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公開認股權證成員srt:最低會員2023-12-310001205922us-gaap:研發費用會員2024-01-012024-09-300001205922us-gaap:附加股本會員2024-03-310001205922vcnx:已修改會員us-gaap:附加股本會員2024-01-012024-03-310001205922美元指數:傢俱和固定設備成員2024-09-3000012059222017-11-012017-11-300001205922us-gaap:度量風險輸入無風險利率會員vcnx:私人透支權證會員最大會員2024-09-300001205922美國通用會計準則:普通股會員vcnx:預先擬定認股權證會員2023-10-030001205922vcnx:私募認股權證會員2023-12-310001205922vcnx:公開認股權證會員最大會員美國通用會計準則:測量輸入-預期期限會員2024-09-300001205922vcnx:證券購買協議會員2024-03-280001205922美元指數:風險無風險利率輸入成員vcnx:私募權證成員srt:最大成員2023-12-310001205922美元指數:普通股份成員2024-09-300001205922美元指數:額外資本溢價成員2024-04-012024-06-300001205922美元指數:普通股份成員vcnx:2023年三月私募成員2023-03-300001205922美元指數:庫存普通股份成員2023-12-310001205922美元指數:租賃改良成員2023-12-310001205922美國通用會計準則:A類優先股成員2024-09-300001205922美國通用會計準則:優先股成員2022-12-310001205922國家:美國2023-01-012023-12-310001205922美國通用會計準則:優先股成員2023-12-310001205922vcnx:私募認購權證成員美國通用會計準則:重大財務指標再發生成員2024-09-300001205922vcnx:小型企業行政管理局薪資保護方案成員2020-05-080001205922US-GAAP:優先股會員2024-03-310001205922VCNX:公開發行和私募會員2024-03-270001205922VCNX:公開認股權證會員2024-09-300001205922VCNX:優先贖回權證下的未償債務股份會員2024-09-300001205922US-GAAP:普通股會員VCNX:ADDF認股權證會員2024-01-012024-09-300001205922VCNX:2024年2月私募會員VCNX:普通股和優先贖回權證會員2024-02-0600012059222024-01-012024-09-300001205922vcnx: 公開發行和私募成員2024-03-272024-03-270001205922us-gaap:後續事項成員2022-08-012024-10-310001205922vcnx: 公開認股權證成員2023-10-032023-10-030001205922vcnx: 公開認股權證成員srt: 最大成員us-gaap:預期期限計量輸入成員2023-12-310001205922vcnx: 二零二三年三月私募成員vcnx: 投資者一成員2023-03-300001205922vcnx:私募認購權證會員vcnx:11月認購權證發售會員2024-01-012024-03-310001205922us-gaap:FairValueInputsLevel3Membervcnx:私募認購權證會員美元指數:可重複的公允價值衡量會員2024-09-300001205922美元指數:額外實收資本會員2024-09-300001205922美元指數:優先股會員2024-07-012024-09-300001205922美元指數:可重複的公允價值衡量會員2024-01-012024-09-300001205922vcnx:公開認股權證會員美國通用會計準則:重複發生的公平價值計量會員2024-09-300001205922vcnx:預先資金認股權證下潛在優先股份會員2023-12-310001205922美國通用會計準則:公允價值輸入第3級會員vcnx:私人配售認股權證會員美國通用會計準則:重複發生的公平價值計量會員2023-12-310001205922美國通用會計準則:公允價值輸入第3級會員vcnx:測量輸入預期波動性會員2024-09-300001205922US-GAAP:員工股票期權成員2024-01-012024-09-300001205922VCNX:證券購買協議成員US-GAAP:後續事項成員us-gaap:私募成員2024-11-142024-11-1400012059222023-03-310001205922US-GAAP:研發費用成員2024-07-012024-09-300001205922VCNX:測量輸入波動率成員VCNX:公開認股權證成員SRT:最大成員2023-12-310001205922vcnx:私募配售會員美國通用會計準則:其他普通股本以上者會員2024-01-012024-03-310001205922vcnx:私募認股權證會員srt:最低會員美國通用會計準則:測量輸入股價會員2024-09-300001205922vcnx:公開認股權證會員2023-10-030001205922美國通用會計準則:普通股會員2024-03-310001205922vcnx:私募認股權證會員srt:最低會員us-gaap:預計測量輸入條款會員2024-09-300001205922vcnx:測量輸入波動性會員vcnx:私募認股權證會員srt:最低會員2023-12-310001205922SRT:情景預測成員2024-09-012025-10-310001205922us-gaap:留存收益會員2024-07-012024-09-300001205922us-gaap:普通股會員vcnx:公開認股權證會員2024-03-272024-03-270001205922美國通用會計準則:測量輸入預期股息率會員vcnx:私人配售認股權證會員srt:最低會員2023-12-310001205922vcnx:預先資金認股權證會員vcnx:證券購買協議會員美國通用會計準則:後續事項會員2024-11-130001205922美國通用會計準則:優先股會員2024-04-012024-06-300001205922美元指數:普通庫存2024-06-300001205922vcnx : 私人配置提議會員2024-01-012024-03-310001205922vcnx : 轉換優先股股票的普通股權益會員2024-09-300001205922美元指數:風險無息利率測量輸入vcnx : 公開認股權證會員srt : 最大會員2023-12-310001205922vcnx : 公開認股權證會員srt : 最小會員us-gaap:MeasurementInputExpectedTermMember2023-12-310001205922vcnx:私募認股權會員2024-09-300001205922vcnx:證券購買協議會員vcnx:預先撥款認股權會員美元指數:後續事件成員2024-11-132024-11-130001205922vcnx:公開認股權會員2023-12-310001205922US-GAAP: 預期股息率測量輸入會員vcnx:私募認股權會員最小成員2024-09-300001205922US-GAAP:留存收益成員2023-03-310001205922us-gaap:其他資本公積成員2023-06-300001205922vcnx:預融資認股權和公開認股權會員2023-10-032023-10-030001205922us-gaap:FairValueInputsLevel1Memberus-gaap: 貨幣市場基金成員us-gaap: 循環進行的公允價值衡量成員2024-09-300001205922vcnx:測量輸入波動率會員vcnx:公開認股權證會員最大成員2024-09-3000012059222023-01-012023-12-310001205922vcnx:股票期權成員2024-09-300001205922vcnx:證券購買協議會員2024-11-132024-11-130001205922us-gaap:普通股股本成員vcnx:公開發行和私募會員2024-03-272024-03-2700012059222023-12-310001205922vcnx:誘因函協議會員vcnx:新認股權證會員2024-09-300001205922vcnx:公共認股權證會員2024-07-012024-09-300001205922vcnx:研究設備會員2024-09-300001205922vcnx:私人配置認股權證會員vcnx:十一月認股權發行會員2023-10-032023-10-030001205922vcnx:誘導書面協議會員vcnx:新認股權會員us-gaap:私募成員2024-09-170001205922vcnx:二零二四年二月私募會員vcnx:私募認股權成員2024-01-012024-03-310001205922美國通用會計準則:庫存普通股2024-09-300001205922vcnx:私募認股權成員2024-01-012024-09-300001205922vcnx:私募認股權成員us-gaap:重複發生的公允價值衡量成員2023-12-310001205922us-gaap:重複發生的公允價值衡量成員2024-09-300001205922美元指數:傢俱和固定設備成員2023-12-310001205922us-gaap:普通股成員2023-06-300001205922us-gaap:FairValueInputsLevel3Membervcnx:公共認股權成員us-gaap:可重複的公允價值衡量成員2023-12-310001205922vcnx:小型企業管理局工資保護計劃成員2021-11-080001205922vcnx:股票期權基礎的已發行股份成員2023-12-310001205922美國通用會計準則:優先股成員2024-06-300001205922vcnx:Surface Oncology Inc成員vcnx:獨家產品許可成員2023-01-012023-09-300001205922美元指數:普通股庫存成員2024-03-3100012059222024-07-012024-09-300001205922美元指數:普通股庫存成員2022-12-310001205922美元指數:租賃改良成員2024-09-300001205922vcnx:公開認股權證成員srt:最低成員us-gaap:測算輸入股價成員2024-09-300001205922vcnx:2023年三月私人配售成員vcnx:投資者三成員2023-03-302023-03-3000012059222023-03-302023-03-300001205922vcnx:證券購買協議成員2024-03-282024-03-280001205922vcnx:公開認股權證成員srt:最低成員us-gaap:預期期限測量輸入成員2024-09-3000012059222024-04-012024-06-300001205922vcnx:私人配售認股權證成員us-gaap:股價測量輸入成員srt:最大成員2024-09-300001205922vcnx:小型企業管理局薪酬保護計劃成員2020-05-072020-05-080001205922美國通用會計準則:重複發生成員的公允價值測量2023-09-30iso4217:美元xbrli:股份vcnx:分段管理器vcnx:細分vcnx:P值xbrli:純形vcnx:交易日vcnx:里程碑xbrli:股份vcnx:百分點vcnx:目標抗原vcnx:業務活動iso4217:美元指數

 

 

 

美國

證券交易委員會

華盛頓特區20549

 

表格 10-Q

 

 

根據1934年證券交易法第13或15(d)條款的季度報告。

截至季度結束 九月三十日, 2024

根據1934年證券交易法第13或15(d)條款的過渡報告

從 至過渡期間

委員會檔案編號: 001-38624

 

Vaccinex, Inc.

(依憑章程所載的完整登記名稱)

 

特拉華州

16-1603202

(依據所在地或其他管轄區)

的註冊地或組織地點)

(國稅局雇主

識別號碼)

1895 Mount Hope Avenue

羅切斯特, 紐約

14620

(總部辦公地址)

(郵遞區號)

 

註冊人的電話號碼,包括區號:(585) 271-2700

 

根據《1934年證券交易法》第12(b)條,註冊的證券:

 

每種類別的名稱

交易標的(s)

每個註冊交易所的名稱

普通股,每股面值0.0001美元

VCNX

納斯達克資本市場

 

請在核對標記上打勾,確認申報人(1)已在前12個月(或申報人被要求提交此類申報的縮短期間)內提交證券交易所法案第13條或第15(d)條要求申報的所有報告,以及(2)過去90天一直處於此類申報要求的範圍內。

請打勾號表明註冊人是否根據《S-t條例405條規定(本章節232.405號)的規定,在過去12個月內(或註冊人需要提交此類文件的更短期限內),已提交每個交互數據文件。

請勾選指示登記者是否為大型快速提交人、快速提交人、非快速提交人、較小的報告公司或新興成長型公司。請參閱交易所法規120億2條,了解「大型快速提交人」、「快速提交人」、「較小的報告公司」和「新興成長型公司」的定義。

大型加速歸檔人

加速歸檔人

 

 

 

 

 

 

 

非加速歸檔人

小型報告公司

 

 

 

 

 

 

 

新興成長型企業

 

 

 

 

 

 

如果一家新興成長型公司,請用勾選標記表示該申報人已選擇不使用根據證交所法案13(a)條款提供的任何新的或修訂過的財務會計準則的延長過渡期。

請勾選是否屬於外殼公司(根據交易所法案第120億2條的定義)。是

 

截至二零二四年十一月十二日,註冊人有 2,599,728 普通股股份,每股面值 0.0001 美元,未發行。

 

 


 

 

vaccinex inc.

表格10-Q

目錄

 

 

 

 

頁面

 

 

 

 

 

第一部分 – 財務資訊

 

 

 

 

 

 

 

 

 

 

項目1.

基本報表

 

3

 

 

 

 

 

總賬表(未經審核)

 

3

 

 

 

 

簡明營運報表及綜合虧損報表(未經審核)

 

4

 

 

 

 

 

簡明股東權益(虧損)報表(未經審核)

 

5

 

 

 

 

簡明現金流量表(未經核數)

 

6

 

 

 

 

摘要的財務報表附註(未經審計)

 

7

 

 

 

 

項目 2。

管理層對財務狀況和業績的討論與分析

 

25

 

 

 

 

項目 3。

市場風險的定量和定性披露。

 

37

 

 

 

 

項目 4。

內部控制及程序

 

37

 

 

 

 

 

 

 

 

 

其他資訊第二部分

 

 

 

 

 

 

 

 

 

 

项目1A。

風險因素

 

38

 

 

 

 

第6項。

展品

 

40

 

 

 

 

簽名

 

41

 

2


 

 

第一部分——財務所有信息

項目1。 基本報表

Vaccinex,醫療公司。

簡明 資產負債表(未經審計)

(以千計,除分享和每分享數據外)

 

 

 

截至
2024年9月30日

 

 

截至
2023年12月31日

 

資產

 

 

 

 

 

 

流動資產:

 

 

 

 

 

 

現金及現金等價物

 

$

2,906

 

 

$

1,535

 

應收賬款

 

 

985

 

 

 

961

 

預付費用及其他流動資產

 

 

852

 

 

 

853

 

衍生工具資產

 

 

14

 

 

 

-

 

總流動資產

 

 

4,757

 

 

 

3,349

 

物業和設備,淨值

 

 

82

 

 

 

136

 

經營租賃資產使用權

 

 

15

 

 

 

146

 

資產總計

 

$

4,854

 

 

$

3,631

 

負債和股東權益

 

 

 

 

 

 

流動負債:

 

 

 

 

 

 

應付賬款

 

$

4,865

 

 

$

2,039

 

應計費用

 

 

1,200

 

 

 

1,242

 

遞延收入

 

 

51

 

 

 

63

 

長期債務的流動部分

 

 

44

 

 

 

75

 

經營租賃負債

 

 

15

 

 

 

146

 

認股權責任

 

 

-

 

 

 

2,351

 

總流動負債

 

 

6,175

 

 

 

5,916

 

長期債務

 

 

-

 

 

 

26

 

負債合計

 

 

6,175

 

 

 

5,942

 

承諾事項和不確定事項(第6頁)

 

 

 

 

 

 

股東權益(赤字):

 

 

 

 

 

 

可轉換優先股(A系列),面值爲$0.001每股開多; 10,000,000 授權股份, 10截至2024年9月30日,已發行流通的股份爲 沒有截至2023年12月31日授權、發行或流通的股份;總清算優先權爲$1,750,000 和$0截至2024年9月30日和2023年12月31日,分別爲

 

 

1,522

 

 

 

-

 

 -每股--股份數已於2023年7月31日和2024年4月30日授權;0.0001每股開多; 100,000,000已授權股份數
截至2024年9月30日和2023年12月31日;
2,599,733892,622
截至2024年9月30日和2023年12月31日發行的股份;
 
2,599,728892,617截至2024年9月30日的流通股份
以及截至2023年12月31日,

 

 

1

 

 

 

-

 

追加實收資本

 

 

352,354

 

 

 

337,627

 

即期收購庫藏股;截至2022年9月25日,共計157,773股,截至2022年6月26日,共計157,087股。5截至2024年9月30日和2023年12月31日的普通股股份

 

 

(11

)

 

 

(11

)

累積赤字

 

 

(355,187

)

 

 

(339,927

)

股東權益總額/(赤字)

 

 

(1,321

)

 

 

(2,311

)

負債和股東權益總計

 

$

4,854

 

 

$

3,631

 

 

附註是這份基本報表的一個組成部分。

3


 

 

VACCINEX, INC.

股東權益(遞減)簡版(未經審計)損益及綜合損失表(未經審計)

(以千計,股票和每股數據除外)

 

 

 

截至9月30日的三個月

 

 

截至9月30日的九個月

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

 

 

 

 

 

 

 

收入

 

$

52

 

 

$

20

 

 

$

388

 

 

$

570

 

成本和費用:

 

 

 

 

 

 

 

 

 

 

 

 

研發

 

 

3,165

 

 

 

4,355

 

 

 

10,412

 

 

 

13,217

 

一般和行政

 

 

1,439

 

 

 

1,499

 

 

 

5,324

 

 

 

5,250

 

總成本和費用

 

 

4,604

 

 

 

5,854

 

 

 

15,736

 

 

 

18,467

 

營業損失

 

 

(4,552

)

 

 

(5,834

)

 

 

(15,348

)

 

 

(17,897

)

利息支出

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1

)

warrants的結算損失

 

 

(1,106

)

 

 

-

 

 

 

(1,106

)

 

 

-

 

融資成本 - warrant負債

 

 

-

 

 

 

-

 

 

 

(28

)

 

 

-

 

權證負債公允價值變動

 

 

(71

)

 

 

-

 

 

 

1,291

 

 

 

-

 

公允價值變動損益(衍生工具)

 

 

-

 

 

 

-

 

 

 

(81

)

 

 

-

 

其他收入(費用),淨額

 

 

(3

)

 

 

922

 

 

 

12

 

 

 

964

 

稅前虧損

 

 

(5,732

)

 

 

(4,912

)

 

 

(15,260

)

 

 

(16,934

)

所得稅準備金

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

歸屬於Vaccinex, Inc.普通股股東的淨虧損

 

$

(5,732

)

 

$

(4,912

)

 

$

(15,260

)

 

$

(16,934

)

全面損失

 

$

(5,732

)

 

$

(4,912

)

 

$

(15,260

)

 

$

(16,934

)

歸屬於Vaccinex, Inc.普通股的每股淨虧損
股東基礎和稀釋

 

$

(2.83

)

 

$

(15.25

)

 

$

(8.85

)

 

$

(59.95

)

計算每股淨虧損時使用的加權平均股份
歸屬於Vaccinex, Inc.普通股股東,基本和
64,788

 

 

2,026,920

 

 

 

322,153

 

 

 

1,724,088

 

 

 

282,467

 

 

附註是這份基本報表的一個組成部分。

4


 

Vaccinex,醫療公司。

基本報表 股東權益(赤字)(未經審計)

(以千爲單位,除股票數據外)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

優先股

 

 

普通股

 

 

 

 

 

庫藏股

 

 

 

 

 

 

 

 

 

股份

 

 

金額

 

 

股份

 

 

金額

 

 

額外的
實收股本
資本

 

 

普通
股票
股份

 

 

金額

 

 

累計
虧損

 

 

總計
股東權益
股本/(虧損)

 

2023年1月1日餘額

 

 

-

 

 

$

-

 

 

 

237,532

 

 

$

-

 

 

$

324,880

 

 

 

5

 

 

$

(11

)

 

$

(319,676

)

 

$

5,193

 

普通股發行

 

 

-

 

 

 

-

 

 

 

23,693

 

 

 

-

 

 

 

2,040

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

2,040

 

基於股票的補償

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

129

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

129

 

淨虧損

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(4,962

)

 

 

(4,962

)

截至2023年3月31日的餘額

 

 

-

 

 

 

-

 

 

 

261,225

 

 

 

-

 

 

 

327,049

 

 

 

5

 

 

 

(11

)

 

 

(324,638

)

 

 

2,400

 

發行普通股

 

 

-

 

 

 

-

 

 

 

51,486

 

 

 

-

 

 

 

4,111

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

4,111

 

基於股票的補償

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

126

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

126

 

淨虧損

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(7,060

)

 

 

(7,060

)

截至2023年6月30日的餘額

 

 

-

 

 

 

-

 

 

 

312,711

 

 

 

-

 

 

 

331,286

 

 

 

5

 

 

 

(11

)

 

 

(331,698

)

 

 

(423

)

發行普通股

 

 

-

 

 

 

-

 

 

 

34,327

 

 

 

-

 

 

 

1,351

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,351

 

基於股票的補償

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

115

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

115

 

淨虧損

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(4,912

)

 

 

(4,912

)

截至2023年9月30日的餘額

 

 

-

 

 

$

-

 

 

 

347,038

 

 

$

-

 

 

$

332,752

 

 

 

5

 

 

$

(11

)

 

$

(336,610

)

 

$

(3,869

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

優先股

 

 

普通股

 

 

 

 

 

庫藏股

 

 

 

 

 

 

 

 

 

股份

 

 

金額

 

 

股份

 

 

金額

 

 

額外的
實收股本
資本

 

 

普通
股票
股份

 

 

金額

 

 

累計
虧損

 

 

總計
股東權益
股本/(虧損)

 

截至2024年1月1日的餘額

 

 

-

 

 

$

-

 

 

 

892,622

 

 

$

-

 

 

$

337,627

 

 

 

5

 

 

$

(11

)

 

$

(339,927

)

 

$

(2,311

)

普通股發行

 

 

-

 

 

 

-

 

 

 

64,816

 

 

 

-

 

 

 

2

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

2

 

基於股票的補償

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

96

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

96

 

在定向增發中發行普通股票和預先融資權證

 

 

-

 

 

 

-

 

 

 

626,867

 

 

 

1

 

 

 

4,223

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

4,224

 

在定向增發中發行權證

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

750

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

750

 

權證發行

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

556

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

556

 

優先股發行

 

 

10

 

 

 

1,236

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,236

 

公共warrants的再分類,經修訂

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,199

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,199

 

定向增發warrants的再分類,經修訂

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

800

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

800

 

淨虧損

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(3,897

)

 

 

(3,897

)

截至2024年3月31日的餘額

 

 

10

 

 

 

1,236

 

 

 

1,584,305

 

 

 

1

 

 

 

345,253

 

 

 

5

 

 

 

(11

)

 

 

(343,824

)

 

 

2,655

 

基於股票的補償

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

112

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

112

 

優先股折扣的攤銷

 

 

-

 

 

 

143

 

 

 

-

 

 

 

-

 

 

 

(143

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

發行限制股

 

 

-

 

 

 

-

 

 

 

543

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

淨虧損

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(5,631

)

 

 

(5,631

)

截至2024年6月30日的餘額

 

 

10

 

 

 

1,379

 

 

 

1,584,848

 

 

 

1

 

 

 

345,222

 

 

 

5

 

 

 

(11

)

 

 

(349,455

)

 

 

(2,864

)

基於股票的補償

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

76

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

76

 

優先股折扣的攤銷

 

 

-

 

 

 

143

 

 

 

-

 

 

 

-

 

 

 

(143

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

執行期權

 

 

-

 

 

 

-

 

 

 

1,014,885

 

 

 

-

 

 

 

5,211

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

5,211

 

權證發行

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,988

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,988

 

淨虧損

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(5,732

)

 

 

(5,732

)

截至2024年9月30日的餘額

 

 

10

 

 

$

1,522

 

 

 

2,599,733

 

 

$

1

 

 

$

352,354

 

 

 

5

 

 

$

(11

)

 

$

(355,187

)

 

$

(1,321

)

 

附註是這份基本報表的一個組成部分。

5


 

 

Vaccinex,醫療公司。

股東權益(遞減)簡版(未經審計)現金流量表(未經審計)

(以千爲單位)

 

 

 

 

截至9月30日的九個月

 

 

 

2024

 

 

2023

 

 

 

 

 

經營活動產生的現金流量:

 

 

 

 

 

 

淨虧損

 

$

(15,260

)

 

$

(16,934

)

調整爲淨損失到經營活動現金流量淨使用:

 

 

 

 

 

 

折舊費

 

 

77

 

 

 

92

 

基於股票的補償

 

 

284

 

 

 

370

 

權證責任公允價值變動

 

 

(1,291

)

 

 

-

 

公允價值變動損益(衍生工具)

 

 

81

 

 

 

-

 

warrants的結算損失

 

 

1,106

 

 

 

-

 

運營資產和負債的變化:

 

 

 

 

 

 

應收賬款

 

 

(24

)

 

 

(758

)

預付費用及其他流動資產

 

 

1

 

 

 

17

 

應付賬款

 

 

2,826

 

 

 

2,707

 

應計費用

 

 

(42

)

 

 

864

 

遞延收入

 

 

(12

)

 

 

-

 

用於經營活動的淨現金

 

 

(12,254

)

 

 

(13,642

)

投資活動產生的現金流量:

 

 

 

 

 

 

購置固定資產等資產支出

 

 

(22

)

 

 

(67

)

投資活動中使用的淨現金

 

 

(22

)

 

 

(67

)

籌資活動產生的現金流量:

 

 

 

 

 

 

普通股發行所得,及
預先融資的warrants在定向增發中的發行

 

 

2,529

 

 

 

-

 

行使認股權收到的款項

 

 

5,920

 

 

 

-

 

在定向增發中發行的warrants所得

 

 

1,113

 

 

 

-

 

普通股定向增發的收益

 

 

-

 

 

 

6,234

 

開多期債務償還

 

 

(58

)

 

 

(57

)

優先股及相關warrants的發行收益

 

 

1,697

 

 

 

-

 

普通股的發行收益,以及
private placement warrants

 

 

2,446

 

 

 

-

 

普通股發行收入

 

 

-

 

 

 

1,268

 

融資活動提供的淨現金

 

 

13,647

 

 

 

7,445

 

現金及現金等價物的淨增加/(減少)

 

 

1,371

 

 

 

(6,264

)

現金及現金等價物–期初

 

 

1,535

 

 

 

6,391

 

現金及現金等價物–期末

 

$

2,906

 

 

$

127

 

非現金投資和
   融資活動的補充披露:

 

 

 

 

 

 

warrant 激勵(產生但未支付的交易費用)

 

$

297

 

 

 

 

 

附註是這份基本報表的一個組成部分。

6


 

Vaccinex,醫療公司。

財務報表說明d經審核的基本報表(未經審計)

附註1. 公司及業務性質

Vaccinex,Inc.(以下簡稱「公司」)成立於2001年4月,總部位於紐約羅切斯特。公司是一家處於臨床階段的生物技術公司,致力於發現和開發用於治療嚴重疾病和未滿足醫療需求的靶向生物治療藥物,包括神經退行性疾病、癌症和自身免疫疾病。自成立以來,公司幾乎所有的努力都投入到產品研究、製造和臨床開發以及籌集資本方面。

公司面臨一系列與其他早期生物技術公司普遍存在的風險和不確定性,包括但不限於對產品候選者的成功開發和商業化的依賴性、快速技術變革和競爭、對關鍵人員和合作夥伴的依賴、專利技術和專利保護的不確定性、臨床試驗的不確定性、營運業績和財務表現的波動性、獲取額外資金的需求、符合政府監管、技術和醫療風險、公司成長管理和營銷效果的有效性。如果公司無法成功將任何產品候選者商業化或達成合作,將無法產生產品收入或實現盈利能力。

持續經營

這些簡明財務報表是根據適用於持續經營的公認會計原則編制的,預計在正常業務過程中實現資產和滿足負債。

公司自成立以來一直遭受巨額虧損和經營活動現金流出,並預計將在能夠通過產品候選者的商業化產生重大收入之前繼續出現虧損。公司報告截至2024年9月30日的九個月中經營活動中使用的現金爲$12.3 百萬,並累計赤字爲$355.2 截至2024年9月30日,公司的淨資產爲1000萬美元。鑑於公司預期的經營需求和現有的現金及現金等價物,公司預計流動性不足,無法維持運營並在發佈簡明財務報表後一年內滿足其義務。這些情況和事件對公司能夠繼續作爲持續經營單位的能力產生重大懷疑。

作爲對這些情況的回應,管理層目前正在評估不同的策略,以獲得未來運營所需的資金。融資策略可能包括但不限於公開或私人出售股權、債務融資或來自其他資本來源的資金,例如政府資金、合作、戰略聯盟、出售非核心資產或與第三方達成許可協議。無法保證公司將能夠獲得額外融資,或者如有融資,是否足以滿足其需求或具有優惠條款。由於管理層的計劃尚未最終確定且不在公司的控制範圍內,因此無法認爲這些計劃的實施是可能的。因此,公司得出結論,管理層的計劃無法消除對公司繼續作爲持續經營單位的重大懷疑。

簡明財務報表未包括與資產金額的收回能力和分類,或者可能由於這種不確定性的結果而導致的負債金額和分類相關的任何調整。

 

7


 

注意事項 2.重要會計政策摘要

列報和合並的基礎

隨附的未經審計的簡明財務報表反映了公司的賬目和業務,是根據美利堅合衆國普遍接受的中期財務信息會計原則(「GAAP」)編制的(「會計準則編纂」(「ASC」)270, 臨時報告)以及10-Q表格和第S-X條例第8條的說明。因此,這些財務報表不包括按照公認會計原則全面列報財務狀況、經營業績和現金流所需的所有信息。管理層認爲,簡明財務報表反映了爲公允列報公司在所報告期間的業績而認爲必要的所有調整(包括正常的經常性調整)。

這些簡明財務報表應與公司於2024年4月25日向美國證券交易委員會提交的截至2023年12月31日止年度的10-K/A表年度報告中包含的公司經審計的財務報表和相關附註一起閱讀。

普通股反向拆分

2023 年 9 月 25 日, 公司實行了 「一對一」15 反向拆分其已發行的普通股。 2024年2月19日,公司以1比1的價格對公司普通股進行了第二次反向分割14 基礎。所有列報期限的所有每股金額、已發行普通股、認股權證和股票薪酬金額均已追溯調整,以反映這些反向股票拆分。 普通股的面值保持在美元0.0001 每股。

估算值的使用

這些簡明財務報表是根據美國公認會計原則編制的。根據美國公認會計原則編制財務報表要求管理層做出估算和假設,以影響截至簡明財務報表之日報告的資產負債金額、或有資產負債的披露以及報告期內報告的支出金額。此類管理估計包括與股票期權獎勵估值、認股權證負債估值、衍生資產估值以及遞延所得稅資產估值補貼中使用的假設有關的估計。實際結果可能與這些估計有所不同。

可轉換優先股

2024年3月,公司發行了新指定的可轉換優先股系列的股票(見附註9)。可轉換優先股包含嵌入式贖回功能,除了可轉換優先股的主持工具外,還需要進行分叉和單獨覈算。根據ASC主題815,公司將嵌入式贖回功能的公允價值作爲衍生資產記錄在公司的資產負債表上, 衍生品和套期保值。有關衍生資產公允價值衡量中使用的關鍵輸入,請參閱附註4。

金融工具的公允價值

金融工具包括現金、應收賬款、衍生資產、應付賬款、應計負債、長期債務、權證負債和可轉換優先股。現金、應收賬款、應付賬款、應計負債、債務和可轉換優先股均按其賬面價值列報,賬面價值近似於公允價值,因爲此類金額的預計收到或付款日期很短。認股權證負債和衍生資產按公允價值定期計量,假設見附註4。

8


 

信用風險、其他風險和不確定性集中

公司面臨多種風險,包括但不限於資本不足;可能會從納斯達克退市;臨床前測試或臨床試驗可能失敗;無法獲得產品候選人的監管批准;競爭對手開發新技術創新;製造和商業供應操作的潛在中斷;專有藥物候選人的商業化策略和啓動計劃不成功;訴訟中固有的風險,包括所謂的集體訴訟;市場對公司產品的接受度;以及對專有技術的保護。

可能使公司面臨信用風險集中情況的金融工具主要包括現金及現金等價物。現金等價物存放在有息貨幣市場帳戶中。儘管公司將現金存放在多個金融機構中,現金餘額有時可能超過聯邦存款保險公司所保險金額。管理層認爲,與這些餘額相關的金融風險是最低的,迄今爲止沒有經歷任何損失。

公司歷史上通過與投資者的交易來籌集資金,投資者中包括董事會成員和由某些董事會成員控制的實體。因此,公司的董事直接或間接地控制着公司的顯著持股比例。公司無法保證未來融資會以充足的金額或可接受的條款可用,或其董事或由某些董事會成員控制的實體會願意或能夠參與公司未來的資本籌集。

公司依靠第三方製造商製造藥物成分和用於臨床試驗的藥物產品。公司還依賴於某些第三方供應鏈。與這些第三方製造商的爭議或來自第三方供應商的商品或服務短缺可能會延遲公司產品候選人的製造,並對其運營結果產生不利影響。

最近發佈的會計聲明

2023年12月,FASB發佈了ASU 2023-09,所得稅 (話題740) 改進所得稅披露。 ASU 2023-09要求在稅率調節表中披露有關聯邦、州和外國所得稅的額外信息類別,並且如果項目滿足量化閾值,還需要提供某些類別的調節項目的更多細節。該ASU要求實體在年度期間披露支付的所得稅,扣除退款後,按聯邦(國家)、州和外國稅種進行分列,並根據量化閾值對信息按管轄區進行分列。該指導原則對披露要求進行了其他幾項更改。ASU要求前瞻性地應用,並可選擇追溯適用。該ASU適用於2024年12月15日後開始的財政年度。公司目前正在評估採納該指導原則對其基本報表和披露的影響。

2023年11月,FASB發佈了ASU 2023-07,分部報告 (主題280): 對可報告 сегмент 披露的改進。 ASU 2023-07改善了可報告業務部門的披露要求,主要是通過增強對重要業務部門費用的披露。此外,ASU增強了中期披露要求,澄清了實體可以披露多項利潤或虧損的業務部門指標的情況,幷包含其他披露要求。ASU並未改變實體如何識別其經營部門、聚合這些經營部門,或應用定量閾值以確定其可報告部門。ASU要求對財務報表中呈現的所有期間進行追溯應用。ASU自2023年12月15日之後開始的財政年度生效,並適用於2024年12月15日之後開始的財政年度中的中期期間。公司目前正在評估採納該指南對其基本報表和披露的影響。

9


 

 

注意 3. 資產負債表元件

資產和設備

固定資產和設備包括以下項目(以千爲單位):

 

 

 

截至
2024年9月30日

 

 

截至
2023年12月31日

 

租賃改良

 

$

3,277

 

 

$

3,277

 

研究設備

 

 

3,373

 

 

 

3,351

 

傢俱和固定裝置

 

 

350

 

 

 

350

 

計算機設備

 

 

250

 

 

 

250

 

234,036

 

 

7,250

 

 

 

7,228

 

減:累計折舊與攤銷

 

 

(7,168

)

 

 

(7,091

)

物業和設備,淨值

 

$

82

 

 

$

136

 

 

與固定資產和設備相關的折舊費用爲$,分別爲2023年12月31日和2022年底的三個月,其中$列入商品成本,$列入一般和行政費用。有關固定資產和設備的折舊費用爲$,分別爲2023年6月30日和2022年底的六個月,其中$列入一般和行政費用。24,000 and $77,000 截至2024年9月30日三個月和九個月的淨利潤爲$31,000 and $92,500 分別爲截至2023年9月30日的三個月和九個月。

 

應計費用

應計費用包括以下內容(以千爲單位):

 

 

 

截至
2024年9月30日

 

 

截至
2023年12月31日

 

 

 

 

 

 

 

 

已計提的臨床試驗成本

 

$

649

 

 

$

853

 

應計的工資和相關福利

 

 

238

 

 

 

295

 

已計提的諮詢和法律費用

 

 

204

 

 

 

58

 

應計其他

 

 

109

 

 

 

36

 

應計費用

 

$

1,200

 

 

$

1,242

 

 

第4條 金融資產的公允價值衡量

 

以非重複計量方式計量的資產和負債

在簡明的資產負債表中以非經常性方式記錄的資產和負債根據用於衡量其公允價值的輸入所涉及的判斷水平進行分類。金融工具包括現金、應收賬款、應付賬款、應計負債和長期債務。現金、應收賬款、應付賬款、應計負債和債務均按其賬面價值計量,由於這些金額的預計收款或支付日期較短,其賬面價值近似於公允價值。

以公允價值計量的資產和負債的重複計量

公允價值衡量標準還適用於定期(每個報告期)以公允價值衡量的某些金融資產和金融負債。對於公司而言,這些金融資產和金融負債包括存放在貨幣市場基金中的現金等價物、認股權證負債和衍生資產。公司沒有任何以定期以公允價值衡量的非金融資產或負債。

資產或負債在公允價值層次結構內的公允價值衡量水平是基於任何對公允價值衡量有重要作用的輸入的最低水平。

10


 

以下表格詳細列出了公司按照公允價值層次(以千爲單位)劃分的金融資產和負債的公允價值。

 

 

 

截至2024年9月30日

 

 

 

公允價值

 

 

一級

 

 

二級

 

 

三級

 

財務資產:

 

 

 

 

 

 

 

 

 

 

 

 

貨幣型基金

 

$

900

 

 

$

900

 

 

$

-

 

 

$

-

 

衍生工具資產

 

 

14

 

 

 

-

 

 

 

-

 

 

 

14

 

所有資產合計

 

$

914

 

 

$

900

 

 

$

-

 

 

$

14

 

 

 

 

截至2023年12月31日

 

 

 

公允價值

 

 

一級

 

 

二級

 

 

三級

 

財務資產:

 

 

 

 

 

 

 

 

 

 

 

 

貨幣型基金

 

$

1,337

 

 

$

1,337

 

 

$

-

 

 

$

-

 

所有資產合計

 

$

1,337

 

 

$

1,337

 

 

$

-

 

 

$

-

 

 

 

 

截至2024年9月30日

 

 

 

公允價值

 

 

一級

 

 

二級

 

 

三級

 

財務負債:

 

 

 

 

 

 

 

 

 

 

 

 

認股權負債-公開認股權

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

認股權負債-定向增發認股權

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

全部金融負債

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

 

 

截至2023年12月31日

 

 

 

公允價值

 

 

一級

 

 

二級

 

 

三級

 

財務負債:

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liabilities - public warrants

 

$

2,275

 

 

$

-

 

 

$

-

 

 

$

2,275

 

Warrant liabilities - private placement warrants

 

 

76

 

 

 

-

 

 

 

-

 

 

 

76

 

全部金融負債

 

$

2,351

 

 

$

-

 

 

$

-

 

 

$

2,351

 

 

公司在2024年3月31日和2023年3月31日結束的三個月內都沒有記錄任何所得稅支出。公司已爲所有報表期的淨運營虧損記錄了完整的減值準備,並未在隨附的簡明財務報表中反映任何此類淨運營虧損的盈餘。沒有t transfer any assets or liabilities measured at fair value on a recurring basis to or from Level 1, Level 2, and Level 3 during either of the nine months ended September 30, 2024, and 2023.

 

權證負債的公允價值衡量

公司使用Black-Scholes定價模型,採用三級輸入來確定其權證負債的公允價值。用於確定權證負債估計公允價值的輸入包括評估日的基礎股票公允價值、權證期限以及基礎股票的預期波動率。在權證負債的公允價值衡量中使用的重要不可觀察輸入是權證的估計期限。

2024年9月30日,用於估計權證負債公允價值的各自估值模型的關鍵輸入如下:

 

 

 

 

 

 

 

 

公開warrants

 

 

私募認股權證

 

 

 

 

 

 

 

 

 

 

無風險利率

 

 

3.81

%

 

 

5.40

%

 

 

4.08

%

 

 

5.40

%

波動率

 

 

83

%

 

 

130

%

 

 

83

%

 

 

130

%

股息收益率

 

 

0

%

 

 

0

%

 

 

0

%

 

 

0

%

預期期限(年)

 

 

0.003

 

 

 

4.760

 

 

 

0.003

 

 

 

5.010

 

股價

 

$

6.000

 

 

$

9.310

 

 

$

6.000

 

 

$

9.310

 

用於估算2023年12月31日認股權證負債公允價值的各自估值模型的關鍵輸入如下:

11


 

 

 

 

 

 

 

 

公開warrants

 

 

私募認股權證

 

 

 

 

 

 

 

 

 

 

無風險利率

 

 

3.81

%

 

 

5.42

%

 

 

3.81

%

 

 

5.33

%

波動率

 

 

99

%

 

 

113

%

 

 

102

%

 

 

113

%

股息收益率

 

 

0

%

 

 

0

%

 

 

0

%

 

 

0

%

預期期限(年)

 

 

0.75

 

 

 

5.01

 

 

 

0.75

 

 

 

5.01

 

股價

 

$

9.310

 

 

$

13.160

 

 

$

9.310

 

 

$

12.880

 

下表總結了公司認可的權證負債的公允價值變動,這些變動反映在截至2024年9月30日的經營活動和全面損益各報表中(以千爲單位):

 

 

 

 

 

 

公開warrants

 

 

私募認股權證

 

 

總計

 

2024年1月1日的權證負債

 

$

2,275

 

 

$

76

 

 

$

2,351

 

權證發行

 

 

-

 

 

 

1,113

 

 

 

1,113

 

重新分類爲股本

 

 

(1,199

)

 

 

(800

)

 

 

(1,999

)

取消認股權證

 

 

(77

)

 

 

-

 

 

 

(77

)

執行期權

 

 

(90

)

 

 

(7

)

 

 

(97

)

公允價值變動

 

 

(909

)

 

 

(382

)

 

 

(1,291

)

2024年9月30日認股權證負債

 

$

-

 

 

$

-

 

 

$

-

 

 

截至2023年7月31日,續借貸款協議下未償還的借款額爲沒有 公司資產負債表中報告的權證負債 2023年9月30日的權證負債公允價值變動,或者在截至2023年9月30日的綜合損益簡表中的變動。

 

衍生資產的公允價值測量

衍生資產的公允價值是通過使用二叉樹格倫模型(BLM)來確定的。應用BLM方法需要使用多個輸入和一些重要的不可觀察到的假設,包括波動率。在確定公司衍生資產的預期波動率時需要做出重要判斷。

以下表格提供了用於估計「Level 3資產」公允價值的測量輸入的定量信息:

 

 

 

2024年9月30日

 

無風險利率

 

 

5.12

%

預期波動率

 

 

40.00

%

預期期限(以年爲單位)

 

 

0.50

 

每股行使價格

 

$

7.77

 

股份數量

 

 

10

 

 

以下表格顯示了截至九個月結束時衍生資產的變化 2024年9月30日(以千爲單位):

 

 

 

 

 

2024年1月1日的衍生資產

 

$

-

 

可轉換優先股的發行

 

 

95

 

公允價值變動

 

 

(81

)

2024年9月30日的衍生資產

 

$

14

 

 

12


 

 

備註 5. 合作協議

surface oncology, Inc.

在2017年11月,公司與surface oncology, Inc.(「surface」)簽訂了一項研究合作和許可期權協議,以識別和選擇針對 的靶抗原,使用公司根據協議所描述的專有科技。在協議下,surface可以通過向公司提供書面通知,購買可執行的獨佔期權,以獲得(i)獨佔產品許可,製造、使用、賣出和進口包含針對第一個抗原的抗體的產品,以及(ii)獨佔研究工具許可,以使用針對第二個抗原的抗體進行研究。surface購買了第一個選項並行使了第二個選項,我們於2019年第三季度與surface簽訂了獨佔研究工具許可協議。

根據研究合作和許可期權協議,surface支付了一筆前期科技接入費用爲$250,000 並在每完成一個里程碑時進行付款。 根據協議,爲第一個靶標抗原指定了里程碑。對於第二個靶標抗原,Surface必須根據公司在執行協議中描述的工作計劃所花費的時間向公司支付費用。Surface需要償還公司在執行工作計劃中產生的費用(i)根據研究資金預算詳細說明的工作計劃和(ii)根據協議中描述的公司項目知識產權的專利申請和訴訟費用。每個期權的行使也將涉及許可證費用和年度維護費用,對於產品許可證,還包括特許權使用費和額外的里程碑付款。本協議將在兩個研究項目和所有評估和測試階段的到期中最晚的一個到期時終止。 截至9月30日的九個月期間,2023年,公司記錄了$500,000 的營業收入,以實現里程碑事件。在2023年,Surface終止了針對第一個靶標的獨佔研究許可協議,因此不再需要支付維護費。Surface oncology已將該項目的第二個靶標分許可給Coherus BioSciences, Inc.(「Coherus」),後者正在積極進行第二個靶標的1/2期開發。Coherus已承擔支付第二個靶標的研究合作和許可期權協議中考慮的維護費和其他費用的責任。

 

註釋6. 承諾和或有事項

納斯達克違規通知書

2024年4月11日,公司收到納斯達克上市資格工作人員的通知函,告知公司根據其2023年12月31日截止年度的10-K表格中的基本報表, 不再符合納斯達克上市規則5550(b)(1)的要求,需保持至少$2.5 百萬美元的股東權益以繼續在納斯達克資本市場上市(「權益標準」),或在最近完成的財年或最近三個財年中兩個的上市證券市場價值達到$35.0 600萬美元,或者來自持續經營的淨利潤達到200萬美元500,000 (「替代標準」),並可能面臨退市。通知信件對公司在納斯達克資本市場的上市沒有立即影響, 公司及時提交了恢復符合權益標準的計劃。

在2024年6月5日,納斯達克通知公司,給予其延期,要求在2024年9月30日或之前恢復並證明符合股本標準。截至2024年9月30日,我們的股東權益爲負數 $1.3百萬美元。在2024年10月7日,公司收到了來自納斯達克上市工作人員的函件,指出公司尚未恢復對股本標準或替代標準的合規性。因此,除非公司及時請求對這一決定向納斯達克聽證小組提出上訴,否則納斯達克將採取措施暫停公司普通股的交易,並將公司的證券自納斯達克資本市場除牌。公司及時對該決定提出了上訴,這自動暫停了任何暫停或除牌的行動,待聽證小組的決定和聽證會於2024年12月5日舉行後,由聽證小組授予的任何額外延期屆滿。因此,公司普通股預計將至少在此之前繼續在納斯達克資本市場上市。

13


 

時。 然而,並不能保證聽證會將批准公司提出的繼續上市請求,或者公司能夠在聽證會可能授予的任何額外合規期內展示符合於權益標準或其他替代標準。

取消認股權證

某些我們要求取消的認股權證持有人通知公司,他們認爲自己持有的認股權證仍然有效。這些被取消的認股權證代表的股份數量約佔公司2024年9月30日未發行基礎上的總流通股的 8%。如果這種誤解持續下去,並需要達成解決方案,可能會對公司產生不利影響,包括支付損害賠償金或發行額外的普通股。雖然公司認爲對於這個問題有有力的辯護,打算積極捍衛自己的立場,但解決這些事項的過程本質上是不確定的,可能需要很長一段時間,因此無法預測這一事項的最終解決方案。

其他預期情況

公司業務正常運營中可能需要面對索賠和評估。當公司相信已經可能發生一項負債,並且金額可以合理估計時,公司會記錄負債準備金。確定概率和估計金額都需要做出重大判斷。

在業務正常運行中,公司可能捲入法律訴訟。當公司認爲可能已經發生一項負債並且金額可以合理估計時,將爲此類事項計提負債準備金。當只能確定一定範圍內的可能損失時,會計提取最有可能的範圍內的金額。如果該範圍內沒有任何一個金額比該範圍內的其他任何一個金額更好的估計,則選擇該範圍內的最低金額進行計提。對訴訟損失或風險的計提可能包括例如潛在損害賠償金、外部法律費用和預計會發生的其他直接相關成本的估計。截至2024年9月30日和2023年12月31日,公司未涉及任何重大法律訴訟。

注7. 租賃

公司向1895管理有限公司租賃其設施,該公司由與公司董事關聯的實體控制,租賃爲不可取消的經營租賃。租賃協議要求每月租金支付$15,048 ,直到2024年10月31日。公司於2024年9月簽署了租賃延長協議,要求定期租金支付,總計$180,578,延續到2025年10月。公司負責與設施相關的所有維護、公共事業、保險和稅款。公司已選擇不將租賃元件與非租賃元件分開這一實際簡化措施。

公司根據ASC 842覈算其租賃 租賃 具有12個月或更短初始期限的租賃不會在簡式資產負債表上記錄。公司在租賃開始時確定安排是否爲租賃。使用權資產代表公司在租賃期間使用基礎資產的權利,而租賃負債代表公司因租賃產生的租金支付義務。經營租賃的使用權資產和租賃負債是基於租賃期限內租金支付的現值確認的。 租賃未提供隱含利率,因此在確定租金支付的現值時,公司使用適用租賃的增量借款利率,該利率爲 7.0%. 公司在剩餘租賃期限內按直線法確認租賃費用。

截至2024年9月30日,未來最低經營租賃付款總額爲$15,048,減去$的折算利息87,經營租賃負債爲$14,961。截至2024年和2023年9月30日的九個月期間,計入租賃負債的現金支付爲$90,290 and $135,434,分別。

截至2024年和2023年9月30日的三個月和九個月期間,因經營租賃而產生的租賃費用爲$45,144 和,$135,434租賃費用是一般和行政費用的元件。

14


 

Note 8. 長期債務

2020年5月8日,公司根據小型企業管理局的薪資保護計劃("PPP貸款")獲得了一筆貸款,金額爲$1,133,600。 PPP貸款最初在 2022年5月8日到期,到期日前不需要償還本金,並以 1.0%的年利率計息,利息支付從 2020年11月8日開始,減去任何潛在寬恕金額。2021年11月8日,公司獲得了$的貸款寬恕。876,171 貸款剩餘金額進行了再融資。該貸款有一個到期日爲 2025年5月8日,計息 1%,每月還款$6,334。公司分別在2024年9月30日結束的三個月和九個月期間記錄了利息費用$141 and $585336 and $1,141 分別在2023年9月30日結束的三個和九個月期間,列示在其損益表和綜合損益表中。

 

附註 9. 可轉換優先股

2024年3月28日,公司與阿爾茨海默氏病藥物研發基金會簽署了一份證券購買協議,根據該協議,公司出售了一系列新指定的可轉換優先股,即A系列優先股,以及購買最多的warrants 229,057 公司的普通股(「ADDF Warrants」),總購買價格爲$1.75 百萬。請參見附註10,ADDF Warrants。我們的A系列優先股可以在持有人選擇的情況下,在公司公開發布其SIGNAL-AD阿爾茨海默病研究的頂線數據(「數據發佈」)後任何時間轉換爲普通股7.77 轉換價格等於以下兩者中較大者(a)$普通股的每股價格和(b)(i)如果普通股在交易市場上交易或其價格在OTCQB或OTCQX上報告,則在交付轉換通知前的最後三個交易日的成交量加權平均價格,(ii)如果其時在粉紅色開放市場上交易,則爲普通股的最新買盤價格,或(iii)在所有其他情況下,則爲獨立評估師確定的普通股的公允市場價值,該轉換權在公司贖回權的擬議生效日期前的最後一個完整日或在被視爲清算事件的固定贖回日期(通常定義爲涉及公司的某些基本交易,包括合併或出售公司幾乎所有資產)之前終止。

A系列優先股不可投票,不具有強制贖回,並且每年提供 5%的累計分紅派息,增加 2 每年百分比點數,分紅率不得超過 12系列A優先股也將按轉換基礎參與支付給我們普通股持有者的任何定期或特別分紅。

此外,系列A優先股的清算優先權等於以下兩者中的較大者:(i) $175,000 每股,受系列A優先股的任何股票分紅、股票拆分、合併或其他類似資本重組的適當調整(「原始股價」)影響,加上任何已產生但未支付的分紅,無論是否已宣佈,以及任何其他已宣佈但未支付的分紅,或(ii) 如果所有系列A優先股在此清算、解散、清算或被視爲清算事件之前已轉換爲普通股,將按每股應支付的金額。

公司也同意,只要系列A優先股未贖回,公司在未經持有者書面同意的情況下將不進行, 50.1% 的系列A優先股,(i) 以對系列A優先股不利的方式修改、改變或廢除公司章程或章程的任何條款,或(ii) 在2026年3月29日前,承擔超過$的借款債務。1.0 百萬美元。

公司有權在披露相對於安慰劑組患者的pepinemab治療患者增加的公共公告後的任何時間,以原始股價每股的價格贖回系列A優先股,該公告的統計顯著性具有不大於或等於的p值。 0.05在接受40 mg/kg pepinemab或安慰劑後,使用[18F]氟脫氧葡萄糖(FDG)-PET評估的基線與12個月之間的腦代謝FDG-PET標準攝取值比率的變化,如公司SIGNAL-AD阿爾茨海默病研究的協議和相關統計分析計劃所述,前提是(i)持有人未持有公司或其任何董事、員工、代理人或附屬機構提供的任何重要非公開信息,以及(ii)文件中有有效的轉售註冊聲明,覆蓋基礎普通股。

15


 

A系列優先股具有 「利率上升證券」 的特徵,如美國證券交易委員會工作人員會計公告主題5Q 「增息優先股」 所述。因此,A系列優先股的折扣被視爲未申報的股息成本,使用實際利息法在永久股息開始之前的一段時間內攤銷,方法是從留存收益中扣除估算的股息成本,或者在沒有留存收益的情況下額外支付資本,將A系列優先股的賬面金額增加相應金額,以在預期贖回日將初始確認價值增加到預期結算價值。每個時期的攤銷額是指與該期間規定的股息相比使A系列優先股賬面金額的有效成本率保持不變的金額。

A系列優先股的每股都包含贖回功能,允許在發生自願或非自願清算、解散、公司清盤或認定清算事件(「清算事件」)中定義的情況下贖回A系列優先股。此類合格清算事件發生後,A系列優先股持有人有權獲得公司的現金或資產,然後才能向普通股持有人進行或分派任何款項,A系列優先股的每股金額等於或大於(i)美元175,000 加上所有應計和未付的股息,無論是否申報(「清算優先權」);或(2)如果該持有人在支付之日前不久轉換A系列優先股股票,但附帶某些附加條件,則持有人將獲得的每股金額。

嵌入式贖回功能要求公司在發生某些符合條件的清算事件時以清算優先金額結算A系列優先股。當過去三個交易日的普通股成交量加權平均價格大於美元時,持有人行使嵌入式轉換功能7.77根據指定證書的定義,通過發行固定金額爲美元的可變數量的普通股來結算A系列優先股175,000 每股。由於這些嵌入式特徵規定以與其標的資產無關的名義金額進行結算,因此嵌入式特徵均符合衍生品的定義。

根據ASC 815,符合衍生品會計定義的某些合同條款必須與嵌入衍生品的金融工具分開計算(注2)。公司得出的結論是,當過去三個交易日的普通股成交量加權平均價格大於美元時,贖回功能和持有人可以選擇進行轉換7.77根據指定證書的定義,構成嵌入式衍生品,因此需要與A系列優先股分開。

如果發生任何清算或被視爲清算事件(如指定證書所定義),在向普通股持有人進行任何分配或付款或爲其分期付款之前,A系列優先股持有人有權從公司獲得等於美元的資產175,000 加上每股所有應計和未付的股息,無論是否申報,總清算價值爲美元1.75 截至 2024 年 9 月 30 日,百萬人。這些贖回條款被確定爲需要從A系列優先股中分離的嵌入式衍生品。

首次發行時,公司記錄了嵌入式衍生品的公允價值,金額爲美元95 千作爲衍生資產和A系列優先股的溢價。衍生品在每個報告期均按公允價值進行調整,公允價值的變動計入收益。

因此,根據發行之日工具的相對公允價值,公司分配了大約 $0.57 ADDF認股權證總收益中的百萬美元和美元1.18 A系列優先股總收益中的百萬美元,扣除美元95 千,歸因於衍生資產。

 

Note 10。認股權證

公開warrants

2023年10月3日公司在公開發行中售出(i) 542,857 公司普通股連同可購買的認股權證 542,857 普通股份以及(ii)代替普通股的,可行權的預資助認股權證 142,857 股份 普通股連同公開認股權證

16


 

最多購買 142,857 普通股(「發行」)。每份公開認股權證的初始行使價等於美元14.00 每股。公開認股權證可立即行使並有到期日 五年 自發行之日起。普通股和隨附的公開認股權證的合併公開募股價爲美元14.00 每股及隨附的公開認股權證,以及預先注資的認股權證和隨附的公開認股權證均以公開發行價的合併價格出售13.986 每份預先注資的認股權證和隨附的公開認股權證,總收益爲美元9.6 百萬,扣除公司應付的配售代理費和發行費。如果持有人在行使後立即實益擁有的普通股總數超過規定的受益所有權限制,則公共認股權證的行使通常受到限制;但是,前提是持有人可以通過提供來增加或減少受益所有權限制 61 提前幾天通知公司,但不得超過任何百分比 9.99%。2024 年 7 月 18 日 142,857 預先注資的認股權證已行使並轉換爲普通股。

公司有權通過向持有人的公開認股權證的任何部分發出召集通知,「召回」 持有人公開認股權證的任何部分 30 幾天前,該公司公開宣佈,與安慰劑治療的患者相比,接受pepinemab治療的患者人數有所增加,其統計意義的p值小於或等於 0.05,如公司SIGNAL-AD阿爾茨海默氏病研究協議和相關的統計分析計劃(「正面數據發佈」)所述,[18F] 氟脫氧葡萄糖(FDG)-PET評估的在基線至第12個月之間腦代謝的標準攝取值比率的變化。發出電話通知後,公開認股權證將繼續可行使。每份公開認股權證都將被取消,並且不能再行使,前提是持有人未能在其中及時行使被召部分的公開認股權證 20 公司發佈電話通知後的交易日。

如果進行基本面交易,則公開認股權證要求公司根據Black-Scholes定價模型估值進行付款,使用特定輸入,根據ASC 815,這些工具不被視爲與公司自有股票掛鉤。公開認股權證還包含某些條款,這些條款規定根據特定事件的發生或不發生進行調整,該事件與標準估值模型中的隱含假設不一致,標準估值模型也排除了根據ASC 815將這些工具視爲與公司股票掛鉤的情況。因此, 發行時, 公司將公開認股權證列爲負債, 在發行日的公允價值約爲 $3.5 百萬。

2024年3月,公司與大約持有人簽訂了認股權證修訂協議 83本次發行中爲修改公開認股權證中的上述條款而發行的公開認股權證的百分比。根據ASC 815,經修訂的公開認股權證不再被視爲與公司股票掛鉤。結果,$1.2 在公司截至2024年9月30日的九個月的簡明股東權益(赤字)表中,有100萬筆公開認股權證負債被重新歸類爲權益。此外,經修訂的公開認股權證在修訂之日被標記爲公允價值,從而使認股權證負債的公允價值變動收益爲美元0.7 公司截至2024年9月30日的九個月的簡明運營報表和綜合虧損報表中爲百萬美元。

私募認股權證

2023年11月,根據與某些投資者簽訂的證券購買協議,公司發行並出售了私募認股權證進行購買 37,694 普通股。每份私募認股權證都有行使價,如果發生股票分割、合併(包括反向股票拆分)或類似事件,該行使價將按比例進行調整。私募認股權證可立即行使併到期 五年 從發行之日起,公司有權在與公開認股權證相同的條件和條款下 「贖回」 私募權證的任何部分。私募認股權證受與公共認股權證和預先注資認股權證相同的實益所有權限制。根據ASC 815,私募認股權證發行後不被視爲與公司自有股票掛鉤。因此,私募認股權證在發行時進行了負債分類,並按其各自的發行日期公允價值入賬。

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開啓 2024年2月6日,公司簽訂了證券購買協議,根據該協議我們發行和出售 274,182 我們的普通股以及私募認股權證,最多可購買 274,182 普通股和(ii)預先注資的認股權證,最多可購買 90,363 普通股和私募認股權證,最多可購買 90,363 我們的普通股(「2024年2月SPA」)。每份私募認股權證均可立即行使,初始行使價爲美元14.00 每股。普通股和隨附的私募認股權證的總價格爲美元10.15 每股和隨附的私募認股權證,以及預先注資的認股權證和隨附的私募認股權證以總價格出售,價格爲美元10.1486 每份預先注資的認股權證和隨附的私募認股權證,總收益約爲美元3.7 百萬。

公司有權 「召開」 持有人私募認股權證任何部分的行使,向持有人發出看漲通知 30 天數,如果是11月的私募認股權證,或 120 就2月份的私募認股權證而言,在正面數據發佈後的幾天內。在發出徵集通知後,私募認股權證將繼續可以行使。每份私募權證都將被取消,並且不能再行使,前提是持有人未能在其中及時行使私募權證部分的私募權證 20 交易日,如果是11月的私募認股權證,或 30 就2月份私募認股權證而言,交易日是在公司發佈電話通知之後,前提是行使私募權證的贖回部分將導致持有人持有的普通股超過規定的實益所有權限制,在行使私募認股權證中規定的該部分時,不是發行股票,而是修改該部分的條款,使其與之一致預先注資的認股權證的條款。 根據ASC 815,私募認股權證發行後不被視爲與公司自有股票掛鉤。因此,私募認股權證在發行時被歸類爲負債並在發行日公允價值入賬。

2024年3月,公司與認股權證的持有人簽訂了認股權證修訂協議 1002023 年 11 月發行的私募認股權證的百分比以及私募權證的持有人 972024年2月SPA中爲修改私募認股權證中的上述條款而發行的私募認股權證的百分比。結果, 354,693 根據ASC 815,經修訂的2023年11月和2024年2月的SPA私募認股權證不再被排除在考慮與公司股票掛鉤的範圍內。該公司對美元進行了重新分類0.8 根據ASC 815-40提供的指導,在公司截至2024年9月30日的九個月的簡明股東權益/赤字表中,經修訂的私募認股權證中有100萬份爲股權。經修訂的私募認股權證在修訂之日被標記爲公允價值,導致認股權證負債公允價值變動的收益爲 $0.36 公司截至2024年9月30日的九個月的簡明運營報表和綜合虧損報表中爲百萬美元。

2024年3月27日,公司簽訂了證券購買協議,根據該協議,公司發行和出售 193,000 公開發行中的公司普通股以及最多可購買的私募認股權證 193,000 同時進行私募的普通股,合併價格爲美元7.77 每股及隨附的私募認股權證,總收購價約爲美元1.5 百萬。公司有權在與公開認股權證和11月私募認股權證相同的條件和條款下 「贖回」 這些私募認股權證的任何部分。另外,2024年3月27日,公司簽訂了不同形式的證券購買協議,根據該協議,公司出售了該協議 159,683 普通股和私募認股權證,最多可購買 159,683 私募中的普通股,合併價格爲美元7.77 每股及隨附的私募認股權證,總收購價約爲美元1.25 百萬。公司有權在與2月份私募認股權證相同的條件和條款下 「贖回」 這些私募認股權證的任何部分。

公司對2024年3月的私募認股權證進行了評估,得出的結論是,這些認股權證符合在額外實收資本範圍內歸類爲股東權益的標準。這些私募認股權證之所以被歸類爲股權,是因爲它們(1)是獨立的金融工具,可以合法地與普通股分開行使,(2)可以立即行使,(3)不體現公司回購股票的義務,(4)允許持有人在行使時獲得固定數量的普通股,(5)與公司普通股掛鉤以及(6)滿足股票分類標準。

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因此,公司分配了大約$0.84 剩餘收益中的百萬美元(在將收益分配給普通股並等於發行日公允價值的金額後)以相對公允價值的基礎分配給3月的定向增發warrants,以便在發行日確認在額外實收資本中。

 

公共warrants和定向增發warrants的看漲

在2024年8月,公司根據warrants的條款呼籲取消公共warrants和定向增發warrants,允許公司在宣佈在公司的SIGNAL-AD試驗中獲得阿爾茨海默病治療的pepinemab時,FDG-PEt信號在患者中顯著增加後呼叫warrants進行取消。之後,所有未根據誘導函協議行使的公共warrants和定向增發warrants於2024年9月被取消。至2024年9月30日, 沒有沒有一份定向增發warrants或公共warrants是有效的。

誘導交易

在2024年9月17日,公司與現有warrants的持有者(「持有者」)簽訂了誘導函協議(「誘導函協議」),以購買總計高達 1,067,4920.010.0001 每股,最初在2023年10月至2024年3月期間向持有人發行的公衆warrants或定向增發warrants(以下稱爲「現有warrants」)。根據誘導函協議,持有人同意以較低的行使價格現金行使現有warrants,價格爲$5.636 每股,作爲對公司同意發行新的未註冊普通warrants(以下稱爲「新warrants」)以購買多達 1,601,238 股普通股(以下稱爲「新warrant股份」),這些股份以$的價格在定向增發中發行並出售0.125 每個新warrant的價格爲$5.636 每股,立即可行使,並在 2029年9月18日到期。現有warrants的行使包括在發行中發行的公衆warrants以及在2024年2月股份購買協議中發行的定向增發warrants,這些warrants在2024年3月並未被重新歸類爲權益。公司於2024年9月17日對發行的公衆warrants和在2024年2月股份購買協議分類爲負債的定向增發warrants進行了重新估值,得到了公允價值爲$0.2 百萬。全年普通股權證負債公平價值的下降導致在收益表中對普通股權證負債的抵消收益。

現有warrants的行使導致公司發行了 872,028 普通股的股份,並根據現有warrants的條款,對超出適用warrants所包含的特定有利所有權限制的持有人進行了預先融資 195,464 普通股的股份,如果普通股已經發行,這些股份將超過適用的現有warrants中的有利所有權限制。

公司通過行使現有warrants和銷售新warrants所獲得的總收入約爲$6.2 百萬,在扣除財務顧問費用和預計交易費用之前。根據誘因信函協議所涉及交易的完成部分發生在2024年9月18日,部分發生在2024年9月19日。

ADDF warrants

與阿爾茨海默病藥物發現基金的證券購買協議相關,公司出售了ADDF warrants,最多可購買 229,057 普通股的股份。每個ADDF權證的初始行使價格等於$7.64 每股,因拆股並股、合併(包括反向拆股)或類似事件而進行比例調整。這些ADDF權證可以立即行使,並將在 2029年3月29日.

公司評估了ADDF權證,並得出結論認爲它們符合分類爲股東權益的標準,屬於額外的實收資本。ADDF權證被分類爲股權,因爲它們(1) 是獨立的金融工具,法律上可以與普通股分開行使並單獨行使,(2)

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可立即行使,(3)不構成公司回購股票的義務,(4)允許持有人在行使時獲得固定數量的普通股,(5)與公司普通股掛鉤,(6)符合股票分類標準。

截至2024年9月30日,所有ADDF認股權證均未執行。

預先融資認股權證

在2024年9月的激勵交易中行使現有認股權證方面,公司預先提供了資金 195,464 現有認股權證所依據的普通股股份,如果發行普通股,則適用持有人將超過適用現有認股權證中規定的受益所有權限制。

與2024年2月的SPA有關,公司出售了可行使的預先注資的認股權證 90,363 普通股。每份預先注資的認股權證的初始行使價等於美元0.0014 每股,如果發生股票分割、組合(包括反向股票拆分)或類似事件,將進行比例調整。預先注資的認股權證可以隨時行使,在全部行使之前不會過期。預先注資的認股權證受到與私募認股權證相同的受益所有人限制。

公司對預先注資的認股權證進行了評估,得出的結論是,這些認股權證符合在額外實收資本範圍內歸類爲股東權益的標準。預先注資的認股權證之所以歸類爲股權,是因爲它們(1)是獨立的金融工具,可以合法地與普通股分開行使,(2)可以立即行使,(3)不體現公司回購股票的義務,(4)允許持有人在行使時獲得固定數量的普通股,(5)與公司普通股掛鉤以及(6)滿足股票分類標準。

因此,公司分配了大約 $0.9 剩餘的收益(以相當於發行日公允價值的金額分配給負債分類的私募認股權證的收益後)中的100萬筆按相對公允價值計入預先融資的認股權證,用於在發行之日確認額外的實收資本。

截至2024年9月30日,與2024年9月激勵交易相關的所有2024年2月SPA預先注資認股權證和預先籌資的股票均已流通。

注11. 爲發行而保留的普通股

普通股已爲以下潛在未來發行而保留:

 

 

 

截至
2024年9月30日

 

 

截至
2023年12月31日

 

期權行權所需股數

 

 

84,358

 

 

 

14,323

 

未來股票期權發放可使用的股份數

 

 

3,318

 

 

 

528

 

普通認股權證的基礎股份

 

 

-

 

 

 

685,714

 

定向增發認股權證的基礎股份

 

 

1,830,297

 

 

 

37,694

 

可轉換優先股份的基礎股份-如果轉換

 

 

225,225

 

 

 

-

 

預先融資認股權證的基礎股份

 

 

285,827

 

 

 

142,857

 

普通股總量:

 

 

2,429,025

 

 

 

881,116

 

 

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註釋12. 股票基礎薪酬

2011員工股權計劃

隨着公司在2018年8月通過的2018年綜合激勵計劃的採用,公司停止在2011年員工股權計劃(「2011計劃」)下授予期權。然而,2011計劃將繼續管理之前授予的未償還期權的條款和條件。任何由於到期、沒收、取消或以其他方式未發行的與2011計劃相關的獎勵的股票將可以在2018年綜合激勵計劃下發放。在2011計劃下授予的期權將在五年內到期, 十年我的意見

2018年綜合激勵計劃

在2018年8月,公司的董事會通過並獲得股東批准的2018年綜合激勵計劃,允許向員工、顧問和諮詢師授予限制性股票、期權和股票增值權獎勵。

2018年6月22日,公司的董事會通過了2018年綜合激勵計劃的第一次修正案,需經股東批准,以(i) 增加2018計劃下可發行普通股的一次性自動增加,(ii) 增加每年2018計劃下可發行普通股的自動增加百分比,以及(iii) 將2018計劃的期限延長至2034年3月21日。2024年5月9日,公司的股東批准了2018年綜合激勵計劃的第一次修正案。

根據2018年綜合激勵計劃(「2018計劃」)授予的股票期權,可以是激勵股票期權或非法定股票期權。激勵股票期權可授予員工、顧問和諮詢師,行使價格不得低於授予日期普通股的公允價值。如果在授予時,期權持有者擁有代表超過 10 %的公司所有類別股票的投票權,則行使價格必須至少是 110 %的公允價值,具體由董事會決定。非法定股票期權可以授予員工、顧問和諮詢師,行使價格可以低於授予時普通股的公允市場價值,但在任何情況下不得低於董事會爲該股票確定的適當對價。股票期權的歸屬期由董事會決定,範圍爲零至 八年。根據2018計劃授予的股票期權在五年內到期,或 十年我的意見

公司最初保留了 2,024 根據2018年計劃的獎勵,發行的普通股數量爲某些調整後的數量。任何與2011年計劃下已頒發獎勵相關的普通股,在2018年計劃生效日時,若因到期、沒收、取消或其他原因終止且未能發行這些股票,將被添加到幷包括在2018年計劃可供授予的普通股數量中。此外,(i) 在2024年5月9日,2018年計劃下預留髮行的普通股數量自動增加了 55,422 股,這代表了 4.5%的2024年3月22日已發行普通股總數,(ii) 從2020年1月1日起至2024年1月1日及從2025年1月1日起,直到2018年計劃到期,2018年計劃下可供發行的普通股數量將每年自動增加 2%和 3%,分別是截止至前一年的12月31日公司已發行和流通的普通股總數或公司董事會決定的較少數量,可能爲零。因此,在2024年1月1日, 17,849 額外的普通股可供在2018年計劃下發行。

21


 

525,948股

 

 

 

股票
選項

 

 

加權-
平均
行使
價格

 

 

加權-
平均
剩餘
加權
壽命(年)

 

 

總計
截至2023年7月29日的餘額
價值(以千爲單位)

 

截至2024年1月1日的餘額

 

 

14,323

 

 

$

446.93

 

 

 

7.7

 

 

$

-

 

已授予

 

 

73,906

 

 

 

5.75

 

 

 

9.6

 

 

 

 

已行權

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

被取消

 

 

(3,847

)

 

 

212.95

 

 

 

 

 

 

 

已過期

 

 

(24

)

 

 

3,129.00

 

 

 

 

 

 

 

截至2024年9月30日的餘額

 

 

84,358

 

 

$

70.51

 

 

 

9.2

 

 

$

-

 

截至2024年9月30日可行使的期權

 

 

15,773

 

 

$

329.72

 

 

 

7.7

 

 

$

-

 

 

2024年9月30日結束的九個月內,授予員工和董事的股票期權的加權平均授予日期公允價值爲 $3.79 美元和每股4.15 每股,分別。截至九個月結束時實現的股票期權的授予日期公允價值之和 2024年和2023年9月30日 $452,234 and $513,718,分別。

股票期權的內在價值是基於截至2024年9月30日和2013年12月31日公司普通股的行使價格和公允價值之間的差異計算的。已行使股票期權的內在價值是基於行使日期時基礎普通股的公允價值與行使價格之間的差異

截至2024年9月30日和2013年12月31日,授予員工的股票期權相關的未確認補償成本總額爲$342,729 and $448,511,分別,預計將在加權平均期間內確認 1.542.16年。

員工期權的授予日公允價值是使用Black-Scholes期權定價模型以以下加權平均假設估計的:

 

 

 

截至9月30日的九個月

 

 

 

2024

 

 

2023

 

預期期限(以年爲單位)

 

 

6.0

 

 

 

6.0

 

預期波動率

 

 

75

%

 

 

75

%

無風險利率

 

 

4.5

%

 

 

3.7

%

預期股息收益率

 

 

-

%

 

 

-

%

 

 

在損益表和綜合損益表中確認的總股票補償費用如下(以千爲單位):

 

 

 

截至9月30日的三個月

 

 

截至9月30日的九個月

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

研發

 

$

22

 

 

$

48

 

 

$

99

 

 

$

148

 

一般和行政

 

 

54

 

 

 

67

 

 

 

185

 

 

 

222

 

總股權補償費用

 

$

76

 

 

$

115

 

 

$

284

 

 

$

370

 

 

註釋 13. 稅收

No 截至2024年9月30日的三個月或九個月期間,已確認所得稅準備。本公司仍處於累計虧損狀態,截止2024年9月30日,已對其淨遞延所得稅資產記錄了全部估值備抵。

22


 

公司評估稅務立場的確認標準爲更可能實現的標準,並且符合確認條件的稅務立場按稅收利益的最大金額計量,該金額超過50%的可能性。據2024年9月30日和2023年12月31日,公司已經 沒有 未確認的所得稅利益,如果確認將影響公司的有效稅率。

 

第14條。歸屬於普通股股東的每股淨虧損

 

以下加權平均普通股等價物被排除在攤薄每股淨虧損的計算之外,因爲它們產生了抗稀釋效應:

 

 

 

截至9月30日的三個月

 

 

截至9月30日的九個月

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

 

 

 

 

 

 

 

 

期權購買普通股

 

 

86,413

 

 

 

14,499

 

 

 

54,041

 

 

 

11,835

 

公開認股權證購買普通股

 

 

551,553

 

 

 

-

 

 

 

640,994

 

 

 

-

 

可轉換優先股中的轉換普通股份

 

 

225,225

 

 

 

-

 

 

 

153,450

 

 

 

-

 

定向增發認股權證購買普通股

 

 

1,149,565

 

 

 

-

 

 

 

803,043

 

 

 

-

 

 

注意事項 15.區段和地理信息

 

該公司的首席運營決策者兼首席執行官對經營業績進行彙總審查,以分配資源和評估財務業績。該公司有 商業活動、靶向生物療法的發現和開發,用於治療醫療需求未得到滿足的嚴重疾病和病症,還有 對運營或經營業績負責的細分市場經理。因此,該公司經營於 可報告的細分市場。截至2024年9月30日和2023年12月31日,所有長期資產均位於美國。

Note 16. RELATED PARTY TRANSACTIONS

As discussed in Note 7, the Company leases its facility from 1895 Management, Ltd., a New York corporation controlled by an entity affiliated with the Company’s chairman and major stockholder of the Company. Lease expense incurred under the operating lease for each of the three-month and nine-month periods ended September 30, 2024 and 2023 was $45,144 and, $135,434, respectively.

 

On March 30, 2023, the Company entered into a Stock Purchase Agreement, pursuant to which the Company issued and sold 23,693 shares of its common stock at a purchase price of $86.10 per share for aggregate gross proceeds of $2.04 million (the "March 2023 Private Placement”). FCMI Parent Co. (“FCMI”), which is controlled by Albert D. Friedberg, the chairman of the Company’s board of directors, and Vaccinex (Rochester) L.L.C., which is majority owned and controlled by Dr. Maurice Zauderer, the Company’s President, Chief Executive Officer, and a member of the Company’s board of directors, purchased 23,229 shares of the Company's common stock for an aggregate purchase price of $2.0 million in the March 2023 Private Placement. In addition, FCMI made a binding commitment in the Stock Purchase Agreement to purchase, on or prior to May 15, 2023, up to an additional $2.96 million of shares of the Company's common stock, less the aggregate purchase price of securities of the Company other than the shares sold by the Company to investors other than FCMI and its affiliates after the closing and on or prior to May 15, 2023, and subject to the terms and conditions of the Stock Purchase Agreement.

 

On February 6, 2024, the Company entered into a securities purchase agreement pursuant to which it issued and sold 274,182 shares of our common stock together with private placement warrants to purchase up to 274,182 shares of common stock and (ii) pre-funded warrants to purchase up to 90,363 shares of common stock together with private placement warrants to purchase up to 90,363 shares of our common stock (the “February 2024 SPA”). The shares of common stock and accompanying private placement warrants were sold at a combined price of $10.15 per share and the accompanying private placement warrant, and the pre-funded warrants and accompanying private placement warrants were sold at a combined price of $10.1486 per pre-funded warrant and accompanying private

23


 

placement warrant, for aggregate gross proceeds of approximately $3.7 million. FCMI and Vaccinex (Rochester), L.L.C. purchased shares of the Company’s common stock and accompanying warrants in this transaction.

On March 27, 2024, the Company entered into a securities purchase agreement in a different form pursuant to which the Company sold 159,683 shares of common stock and warrants to purchase up to 159,683 shares of common stock in a private placement at a combined price of $7.77 per share and accompanying warrant for an aggregate purchase price of approximately $1.25 million. FCMI and Vaccinex (Rochester), L.L.C. purchased shares of the Company's common stock and accompanying warrants in this transaction. This transaction closed on March 28, 2024.

On September 17, 2024, the Company entered into the Inducement Letter Agreements as described in Note 10 above. FCMI and Vaccinex (Rochester), L.L.C. participated in the transactions contemplated by the Inducement Letter Agreements.

 

Note 17. SUBSEQUENT EVENTS

On November 13, 2024, the Company entered into a securities purchase agreement pursuant to which the Company issued and sold to the purchasers named therein (the “Investors”) an aggregate of (i) 76,909 shares (“Shares”) of the Company’s common stock (“Common Stock”) at a price of $3.25 per Share and (ii) pre-funded warrants (“Pre-Funded Warrants”) to purchase up to 584,646 shares of Common Stock at a price of $3.2499 per Pre-Funded Warrant (such transaction, the “Private Placement”). The Private Placement closed on November 14, 2024 for aggregate gross proceeds to the Company of approximately $2.15 million.

The Pre-Funded Warrants have an initial exercise price of $0.0001 per share, are immediately exercisable, and may be exercised at any time until they are exercised in full, subject to a 39.99% beneficial ownership limitation provision contained therein. The Investors are FCMI Parent Co., which purchased Shares and Pre-Funded Warrants and is controlled by Albert D. Friedberg, chair of the Company’s board of directors, and Vaccinex (Rochester), L.L.C., which purchased Shares and is controlled by Maurice Zauderer, Ph.D., the Company’s president, chief executive officer and a member of the Company’s board of directors.

24


 

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

References in this Quarterly Report on Form 10-Q, or this Report, to the “Company,” “we,” “our,” or “us” mean Vaccinex, Inc. and its subsidiaries except where the context otherwise requires You should read the following discussion and analysis of financial condition and results of operations together with our condensed financial statements and related notes included elsewhere in this Report, as well as the audited financial statements, related notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations and other disclosures included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, or the Annual Report.

Cautionary Note Regarding Forward-Looking Statements

The following discussion and other parts of this Report contain forward-looking statements that involve risk and uncertainties, such as statements of our plans, objectives, expectations, and intentions. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “expects,” “plans,” “anticipate,” “believes,” “estimates,” “potential,” or “continue,” or the negative of these terms or other comparable terminology. Forward-looking statements include, but are not limited to, statements about:

our ability to continue as a going concern;
our ability to regain compliance with the Nasdaq listing requirements;
the sufficiency of the financing arrangements we have entered into, that are intended to fund our payroll and certain other operations for a limited period of time, and our ability to service our outstanding debt obligations;
our estimates regarding our expenses, future revenues, anticipated capital requirements and our needs for additional financing;
the implementation of our business model and strategic plans for our business and technology;
the timing and success of the commencement, progress, and receipt of data from any of our preclinical and clinical trials;
our expectations regarding the potential safety, efficacy, or clinical utility of our product candidates;
the expected results of any clinical trial and the impact on the likelihood or timing of any regulatory approval;
the difficulties in obtaining and maintaining regulatory approval of our product candidates;
the rate and degree of market acceptance of any of our product candidates;
the success of competing therapies and products that are or become available;
regulatory developments in the United States and foreign countries;
current and future legislation regarding the healthcare system;
the scope of protection we establish and maintain for intellectual property rights covering our technology;
developments relating to our competitors and our industry;
our failure to recruit or retain key scientific or management personnel or to retain our executive officers;
the performance of third parties, including collaborators, contract research organizations and third-party manufacturers;
the development of our commercialization capabilities, including the need to develop or obtain additional capabilities; and
our use of the proceeds from the offerings of our common stock.

25


 

Although we believe that the expectations reflected in the forward-looking statements contained herein are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. These statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the risk factors identified in the “Risk Factors” section of this Report, and in Part I, Item 1A of the Annual Report on Form 10-K, as well as in our other filings with the Securities and Exchange Commission, or SEC. The forward-looking statements speak only as of the date they were made. Except as required by law, after the date of this Report, we are under no duty to update or revise any of the forward-looking statements, whether as a result of new information, future events or otherwise. We qualify all of our forward-looking statements by the foregoing cautionary statements.

Common Stock Reverse Splits

On September 25, 2023, the Company effected a 1-for-15 reverse stock split of its issued shares of common stock. On February 19, 2024, the Company effected a second reverse split of shares of the Company's common stock on a 1-for-14 basis. All per share amounts, common shares outstanding, warrants, and stock-based compensation amounts for all periods presented have been retroactively adjusted to reflect these reverse stock splits. The shares of common stock retain a par value of $0.0001 per share.

Company Overview

We are a clinical-stage biotechnology company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs, including neurodegenerative diseases, cancer, and autoimmune disorders. We believe we are the leader in the field of semaphorin 4D, or SEMA4D, biology and that we are the only company targeting SEMA4D as a potential treatment for neurodegenerative diseases, cancer, and autoimmune disorders. SEMA4D is an extracellular signaling molecule that regulates the activity of immune and inflammatory cells at sites of injury, cancer, or infection. We are leveraging our SEMA4D antibody platform and our extensive knowledge of SEMA4D biology to develop our lead product candidate, pepinemab, an antibody that we believe utilizes novel mechanisms of action. We are focused on developing pepinemab for the treatment of Alzheimer’s disease, Huntington’s disease, head and neck cancer, and pancreatic cancer. Additionally, third party investigators are studying pepinemab in clinical trials in breast cancer, as well as in “window of opportunity” studies in other indications, including head and neck cancer, and melanoma. We have developed multiple proprietary platform technologies and are developing product candidates to address serious diseases or conditions that have a substantial impact on day-to-day functioning and for which treatment is not addressed adequately by available therapies. We employ our proprietary platform technologies, including through our work with our academic collaborators, to identify potential product candidates for sustained expansion of our internal product pipeline and to facilitate strategic development and commercial partnerships.

Our lead platform technologies include our SEMA4D antibody platform and our ActivMAb antibody discovery platform. Our lead product candidate, pepinemab, is currently in clinical development for the treatment of Alzheimer’s disease, head and neck, pancreatic and breast cancer, through our efforts or through investigator-sponsored trials. Our additional product candidates, VX5 (CXCL13 Mab) and CXCR5 Mab are in earlier stages of development and were selected using our ActivMAb platform. We believe our multiple platform technologies position us well for continued pipeline expansion and partnership opportunities going forward.

We have generated a limited amount of service revenue from collaboration agreements but have not generated any revenue from sales of our product candidates to date. We continue to incur significant development and other expenses related to our ongoing operations. As a result, we are not and have never been profitable and have incurred losses in each period since our inception, resulting in substantial doubt in our ability to continue as a going concern. We reported a net loss of $5.7 million and $4.9 million for the three months ended September 30, 2024 and 2023, respectively, and a net loss of $15.3 million and $16.9 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, and December 31, 2023, we had cash and cash equivalents of $2.9 million and $1.5 million, respectively. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, our product candidates. We may also encounter unforeseen expenses, difficulties, complications,

26


 

delays, and other unknown factors which may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues, if any.

Our recurring net losses and negative cash flows from operations raised substantial doubt regarding our ability to continue as a going concern within one year after the issuance of our condensed financial statements for the three and nine months ended September 30, 2024. Until we can generate sufficient revenue from the commercialization of our product candidates, we expect to finance our operations through the public or private sale of equity, debt financing or other capital sources, such as government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. To date, we have relied on equity and debt financing to fund its operations, in addition to capital contributions from noncontrolling interests and a limited amount of service revenue from collaboration agreements.

In August 2024, we called for cancellation the public warrants and the private placement warrants pursuant to terms of the warrants permitting us to call the warrants for cancellation following the announcement of a statistically significant increase in FDG-PET signal in patients in our SIGNAL-AD trial of pepinemab for the treatment of Alzheimer’s disease. All of the public warrants and private placement warrants not exercised pursuant to the Inducement Letter Agreements were thereafter canceled in September 2024. As of September 30, 2024, none of the private placement warrants or the public warrants were outstanding. A holder of certain of the warrants that we called for cancellation has notified us that it believes that the warrants it held are still outstanding. The number of shares represented by these canceled warrants represents approximately 8% of our outstanding shares as of September 30, 2024, on a pre-issuance basis. Should this misunderstanding continue and a resolution be required and reached, there could be adverse impacts to the Company, including the payment of damages or the issuance of additional shares of common stock.

On September 17, 2024, we entered into the Inducement Letter Agreements with the Holders of the Existing Warrants. Pursuant to the Inducement Letter Agreements, the Holders agreed to exercise for cash the Existing Warrants at a reduced exercise price of $5.636 per share in consideration of our agreement to issue the New Warrants to purchase up to 1,601,238 shares of common stock, which were issued and sold in a private placement at a price of $0.125 per New Warrant. Each New Warrant had an initial exercise price equal to $5.636 per share, was immediately exercisable, and expires September 18, 2029. The gross proceeds to us from the exercise of the Existing Warrants and the sale of the New Warrants were approximately $6.2 million, prior to deducting financial advisory fees and estimated transaction expenses. FCMI Parent Co. (“FCMI”), which is controlled by Albert D. Friedberg, the chairman of our board of directors, and Vaccinex (Rochester) L.L.C., which is majority owned and controlled by Dr. Maurice Zauderer, our President, Chief Executive Officer, and a member of our board of directors, participated in the transactions contemplated by the Inducement Letter Agreements.

On March 28, 2024, we entered into a securities purchase agreement with Alzheimer’s Drug Discovery Foundation pursuant to which we sold shares of a newly designated series of convertible preferred stock, our Series A Preferred Stock, and warrants to purchase up to 229,057 shares of our common stock for an aggregate purchase price of $1.75 million.

On March 27, 2024, we entered into a securities purchase agreement pursuant to which we issued and sold 193,000 shares of our common stock in a public offering together with warrants to purchase up to 193,000 shares of common stock in a concurrent private placement at a combined price of $7.77 per share and accompanying warrant for an aggregate purchase price of approximately $1.5 million. Separately on March 27, 2024, we entered into a securities purchase agreement in a different form pursuant to which we sold 159,683 shares of common stock and warrants to purchase up to 159,683 shares of common stock in a private placement at a combined price of $7.77 per share and accompanying warrant for an aggregate purchase price of approximately $1.25 million. FCMI and Vaccinex (Rochester) L.L.C. purchased shares of our common stock and accompanying warrants in the latter transaction.

On February 6, 2024, we entered into a securities purchase agreement pursuant to which we issued and sold 274,182 shares of our common stock together with warrants to purchase up to 274,182 shares of common stock at a combined price of $10.15 per share and accompanying warrant and (ii) pre-funded warrants to purchase up to 90,363 shares of common stock together with warrants to purchase up to 90,363 shares of our common stock at a combined price of $10.1486 per pre-funded warrant and accompanying warrant, for aggregate gross proceeds of

27


 

approximately $3.7 million. FCMI and Vaccinex (Rochester) L.L.C. purchased 118,227 and 29,557 shares of our common stock and accompanying warrants, respectively, in the February 2024 offering for an aggregate purchase price of $1.5 million.

 

Our cash and cash equivalents were $2.9 million and total current assets were $4.8 million at September 30, 2024, which will be insufficient to fund our planned operations through one year of the date that these condensed financial statements are available for issuance. See Note 1 of our unaudited condensed financial statements. There can be no assurances that we will be able to secure additional financing when needed, or if available, that it will be sufficient to meet our needs or on favorable terms.

Nasdaq Deficiency Notice

On April 11, 2024, the Company received a letter from the Listing Qualifications staff of Nasdaq notifying the Company that based on the financial statements contained in its Form 10-K for the year-ended December 31, 2023, it no longer complies with the requirement under Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders’ equity for continued listing on the Nasdaq Capital Market (the “Equity Standard”) or the alternative requirements of having a market value of listed securities of $35.0 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years (the “Alternative Standards”) , and may be subject to delisting. The notification letter had no immediate effect on the Company’s listing on the Nasdaq Capital Market and the Company timely submitted a plan to regain compliance with the Equity Standard.

On June 5, 2024, Nasdaq notified the Company that it has been provided an extension to regain and evidence compliance with the Equity Standard on or before September 30, 2024. As of September 30, 2024, we had a stockholders' deficit of $1.3 million. On October 7, 2024, the Company received a letter from the Nasdaq Listing Staff stating that the Company had not regained compliance with the Equity Standard or the Alternatives Standards and that, as a result, unless the Company timely requested an appeal of this determination to a Nasdaq Hearings Panel, Nasdaq would move to suspend trading of the Company’s common stock and to have the Company’s securities delisted from the Nasdaq Capital Market. The Company timely appealed the determination, which automatically stayed any suspension or delisting action pending the Hearings Panel’s decision and the expiration of any additional extension period granted by the Hearings Panel following the hearing set for December 5, 2024. As a result, the Company’s common stock is expected to remain listed on the Nasdaq Capital Market through at least that time. However, there can be no assurance that the Hearings Panel will grant the Company’s request for continued listing or that the Company will be able to demonstrate compliance with the Equity Standard or the Alternative Standards within any additional compliance period that may be granted by the Hearings Panel.

Clinical Update

Alzheimer's Disease

The Company initiated a randomized, placebo-controlled, multi-center phase 1/2a clinical study of pepinemab in AD, or the SIGNAL-AD trial, in 2021. On March 28, 2024, we entered into a second agreement with Alzheimer’s Drug Discovery Foundation pursuant to which we sold shares of a newly designated series of convertible preferred stock, our Series A Preferred Stock, and warrants to purchase up to 229,057 shares of our common stock for an aggregate purchase price of $1.75 million. This trial is based on evidence from the SIGNAL clinical trial in HD that showed treatment with pepinemab reduced cognitive decline and induced a sharp increase in glucose metabolism in the brain during HD disease progression as detected by conventional FDG-PET imaging. Previous studies in AD have shown that decline in glucose metabolism correlates with cognitive decline. In April 2023, we reached our enrollment target for the Phase 1b/2 SIGNAL-AD study evaluating pepinemab as a potential treatment for people with Mild Cognitive Impairment (MCI) or mild dementia due to AD. On April 25, the Company provided an update regarding plans for analysis of biomarkers and clinical outcome measures during a presentation at 12th Annual Alzheimer’s & Parkinson’s Drug Development Summit. All 50 participants have completed 12-months of treatment on June 30, 2024, and SIGNAL-AD topline data was reported by Eric Siemers, MD, Principal Investigator of the SIGNAL-AD trial at the Alzheimer's Association International Conference in Philadelphia on July 31, 2024. Additional efficacy data for SIGNAL-AD was reported by Elizabeth Evans, PhD, Senior VP Discovery and

28


 

Translational Research and Chief Operating Officer on October 31, 2024, at the Clinical Trials on Alzheimer’s Disease Conference in Madrid, Spain.

An important secondary endpoint of the study was to determine whether pepinemab prevents decline in brain metabolic activity consistent with blocking astrocyte reactivity as evidenced by an increase in FDG-PET imaging signal in a major brain region known to be affected by disease progression. This was determined over the course of 12-months of treatment with pepinemab relative to placebo. Pepinemab treatment resulted in a statistically significant increase (p=0.0297) in FDG-PET signal in the medial temporal cortex of patients with Mild Cognitive Impairment (MCI) due to AD. The medial temporal region of brain includes hippocampus and entorhinal cortex, known to be affected during early disease progression in many patients with MCI. A similar significant result of pepinemab treatment on brain metabolic activity was previously shown in our phase 2 study of HD, which we believe highlights mechanistic similarities in the pathology of these two neurodegenerative diseases.

Although the present study was not sufficiently powered to detect cognitive effects or changes in some additional secondary endpoints with statistical significance, we previously reported that, in a larger study that enrolled approximately 90 HD patients/arm with early symptoms of cognitive deficits, seemingly similar to MCI in AD, pepinemab treatment improved performance on key cognitive and psychological measures.

We believe that results of the SIGNAL-AD study demonstrate that pepinemab has a similar effect in Alzheimer’s to those we previously described for a key outcome in Huntington’s disease, preventing the characteristic disease-related decline of brain metabolic activity in a brain region known to be affected early in disease progression. This positive data release suggests that pepinemab has the potential to benefit patients with MCI due to AD. AD and HD share important pathological features and clinical symptoms, and we believe that our approach of confirming similar treatment effects of pepinemab in these two different neurodegenerative diseases is strongly supportive of pepinemab as a potentially well-tolerated and effective treatment for both Alzheimer’s and Huntington’s disease.

Our study indicates that pepinemab may be most effective in patients with early stage symptoms, e.g., Mild Cognitive Impairment (MCI) or Mild Dementia due to AD. This suggests that a promising treatment strategy would be to identify people with MCI as early as possible and to treat with pepinemab to keep them from progressing for as long as possible. We believe that, to date, no disease modifying therapy has been shown to be effective in later stages of AD dementia.

The Alzheimer’s Association estimates that 12% to 18% of people age 60 or older are living with MCI due to AD and that about one-third of these patients will develop dementia within five years. A drug that can slow progression of MCI could significantly extend a rewarding and productive life for people at risk.

Pepinemab has been well-tolerated in clinical trials that enrolled a total of more than 600 patients primarily in neurological indications, AD, HD, and MS. Current concerns about the limitations of treatment with approved anti-Aβ amyloid antibodies such as Leqembi™ (Eisai and Biogen) and Kisunla™ (Eli Lilly) might make pepinemab, if approved, attractive as either an alternative for patients at high risk for adverse events related to treatment with Leqembi or Kisunla, and could also be a complementary treatment to enhance benefit of such anti-Aβ antibodies to patients.

Cancer

As prespecified in the study protocol, the Company analyzed interim data from the first 36 patients in the open-label, single-arm, Phase 2 KEYNOTE B-84 study (NCT04815720) evaluating pepinemab and KEYTRUDA™ in immunotherapy naïve patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The study was based on preclinical and clinical studies demonstrating that antibody blockade of semaphorin 4D (SEMA4D) in combination with immune checkpoint inhibitors (ICI) promotes infiltration of CD8+ cytotoxic T cells and inhibits the recruitment and function of myeloid derived suppressor cells (MDSC) in tumors, enabling enhanced ICI efficacy. The study results showed that pepinemab in combination with KEYTRUDA™ resulted in an approximately 2X increase in objective responses (ORR) and median progression free survival (PFS) in patients with hard-to-treat PD-L1-low tumors, those with combined positive score <20 (CPS<20), compared to historical response rates for ICI monotherapy in this population. ORR for the CPS<20 population was 21.1% with median PFS

29


 

of 5.79 months, which is almost 2X that of historical response to checkpoint monotherapy in this population, ORR 11.9% and PFS 2.2 months. In contrast, patients in the CPS>20 subgroup (n=17) responded similarly to historical ICI monotherapy data. Biopsy data suggest that treatment-induced formation of highly organized lymphoid aggregates, tertiary lymphoid structures (TLS), correlate with disease control. TLS are characterized by a high density of B cells, antigen-presenting dendritic cells and activated T cells including stem-like TCF-1+, PD-1+, CD8+ T cells whose expansion and differentiation has previously been shown to be central for response to checkpoint inhibitors. The safety of pepinemab in combination with KEYTRUDA is regularly reviewed by an independent safety committee and has to date been found to be well tolerated.

 

In January and March 2024, the Company and its collaborators presented posters at the ASCO Gastrointestinal Cancers Symposium and the Society for Surgical Oncology Annual Meeting, respectively:

Phase 1b/2 PDAC Study: The team from University of Rochester Cancer Center and Wilmot Cancer Institute presented the plan for the single-arm, open-label study to evaluate pepinemab in combination with BAVENCIO®(avelumab) as second line combination immunotherapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC, TPS4195, NCT05102721). The Company-sponsored study will employ a Bayesian Optimal Interval (BOIN) Design in the Phase 1b segment and a Simon two stage assessment in the Phase 2 segment and is expected to enroll 40 subjects. The trial rationale is supported by data from prior studies suggesting that pepinemab may reduce immune suppression in the TME, rendering “cold” tumors such as PDAC to become “hot” and enhancing efficacy of ICIs such as avelumab. The study is being conducted with grant support from the Gateway Discovery Award.

 

Financial Overview

Revenue

To date, we have not generated any revenue from sales of our product candidates. The Company recorded service revenue of $52,000 and $20,000 during the three months ended September 30, 2024 and 2023, respectively. The Company recorded service revenue of $388,000 and $70,000 during the nine months ended September 30, 2024 and 2023, respectively, and $500,000 in revenue related to the achievement of a contractual milestone during the nine months ended September 30, 2023 from our collaboration agreement with Surface Oncology.

 

Our ability to generate revenue and become profitable depends on our ability to successfully obtain marketing approval of and commercialize our product candidates. We do not expect to generate product revenue in the foreseeable future as we continue our development of, and seek regulatory approvals for, our product candidates, and potentially commercialize approved products, if any.

Operating Expenses

Research and Development. Research and development expenses consist primarily of costs for our clinical trials and activities related to regulatory filings, employee compensation-related costs, supply expenses, equipment depreciation and amortization, consulting, and other miscellaneous costs. The following table sets forth the components of our research and development expenses and the amount as a percentage of total research and development expenses for the periods indicated.

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

 

%

 

 

(in thousands)

 

 

%

 

 

(in thousands)

 

 

%

 

 

(in thousands)

 

 

%

 

Clinical trial costs

 

$

1,578

 

 

 

50

%

 

$

2,728

 

 

 

63

%

 

$

5,173

 

 

 

50

%

 

$

8,206

 

 

 

62

%

Wages, benefits, and related costs

 

 

1,184

 

 

 

37

%

 

 

1,158

 

 

 

27

%

 

 

3,586

 

 

 

34

%

 

 

3,609

 

 

 

27

%

Preclinical supplies and equipment depreciation

 

 

318

 

 

 

10

%

 

 

365

 

 

 

8

%

 

 

1,203

 

 

 

12

%

 

 

1,105

 

 

 

9

%

Consulting, non-clinical trial services, and other

 

 

84

 

 

 

3

%

 

 

104

 

 

 

2

%

 

 

449

 

 

 

4

%

 

 

297

 

 

 

2

%

Total research and development expenses

 

$

3,165

 

 

 

 

 

$

4,355

 

 

 

 

 

$

10,412

 

 

 

 

 

$

13,217

 

 

 

 

 

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We expense research and development costs as incurred. We record costs for certain development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment. We do not allocate employee-related costs, depreciation, rental and other indirect costs to specific research and development programs because these costs are deployed across multiple product programs under research and development.

Our current research and development activities primarily relate to clinical development in the following indications:

Alzheimer’s Disease. We initiated a randomized, placebo-controlled, multi-center phase 1/2a clinical study of pepinemab in AD, or the SIGNAL-AD trial, in 2021. This trial is based on evidence from the SIGNAL clinical trial in HD that showed treatment with pepinemab reduced cognitive decline and induced a sharp increase in glucose metabolism in the brain during HD disease progression as detected by conventional FDG-PET imaging. Previous studies in AD have shown that decline in glucose metabolism correlates with cognitive decline. In April 2023, we reached our enrollment target for the Phase 1b/2 SIGNAL-AD study evaluating pepinemab as a potential treatment for people with mild dementia due to AD. As of June 6, 2024, the last patient completed their last visit in the SIGNAL-AD Phase 1b/2 study of pepinemab treatment for Alzheimer’s disease. SIGNAL-AD topline data was reported by Eric Siemers, MD, Principal Investigator of the SIGNAL-AD trial at the Alzheimer's Association International Conference in Philadelphia on July 31, 2024. Additional efficacy data for SIGNAL-AD was reported by Elizabeth Evans, PhD, Senior VP Discovery and Translational Research and Chief Operating Officer on October 31, 2024 at the Clinical Trials on Alzheimer’s Disease Conference in Madrid, Spain.
Cancer Studies. We and others have shown that SEMA4D, the target of pepinemab, is highly expressed in head and neck cancer where it impedes recruitment and activation of cytotoxic T cells that can attack the tumor while also inducing differentiation of myeloid derived suppressor cells that inhibit any remaining tumoricidal immune activity. Head and neck cancer is, therefore, a cancer in which immunotherapy with pepinemab in combination with a checkpoint inhibitor such as KEYTRUDA could be uniquely effective. We have entered into a collaboration with Merck, Sharp & Dohme, who is supplying KEYTRUDA, for first-line treatment of head and neck cancer patients and have analyzed interim data from the first 36 patients in the study. In a similar arrangement, we are collaborating with Merck KGaA (EMD Serono in the U.S.), who is supplying Bavencio, another checkpoint inhibitor, for combination with pepinemab in pancreatic cancer. Pepinemab is also being evaluated by third parties in investigator-sponsored trials, or ISTs, for breast cancer, and in multiple “window of opportunity” studies in additional cancer indications.
Huntington’s Disease. We have currently paused our research efforts for HD. We evaluated pepinemab for the treatment of HD in our Phase 2 SIGNAL trial. Topline data for this trial, consisting of 265 subjects, was reported in late September 2020. Although the study did not meet its prespecified primary endpoints, it provided important new information, including evidence of cognitive benefit and a reduction in brain atrophy and increase in brain metabolic activity in patients with manifest disease symptoms. An improved study design would focus on patients with early signs of cognitive or functional deficits since they appeared to derive the greatest treatment benefit. The Company is evaluating its development strategy in terms of business opportunity and other near-term clinical activities. To advance planning for a potential phase 3 study of pepinemab in HD, we requested a Type C meeting with the FDA to discuss details of the study design and key endpoints. We received requested clarifications regarding suitable endpoints for regulatory review from the FDA, and these will be incorporated in a possible future phase 3 study.

 

 

 

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Results of Operations

The following table set forth our results of operations for the periods presented (in thousands):

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Revenue

 

$

52

 

 

$

20

 

 

$

388

 

 

$

570

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

3,165

 

 

 

4,355

 

 

 

10,412

 

 

 

13,217

 

General and administrative

 

 

1,439

 

 

 

1,499

 

 

 

5,324

 

 

 

5,250

 

Total costs and expenses

 

 

4,604

 

 

 

5,854

 

 

 

15,736

 

 

 

18,467

 

Loss from operations

 

 

(4,552

)

 

 

(5,834

)

 

 

(15,348

)

 

 

(17,897

)

Interest expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1

)

Loss on settlement of warrants

 

 

(1,106

)

 

 

-

 

 

 

(1,106

)

 

 

-

 

Financing costs - warrant liabilities

 

 

-

 

 

 

-

 

 

 

(28

)

 

 

-

 

Change in fair value of warrant liabilities

 

 

(71

)

 

 

-

 

 

 

1,291

 

 

 

-

 

Change in fair value of derivative asset

 

 

-

 

 

 

-

 

 

 

(81

)

 

 

-

 

Other (expense) income, net

 

 

(3

)

 

 

922

 

 

 

12

 

 

 

964

 

Loss before provision for income taxes

 

 

(5,732

)

 

 

(4,912

)

 

 

(15,260

)

 

 

(16,934

)

Provision for income taxes

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Net loss attributable to Vaccinex, Inc.

 

$

(5,732

)

 

$

(4,912

)

 

$

(15,260

)

 

$

(16,934

)

 

Comparison of the Three Months Ended September 30, 2024 and 2023

Revenue

The Company recorded service revenue of $52,000 and $20,000 during the three months ended September 30, 2024 and 2023, respectively.

Operating Expenses

 

 

Three Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

$ Change

 

 

% Change

 

 

 

(in thousands)

 

 

 

 

Research and development

 

$

3,165

 

 

$

4,355

 

 

$

(1,190

)

 

 

(27

)%

General and administrative

 

 

1,439

 

 

 

1,499

 

 

 

(60

)

 

 

(4

)%

Total operating expenses

 

$

4,604

 

 

$

5,854

 

 

$

(1,250

)

 

 

(21

)%

 

Research and Development. Research and development expenses in the three months ended September 30, 2024 decreased by $1.2 million, or 27%, compared to the three months ended September 30, 2023. The decrease was primarily attributable to the winding down of the SIGNAL-AD trial, a pause in enrollment for the head and neck cancer trial, and less drug manufacturing costs.

 

General and Administrative. General and administrative expenses consist primarily of the necessary costs associated with maintaining the Company’s daily operations and administration of the Company’s business. General and administrative expenses in the three months ended September 30, 2024 were essentially the same when compared to the three months ended September 30, 2023.

 

 

32


 

Comparison of the Nine Months Ended September 30, 2024 and 2023

Revenue

The Company recorded service revenue of $388,000 and $70,000 during the nine months ended September 30, 2024 and 2023, respectively, and $500,000 in revenue during the nine months ended September 30, 2023 from our collaboration agreement with Surface Oncology.

 

Operating Expenses

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

$ Change

 

 

% Change

 

 

 

(in thousands)

 

 

 

 

Research and development

 

$

10,412

 

 

$

13,217

 

 

$

(2,805

)

 

 

(21

)%

General and administrative

 

 

5,324

 

 

 

5,250

 

 

 

74

 

 

 

1

%

Total operating expenses

 

$

15,736

 

 

$

18,467

 

 

$

(2,731

)

 

 

(15

)%

 

 

Research and Development. Research and development expenses in the nine months ended September 30, 2024 decreased by $2.8 million, or 21%, compared to the nine months ended September 30, 2023. The decrease was primarily attributable to the winding down of the SIGNAL-AD trial, a pause in enrollment for the head and neck cancer trial, and less drug manufacturing costs.

General and Administrative. General and administrative expenses consist primarily of the necessary costs associated with maintaining the Company’s daily operations and administration of the Company’s business. General and administrative expenses in the nine months ended September 30, 2024 were essentially the same when compared to the nine months ended September 30, 2023.

 

Liquidity and Capital Resources

To date, we have not generated any revenue from sales of our product candidates. Our recurring net losses and negative cash flows from operations raised substantial doubt regarding our ability to continue as a going concern within one year after the issuance of our unaudited condensed financial statements. During the nine months ended September 30, 2024 and the year-ended December 31, 2023, we have generated a limited amount of revenue through the achievement of contractually stated milestones as well as grants, and the performance of services from collaboration agreements, including through our ActivMAb platform. See Note 1 of our unaudited condensed financial statements. Since our inception in 2001, we have relied on public and private sales of equity and debt financing to fund our operations, in addition to capital contributions from noncontrolling interests and limited-service revenue from collaboration agreements.

During the nine months ended September 30, 2024, the Company sold 208 shares of the Company’s common stock at a weighted average price per share of $10.30 through the Open Market Sale Agreement, for net proceeds of $2,077, respectively.

Additionally, during the nine months ended September 30, 2024 the Company received aggregate gross proceeds of approximately $14.1 million from (i) private placements of 433,865 shares of common stock, 90,363 pre-funded warrants and 717,228 warrants to purchase shares of common stock (ii) a public offering of 193,000 shares of common stock (iii) sale of 10 shares of our Series A Preferred Stock, and warrants to purchase up to 229,057 shares of our common stock, and (iv) exercise of warrants.

Series A Preferred Stock

On March 28, 2024, we sold shares of a newly designated series of our preferred stock, the Series A Preferred Stock. Our Series A Preferred Stock is convertible at the election of the holder at any time after the public announcement by the Company of top-line data from its SIGNAL-AD Alzheimer’s disease study (the “Data Release”) into shares of common stock at a conversion price equal to the greater of (a) $7.77 per share of common

33


 

stock and (b)(i) the volume weighted average price of the common stock for the last three trading days prior to delivery of the conversion notice if the common stock is traded on a trading market or if its prices are reported on OTCQB or OTCQX, (ii) the most recent bid price of the common stock if it is then traded on The Pink Open Market, or (iii) in all other cases the fair market value of the common stock as determined by an independent appraiser, which conversion right is subject to termination on the last full day preceding the proposed effective date for exercise of the Company’s redemption right or the date fixed for redemption upon a Deemed Liquidation Event (generally defined to include certain fundamental transactions involving the company including a merger or sale of substantially all of the Company’s assets) or on a liquidation, dissolution or winding up of the Company.

The Series A Preferred Stock is non-voting, has no mandatory redemption, and carries an annual 5% cumulative dividend, increasing by 2% each year, which dividend rate shall not exceed 12%. The Series A Preferred Stock will also participate on an as-converted basis in any regular or special dividends paid to holders of our common stock.

In addition, the Series A Preferred Stock has a liquidation preference equal to the greater of (i) $175,000 per share, subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series A Preferred Stock (the “Original Share Price”), plus any accrued but unpaid dividends thereon, whether or not declared, together with any other dividends declared but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series A Preferred Stock been converted into common stock immediately prior to such liquidation, dissolution, winding up or Deemed Liquidation Event.

The Company also agreed that so long as the Series A Preferred Stock is outstanding, the Company will not, without the written consent of the holders of 50.1% of the Series A Preferred Stock, (i) amend, alter, or repeal any provision of the Company’s certificate of incorporation or bylaws in a manner adverse to the Series A Preferred Stock or (ii) until March 29, 2026, incur any indebtedness for borrowed money in excess of $1.0 million.

The Company has the right to redeem the Series A Preferred Stock at a price equal to the Original Share Price per share at any time after a public announcement of an increase in pepinemab-treated patients relative to placebo-treated patients, with statistical significance having a p-value of less than or equal to 0.05, in the change of the FDG-PET standard uptake value ratio for brain metabolism between baseline and month 12 as assessed by [18F]fluorodeoxyglucose (FDG)-PET in the resting state following administration of 40 mg/kg pepinemab or placebo, as applicable, as described in the protocol for the Company’s SIGNAL-AD Alzheimer’s disease study and the associated Statistical Analysis Plan, provided that (i) the holder is not in possession of any material nonpublic information that was provided by the Company or any of its directors, directors, employees, agents, or affiliates and (ii) there is an effective resale registration statement on file covering the underlying common stock.

The holders of outstanding shares of Series A Preferred Stock have no voting rights with respect to such shares of Series A Preferred Stock on any matter presented to the Company’s stockholders, except as required by law or as specifically set forth in the Certificate of Designation of Series A Preferred Stock.

Operating Capital Requirements

Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, third-party research services and amounts due to vendors for research supplies. As of September 30, 2024 and December 31, 2023, our principal source of liquidity was cash and cash equivalents in the amount of $2.9 million and $1.5 million, respectively. Given our projected operating requirements, our existing cash and cash equivalents and marketable securities, we will seek to complete an additional financing transaction or transactions in order to continue operations.

Since our inception in 2001, we have incurred significant net losses and negative cash flows from operations. For the nine months ended September 30, 2024 and 2023, we reported a net loss of $15.3 million and $16.9 million, respectively. For the nine months ended September 30, 2024 and 2023, we reported cash used in operations of $12.3 million and $13.6 million, respectively. As of September 30, 2024 and December 31, 2023, we had an accumulated deficit of $355.2 million and $339.9 million, respectively. We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates. We are subject to risks associated with the development of new

34


 

biopharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors, which may adversely affect our business.

Our recurring net losses and negative cash flows from operations, as well as forecast of continued losses and negative cash flows from operations, raised substantial doubt regarding our ability to continue as a going concern within one year after the issuance of our financial statements for the year ended December 31, 2023. Until we can generate a sufficient amount of revenue from the commercialization of our product candidates, we expect to finance our operations through the public or private sale of equity, debt financing, or other capital sources, such as government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. Our cash and cash equivalents were $2.9 million and total current assets were $4.8 million at September 30, 2024, which the Company is projecting will be insufficient to sustain its operations through one year following the date that the financial statements are issued.

Financing strategies we may pursue include, but are not limited to, the public or private sale of equity, debt financing or funds from other capital sources, such as government funding, collaborations, strategic alliances, or licensing arrangements with third parties. There can be no assurances additional capital will be available to secure additional financing, or if available, that it will be sufficient to meet our needs on favorable terms. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development of one or more of our product candidates. If we raise additional funds through the public or private sale of equity or debt financing, it could result in dilution to our existing stockholders or increased fixed payment obligations and these securities may have rights senior to those of our common stock and could contain covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license our intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition, and prospects.

Cash Flows

The following table summarizes our cash flows for the periods presented:

 

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

Cash used in operating activities

 

$

(12,254

)

 

$

(13,642

)

Cash used in investing activities

 

 

(22

)

 

 

(67

)

Cash provided by financing activities

 

 

13,647

 

 

 

7,445

 

 

Operating Activities. We have historically experienced negative cash flows as we have developed our product candidates and continued to expand our business. Our net cash used in operating activities primarily results from our net loss adjusted for non-cash expenses and changes in working capital components as we have continued our research and development and is influenced by the timing of cash payments for research related expenses. Our primary uses of cash from operating activities are compensation and related expenses, employee-related expenditures, third-party research services and amounts due to vendors for research supplies. Our cash flows from operating activities will continue to be affected principally by the extent to which we increase spending on personnel, research and development and other operating activities as our business grows.

During the nine months ended September 30, 2024 and 2023, operating activities used $12.3 million and $13.6 million, respectively, in cash, primarily as a result of our continued efforts of discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs without any product revenue, resulting in a net loss of $15.3 million and $16.9 million, respectively.

Investing Activities. The investing activities during the nine months ended September 30, 2024 and 2023, were due to purchases of property and equipment.

Financing Activities. During the nine months ended September 30, 2024, financing activities provided $14.1 million, from the private placement of common stock and pre-funded warrants, with accompanying warrants, the

35


 

public offering of common stock and private placement of accompanying warrants, the sale of Series A Preferred Stock and accompanying warrants, and the exercise of warrants. During the nine months ended September 30, 2023, financing activities provided a net of $7.4 million, of which $6.3 million was due to private placements of common stock, $1.0 million through an award from the Alzheimer’s Drug Discovery Foundation in the form of an investment in our common stock and $0.2 million was due to the issuance of the Company’s common stock pursuant to the Open Market Sale Agreement.

Critical Accounting Policies and Estimates

Our unaudited condensed financial statements are prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosures. We evaluate our estimates and assumptions on an ongoing basis. Our estimates are based on historical experience and various other assumptions that we believe to be reasonable under the circumstances. Our actual results could differ from these estimates.

There have been no material changes to our critical accounting policies and significant judgments during the nine months ended September 30, 2024, other than those discussed in Note 2 of our unaudited condensed financial statements as of and for the nine months ended September 30, 2024, included elsewhere in this quarterly report on Form 10-Q.

Impact of Recent Accounting Pronouncements

For a discussion on the impact of recent accounting pronouncements on our business, see Note 2 to our unaudited condensed financial statements.

36


 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

As a smaller reporting company, we are not required to provide the information required by this item.

Item 4. Controls and Procedures

Evaluation of disclosure controls and procedures

Our Chief Executive Officer (our principal executive officer) and Chief Financial Officer (our principal financial officer), with the participation of our management evaluated the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as of September 30, 2024, the end of the period covered by this Form 10-Q. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of September 30, 2024, our disclosure controls and procedures were effective.

Changes in internal control over financial reporting

There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended September 30, 2024 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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Part II - OTHER INFORMATION

Item 1A. Risk Factors

An investment in our stock involves a high degree of risk. You should carefully consider the risks set forth in this section, and in Part I, Item 1A of the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the "Annual Report"), and all of the other information set forth in this Report, the Annual Report, and in the other reports we file with the SEC. If any of the risks contained in those reports actually occur, our business, results of operation, financial condition, and liquidity could be harmed, the value of our securities could decline, and you could lose all or part of your investment. Except as set forth below, there have been no material changes from risk factors disclosed in the Annual Report on Form 10-K. See the discussion of the Company’s risk factors under Part I, Item 1A. of the Annual Report.

We are currently not in compliance with the continued listing standards of the Nasdaq Capital Market, and if we are unable to regain compliance, our common stock will be delisted from the exchange.

Our common stock is currently listed for trading on the Nasdaq Capital Market under the symbol “VCNX." The continued listing of our common stock on Nasdaq is subject to our compliance with a number of listing standards, including Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders’ equity (the “Equity Standard”) or the alternative requirements of having a market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years (the “Alternative Standards”). On April 11, 2024, Nasdaq informed us that based on the financial statements contained in our Form 10-K for the year-ended December 31, 2023, the Company is no longer in compliance with the Equity Standard or the Alternative Standards and we may be subject to delisting. The notification letter had no immediate effect on the Company’s listing on the Nasdaq Capital Market and the Company timely submitted a plan to regain compliance with the Equity Standard.

On June 5, 2024, Nasdaq notified the Company that it has been provided an extension to regain and evidence compliance with the Equity Standard on or before September 30, 2024. As of September 30, 2024, we had a stockholders' deficit of $1.3 million. On October 7, 2024, the Company received a letter from the Nasdaq Listing Staff stating that the Company had not regained compliance with the Equity Standard or the Alternatives Standards and that, as a result, unless the Company timely requested an appeal of this determination to a Nasdaq Hearings Panel, Nasdaq would move to suspend trading of the Company’s common stock and to have the Company’s securities delisted from the Nasdaq Capital Market. The Company timely appealed the determination, which automatically stayed any suspension or delisting action pending the Hearings Panel’s decision and the expiration of any additional extension period granted by the Hearings Panel following the hearing set for December 5, 2024. As a result, the Company’s common stock is expected to remain listed on the Nasdaq Capital Market through at least that time. However, there can be no assurance that the Hearings Panel will grant the Company’s request for continued listing or that the Company will be able to demonstrate compliance with the Equity Standard or the Alternative Standards within any additional compliance period that may be granted by the Hearings Panel.

A delisting or even notification of failure to comply with such requirements would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In addition, the delisting of our common stock could lead to a number of other negative implications such as a loss of media and analyst coverage, a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and likely result in a reduced level of trading activity in the secondary trading market for our securities, and materially adversely impact our ability to raise capital on acceptable terms or at all. Delisting from Nasdaq could also have other negative results, including the potential loss of confidence by our current or prospective third-party providers and collaboration partners, the loss of institutional investor interest, and fewer licensing and partnering opportunities. In the event of a delisting, we would take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.

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If our common stock were no longer listed on Nasdaq, investors might only be able to trade on one of the over-the-counter markets, if at all. There is no assurance that prices for our common stock would be quoted on one of these other trading systems or that an active trading market for our common stock would exist, which would materially and adversely impact the market value of our common stock and your ability to sell our common stock.

The Series A Preferred Stock ranks senior to the Company’s common stock with respect to rights on the distribution of assets upon liquidation, dissolution and winding up.

The Series A Preferred Stock has a liquidation preference before our common stockholders equal to the greater of (i) $175,000 per share for a total of $1.75 million, subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series A Preferred Stock (the “Original Share Price”), plus any accrued but unpaid dividends thereon, whether or not declared, together with any other dividends declared but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series A Preferred Stock been converted into common stock immediately prior to such liquidation, dissolution, winding up or Deemed Liquidation Event. As of September 30, 2024, the holder of the shares of Series A preferred stock were entitled to a liquidation preference of $1.75 million, in the event of any liquidation, dissolution or winding up of the Company. Further, upon the occurrence of Deemed Liquidation Event (generally defined to include certain fundamental transactions involving the Company including a merger or sale of substantially all of the Company’s assets) or other liquidation of the Company, the holders of the Series A Preferred Stock will receive a distribution of the Company’s assets per their liquidation preference before any holders of common stock receive a distribution. As a result, in the event of a liquidation of the Company the proceeds received by the common stockholder may be reduced.

Shares of common stock issuable upon conversion of our Series A Preferred Stock will be dilutive to our existing shareholders upon conversion and adversely affect the market price of our common stock.

As of September 30, 2024, we had outstanding 10 shares of Series A Preferred Stock with an aggregate liquidation preference of $1.75 million. No shares of the outstanding Series A Preferred Stock are convertible before the public announcement by the Company of top-line data from its study “SEMA4D Blockade Safety and Brain Metabolic Activity in Alzheimer’s Disease (AD)” (the “Data Release”). The Data Release was made on July 31, 2024, but no shares of Series A Preferred Stock have to date been converted into shares of common stock. The issuance of common stock upon conversion of the Series A Preferred Stock would result in immediate dilution to existing holders of our common stock.

The Alzheimer’s Drug Discovery Foundation may be able to sell shares of our common stock in the public market, which may cause the market price of our common stock to decrease, and therefore make it more difficult to raise equity financing or issue equity as consideration in an acquisition.

Our registration rights agreement with the Alzheimer’s Drug Discovery Foundation requires us to register all shares of common stock held by the Alzheimer’s Drug Discovery Foundation issuable upon conversion of the Series A Preferred Stock and upon the exercise of certain warrants issued in connection with the Series A Preferred Stock under the Securities Act of 1933, as amended. The registration rights for the Alzheimer’s Drug Discovery Foundation allows it to sell its shares without compliance with the volume and manner of sale limitations under Rule 144 promulgated under the Securities Act and facilitates the resale of such securities into the public market. The market value of our common stock could decline as a result of sales by the Alzheimer’s Drug Discovery Foundation from time to time. In particular, the future sale of a substantial number of the shares of our common stock by the Alzheimer’s Drug Discovery Foundation within a short period of time, or the perception that such sale might occur, could cause our stock price to decrease, make it more difficult for us to raise funds through future offerings of our common stock or acquire other businesses in the future using our common stock as consideration for the purchase price.

 

 

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Item 6. Exhibits

INDEX TO EXHIBITS

 

Exhibit No.

Description

 

 

 

4.1

 

Form of Common Stock Purchase Warrant (incorporated herein by reference from Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on September 19, 2024)

 

 

 

10.1

 

Form of Inducement Letter Agreement, by and between the Company and each purchaser identified on the signature pages thereto, dated as of September 17, 2024 (incorporated herein by reference from Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on September 19, 2024).

 

 

 

  31.1*

 

Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

  31.2*

 

Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

  32.1**

 

Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

101.INS

 

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents

 

   104

 

The cover page for the Company’s Quarterly Report on Form 10-Q has been formatted in Inline XBRL and contained in Exhibit 101

 

* Filed herewith.

** Furnished herewith.

 

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SIGNATURES

 

Pursuant to the requirements 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.

 

Vaccinex, Inc.

(Registrant)

November 14, 2024

By:

/s/ Maurice Zauderer

Maurice Zauderer, Ph.D.

President & Chief Executive Officer

(Principal Executive Officer)

November 14, 2024

By:

/s/ Jill Sanchez

Jill Sanchez, CPA

Chief Financial Officer

(Principal Financial Officer)

 

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