過Maxim作爲代理商（「本次發行」）。EDA下的銷售是根據S-3貨架註冊聲明登記的。 根據EDA的條款，Maxim將有權按固定費率收取交易費 3.0已售股票總銷售價格的百分比 在 EDA 之下。在截至2023年12月31日的年度中，公司出售了 598,114 EDA下的股份，總收益約爲 $344,000，其中包括 3.0向 Maxim 收取的費用爲 $ 的百分比10,326。在截至2024年9月30日的三個月中，公司出售了 10,975 股份 根據EDA，總收益約爲美元4,110，其中包括 3.0向 Maxim 收取的費用爲 $ 的百分比123。在結束的九個月中 2024 年 9 月 30 日，公司出售了 1,305,653 EDA下的股份，總收益約爲美元630,204 其中包括 一個 3.0向 Maxim 收取的費用爲 $ 的百分比18,906.

 

股權 購買協議

 

在2024年3月28日，公司與Atlas Sciences, LLC（「Atlas」）簽署了購買協議和註冊權協議， 根據該協議，Atlas承諾在購買協議簽署之日起的24個月內購買最多$15,000,000 公司的普通股。根據購買協議，實際籌集的金額無法保證。

 

根據購買協議的條款，公司有權自行決定向投資者發行看跌股票 在 95% 以當天交易的股票市場價格計算。根據購買協議的銷售每日最高限額爲：$500,000, 中位日成交量，以及有益擁有權限制爲 4.99% 以及在購買協議生效時最多爲 19.99% 的流通股票總數。2024年4月，公司向SEC提交了一份S-1表格的註冊聲明， 註冊了共計 9,975,000 股票以便於根據Atlas協議進行轉售，其中包括 9,636,400 公司可以向Atlas出售的股票，以及 338,600 作爲承諾股票發給Atlas的股票。註冊聲明在2024年5月1日生效。在截至2024年9月30日的三個月內沒有發行股票。截止到2024年9月30日，總共 759,685 根據購買協議發行的股票總額約爲$128,000.

 

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證券購買協議

 

在2024年5月31日，公司簽署了一項證券購買協議（「購買協議」），以完成與單一合格投資者（「購買方」）的交易（「交易」），根據該協議，2024年6月3日，公司向購買方發行，(i) 在一次註冊直接發行中， 5,640,958 公司的普通股（「分享」），面值$0.001 和(ii) 在一次同步的定向增發中，公司向購買方發行了可購買總共 5,640,958 股普通股的A類普通權證（「A Warrants」），行使價格爲$0.363 每股，和B類普通權證，購買總共 5,640,958 股普通股的可購買權證（「B Warrants」，與A Warrants一起稱爲「普通權證」），行使價格爲$0.363 每股。A Warrants和B Warrants在發行日期後六個月內不可行使，分別在發行日期後的24個月和五年六個月後到期。普通權證和根據這些權證行使後可發行的普通股是根據證券法第4(a)(2)條和相關規則506(b)的註冊豁免進行提供的。

 

這些 股份是根據公司的即發註冊聲明提供的，註冊表格爲S-3（文件編號：333-262280），該註冊聲明於2022年2月4日生效（經過不時修訂，稱爲「註冊聲明」）。

 

根據購買協議的條款，除某些例外情況外，公司在發行日期後的60天內不能發行任何權益證券，前提是公司能夠在30天后與承銷商利用其上市發行計劃。此外，公司在發行日期後的120天內不能進行變動利率交易（除與承銷商的ATm計劃外）。此外，公司的高管和每位董事已與公司簽署了鎖定協議，按照協議，他們同意在交易完成後的90天內不提供、出售、轉讓或以其他方式處置公司的證券，前提是符合某些例外情況。

 

普通認股權證的行使價格和普通認股權證股份的數量，在發生任何股票紅利或拆分、反向股票拆分、資本重組、重組或類似交易時，須進行調整，如普通認股權證中所述。如果發生基本交易（如普通認股權證中定義），那麼繼任實體將繼承並替代公司，並可以行使公司可能行使的所有權利和權力，並將承擔其在普通認股權證下的所有義務，其效力與繼任實體被列在權證本身上是一樣的。普通認股權證持有者將擁有普通認股權證中定義的額外權利。只有在沒有當前註冊聲明允許公共轉售時，普通認股權證才可「無現金」行使。在這方面，公司已提交註冊聲明，以註冊普通認股權證股份的轉售，提供因行使普通認股權證而發行及可發行的股份的轉售。該註冊聲明於2024年7月11日被SEC宣佈生效。公司已同意合理努力使該註冊聲明始終保持有效，直到沒有購買者擁有任何認股權證或可因行使認股權證而獲得的認股權證股份。

 

Maxim 集團有限責任公司作爲「配售代理」（「配售代理」）以「合理商業最佳努力」的方式， 根據2024年5月31日的配售代理協議（「配售代理協議」）， 與公司和配售代理之間進行交易。根據配售代理協議，配售代理收取了現金費用， 8% 的交易中出售的證券所支付給公司的總毛收入的 以及某些自付費用的報銷。

 

公司在ASC 480 – 負債與權益的區分指導下評估了普通Warrants，並確定它們作爲獨立的基本報表金融工具在適用範圍內，但未滿足負債分類的標準，因此在簡化合並的基本報表中被分類爲權益。分配給這些Warrants的收益總計約爲$2.5 截至2024年9月30日的九個月內，沒有普通Warrants被行使，所有Warrants在2024年9月30日仍然與本協議相關並且有效。

 

於 2024年9月30日，公司簽署了證券購買協議，以完成與單一合格投資者的發行。 更多信息請參見注釋15：後續事件。

 

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備註 10: 每股淨虧損

 

基本 和稀釋後的每股淨虧損是根據期間內流通的普通股加權平均股數計算的。 對應的普通股股數，包括期權和Warrants，總計爲 14,574,557 和 2,763,020 在2024年和2023年截至9月30日的九個月中，共計爲的股數，因其效果是 反稀釋的，所以從稀釋每股淨虧損的計算中排除。

 

注意 11: 最近的會計公告

 

公司已實施所有生效的新會計公告。除非另有說明，否則這些公告對基本報表沒有任何重大影響，公司也不認爲有其他發佈的新會計公告可能對其財務狀況或經營成果產生重大影響。自提交以來，FASB發佈的會計公告 截至2023年12月31日的第10-K表格年度報告 管理層認爲這些公告對公司的當前或未來基本報表沒有或不相信會產生重大影響。

 

注意 12: 公允價值

 

公允價值

 

該公司遵守FASB ASC 820「公允價值計量」的規定，適用於其金融和非金融資產 及負債。ASC 820定義了公允價值，建立了公允價值計量的框架，並擴展了對每個主要資產 和負債類別在定期或不定期基礎上以公允價值計量的披露。

 

現金及現金等價物、其他資產、應付賬款和應計費用的公允價值與其賬面價值相近，這歸因於這些項目的短期到期，因此被視爲公允價值計量標準的一級工具。公司還擁有在發生重大交易時具有現金結算特徵的某些Warrants。與公司2024年6月普通股和Warrants發行相關的Warrants（「2024年6月Warrants」）的公允價值是通過蒙特卡羅模擬計算得出的。

 

The Company also had certain redeemable warrants in the Rights Offering with a cash settlement feature in the occurrence of a Fundamental Transaction. No Fundamental Transaction occurred. In March 2024, 205,000 of these warrants converted on a cashless basis and 5,830,028 expired.

 

公司使用布萊克-斯科爾斯模型估算了2024年6月Warrants的公允價值，該模型使用多個輸入，包括公司的 股價、權證的行使價格、公司股價的波動性、無風險利率和權證的預期期限。

 

公司利用以下假設來估算A類Warrants的公平價值：

 

   九月三十日   12月31日 
   2024   2023 
每股基礎價格  $0.350    — 
每股行使價格  $0.363    — 
無風險利率   4.42%   — 
預期持有期   5.5 年    — 
預期波動率   110%   — 
預期股息收益率   —    — 

 

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The Company utilized the following assumptions to estimate the fair value of the Class B Warrants:

 

   September 30,   December 31, 
   2024   2023 
Underlying price per share  $0.350    — 
Exercise price per share  $0.363    — 
Risk-free interest rate   4.82%   — 
Expected holding period   2 years    — 
Expected volatility   89%   — 
Expected dividend yield   —    — 

 

The significant assumptions using the Monte Carlo Simulation approach for valuation of the Warrants are:

 

(i)無風險 利率. 分紅派息的無風險利率基於美國國債 常量到期日，適用於剩餘預期持有期與分紅派息的到期日相對應。
(ii)預期 持有期. 預期持有期表示分紅派息 預計在被行使之前的有效期。公司在每個估值日期利用分紅派息的剩餘合同期限作爲預期持有期。
(iii)預期 波動率. 預期股票波動率基於公司 在剩餘預期持有期的最後一天的每日歷史股票價值觀察。
(iv)預期 分紅收益率. 預期分紅收益率基於公司的預期 分紅派息在剩餘預期持有期內的支付情況。由於公司從未發行分紅，預期分紅收益率爲0%，這一假設將在未來計算中繼續適用，除非公司改變其分紅政策。
(v)預計 基本交易的概率。 看跌權利在以下情況下產生： 1）是一筆全現金交易；（2）導致公司私有化；或者（3）是涉及未在國家證券交易所交易的個人或實體的交易。公司認爲這種情況不太可能發生，因爲：

 

1.該公司目前僅有一款獲得FDA批准的產品，但目前尚未進行商業銷售。
2.該公司將需要進行額外的臨牀試驗以獲得其旗艦產品的FDA批准。
3.行業板塊和市場條件持續存在不確定性，爲任何交易增加了風險。
4.生命科學公司的性質在很大程度上依賴於未來的資金和高固定成本，包括研發。
5.該公司的收入流非常有限，無法滿足其運營或在製造設施施工方面的資金需求；並且
6.該公司的權利協議和高管協議使得其對潛在買家的吸引力降低。

 

在分析看跌潛在責任的可能性時，考慮到上述因素，公司估計觸發看跌權利的概率區間爲：

 

概率區間  概率 
低   0.5%
中等   1.0%
高   5.0%

 

蒙特卡洛模擬已經納入了一個 5.0%的基礎交易概率，適用於證券的整個生命週期。

 

(vi)預期 重大交易公告的時間。 由於公司對重大交易沒有具體期望，基於上述原因，公司在預期持有期內採用了離散的 均勻概率分佈來模擬在預期持有期內發生重大交易公告的潛在可能性。
(vii)預期 重大交易公告時的100天波動率. 未來波動率的估計是必要的，因爲沒有直接測量未來股價波動的機制。利用公司過去100天的每日股票價值觀察數據，作爲對未來波動率估計的替代指標，採用了Warrants授予日期前的100天數據，設定下限爲100%。

 

18
 

 

(viii)Expected Risk-Free Interest Rate at Announcement of a Fundamental Transaction. The Company utilized a risk-free interest rate corresponding to the forward U.S. Treasury rate for the period equal to the time between the date forecast for the public announcement of a Fundamental Transaction and the Warrant expiration date for each simulation.
(ix)Expected Time Between Announcement and Consummation of a Fundamental Transaction. The expected time between the announcement and the consummation of a Fundamental Transaction is based on the Company’s experience with the due diligence process performed by acquirers and is estimated to be six months. The Monte Carlo Simulation approach incorporates this additional period to reflect the delay Warrant Holders would experience in receiving the proceeds of the Put.

 

While the assumptions remain consistent from period to period (e.g., utilizing historical stock prices), the actual historical prices input for the relevant period input change.

 

The Company accounts for certain assets and liabilities at fair value. The hierarchy below lists three levels of fair value based on the extent to which inputs used in measuring fair value are observable in the market. AIM categorizes each of its fair value measurements in one of these three levels based on the lowest level input that is significant to the fair value measurement in its entirety. These levels are:

 

1.級別 1 – 報價在報告日期時，針對相同的資產或負債在活躍市場中可獲得。通常，這包括在活躍市場中交易的債務和股權證券。
2.級別 2 – 除級別1價格外的可觀察輸入，例如類似資產或負債的報價價格；在非活躍市場中的報價價格；或其他可觀察的輸入，或可以通過可觀察的市場數據確認的輸入，適用於資產或負債的絕大部分期限。通常，這包括在非活躍市場中未交易的債務和股權證券。
3.級別 3 – 支持市場活動極少或沒有活動的不可觀察輸入，這些輸入對資產或負債的公允價值具有重要意義。級別3的資產和負債包括使用定價模型、折現現金流方法或其他估值技術確定其價值的金融工具，以及需要重大管理判斷或估計才能確定公允價值的工具。截至2024年9月30日，公司已將具有現金結算特徵的Warrants歸類爲級別3。管理層評估多種輸入，然後根據這些輸入估算公允價值。如上所述，公司在評估Warrants時使用了蒙特卡羅模擬模型。

 

下表列出了按層級分類以公允價值計量的資產和負債餘額（單位：千）

 

   截至2024年9月30日 
   總計   一級   二級   第三級 
資產:                
現金等價物  $67   $67   $—   $— 
可售證券  $6,287   $6,287   $—   $— 

 

   截至2023年12月31日 
   總計   一級   二級   第三級 
資產:                
現金等價物  $4,805   $4,805   $—   $— 
可售證券  $7,631   $7,631   $—   $— 

 

 

注意 13: 租賃

 

公司租賃辦公和實驗室設施以及其他設備，簽署不可撤銷的經營租賃合同，初始期限通常在 1 至 5 年，租賃合同將在2024年至2027年間的不同日期到期，租金每月支付在1,000 美元以下至17,000美元。某些租賃合同包括額外的續租選項，期限從 1 至 5 年不等。AIm已將所有租賃合同分類爲經營租賃。

 

截至2024年9月30日和2023年12月31日，使用權資產的餘額爲$653,000 和 $697,000，以及相應的 運營租賃負債餘額爲$669,000 和 $718,000，分別爲。使用權資產的賬面價值爲，減去累計攤銷$404,000 和 $363,000 截至2024年9月30日和2023年12月31日，分別爲。

 

19
 

 

AIM recognized rent expense associated with these leases are follows:

 

   2024年9月30日   2023年9月30日 
   (以千爲單位) 
   2024年9月30日   2023年9月30日 
租賃成本：          
經營租賃成本  $226   $214 
開空和變量租賃成本   205    253 
           
總租賃成本  $431   $467 
租賃成本的分類          
研發  $358   $400 
一般管理費用   73    67 
          
總租賃成本  $431   $467 

 

公司租賃的剩餘租期在 6 和 35 個月之間。截止2024年9月30日，加權平均剩餘租期爲 32 個月。截止2023年12月31日，加權平均剩餘租期爲 41 個月。公司租賃的加權平均增量借款利率爲 10.2%，截至2024年9月30日，以及 10%，截至2023年12月31日。

 

未來 截至2024年9月30日的最低付款如下：

 

截止至12月31日的年度
（以千爲單位）		    
2024  $78 
2025   276 
2026   244 
2027   159 
之後   — 
減去應計利息   (88)
總計  $669 

 

注意 14： 研究、諮詢和供應協議

 

公司已與第三方服務提供商簽訂研究、諮詢和供應協議，以進行治療藥物的研發活動，包括臨牀試驗。識別研發成本涉及審查未結合同和採購訂單，與相關公司和第三方人員溝通，以識別已完成的服務，並在公司尚未收到發票或其他實際費用通知的情況下，證實所提供服務的級別及其相關成本。當這些研發成本發生時，公司將其計入費用。

 

截至2024年9月30日的三個月期間，研發費用包括：臨牀研究（$582,000）、製造業 和工程（$306,000）、質量控制（$398,000）和法規（$151,000).

 

在截至2023年9月30日的三個月期間，研究與開發費用包括：臨牀研究（$1,916,000），製造業 和工程（$396,000），質量控制（$251,000）和監管（$170,000).

 

截至2024年9月30日的九個月期間，研發費用包括：臨牀研究（$1,880,000）、製造業 和工程（$882,000）、質量控制（$1,232,000）和法規（$540,000).

 

在截至2023年9月30日的九個月期間，研發費用包括：臨牀研究（$3,845,000）、製造業 和工程（$2,783,000）、質量控制（$752,000）和法規（$359,000).

 

20
 

 

以下總結了與AIm相關的我們在研究、諮詢和供應成本方面的最重要合同，這些合同與截至2024年9月30日的九個月內的研究和開發成本有關。

 

Amarex 臨牀研究有限責任公司

 

Amarex 是AIM多個大型臨牀研究的主要管理者。AIM與Amarex臨牀研究LLC（「Amarex」）有多個合同。在截至2024年9月30日和2023年9月30日的三個月中，公司大約發生了$275,400 和516,284，分別與這些持續的協議相關。在截至2024年9月30日和2023年9月30日的九個月中，公司大約發生了$881,987 和 $1,294,265，分別與這些持續的協議相關：

 

●胰腺癌 - 在2022年4月，AIm與Amarex執行了一份工作訂單，Amarex負責管理一項針對局部晚期胰腺癌患者的2期臨牀試驗，指定爲AMP-270。根據工作訂單，AIm預計Amarex對該研究的管理將花費大約$8,400,000。這個估算包括大約$1,000,000 ，並且不包括某些第三方和研究者的費用及研究完成所需的增量。AIm預計該研究將大約需要 4.6 年才能完成。

 

○在截至2024年9月30日的三個月期間，公司發生了大約$129,000 與此協議有關。 在截至2023年9月30日的三個月期間，公司發生了大約$82,600 與此協議有關。

 

○在截至2024年9月30日的九個月期間，公司產生了大約$141,100 與此協議相關。 在截至2023年9月30日的九個月期間，公司產生了大約$350,600 與此協議相關。

 

●後COVID 狀態 - 在2022年9月，AIm與Amarex執行了一份工作訂單，依據該訂單 Amarex正在管理一項針對後COVID狀態患者的第二階段試驗。AIm爲該研究提供資金。AIm預計該研究的費用將約爲$6,400,000，其中包括約$125,000，研究者費用估計約爲$4,400,000 並且不包括某些其他第三方費用和附加費用。在2023年，原始工作 訂單增加到約$6,600,000 用於增加患者報告結果 (PRO) 電子問卷（供患者完成的設備/平板）；與ePRO系統相關的服務以及額外的安全監測服務，以及對研究 文檔的更改（如方案修正），導致向FDA提交額外的IND申請。這項研究在2023年完成，儘管某些活動仍在進行中。

 

○在截至2024年9月30日的三個月期間，公司發生了大約$27,500 與本協議相關。 在截至2023年9月30日的三個月期間，公司約花費了$447,600 與此協議有關。

 

○在截至2024年9月30日的九個月期間，公司產生了大約$195,800 與本協議相關。在截至2023年9月30日的九個月內，公司產生了約$783,400 與此協議有關。

 

21
 

 

歡慶的HollisterStier

  

Jubilant HollisterStier（"Jubilant"）是AIM在阿根廷的Ampligen批准授權首席醫療官。2017年，公司與Jubilant簽署了協議，根據該協議，Jubilant將爲公司生產Ampligen®的批次。自2017年與Jubilant合作以來，已經制造並釋放了兩批超過 16,000 單位的Ampligen，生產和釋放發生在2018年。第一批是爲美國的成本回收CFS計劃以及擴展的腫瘤學臨牀試驗而指定用於人類使用。第二批除了用於這些項目外，還被指定用於阿根廷的商業分銷，以治療CFS。Jubilant在2019年12月和2020年1月又製造了兩批Ampligen。在2023年12月，Jubilant完成了臨牀使用的 9,042 瓶Ampligen的製造。

 

○截至2024年9月30日的三個月期間，公司沒有任何費用與該協議相關。 無截至2023年9月30日的三個月期間，公司沒有任何費用與該協議相關。 無沒有產生與該協議相關的任何費用。

 

○在截至2024年9月30日的九個月期間，公司產生了大約$1,200 與此協議有關。 在截至2023年9月30日的九個月期間，公司發生了大約$1,432,000 與此協議有關。

 

斯特林 製藥解決方案

 

在 2022年，公司與Sterling Pharma Solutions（「Sterling」）簽訂了主服務協議和質量協議， 用於製造公司的聚合物I和聚合物C12U多核苷酸，並在Sterling位於英國達德利的地點轉移相關測試方法， 以生產製造藥物Ampligen所需的聚合物前體。

 

○在截至2024年9月30日的三個月期間，公司發生了大約$133,000 與本協議相關 在截至2023年9月30日的三個月內，公司並未 無發生與本協議相關的任何費用。

 

○在截至2024年9月30日的九個月期間，公司產生了大約$261,600 與本協議相關。在截至2023年9月30日的九個月內，公司產生了約$357,000 與此協議有關。

 

伊拉斯謨

 

在 2022年12月，公司與鹿特丹伊拉斯姆斯大學醫學中心簽訂了聯合臨牀研究協議，以進行 II 期研究：將抗 PD-L1 免疫檢查點抑制劑 durvalumab 與 TLR-3 激動劑林他多莫德聯合治療轉移患者 胰腺導管腺癌的治療療效。這是一項與阿斯利康合作的研究。AIM 的有限責任 僅限於提供 Ampligen。此外，2023 年 4 月，AiM 同意向 Erasmus MC 提供 $ 的無限制補助金200,000 用於胰腺癌患者的免疫監測。

 

○截至2024年9月30日的三個月期間，公司沒有任何費用與該協議相關。 無不承擔與本協議相關的任何費用。 在截至2023年9月30日的三個月期間，公司並沒有任何費用。 無沒有產生與該協議相關的任何費用。

 

○在截至2024年9月30日的九個月期間，公司產生了大約$79,000 與此協議有關。 在截至2023年9月30日的九個月期間，公司產生了大約$100,000 與此協議有關。

 

Azenova Sales International

 

In October 2023, the Company entered into a consulting agreement with Azenova, LLC whereas Azenova will provide business development services for AIM’s Ampligen product for solid tumors for a 12-month term that is extendable upon the agreement of the parties. In exchange for its services, Azenova will receive a fixed monthly retainer of $30,000 per month in addition to 360,000 stock options that vest monthly. In August 2024, an agreement was made to reduce the fixed monthly retainer fee to $10,000.

 

○During the three months ended September 30, 2024, the Company incurred approximately $50,000 related to this agreement. During the three months ended September 30, 2023, the Company did not incur any expense related to this agreement.

 

○During the nine months ended September 30, 2024, the Company incurred approximately $230,000 related to this agreement. During the nine months ended September 30, 2023, the Company did not incur any expense related to this agreement.

 

22
 

 

Alcami

 

In September 2023, the Company entered into an agreement with Alcami Corporation to perform an extractables study for a primary packaging component. The agreement called for fixed costs of approximately $30,000 upon completion of the study and issue of the final report, along with solvent costs, and pass through items to be billed on a per activity basis. The final bill for the initial study was received in December 2023.

 

 ○During the three months ended September 30, 2024, the Company did not incur any expense for lab services from Alcami. During the three months ended September 30, 2023, the Company incurred approximately $8,800 of lab services from Alcami.

 

○During the nine months ended September 30, 2024, the Company incurred approximately $14,000 of lab services from Alcami. During the nine months ended September 30, 2023, the Company incurred approximately $25,000 of lab services from Alcami.

 

Note 15: Subsequent Events

 

On September 30, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) to complete an offering (the “Transactions”) with a single accredited investor (the “Purchaser”). The Transactions closed on October 1, 2024. Pursuant to the Purchase Agreement, at closing, the Company issued to the Purchaser, (i) in a registered direct offering, 4,653,036 shares of the Company’s common stock (the “Shares”), par value $0.001 per share (“Common Stock”); and (ii) in a concurrent private placement, the Company issued to the Purchaser Class C common warrants to purchase an aggregate of up to 4,653,036 shares of its Common Stock (the “C Warrants”) at an exercise price of $0.28 per share and Class D common warrants to purchase an aggregate of up to 4,653,036 shares of its Common Stock (the “D Warrants” and, along with the C Warrants, the “Common Warrants”) at an exercise price of $0.28 per share. The C Warrants and D Warrants will not be exercisable for six months after the issuance date and will expire, respectively, 24 months and five years and six months after the issuance date. The Common Warrants and the shares of Common Stock issuable upon the exercise of such warrants were offered pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.

 

The Company received aggregate gross proceeds from the Transactions of approximately $1.26 million, before deducting fees to the Placement Agent and other estimated offering expenses payable by the Company. The shares underlying the Common Warrants are being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-262280), which was declared effective on February 4, 2022 (as amended from time to time, the “Registration Statement”).

 

Pursuant to the terms of the Purchase Agreement, subject to certain exceptions, the Company cannot issue any equity securities for 60 days following the closing of the Transactions (the “Closing Date”), provided that the Company will be able to utilize it’s at-the-market offering (the “ATM”) program with the Placement Agent after 30 days. Additionally, the Company cannot enter into a variable rate transaction (other than the ATM program with the Placement Agent) for 120 days after the Closing Date. In addition, the Company’s executive officers and each of the Company’s directors have entered into lock-up agreements with the Company pursuant to which each of them has agreed not to, for a period of 90 days from the Closing Date, offer, sell, transfer or otherwise dispose of the Company’s securities, subject to certain exceptions.

 

The exercise price of the Common Warrants, and the number of shares of Common Stock underling the Common Warrant (the “Common Warrant Shares”) will be subject to adjustment in the event of any stock dividend or split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common Warrants. If a Fundamental Transaction (as defined in the Common Warrants) occurs, then the successor entity will succeed to, and be substituted for the Company, and may exercise every right and power that the Company may exercise and will assume all of its obligations under the Common Warrants with the same effect as if such successor entity had been named in the warrant itself. Common Warrant Holders will have additional rights defined in the Common Warrants. The Common Warrants will be exercisable on a “cashless” basis only if there is not a current registration statement permitting public resale. In this regard, the Company has agreed to file a registration statement to register the resale of the Common Warrant Shares as soon as practicable (and in any event within 45 calendar days of the date of the Purchase Agreement) providing for the resale of the Shares issued and issuable upon exercise of the Common Warrants. The Company has agreed to use commercially reasonable efforts to cause such registration statement to become effective within 181 days following the Closing Date and to keep such registration statement effective at all times until no Purchaser owns any Common Warrants or Common Warrant Shares issuable upon exercise thereof.

 

The Company is currently evaluating the Common Warrants under the guidance of ASC 480 – Distinguishing Liabilities from Equity

 

23
 

 

ITEM 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Special Note Regarding Forward-Looking Statements

 

Certain statements in this Report contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. All statements, other than statements of historical fact, included or incorporated herein regarding our strategy, future operations, financial position, future revenues, projected costs, plans, prospects and objectives are forward-looking statements. Words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,” “think,” “may,” “could,” “will,” “would,” “should,” “continue,” “potential,” “likely,” “opportunity” and similar expressions or variations of such words are intended to identify forward-looking statements but are not the exclusive means of identifying forward-looking statements and their absence does not mean that a statement is not forward-looking. Our forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties. These statements are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us. Discussions containing these forward-looking statements may be found, among other places, below in this Item 2: “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in Part II: Other information: Item 1A: “Risk Factors” of this report, and the following sections of our Annual Report on Form 10-K for the year ended December 31, 2023: Part I; Item 1. “Business”, Part I; Item 1A. “Risk Factors”, Part I; Item 3. “Legal Proceedings”, and Part I; Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this Report. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this presentation speak only as of the date of this presentation. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. We are in various stages of seeking to determine whether Ampligen® will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders and the presentation sets forth our current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen® will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Among the studies are clinical trials that provide only preliminary data with a small number of subjects, and no assurance can be given that the findings in these studies will prove true or that the study or studies will yield favorable results. Some of the world’s largest pharmaceutical companies and medical institutions are working on a treatment for COVID-19. Even if Ampligen® proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive, as multiple vaccines, and some treatments, are now available and major pharma companies are working to develop their own disease treatments. Some of the world’s largest pharmaceutical companies are also working on treatments and cures for different types of cancers. No assurance can be given that the use of Ampligen with these proposed treatments and cures will prove effective. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced or incorporated by reference herein. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. In addition, many countries, including Argentina, are still dealing with COVID-19 outbreaks and have made that their primary focus. We believe that this may be delaying our commercialization of Ampligen® in Argentina until COVID-19 is more under control. We cannot assure that our potential foreign operations will not be adversely affected by these risks. No assurance can be given that we will be able to raise additional equity or other financing pursuant to the ATM, Atlas Equity Line or otherwise.

 

Our filings are available at www.aimimmuno.com. The information found on our website is not incorporated by reference into this Report and is included for reference purposes only.

 

We operate in an evolving environment. New risk factors and uncertainties emerge from time to time, and it is not possible for our management to predict all risk factors and uncertainties, nor are we able to assess the impact of all of these risk factors on our business or the extent to which any risk factor, or combination of risk factors, may cause actual results to differ materially from those contained in any forward-looking statements.

 

Given these uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future events or developments.

 

24
 

 

Overview

 

General

 

AIM ImmunoTech Inc. and its subsidiaries (collectively, “AIM”, “Company”, “we”, “us” or “our”) are an immuno-pharma company headquartered in Ocala, Florida, focused on the research and development of therapeutics to treat multiple types of cancers, viral diseases and immune-deficiency disorders. We have established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body, and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.

 

Our flagship products are Ampligen (rintatolimod) and Alferon N Injection (Interferon alfa). Ampligen is a double-stranded RNA (“dsRNA”) molecule being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen has not been approved by the FDA or marketed in the United States but is approved for commercial sale in the Argentine Republic for the treatment of severe Chronic Fatigue Syndrome (“CFS”).

 

We are currently proceeding primarily in four areas:

 

●Conducting clinical trials to evaluate the efficacy and safety of Ampligen for the treatment of pancreatic cancer.
●Evaluating Ampligen across multiple cancers as a potential therapy that modifies the tumor microenvironment with the goal of increasing anti-tumor responses to checkpoint inhibitors.
●Exploring Ampligen’s antiviral activities and potential use as a prophylactic or treatment for existing viruses, new viruses and mutated viruses thereof.
●Evaluating Ampligen as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”) and fatigue and/or the Post-COVID condition of fatigue.

 

We are prioritizing activities in an order related to the stage of development, with those clinical activities such as pancreatic cancer, ME/CFS and Post-COVID conditions having priority over antiviral experimentation. We intend that priority clinical work be conducted in trials authorized by the Food and Drug Administration (“FDA”) or European Medicines Agency (“EMA”), which trials support a potential future NDA. However, our antiviral experimentation is designed to accumulate additional preliminary data supporting their hypothesis that Ampligen is a powerful, broad-spectrum prophylaxis and early-onset therapeutic that may confer enhanced immunity and cross-protection. Accordingly, we will conduct antiviral programs in those venues most readily available and able to generate valid proof-of-concept data, including foreign venues.

 

Please see “Immuno-Oncology” below.

 

Immuno-Oncology.

 

We are focused on pancreatic cancer because testing results, to date, primarily conducted in the Netherlands, have been very promising. The Netherlands study generated statistically significant data indicating that Ampligen extended survival well beyond the Standard of Care (“SOC”), when compared to well-matched historical controls. These data support the proposition that Ampligen, when administered to either patients with locally advanced or metastatic pancreatic cancer after systemic chemotherapy showed a statistically significant increase in survival rate. In October 2021, we and our Contract Research Organization, Amarex, submitted an Investigational New Drug (“IND”) application to the FDA for a planned Phase 2 study of Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer.

 

25
 

 

Because of the differences in the scale of necessary trials, our initial primary focus when it comes to pancreatic cancer will be cases that are locally advanced, rather than metastatic. The number of different approaches to treating metastatic pancreatic cancer — approaches which would be determined by treating physicians — would require a much larger, far more expensive trial than a trial for locally advanced pancreatic cancer. Therefore, we are focusing on patients who have completed FOLFIRINOX and have stable disease. In August 2022, we received Institutional Review Board (“IRB”) approval of the trial protocol in locally advanced pancreatic cancer and announced the trial’s commencement. The study is recruiting patients. Assuming this trial and subsequent planned clinical trials confirm the existing data, our goal is to then submit an NDA for use of Ampligen in pancreatic cancer patients.

 

Ampligen has also demonstrated in the clinic the potential for standalone efficacy in a number of other solid tumors. We have also seen success in increasing survival rates and efficacy in the treatment of animal tumors when Ampligen is used in combination with checkpoint blockade therapies. In fact, in March 2022 we announced interim data from an investigator-initiated, Phase 2, single-arm, efficacy/safety trial to evaluate the effectiveness of combining intensive locoregional intraperitoneal (IP) chemoimmunotherapy of cisplatin with IP Ampligen (TLR-3 agonist) and IV infusion of the checkpoint inhibitor pembrolizumab for patients with recurrent platinum-sensitive ovarian cancer. We believe that data from the study, which is being conducted by the University of Pittsburgh Medical Center and funded by a Merck grant, demonstrated that when combining three drugs – Ampligen and pembrolizumab, which are both immune therapies, with cisplatin, a chemotherapy – evidence of increased biomarkers associated with T cell chemotaxis and cytolytic function has been seen. Importantly, increases of these biomarkers in the tumor microenvironment have been correlated with favorable tumor responses. These successes in the field of immuno-oncology have guided our efforts toward the potential use of Ampligen as a combinational therapy for the treatment of a variety of solid tumor types. The first of our patent applications in this space was granted by the Netherlands on March 15, 2021.

 

Please see “Immuno-Oncology” below.

 

Ampligen as a Potential Antiviral

 

We have a research and pre-clinical history that indicates broad-spectrum antiviral capability of Ampligen in animals. We hope to demonstrate that it has the same effect in humans. To do this, among other things, we need a population infected with a virus. That is why we have spent significant resources on COVID-19 (the disease caused by SARS-CoV-2) which is active and still infecting many subjects. While much would need to be done to get Ampligen to market as a broad-spectrum antiviral, we believe that it is important to focus our efforts first and foremost on thoroughly proving the concept, especially while there is still a large COVID-19-infected population. Previously, animal studies were conducted that yielded positive results utilizing Ampligen to treat numerous viruses, such as Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture of smallpox vaccine) and SARS-CoV-1. We have conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2.

 

The FDA has requested that we provide additional data to assist the agency in evaluating the potential risks and benefits of administering Ampligen to asymptomatic and mild COVID-19 individuals. However, as discussed in more detail below, where the threat to the patient from COVID-19 is high, the FDA has already authorized Ampligen in a clinical trial of patients with COVID-19 who have a pre-existing cancer, although this study is currently suspended. We have also elected to explore studies (initially with healthy volunteers) outside the United States and have already conducted a study in the Netherlands to determine the safety profile of the intranasal delivery of Ampligen.

 

In this regard, CHDR, a foundation located in Leiden in the Netherlands, managed a Phase 1 randomized, double-blind study for us to evaluate the safety, tolerability, and biological activity of repeated administration of Ampligen intranasally. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study was completed, and the Final Safety Report reported no Serious or Severe Adverse Events at any dosage level.

 

While there are approved therapies for COVID-19, we believe that, if Ampligen has the broad-spectrum antiviral properties that we believe that it has, it could be a very valuable tool in treating variants of existing viral diseases, including COVID-19, or novel ones that arise in the future. Unlike most developing therapeutics which attack the virus, Ampligen works differently. We believe that it activates antiviral immune system pathways that fight not just a particular virus or viral variant, but other similar viruses as well.

 

Please see “Ampligen as a Potential Antiviral” below.

 

Ampligen as a Treatment for Post-COVID Conditions

 

In July 2023, we enrolled and dosed the first patient in our Phase 2 study evaluating Ampligen® as a potential therapeutic for people with post-COVID conditions (“AMP-518”). We announced in August 2023 that the study had met the planned enrollment of 80 subjects ages 18 to 60 years who have been randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks. All patients have completed the study, with topline data reported in February 2024 and an analysis of complete patient clinical data reported in January 2024.

 

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Please see “Ampligen as a Treatment for Post-COVID Conditions” below.

 

Ampligen as a treatment for ME/CFS and Post-COVID Conditions

 

We have long been focused on seeking the FDA’s approval for the use of Ampligen to treat myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”). In fact, in February 2013, we received a Complete Response letter (“CRL”) from the FDA for our Ampligen NDA for ME/CFS, stating that we should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.

 

While developing a comprehensive response to the FDA and a plan for a confirmatory trial for the FDA NDA, we proceeded independently in Argentina and, in August 2016, we received approval of an NDA from ANMAT for commercial sale of Ampligen in the Argentine Republic for the treatment of severe CFS. In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales. On June 10, 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina. The next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the product and release tests before granting final approval to begin commercial sales. This testing and approval process is ongoing due to ANMAT’s internal processes. Once final approval by ANMAT is obtained, GP Pharm will be responsible for distributing Ampligen in Argentina.

 

The FDA authorized an open-label treatment protocol (“AMP-511”) allowing patient access to Ampligen for treatment in a study under which severely debilitated CFS patients have the opportunity to be on Ampligen to treat this very serious and chronic condition. The data collected from the AMP-511 protocol through a consortium group of clinical sites provide safety information regarding the use of Ampligen in patients with CFS. The AMP-511 protocol is ongoing. In October 2020, we received IRB approval for the expansion of the AMP-511 protocol to include patients previously diagnosed with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms that we refer to as Post-COVID conditions. As of September 30, 2024, there were 7 patients enrolled in this open-label, expanded access treatment protocol (including two patients with Post-COVID Conditions). To date, there have been eight such Post-COVID patients treated in the study. AIM previously reported positive preliminary results based on data from the first four Post-COVID Condition patients enrolled in the study. The data show that, by week 12, compared to baseline, there was what the investigators considered a clinically significant decrease in fatigue-related measures.

 

We plan on a comprehensive follow through with the FDA regarding the use of Ampligen as a treatment for ME/CFS. We have learned a great deal since the FDA’s CRL and plan to adjust our approach to concentrate on specific ME/CFS symptoms. Responses to the CRL and a proposed confirmatory trial are being worked on now by our R&D team and consultants.

 

Please see “Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)” below.

 

Atlas Equity Line of Credit

 

On March 28, 2024, we entered into a purchase agreement (the “Purchase Agreement”) and a registration rights agreement (the “Registration Rights Agreement”) with Atlas Sciences, LLC, a Utah limited liability company (“Atlas”), pursuant to which Atlas has committed to purchase up to $15 million of our common stock. No assurance can be given as to the actual amount that will be raised pursuant to the Purchase Agreement.

 

Under the terms and subject to the conditions of the Purchase Agreement, we have the right, but not the obligation, to sell to Atlas, and Atlas is obligated to purchase up to $15 million of our common stock (the “Commitment Amount”). Such sales by us, if any, will be subject to certain limitations, and may occur from time to time, at our sole discretion, over the 24-month period commencing on the date that a registration statement covering the resale of shares that have been and may be issued under the Purchase Agreement. We agreed to file the registration statement with the SEC pursuant to the Registration Rights Agreement. Sales could not commence until the registration statement was declared effective by the SEC and a final prospectus in connection therewith is filed and the other conditions set forth in the Purchase Agreement are satisfied. The registration statement was declared effective and the final prospectus was filed on May 1, 2024.

 

Atlas has no right to require us to sell any shares to Atlas, but Atlas is obligated to make purchases as we direct, subject to certain conditions. There are no upper limits on the price per share that Atlas must pay for shares of common stock. Actual sales of shares to Atlas will depend on a variety of factors to be determined by us from time to time, including, among others, market conditions, the trading price of the common stock and determinations by us as to the appropriate sources of funding for us and our operations.

 

The net proceeds under the Purchase Agreement will depend on the frequency and prices at which we sell shares to Atlas. We expect that any proceeds received by us will be used for working capital and general corporate purposes.

 

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We cannot sell shares below the Minimum Price (as defined by the NYSE American) under the Purchase Agreement that would represent, in the aggregate, more than 19.99% of the outstanding shares on the date that the Purchase Agreement was executed. Before we could do that, we would need to obtain stockholder approval.

 

We have agreed with Atlas that we will not enter into any “variable rate” transactions with any third party for a period defined in the Purchase Agreement. Atlas has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of our shares. Pursuant to the purchase agreement, our ATM with Maxim Group is not deemed to be a variable rate transaction.

 

As consideration for Atlas’s irrevocable commitment to purchase shares upon the terms of and subject to satisfaction of the conditions set forth in the Purchase Agreement, upon execution of the Purchase Agreement, we agreed to pay Atlas an initial commitment fee in shares equal to 1.0% of the Commitment Amount. The initial commitment fee was paid upon execution of the Purchase Agreement through the issuance of 338,600 shares of common stock.

 

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and indemnification obligations of the parties. We have the right to terminate the Purchase Agreement at any time, at no cost or penalty.

 

During any period where bankruptcy, insolvency, reorganization or liquidation proceedings or other proceedings, voluntary or involuntary, for relief under any bankruptcy law or any law for the relief of debtors shall be instituted or anticipated by or against us or any of our subsidiaries, and in the case of such a proceeding being involuntary or commenced against us, which is not dismissed within 60 days, we may not initiate any purchase of shares by Atlas.

 

The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting parties. The foregoing descriptions of the Agreements are qualified in their entirety by reference to the full text of these Agreements which were filed as exhibits 10.104 and 10.105 to our 2023 Annual Report on Form 10-K.

 

Securities Purchase Agreement

 

On May 31, 2024, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) to complete an offering (the “Transactions”) with a single accredited investor (the “Purchaser”), pursuant to which we issued to the Purchaser, (i) in a registered direct offering, 5,640,958 shares of our common stock (the “Shares”), par value $0.001 per share (“Common Stock”) and (ii) in a concurrent private placement, we issued to the Purchaser Class A common warrants to purchase an aggregate of up to 5,640,958 shares of its common stock (the “A Warrants”) at an exercise price of $0.363 per share and Class B common warrants to purchase an aggregate of up to 5,640,958 shares of its common stock (the “B “Warrants” and, along with the A Warrants, the “Common Warrants”) at an exercise price of $0.363 per share. The A Warrants and B Warrants will not be exercisable for six months after the issuance date and will expire, respectively, 24 months and five years and six months after the issuance date. The Common Warrants and the shares of common stock issuable upon the exercise of such warrants are offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.

 

We received aggregate gross proceeds from the Transactions of approximately $2,047,688, before deducting fees to the Placement Agent and other estimated offering expenses payable by us. The Shares are being offered by us pursuant to a shelf registration statement on Form S-3 (File No. 333-262280), which was declared effective on February 4, 2022 (as amended from time to time, the “Registration Statement”).

 

Pursuant to the terms of the Purchase Agreement, subject to certain exceptions, we could not issue any equity securities for 60 days following the issuance date, provided that we are able to utilize the at-the-market offering program with the Placement Agent after 30 days. Additionally, we cannot enter into a variable rate transaction (other than the ATM program with the Placement Agent) for 120 days after the issuance date. In addition, our executive officers and each of our directors have entered into lock-up agreements with us pursuant to which each of them has agreed not to, for a period of 90 days from the closing of the Transactions, offer, sell, transfer or otherwise dispose of our securities, subject to certain exceptions.

 

The exercise price of the Common Warrants, and the number of Common Warrant Shares, are subject to adjustment in the event of any stock dividend or split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common Warrants. If a Fundamental Transaction (as defined in the Common Warrants) occurs, then the successor entity will succeed to, and be substituted for us, and may exercise every right and power that we may exercise and will assume all of its obligations under the Common Warrants with the same effect as if such successor entity had been named in the warrant itself. Common Warrant Holders will have additional rights defined in the Common Warrants. The Common Warrants are exercisable on a “cashless” basis only if there is not a current registration statement permitting public resale. In this regard, the Company filed a registration statement to register the resale of the Common Warrant Shares. That registration statement was declared effective by the SEC on July 11, 2024. The Company has agreed to use commercially reasonable efforts to keep such registration statement effective at all times until no Purchaser owns any Warrants or Warrant Shares issuable upon exercise thereof.

 

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Maxim Group LLC acted as the placement agent (the “Placement Agent”) on a “commercially reasonable best efforts” basis, in connection with the Transactions pursuant to the Placement Agency Agreement, dated May 31, 2024 (the “Placement Agency Agreement”), by and between us and the Placement Agent. Pursuant to the Placement Agency Agreement, the Placement Agent was paid a cash fee of 8% of the aggregate gross proceeds paid to the Company for the securities sold in the Transactions and reimbursement of certain out-of-pocket expenses.

 

On September 30, 2024, the Company entered into a Securities Purchase Agreement to complete an offering with a single accredited investor. For more information see Note 15: Subsequent Events.

 

OUR PRODUCTS

 

Our primary pharmaceutical product platform consists of Ampligen (rintatolimod), a first-in-class drug of large macromolecular double-stranded (ds) RNA (ribonucleic acid) molecules, and our FDA-approved natural alpha-interferon product, Alferon N Injection.

 

Ampligen is approved for sale in Argentina (to 2026) for severe CFS and is an experimental drug in the United States currently undergoing clinical development for the treatment of certain cancers, ME/CFS and Post-COVID Conditions. Over its developmental history, Ampligen has received various designations, including Orphan Drug Product Designation (FDA and EMA), Treatment protocol (e.g., “Expanded Access” or “Compassionate” use authorization) with Cost Recovery Authorization (FDA) and “promising” clinical outcome recognition based on the evaluation of certain summary clinical reports (“AHRQ” or Agency for Healthcare Research and Quality). Based on the results of published, peer-reviewed pre-clinical studies and clinical trials, we believe that Ampligen may have broad-spectrum antiviral and anti-cancer properties.

 

We believe that nucleic acid compounds represent a potential new class of pharmaceutical products designed to act at the molecular level for treatment of many human diseases. Ampligen represents the first drug in the class of large (macromolecular) dsRNA molecules to apply for NDA review. There are two forms of nucleic acids: deoxyribonucleic acid (“DNA”) and ribonucleic acid (“RNA”). DNA is a group of naturally occurring molecules found in chromosomes, the cell’s genetic machinery. RNA is a group of naturally occurring informational molecules which orchestrate a cell’s behavior which, in turn, regulates the action of groups of cells, including the cells which comprise the body’s immune system. RNA directs the production of proteins and regulates certain cell activities including the activation of an otherwise dormant cellular defense against viruses and tumors. Our drug technology utilizes specifically configured RNA and is a selective Toll-like Receptor 3 (“TLR3”) agonist that can be administered intravenously, intranasally and intraperitoneally. Ampligen has been assigned the generic name rintatolimod by the United States Adopted Names Council (“USANC”) and has the chemical designation poly(I):poly(C12U).

 

Expanded Access Program/Early Access Programs/clinical trials of Ampligen that have been conducted or that are ongoing include studies of the potential treatment of patients with pancreatic cancer, renal cell carcinoma, malignant melanoma, non-small cell lung cancer, ovarian cancer, breast cancer, colorectal cancer, prostate cancer, ME/CFS, Hepatitis B, HIV, COVID-19 and Post-COVID conditions.

 

We have received approval of our NDA from ANMAT for the commercial sale of Ampligen in the Argentine Republic for the treatment of severe CFS. The product will be marketed by GP Pharm, our commercial partner in Latin America. Shipment of the drug product to Argentina was initiated in 2018 to complete the release testing by ANMAT needed for commercial distribution. In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales. In June 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina. We are currently working with GP Pharm on the commercial launch of Ampligen in Argentina. Commercialization in Argentina will require, among other things, GP Pharm to establish disease awareness, medical education, creation of an appropriate reimbursement level, design of marketing strategies and completion of manufacturing preparations for launch and ANMAT conducting a final inspection of the product and release tests before granting final approval to begin commercial sales. AIM has supplied GP Pharm with the Ampligen required for testing and ANMAT release. This testing and approval process is ongoing due to ANMAT’s internal processes. Once final approval by ANMAT is obtained, GP Pharm will begin distributing Ampligen in Argentina. Argentina has experienced hyper-inflation and recently devalued its currency to the U.S. dollar by 50%. Contracts with GP Pharm are U.S. dollar contracts and the parties must evaluate the impact of the recent devaluation on its relationship.

 

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The FDA has authorized an open-label expanded access treatment protocol (AMP-511) allowing patient access to Ampligen in a study under which severely debilitated CFS patients have the opportunity to be on Ampligen to treat this serious and chronic condition. The AMP-511 protocol started in the 1990s and is ongoing. The data collected from the AMP-511 protocol through clinical sites provide safety information regarding the use of Ampligen in patients with CFS. We are establishing an enlarged database of clinical safety information which we believe will provide further documentation regarding the absence of autoimmune disease associated with Ampligen treatment. We believe that continued efforts to understand existing data, and to advance the development of new data and information, will ultimately support our future filings for Ampligen and/or the design of future clinical studies that the FDA requested in a CRL. The FDA approved an increased reimbursement level from $200 to $345 per 200 mg vial of Ampligen, due to increased production costs; which was re-authorized in 2021, 2022, 2023 and 2024. At this time, we do not plan on passing this adjustment along to the patients in this program. In October 2020, we received IRB approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include patients previously diagnosed with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms that we refer to as Post-COVID conditions. As of September 30, 2024, there were 7 patients enrolled in this open-label expanded access treatment protocol. In July 2022, AIM reported positive preliminary results based on data from the first four Post-COVID Condition patients enrolled in the study. The data show that, by week 12, compared to baseline, the investigators observed what they considered a clinically significant decrease in fatigue-related measures. To date, there have been eight such Post-COVID patients treated in this study.

 

In May 2016, we entered into a five-year agreement with myTomorrows, a Netherlands based company, for the commencement and management of an Early Access Program (“EAP”) in Europe and Turkey related to ME/CFS. Pursuant to the agreement, as amended, myTomorrows also is managing all Early Access Programs and Special Access Programs in Europe, Canada, and Turkey to treat pancreatic cancer and ME/CFS patients. The agreement was automatically extended for a period of 12 months on May 20, 2021; has been automatically extended for 12 months on each subsequent May 20; and will continue to be automatically extended for periods of 12 months every May 20 until terminated or the terms of the agreement are met.

 

In June 2018, Ampligen was cited as outperforming two other TLR3 agonists — poly IC and natural double stranded RNA — in creating an enhanced tumor microenvironment for checkpoint blockade therapy in the journal of Cancer Research . In a head-to-head study in explant culture models, Ampligen activated the TLR3 pathway and promoted an accumulation of killer T cells but, unlike the other two TLR3 agonists, it did so without causing regulatory T cell (Treg) attraction. These findings were considered important because they indicate that Ampligen selectively reprograms the tumor microenvironment by inducing the beneficial aspects of tumor inflammation (attracting killer T cells), without amplifying immune-suppressive elements such as regulatory T cells. The study was conducted at the University of Pittsburgh and Roswell Park as a part of the NIH-funded P01 CA132714 and Ovarian Cancer Specialized Program of Research Excellence (“SPORE”).

 

In 2018, we completed production of two commercial-size batches of more than 16,000 vials of Ampligen, following its “Fill & Finish” at Jubilant HollisterStier, the Contract Manufacturing Organization. These lots passed all required testing for regulatory release for human use and are being used for multiple programs, including: the treatment of ME/CFS; the pancreatic cancer EAP in the Netherlands; and will continue to be used for ongoing and future clinical studies in oncology. Lots of Ampligen were manufactured in December 2019, January 2020 and December 2023. Additionally, in December 2020, we added Pharmaceutics International Inc. (“Pii”) as a “Fill & Finish” provider to enhance our capacity to produce Ampligen. This addition amplifies our manufacturing capability by providing redundancy and cost savings. The contracts augment our active and in-process fill and finish capacity.

 

Immuno-Oncology

 

The potential of Ampligen as an immuno-oncology therapeutic has been a major focus of AIM since our current leadership took over in 2016. We have been working with the University of Pittsburgh’s chemokine modulation research initiative, which includes the use of Ampligen as a potential adjuvant to modify the tumor microenvironment (“TME”) with the goal of increasing anti-tumor responses to check point inhibitors (“CPI”). As part of this collaboration, we have supplied Ampligen to the University. The study, under the leadership of Robert P. Edwards, MD, chair of gynecologic services at Magee-Women’s Hospital of the University of Pittsburgh School of Medicine, and Professor of Surgery Pawel Kalinski, M.D., Ph.D., at Roswell Park, Buffalo, N.Y., involved the chemokine modulatory regimen developed by Dr. Kalinski’s group and successfully completed the Phase 1 dose escalation in patients with resectable colorectal cancer.

 

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Multiple Ampligen clinical trials are underway or recently completed at major university cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors. The underway trials include:

 

●Pancreatic Cancer Trial

 

○The Phase 2 AMP-270 clinical trial is a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the U.S. and Europe. In March 2022, the FDA granted clearance to proceed with the study. In April 2022, we executed a work order with Amarex to manage the clinical trial. In August 2022, we received IRB approval of the trial protocol and so announced the trial’s commencement. The authorization to proceed with the Phase 2 pancreatic cancer clinical trial has been received with potential sites in the Netherlands at Erasmus MC, and also at major cancer research centers in the United States such as The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC). A Type D meeting package seeking the FDA guidance on expansion of inclusion criteria and treatment arms to be included was submitted to the FDA. In June 2024, a written response to that meeting package was received from the FDA. The study protocol was amended and resubmitted to the FDA in October 2024. The study is still recruiting patients under the current protocol. (https://clinicaltrials.gov/ct2/show/NCT05494697).

 

○The DURIPANC Study is a Phase 1b/2 clinical trial combining Ampligen with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer. The primary objective of the Phase 1b portion is to determine the safety of combination therapy. Investigators at Erasmus Medical Center (“Erasmus MC”) in the Netherlands had completed the safety evaluation of subjects enrolled in the first dose level of the dose escalation design, finding the combination therapy to be generally well-tolerated with no severe adverse events or dose-limiting toxicities. That first cohort has now reached the pre-determined 6-month stability assessment timepoint and AIM is pleased to announce that two of the three subjects remain stable. The subjects will continue to be treated and receive formal assessment of progression every three months. The standard for calculating median progression-free survival (“PFS”) requires that 50% or more of the subjects have seen disease progression. Because 67% of the patients in the cohort evaluated at 6 months have remained stable, AIM cannot yet report on PFS. Two of the three subjects in the higher-dose second cohort of subjects also have stable disease, although they have not yet reached the 6-month stability assessment timepoint. Investigators continue to treat and monitor these subjects.

 

●Advanced Recurrent Ovarian Cancer

 

○Results of the Phase 1 portion of a Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer were published in the American Association for Cancer Research publication, Clinical Cancer Research (Clin Cancer Res January 19, 2022 DOI: 10.1158/1078-0432.CCR-21-3659). The study results represent an important extension of prior studies using human tumor explants that showed Ampligen’s potentially important role as a TLR3 agonist acting synergistically with high-dose IFNα and celecoxib to selectively enhance Teff cell-attractants while suppressing Treg-attractants in the tumor microenvironment with a concomitant increase in the Teff/Treg ratio. The importance of boosting the Teff/Treg ratio in the tumor microenvironment is that it is associated with the conversion of ‘cold’ tumors into ‘hot’ tumors, which have an increased sensitivity to chemo-immunotherapy and an improved chance of showing tumor regression. The Phase 1 portion was designed to establish intraperitoneal safety. The Phase 2 portion of the study is recruiting subjects. https://clinicaltrials.gov/ct2/show/NCT02432378

 

○A Phase 2 study of advanced recurrent ovarian cancer using cisplatin, pembrolizumab, plus Ampligen; up to 45 patients to be enrolled; enrollment has commenced, and numerous patients have commenced treatment. In April 2024, researchers released topline data that saw an Objective Response Rate (“ORR”) of 45% in platinum-sensitive subjects with recurrent ovarian cancer. ORR includes complete response (“CR”) and partial response (“PR”) to treatment. There was a total Clinical Benefit Rate (“CBR”) of 55% when including patients who experienced stable disease (“SD”). Researchers also reported a median Progression-Free Survival (“PFS”) of 7.8 months. Based on these results and other research suggesting a similar effect in other solid tumor types, AIM sees an Ampligen combination therapy as having potential across multiple types of cancers. Additional clinical studies are underway and planned in many of these types of tumors to further confirm these effects.” https://clinicaltrials.gov/ct2/show/NCT03734692

 

In March 2021, we were granted a patent by the Netherlands Patent Office with granted patent claims that include, but are not limited to, the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors (e.g. pembrolizumab, nivolumab). We believe that the above positive data makes this patent have heightened potential. Similar patents are pending in other countries.

 

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●Stage 4 Metastatic Triple Negative Breast Cancer - Phase 1 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab. Eight patients were enrolled and 6 patients were evaluable. https://www.clinicaltrials.gov/ct2/show/NCT03599453. The key findings announced first in April 2022, and later published in November 2023, included:

 

○The pre-determined primary endpoint of efficacy was met (increase in CD8 in TME).

 

○Uniform increase of immune markers upon treatment was observed: CD8 mRNA (6.1-fold; p-0.034), GZMB mRNA (3.5-fold; p=0.058), ratios of CD8 /FOXP3 and GZMB/FOXP3 (5.7-fold; p=0.036, and 7.6-fold; p=0.024 respectively), thus successfully meeting the pre-determined primary endpoint in the study (increase in CD8 in TME).

 

○In addition, an increase in CTL attractants CXCL10 (2.6-fold; p=0.104) and CCL5 (3.3-fold; p=0.019) was observed. In contrast, Treg marker FOXP3 or Treg attractants CCL22 or CXCL12 were not enhanced.

 

○Three patients had stable disease lasting 2.4, 2.5 and 3.8 months, as of data cut off September 1, 2021.

 

○An additional patient (non-evaluable) had a partial response (breast tumor autoamputation) with massive tumor necrosis in the post-CKM biopsy.

 

●Stage 4 Colorectal Cancer Metastatic to the Liver - Phase 2a study of Ampligen as a component of chemokine modulatory regimen on colorectal cancer metastatic to liver; recruitment has been completed; 19 patients were enrolled and 12 patients were evaluable for the primary endpoint https://clinicaltrials.gov/ct2/show/NCT03403634. The key findings announced in April 2022 included:

 

○The study’s primary endpoint was met, evidenced by increased CD8a expression post-treatment (p=0.046).

 

○Saw increase in the CD8a/CD4 (p=0.03), CD8a/FOXP3 (p<0.01) and GZMB/FOXP3 (p<0.01) ratios.

 

○The expression of CTL-attracting chemokines CCL5 (p=0.08), CXCL9 (p=0.05), and CXCL10 (p=0.06) were increased, while expression of the Treg/MDSC attractant CXCL12 (p=0.07) was decreased post-treatment.

 

○Median OS was 10.5 (90% CI 2.2-15.2) months, and the median PFS was 1.5 (90% CI 1.4, 1.8) months.

 

○No tumor responses were seen. The treatment was well tolerated. Of all enrolled patients (N=19), adverse events were noted in 74% of patients, with the most common being fatigue (58%). Grade 3 or higher adverse events were rare (5%).

 

●Early-Stage Prostate Cancer - Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. Patient enrollment has been initiated in this study designed for up to 45 patients. The study is temporarily suspended due to the Merck discontinuation of Intron-A production. Roswell Park has had a Type-C meeting with the FDA and is currently performing the necessary experiments to replace Intron-A with a generic alpha-interferon. We expect this trial to resume in the near future. https://clinicaltrials.gov/ct2/show/NCT03899987

 

●Early-Stage Triple Negative Breast Cancer - The objective of this Phase 1 study is to evaluate the safety and tolerability of a combination of Ampligen, celecoxib with or without Intron A, when given along with chemotherapy in patients with early-stage triple negative breast cancer. The now completed (as of September 2022) topline results from the study confirm the positive findings that were previously presented at the 2022 Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting in a poster presentation titled Safety and efficacy of de-escalated neoadjuvant chemoimmunotherapy of triple negative breast cancer (TNBC) using chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib). The primary endpoint of the study was safety and tolerability. The results demonstrated that treatment was well-tolerated with mostly grade 1 or 2 treatment-related adverse events (TRAEs) without dose-limiting toxicities (DLTs) or delayed or immune-related toxicities. DLT was defined as grade 3 or higher toxicities within the first 3 weeks. Secondary endpoints included pCR rate where 5/9 (56%) of patients attained pCR and 1 more patient attained ypTmic. Tumor and blood biomarkers were also analyzed in exploratory studies. https://clinicaltrials.gov/ct2/show/NCT04081389

 

●Refractory Melanoma — Roswell Park Comprehensive Cancer Center (“Roswell Park”), in a clinical trial fully funded by the National Cancer Institute (NCI), has commenced patient enrollment in its Phase 2 study in subjects with primary PD-1/PD-L1 resistant melanoma. The Phase 2 study will evaluate type-1 polarized dendritic cell (αDC1) vaccine in combination with tumor-selective chemokine modulation (“CKM”) comprised of Interferon alpha 2b, Ampligen (rintatolimod) and Celecoxib. Up to 24 patients are to be enrolled. The study was temporarily suspended due to the Merck discontinuation of Intron-A production but has since resumed recruitment (See: https://www.clinicaltrials.gov/show/NCT04093323).

 

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●Metastatic or Unresectable Triple Negative Breast Cancer – This phase 1/2a trial tests the safety, side effects, and best dose of chemokine modulation therapy (CKM) (rintatolimod, celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). The study is recruiting subjects.

 

https://clinicaltrials.gov/study/NCT05756166

 

Additional Progress and Analysis Related to Pancreatic Cancer

 

In January 2017, the EAP established under our agreement with myTomorrows to enable access of Ampligen to ME/CFS patients was extended to pancreatic cancer patients beginning in the Netherlands. myTomorrows is our exclusive service provider in Europe and Turkey and will manage all EAP activities relating to the pancreatic cancer extension of the program. In February 2018, the agreement with myTomorrows was extended to cover Canada to treat pancreatic cancer patients, pending government approval. There have been no physician requests to date that would cause the program to move forward with the approval process.

 

A total of 42 pancreatic cancer patients initially received treatment with Ampligen immuno-oncology therapy under the EAP program at Erasmus MC in the Netherlands; that initial program has since continued to expand and proceed with additional patients to be treated with Ampligen supervised by Prof. C.H.J. van Eijck, MD. In March 2024, the team at Erasmus MC published a thorough data analysis in an article titled “Rintatolimod in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell Responses” in the journal Clinical Cancer Research. The positive clinical findings relate to changes in the tumor microenvironment after Ampligen use. We are working with our Contract Research Organization, Amarex Clinical Research LLC, to seek FDA “fast-track.” We have applied for fast-track status; have received denials to date; and are currently working through the FDA process to provide all the materials and information required to achieve fast-track status.

 

A manuscript titled “Rintatolimod in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell Responses,” was published in the print version of the journal Clinical Cancer Research in August 2024. Researchers at the Erasmus University Medical Center (“Erasmus MC”) found that Ampligen treatment in pancreatic cancer patients enhances peripheral immune activity at the transcriptomic and proteomic levels, particularly involving type 1 conventional dendritic cells (cDC1s) and T cells. Post-Ampligen, the increased peripheral abundance of BTLA+XCR1+ cDC1s and CD4+SELL+ T cells correlated with improved clinical outcomes. Patients with stable disease exhibited pronounced overexpression of genes related to DC and T cell activation. Notably, the expression of immune checkpoints PD-L1 and PD-L2 decreased post-Ampligen across all patients.

 

Additionally:

 

●In December 2020, the FDA granted Ampligen Orphan Drug Designation status for the treatment of pancreatic cancer. The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the United States or meets cost recovery provisions of the act. The status helps incentivize the treatment of therapies to treat unmet medical needs by providing a company with seven years of exclusivity rights once a drug reaches market.

 

●In February 2021, our subsidiary, NV Hemispherx Biopharma Europe, received formal notification from the European Commission (“EC”) granting Orphan Medicinal Product Designation for Ampligen as a treatment for pancreatic cancer. Orphan products, once commercially approved in the European Union (“EU”), receive benefits including up to ten years of protection from market competition from similar medicines with similar active component and indication for use that are not shown to be clinically superior.

 

In June 2021, Ampligen was featured in a publication containing state-of-the-art methodologies in the peer-reviewed medical journal Cancers as a potential treatment option for cancer patients who are infected with SARS-CoV-2. The study’s authors stated that Ampligen has the potential to reduce the severity of the deadly respiratory disease COVID-19. According to laboratory data presented in the publication, “Rintatolimod [Ampligen] activated the innate and the adaptive immune systems by activating a cascade of actions in human pancreatic cancer cells”, including:

 

●Stimulation of interferon regulatory factors and activation of the interferon signaling pathway,

 

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●Production of immunomodulatory activity and
●Induction of the expression of MHC class I and II histocompatibility

 

The full journal article is titled: “Rintatolimod Induces Antiviral Activities in Human Pancreatic Cancer Cells: Opening for an Anti-COVID-19 Opportunity in Cancer Patients?” Cancers is a peer-reviewed, open access journal of oncology published semimonthly online by MDPI. The study’s authors include Prof. C.H.J. van Eijck, MD, PhD, the lead investigator at Erasmus Medical Center in the Netherlands.

 

In October 2021, we and Amarex submitted an IND application with the FDA for a planned Phase 2 study of Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer. In December 2021, the FDA responded with a Clinical Hold on the proposed study. We submitted our response to the FDA in February 2022. In March 2022, we received notification from the FDA that the Clinical Hold was released and cleared, meaning that we are now able to proceed with the study specifically to treat locally advanced pancreatic cancer patients. In August 2022, we received IRB approval of the trial protocol and so announced the trial’s commencement.

 

A Type D meeting package seeking the FDA guidance on expansion of inclusion criteria and treatment arms to be included was submitted to the FDA. In June 2024, a written response to that meeting package was received from the FDA. The study protocol was amended and resubmitted to the FDA in October 2024. The study is still recruiting patients under the current protocol.

 

Positive data was published in March 2022 in a manuscript titled, “Rintatolimod (Ampligen®) enhances numbers of peripheral B cells and is associated with longer survival in patients with locally advanced and metastasized pancreatic cancer pre-treated with FOLFIRINOX: a single-center named patient program,” in Cancers Special Issue: Combination and Innovative Therapies for Pancreatic Cancer. In the single-center, named-patient program, patients with locally advanced pancreatic cancer (LAPC) or metastatic disease were treated with Ampligen for 6 weeks, at 2 doses per week with 400 mg per infusion. The study found that Ampligen improved the median survival of these patients. The study’s primary endpoints were the Systemic Immune-Inflammation Index (SIII), the Neutrophils to Lymphocyte Ratio (NLR), and absolute counts of 18 different populations of circulating immune cells as measured by flow cytometry. Secondary endpoints were progression-free survival (PFS) and overall survival (OS). The median overall survival in the Ampligen group was 19 months, compared to a historical control group and subgroup (7.5 and 12.5, respectively) that did not receive Ampligen.

 

Also in March 2022, we announced that study data evaluating the direct effects of Ampligen on human pancreatic ductal adenocarcinoma (PDAC) cells was accepted for presentation at the 15th Annual International Hepato-Pancreato-Biliary Association World Congress in New York, NY. For the study, three PDAC cell lines (CFPAC-1, MIAPaCa-2, and PANC-1) were treated with various concentrations of Ampligen and their corresponding vehicle control. The proliferation and migration effects were examined using in-vitro assays and the molecular effect was examined by targeted gene expression profiling. Additionally human PDAC samples were used to validate the expression of toll-like receptor 3 (TLR3) by immunohistochemistry. Results from the study demonstrated Ampligen decreased the proliferation and migration ability of CFPAC-1 cells. In addition, it decreased the proliferation of MIAPaCa-2 cells and the migration of PANC-1 cells. However, it did not have a dual effect in MIAPaCa-2 and PANC-1 cells. Interestingly, TLR3 was highly expressed in CFPAC-1 cells, low expressed in MIAPaCa-2 and not expressed in PANC-1. Gene expression analysis revealed the upregulation of interferon-related genes, chemokines, interleukins and cell cycle regulatory genes. The heterogeneity of TLR3 expression was confirmed in human PDAC samples. Based on these results, treating pancreatic cancer with Ampligen may have a direct anti-tumor effect in pancreatic cancer cells expressing TLR-3.

 

Ampligen as a Potential Antiviral

 

Following the SARS-CoV-1 outbreak in 2002-03, Ampligen exhibited excellent antiviral properties and protective survival effect in NIH-contracted studies of SARS-CoV-1-infected mice, which is very similar to SARS-CoV-2, the novel virus that causes COVID-19.

 

●The Barnard 2006 study (https://journals.sagepub.com/doi/abs/10.1177/095632020601700505) found that Ampligen reduced virus lung levels to below detectable limits.

 

●The Day 2009 study (https://www.sciencedirect.com/science/article/pii/S0042682209005832) found that, instead of 100% mortality, there was 100% protective survival using Ampligen.

 

We compared key transcription regulatory sequences of SARS-CoV-1 to SARS-CoV-2 and found significant similarities, suggesting highly probable extension of the antiviral effects of Ampligen in the earlier NIH-contracted SARS experiments to COVID-19. The SARS-CoV-2 virus – which causes COVID-19 – shares important genomic and pathogenic similarities with SARS-CoV-1 (hence its name). Since Ampligen has shown antiviral activity against more distantly related coronaviruses, there was a reasonable probability that the antiviral effects of Ampligen against SARS-CoV-1 will likely extend to SARS-CoV-2, and as discussed below, recently, Ampligen has demonstrated ex vivo antiviral activity against SARS-CoV-2. We believe that this creates a compelling case for clinical trials to evaluate Ampligen as a potential tool in the fight against COVID-19.

 

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Since the late 2019 outbreak of SARS-CoV-2, we have been actively engaged in determining whether Ampligen could be an effective treatment for this virus or could be part of a vaccine. We believe that Ampligen has the potential to be both an early-onset treatment for and prophylaxis against SARS-CoV-2. We believe that prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against the new virus.

 

In February 2020, we filed three provisional patent applications related to Ampligen in our efforts toward joining the global health community in the fight against the deadly coronavirus (See: https://aimimmuno.com/press-release/aim-immunotech-files-provisional-patent-application-for-the-use-of-ampligenr-as-a-potential-therapy-for-covid-19-induced-chronic-fatigue/). Our three provisional patent applications include: 1) Ampligen as a therapy for the coronavirus; 2) Ampligen as part of a proposed intranasal universal coronavirus vaccine that combines Ampligen with inactivated coronavirus, conveying immunity and cross-protection and; 3) a high-volume manufacturing process for Ampligen. Under the Patent Cooperation Treaty of 1970, which provides international protections for patents, these three provisional patent applications were converted into two international patent applications based on the date of their filings.

 

In August 2020, we contracted Amarex to act as our Clinical Research Organization and provide regulatory support with regard to a possible clinical trial testing Ampligen’s potential as a COVID-19 prophylaxis via intranasal delivery.

 

Beginning in April 2020, we entered into confidentiality and non-disclosure agreements with numerous companies for the potential outsourcing of the production of polymer, enzyme, placebo as well as Ampligen.

 

In May 2020, the FDA authorized an IND for Roswell Park to conduct a Phase 1/2a study of a regimen of Ampligen and interferon alpha in cancer patients with COVID-19 infections. This clinical trial, sponsored by Roswell Park in collaboration with us, will test the safety of this combination regimen in patients with cancer and COVID-19, and the extent to which this therapy will promote clearance of the SARS-CoV-2 virus from the upper airway. Several subjects have been treated. It is planned that the phase 1/2a study will enroll up to 44 patients in two stages. Phase 1 will see 12-24 patients receiving both Ampligen and interferon alpha-2b at escalating doses. Once that initial phase is complete, further study participants will be randomized to two arms: one receiving the two-drug combination and a control group who will not receive Ampligen or interferon alpha but will receive best available care. We are a financial sponsor of the study and will provide Ampligen at no charge for this study. In November 2020, the first patient in the study had been enrolled and treated. This study was amended to add 20 patients, with 10 randomized to receive a single dose of Ampligen and 10 patients to receive current best therapies. (See clinicaltrials.gov/NCT04379518). Due to a shortage of qualifying subjects with COVID-19 and cancer as a result of the positive impact of vaccinations and treatments for COVID-19, Roswell is seeking approval to expand the qualifying subject criteria to include other diseases lethal to immuno-compromised cancer patients, such as influenza. Accordingly, the study is temporarily suspended while seeking said approvals.

 

We also entered into a specialized services agreement with Utah State University and have supplied Ampligen to support the University’s Institute for Viral Research in its research into SARS-CoV-2. The Utah State results show that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.

 

In October 2020, we received IRB approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include patients previously diagnosed with SARS-CoV-2, but who still demonstrate chronic fatigue-like symptoms. Patients in the trial are treated with our flagship pipeline drug Ampligen. In January 2021, we commenced with the treatment of the first previously diagnosed COVID-19 patient with long-COVID symptoms (i.e., Long Hauler) also known as Post-COVID Conditions in the AMP-511 study. Enrollment of post-COVID patients continues in the study.

 

In January 2021, we entered into a Sponsor Agreement with CHDR to manage a Phase 1 randomized, double-blind study to evaluate the safety and activity of repeated intranasal administration of Ampligen. AIM funded and sponsored the study. This study was designed to assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study was completed, and the Final Safety Report reported no Serious or Severe Adverse Events at any dosage level. We believe that the trial is a critical step in our ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases. Amarex provided us with monitoring support during the trial.

 

Additionally, we filed two COVID-19-related provisional patent applications in the third quarter of 2021. In August, we filed an application for Ampligen as both an intranasal and an intravenous therapy for what we describe as Post-COVID conditions. The people suffering from Post-COVID conditions, including some young adults, can be afflicted with severe difficulties in concentrating; serious memory problems; and the inability to live an active lifestyle, to work and even to perform everyday tasks. Early data has demonstrated that patients with symptoms of Post-COVID conditions being treated with Ampligen in the ongoing AMP-511 Expanded Access Program have reported improvements in fatigue symptoms. Similarly, in ME/CFS, data supports the claim that Ampligen improves fatigue symptoms. Then in September 2022, we filed a patent application for Ampligen as a potential early-onset intranasal therapy designed to enhance and expand infection-induced immunity, epitope spreading, cross-reactivity and cross-protection in patients exposed to a wide range of RNA respiratory viruses, such as influenza, Rhinoviruses and SARS-CoV-2.

 

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In addition to securing these two provisional patent applications, we also moved forward with proposed studies in these areas and with Pre-Investigational New Drug Applications in September 2021. One pre-IND was for a Phase 2, two-arm, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Ampligen in patients experiencing Post-COVID conditions (originally referred to as Post-COVID Cognitive Dysfunction (PCCD) and has been revised to Post-COVID conditions).

 

Ampligen as a Treatment for Post-COVID Conditions

 

In July 2023, we enrolled and dosed the first patient in our Phase 2 study evaluating Ampligen® as a potential therapeutic for people with post-COVID conditions (“AMP-518”). We announced in August 2023 that the study had met the planned enrollment of 80 subjects ages 18 to 60 years who have been randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks. All patients have completed the study and topline data was reported in February 2024.

 

In September 2024, we announced that an analysis of the complete clinical patient data from the AMP-518 clinical trial supported our belief in Ampligen as a potential therapeutic for people with the moderate-to-severe Post-COVID condition of fatigue, and that this would be the likely subject population for AIM’s planned follow-up clinical trial. Study subjects with Long COVID were, on average, able to walk farther in a Six-Minute Walk Test (“6MWT”) when compared to subjects who received a placebo. The 6MWT measured the distance a subject was able to walk in six minutes as a baseline and then again at 13 weeks. A clear signal of significant potential (p <0.02, two-tailed T-test) was observed in Ampligen-treated subjects with a baseline 6MWT less than 205 meters, who saw a mean improvement of 139 meters, compared to a mean improvement of 91 meters in the corresponding part of the group who received the placebo. AIM therefore believes that any future trial design should focus on Ampligen’s therapeutic potential for subjects whose Long COVID-related fatigue can be categorized as moderate or worse.

 

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

 

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), also known as Chronic Fatigue Immune Dysfunction Syndrome (“CFIDS”) and Chronic Fatigue Syndrome (CFS), is a serious and debilitating chronic illness and a major public health problem. ME/CFS is recognized by both the government and private sector as a significant unmet medical need, including the U.S. National Institutes of Health (“NIH”), FDA and the CDC.

 

Many severe ME/CFS patients become completely disabled or totally bedridden and are afflicted with severe pain and mental confusion even at rest. ME/CFS is characterized by incapacitating fatigue with profound exhaustion and extremely poor stamina, sleep difficulties and problems with concentration and short-term memory. It is also accompanied by flu-like symptoms, pain in the joints and muscles, tender lymph nodes, sore throat and new headaches. A distinctive characteristic of the illness is a worsening of symptoms following physical or mental exertion, which do not subside with rest.

 

The high number of younger people being hospitalized for COVID-19 suggests considerable numbers of people in the prime of their lives may have a COVID-induced ME/CFS-like illness in their future. According to a 2016 journal article, the estimated annual cost of lost productivity related to ME/CFS was $9-37 billion in the United States, and for direct medical costs it was $9-14 billion.

 

In June of 2020, we filed a provisional patent application for, among other discoveries, the use of Ampligen as a potential early-onset therapy for the treatment of COVID-19-induced chronic fatigue.

 

Many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report chronic fatigue, difficulty sleeping and shortness of breath months after recovering from the acute illness. “After one year, 17% of patients had not returned to work and 9% more had not returned to their pre-SARS work levels,” according to Simmaron Research. Now there is increasing evidence that patients with COVID-19 can develop a similar, ME/CFS-like illness. These patients are commonly referred to as “Long Haulers.”

 

In October 2020, we received IRB approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include patients previously diagnosed with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms. For more information on our AMP-511 Expanded Access Program, please see “OUR PRODUCTS: Ampligen” above.

 

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In November 2020, we announced the publication of statistically significant data detailing how Ampligen could have a considerable positive impact on people living with ME/CFS when administered in the early stages of the disease. The data were published in PLOS ONE, a peer-reviewed open access scientific journal published by the Public Library of Science. AIM researchers found that the TLR3 agonist Ampligen substantially improved physical performance in a subset of ME/CFS patients.

 

As noted above in Overview; General; Ampligen as a treatment for ME/CFS, we have long been focused on seeking the FDA’s approval for the use of Ampligen to treat ME/CFS. In fact, in February 2013, we received a CRL from the FDA for our Ampligen NDA for ME/CFS, stating that we should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.

 

While developing a comprehensive response to the FDA and a plan for a confirmatory trial for the FDA NDA, we proceeded independently in Argentina and, in August 2016, we received approval of an NDA from ANMAT for commercial sale of Ampligen in the Argentine Republic for the treatment of severe CFS. In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales. On June 10, 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina. The next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the product and release tests before granting final approval to begin commercial sales. This testing and approval process is currently delayed due to ANMAT’s internal processes. Once final approval by ANMAT is obtained, GP Pharm will begin distributing Ampligen in Argentina.

 

We plan on a comprehensive follow through with the FDA regarding the use of Ampligen as a treatment for ME/CFS. We have learned a great deal since the FDA’s CRL and plan to adjust our approach to concentrate on specific ME/CFS symptoms. Responses to the CRL and a proposed confirmatory trial are being worked on now by our R&D team and consultants.

 

Other Diseases

 

In Europe, the EMA has approved the Orphan Medicinal Products Designation for Ampligen as a potential treatment of Ebola virus disease and for Alferon N Injection as a potential treatment of MERS.

 

We concluded our series of collaborations designed to determine the potential effectiveness of Ampligen and Alferon N Injection as potential preventive and/or therapeutic treatments for Ebola-related disorders. Although we believe that the threat of both MERS and Ebola globally may reemerge in the future, it appears that the spread of these disorders has diminished.

 

In April 2021, we entered into an MTA with the University of Cagliari Dipartimento di Scienze della Vita e dell’Ambiente (“UNICA”), an educational institution, under the laws of Italy, located in Monserrato (Cagliari), Italy. The MTA relates to the research and development of the effects of Ampligen and its ability to induce interferon production in several cell lines, and also on the ability of the Ebola virus protein VP35 to bind to viral dsRNA and impede interferon’s upregulation and activity, and on Ampligen’s ability to reverse VP35 inhibition of interferon production in biological systems. The data analysis was published in the peer-reviewed journal Antiviral Research, in a manuscript titled “Ebola virus disease: In vivo protection provided by the PAMP restricted TLR3 agonist rintatolimod and its mechanism of action.” We believe that the analysis supports a dual mechanism of action when Ampligen is used as a prophylactic therapy against Ebola Virus Disease.

 

In May 2021, we filed a U.S. Provisional Patent Application for Ampligen as a potential therapeutic to possibly slow, halt, or reverse the progression of Alzheimer’s disease.

 

In November 2022, we received notice that the FDA had granted Orphan Drug Designation to Ampligen for the treatment of Ebola virus disease.

 

In October 2024, we were granted U.S. patent No. 12,102,649, covering both compositions and methods comprising Ampligen in the treatment of endometriosis, a painful chronic condition in which tissue similar to the lining of the uterus grows outside the uterus, causing severe pelvic pain and making it difficult or impossible to become pregnant. The patented method involves the administration of a therapeutically effective amount of a pharmaceutical composition containing our proprietary double-stranded RNA products. The versatile administration options offer flexibility for patient-specific needs and care. The patent also covers treatments targeting recurrent endometriosis and includes options for co-administration with interferons, including well-known types such as alpha and beta interferons.

 

Alferon N Injection®

 

Alferon N Injection is the registered trademark for our injectable formulation of natural alpha interferon. Alferon N Injection is the only natural-source, multi-species alpha interferon currently approved for sale in the United States and Argentina for the intralesional (within lesions) treatment of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of age or older. Alferon N Injection is also approved in Argentina for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferons. Argentina has experienced hyper-inflation and recently devalued its currency to the U.S. dollar by 50%. Contracts with GP Pharm are U.S. dollar contracts and the parties must evaluate the impact of the recent devaluation on its relationship. Certain types of human papilloma viruses (“HPV”) cause genital warts, a sexually transmitted disease (“STD”). According to the CDC, HPV is the most common sexually transmitted infection, with approximately 79 million Americans — most in their late teens and early 20s — infected with HPV. In fact, the CDC states that “HPV is so common that nearly all sexually active men and women get the virus at some point in their lives.” Although they do not usually result in death, genital warts commonly recur, causing significant morbidity and entail substantial health care costs.

 

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Interferons are a group of proteins produced and secreted by cells to combat diseases. Researchers have identified four major classes of human interferon: alpha, beta, gamma and omega. Alferon N Injection contains a multi-species form of alpha interferon. The worldwide market for injectable alpha interferon-based products has experienced rapid growth and various alpha interferon injectable products are approved for many major medical uses worldwide. Alpha interferons are manufactured commercially in three ways: by genetic engineering, by cell culture, and from human white blood cells. All three of these types of alpha interferon are or were approved for commercial sale in the United States. Our natural alpha interferon is produced from human white blood cells. The potential advantages of natural alpha interferon over recombinant (i.e., synthetic) interferon produced and marketed by other pharmaceutical firms may be based upon their respective molecular compositions. Natural alpha interferon is composed of a family of proteins containing many molecular species of interferon. In contrast, commercial recombinant alpha interferon products each contain only a single species. Researchers have reported that the various species of interferons may have differing antiviral activity depending upon the type of virus. Natural alpha interferon presents a broad complement of species, which we believe may account for its higher activity in laboratory studies. Natural alpha interferon is also glycosylated (i.e., partially covered with sugar molecules). Such glycosylation is not present on the currently U.S.-marketed recombinant alpha interferons. We believe that the absence of glycosylation may be in part responsible for the production of interferon-neutralizing antibodies seen in patients treated with recombinant alpha interferon. Although cell culture-derived interferon is also composed of multiple glycosylated alpha interferon species, the types and relative quantity of these species are different from our natural alpha interferon.

 

Alferon N Injection [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multi-species alpha interferon product. There are essentially no neutralizing antibodies observed against Alferon N Injection to date and the product has a relatively low side-effect profile. The recombinant DNA derived alpha interferon formulations have been reported to have decreased effectiveness after one year of treatment, probably due to neutralizing antibody formation (See “Manufacturing” and “Marketing/Distribution” sections below for more details on the manufacture and marketing/distribution of Alferon N Injection). The production of new Alferon N Injection Active Pharmaceutical Ingredient, or API, is currently on hold. We do not know when, if ever, our products will be generally available for commercial sale for any indication. Additionally, on May 9, 2023, we were granted a U.S. Patent for a method for preventing or reducing antigenic drift or viral reassortment in a host animal comprising determining if a host animal has been exposed to or infected by an avian influenza virus and administering to the exposed host animal alpha-interferon.

 

MANUFACTURING

 

ANMAT in Argentina approved Ampligen for commercial distribution for the treatment of CFS in 2016. Shipment of the drug product to Argentina was initiated in 2018 to complete the release testing by ANMAT needed for commercial distribution. In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales. In June 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina. We are currently working with GP Pharm on the commercial launch of Ampligen in Argentina (See “Our Products; Ampligen” above).

 

Following our approval in Argentina, in 2017 we engaged Jubilant HollisterStier (“Jubilant”) to be our authorized CMO for Ampligen. Two lots of Ampligen consisting of more than 16,000 units were manufactured and released in 2018; these lots have been designated for human use in the United States in the cost recovery CFS program and for expanded oncology clinical trials. The production of additional polymer (Ampligen intermediates) took place in 2019 at our New Brunswick facility. Additionally, Jubilant manufactured three more lots of Ampligen in December 2019, January 2020 and December 2023. In addition, we have supplied GP Pharm with the Ampligen required for testing and ANMAT release. Once final approval by ANMAT is obtained, we anticipate that GP Pharm will begin distributing Ampligen in Argentina.

 

In December 2020, we added Pii as a “Fill & Finish” provider to enhance our capacity to produce Ampligen. This addition amplifies our manufacturing capability by providing redundancy and cost savings. The contracts augment our existing fill and finish capacity. We are prepared to initiate the production of additional Ampligen when and if needed.

 

In June 2022 we entered into a lease agreement with the New Jersey Economic Development Authority for a 5,210 square-foot, state-of-the-art R&D facility at the New Jersey Bioscience Center (NJBC), primarily consisting of two separate laboratory suites. The lease commenced on July 1, 2022, and runs through August 31, 2027, but can be extended for an additional five-year period. The facility is AIM’s operations, research and development center.

 

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Our business plan calls for the utilization of one or more CMOs to produce Ampligen API. While we believe we have sufficient Ampligen API to meet our current needs, we are also continually exploring new efficiencies so as to maximize our ability to fulfill future obligations. In this regard, on December 5, 2022, we entered into a Master Service Agreement and a Quality Agreement with Sterling Pharma Solutions (“Sterling”) for the manufacture of our Poly I and Poly C12U polynucleotides and transfer of associated test methods at Sterling’s Dudley, UK location to produce the polymer precursors to manufacture the drug Ampligen. We are utilizing Sterling’s expertise to refine our approach to polymer production. In March 2023, we submitted a purchase order for a total of $1,432,257 to manufacture additional lots of Ampligen at Jubilant. An additional lot was manufactured by Jubilant in December 2023.

 

Our second product, Alferon N Injection, is approved by the FDA for commercial sales in the United States for the treatment of genital warts. It is also approved by ANMAT in Argentina for commercial sales for the treatment of genital warts and in patients who are refractory to treatment with recombinant interferons. Commercial sales of Alferon N Injection in the United States will not resume until new batches of commercial filled and finished product are produced and released by the FDA. We will need the FDA’s approval to release commercial product once we have identified our new manufacturing approach and submitted satisfactory stability and quality release data. Currently, we are not manufacturing Alferon N Injection and there is no definitive timetable to resume production.

 

LICENSING/COLLABORATIONS/JOINT VENTURES

 

To enable potential availability of Ampligen to patients on a worldwide basis, we have embarked on a strategy to license the product and/or to collaborate and/or create a joint venture with companies that have the demonstrated capabilities and commitment to successfully gain approval and commercialize Ampligen in their respective global territories of the world. Ideal partners would have the following characteristics: well-established global and regional experience and coverage; robust commercial infrastructure; a strong track record of successful development and registration of in-licensed products; and a therapeutic area fit (e.g., ME/CFS, immuno-oncology).

 

MARKETING/DISTRIBUTION

 

In May 2016, we entered into a five-year, exclusive Renewed Sales, Marketing, Distribution and Supply Agreement (the “Agreement”) with GP Pharm. Under this Agreement, GP Pharm was responsible for gaining regulatory approval in Argentina for Ampligen to treat severe CFS in Argentina and for commercializing Ampligen for this indication in Argentina. We granted GP Pharm the right to expand rights to sell this experimental therapeutic into other Latin America countries based upon GP Pharm achieving certain performance milestones. We also granted GP Pharm an option to market Alferon N Injection in Argentina and other Latin America countries (See “Our Products; Ampligen” above). The GP Pharm contract was extended in May 2021 with an end date of May 24, 2024. While we are in discussions with GP Pharm to extend the agreement, we are also open to the possibility of looking for a new partner. In August 2021, ANMAT granted a five-year extension to a previous approval to sell and distribute Ampligen to treat severe CFS in Argentina. This extends the approval until 2026.

 

In May 2016, we entered into a five-year agreement (the “Impatients Agreement”) with Impatients, N.V. (“myTomorrows”), a Netherlands-based company, for the commencement and management of an EAP in Europe and Turkey (the “Territory”) related to ME/CFS. Pursuant to the agreement, myTomorrows, as our exclusive service provider and distributor in the Territory, is performing EAP activities. These activities will be directed to (a) the education of physicians and patients regarding the possibility of early access to innovative medical treatments not yet the subject of a Marketing Authorization (regulatory approval) through named-patient use, compassionate use, expanded access and hospital exemption, (b) patient and physician outreach related to a patient-physician platform, (c) the securing of Early Access Approvals (exemptions and/or waivers required by regulatory authorities for medical treatments prior to Marketing Authorization) for the use of such treatments, (d) the distribution and sale of such treatments pursuant to such Early Access Approvals, (e) pharmacovigilance (drug safety) activities and/or (f) the collection of data such as patient-reported outcomes, doctor-reported experiences and registry data. We are supporting these efforts and supplying Ampligen to myTomorrows at a predetermined transfer price. In the event that we receive Marketing Authorization in any country in the Territory, we will pay myTomorrows a royalty on products sold. Pursuant to the Impatients Agreement, the royalty would be a percentage of Net Sales (as defined in the Impatients Agreement) of Ampligen sold in the Territory where Marketing Authorization was obtained. The formula to determine the percentage of Net Sales will be based on the number of patients that are entered into the EAP. We believe that disclosure of the exact maximum royalty rate and royalty termination date could cause competitive harm. However, to assist the public in gauging these terms, the actual maximum royalty rate is somewhere between 2% and 10% and the royalty termination date is somewhere between five and fifteen years from the First Commercial Sale of a product within a specific country. The parties established a Joint Steering Committee comprised of representatives of both parties to oversee the EAP. No assurance can be given that activities under the EAP will result in Marketing Authorization or the sale of substantial amounts of Ampligen in the Territory. The agreement was automatically extended for a period of 12 months on May 20, 2021; has been automatically extended for 12 months on each subsequent May 20; and will continue to be automatically extended for periods of 12 months every May 20 until terminated or the terms of the agreement are met.

 

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In January 2017, ANMAT granted a five-year extension to a previous approval to sell and distribute Alferon N Injection (under the brand name “Naturaferon”) in Argentina. This extended the approval until 2022. A request to extend the approval beyond 2022 has been filed and is still under review. In February 2013, we received ANMAT approval for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferon, with Naturaferon in Argentina.

 

In January 2017, the EAP through our agreement with myTomorrows designed to enable access of Ampligen to ME/CFS patients was extended to pancreatic cancer patients beginning in the Netherlands. myTomorrows is our exclusive service provider in the Territory and will manage all EAP activities relating to the pancreatic cancer extension of the program.

 

In August 2017, we extended our agreement with Asembia LLC, formerly Armada Healthcare, LLC, to undertake the marketing, education and sales of Alferon N Injection throughout the United States. This agreement has expired. We were in discussions with Asembia about the possibility of continuing the relationship, while also exploring the possibility of working with other, similar companies. However, we still do not foresee an immediate need for this service and continue to push this search further out in our expected timeline.

 

In February 2018, we signed an amendment to the EAP with myTomorrows. This amendment extended the Territory to cover Canada to treat pancreatic cancer patients, pending government approval. In March 2018, we signed an amendment to the EAP with myTomorrows, pursuant to which myTomorrows will be our exclusive service provider for special access activities in Canada for the supply of Ampligen for the treatment of ME/CFS.

 

In December 2020, we entered into a signed Letter of Agreement with myTomorrows for the delivery of Ampligen for the treatment of up to 16 pancreatic cancer patients. In November 2021, we entered into a signed Letter of Agreement with myTomorrows for the delivery of Ampligen for the treatment of up to an additional 5 pancreatic cancer patients. In March 2022, we entered into a signed Letter of Agreement with myTomorrows for the delivery of Ampligen for the treatment of up to an additional 10 pancreatic cancer patients. In November 2022, we entered into a signed Letter of Agreement with myTomorrows for the delivery of Ampligen for the treatment of up to an additional 10 pancreatic cancer patients.

 

401(k) Plan

 

We have a defined contribution plan, entitled the AIM ImmunoTech Employees 401(k) Plan and Trust Agreement (the “401(k) Plan”). Our full-time employees are eligible to participate in the 401(k) Plan following 61 days of employment. Subject to certain limitations imposed by federal tax laws, participants are eligible to contribute up to 15% of their salary (including bonuses and/or commissions) per annum. Participants’ contributions to the 401(k) Plan may be matched by us at a rate determined annually by the Board of Directors.

 

Each participant immediately vests in his or her deferred salary contributions as well as our safe harbor contributions. A 6% safe harbor matching contribution by us was reinstated effective January 1, 2021. For the nine months ending September 30, 2024 we made approximately $134,200 in contributions, and for the year ending December 31, 2023 approximately $162,000 in contributions were made.

 

New Accounting Pronouncements

 

See “Note 10: Recent Accounting Pronouncements”.

 

Critical Accounting Policies and Use of Estimates

 

There have been no material changes in our critical accounting policies and estimates from those disclosed in Part II; Item 7: “Management’s Discussion and Analysis of Financial Condition and Results of Operations; Critical Accounting Policies” contained in our Annual Report on Form 10-K for the year ended December 31, 2023 except for the policies regarding “Distinguishing Liabilities from Equity” and “Derivative Instruments”.

 

Distinguishing Liabilities from Equity

 

The Company has adopted the guidance of ASC 480 in evaluating how it classifies and measures in its statement of financial position certain financial instruments with characteristics of both liabilities and equity. Under this guidance the Company evaluates free-standing financial instruments to determine whether the instruments are classified as liabilities or equity. The evaluation includes determining whether the instruments are mandatorily redeemable, whether redemption includes a transfer of assets, and whether the redemption feature is conditional.

 

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Derivative Instruments

 

The Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives requiring bifurcation in accordance with ASC Topic 815, Derivatives and Hedging. Derivative instruments are measured at fair value at issuance and at each reporting date in accordance with ASC 820 with changes in fair value recognized in the period of change in the consolidated statements of operations and comprehensive loss.

 

RESULTS OF OPERATIONS

 

Three months ended September 30, 2024 versus three months ended September 30, 2023

 

Net Loss

 

Our net loss was approximately $3,700,000 and $7,816,000 for the three months ended September 30, 2024, and 2023, respectively, representing a decrease in loss of approximately $4,116,000 or 53%. This decrease in loss was primarily due to the following:

 

●a decrease in research and development expenses of $1,297,000,
●a decrease in general and administrative expenses of $2,360,000,
●a decrease in production costs of $22,000,
●an increase in gain on investments of $583,000,
●an increase in interest and other income of $424,000; offset by
●a decrease in gain from sale of Income tax operating of $318,000, and an
●increase in interest expense of $202,000.

 

Net loss per share was $ (0.06) and $(0.16) for the three months ended September 30, 2024, and 2023, respectively. The weighted average number of shares of our common stock outstanding as of September 30, 2024, was 57,677,016 as compared to 48,635,165 as of September 30, 2023.

 

Revenues

 

Revenues from our Ampligen® Cost Recovery Program were $35,000 and $46,000 for the three months ended September 30, 2024, and 2023, respectively, representing a decrease of $11,000 which is primarily related to the fluctuation of patient participation.

 

For the three months ended September 30, 2024 and 2023, we had no Alferon N Injection® Finished Good product to commercially sell and all revenue was generated from the EAP and our FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to Ampligen® for treatment in an open-label safety study.

 

Interest and Other Income

 

Interest and other income for the three months ended September 30, 2024, and 2023 was approximately $718,000 and $294,000, respectively, reflecting an increase of approximately $424,000. The increase was primarily due to an amendment in September 2024 to an original agreement that was executed by us and Amarex clarifying and changing the nature of a remaining execution fee of $725,437. The amendment allowed that the remainder would not be exclusive to the original agreement, that the nature of the payment changed from an execution fee to a fully refundable deposit, and that it could be applied to any invoice upon mutual agreement of the parties, removed the threshold contingencies, and if such invoices were not sufficient to exhaust the balance, that the refund would be refunded in cash. Therefore, the nature of the payment changed to deposit status and outstanding invoices were applied against the deposit resulting in an overall increase in other income of $657,300 for the three months ended September 30, 2024. The increase in other income was offset by decreased interest income for the three months ended September 30, 2024 of approximately $233,000 interest income was $61,000 and $294,000, for the three months ended September 30, 2024 and 2023, respectively.

 

Gain (loss) on Investments, net

 

Gain (loss) on investments for the three months ended September 30, 2024, and 2023 was approximately $273,000 and ($310,000), respectively, reflecting an increase in gain on investments of approximately $583,000. The increase in gain was due to the change in the fair value of equity investments.

 

Production Costs

 

Production costs were approximately $8,000 and $30,000, respectively, for the three months ended September 30, 2024, and 2023, representing a decrease of $22,000 in production costs. This decrease was due to an increase in production costs for the three months ended 2023 due to production starting in that quarter.

 

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Gain (loss) from sale of income tax operating loss

 

The quarterly income tax benefit for the three months ended September 30, 2024, was $0 compared to a gain of $318,000 for the three months ended September 30, 2023. This was due to the lifetime limit of $20,000,000 for the sale of the New Jersey NOL being reached and therefore no tax provision was calculated in 2024.

 

Research and Development Costs

 

Overall Research and Development (“R&D”) costs for the three months ended September 30, 2024, were approximately $1,437,000, as compared to $2,734,000 for the same period a year ago, reflecting a decrease of approximately $1,297,000. The primary reason for the decrease in R&D costs was a decrease in clinical expenses of $1,384,000 as well as a decrease in outside contractors of $20,000 offset by an increase in patent and trademark expenses of approximately $44,000, salaries of $18,000, rent expense of $16,000, computer & information services expense of $16,000 as well as consultant fees of $13,000.

 

General and Administrative Expenses

 

General and Administrative (“G&A”) expenses for the three months ended September 30, 2024, and 2023, were approximately $3,079,000 and $5,439,000, respectively, reflecting a decrease of approximately $2,360,000. The decrease in G&A expenses for the three months ended September 30, 2024 was due primarily to approximate decreases of professional fees of $2,395,000, public relation expenses of $138,000, insurance expense of $55,000, rent expense of $33,000, office expenses of $30,000, salaries of $27,000 offset by increases of stock compensation of $280,000, and license and taxes of $44,000.

 

Interest Expenses

 

Interest expenses for the three months ended September 30, 2024 was approximately $202,000 and there was no interest expense for the three months ended September 30, 2023. The increase in interest expense for the three months ended September 30, 2024 was due to the interest expense incurred related to the Note Purchase Agreement entered into on February 16, 2024 with Streeterville.

 

Nine months ended September 30, 2024 versus nine months ended September 30, 2023

 

Net Loss

 

Our net loss was approximately $11,353,000 and $16,386,000 for the nine months ended September 30, 2024, and 2023, respectively, representing a decrease in loss of approximately $5,033,000 or 31%. This decrease in loss was primarily due to the following:

 

●a decrease in research and development expenses of $3,206,000,
●a decrease in general and administrative expenses of $795,000,
●a decrease in production costs of $6,000,
●an increase in gain on investments of $297,000,
●an increase in interest and other income of $2,568,000; offset by
●a decrease in gain from sale of Income tax operating of $900,000,
●an increase in warrant valuation of $458,000, and an
●increase in interest expense of $453,000.

 

Net loss per share was $ (0.21) and $(0.34) for the nine months ended September 30, 2024, and 2023, respectively. The weighted average number of shares of our common stock outstanding as of September 30, 2024, was 53,351,467 as compared to 48,483,802 as of September 30, 2023.

 

Revenues

 

Revenues from our Ampligen® Cost Recovery Program were $125,000 and $137,000 for the nine months ended September 30, 2024, and 2023, respectively, representing a decrease of $12,000 which is primarily related to the fluctuation of patient participation.

 

For the nine months ended September 30, 2024 and 2023, we had no Alferon N Injection® Finished Good product to commercially sell and all revenue was generated from the EAP and our FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to Ampligen® for treatment in an open-label safety study.

 

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Interest and Other Income

 

Interest and other income for the nine months ended September 30, 2024, and 2023 was approximately $3,379,000 and $811,000, respectively, reflecting an increase of approximately $2,568,000. The increase was primarily due to a recovery of $2,500,000 from the primary level of the Director and Officer (D&O) insurance proceeds during the nine months ended September 30, 2024 related to legal costs recovered related to shareholder litigation matters in addition to an amendment in September 2024 to an original agreement that was executed by us and Amarex clarifying and changing the nature of a remaining execution fee of $725,437. The amendment allowed that the remainder would not be exclusive to the original agreement, that the nature of the payment changed from an execution fee to a fully refundable deposit, and that it could be applied to any invoice upon mutual agreement of the parties, removed the threshold contingencies, and if such invoices were not sufficient to exhaust the balance, that the refund would be refunded in cash. Therefore, the nature of the payment changed to deposit status and outstanding invoices were applied against the deposit. These changes resulted in an approximate overall increase in interest and other income of $3,379,000 for the nine months ended September 30, 2024. During the nine months ended September 30, 2023, interest earnings were $811,000.

 

Gain (loss) on Investments, net

 

Gain (loss) on investments for the nine months ended September 30, 2024, and 2023 was approximately $96,000 and ($201,000), respectively, reflecting an increase in the gain on investments of approximately $297,000. The increase in gain was due to the change in the fair value of equity investments.

 

Production Costs

 

Production costs were approximately $24,000 and $30,000, respectively, for the nine months ended September 30, 2024, and 2023, representing a decrease of $6,000 in production costs.

 

Gain (loss) from sale of income tax operating loss

 

The quarterly income tax benefit for the nine months ended September 30, 2024, was $0 compared to a gain of $900,000 for the nine months ended September 30, 2023. This was due to the lifetime limit of $20,000,000 for the sale of the New Jersey NOL being reached and therefore no tax provision was calculated in 2024.

 

Research and Development Costs

 

Overall Research and Development (“R&D”) costs for the nine months ended September 30, 2024, were approximately $4,533,000, as compared to $7,739,000 for September 30, 2023, reflecting a decrease of approximately $3,206,000. The primary reason for the decrease in R&D costs were approximate decreases in outside contractors of $1,770,000, clinical expenses of $1,738,000, computer and IT services of $111,000 offset by an increase in salaries of $270,000, patent and trademark expenses of $34,000, rent expense of $30,000, consulting fees of $27,000, manufacturing expenses of $24,000, insurance of $18,000 and maintenance expense of $17,000.

 

General and Administrative Expenses

 

General and Administrative (“G&A”) expenses for the nine months ended September 30, 2024, and 2023, were approximately $9,485,000 and $10,280,000, respectively, reflecting a decrease of approximately $795,000. The decrease in G&A expenses for the nine months ended September 30, 2024 was due primarily to approximate decreases in legal professional fees of approximately $968,000, insurance expense of $208,000, public relations fees of $141,000, travel expenses of $58,000, interest expense of $23,000, rent expense of $19,000 offset by an increase in investment banker fees of $314,000 and stock compensation of $308,000.

 

Interest Expenses

 

Interest expenses for the nine months ended September 30, 2024 was approximately $453,000 and there was no interest expense for the nine months ended September 30, 2023. The increase in interest expense for the nine months ended September 30, 2024 was due to the interest expense incurred related to the Note Purchase Agreement entered into on February 16, 2024 with Streeterville.

 

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Liquidity and Capital Resources

 

Cash used in operating activities for the nine months ended September 30, 2024, was approximately $10,933,000 compared to approximately $11,509,000 for the same period in 2023, a decrease of $576,000. The primary reasons for this decrease were a decrease in net loss during the nine months of $5,033,000 as well as a decrease in gain from sale of income tax operating losses of $900,000, an increase in equity-based compensation of $308,000 and an increase in loss on issuance of warrants of $458,000. This is partially offset by an increase in cash utilized for accounts payable of $2,590,000, an increase in accrued expenses of $1,714,000, prepaid expenses of $255,000 as well as a decrease in funds received from the 2023 sale of New Jersey net operating loss and received in 2024 of $495,000.

 

Cash provided by investing activities for the nine months ended September 30, 2024, was approximately $1,002,000 compared to cash used in investing activities for the nine months ended September 30, 2023, of approximately $618,000, representing a change of $1,620,000. The primary reason for the change was the cash provided by the net purchase and sale of marketable securities activity of $1,439,000 compared to cash used in the net purchase and sale of marketable securities of $231,000 for the same period in 2023, the loss on sale of property and equipment of $0 in the current period in 2024, compared with $10,000 in the same period in 2023 as well as the net purchase and abandonment of patents in the current period in 2024 of $417,000 compared with the net purchase and abandonment of patents in the same period in 2023 of $377,000.

 

Cash provided by financing activities for the nine months ended September 30, 2024, was approximately $5,407,000 compared to approximately $338,000 for the same period in 2023, representing an increase of $5,069,000. The primary reason for this increase was the receipt of $2,367,000 in net proceeds from the notes payable, net of issuance cost, an increase in the sale of shares in the current period in 2024 of $860,000 compared to $338,000 in the same period in 2023 as well as an increase in warrant valuation of $2,047,000 in the current period in 2024.

 

Our principal source of liquidity is our cash and cash equivalents, marketable securities, and proceeds from financing activities to provide the necessary funding to meet our obligations as they become due. As noted above, as of September 30, 2024, we had approximately $7,202,000 in cash, cash equivalents and marketable securities, inclusive of approximately $6,287,000 in marketable securities, representing a decrease of approximately $5,868,000 from December 31, 2023. In addition, we have suffered losses from operations and net cash used on operating activities for the three-month period ended September 30, 2024, and have a working capital deficit. These conditions raise substantial doubt regarding our ability to continue as a going concern for a period of at least one year from the date of issuance of these unaudited condensed consolidated financial statements. See Note 1 to our Unaudited Condensed Consolidated Financial Statements.

 

The accompanying condensed consolidated financial statements have been prepared assuming that we will continue as a going concern. On September 30, 2024, our current liabilities exceeded our current assets by $2,530,000 which raised doubt our ability to continue as a going concern. Additionally, at September 30, 2024, our stockholders’ equity was below the minimum requirements for continued listing on the NYSE American.

 

Management evaluated the conditions, and their significance of those conditions related to our ability to meet our obligations and determined that the primary cause of the working capital deficit was related to an accounts payable balance of $6,300,000. This balance includes $4,900,000 of legal fees related to litigation. We are currently negotiating with the law firm to reduce prior billings. These negotiations are ongoing and could, if resolved favorably to us, partially alleviate the working capital deficit. Further we are continuing to negotiate the recovery of an additional $2.5 million from our secondary director and officer coverage. There is no assurance as to the timing or outcome of our efforts. If we are unable to implement sufficient mitigation efforts, we may be forced to limit our business activities or be unable to continue as a going concern, which would have a material adverse effect on our results of operations and financial condition.

 

On September 6, 2024, an amendment to an agreement dated April 7, 2022, was executed by us and Amarex clarifying and changing the nature of the remaining execution fee of $725,437. The amendment allowed that the remainder would not be exclusive to the agreement dated on April 7, 2022, that the nature of the payment changed from an execution fee to a fully refundable deposit, and that it could be applied to any invoice upon mutual agreement of the parties, removed the threshold contingencies, and if such invoices were not sufficient to exhaust the balance, that the refund would be refunded in cash. Due to the changes brought about by the amendment, the nature of the payment changed to deposit status. At September 30, 2024, we had an outstanding deposit of $653,000 which may be used to offset future clinical research expenditures. This deposit is listed as a non-current asset on the balance sheet but could provide working capital if the timing of expenditures are realized within the next 15 months.

 

Additionally, we received $2.5 million of insurance recoveries under the first layer of our director and officer insurance policy during the quarter ended June 30, 2024. We believe, but cannot assure, that an additional $2.5 million will be recovered under the second layer of our director and officer insurance policy, however, the insurer has initially denied our claim for the additional $2.5 million. We continue to pursue the collection of $2.5 million. If received, these proceeds would alleviate the negative working capital. There is no assurance as to the timing or outcome of our efforts.

 

As a research and development company, we are conducting research necessary to bring our product, Ampligen, to market. As such, we primarily rely on financing activities to provide the necessary funding to meet our obligations as they become due. AIM has a long and demonstrated history of success in these efforts, however, there is no assurance that we will be successful in attaining the necessary funding in the future.

 

We currently have two capital mechanisms in place:

 

On April 19, 2023, we entered an ATM offering. The agreement expires on April 19, 2025.

 

In February 2024, we entered into an agreement with Atlas Sciences, LLC. Under the terms of the Agreement Atlas may purchase up to $15.0 million of our common stock puts at 95% of the then share market value at our sole discretion with no restrictions on our use of the proceeds. Limitations of the agreement include volume based on average daily trading volume limited to 4.99% of total shares outstanding for each put. There is no assurance as to the amount of funds that will be realized pursuant to the agreement.

 

No assurance can be given as to the amount of funding that will be received from either of these capital mechanisms.

 

In addition to providing working capital, if fully realized, we believe that the capital mechanisms could possibly provide the equity necessary to correct the deficiency as required by the NYSE American.

 

We are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise needed to commercialize the many potential therapeutic aspects of our experimental drugs and our FDA approved drug Alferon N Injection.

 

The development of our products requires the commitment of substantial resources to conduct the time-consuming research, preclinical development, and clinical trials that are necessary to bring pharmaceutical products to market. We believe, based on our current financial condition, that we have adequate funds to meet our anticipated operational cash needs and fund current clinical trials over approximately the next fifteen months. At present we do not generate any material revenues from operations, and we do not anticipate doing so in the near future. We may need to obtain additional funding in the future for new studies and/or if current studies do not yield positive results, require unanticipated changes and/or additional studies. In this regard, in February 2022, the SEC declared our S-3 shelf Registration Statement effective which will allow us to raise additional capital in the future. On April 19, 2023, we entered into an Equity Distribution Agreement (the “EDA”), with Maxim Group LLC (“Maxim”), pursuant to which we may sell from time to time, shares of our common stock having an aggregate offering price of up to $8.5 million through Maxim, as agent. Sales under the EDA were registered under the S-3 Shelf Registration Statement. Under the terms of the Distribution Agreement, Maxim is entitled to a transaction fee at a fixed rate of 3.0% of the gross sales price of Shares sold under the EDA. For the nine months ended September 30, 2024, we sold 1,305,653 shares under the EDA for total gross proceeds of approximately $630,204, which includes a 3.0% fee to Maxim of $18,906. During the year ended December 31, 2023, we sold 598,114 shares under the EDA for total gross proceeds of approximately $344,000, which includes a 3.0% fee to Maxim of $10,326. We hope to raise additional funds through the EDA. No assurance can be given as to the amount of any additional sales pursuant to the EDA.

 

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In addition, we raised $2,500,000 in net proceeds from the sale of an unsecured Note and entered into an equity line of credit to raise up to 15,000,000 (see Overview; The Atlas Equity Line of Credit above). Under the terms of the Atlas Equity Line of Credit, we, at our sole discretion, shall have the right to issue Put shares to the Investor at 95% of the Market Price of the shares on the day of trade. Sales under the agreement are limited to a daily maximum of the lessor of: $500,000, the Median Daily Trading volume, and a beneficial ownership limitation of 4.99% and a maximum of 19.99% of the outstanding shares at the time of the agreement. In April 2024, we filed a registration statement with the SEC on Form S-1 registering a total of 9,975,000 shares for resale pursuant to the Atlas Agreements, consisting of 9,636,400 shares that can be sold by us to Atlas and 338,600 shares that were issued to Atlas as Commitment Shares. The registration statement was declared effective and the final prospectus was filed on May 1, 2024. As of September 30, 2024, a total of 759,685 shares have been issued pursuant to this agreement for a total of approximately $128,000. No assurance can be given as to the amount of funds that will be raised pursuant to the Atlas Equity Line of Credit.

 

Securities Purchase Agreement

 

On May 31, 2024, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) to complete an offering (the “Transactions”) with a single accredited investor (the “Purchaser”), pursuant to which we issued to the Purchaser, (i) in a registered direct offering, 5,640,958 shares of our common stock (the “Shares”), par value $0.001 per share (“Common Stock”) and (ii) in a concurrent private placement, we issued to the Purchaser Class A common warrants to purchase an aggregate of up to 5,640,958 shares of its common stock (the “A Warrants”) at an exercise price of $0.363 per share and Class B common warrants to purchase an aggregate of up to 5,640,958 shares of our common stock (the “B “Warrants” and, along with the A Warrants, the “Common Warrants”) at an exercise price of $0.363 per share. The A Warrants and B Warrants are not exercisable for six months after the issuance date and will expire, respectively, 24 months and five years and six months after the issuance date. The Common Warrants and the shares of common stock issuable upon the exercise of such warrants are offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.

 

We received aggregate gross proceeds from the Transactions of approximately $2,047,688, before deducting fees to the Placement Agent and other estimated offering expenses payable by us. The Shares are being offered by us pursuant to a shelf registration statement on Form S-3 (File No. 333-262280), which was declared effective on February 4, 2022 (as amended from time to time, the “Registration Statement”).

 

Pursuant to the terms of the Purchase Agreement, subject to certain exceptions, we could not issue any equity securities for 60 days following the issuance date, provided that we were able to utilize our at-the-market offering program with the Placement Agent after 30 days. Additionally, we could not enter into a variable rate transaction (other than the ATM program with the Placement Agent) for 120 days after the issuance date. In addition, our executive officers and each of our directors have entered into lock-up agreements with us pursuant to which each of them has agreed not to, for a period of 90 days from the closing of the Transactions, offer, sell, transfer or otherwise dispose of our securities, subject to certain exceptions.

 

The exercise price of the Common Warrants, and the number of Common Warrant Shares, are subject to adjustment in the event of any stock dividend or split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common Warrants. If a Fundamental Transaction (as defined in the Common Warrants) occurs, then the successor entity will succeed to, and be substituted for us, and may exercise every right and power that we may exercise and will assume all of its obligations under the Common Warrants with the same effect as if such successor entity had been named in the warrant itself. Common Warrant Holders will have additional rights defined in the Common Warrants. The Common Warrants will be exercisable on a “cashless” basis only if there is not a current registration statement permitting public resale. In this regard, the Company filed a registration statement to register the resale of the Common Warrant Shares. That registration statement was declared effective by the SEC on July 11, 2024. The Company has agreed to use commercially reasonable efforts to cause such registration statement to become effective within 181 days following the issuance date and to keep such registration statement effective at all times until no Purchaser owns any Warrants or Warrant Shares issuable upon exercise thereof.

 

Maxim Group LLC acted as the placement agent (the “Placement Agent”) on a “commercially reasonable best efforts” basis, in connection with the Transactions pursuant to the Placement Agency Agreement, dated May 31, 2024 (the “Placement Agency Agreement”), by and between us and the Placement Agent. Pursuant to the Placement Agency Agreement, the Placement Agent received a cash fee of 8% of the aggregate gross proceeds paid to the Company for the securities sold in the Transactions and reimbursement of certain out-of-pocket expenses.

 

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No assurance can be given as to the amount of funds that could be raised or the potential dilution to current stockholders. If we are unable to commercialize and sell Ampligen and/or recommence material sales of Alferon N Injection, our operations, financial position and liquidity may be adversely impacted, and additional financing may be required. There can be no assurances that, if needed, we will be able to raise adequate funds from the EDA or otherwise, or enter into licensing, partnering or other arrangements to advance our business goals. We may seek to access the public equity market whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time. We are unable to estimate the amount, timing or nature of future sales of outstanding common stock or instruments convertible into or exercisable for our common stock. Any additional funding may result in significant dilution and could involve the issuance of securities with rights, which are senior to those of existing stockholders. See Part I, Item 1A - “Risk Factors; We may require additional financing which may not be available” in our Annual Report on Form 10-K for the year ended December 31, 2023.

 

On September 30, 2024, the Company entered into a Securities Purchase Agreement to complete an offering with a single accredited investor. For more information see Note 15: Subsequent Events.

 

NYSE American Continued Listing Requirements

 

To maintain our listing on the NYSE American (the “NYSE American”), among other things, we are required to maintain Stockholders Equity of $6,000,000 or we may receive a warning or a delisting notice. In either event, we would be provided a period in which to submit a plan to meet listing standards. Taking into account funds received after September 30, 2024, our Stockholders’ Equity is $4,291,888.

 

If the common stock ultimately were to be delisted for any reason, it could negatively impact us by (i) reducing the liquidity and market price of our common stock; (ii) reducing the number of investors willing to hold or acquire the common stock, which could negatively impact our ability to raise equity financing; (iii) limiting our ability to use a registration statement to offer and sell freely tradable securities, thereby preventing us from accessing the public capital markets; and (iv) impairing our ability to provide equity incentives to our employees.

 

ITEM 3: Quantitative and Qualitative Disclosures About Market Risk

 

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

 

ITEM 4: Controls and Procedures

 

Our Chief Executive Officer (“CEO”) and the Chief Financial Officer (“CFO”) performed an evaluation of the effectiveness of our disclosure controls and procedures, which have been designed to permit us to effectively identify and timely disclose important information. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on that evaluation, our CEO and CFO concluded that the controls and procedures were effective as of September 30, 2023, to ensure that material information was accumulated and communicated to our management, including our CEO and CFO, is appropriate to allow timely decisions regarding required disclosure.

 

During the nine months ended September 30, 2024, we made no change in our internal controls over financial reporting that has materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.

 

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Part II – OTHER INFORMATION

 

ITEM 1: Legal Proceedings

 

Since the filing of the June 30, 2024 Form 10-Q:

 

AIM ImmunoTech, Inc. v. Tudor, et al., in the United States District Court for the Middle District of Florida, Ocala Division, Case No. 5:2022cv00323. On April 22, 2024, the District Court issued an order granting-in-part Lautz and Jorgl’s Rule 59(e) and Rule 11 motions, respectively. The court entered an order finding Jorgl and Lautz were entitled to recover attorney’s fees and costs and entered judgment on behalf of Jorgl for $216,936, and on behalf of Lautz for $76,473. AIM has appealed these judgments to the United States Court of Appeals for the Eleventh Circuit, and secured a stay of the enforcement of the judgments pending the 11th Circuit Appeal. AIM’s appeal does not seek damages. AIM filed its initial brief on September 4, 2024. The parties attended mediation on November 5, 2024. The parties did not reach an agreement, and mediation impassed. The Appellees’ brief is due on December 5, 2024.

 

On June 18, 2024, The Carlyle Appellate Law firm was engaged for the above referenced appeal. It is anticipated that a Notice of appearance by Carlyle has been filed in that matter. AIM is exposed in this matter for the amount of those Judgments (which have been bonded by AIM), interest on those judgements, as well as potentially paying attorney’s fees in the event the appeal is unsuccessful.

 

Kellner v. AIM ImmunoTech Inc. et al., in the Supreme Court of the State of Delaware, Case No. 3, 2024. On January 16, 2024, the Delaware Supreme Court granted-in-part Kellner’s motion to expedite and scheduled oral argument before the en banc Delaware Supreme Court for April 10, 2024. On April 10, 2024, the en banc Delaware Supreme Court heard oral argument from AIM and Kellner in this matter and took the matter under consideration. On July 11, 2024, the Delaware Supreme Court issued a decision affirming in part and reversing in part the Court of Chancery’s December 28, 2023 opinion, and not remanding the matter to the Court of Chancery. The Supreme Court held that certain of the bylaws adopted by the board were legally invalid and inequitable. The board has subsequently revised the bylaws to address and correct said deficiencies. The Delaware Supreme Court also held that no further action was required with respect to Kellner’s rejected nominations because Kellner and his nominees engaged in deceptive conduct during the nomination process, including by submitting false and misleading information in connection with their nominations. Prior to this appeal, the Vice Chancellor noted in her December 28, 2023 post-trial decision, that “‘[t]he context in which the Board received’ the Kellner Notice ‘cannot be ignored.’ The Kellner Notice followed a proxy contest where Jorgl became an AIM stockholder solely to front a nomination and shield undisclosed persons behind the scenes. Those persons included two white collar criminals—one of whom had become increasingly hostile to AIM and had misrepresented himself as an AIM representative to third parties. It would have been obvious to the Board that the new nomination behind Kellner carried over from the prior year. Chioini was a constant, Deutsch remained involved (now as a nominee), and Baker Hostetler continued to advise the effort. The threat to return ‘guns blazing’ in 2023 came to fruition.”

 

On July 26, 2024, Kellner filed a Motion for Reargument, requesting the Supreme Court of the State of Delaware to reconsider certain aspects of its ruling and requesting clarification that the trial court retains jurisdiction for any fee applications. By order dated July 29, 2024, the Supreme Court denied Kellner’s Motion for Reargument, directed that the case be closed, and specifically ruled that “The case is not remanded for an award of attorneys’ fees and costs” and deemed that the “this Case is Closed.”

 

On August 27, 2024, counsel to Kellner delivered to us a demand for certain books and records under Section 220 of the DGCL, and a letter requesting that we reimburse him for his fees and expenses incurred in the Kellner litigation. In the request for fee reimbursement letter, Kellner stated that he was prepared to file an action in the Delaware Court of Chancery to require AIM to pay his fees and expenses if the matter could not be resolved without court intervention. By letter dated, November 8, 2024, AIM, through its counsel, denied the request, noting, among other things, that the Delaware Supreme Court issued an order on July 29, 2024, denying Kellner’s Motion for Reargument of the appeal in the Kellner litigation, directing that the case be closed, and specifically ruling that “[t]he case is not remanded for an award of attorneys’ fees and costs.”

 

BioLife

 

On September 6, 2024, the parties filed a Stipulation with the Court dismissing the counterclaims, without prejudice, in order to allow the Superior Court (appellate) to consider the Appeal issues without the need for duplicate trials. The Stipulation was accepted by the Court on October 17, 2024 dismissing the counterclaims. On October 7 we perfected our Appeal in the Superior Court. On November 7, 2024, we served our Concise Statement of Matters Complained of on Appeal. The Superior Court has not yet issued a briefing or argument schedule on the matters to be considered on appeal. No estimate can be made at this time regarding the scheduling or ultimate determination of the matters set forth in the Petition and the underlying issues presented in the appeal. No judgement can be made at this time of the likelihood of the Company prevailing on its claims.

 

ITEM 1A: Risk Factors

 

Please carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 29, 2023, which could materially affect our business, financial condition, or future results. The risks described in the above reports are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially adversely affect our business, financial condition and operating results. Please also see “Special Note Regarding Forward-Looking Statements” above.

 

Except as described below, there have been no material changes in or additions to the risk factors included in our Quarterly Report on Form 10-Q for the period ended September 30, 2024 or our Annual Report on Form 10-K for the year ended December 31, 2023.

 

The accompanying unaudited condensed consolidated financial statements have been prepared assuming we will continue as a going concern. Our management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern for one year from the date these financial statements are issued. This evaluation does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented or are not within our control as of the date the financial statements are issued. When substantial doubt about our ability to continue as a going concern exists, management evaluates whether the mitigating effect of its plans sufficiently alleviates the substantial doubt. If we are unable to implement sufficient mitigation efforts, we may be forced to limit our business activities or be unable to continue as a going concern, which would have a material adverse effect on our results of operations and financial condition.

 

Please see Item 2: “Management’s Discussion and Analysis of Financial Condition and Results of Operations; Liquidity and Capital Resources” with regard to issues related to our common stock continuing to be listed on the NYSE American.

 

ITEM 2: Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

ITEM 3: Defaults upon Senior Securities

 

None.

 

ITEM 4: Mine Safety Disclosures

 

Not Applicable.

 

ITEM 5: Other Information

 

None.

 

ITEM 6: Exhibits

 

(i)Exhibits - See exhibit index below.

 

Exhibit No.

  

Description

3.1(i)(1)  

Certificate of Incorporation as Amended and Restated.

     
3.1(i)(2)   Certificate of Increase of Series A Junior Participating Preferred Stock (incorporated by reference to exhibit 3.1 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended March 31, 2023).
     
3.1 (i)(3)  

Certificate of Amendment to the Certificate of Incorporation (incorporated by reference to exhibit 3(i).1 to the Company’s Current report on Form 8-K (No. 001-27072) filed June 3, 2019).

     
3.1(ii)   Amended and Restated By-Laws of Registrant (incorporated by reference to exhibit 3.1(ii) to the Company’s Current report on Form 8-K (No. 001-27072) filed August 1, 2024).
     
4.1   Common Stock Certificate.
     
4.2   Third Amended and Restated Rights Agreement, dated May 12, 2023 between AIM ImmunoTech Inc. (formerly, Hemispherx Biopharma, Inc.) and American Stock Transfer & Trust Company, LLC. (incorporated by reference to exhibit 4.6 to Amendment No. 3 to the Company’s Registration Statement on Form 8-A12B (No. 001-27072) filed May 15, 2023).
     
10.1   February 16, 2024 Note Purchase Agreement with Streeterville Capital LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K (No. 001-27072) filed February 20, 2024).
     
10.2   February 16, 2024 Promissory Note with Streeterville Capital LLC (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K (No. 001-27072) filed February 20, 2024).
     
10.3   March 28, 2024 Atlas Equity Purchase Agreement (incorporated by reference to Exhibit 10.104 to the Company’s annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2023) filed April 1, 2024).

 

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10.4   March 28, 2024 Atlas Registration Rights Agreement (incorporated by reference to Exhibit 10.105 to the Company’s annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2023) filed April 1, 2024).
     
10.5   March 15, 2024 Addendum 1 to Lease for Ocala office (incorporated by reference to Exhibit 10.107 to the Company’s Registration Statement on Form S-1 (No. 333-278839) filed April 19, 2024).
     
10.6   Form of Securities Purchase Agreement, dated as of May 31, 2024, by and among the Company and a Purchaser (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 001-27072) filed June 3, 2024).
     
10.7   August 12, 2024 Amendment to Employment Agreement for Thomas K Equels (incorporated by reference to exhibit 10.4 to the Company’s Quarterly report on form 10-Q (No. 001-27072) for period ended June 30, 2024).
     
10.8   August 12, 2024 Amendment to Employment Agreement for Peter W Rodino III (incorporated by reference to exhibit 10.5 to the Company’s Quarterly report on form 10-Q (No. 001-27072) for period ended June 30, 2024).
     
10.9   September 11, 2024 Amendment to Employment Agreement for Thomas K Equels (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 001-27072) filed September 12, 2024).
     
10.10   September 11, 2024 Amendment to Employment Agreement for Peter W. Rodino III (incorporated by reference to exhibit 10.2 to the Company’s Current report on Form 8-K (No. 001-27072) filed September 12, 2024).
     
10.11   September 30, 2024 Securities Purchase Agreement (incorporated by reference to exhibit 10.1 to the Company’s Current Report on Form 8-K (No. 001-27072) filed October 1, 2024).
     
10.12   September 30, 2024 Placement Agency Agreement with Maxim Group LLC (incorporated by reference to exhibit 1.1 to the Company’s Current Report on Form 8-K (No. 001-27072) filed October 1, 2024).
     
10.13   October 1, 2024 Class C Common Stock Purchase Warrant with Armistice Capital Master Fund Ltd (incorporated by reference to exhibit 4.1 to the Company’s Current Report on Form 8-K (No. 001-27072) filed October 1, 2024).
     
10.14   October 1, 2024 Class D Common Stock Purchase Warrant with Armistice Capital Master Fund Ltd (incorporated by reference to exhibit 4.2 to the Company’s Current Report on Form 8-K (No. 001-27072) filed October 1, 2024).
     
10.15   September 19, 2024 Lease extension for Riverton office*
     
31.1   Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Executive Officer. *
     
31.2   Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Financial Officer. *
     
32.1   Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Executive Officer. *
     
32.2   Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Financial Officer. *

 

101.INS   Inline XBRL Instance Document
     
101.SCH   Inline XBRL Taxonomy Schema
     
101.CAL   Inline XBRL Taxonomy Calculation Linkbase
     
101.DEF   Inline XBRL Taxonomy Definition Linkbase
     
101.LAB   Inline XBRL Taxonomy Label Linkbase
     
101.PRE   Inline XBRL Taxonomy Presentation Linkbase
     
104   Cover Page Interactive Data File (Embedded within the Inline XBRL document and included in Exhibit)

 

 

  * 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.

 

  AIM IMMUNOTECH INC.
   
  /s/ Thomas K. Equels
  Thomas K. Equels, Esq.
  Chief Executive Officer & President
   
  /s/ Robert Dickey IV
  Robert Dickey IV
  Chief Financial Officer
   
Date: November 14, 2024  

 

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