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目錄

美國

證券交易委員會

華盛頓特區 20549

 

表格 10-Q

(標記一個)

根據部分提交的季度報告 1934年證券交易所法案第13條或第15(d)條

 

截至2024年6月30日季度結束 2024年9月30日

 

 

TRANSITION REPORt PURSUANt TO SECTION 1934年證券交易所法案第13條或第15(d)條

 

過渡期從                     至                  

 

委員會文件編號 001-33678

 

novabay pharmaceuticals, inc.

(依憑章程所載的完整登記名稱)

 

特拉華州

68-0454536

(成立地或組織其他管轄區)

(聯邦稅號)

 

2000 Powell Street, Suite 1150, 艾默維爾, 加利福尼亞州 94608

(總部辦公地址) (郵政編碼)

 

申報人於2024年股東權益計劃協議(以下簡稱“權益計劃協議”)中提交的Registrant的股東權益計劃(以下簡稱“權益計劃”),已於2024年7月24日獲得董事會批准。權益計劃的目的是,盡可能防止公司被潛在買盤接管,並確保誠實和公平的證券接管競標過程,以及確保董事會有足夠時間評估未經請求的證券接管競標並探索和發展最大化股東價值的替代方案。s Telephone Number, Including Area Code: (510) 899-8800

 

根據法案第12(b)條登記的證券:

 

每個班級的標題

交易標的(s)

每個交易所的名稱

已登記

每股普通股,面值為0.01美元

NBY

紐交所美國板塊

 

根據法案第12(g)條登記的證券:無。

 

標明並以核准符號表示,證券交易法 1934 年第 13 或 15(d) 條要求之申報已經登記來進行報告了,該報告需涵蓋過去12個月期間 (或是公司需要進行該等報告的較短期間),並且過去90天內已經受到相關的申報要求。☒    否 ☐

 

請勾選以下方框以指示公司是否在過去12個月內(或公司需要提交此類文件的較短期間內)按照S-t法規第405條的要求提交了所有互動數據文件。 ☒    不適用 ☐

 

請勾選該申報者是否為大型快速申報者、快速申報者、非快速申報者、小型報告公司或新興成長公司。請參閱交易所法案第1202條中“大型快速申報者”、“快速申報者”、“小型報告公司”和“新興成長公司”的定義。

 

大型快速申報者

加速披露人

新興成長型企業

非加速歸檔人 

小型報告公司

   

 

如果是新興成長型企業,在符合任何依據證券交易法第13(a)條所提供的任何新的或修改的財務會計準則的遵循的延伸過渡期方面,是否選擇不使用核准記號進行指示。☐

 

檢查標記指示申報人是否為空殼公司(如Exchange Act第120億2條的定義)。 是不☒

 

截至2024年11月5日,其普通股的流通股數共為 4,885,693 家居登記的普通股總共有股份流通。

 

 

 

 

novabay pharmaceuticals, inc.

 

目 錄

 

第I部分

財務信息

 

项目1。

基本報表

3
     
 

資產負債表摘要:2024年9月30日(未經審核)和2023年12月31日

3

     
 

綜合營運報表摘要:截至2024年9月30日及2023年的三個月和九個月 (未經審計)

4
     
 

股東權益的縮編合併財務報表 權益(赤字):截至2024年9月30日及2023年的三個月和九個月 (未經審計)

5
     
 

截至2024年和2023年9月30日之間的綜合現金流量表 (未經審計)

7
     
 

基本財務報表附註(未經審計)

8
     

项目2。

管理對財務狀況和營運結果的討論和分析

46
     

项目3。

市場風險的定量和定性披露。

57
     

項目 4。

內部控制及程序

57

 

第二部分

其他信息

 

项目1。

法律訴訟

58
     

项目1A。

風險因素

58
     

项目2。

股票權益的未註冊銷售和資金用途

59
     

项目3。

優先證券違約

59
     

項目 4。

礦業安全披露

59
     

项目5。

其他信息

59
     

第6項。

展品

60
     

簽名

62

 

 

除非情境需要不同,本報告中所有提及的"我們","我們的","我們","公司"和"novabay"指的是novabay pharmaceuticals,一家特拉華州公司,如適用,也包括其以前的全資附屬公司DERMAdoctor,一家密蘇里州有限責任公司。

 

公司擁有美國的活躍商標註冊,以及在其他許多國家國際間的商標註冊和待申請,我們的主要商標包括“Avenova®”,“CelleRx®”,“PhaseOne®”和其它國家。 “NeutroPhase®”等商標是NovaBay直接持有。而“DERMAdoctor®”,“Kakadu C®”,“AIN’t Misbehavin’®”和“KP Duty®”是由我們前全資子公司DERMAdoctor直接持有。 “DERMAdoctor®”是由我們之前的全資子公司DERMAdoctor直接持有。

 

於2024年5月30日,公司實施了普通股1換35的逆向股票拆分("")。附帶的基本報表和相關附註反映了這次逆向股票拆分的追溯效應。股票合併倒數附帶的基本報表和相關附註反映了這次逆向股票拆分的追溯效應。

 

 

 
 

第I部分

財務信息

 

項目 1。

基本報表

 

 

novabay pharmaceuticals, inc.

 

縮表合併資產負債表

(以千為單位,除每股面額金額外)

 

   

九月三十日,

2024

   

12月31日,

2023

 
   

(未經查核)

         
                 

資產

               

流動資產:

               

現金及現金等價物

  $ 776     $ 2,924  

應收賬款淨額,扣除信用損失準備($3 at September 30, 2024 and December 31, 2023)

    704       680  

存貨淨額,扣除存貨過剩及淘汰存貨以及成本或預估淨可實現價值調整($126 15.1264 於2024年9月30日和2023年12月31日分別

    473       564  

預付費用及其他流動資產

    326       256  

流動資產,已中止運作

          2,730  

全部流動資產

    2,279       7,154  

營運租賃權使用資產

    1,042       1,296  

物業及設備,扣除折舊後淨值

    61       87  

其他資產

    495       478  

其他資產、停業營運

          19  

總資產

  $ 3,877     $ 9,034  
                 

負債及股東權益 股東權益

               

負債:

               

流動負債:

               

應付賬款

  $ 396     $ 906  

應付負債

    1,147       1,169  

扣除折扣後的保證可轉換票據

          1,137  

扣除折扣後的無抵押可轉換票據

    51        

營業租賃負債

    390       368  

流動負債,已停止營運

          698  

流動負債合計

    1,984       4,278  

認股權負債

          334  

非流動營業租賃負債

    821       1,108  

總負債

    2,805       5,720  

承諾事項和或附帶條件(注8)

           

股東權益:

               

優先股,面額$0.01,授權股數為5,000,000股,發行且流通股數為截至2024年6月30日和2023年12月31日之184,668,188股和181,364,180股。0.01 面額為0.0001; 5,000 截至2024年6月30日和2023年12月31日,已發行及流通股份16,096,296和15,953,212股,

               

B系列優先股; 16 2024年9月30日和2023年12月31日分別發行並流通的股份

    6       275  

C輪優先股; 01 2024年9月30日和2023年12月31日分別發行並流通的股份

          1,675  

0.010.01 面額為0.0001; 150,000 股份已授權 4,885321 於2024年9月30日和2023年12月31日分別已發行及流通股數*

    49       3  

額外資本溢額*

    183,262       176,210  

累積虧損

    (182,245 )     (174,849 )

股東權益總額

    1,072       3,314  

负债合计 及股東權益

  $ 3,877     $ 9,034  

 

*

在對1比35的逆向股票合併進行追溯生效之後 5月30日生效的逆向股票拆分。

 
 

 

附註是這些未經審計的簡明綜合財務報表的一個組成部分。

 

-3-

 

 

novabay pharmaceuticals, inc.

 

綜合營業損益匯縮陳述

(未經查核)

(以千美元為單位,除每股數據外)

 

   

三個月結束了

九月三十日,

   

截至九個月

九月三十日,

 
   

2024

   

2023

   

2024

   

2023

 

銷售:

                               

營業收入淨額

  $ 2,424     $ 2,471     $ 7,435     $ 8,326  

其他營業收入,淨額

    17       10       37       28  

總銷售額,淨額

    2,441       2,481       7,472       8,354  
                                 

營業成本

    848       819       2,493       3,353  

毛利潤

    1,593       1,662       4,979       5,001  

營業費用:

                               

研發費用

    4       4       32       36  

銷售和市場推廣費用

    947       1,263       3,021       3,674  

總務與行政

    1,703       1,093       5,611       4,385  

創業子公司出售損失

                865        

營業費用總計

    2,654       2,360       9,529       8,095  

營業虧損

    (1,061 )     (698 )     (4,550 )     (3,094 )
                                 

公允價值權證負債變動的非現金收益

                114       216  

嵌入性衍生負債公允價值變動的非現金(虧損)收益

                (18 )     40  

可轉換票據利息累積及折價攤銷

    (138 )     (655 )     (871 )     (1,156 )

清償擔保可轉換票據

    (13 )           (13 )      

其他費用,淨額

                (549 )     (432 )

持續營運淨損失

    (1,212 )     (1,353 )     (5,887 )     (4,426 )
                                 

停止運作的淨虧損(附註18)

          (404 )     (124 )     (1,106 )

淨損失

    (1,212 )     (1,757 )     (6,011 )     (5,532 )

減少:由於普通股認股權行使價調整而增加累積赤字

    (1,005 )           (1,005 )      

減少:由於優先股轉換價格調整而增加累積赤字

                (380 )     (1,996 )

歸屬於普通股股東的淨虧損

  $ (2,217 )   $ (1,757 )   $ (7,396 )   $ (7,528 )
                                 

每股基本及稀釋淨虧損

                               

每股繼續營運淨損失*

  $ (0.60 )   $ (10.10 )   $ (3.90 )   $ (67.89 )

每股已停止運作淨損失*

          (3.01 )     (0.07 )     (11.69 )

歸屬於普通股股東的每股基本和稀釋淨損失*

  $ (0.60 )   $ (13.11 )   $ (3.97 )   $ (79.58 )

用於計算每股普通股淨虧損(基本和稀釋)的加權平均普通股股份

    3,710       134       1,863       95  

 

*

在將生效日期設定為2024年5月30日的1比35的逆向股票拆分後,給予追溯效力。

 

附註是這些未經審計的簡明綜合財務報表的一個組成部分。

 

-4-

 

 

novabay pharmaceuticals, inc.

股東總權益縮減財務報表’ 權益(赤字)

(未經查核)

(以千為單位)

 

   

優先股

   

普通股

   

額外的

已付款

   

累計

   

總計

股東权益

股權

 
   

股份

   

金額

   

分享*

   

金額*

   

資本*

   

赤字累計

   

(赤字)

 

2023年12月31日餘額

    7     $ 1,950       321     $ 3     $ 176,210     $ (174,849 )   $ 3,314  

淨損失

    -       -       -       -       -       (3,214 )     (3,214 )

將B系列優先股轉換為普通股

    (5 )     (231 )     537       5       226       -       -  

將C系列優先股轉換為普通股

    (0 )     (234 )     57       1       233       -       -  

調整C系列優先股轉換價格

    -       -       -       -       380       (380 )     -  

與員工和董事股票獎勵相關的以股票為基礎的補償費用

    -       -       -       -       60       -       60  

2024年3月31日止結餘

    2     $ 1,485       915     $ 9     $ 177,109     $ (178,443 )   $ 160  

淨損失

    -       -       -       -       -       (1,585 )     (1,585 )

將B系列優先股轉換為普通股

    (0 )     (37 )     88       1       36       -       -  

將C系列優先股轉換為普通股

    (1 )     (1,442 )     148       1       1,441       -       -  

修改普通股認股權證與2024認股權調價交易有關

    -       -       -       -       69       -       69  

發行普通股與2024認股權調價交易相關,扣除發行成本后净數

    -       -       90       1       129       -       130  

將2023年12月認股權重新分類為非負債

    -       -       -       -       212       -       212  

將2024年3月認股權重新分類為非負債

    -       -       -       -       100       -       100  

重新分類嵌入式衍生負債

    -       -       -       -       242       -       242  

發行股份以換取 35因為四捨五入功能進行1:1的股票合併。

    -       -       107       1       (1 )     -       -  

與員工和董事股票獎勵相關的股份報酬費用。

    -       -       -       -       55       -       55  

董事受限制股票獎勵的授予。

    -       -       0       0       0       -       0  

2024年6月30日餘額

    1     $ 6       1,348     $ 13     $ 179,392     $ (180,028 )   $ (617 )

淨損失

    -       -       -       -       -       (1,212 )     (1,212 )

在一項在證券在個單獨包銷中發行普通股和預資金認股權,扣除發行成本。

    -       -       1,495       15       2,843       -       2,858  

行使預付權證

    -       -       2,042       21       -       -       21  

調整普通股認股權行使價。

    -       -       -       -       1,005       (1,005 )     -  

與員工和董事股票獎勵相關的股票基礎薪酬費用

    -       -       -       -       22       -       22  

2024年9月30日結餘

    1     $ 6       4,885     $ 49     $ 183,262     $ (182,245 )   $ 1,072  

 

-5-

 

   

優先股

   

普通股

   

額外的

已付款

   

累計

   

總計

股東权益

股權

 
   

股份

   

金額

   

分享*

   

金額*

   

資本*

   

赤字累計

   

(赤字)

 

2022年12月31日結餘

    14     $ 2,973       58     $ 1     $ 165,732     $ (158,152 )   $ 10,554  

淨損失

    -       -       -       -       -       (1,739 )     (1,739 )

與員工和董事股票獎勵相關的股票基礎薪酬費用

    -       -       -       -       75       -       75  

2023年3月31日結束餘額

    14     $ 2,973       58     $ 1     $ 165,807     $ (159,891 )   $ 8,890  

淨損失

    -       -       -       -       -       (2,036 )     (2,036 )

將B系列優先股轉換為普通股

    (3 )     (121 )     54       0       121       -       -  

將C系列優先股轉換為普通股

    (1 )     (728 )     8       0       728       -       -  

普通股票認股權證的修改

    -       -       -       -       285       -       285  

Series b優先股轉換價格的調整

    -       -       -       -       1,802       (1,802 )     -  

調整C系列優先股轉換價格

    -       -       -       -       194       (194 )     -  

2023年5月Warrants的再分類

    -       -       -       -       1,360       -       1,360  

與員工和董事股票獎勵相關的股票基礎薪酬費用

    -       -       -       -       64       -       64  

董事受限制股票獎勵的授予。

    -       -       0       0       0       -       0  

2023年6月30日結餘

    10     $ 2,124       120     $ 1     $ 170,361     $ (163,923 )   $ 8,563  

淨損失

    -       -       -       -       -       (1,757 )     (1,757 )

將B系列優先股轉換為普通股

    (3 )     (147 )     66       1       146       -       -  

重新分類嵌入式衍生負債

    -       -       -       -       169       -       169  

與員工和董事股票獎勵相關的股票基礎薪酬費用

    -       -       -       -       62       -       62  

截至2023年9月30日的結餘

    7     $ 1,977       186     $ 2     $ 170,738     $ (165,680 )   $ 7,037  

 

*

在將生效日期設定為2024年5月30日的1比35的逆向股票拆分後,給予追溯效力。

 

附註是這些未經審計的簡明綜合財務報表的一個組成部分。

 

-6-

 

 

novabay pharmaceuticals, inc.

 

簡明財務報表現金流量表

(未經查核) 

(以千為單位)

 

   

截至9月30日的九個月

 
   

2024

   

2023

 
                 

營業活動:

               

淨損失

  $ (6,011 )   $ (5,532 )

已中止運作的操作所導致的淨損失

    124       1,106  

調整為使淨虧損轉化為經營活動所使用現金:

               

固定資產及設備折舊

    32       39  

與員工和董事股票獎勵相關的股票基礎薪酬費用

    137       201  

非現金資產處分損失

    865        

為獲得擔保可轉債票持有人同意而發生的非現金費用

    368        

普通股認股權憑證的修改,包括在其他費用淨額中

    69       285  

公允價值權證負債變動的非現金收益

    (114 )     (216 )

嵌入式衍生負債公平價值變動的非現金損失(收益)

    18       (40 )

租賃使用權上的非現金攤銷

    254       222  

可轉換票據的利息累計和債務折扣攤銷

    871       1,119  

營運資產和負債的變化:

               

應收帳款

    (24 )     913  

存貨

    83       (195 )

預付費用及其他流動資產

    (70 )     82  

其他資產

    (16 )     (10 )

應付款及應計費用

    (532 )     (1,289 )

營業租賃負債

    (265 )     (224 )

持續營運中之營運活動使用的凈現金

    (4,211 )     (3,539 )
                 

投資活動:

               

處分附屬公司所得款項

    1,070        

購買不動產和設備

    (6 )     (16 )

繼續營業活動中提供的(用於)投資活動的淨現金

    1,064       (16 )
                 

融資活動:

               

來自認股權及預資的行使所得款項

    247        

普通股及預資認股權在承銷登記直接供應中發行所得款項,扣除發行成本後淨額

    2,858        

有擔保可轉換票據及2023年5月認股權的發行所得款項,扣除折扣後淨額

          3,000  

有擔保可轉換票據的支付

    (1,990 )     (770 )

債券發行成本

    (115 )     (294 )
融資活動提供的淨現金,持續營運     1,000       1,936  
                 

現金、現金等價物和受限現金的淨減少,持續營運

    (2,147 )     (1,619 )

現金及現金等價物的淨減少,已停止營運

    (206 )     (279 )

現金、現金等價物和受限現金的淨減少,合併資料

    (2,353 )     (1,898 )

現金、現金等價物和受限現金,年初,合併

    3,606       5,846  

減:已停止營運之現金及現金等價物,期末

          (293 )

持續營業的現金、現金等價物和受限現金期末

  $ 1,253     $ 3,655  

 

   

九個月截至九月三十日

 
   

2024

   

2023

 

現金流量資訊的補充披露:

               

持續營運中支付的利息

  $ 147     $ 174  

停用營運中支付的利息

          15  

 

 

   

截至9月30日的九個月

 
   

2024

   

2023

 

非現金信息的補充披露:

               

普通股轉換為優先股

  $ 1,944     $ 995  

與優先股相關的下滑回合特徵調整

    380       1,996  

與普通股權證相關的下滑回合特徵調整

    1,005        

與無擔保可轉換票據相關的嵌入式衍生負債發行

    224        

權證負債轉移到權益

    312       1,360  

衍生負債轉移到權益

    242       169  

 

附註是這些未經審計的簡明綜合財務報表的一個組成部分。

 

-7-

 

 

備註 1。 組織

 

novabay pharmaceuticals Inc.("我們的,” “我們,” “我們” 或“公司”權益代理”)研發並銷售經科學證實的眼部護理和傷口護理產品。我們的領先產品Avenova®抗菌眼瞼和睫毛溶液,或Avenova噴霧,經實驗室測試證實具有廣泛的抗菌特性,可清除皮膚周圍的異物,包括微生物和碎片,包括眼睫周圍的皮膚。Avenova噴霧配製我們的專利穩定和純形式次氯酸,經美國食品和藥物管理局("「監管當局」指任何國家或超國家政府機構,包括美國食品藥品監督管理局(及其任何繼任實體)(以下簡稱「FDA」)在美國、歐洲藥品管理局(及其任何繼任實體)(以下簡稱「EMA」)或歐洲委員會(及其任何繼任實體,如適用)在歐盟、或日本內閣府健康福祉廳,或日本藥品醫療機器等級機構(或任何繼任者)(以下簡稱「MHLW」),在日本,英國藥物和保健品監管局(以下簡稱「MHRA」),或任何國家的任何衛生監管當局均為本文所述國家藥品的開發、商業化,以及進行監管審批負責的對應機構,包括但不限於HGRAC。Avenova Spray在美國有售。Avenova Spray主要通過線上銷售渠道直接面向消費者,也可通過處方配藥由眼科專家供應,用於眼瞼炎和乾眼症。由於乾眼是一種複雜的狀況,我們為家用標準治療方案的每一步提供一系列科學開發的產品,包括Avenova潤滑眼滴提供即時緩解、Avenova的NovaWipes、Avenova的溫熱眼罩舒緩眼睛,以及Avenova的i-Chek用於監控眼瞼健康。

 

我們還製造和賣出我們專有的次氯酸形式,用於透過我們的NeutroPhase和PhaseOne品牌產品來進入傷口護理市場。NeutroPhase和PhaseOne用於手術程序中的清潔和灌洗,以及處理傷口、燒傷、潰瘍和其他傷害。公司目前通過經銷商銷售這些產品。

 

透過我們之前的子公司DERMAdoctor,LLC(DERMAdoctor),公司提供超過30款針對常見皮膚問題的皮膚科醫師研發產品,從老化和瑕疵到乾燥皮膚、多汗和毛囊角化。2024年3月25日,我們宣布已出售DERMAdoctor(“DERMAdoctor出售”).

 

公司主要經營 兩個 報告的業務部門分為:(1) 眼部護理和傷口護理以及 (2) 皮膚護理。正如上文所述,於2024年3月25日,我們完成了DERMAdoctor的出售,導致了我們皮膚護理部門的銷售。

 

該公司於2000年1月19日根據加利福尼亞州法律成立為NovaCal Pharmaceuticals, Inc. 直至2002年7月1日才開始運營,當天收購了加利福尼亞州有限責任公司NovaCal Pharmaceuticals, LLC的所有營運資產。該公司於2007年2月將其名稱從NovaCal Pharmaceuticals, Inc. 更改為novabay pharmaceuticals, Inc. 該公司於2010年6月更改了其成立州(以下簡稱為“. 變更成立地點”),現在根據德拉瓦州法律成立。 本文件中對“公司”的所有參照均指重新設立日期前的加利福尼亞公司和重新設立日期後的特拉瓦公司。重設立”現貨公司” 一詞在此處指重新設立日期前的加利福尼亞公司,以及在重新設立日期後指德拉瓦公司。

 

公司於2024年5月30日生效實施了1比-的反向拆分。35 公司於2024年5月30日生效實施了我們優先股(“”)的1比-反向拆分。(詳情請參見註釋12“股東權益”)。股票合併倒數除非另有具體說明,所有股票數量、股價、行使/轉換價格和每股金額均已以追溯方式進行調整,以反映這次1比-的反向股票拆分。35 反向股票拆分。

 

潛在資產出售交易及清算

 

於2024年9月19日,公司與PRN醫生推薦營養補充品有限責任公司(下稱「原本的 購買協議」)簽訂了資產購買協議本金,根據該協議,PRN將收購公司以Avenova品牌銷售的眼護產品及相關,即「Avenova資產」為何Corcept Therapeutics股票今天飆升?資產出售交易)。在2024年11月5日,公司修訂了原始購買協議(“APA修正”,連同原始購買協議一起,為公司提供了,購買協議),規定了增加基本購買價格為11.5 百萬增加。9.5 百萬,並要求PRN向公司提供1.0 百萬美元的資產貸款票據,詳情如下並在附註19“後續事項”下(“橋梁貸款”。根據購買協議,資產出售交易受某些結束條件約束,包括股東同意。假設獲得股東批准並符合其他結束條件,公司預計將在2024年第四季度完成資產出售交易。

 

資產銷售交易將構成本公司產生營收及營運資產的大部分;然而,PRN 不會購買本公司的任何其他產品和資產,包括與本公司的傷口護理、泌尿科或皮膚科業務有關的產品和資產。公司董事會(」董事會」) 一致通過資產出售交易,並進一步裁定,如果資產出售交易完成,最佳機會將股東最佳化價值,是根據完整清算和解散計劃進行清盤和解散(解散計劃」) 根據特拉華州法律,可能會導致我們的剩餘資產價值分發給我們的股東(」解散”).

 

公司已召集股東特別會議(以下簡稱“董事會”),於2024年11月22日就股東批准(1)資產出售交易及(2)解散事項進行投票,惟董事會可依自行判斷決定是否繼續進行解散事項。特別會議

 

2024年10月29日,公司宣布,董事會裁定Refresh Acquisitions BidCo LLC提出的未經請求且不具約束力的收購提議,以購買Avenova資產,為“優越提案”(如購買協議所定義)。因此,公司通知董事會已做出的裁定,以及公司打算根據條款終止購買協議,除非公司收到PRN的修訂提案,以使董事會裁定Refresh無約請提議不再是“優越提案”,所有這些都應遵照購買協議所提供的程序。Refresh資產Refresh未經請求提議

 

2024年11月5日,公司與PRN簽署APA修訂原始購買協議。 APA修訂提供了對原始購買協議的主要修改,包括:(i)將基本購買價格提高至$11.5 百萬增加。9.5 百萬;(ii)刪除債務融資的附帶條件和相關的PRN陳述,同時新增一項新的PRN陳述,即其擁有足夠的資金支付$11.5 百萬基本購買價格;(iii)PRN向公司提供橋接貸款;(iv)PRN向公司提供來自Roundtable Healthcare Partners V, L.P.的權益融資承諾函(稱為“股權承諾函”),提供最多$13.0 百萬的融資,用於PRN的母公司Acumen Intermediate Holdings, LLC,並貢獻給PRN用於支付資產出售交易的購買價格(以此更新條款,稱為“修訂的PRN交易條款”).

 

公司於2024年11月5日簽訂了橋梁貸款協議,該協議規定公司將從PRN作為貸方獲得最高美金資產50萬美元的抵押貸款。1.0 ,其中每筆款項為500萬美元,分別於2024年11月22日後及2024年12月6日後向PRN提供書面通知後注資。0.5 。橋梁貸款所借資金必須用於營運資金用途,將以年息利率發放,並以所有的公司資產作為抵押品。 10橋梁貸款是一項短期抵押貸款,應於資產出售交易完成時(應從購買價中償還),或者在購買協議終止時立即償還,或在2025年2月28日前償還。

 

-8-

 

有關資產出售交易(包括修訂PRN交易條款、APA修正和橋接貸款)、提供刷新的自願要約和解散的更多信息,請參閱附錄19“後續事項”,公司於2024年9月20日、2024年10月29日和2024年11月6日提交給證券交易委員會(“ 交易所 ”)的公司當前報告書8-k,以及公司於2024年10月16日提交給SEC的14A表格中的公司明確代理聲明(可能會有補充,“美國證券交易委員會特別會議 委託書聲明”).

 

在2062年第四季度開始,公司停用能源業務。

 

2024年3月25日,公司以總售價$_______________完成DERMAdoctor的出售。1.1百萬美元。公司在截至2024年3月31日的三個月期間承認DERMAdoctor出售的損失,金額約為$_______________,該損失記錄在未經審核的簡明綜合營業報表的子公司出售損失中。0.9百萬美元。公司在截至2024年3月31日的三個月期間承認DERMAdoctor出售的損失,金額約為$_______________,該損失記錄在未經審核的簡明綜合營業報表的子公司出售損失中。

 

關於DERMAdoctor出售業務,公司與new age Investments, LLC簽訂了過渡服務協議,以提供一個常規和有序的業務過渡,其中包括new age Investments, LLC提供的倉儲服務以及公司提供的履行服務,自簽訂過渡服務協議以來一直納入後續期間的營運。

 

經營概念

 

公司在其大部分公司歷史中持續經營虧損,預計其2024年的支出將超過2024年的收入。此外,公司預計將繼續承擔經營虧損和負現金流。因此,公司確定其計劃的營運情況對其繼續作為一個持續經營機構的能力至少存在著重大疑慮,這一疑慮持續時間至少為從此無審核條件的精簡綜合財務報表之發行日期起的十二個月。此外,不斷變化的情況可能導致公司的現金支出速度比目前預期得快得多,並且由於公司無法控制的影響更廣泛的經濟情況,如通脹周期、供應鏈問題、全球流行病和國際衝突(例如以色列和哈馬斯、俄羅斯和烏克蘭以及中國和台灣之間的衝突),公司可能需要花費比目前預期更多的現金。

 

2024年9月16日,董事會一致批准了資產出售交易和解散,這兩者都需經公司股東批准。2024年11月5日,公司簽署了APA修正案,其中包括將基本購買價提高到$11.5 百萬增加。9.5 百萬美元,並促使PRN向公司提供橋接貸款,詳細內容請參見附註19“後續事件”下面所述。公司將於2024年11月22日舉行特別會議,以取得股東對資產出售交易和解散的批准,根據特別會議代理書。

 

為解決公司目前的流動性和短期資本需求,公司已經並將繼續評估不同計劃和戰略交易,以籌集資金進行業務,包括:(1) 通過債務和股權融資或其他來源籌集額外資本;(2) 減少業務支出,包括減少一個或多個銷售和營銷計劃的支出或重組業務以改變其開支結構;和/或(3) 某些業務或產品線及相關資產的出售,例如資產售出交易和DERMAdoctor 出售。如果資產售出交易和/或解散未完成,我們將繼續公司的存在,董事會將繼續探討確保業務運作獲得即時資金的選項,因為可用資本和流動性大幅減少,公司可選擇的戰略替代方案包括將資本返還給股東或者,如果缺乏任何資金或其他可行的替代方案,或者在運營所需的資本不足時,公司可能需要申請破產保護或開始類似的州法律程序。在這些戰略選項方面,公司可能通過額外的定向增發交易或已註冊的公開發行發行證券,包括普通股、優先股、可轉換債務證券和權證,此舉可能需要對證券交易委員會提交S-1表格或S-3表格的註冊聲明。儘管公司認為來自於2024年公開發行(定義請見註9 “融資活動”)、2024年權證重新定價交易(定義請見註9 “融資活動”)和DERMAdoctor 出售改善了公司2024年前九個月的流動性,但無法保證公司將成功完成資產售出交易和/或解散,或以其他資本籌集策略的水平來達到解決公司持續和未來現金流和流動性需求所必要的水準。隨函附上的未經審計的簡明合併財務報表已經準備,假定公司將繼續運作,作為持續經營的基礎,這意味著資產將實現,並且負債將在業務通常運作的過程中解決。這些未經審計的簡明合併財務報表不包括任何調整,以反映由於與公司作為持續經營的能力相關的不確定性可能對資產的回收性和分類或可能導致的負債金額的未來影響。如果公司的股東批准解散,公司將認為清算即將來臨,並根據美國一般公認會計準則採取清算基礎的會計。美國通用會計原則”).

 

 

 

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES 

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and are expressed in U.S. dollars. In management’s opinion, the unaudited condensed consolidated financial statements include all normal and recurring adjustments that are considered necessary for the fair presentation of the Company’s financial position and operating results.

 

Principles of Consolidation

 

The accompanying condensed consolidated financial statements include the accounts of the Company and its former wholly-owned subsidiary, DERMAdoctor, as of and for the nine months ended September 30, 2024. All significant intercompany balances and transactions have been eliminated in consolidation. As of March 25, 2024, the Company divested its wholly-owned subsidiary pursuant to the DERMAdoctor Divestiture. The financial results for DERMAdoctor have been presented as discontinued operations in the accompanying condensed consolidated financial statements. For the nine months ended September 30, 2024, all gains and losses on disposition, along with the sales, costs and expenses attributable to discontinued operations, have been aggregated in the captions entitled “Loss on divestiture of subsidiary” and “Net loss from discontinued operations” in our unaudited condensed consolidated statements of operations.

 

Financial Statement Reclassification

 

Certain account balances from prior periods have been reclassified in these unaudited condensed consolidated financial statements to conform to current period classifications. The prior year amounts have been modified in these unaudited condensed consolidated financial statements to properly report amounts under current operations and discontinued operations (see Note 18, “Divestiture and Discontinued Operations”).

 

Further, certain prior period operating lease balances on the Condensed Consolidated Statements of Cash Flows originally reported within changes in “Operating lease right-of-use assets” are now within “Non-cash right-of-use amortization” to conform to the current year presentation. These changes had no impact on the Company's net decrease in case, cash equivalents, and restricted cash in the prior year nor any of the subtotal changes of cash from operating, investing, or financing activities.

 

Use of Estimates

 

The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results may differ significantly from those estimates. Significant estimates made by management include, but are not limited to, contract liabilities related to product sales such as product returns, assumptions for valuing warrants, assumptions for valuing derivative liabilities, the fair value of contingent consideration, intangible assets, goodwill, stock-based compensation, income taxes and other contingencies.

 

These estimates are based on management’s best estimates and judgment. Actual results may differ from these estimates. Estimates, judgments, and assumptions are continuously evaluated and are based on management’s experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. Uncertainty about these assumptions, judgments and estimates could result in outcomes that require a material adjustment to the carrying amount of assets or liabilities affected in future periods.

 

Unaudited Condensed Consolidated Interim Financial Information

 

The accompanying unaudited condensed consolidated financial statements and related disclosures have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only recurring adjustments, necessary for a fair presentation.

 

The year-end condensed consolidated balance sheet data was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The unaudited condensed consolidated results of operations for any interim period are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period.

 

The condensed consolidated financial statements and notes included herein should be read in conjunction with the annual consolidated financial statements and notes for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 26, 2024 and amended on March 29, 2024 (collectively, the “2023 Annual Report”).

 

 

Cash, Cash Equivalents, and Restricted Cash

 

The Company considers all highly-liquid instruments with a stated maturity of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents are stated at cost, which approximates fair value. As of September 30, 2024 and December 31, 2023, the Company’s cash and cash equivalents were held in a major financial institution in the United States.

 

The following table provides a reconciliation of the cash, cash equivalents, and restricted cash reported in the condensed consolidated balance sheets (in thousands):

 

   

September 30,

   

December 31,

 
   

2024

   

2023

 

Cash and cash equivalents

  $ 776     $ 3,130  

Cash and cash equivalents, discontinued operations

          (206 )

Restricted cash included in other assets

    477       476  

Total cash, cash equivalents, and restricted cash in the condensed consolidated statements of cash flows

  $ 1,253     $ 3,400  

 

The restricted cash amount included in other assets on the condensed consolidated balance sheets represents amounts held as certificates of deposit for long-term financing and lease arrangements as contractually required by our financial institution and landlord.

 

Concentrations of Credit Risk and Major Partners

 

Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash, cash equivalents and restricted cash. The Company maintains deposits of cash, cash equivalents and restricted cash with a major financial institution in the United States.

 

The Company has a significant amount of its cash balances at financial institutions which, throughout the year, regularly exceed the federally insured limit of $250,000. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flows.

 

During the three and nine months ended September 30, 2024 and 2023, revenues from significant product categories were as follows (in thousands):

 

   

Three Months Ended

September 30,

   

Nine Months Ended

September 30,

 
   

2024

   

2023

   

2024

   

2023

 

Avenova Spray

  $ 2,170     $ 2,064     $ 6,391     $ 5,759  

NeutroPhase

                      1,043  

Other products

    254       407       1,044       1,524  

Total product revenue, net

    2,424       2,471       7,435       8,326  

Other revenue, net

    17       10       37       28  

Total sales, net

  $ 2,441     $ 2,481     $ 7,472     $ 8,354  

 

During the three and nine months ended September 30, 2024 and 2023, revenues were derived primarily from sales of Avenova branded products, directly to consumers through Amazon.com and Avenova.com. Sales of Avenova Spray via Amazon comprised 73% and 66% of total Avenova Spray net revenue during the three months ended September 30, 2024 and 2023, respectively. Sales of Avenova Spray via Amazon comprised 74% and 68% of total Avenova Spray net revenue during the nine months ended September 30, 2024 and 2023, respectively.

 

As of September 30, 2024 and December 31, 2023, accounts receivable from continuing operations from our major distribution partners and major retailers greater than 10% were as follows:

 

   

September 30,

   

December 31,

 

Major distribution partner

 

2024

   

2023

 

Major U.S. Retailer A

    43 %     22 %

Avenova Spray Pharmacy Distributor A

    31 %     14 %

Chongqing Pioneer Pharma Holdings Limited

    * %     36 %

 

* Less than 10%

 

 

The Company relies on one contract manufacturer to produce its products. The Company does not have any manufacturing facilities and intends to continue to rely on third parties for the supply of finished goods. Our contract manufacturer may or may not be able to meet the Company’s needs with respect to timing, quantity or quality. In particular, it is possible that the Company may suffer from unexpected delays in light of global supply chain issues.

 

Fair Value of Financial Assets and Liabilities

 

The Company’s financial instruments include cash and cash equivalents, restricted cash, accounts receivable, accounts payable, accrued liabilities, warrant liabilities, and contingent consideration. The Company’s cash and cash equivalents, restricted cash, accounts receivable, accounts payable, and accrued liabilities are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments.

 

The Company follows Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures, with respect to assets and liabilities that are measured at fair value on a recurring basis and nonrecurring basis. Under this standard, fair value is defined as the exit price, or the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants as of the measurement date. The standard also establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use in valuing the asset or liability developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the factors market participants would use in valuing the asset or liability developed based upon the best information available in the circumstances. There are three levels of inputs that may be used to measure fair value:

 

Level 1 – quoted prices in active markets for identical assets or liabilities;

Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable; and

Level 3 – inputs that are unobservable (for example, cash flow modeling inputs based on assumptions).

 

Categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement.

 

See additional information in Note 3, “Fair Value Measurements”.

 

Allowance for Credit Losses

 

The Company maintains an allowance for estimated losses resulting from the inability of its customers to meet their financial obligations to the Company. The Company recognizes an allowance for credit losses based on factors such as historical experience, contract terms and general and market business conditions. The Company’s future collection experience can differ significantly from historical collection trends due to such factors as changing customer circumstances and uncertain economic and industry trends. The allowance is re-evaluated on a regular basis and adjusted as needed. Once a receivable is deemed to be uncollectible, such balance is charged against the allowance. Management recorded a reserve for allowance for credit losses of $3 thousand as of September 30, 2024 and December 31, 2023.

 

Inventory

 

Inventory is comprised of (1) raw materials and supplies, such as bottles, packaging materials, labels, boxes and pumps; (2) goods in progress, which are normally filled but unlabeled bottles; and (3) finished goods. The Company utilizes a contract manufacturer to produce its products and the price paid to these manufacturers is included in inventory. Inventory is stated at the lower of cost or estimated net realizable value determined by the first-in, first-out method. At September 30, 2024 and December 31, 2023, management had recorded an allowance for excess and obsolete inventory and lower of cost or estimated net realizable value adjustments of $126 thousand and $264 thousand, respectively.

 

Property and Equipment, net

 

Property and equipment are stated at cost, less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets of five to seven years for office and laboratory equipment, three to five years for computer equipment and software, and five to seven years for furniture and fixtures. Leasehold improvements are amortized over the shorter of the estimated useful life of the asset or the lease term.

 

The costs of normal maintenance, repairs, and minor replacements are expensed as incurred. 

 

 

Business Combinations, Goodwill and Indefinite-Lived Intangible Assets

 

We account for business combinations using the acquisition method of accounting, in accordance with ASC 805, Business Combinations. The acquisition method requires that identifiable assets acquired and liabilities assumed are recognized and measured at fair value on the acquisition date, which is the date that the acquirer obtains control of the acquired business. Intangible assets are measured at their respective fair values as of the acquisition date. Goodwill represents the excess of the consideration transferred over the estimated fair value of assets acquired and liabilities assumed in a business combination.

 

Goodwill and indefinite-lived intangible assets are tested for impairment annually, or more frequently if events or changes in circumstances indicate that it is more likely than not that the assets are impaired.

 

Goodwill is evaluated for impairment by first performing a qualitative assessment to determine whether a quantitative goodwill test is necessary. If it is determined, based on qualitative factors, that the fair value of the reporting unit may more likely than not be less than carrying amount, or if significant adverse changes in the Company’s future financial performance occur that could materially impact fair value, a quantitative goodwill impairment test would be required. Additionally, management can elect to forgo the qualitative assessment and perform the quantitative test. If the qualitative assessment indicates that the quantitative analysis should be performed, or if management elects to bypass a qualitative assessment, the Company then evaluates goodwill for impairment by comparing the fair value of the reporting unit to its carrying amount, including goodwill. The quantitative assessment for goodwill requires management to estimate the fair value of the Company’s reporting units using either an income or market approach or a combination thereof.

 

Management makes critical assumptions and estimates in completing impairment assessments of goodwill and indefinite-lived intangible assets. The Company’s cash flow projections look several years into the future and include assumptions on variables such as future sales and operating margin growth rates, economic conditions, probability of success, market competition, inflation and discount rates.

 

The Company did not record any goodwill or indefinite-lived asset impairment charges during the three or nine months ended September 30, 2024 or September 30, 2023.

 

Valuation of Contingent Consideration Resulting from a Business Combination

 

In connection with the DERMAdoctor acquisition, the Company was subject to paying consideration that was contingent upon the achievement of specified milestone events. The Company recorded this contingent consideration at its fair value on the acquisition date. Each quarter thereafter, the Company revalued the contingent consideration and recorded changes in fair value within the condensed consolidated statements of operations. The DERMAdoctor acquisition milestone events consisted of financial targets for calendar years 2022 and 2023 which were not met. As a result, the liability recorded for potential earn out payments in the Company’s condensed consolidated balance sheets was zero as of September 30, 2024 and December 31, 2023.

 

Long-Lived Assets 

 

The Company’s intangible assets that do not have indefinite lives, primarily trade secrets and product formulations, are amortized over their estimated useful lives. All of the Company’s intangible assets subject to amortization and other long-lived assets, are reviewed for impairment in accordance with ASC 360, Property, Plant and Equipment, which requires that companies consider whether events or changes in facts and circumstances, both internally and externally, may indicate that an impairment of long-lived assets held for use are present. The Company reviews long-lived assets for impairment at least annually or whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the asset, the assets are written down to their estimated fair values and the loss is recognized in the condensed consolidated statements of operations.

 

The Company did not record any long-lived asset impairments during the three or nine months ended September 30, 2024 or September 30, 2023.

 

Leases

 

At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow, on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use assets may be required for items such as initial direct costs paid or incentives received.

 

 

The Company has elected to combine lease and non-lease components as a single component. This will potentially result in the initial and subsequent measurement of the balances of the right-of-use assets and lease liability for leases being greater than if the policy election was not applied. Leases include variable components (e.g., common area maintenance) that are paid separately from the monthly base payment based on actual costs incurred and therefore were not included in the right-of-use assets and lease liability but are reflected as an expense in the period incurred.

 

The lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized in the condensed consolidated balance sheets as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current.

 

Common Stock Warrants

 

The Company accounts for the issuance of common stock purchase warrants issued in accordance with the provisions of ASC 480, Distinguishing Liabilities from Equity and ASC 815, Derivatives and Hedging.

 

The Company classifies as equity any warrants that (i) require physical share settlement or net-share settlement or (ii) give the Company a choice of net-cash settlement (physical share settlement or net-share settlement). The Company classifies as liabilities any warrants that (i) require net-cash settlement, (ii) give the counterparty a choice of net-cash physical settlement or net-share settlement. In accordance with ASC 815, the Company also classifies as liabilities any warrants during the period which the shares underlying the contract are subject to stockholder approval before the warrant can be exercised.

 

For warrants that are classified as liabilities, the Company records the fair value of the warrants upon issuance and at each balance sheet date with changes in the estimated fair value recorded as a non-cash gain or loss in the condensed consolidated statements of operations. The fair values of these warrants are determined using the Black Scholes option pricing model. These values are subject to a significant degree of management’s judgment. See Note 3, “Fair Value Measurements”, subheading “Black Scholes Valuation Models and Assumptions” and Note 11, “Common Stock Warrants”, subheading “Summary of Common Stock Warrant Liabilities”.

 

Amendments to warrant terms are recorded as a non-cash gain or loss on modification of common stock warrants. The gain or loss represents the decrease or increase in the fair value of the amended warrants when comparing the value immediately before and after amendment using the Black Scholes option pricing model. See Note 3, “Fair Value Measurements”, subheading “Black Scholes Valuation Models and Assumptions”.

 

Preferred Stock

 

Terms of the Company’s outstanding Preferred Stock historically included a Ratchet whereby the applicable conversion price could be adjusted (as defined and described in Note 12, “Stockholders’ Equity”). The applicable Ratchet provisions of the Company’s outstanding Preferred Stock terminated during the quarter ended March 31, 2024. When a conversion price was adjusted under the Ratchet, the Company recorded a deemed dividend as a reduction to income available to common stockholders. In accordance with ASC 820, the deemed dividend was measured as the difference between (1) the fair value of the Preferred Stock immediately prior to the conversion price adjustment (but without the anti-dilution protection feature) and (2) the fair value of the Preferred Stock immediately after the conversion price adjustment (but without the anti-dilution protection feature). These fair values were determined using the Black Scholes option pricing model. These values are subject to a significant degree of management’s judgment. See also Note 3, “Fair Value Measurements”, subheading “Black Scholes Valuation Models and Assumptions”.

 

 

Revenue Recognition

 

The Company’s product revenue recognition policies are established in accordance with ASC 606, Revenue from Contracts with Customers, in accordance with the following five steps:

 

 

i.

identify the contract(s) with a customer;

 

ii.

identify the performance obligations in the contract;

 

iii.

determine the transaction price;

 

iv.

allocate the transaction price to the performance obligations in the contract; and

 

v.

recognize revenue when (or as) the entity satisfies performance obligations.

 

Revenue is recognized in accordance with the amount of consideration which the Company expects to receive.

 

Revenue generated from end consumers through third-party online retailers, such as Amazon, as well as the Company’s web store (Avenova.com) is recognized on a “sell-through” basis when control of the goods is transferred to the consumer, which generally occurs upon delivery of the products to the party fulfilling the consumer’s order. Revenue is recorded net of any discounts and estimates for refunds and product returns. Fees paid to third-party online retailers and fulfillment parties are recorded as incurred in the Company’s condensed consolidated statements of operations. Fulfillment and shipping and handling fees are recorded as product cost of goods sold. Selling commissions and advertising and promotion fees are recorded as sales and marketing expenses.

 

Revenue generated through major pharmacy distributors is recognized on a “sell-in” basis when control of the goods is transferred to the distributor, which generally occurs upon delivery of the products to the distributor. Revenue is recorded net of consideration for contract liabilities for distributor services, discounts, rebates, and product returns. The Company estimates returns and other contract liabilities based on historical data which is updated quarterly. Payment for products sold is typically due 60 days after delivery to the distributor.

 

Revenue generated from end consumers through the Company’s partner pharmacies is recognized on a “sell-through” basis when control of the goods is transferred to the consumer.

 

Revenue generated from other retailers is recognized on a “sell-through” basis, net of estimated future product returns, when control of the goods is transferred to the retailer, which generally occurs upon delivery of the products to a third-party carrier who is delivering the products to the retailer.

 

The Company defers recognition for pre-payments until the Company’s performance obligations are satisfied.

 

 

Cost of Goods Sold

 

Cost of goods sold includes third-party manufacturing costs, shipping and handling costs, third-party fulfillment fees, and other costs associated with products sold. Cost of goods sold also includes any necessary allowances for excess and obsolete inventory as well as lower of cost and estimated net realizable value.

 

Research and Development Costs

 

The Company charges research and development costs to expense as incurred. These costs include all costs associated with research, development and regulatory activities.

 

Patent Costs

 

Patent costs are expensed in the period in which they are incurred. Patent expenses are included in general and administrative expenses in the condensed consolidated statements of operations.

 

Advertising Costs

 

Advertising costs are expensed in the period in which the costs are incurred. Advertising costs are included in sales and marketing expenses in the condensed consolidated statements of operations. Advertising expenses were $0.1 million and $0.3 million for the three months ended September 30, 2024 and 2023, respectively. Advertising expenses were $0.5 million and $0.8 million for the nine months ended September 30, 2024 and 2023, respectively.

 

Stock-Based Compensation

 

The Company’s stock-based compensation includes grants of stock options and restricted stock units (“RSUs”) to employees, consultants and non-employee directors. The expense associated with these grants is recognized in the Company’s condensed consolidated statements of operations based on their fair values as they are earned under the applicable vesting terms. For stock options granted, the fair value of the stock options is estimated using a Black Scholes option pricing model. The Company accounts for RSUs issued to employees and non-employees (directors, consultants and advisory board members) based on the fair market value of the Company’s common stock on the date of issuance. See Note 13, “Equity-Based Compensation” for further information regarding stock-based compensation expense and the assumptions used in estimating the expense.

 

 

Income Taxes

 

The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recognized if it is more likely than not that some portion or the entire deferred tax asset will not be recognized.

 

Net Loss per Share

 

The Company computes net loss per share by presenting both basic and diluted earnings (loss) per share (“EPS”) as shown in the Company’s condensed consolidated statements of operations.

 

Basic EPS is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period, including stock options and warrants, using the treasury stock method. In computing diluted EPS, the average stock price for the period is used to determine the number of shares assumed to be purchased from the exercise of stock options or warrants. Potentially dilutive common share equivalents are excluded from the diluted EPS computation in net loss periods if their effect would be anti-dilutive.

 

For the three and nine months ended September 30, 2024 and 2023, the Series B Preferred Stock and Series C Preferred Stock (both as defined below) were excluded from the computation of diluted net loss per share as their inclusion on an “if converted” basis would have been anti-dilutive. The Series B Preferred Stock and Series C Preferred Stock were considered anti-dilutive because such securities did not have a contractual obligation to participate in losses of the Company.

 

The following outstanding preferred stock, stock options and stock warrants were excluded from the diluted EPS computation as their effect would have been anti-dilutive:

 

   

Balance at September 30,

 
   

2024*

   

2023*

 

Common stock equivalent of Series B Non-Voting Convertible Preferred Stock (the “Series B Preferred Stock”)

    15,065       135,300  

Common stock equivalent of Series C Non-Voting Convertible Preferred Stock (the “Series C Preferred Stock”)

          24,134  

Stock options

    6,893       4,240  

Stock warrants

    10,836,275       210,929  
      10,858,233       374,603  

 

*

After giving retroactive effect to the 1-for-35 Reverse Stock Split that became effective May 30, 2024.

 

 

Recent Accounting Pronouncements

 

For information regarding recent accounting pronouncements that could affect our business, results of operations, financial condition, and liquidity, see Note 2, “Summary of Significant Accounting Policies” included in our 2023 Annual Report. The Company continues to evaluate the potential impact of adopting the new accounting guidance on its consolidated financial position, results of operations and cash flows.

 

 

 

NOTE 3. FAIR VALUE MEASUREMENTS

 

The following table presents the Company’s financial instruments measured at fair value on a recurring basis as of September 30, 2024 and December 31, 2023 (in thousands):

 

           

Fair Value Measurements Using

 
           

Quoted

                 
           

Prices in

                 
           

Active

                 
           

Markets

   

Significant

         
           

for

   

Other

   

Significant

 
   

Balance at

   

Identical

   

Observable

   

Unobservable

 
   

September

   

Items

   

Inputs

   

Inputs

 
   

30, 2024

   

(Level 1)

   

(Level 2)

   

(Level 3)

 

Assets

                               

Restricted cash held as a certificate of deposit

  $ 477     $ 477     $     $  

 

 

           

Fair Value Measurements Using

 
           

Quoted

                 
           

Prices in

                 
           

Active

                 
           

Markets

   

Significant

         
           

for

   

Other

   

Significant

 
   

Balance at

   

Identical

   

Observable

   

Unobservable

 
   

December

   

Items

   

Inputs

   

Inputs

 
   

31, 2023

   

(Level 1)

   

(Level 2)

   

(Level 3)

 

Assets

                               

Restricted cash held as a certificate of deposit

  $ 476     $ 476     $     $  
                                 

Liabilities

                               

Warrant liabilities

  $ 334     $     $ 334     $  

 

The Company’s restricted cash held as certificates of deposit are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency.

 

The Secured Convertible Notes and Unsecured Convertible Notes (see Note 10, “Convertible Notes”) are carried at proceeds, net of discounts, which management believes approximates fair value. As a result of certain call and put options within the Secured Convertible Notes and Unsecured Convertible Notes, the Company recorded an embedded derivative liability on its condensed consolidated balance sheets with a corresponding debt discount which is netted against the face value of the Secured Convertible Notes and Unsecured Convertible Notes. The fair value of the embedded derivatives were calculated using the Black Scholes valuation model using Level 2 inputs of the fair value hierarchy.

 

 

The fair value of the December 2023 Warrants issued in conjunction with the 2023 Warrant Reprice Transaction as well as the accounting for the warrant amendment and preferred stock conversion price adjustments that resulted from the 2023 Warrant Reprice Transaction were classified within Level 2.

 

See Note 11, “Common Stock Warrants”, subheading “Summary of Common Stock Warrant Liabilities”, for a reconciliation of the beginning and ending balances for the warrant liabilities measured at fair value on a recurring basis using significant other observable inputs (Level 2) during the three and nine months ended September 30, 2024 and 2023.

 

There were no transfers in or out of Level 1, Level 2 or Level 3 assets and liabilities for the three and nine months ended September 30, 2024 and 2023.

 

Black Scholes Valuation Models and Assumptions

 

The Company utilizes a Black Scholes model for various valuations as outlined throughout this report. The following tables summarize the assumptions utilized for valuations impacting results for the periods reported. See also Note 13, “Equity-Based Compensation” for related Black Scholes valuation assumptions.

 

Warrant Liabilities

 

Various of the Company’s warrants have been subject to stockholder approval upon issuance or amendment and prior to exercise. Warrants requiring stockholder approval are recorded as a liability at fair value upon issuance or amendment and continue to be recorded as a liability at fair value at each reporting date until stockholder approval occurs at which time they are transferred to stockholders’ equity at their fair value on the date of approval. Fair value was determined using a Black Scholes model as outlined below. See Note 11, “Common Stock Warrants” for additional information and the definitions of the Company’s warrants.

 

   

May 2023

Warrants

   

May 2023

Warrants

   

December

2023

Warrants

   

December

2023

Warrants

 

Measurement event

 

Issuance

   

Stockholder Approval

   

Reporting Date

   

Stockholder Approval

 
                         

Date

 

May 1, 2023

   

June 9, 2023

   

December 31, 2023

   

May 28, 2024

 

Total Value

 

$1.6 million

   

$1.4 million

   

$0.3 million

   

$0.2 million

 

Gain (Loss)

 

not applicable

   

$0.2 million

   

$56 thousand

   

$(51 thousand)

 
                                 

Assumptions:

                               

Exercise price

  $ 45.50     $ 45.50     $ 8.75     $ 8.75  

Market price

 

$

25.20  (a)   $ 23.80     $ 7.14     $ 4.94  

Volatility

    80.1 %     77.6 %     79.3 %     83.9 %

Risk-free rate

    3.60 - 4.04 %     3.92 - 4.59 %     3.85 %     4.56 %

Dividend yield

    0.0 %     0.0 %     0.0 %     0.0 %

Term (years)

    2.1 - 5.1       2.0 - 5.0       5.5       5.1  

 

 

   

March

   

March

 
   

2024

   

2024

 
   

Warrant

   

Warrant

 

Measurement event

 

Reporting Date

   

Stockholder Approval

 

Date

 

March 31, 2024

   

May 28, 2024

 

Total Value

 

$0.1 million

   

$0.1 million

 

Gain (Loss)

 

$21 thousand

   

$(28 thousand)

 
                 

Assumptions:

               

Exercise price

  $ 4.90     $ 4.90  

Market price

  $ 3.66     $ 4.94  

Volatility

    86.9 %     83.9 %

Risk-free rate

    4.21 %     4.56 %

Dividend yield

    0.0 %     0.0 %

Term (years)

    5.5       5.3  

 

 

(a)

Adjusted for the dilutive effect of the 2023 Private Placement. See additional discussion above.

 

Warrant Modifications

 

Amendments to warrant terms are recorded as a non-cash gain (or loss) on modification of common stock warrants. The gain or loss represents the decrease or increase in the fair value of the amended warrants when comparing the value immediately before and after amendment using the Black Scholes option pricing model. Fair value was determined using a Black Scholes model as outlined below.

 

   

July 2020, November 2021,

September 2022 & November 2022

Warrants

 

Measurement event

 

Prior to amendment

   

After amendment

 

Date

 

April 27, 2023

   

April 27, 2023

 

Total Value

 

$0.3 million

   

$0.5 million

 

Loss

 

not applicable

   

$0.2 million

 
                 

Assumptions:

               

Exercise price

  $ 220.50     $ 52.50  

Market price

 

$

25.20 (a)  

$

25.20 (a)

Volatility

    80.1 %     80.1 %

Risk-free rate

    3.59 - 4.73 %     3.59 - 4.73 %

Dividend yield

    0.0 %     0.0 %

Term (years)

    1.1 - 5.6       1.1 - 5.6  

 

 

   

May 2023 Warrants

 

Measurement event

 

Prior to amendment

   

After amendment

 

Date

 

December 21, 2023

   

December 21, 2023

 

Total Value

 

$56 thousand

   

$0.2 million

 

Loss

 

not applicable

   

$0.1 million

 
                 

Assumptions:

               

Exercise price

  $ 45.50     $ 8.75  

Market price

  $ 8.07     $ 8.07  

Volatility

    79.3 %     79.3 %

Risk-free rate

    3.92 - 4.62 %     3.92 - 4.62 %

Dividend yield

    0.0 %     0.0 %

Term (years)

    1.5 - 4.5       1.5 - 4.5  

 

   

September 2022, November 2022,

and May 2023 Warrants

 

Measurement event

 

Prior to amendment

   

After amendment

 

Date

 

June 14, 2024

   

June 14, 2024

 

Total Value

 

$66 thousand

   

$0.1 million

 

Loss

 

not applicable

   

$70 thousand

 
                 

Assumptions:

               

Exercise price

  $ 8.75-52.50     $ 2.50  

Market price

  $ 2.51     $ 2.51  

Volatility

    89.3 %     89.3 %

Risk-free rate

    4.27 - 5.08 %     4.27 - 5.08 %

Dividend yield

    0.0 %     0.0 %

Term (years)

    1.0 - 4.4       1.0 - 4.4  

 

 

(a)

Adjusted for the dilutive effect of the 2023 Private Placement. See additional discussion above.

 

Warrant Down Round Feature Adjustment

 

Terms of the Company’s outstanding 2024 July Warrants included a down round feature adjustment whereby the applicable exercise price was automatically adjusted (see Note 9, “Financing Activities”). When the exercise price was adjusted, the Company recorded a deemed dividend as a reduction to income available to common stockholders. In accordance with ASC 820, the deemed dividend is measured as the difference between (1) the fair value of the 2024 July Warrants immediately prior to the conversion price adjustment and (2) the fair value of the 2024 July Warrants immediately after the conversion price adjustment. Fair value was determined using a Black Scholes model, as outlined below.

 

   

Series F-1

 

Measurement event

 

Prior to adjustment

   

After adjustment

 
                 

Date

 

September 27, 2024

   

September 27, 2024

 

Total value

 

$1.7 million

   

$1.9 million

 

Deemed dividend

 

not applicable

   

$0.2 million

 
                 

Assumptions:

               

Exercise price

  $ 1.10     $ 0.66  

Market price 

 

$

0.71     $ 0.71  

Volatility

    97.1 %     97.1 %

Risk-free rate

    3.55 %     3.55 %

Dividend yield

    0.0 %     0.0 %

Term (in years)

    4.84       4.84  

 

 

   

Series F-2

 

Measurement event

 

Prior to adjustment

   

After adjustment

 
                 

Date

 

September 27, 2024

   

September 27, 2024

 

Total value

 

$0.2 million

   

$0.6 million

 

Deemed dividend

 

not applicable

   

$0.4 million

 
                 

Assumptions:

               

Exercise price

  $ 1.10     $ 0.66  

Market price

  $ 0.71     $ 0.71  

Volatility

    97.1 %     97.1 %

Risk-free rate

    4.64 %     4.64 %

Dividend yield

    0.0 %     0.0 %

Term (in years)

    0.34       0.34  

 

   

Series F-3

 

Measurement event

 

Prior to adjustment

   

After adjustment

 
                 

Date

 

September 27, 2024

   

September 27, 2024

 

Total value

 

$0.6 million

   

$1.0 million

 

Deemed dividend

 

not applicable

   

$0.4 million

 
                 

Assumptions:

               

Exercise price

  $ 1.10     $ 0.66  

Market price

  $ 0.71     $ 0.71  

Volatility

    97.1 %     97.1 %

Risk-free rate

    4.10 %     4.10 %

Dividend yield

    0.0 %     0.0 %

Term (in years)

    0.84       0.84  

 

 

Preferred Stock Conversion Price Adjustments

 

Terms of the Company’s outstanding Preferred Stock historically included a Ratchet whereby the applicable conversion price could be adjusted (see Note 12, “Stockholders’ Equity”). The applicable Ratchet provisions of the Company’s outstanding Preferred Stock terminated during the quarter ended March 31, 2024. When a conversion price was adjusted under the Ratchet, the Company recorded a deemed dividend as a reduction to income available to common stockholders. In accordance with ASC 820, the deemed dividend is measured as the difference between (1) the fair value of the Preferred Stock immediately prior to the conversion price adjustment (but without the anti-dilution protection feature) and (2) the fair value of the Preferred Stock immediately after the conversion price adjustment (but without the anti-dilution protection feature). Fair value was determined using a Black Scholes model as outlined below.

 

   

Series B & C Preferred Stock

 

Measurement event

 

Prior to Ratchet

   

After Ratchet

 

Date

 

April 27, 2023

   

April 27, 2023

 

Total value (b)

 

$9.6 million

   

$11.6 million

 

Deemed dividend

 

not applicable

   

$2.0 million

 
                 

Assumptions:

               

Exercise price

  $ 220.50     $ 45.50  

Market price

 

$

25.20  (a)  

$

25.20  (a)

Volatility

    80.1 %     80.1 %

Risk-free rate

    4.91 %     4.91 %

Dividend yield

    0.0 %     0.0 %

Term (in years)

    0.8       0.8  

 

   

Series B & C Preferred Stock

 

Measurement event

 

Prior to Ratchet

   

After Ratchet

 

Date

 

December 21, 2023

   

December 21, 2023

 

Total value (b)

 

$1.7 million

   

$6.8 million

 

Deemed dividend

 

not applicable

   

$5.1 million

 
                 

Assumptions:

               

Exercise price

  $ 45.50     $ 8.75  

Market price

  $ 8.07     $ 8.07  

Volatility

    79.3 %     79.3 %

Risk-free rate

    5.43 %     5.43 %

Dividend yield

    0.0 %     0.0 %

Term (years)

    0.3       0.3  

 

 

   

Series C Preferred Stock

 

Measurement event

 

Prior to Ratchet

   

After Ratchet

 

Date

 

March 24, 2024

   

March 24, 2024

 

Total value (b)

 

$0.5 million

   

$0.9 million

 

Deemed dividend

 

not applicable

   

$0.4 million

 
                 

Assumptions:

               

Exercise price

  $ 8.75     $ 4.90  

Market price

  $ 4.77     $ 4.77  

Volatility

    79.9 %     79.9 %

Risk-free rate

    5.51 %     5.51 %

Dividend yield

    0.0 %     0.0 %

Term (in years)

    0.1       0.1  

 

 

(a)

Adjusted for the dilutive effect of the 2023 Private Placement. See additional discussion above.

 

(b)

Includes value of incremental shares underlying preferred stock and adjusted for probability of occurrence.

 

Bifurcatable Derivatives

 

Upon issuance in March 2024, the Unsecured Convertible Notes contained a lender’s conversion option which represented an embedded call option requiring bifurcation as an embedded derivative liability at fair value (see Note 10, “Convertible Notes” for additional discussion). Fair value was determined using a Black Scholes model as outlined below.

 

   

Unsecured

Convertible

Notes derivative

   

Unsecured

Convertible

Notes derivative

 

Measurement event

 

Issuance

   

Shareholder Approval

 

Date

 

March 25, 2024

   

May 28, 2024

 

Total value

 

$0.2 million

   

$0.2 million

 

Gain (Loss)

 

not applicable

   

$(82 thousand)

 
                 

Assumptions:

               

Exercise price

  $ 4.90     $ 4.90  

Market price

  $ 4.51     $ 4.94  

Volatility

    86.9 %     83.9 %

Risk-free rate

    4.54 %     4.94 %

Dividend yield

    0.0 %     0.0 %

Term (years)

    2.0       1.8  

 

Upon issuance in May 2023, the Secured Convertible Notes contained a lender’s conversion option which represented an embedded call option requiring bifurcation as an embedded derivative liability at fair value (see Note 10, “Convertible Notes” for additional discussion). Fair value was determined using a Black Scholes model as outlined below.

 

   

Secured

Convertible

Notes derivative

   

Secured

Convertible

Notes derivative

 

Measurement event

 

Issuance

   

Shareholder Approval

 

Date

 

April 27, 2023

   

June 9, 2023

 

Total value (b)

 

$0.2 million

   

$0.2 million

 

Gain

 

not applicable

   

$40 thousand

 
                 

Assumptions:

               

Exercise price

  $ 45.50     $ 45.50  

Market price

  $ 25.20  (a)   $ 23.80  

Volatility

    80.1 %     76.9 %

Risk-free rate

    4.88 %     5.41 %

Dividend yield

    0.0 %     0.0 %

Term (years)

    0.8       0.7  

 

 

(a)

Adjusted for the dilutive effect of the 2023 Private Placement. See additional discussion above.

 

(b)

Adjusted for probability of occurrence.

 

 

 

NOTE 4. PREPAID EXPENSES AND OTHER CURRENT ASSETS

 

Prepaid expenses and other current assets consisted of the following (in thousands):

 

   

September 30,

   

December 31,

 
   

2024

   

2023

 

Prepaid insurance

  $ 73     $ 66  

Prepaid dues and subscriptions

    63       85  

Prepaid taxes

    49       83  

Prepaid inventory

    25       73  

Other

    116       81  

Prepaid expenses from discontinued operations

          (132 )

Total prepaid expenses and other current assets

  $ 326     $ 256  

 

 

 

NOTE 5. INVENTORY

 

Inventory consisted of the following (in thousands):

 

   

September 30,

   

December 31,

 
   

2024

   

2023

 

Raw materials and supplies

  $ 144     $ 1,027  

Finished goods

    455       2,477  

Less: Reserve for excess and obsolete inventory

    (126 )     (627 )

Inventory, net of reserves, from discontinued operations

          (2,313 )

Total inventory, net

  $ 473     $ 564  

 

 

 

NOTE 6. PROPERTY AND EQUIPMENT 

 

Property and equipment consisted of the following (in thousands):

 

   

September 30,

   

December 31,

 
   

2024

   

2023

 

Office and laboratory equipment

  $ 20     $ 20  

Furniture and fixtures

    157       157  

Computer equipment and software

    414       431  

Leasehold improvements

    152       152  

Total property and equipment, at cost

    743       760  

Less: accumulated depreciation

    (682 )     (673 )

Total property and equipment, net

  $ 61     $ 87  

 

Depreciation expense related to continuing operations was $9 thousand and $13 thousand for the three months ended September 30, 2024 and 2023, respectively, and $32 thousand and $39 thousand for the nine months ended September 30, 2024 and 2023, respectively. The Company recorded no depreciation expense during the three and nine months ended September 30, 2024 and 2023, and no property and equipment as of September 30, 2024 and December 31, 2023 related to discontinued operations.

 

 

 

NOTE 7. ACCRUED LIABILITIES 

 

Accrued liabilities consisted of the following (in thousands):

 

   

September 30,

   

December 31,

 
   

2024

   

2023

 

Contract liabilities (see Note 14)

  $ 751     $ 946  

Employee payroll and benefits

    288       341  

Other

    108       229  

Accrued liabilities from discontinued operations

          (347 )

Total accrued liabilities

  $ 1,147     $ 1,169  

 

 

 

NOTE 8. COMMITMENTS AND CONTINGENCIES

 

Indemnification Agreements

 

As permitted under Delaware law and in accordance with its bylaws, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is or was serving at the Company’s request in such capacity. The term of the indemnification period is for the officer’s or director’s lifetime. The maximum amount of potential future indemnification is unlimited; however, the Company has a director and officer insurance policy that limits its exposure and may enable it to recover a portion of any future payments. The Company believes the fair value of these indemnification agreements is minimal. Accordingly, it has not recorded any liabilities for these agreements as of September 30, 2024 or December 31, 2023.

 

In the normal course of business, the Company provides indemnification of varying scope under its agreements with other entities, typically its clinical research organizations, investigators, clinical sites, suppliers, and others. Pursuant to these agreements, it generally indemnifies, holds harmless, and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified parties in connection with the use or testing of its products or product candidates or with any U.S. patent or any copyright or other intellectual property infringement claims by any third party with respect to its products. The term of these indemnification agreements is generally perpetual. The potential future payments the Company could be required to make under these indemnification agreements is unlimited. Historically, costs related to these indemnification provisions have been immaterial. The Company also maintains various liability insurance policies that limit its exposure. As a result, it believes the fair value of these indemnification agreements is minimal. Accordingly, the Company has not recorded any liabilities for these agreements as of September 30, 2024 or December 31, 2023.

 

Legal Matters

 

From time to time, the Company is subject to various legal proceedings, as well as demands, claims and threatened litigation, which arise in the normal course of our business. The ultimate outcome of any litigation or other legal dispute is uncertain. When a loss related to a legal proceeding or claim is probable and reasonably estimable, the Company accrues its best estimate for the ultimate resolution of the matter. If one or more legal matters are resolved against the Company in a reporting period for an amount above expectations, the Company’s financial condition and operating results for that period may be adversely affected. As of September 30, 2024 and December 31, 2023, there were no legal matters that, in the opinion of management, would ultimately result in liability that would have a material adverse effect on the Company’s financial position, results of operations or cash flows. Any outcome, whether favorable or unfavorable, may materially and adversely affect the Company due to legal costs and expenses, diversion of management attention and other factors. The Company cannot provide assurance that additional contingencies of a legal nature or contingencies having legal aspects will not be asserted against it in the future, and these matters could relate to prior, current, or future transactions or events.

 

Leases

 

The Company leases office space for its corporate headquarters located in Emeryville, California. The current lease term expires on July 31, 2027.

 

 

Lease costs for the three and nine months ended September 30, 2024 and 2023 were as follows (in thousands):

 

   

For the Three Months

Ended

September 30,

   

For the Nine

Months Ended

September 30,

 
   

2024

   

2023

   

2024

   

2023

 

Operating lease – expense

  $ 100     $ 100     $ 300     $ 300  

Operating lease from discontinued operations – expense

          30             91  

Operating lease – included in operating cash flow

    117       113       310       301  

Operating lease from discontinued operations – included in operating cash flow

          33             97  

 

The Company has measured its operating lease liabilities as the present value of minimum lease payments using its incremental borrowing rate over the remaining term for each operating lease. The weighted average remaining lease term and the weighted average discount rate for operating leases from continuing operations are summarized as follows:

 

   

September 30,

2024

   

September 30,

2023

 

Weighted-average remaining lease term (in years)

    2.8       3.6  

Weighted-average discount rate

    5 %     5 %

 

Future lease payments under non-cancelable leases as of September 30, 2024 were as follows (in thousands):

 

2024

 

$

117  

2025

    439  

2026

    444  

2027

    290  

Total future minimum lease payments

    1,290  

Less: Imputed interest

    (79 )

Total

  $ 1,211  
         

Reported as:

       

Operating lease liability

  $ 390  

Operating lease liability – non-current

    821  

Total

  $ 1,211  

 

 

 

NOTE 9. FINANCING ACTIVITIES

 

See Notes 2, Summary of Significant Accounting Policies; 3, Fair Value Measurements; 10, Convertible Notes; 11, Common Stock Warrants and 12, Stockholders Equity for certain defined terms below and additional discussion of financing activities and related accounting policies and fair value estimates.

 

2024 Public Offering

 

On July 26, 2024, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Ladenburg Thalmann & Co., Inc., as the sole underwriter (the “Underwriter”), relating to the issuance and sale in a public offering (the “2024 Public Offering”) of: (i) 1,158,566 shares of common stock and 2,041,814 pre-funded warrants, in lieu of shares of common stock (the “July 2024 Pre-Funded Warrants”), (ii) 3,200,380 Series F-1 warrants to purchase up to 3,200,380 shares of common stock (the “Series F-1 Warrants”), (iii) 3,200,380 Series F-2 warrants to purchase up to 3,200,380 shares of common stock (the “Series F-2 Warrants”) and (iv) 3,200,380 Series F-3 warrants to purchase up to 3,200,380 shares of common stock (the “Series F-3 Warrants”, and together with the Series F-1 Warrants and Series F-2 Warrants, the “July 2024 Warrants”).

 

The Series F-1 Warrants had an exercise price of $1.10 per share at issuance, were exercisable immediately upon issuance, and will expire on the five-year anniversary of the date of issuance. The Series F-2 Warrants had an exercise price of $1.10 per share at issuance, were exercisable immediately upon issuance, and will expire on the six-month anniversary of the date of issuance. The Series F-3 Warrants had an exercise price of $1.10 per share at issuance, were exercisable immediately upon issuance, and will expire on the one-year anniversary of the date of issuance. The July 2024 Pre-Funded Warrants were immediately exercisable at a nominal exercise price of $0.01 per share and could be exercised at any time until the July 2024 Pre-Funded Warrants were exercised in full. As of September 30, 2024, all of the July 2024 Pre-Funded Warrants had been exercised, resulting in the Company issuing 2,041,814 shares of common stock. In connection with such exercises, the Company received net proceeds of approximately $20 thousand.

 

The July 2024 Warrants include a down round feature adjustment where the exercise price was automatically reset to a price equal to the lesser of (i) the then exercise price and (ii) 90% of the volume weighted average prices for the five (5) trading days immediately preceding the date that is sixty calendar days after issuance of the July 2024 Warrants as applicable. Such down round feature adjustment was triggered on September 27, 2024, resulting in a reduced exercise price of $0.66.

 

The exercise price and number of shares of common stock issuable upon exercise of the July 2024 Warrants is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting the common stock and the exercise price. Subject to limited exceptions, a holder may not exercise any portion of its July 2024 Warrants to the extent that the holder would beneficially own more than 4.99% (or, at the election of the holder prior to the date of issuance, 9.99%) of the Company’s outstanding common stock after exercise.

 

In addition, the Company granted the Underwriter a 45-day option to purchase up to 477,272 additional shares of common stock and/or 477,272 Series F-1 Warrants to purchase up to 477,272 shares of common stock, 477,272 Series F-2 Warrants to purchase up to 477,272 shares of common stock and 477,272 Series F-3 Warrants to purchase up to 477,272 shares of common stock, or any combination thereof, as determined by the Underwriter, at the public offering price, less underwriting discounts and commissions, in each case solely to cover over-allotments, if any.

 

The Underwriter partially exercised this option on July 26, 2024, for (i) 336,832 shares of common stock, (ii) 336,832 Series F-1 Warrants to purchase up to 336,832 shares of common stock, (iii) 336,832 Series F-2 Warrants to purchase up to 336,832 shares of common stock and (iv) 336,832 Series F-3 Warrants to purchase up to 336,832 shares of common stock.

 

The 2024 Public Offering closed on July 29, 2024, and the Company received gross proceeds of $3.9 million, without taking into account any underwriting discounts and commissions. A portion of the proceeds were used towards repaying the Secured Convertible Notes, which were repaid in full during the third quarter of 2024.

 

2024 Warrant Reprice Transaction

 

In June 2024, the Company entered into a warrant reprice transaction (the “2024 Warrant Reprice Transaction”) with certain existing holders of (i) warrants issued in September 2022 to purchase common stock, (ii) Series A-1 warrants issued in November 2022 to purchase common stock, (iii) Series B-1 Warrants issued in May 2023 to purchase common stock, and (iv) Series B-2 Warrants issued in May 2023 to purchase common stock (collectively (i) through (iv), the “Existing Warrants”). The participants agreed to exercise a portion of their Existing Warrants at a reduced exercise price of $2.50. Existing Warrants were exercised for an aggregate of 90,381 shares of common stock, resulting in gross proceeds of approximately $0.2 million.

 

 

The Company also issued participants in the 2024 Warrant Reprice Transaction a new June 2024 Warrant to purchase a number of shares of common stock equal to 100% of the shares of common stock exercised. The June 2024 Warrants are substantially similar to the Existing Warrants, except that the June 2024 Warrants will (i) be initially exercisable on the six-month anniversary of the date of issuance; (ii) have an exercise price of $2.57; and (iii) have a term of five (5) years and six (6) months from the date of the closing of the 2024 Warrant Reprice Transaction.

 

The Company incurred total issuance costs of $96 thousand in conjunction with the 2024 Warrant Reprice Transaction. The Company incurred a $69 thousand non-cash loss on the modification of common stock warrants which was recorded in “Other expense, net” during the nine months ended September 30, 2024.

 

2024 Subsidiary Guarantee Termination

 

On March 24, 2024, in connection with completing certain required conditions to close the DERMAdoctor Divestiture, the Company and the holders of the Secured Convertible Notes entered into a First Amendment (the “First Amendment”) to the Company’s Security Agreement, dated April 27, 2023 (the “Security Agreement”), to remove the Membership Units and any assets of DERMAdoctor as collateral for the Company’s obligations pursuant to the Secured Convertible Notes and for DERMAdoctor to be removed as a party to the Security Agreement, and a Consent and Release (the “Subsidiary Guarantee Consent”), to terminate the Subsidiary Guarantee, dated April 7, 2023 (the “Subsidiary Guarantee”) (collectively, the “2024 Subsidiary Guarantee Termination”). To obtain the secured parties’ consent that resulted in the reduction of the collateral available to secure the obligations under the Secured Convertible Notes and as consideration for the secured parties taking the necessary actions to execute and deliver the First Amendment and the Subsidiary Guarantee Consent, the Company provided each secured party the option, at the Secured Party’s election, to receive only upon the closing of the DERMAdoctor Divestiture either a March 2024 Warrant (see Note 11, “Common Stock Warrants”) or an Unsecured Convertible Note (see Note 10 “Convertible Notes”).

 

The Company issued, based on the secured parties’ elections, (i) a March 2024 Warrant to a secured party that is exercisable for an aggregate of 1,000,000 shares of common stock (28,572 shares post-Reverse Stock Split) and (ii) Unsecured Convertible Notes to four secured parties that have an aggregate principal amount of $525 thousand or will be convertible into an aggregate of 3,750,000 shares of common stock (107,146 shares post-Reverse Stock Split). 

 

The Company incurred total issuance costs of $130 thousand in conjunction with the 2024 Subsidiary Guarantee Termination. The Company allocated $19 thousand of the issuance costs to the Unsecured Convertible Notes which was recorded as a discount in the Company’s condensed consolidated balance sheets. The remaining $111 thousand was allocated to the embedded derivative liability and warrant liability and expensed as “Other expense, net” in the Company’s unaudited condensed consolidated statements of operations, during the nine months ended September 30, 2024.

 

2023 Warrant Reprice Transaction

 

In December 2023, the Company entered into a warrant reprice transaction (the “2023 Warrant Reprice Transaction”) whereby the price terms of certain May 2023 Warrants exercisable for 2,528,848 shares of common stock (72,256 shares post-Reverse Stock Split) were amended and exercised. The price of the amended and exercised May 2023 Warrants was reduced from $1.30 ($45.50 post-Reverse Stock Split) to $0.25 ($8.75 post-Reverse Stock Split). The Company also issued to participants in the 2023 Warrant Reprice Transaction, the December 2023 Warrants exercisable for 2,528,848 shares of common stock (72,256 shares post-Reverse Stock Split).

 

The 2023 Warrant Reprice Transaction resulted in gross proceeds of approximately $0.6 million. The Company allocated the gross proceeds between the common stock and December 2023 Warrants issued to participants by applying the relative fair value allocation methodology. The Company allocated $0.2 million in gross proceeds to the common stock and $0.4 million to the December 2023 Warrants. The December 2023 Warrants were initially classified as liabilities from the date of issuance until Company stockholder approval on May 28, 2024, at which time they were reclassified to equity.

 

The Company incurred total issuance costs of $0.2 million in conjunction with the 2023 Warrant Reprice Transaction. The Company allocated $0.1 million of the issuance costs to the common stock which was recorded as a reduction of additional paid-in capital in the Company’s condensed consolidated balance sheets. The remaining $0.1 million was allocated to the warrant liability and expensed as “Other expense, net” in the Company’s unaudited condensed consolidated statements of operations.

 

 

2023 Private Placement

 

In May 2023, the Company closed a private placement (the “2023 Private Placement”) with existing accredited institutional investors of the Company that provided for the issuance and sale of $3.3 million aggregate principal amount of the Secured Convertible Notes and the May 2023 Warrants exercisable for up to 5,076,928 shares of common stock (145,056 shares post-Reverse Stock Split).

 

The Company received gross proceeds of $3.0 million from the 2023 Private Placement. The Company allocated the proceeds from the 2023 Private Placement between the May 2023 Warrants, an embedded derivative liability, and the Secured Convertible Notes by applying the residual fair value methodology. The Company first allocated $1.6 million to the May 2023 Warrants and $0.2 million to the embedded derivative liability with the residual $1.2 million allocated to the Secured Convertible Notes. The embedded derivative liability was subsequently reclassified to equity upon stockholder approval.

 

The Company incurred total issuance costs of $0.7 million in conjunction with the 2023 Private Placement, including a $0.4 million non-cash loss on the warrant modification. The Company allocated $0.3 million of the issuance costs to the Secured Convertible Notes which was recorded as a discount in the Company’s condensed consolidated balance sheets. The remaining $0.4 million was allocated to the embedded derivative liability and warrant liability and expensed as “Other expense, net” in the Company’s unaudited condensed consolidated statements of operations.

 

 

 

NOTE 10. CONVERTIBLE NOTES

 

Unsecured Convertible Notes

 

In March 2024, the Company issued $525 thousand aggregate principal amount unsecured convertible notes (the “Unsecured Convertible Notes”) in conjunction with the 2024 Subsidiary Guarantee Termination. The 2024 Subsidiary Guarantee Termination was executed with certain holders of the Secured Convertible Notes in order to close the DERMAdoctor Divestiture (see additional discussion in Note 9, “Financing Activities” and Note 18, “Divestiture and Discontinued Operations”). The Unsecured Convertible Notes are due March 25, 2026 and bear no stated interest.

 

The Unsecured Convertible Notes may be converted or redeemed for a conversion price equal to $0.14 per share ($4.90 per share post-Reverse Stock Split) at any time at the election of the holder up to the amount of outstanding principal at the time of conversion subject to certain limitations such as beneficial ownership limitations. Upon issuance and as of September 30, 2024, the Unsecured Convertible Notes were convertible for up to 3,750,000 shares of common stock (107,146 shares post-Reverse Stock Split).

 

Upon issuance in March 2024, the lender’s conversion option under the Unsecured Convertible Notes represented an embedded call option requiring bifurcation as an embedded derivative liability because the common stock underlying the option required stockholder approval before the option could be exercised. The fair value of the embedded derivative was determined to be $159 thousand as of March 31, 2024 in accordance with a Black Scholes valuation model. See also Note 3, “Fair Value Measurements”, subheading “Black Scholes Valuation Models and Assumptions”. Upon stockholder approval on May 28, 2024, the embedded call option no longer required liability treatment and was reclassified to equity. The fair value of the embedded derivative liability was determined to be $242 thousand as of May 28, 2024. The change of $83 thousand in fair value between March 31, 2024 and May 28, 2024 was recorded as a non-cash loss on change in fair value of embedded derivative liability in the unaudited condensed consolidated statements of operations. See also Note 3, “Fair Value Measurements”, subheading “Black Scholes Valuation Models and Assumptions”.

 

The discount to the note recorded for the embedded derivative liability upon issuance and debt issuance costs are being amortized to interest expense using the effective interest rate method over the term of the Unsecured Convertible Notes, assuming that the Unsecured Convertible Notes will be redeemed for cash of $525 thousand at time of maturity as of March 25, 2026. During both the three and nine months ended September 30, 2024, the effective interest rate on the Unsecured Convertible Notes was 144%. During the three and nine months ended September 30, 2024, interest expense recognized, including amortization of the issuance costs and debt discount, was $20 thousand and $35 thousand, respectively, which was included in other expense, net in the unaudited condensed consolidated statements of operations.

 

Secured Convertible Notes

 

In May 2023, the Company issued $3.3 million aggregate principal amount Original Issue Discount Senior Secured Convertible Debentures (the “Secured Convertible Notes”) in conjunction with the 2023 Private Placement (see Note 9, “Financing Activities”). The Secured Convertible Notes were issued with a $300 thousand original issue discount. The Secured Convertible Notes were originally due November 1, 2024 and were repaid in full during the third quarter of 2024 from the proceeds of the 2024  Public Offering. The Company paid $13 thousand more than the carrying amount of the Secured Convertible Notes, resulting in a loss on extinguishment that was expensed as “Extinguishment of Secured Convertible Notes” in the unaudited condensed consolidated statements of operations. Upon full repayment, the Company was released from any further obligations under the Secured Convertible Notes with the lenders.

 

Prior to being paid off, the Secured Convertible Notes could be converted or redeemed for a conversion price equal to $1.30 per share ($45.50 per share post-Reverse Stock Split) at any time at the election of the holder up to the amount of outstanding principal at the time of conversion subject to certain limitations such as beneficial ownership limitations. Upon issuance, the Secured Convertible Notes were convertible for up to 2,538,464 shares of common stock (72,528 shares post-Reverse Stock Split).

 

Beginning June 1, 2023, the Company was required to start making a monthly redemption of 1/18th of the original principal amount of the Secured Convertible Notes. Each monthly redemption reduced the outstanding principle of the Secured Convertible Note by $183 thousand and could be made in cash or, under limiting conditions, in stock at the election of the Company. Monthly redemption in cash required a total payment of $193 thousand. Monthly redemption in stock required the issuance of shares equal to $193 thousand divided by the lower of (i) $45.50 or (ii) 90% of the Company’s common stock’s average volume-weighted average price over 10 trading days prior to the redemption. The conditions allowing for redemption in stock were not met and the Company made all monthly redemption payments in cash.

 

 

The Secured Convertible Notes also provided for a redemption equal to up to 20% of the gross proceeds received by the Company from any financing completed while the Secured Convertible Notes were outstanding. In connection with the 2023 Warrant Reprice Transaction (see Note 12, “Stockholders’ Equity”), the Company made such a payment totaling $126 thousand in cash against the Secured Convertible Notes. In connection with the 2024 Warrant Reprice Transaction (see Note 12, “Stockholders’ Equity”), the Company made such a payment totaling $45 thousand in cash against the Secured Convertible Notes. In connection with the 2024 Public Offering (see Note 12, “Stockholders’ Equity”), the Company repaid the remaining balance of the Secured Convertible Notes with a payment totaling $433 thousand in cash.

 

Upon issuance in May 2023, the lender’s conversion option under the Secured Convertible Notes represented an embedded call option requiring bifurcation as an embedded derivative liability because the common stock underlying the option required stockholder approval before the option could be exercised. The fair value of the embedded derivative was determined to be $209 thousand as of the date of issuance. After stockholder approval of the underlying common stock, the embedded call option no longer required liability treatment and was reclassified to equity. The fair value of the embedded derivative liability was determined to be $169 thousand upon stockholder approval. The change of $40 thousand in fair value between the date of issuance and stockholder approval was recorded as a non-cash gain on change in fair value of embedded derivative liability in the consolidated statements of operations. See also Note 3, “Fair Value Measurements”, subheading “Black Scholes Valuation Models and Assumptions”.

 

The lender’s subsequent financing redemption option and certain events of default also represented embedded call options and the Company’s monthly share redemption option represented an embedded put option. The fair value of these options was determined to be immaterial upon issuance and at each subsequent reporting date.

 

The Company allocated $1.2 million of gross proceeds from the 2023 Private Placement to the Secured Convertible Notes.

 

The difference between the $1.2 million allocated to the Secured Convertible Notes and the $3.3 million aggregate principal amount represented discounts for the portion of proceeds allocated to the embedded derivative liability and the May 2023 Warrants (See Note 11, “Common Stock Warrants”) as well as the $0.3 million original issue discount. The Company also allocated $0.3 million of debt issuance costs to the Secured Convertible Notes.

 

The discounts and debt issuance costs were amortized to interest expense using the effective interest rate method over the term of the Secured Convertible Notes. The effective interest rate on the Secured Convertible Notes was 173%. During the three and nine months ended September 30, 2024, interest expense recognized, including amortization of the issuance costs and debt discount, was $12 thousand and $0.8 million, respectively, which was included in other expense, net in the unaudited condensed consolidated statements of operations.

 

 

 

NOTE 11. COMMON STOCK WARRANTS

 

See Notes 2, Summary of Significant Accounting Policies; 3, Fair Value Measurements; 9, Financing Activities; and 12, Stockholders Equity for certain defined terms below and additional discussion of financing activities and related accounting policies and fair value estimates.

 

July 2024 Pre-Funded Warrants

 

In July 2024, in conjunction with the 2024 Public Offering, the Company issued 2,041,814 pre-funded warrants (in lieu of shares of common stock (see additional discussion in Note 9, “Financing Activities”). The July 2024 Pre-Funded Warrants were classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, were immediately exercisable, did not embody an obligation for us to repurchase our shares, and permitted the holders to receive a fixed number of shares of common stock upon exercise.

 

As of September 30, 2024, all of the July 2024 Pre-Funded Warrants had been exercised, resulting in the Company issuing 2,041,814 shares of common stock. In connection with such exercises, the Company received net proceeds of approximately $20 thousand.

 

July 2024 Warrants

 

In July 2024, in conjunction with the 2024 Public Offering, the Company issued new common stock purchase warrants (collectively the “July 2024 Warrants”).

 

 

July 2024 Series F-1 Warrants exercisable for 3,537,212 shares of common stock for an initial exercise price of $1.10 per share through July 30, 2029 (“July 2024 Series F-1 Warrants”); and

 

July 2024 Series F-2 Warrants exercisable for 3,537,212 shares of common stock for an initial exercise price of $1.10 per share through January 29, 2025 (“July 2024 Series F-2 Warrants”); and

 

July 2024 Series F-3 Warrants exercisable for 3,537,212 shares of common stock for an initial exercise price of $1.10 per share through July 29, 2025 (“July 2024 Series F-3 Warrants”).

 

The July 2024 Warrants down round feature adjustment was triggered on September 27, 2024, resulting in a reduced exercise price of $0.66. As a result of the reduced exercise price, a deemed dividend of $1.0 million was recognized in accordance with a Black Scholes valuation model. See Note 3, “Fair Value Measurements”, subheading “Black Scholes Valuation Models and Assumptions”.

 

June 2024 Warrants

 

In June 2024, in conjunction with the 2024 Warrant Reprice Transaction, the Company issued new common stock purchase warrants (the “June 2024 Warrants”) exercisable for 90,381 shares of common stock for $2.57 per share through December 17, 2029.

 

March 2024 Warrant

 

In March 2024, the Company executed the First Amendment and Subsidiary Guarantee Consent as part of the 2024 Subsidiary Guarantee Termination with holders of the Secured Convertible Notes (see Note 10, “Convertible Notes”) in order to close the DERMAdoctor Divestiture (see additional discussion in Note 9, “Financing Activities” and Note 18, “Divestiture and Discontinued Operations”). In exchange for the consent of each holder, the option, at the holder’s election, to receive upon the closing of the DERMAdoctor sale either, a new common stock warrant (the “March 2024 Warrant”), or a new unsecured convertible note (see additional discussion in Note 18, “Divestiture and Discontinued Operations”). One holder elected the option to receive a March 2024 Warrant exercisable for 1,000,000 shares of common stock (28,572 shares post-Reverse Stock Split) for $0.14 per share ($4.90 per share post-Reverse Stock Split).

 

The March 2024 Warrant was initially classified as a liability from the date of issuance until Company stockholder approval on May 28, 2024, at which time it was reclassified to equity.

 

December 2023 Warrants

 

In December 2023, in conjunction with the 2023 Warrant Reprice Transaction, the Company issued new common stock purchase warrants (the “December 2023 Warrants”) exercisable for 2,528,848 shares of common stock (72,256 shares post-Reverse Stock Split) for $0.25 per share ($8.75 per share post-Reverse Stock Split) through June 21, 2029.

 

 

The December 2023 Warrants were initially classified as liabilities from the date of issuance until Company stockholder approval was received on May 28, 2024, at which time it was reclassified to equity.

 

May 2023 Warrants

 

In May 2023, in conjunction with the 2023 Private Placement, the Company issued the following new common stock purchase warrants (collectively, the “May 2023 Warrants”):

 

 

May 2023 Series B-1 Warrants exercisable for 2,538,464 shares of common stock (72,528 shares post-Reverse Stock Split) for an initial exercise price of $1.30 per share ($45.50 per share post-Reverse Stock Split) through June 9, 2028 (“May 2023 B-1 Warrants”); and

 

May 2023 Series B-2 Warrants exercisable for 2,538,464 shares of common stock (72,528 shares post-Reverse Stock Split) for an initial exercise price of $1.30 per share ($45.50 per share post-Reverse Stock Split) through June 9, 2025 (“May 2023 B-2 Warrants”).

 

In December 2023, in conjunction with the 2023 Warrant Reprice Transaction, the Company amended certain May 2023 Warrants to reduce their exercise prices to $0.25 ($8.75 post-Reverse Stock Split). Immediately after amendment, the following May 2023 Warrants were exercised (while any unexercised May 2023 Warrants maintained an exercise price of $1.30 ($45.50 post-Reverse Stock Split)):

 

 

May 2023 B-1 Warrants exercisable for 634,616 shares of common stock (18,132 shares of post-Reverse Stock Split); and

 

May 2023 B-2 Warrants exercisable for 1,894,232 shares of common stock (54,120 shares post-Reverse Stock Split).

 

In June 2024, in conjunction with the 2024 Warrant Reprice Transaction, the Company amended certain May 2023 Warrants to reduce their exercise prices to $2.50. Immediately after amendment, the following May 2023 Warrants were exercised (while any unexercised May 2023 Warrants maintained an exercise price of $8.75):

 

 

May 2023 B-1 Warrants exercisable for 54,396 shares of common stock; and

 

May 2023 B-2 Warrants exercisable for 18,408 shares of common stock.

 

For the amendments in December 2023 and June 2024, the Company recognized a loss on modification of common stock warrants related to the May 2023 Warrants of $170 thousand and $47 thousand, respectively.

 

 

November 2022 Warrants

 

In November 2022, in conjunction with the 2022 Private Placement, the Company issued the following common stock purchase warrants (collectively, the “November 2022 Warrants”):

 

 

November 2022 Series A-1 Warrants exercisable for 515,876 shares of common stock (14,741 shares post-Reverse Stock Split) for an initial exercise price of $6.30 per share ($220.50 per share post-Reverse Stock Split) through November 20, 2028 (“November 2022 A-1 Warrants”); and

 

November 2022 Series A-2 Warrants exercisable for 515,876 shares of common stock (14,741 shares post-Reverse Stock Split) for an initial exercise price of $6.30 per share ($220.50 per share post-Reverse Stock Split) through May 20, 2024 (“November 2022 A-2 Warrants”).

 

In May 2023, in conjunction with the 2023 Private Placement, the Company amended certain November 2022 Warrants to reduce their exercise prices from $6.30 ($220.50 post-Reverse Stock Split) to $1.50 ($52.50 post-Reverse Stock Split) as follows:

 

 

November 2022 A-1 Warrants exercisable for 436,510 shares of common stock (12,473 shares post-Reverse Stock Split); and

 

November 2022 A-2 Warrants exercisable for 436,510 shares of common stock (12,473 shares post-Reverse Stock Split).

 

In May 2024, all November 2022 Series A-2 Warrants for 14,741 shares of common stock remained unexercised and expired.

 

In June 2024, in conjunction with the 2024 Warrant Reprice Transaction, the Company amended certain November 2022 Warrants to reduce their exercise prices from $52.50 to $2.50 as follows:

 

 

November 2022 A-1 Warrants exercisable for 12,473 shares of common stock.

 

For the amendments in May 2023 and June 2024, the Company recognized a loss on modification of common stock warrants related to the November 2022 Warrants of $74 thousand and $16 thousand, respectively.

 

 

September 2022 Warrants

 

In September 2022, in conjunction with the warrant reprice transaction (the “2022 Warrant Reprice Transaction”), the Company issued new common stock purchase warrants (the “September 2022 Warrants”) exercisable for 327,860 shares of common stock (9,371 shares post-Reverse Stock Split) for an initial exercise price of $6.30 per share ($220.50 per share post-Reverse Stock Split) through September 11, 2028.

 

In May 2023, in conjunction with the 2023 Private Placement, the Company amended certain September 2022 Warrants exercisable for 238,574 shares of common stock (6,819 shares post-Reverse Stock Split) to reduce their exercise prices from $6.30 ($220.50 post-Reverse Stock Split) to $1.50 ($52.50 post-Reverse Stock Split).

 

In June 2024, in conjunction with the 2024 Warrant Reprice Transaction, the Company amended certain September 2022 Warrants exercisable for 5,104 shares of common stock to reduce their exercise prices from $52.50 to $2.50.

 

For the amendments in May 2023 and June 2024, the Company recognized a loss on modification of common stock warrants related to the September 2022 Warrants of $28 thousand and $6 thousand, respectively.

 

November 2021 Warrants

 

In November 2021, in conjunction with a private placement transaction, the Company issued new common stock purchase warrants (the “November 2021 Warrants”) exercisable for 1,071,434 shares of common stock (30,616 shares post-Reverse Stock Split) for an initial exercise price of $18.55 per share ($649.25 per share post-Reverse Stock Split) through March 9, 2023.

 

In September 2022, in conjunction with the 2022 Warrant Reprice Transaction, the Company amended all November 2021 Warrants to reduce their exercise prices from $18.55 ($649.25 post-Reverse Stock Split) to $6.30 ($220.50 post-Reverse Stock Split) and extend their termination date to September 11, 2028. Immediately after amendment, November 2021 Warrants were exercised for 7,654 shares of common stock.

 

In May 2023, in conjunction with the 2023 Private Placement, the Company amended certain November 2021 Warrants exercisable for 535,716 shares of common stock (15,308 shares post-Reverse Stock Split) to reduce their exercise prices from $6.30 ($220.50 post-Reverse Stock Split) to $1.50 ($52.50 post-Reverse Stock Split).

 

For the amendments in September 2022 and May 2023, the Company recognized a loss on modification of common stock warrants related to the November 2021 Warrants of $1.5 million and $0.1 million, respectively.

 

July 2020 Warrants

 

In July 2020, in conjunction with a private placement transaction, the Company issued new common stock purchase warrants (the “July 2020 Warrants) exercisable for 197,105 shares of common stock (5,635 shares post-Reverse Stock Split) for an initial exercise price of $57.75 per share ($2,021.25 per share post-Reverse Stock Split) through January 22, 2026.

 

In September 2022, in conjunction with the 2022 Warrant Reprice Transaction, the Company amended certain July 2020 Warrants exercisable for 137,145 shares of common stock (3,921 shares post-Reverse Stock Split) to reduce their exercise prices from $57.75 ($2,021.25 post-Reverse Stock Split) to $6.30 ($220.50 post-Reverse Stock Split). Immediately after amendment, July 2020 Warrants were exercised for 60,000 shares of common stock (1,715 shares post-Reverse Stock Split).

 

In May 2023, in conjunction with the 2023 Private Placement, the Company amended certain July 2020 Warrants exercisable for 77,145 shares of common stock (2,206 shares post-Reverse Stock Split) to reduce their exercise prices from $6.30 ($220.50 post-Reverse Stock Split) to $1.50 ($52.50 post-Reverse Stock Split).

 

For the amendments in September 2022 and May 2023, the Company recognized a loss on modification of common stock warrants related to the July 2020 Warrants of $0.4 million and $9 thousand, respectively.

 

 

Summary of Common Stock Warrant Activity and Outstanding

 

Activity related to common stock warrants outstanding at September 30, 2024 and 2023 were as follows:

 

   

Warrants

   

Weighted-

Average

Exercise

Price

 

Outstanding at December 31, 2022

    65,886     $ 269.54  

Warrants granted

    145,056     $ 45.50  

Warrants exercised

        $  

Warrants expired

        $  

Outstanding at September 30, 2023

    210,942     $ 76.23  
                 

Outstanding at December 31, 2023

    210,946     $ 50.96  

Warrants granted

    10,730,589     $ 0.69  

Pre-funded Warrants granted

    2,041,814     $ 0.01  

Warrants exercised

    (90,381 )   $ 2.50  

Pre-funded Warrants exercised

    (2,041,814 )   $ 0.01  

Warrants expired

    (14,879 )   $ 88.87  

Outstanding at September 30, 2024

    10,836,275     $ 1.41  

 

 

Common stock warrants outstanding as of September 30, 2024 were as follows:

 

Series

 

Exercise

Price*

 

Expiration Date

 

Warrants*

 

July 2020 Warrants

  $ 2,021.25  

January 22, 2026

    1,714  

July 2020 Warrants

  $ 52.50  

January 22, 2026

    2,206  

TLF Warrants

  $ 822.96  

January 15, 2026

    13  

November 2021 Warrants

  $ 220.50  

September 11, 2028

    7,654  

November 2021 Warrants

  $ 52.50  

September 11, 2028

    15,308  

September 2022 Warrants

  $ 220.50  

September 11, 2028

    2,552  

September 2022 Warrants

  $ 52.50  

September 11, 2028

    1,715  

November 2022 A-1 Warrants

  $ 220.50  

November 20, 2028

    2,268  

December 2023 Warrants

  $ 8.75  

June 21, 2029

    72,256  

March 2024 Warrant

  $ 4.90  

March 24, 2029

    28,572  

June 2024 Warrants

  $ 2.57  

December 17, 2029

    90,381  

July 2024 F-1 Warrants

  $ 0.66  

July 30, 2029

    3,537,212  

July 2024 F-2 Warrants

  $ 0.66  

January 29, 2025

    3,537,212  

July 2024 F-3 Warrants

  $ 0.66  

July 29, 2025

    3,537,212  

Outstanding at September 30, 2024

              10,836,275  

 

*

After giving retroactive effect to the 1-for-35 Reverse Stock Split that became effective May 30, 2024.

 

Summary of Common Stock Warrant Liabilities

 

The following is a reconciliation of the beginning and ending balances for warrant liabilities measured at fair value on a recurring basis (in thousands). See additional information per Note 3, “Fair Value Measurements”, subheading “Black Scholes Valuation Models and Assumptions.”

 

Warrant liabilities as of December 31, 2023

  $ 334  

Decrease in fair value of December 2023 Warrant liability during period

    (122 )

Fair value of March 2024 Warrant upon issuance

    92  

Increase in fair value of March 2024 Warrant liability during period

    8  

Reclassification of December 2023 Warrant liability to equity during period

    (212 )

Reclassification of March 2024 Warrant liability to equity during period

    (100 )

Warrant liabilities as of September 30, 2024

  $  

 

 

 

NOTE 12. STOCKHOLDERS EQUITY

 

Authorized Share Capital

 

Under the Company’s Amended and Restated Certificate of Incorporation, as amended, the Company is authorized to issue up to 150,000,000 shares of common stock and up to 5,000,000 shares of preferred stock with rights and preferences as may be approved by the Company’s Board.

 

Reverse Stock Split

 

Effective May 30, 2024, the Company amended its Certificate of Incorporation to effect a 1-for-35 reverse split of its outstanding common stock. The Reverse Stock Split was approved by the Company’s stockholders on May 28, 2024. As a result of the Reverse Stock Split, every 35 shares of the Company’s pre-reverse split outstanding common stock were combined and reclassified into 1 share of common stock. Proportionate voting rights and other rights of common stockholders were not affected by the reverse stock split. Any fractional shares of common stock resulting from the Reverse Stock Split were rounded up to the nearest whole share. All stock options outstanding, common stock reserved for issuance under the Company’s equity incentive plans, common stock reserved for issuance under the Series B Preferred Stock and outstanding warrants were adjusted by dividing the number of affected shares of common stock by 35 and, as applicable, multiplying the exercise/conversion price by 35. Except as otherwise specifically noted, all share numbers, share prices, exercise prices and per share amounts have been adjusted, on a retroactive basis, to reflect this 1-for-35 reverse stock split.

 

Preferred Stock

 

There were two series of preferred stock of the Company outstanding during the three and nine months ended September 30, 2024 and 2023 – the Series B Non-Voting Convertible Preferred Stock (“Series B Preferred Stock”) and the Series C Non-Voting Convertible Preferred Stock (“Series C Preferred Stock”) (and combined, the “Preferred Stock”). The rights and preferences of the Series B Preferred Stock and Series C Preferred Stock are nearly identical. The Preferred Stock does not have any preemptive rights or a preference upon any liquidation, dissolution or winding-up of the Company. Each share of Preferred Stock is convertible into $1,000 of common stock at the conversion price per share applicable at the time of conversion. Until the expiration of such term (as described in more detail below), the Preferred Stock had anti-dilution protection (the “Ratchet”) in the event that the Company sold or granted any of its common stock or any other securities, subject to certain limited exceptions, that would entitle the holder thereof to acquire common stock at an effective price per share that is lower than the then applicable conversion price of the Preferred Stock.

 

Series B Preferred Stock

 

The Company issued 15,000 shares of Series B Preferred Stock in November 2021 in connection with a private placement transaction. As of September 30, 2024 and 2023, 131 and 6,150 shares of Series B Preferred Stock remained outstanding, respectively. As of September 30, 2024 and 2023, outstanding shares of Series B Preferred Stock were convertible into 527,275 shares of common stock (15,065 shares post-Reverse Stock Split) and 4,735,500 shares of common stock (135,300 shares post-Reverse Stock Split) at a conversion price of $0.25 ($8.75 post-Reverse Stock Split) and $1.30 ($45.50 post-Reverse Stock Split), respectively.

 

In accordance with the Ratchet, the Series B Preferred Stock conversion price was reduced as follows (see also Notes 2, “Summary of Significant Accounting Policies” and 3, “Fair Value Measurements”):

 

 

In September 2022, from $14.00 ($490.00 post-Reverse Stock Split) to $6.30 ($220.50 post-Reverse Stock Split), as a result of the 2022 Warrant Reprice Transaction, resulting in a $5.7 million deemed dividend.

 

In April 2023, from $6.30 ($220.50 post-Reverse Stock Split) to $1.30 ($45.50 post-Reverse Stock Split), as a result of the 2023 Private Placement, resulting in a $1.8 million deemed dividend.

 

In December 2023, from $1.30 ($45.50 post-Reverse Stock Split) to $0.25 ($8.75 post-Reverse Stock Split), as a result of the 2023 Warrant Reprice Transaction, resulting in a $4.5 million deemed dividend.

 

On January 29, 2024, the Ratchet of the Series B Preferred Stock expired with no further impact because greater than 75% of the originally issued 15,000 Series B Preferred Stock had been converted into common stock. The Series B Preferred Stock conversion price will remain at $0.25 ($8.75 post-Reverse Stock Split) until all remaining Series B Preferred Stock has been converted.

 

Series C Preferred Stock

 

The Company issued 3,250 shares of Series C Preferred Stock in November 2022 in connection with the 2022 Private Placement (see Note 9, “Financing Activities”). As of September 30, 2024 and 2023, zero and 1,097 shares of Series C Preferred Stock remained outstanding, respectively. As of September 30, 2023, outstanding shares of Series C Preferred Stock were convertible into 844,690 shares of common stock (24,134 shares post-Reverse Stock Split) at a conversion price of $1.30 ($45.50 post-Reverse Stock Split).

 

In accordance with the Ratchet, the Series C Preferred Stock conversion price was reduced as follows (see also Notes 2, “Summary of Significant Accounting Policies” and 3, “Fair Value Measurements”):

 

 

In April 2023, from $6.30 ($220.50 post-Reverse Stock Split) to $1.30 ($45.50 post-Reverse Stock Split), as a result of the 2023 Private Placement, resulting in a $194 thousand deemed dividend.

 

In December 2023, from $1.30 ($45.50 post-Reverse Stock Split) to $0.25 ($8.75 post-Reverse Stock Split), as a result of the 2023 Warrant Reprice Transaction, resulting in a $0.5 million deemed dividend.

 

In March 2024, from $0.25 ($8.75 post-Reverse Stock Split) to $0.14 ($4.90 post-Reverse Stock Split), as a result of the 2024 First Amendment and the Subsidiary Guarantee Consent, resulting in a $0.4 million deemed dividend.

 

On March 27, 2024, the Ratchet of the Series C Preferred Stock expired with no further impact because greater than 75% of the originally issued 3,250 Series C Preferred Stock had been converted into common stock.

 

 

Common Stock

 

See Note 9, “Financing Activities” and Note 11, “Common Stock Warrants” for a description of common stock and common stock warrant-related transactions during the three and nine months ended September 30, 2024 and 2023.

 

 

 

NOTE 13. EQUITY-BASED COMPENSATION

 

Equity Compensation Plans 

 

In October 2007, the Company adopted the 2007 Omnibus Incentive Plan (the “2007 Plan”) to provide for the granting of equity awards, such as stock options, unrestricted and restricted common stock, stock units, dividend equivalent rights, and stock appreciation rights to employees, directors and outside consultants, as determined by the Board. The 2007 Plan expired on March 15, 2017. Upon expiration, new awards cannot be issued pursuant to the 2007 Plan, but outstanding awards continue to be governed by its terms. Stock options granted under the 2007 Plan expire no later than ten years from the date of grant. All stock options outstanding under the 2007 Plan were fully vested as of December 31, 2021.

 

In March 2017, the Company adopted the 2017 Omnibus Incentive Plan (the “2017 Plan”), which was approved by stockholders on June 2, 2017, to provide for the granting of equity awards, such as nonqualified stock options (“NQSOs”), incentive stock options (“ISOs”), restricted stock, performance shares, stock appreciation rights (“SARs”), RSUs and other share-based awards to employees, directors, and consultants, as determined by the Board. The 2017 Plan does not affect awards previously granted under the 2007 Plan. Upon adoption, the 2017 Plan allowed for awards of up to 66,243 shares (1,892 shares post-Reverse Stock Split) of the Company’s common stock, plus an automatic annual increase in the number of shares authorized for awards on the first day of each of the Company’s fiscal years beginning January 1, 2018 through January 1, 2027 equal to (i) 4% of the number of shares of common stock outstanding on the last day of the immediately preceding fiscal year or (ii) such lesser number of shares of common stock as determined by the Board. On June 21, 2024, the number of shares available for future awards under the 2017 Plan was increased by 12,219 shares. As of September 30, 2024, there were 13,650 shares available for future awards under the 2017 Plan.

 

Under the terms of the 2017 Plan, the exercise price of NQSOs, ISOs and SARs may not be less than 100% of the fair market value of the common stock on the date of grant and, if ISOs are granted to an owner of more than 10% of the Company’s stock, then not less than 110% of the fair market value of the common stock on the date of grant. The term of awards will not be longer than ten years or, in the case of ISOs, no longer than five years with respect to holders of more than 10% of the Company’s stock. Stock options granted to employees generally vest over four years, while options granted to directors and consultants typically vest over a shorter period, subject to continued service. The Company issues new shares to satisfy options under the 2007 Plan and the 2017 Plan.

 

Summary of Outstanding Equity Awards

 

The following table summarizes information about the Company’s stock options and restricted stock outstanding at December 31, 2023, and activity during the nine months ended September 30, 2024:

 

(in thousands, except years
and per share data)

 

Awards*

   

Weighted-

Average

Exercise

Price*

   

Weighted-

Average

Remaining

Contractual

Life (years)

   

Aggregate

Intrinsic

Value

 

Outstanding at December 31, 2023

    4     $ 1,145.87       7.3     $ 1  

Restricted stock units granted

    5     $                  

Options forfeited/cancelled

    (2 )   $ 535.07                  

Outstanding at September 30, 2024

    7     $ 470.76       8.5     $ 4  
                                 

Vested and expected to vest at September 30, 2024

    7     $ 474.75       8.5     $ 4  
                                 

Vested and exercisable at September 30, 2024

    1     $ 2,122.83       4.7     $  

 

*

After giving retroactive effect to the 1-for-35 Reverse Stock Split that became effective May 30, 2024.

 

 

The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying stock option awards and the closing market price of the Company’s common stock as quoted on the NYSE American as of September 30, 2024 for options that have an exercise price that is lower than the market price. There were no stock option awards exercised during the three and nine months ended September 30, 2024 and 2023.

 

As of September 30, 2024, total unrecognized compensation cost related to unvested stock options and restricted stock units was approximately $0.1 million. This amount is expected to be recognized as stock-based compensation expense in the Company’s unaudited condensed consolidated statements of operations over the remaining weighted average vesting period of 1.3 years.

 

Equity Awards to Employees and Directors

 

The Company grants options to purchase common stock to its employees and directors at prices equal to or greater than the market value of the stock on the dates the options are granted. The Company has estimated the value of stock option awards as of the date of grant by applying the Black Scholes option pricing model using the single-option valuation approach. The application of this valuation model involves assumptions that are judgmental and subjective in nature. See Note 2, “Summary of Significant Accounting Policies,” for a description of the accounting policies that the Company applied to value its stock-based awards. 

 

During the nine months ended September 30, 2024 and 2023, the Company granted options to employees and directors to purchase an aggregate of zero and 6,150 shares of common stock (177 shares post-Reverse Stock Split), respectively.

 

The weighted-average assumptions used in determining the value of options were as follows: 

 

Assumption

 

For the Nine

Months Ended

September 30,

2023

 

Expected price volatility

    152.99 %

Expected term (in years)

    6.81  

Risk-free interest rate

    3.47 %

Dividend yield

    0.00 %

Weighted-average fair value of options granted during the period

  $ 58.57  

 

Expected Price Volatility—This is a measure of the amount by which the stock price has fluctuated or is expected to fluctuate. The computation of expected volatility was based on the historical volatility of our own stock.

 

Expected Term—This is the period of time over which the options granted are expected to remain outstanding. The expected life assumption is based on the Company’s historical data.

 

Risk-Free Interest Rate—This is the U.S. Treasury rate for the week of the grant having a term approximating the expected life of the option.

 

Dividend Yield—The Company has not made any dividend payments nor does the Company have plans to pay dividends in the foreseeable future.

 

Forfeitures are estimated at the time of grant and reduce compensation expense ratably over the vesting period. This estimate is adjusted periodically based on the extent to which actual forfeitures differ, or are expected to differ, from the previous estimate.

 

During the nine months ended September 30, 2024, the Company granted 5,148 shares of restricted stock to employees and directors. During the nine months ended September 30, 2023, the Company granted 5,148 shares of restricted stock (150 shares post-Reverse Stock Split) to employees and directors.

 

For the three months ended September 30, 2024 and 2023, the Company recognized stock-based compensation expense of $22 thousand and $59 thousand, respectively, for option awards to employees and directors. For the nine months ended September 30, 2024 and 2023, the Company recognized stock-based compensation expense of $124 thousand and $194 thousand, respectively, for option awards to employees and directors.

 

Stock-Based Awards to Non-Employees

 

During the three and nine months ended September 30, 2024, the Company did not grant options to non-employees in exchange for advisory and consulting services. During the three and nine months ended September 30, 2023, the Company granted 36,000 options (1,032 options post-Reverse Stock Split) to non-employees. These options were cancelled in June 2024.

 

The Company did not grant restricted stock to non-employees during the three and nine months ended September 30, 2024 and 2023.

 

For the three and nine months ended September 30, 2024 the Company recognized stock-based compensation expense of zero and $13 thousand, respectively, as it relates to non-employees. For the three and nine months ended September 30, 2023, the Company recognized stock-based compensation expense of $3 thousand and $7 thousand, respectively, as it relates to non-employees.

 

 

Summary of Stock-Based Compensation Expense

 

A summary of the stock-based compensation expense included in results of operations for the options and restricted stock awards discussed above is as follows (in thousands):

 

   

Three Months Ended

September 30,

   

Nine Months Ended

September 30,

 
   

2024

   

2023

   

2024

   

2023

 

Research and development

  $ 3     $ 5     $ 12     $ 16  

Sales and marketing

    8       18       48       49  

General and administrative

    11       39       77       136  

Total stock-based compensation expense

  $ 22     $ 62     $ 137     $ 201  

 

 

 

NOTE 14. DISTRIBUTION AGREEMENTS

 

Transactions under the Company’s major distribution agreements are recognized upon transfer of control of products sold to its major distribution partners at the amount of consideration that the Company expects to be entitled to. The Company records contract liabilities for the amounts that are estimated to be subject to significant reversal, including allowances for services, discounts, rebate programs, and product returns.

 

Product Sales Discounts and Allowances

 

The following table presents activities and ending reserve balances for each significant category of discounts and allowance, which constitute variable consideration, for the nine months ended September 30, 2024 (in thousands): 

 

   

Chargebacks,

Discounts for

Prompt

Payment

   

Other

Customer

Fees

   

Rebates

   

Total

 

Balance at December 31, 2023

  $ 913     $ 12     $ 21     $ 946  

Less discontinued operations

    (218 )                 (218 )

Continuing operations balance at December 31, 2023

    695       12       21       728  

Provision related to sales made in:

                               

Current period

    39       36       77       152  

Payments and customer credits issued

    (14 )     (36 )     (79 )     (129 )

Balance at September 30, 2024

  $ 720     $ 12     $ 19     $ 751  

 

Avenova Spray Pharmacy Distribution Agreements and Specialty Pharmacies

 

Avenova Spray is made available in local pharmacies and major pharmacy retail chains under nationwide distribution agreements with McKesson Corporation, Cardinal Health and AmerisourceBergen. The Company has also entered into direct agreements with preferred pharmacy networks as part of our Partner Pharmacy Program. During the three months ended September 30, 2024 and 2023, the Company earned $153 thousand and $232 thousand, respectively, in sales revenue for its Avenova Spray product from these distribution and partner pharmacy agreements. During the nine months ended September 30, 2024 and 2023, the Company earned $385 thousand and $519 thousand, respectively, in sales revenue for its Avenova Spray product from these distribution and partner pharmacy agreements.

 

Under these product distribution arrangements, the Company had a contract liability balance of $0.8 million and $0.7 million as of September 30, 2024 and December 31, 2023, respectively. The contract liability is included in accrued liabilities in the condensed consolidated balance sheets.

 

Over-the-Counter Sales of Avenova Spray

 

Avenova Spray is offered for sale direct to U.S. customers primarily on Amazon.com, the Company’s website (Avenova.com) and Walmart.com. During the three months ended September 30, 2024 and 2023, the revenue generated from Avenova Spray in these channels was $1.8 million and $1.6 million, respectively. During the nine months ended September 30, 2024 and 2023, the revenue generated from Avenova Spray in these channels was $5.4 million and $4.5 million, respectively.

 

 

 

NOTE 15. EMPLOYEE BENEFIT PLAN

 

The Company has a 401(k) plan covering all eligible employees. The Company provides matching contributions equal to 100% of the first 3% of compensation deferred, plus 50% of the next 2% of compensation deferred. The Company contributed $24 thousand to the 401(k) plan from continuing operations in each of the three months ended September 30, 2024 and 2023. The Company contributed $73 thousand and $70 thousand to the 401(k) plan from continuing operations in the nine months ended September 30, 2024 and 2023, respectively. The Company contributed $8 thousand and $25 thousand to the 401(k) plan from discontinued operations in the three and nine months ended September 30, 2023, respectively.

 

 

 

NOTE 16. RELATED PARTY TRANSACTIONS

 

The following table summarizes information about the Company’s related party revenue and cost of goods sold (in thousands): 

 

   

Three Months Ended

September 30,

   

Nine Months Ended

September 30,

 
   

2024

   

2023

   

2024

   

2023

 

Chongqing Pioneer Pharma Holdings Limited:

                               

Revenue

  $     $     $     $ 1,043  

Cost of goods sold

          28             923  

 

 

 

 

NOTE 17. SEGMENT REPORTING

 

The Company operates as one reportable segment, Eyecare and Wound Care, which is described in further detail below. This is based on the objectives of the business and how our chief operating decision maker (“CODM”), the President and Chief Executive Officer, monitors operating performance and allocates resources.

 

Change in Reportable Segments

 

The Company previously operated in principally two reportable segments, (1) Eyecare and Wound Care and (2) Skincare. During the nine months ended September 30, 2024, in connection with the previously announced strategic shift and upon the DERMAdoctor Divestiture, the Company has ceased to operate the Skincare segment. As a result, the Company changed the level of detail at which our CODM regularly reviews and manages the businesses, resulting in a change to our reportable segments.

 

We now manage and report our operating results through one reportable segment: Eyecare and Wound Care. This change allows us to better align our business models, resources, and cost structure to the specific current and future growth of our business, while maintaining the necessary information and transparency to our stockholders. Our historical segment information has been recast to conform to the current segment structure.

 

 

 

NOTE 18. DIVESTITURE AND DISCONTINUED OPERATIONS

 

On March 12, 2024, the Company entered into an agreement to sell 100% of the membership units of DERMAdoctor for a closing purchase price of $1.1 million. The sale of the membership units closed, and the DERMAdoctor Divestiture occurred, on March 25, 2024. In order to close the sale, the Company was required to obtain the consent of the holders of the Secured Convertibles Notes (see Note 10, “Convertible Notes”) issued in May 2023 to (i) amend the Security Agreement to remove the Membership Units and any assets of DERMAdoctor as collateral for the Company’s obligations pursuant to the Secured Convertible Notes and for DERMAdoctor to be removed as a party to the Security Agreement and (ii) terminate the Subsidiary Guarantee, which DERMAdoctor entered into in connection with the issuance of the Secured Convertible Notes.

 

On March 24, 2024, the Company and the secured parties entered into a First Amendment to the Security Agreement, to effect an amendment to the Security Agreement and a Consent and Release to terminate the Subsidiary Guarantee. To obtain the secured parties’ consent and as consideration for the secured parties taking the necessary actions to execute and deliver the First Amendment and the Subsidiary Guarantee Consent, the Company provided each secured party the option, at the secured party’s election, to receive only upon the closing of the DERMAdoctor Sale Transaction either: a March 2024 Warrant or the Unsecured Convertible Notes (see Note 10 “Convertible Notes”).

 

The accounting requirements for reporting the DERMAdoctor business as discontinued operations were met during the first quarter of 2024. Accordingly, the condensed consolidated financial statements and notes to the condensed consolidated financial statements reflect the results of the DERMAdoctor business as a discontinued operation for the periods presented.

 

In accordance with the provisions of ASC 205-20, the Company has separately reported the assets and liabilities of the discontinued operations in the condensed consolidated balance sheets. The assets and liabilities have been reflected as discontinued operations in the condensed consolidated balance sheets as of December 31, 2023, and consist of the following (in thousands):

 

   

Balance at

December 31,

2023

 
         

ASSETS

       

Current assets:

       

Cash and cash equivalents

  $ 206  

Accounts receivable, net of allowance for credit losses ($0 at December 31, 2023)

    79  

Inventory, net of allowance for excess and obsolete inventory and lower of cost or estimated net realizable value adjustments ($363 at December 31, 2023)

    2,313  

Prepaid expenses and other current assets

    132  

Total current assets, discontinued operations

    2,730  

Other assets

    19  

Total assets, discontinued operations

  $ 2,749  
         

LIABILITIES

       

Liabilities:

       

Current liabilities:

       

Accounts payable

  $ 224  

Accrued liabilities

    347  

Operating lease liabilities

    127  

Total current liabilities, discontinued operations

    698  

Total liabilities, discontinued operations

  $ 698  

 

 

In accordance with the provisions of ASC 205-20, the Company has not included in the results of continuing operations the results of operations of the discontinued operations in the unaudited condensed consolidated statements of operations. The results of DERMAdoctor’s operations for the nine months ended September 30, 2024 and 2023 have been reflected as discontinued operations in the unaudited condensed consolidated statements of operations and consist of the following (in thousands):

 

   

Nine Months Ended

 
   

2024

   

2023

 

Sales:

               

Product revenue, net

  $ 717     $ 2,645  

Total sales, net

    717       2,645  
                 

Cost of goods sold

    493       1,566  

Gross profit

    224       1,079  

Operating expenses

               

Research and development

    2       28  

Sales and marketing

    292       1,413  

General and administrative

    48       749  

Total operating expenses

    342       2,190  

Operating loss

    (118 )     (1,111 )
                 

Other expense, net

    (6 )     5  
                 

Net loss from discontinued operations

  $ (124 )   $ (1,106 )

 

In accordance with the provisions of ASC 205-20, the Company has not included in the results of continuing operations the results of operations of the discontinued operations in the unaudited condensed consolidated statements of cash flows. The results of DERMAdoctor for the nine months ended September 30, 2024 and 2023 have been reflected as discontinued operations in the unaudited condensed consolidated statements of cash flows and consist of the following (in thousands):

 

   

Nine Months Ended September 30,

 
   

2024

   

2023

 
                 

Operating activities:

               

Net loss from discontinued operations

  $ (124 )   $ (1,106 )

Adjustments to reconcile net loss to net cash used in operating activities:

               

Amortization of intangible assets

          114  

Non-cash right-of-use amortization

          83  

Changes in operating assets and liabilities:

               

Accounts receivable

    (262 )     144  

Inventory

    183       139  

Prepaid expenses and other current assets

    (4 )     146  

Other assets

    15       (8 )

Accounts payable and accrued liabilities

    63       299  

Operating lease liabilities

    (31 )     (89 )

Net cash used in operating activities, discontinued operations

    (160 )     (278 )
                 

Investing activities:

               

Cash transferred to New Age Investments, LLC

    (46 )      

Purchases of property and equipment

          (1 )

Net cash used in investing activities, discontinued operations

    (46 )     (1 )
                 

Net decrease in cash and cash equivalents, discontinued operations

  $ (206 )   $ (279 )

 

 

 

NOTE 19. SUBSEQUENT EVENTS

 

The Company has evaluated all subsequent events through the filing date of this Form 10-Q with the SEC, to ensure that this filing includes appropriate disclosure of events both recognized in the unaudited condensed consolidated financial statements as of September 30, 2024, and events which occurred subsequently but were not recognized in the unaudited condensed consolidated financial statements. Except as described below, there were no subsequent events which required recognition, adjustment to or disclosure in the unaudited condensed consolidated financial statements.

 

Asset Sale Transaction--Amendment to Asset Purchase Agreement and Bridge Loan

 

On November 5, 2024, the Company and PRN entered into the APA Amendment to the Original Purchase Agreement. The Purchase Agreement, consistent with the Original Purchase Agreement, continues to provide for the sale of the Avenova Assets to PRN, subject to meeting certain closing conditions including receiving stockholder approval of the Asset Sale Transaction. The APA Amendment provides for the Revised PRN Transaction Terms, including the following primary revisions to the Original Purchase Agreement: (i) an increase in the base purchase price to $11.5 million from $9.5 million; (ii) the removal of debt financing contingencies and related PRN representations, while adding a new PRN representation that it has sufficient funding for the $11.5 million purchase price; (iii) PRN providing the Company with the Bridge Loan; and (iv) PRN providing the  Company with the Equity Commitment Letter.

 

On November 5, 2024, the Company also entered into the Bridge Loan that provides for the Company receiving a secured loan of up to $1.0 million from PRN as lender that will be funded in two tranches of $0.5 million each upon the Company providing written notice to PRN on or after November 22, 2024 and on or after December 6, 2024. The amounts borrowed under the Bridge Loan are required to be used for working capital purposes, will bear interest at a rate of 10% per annum and be secured by all of the Company’s assets as collateral. The Bridge Loan is a short term secured loan that is to be repaid upon the earlier of the closing of the Asset Sale Transaction (to be repaid from the purchase price), immediately upon termination of the Purchase Agreement or February 28, 2025. If any Event of Default (as defined in the Bridge Loan) occurs, the outstanding principal amount of the Bridge Loan, plus any accrued and unpaid interest, shall become immediately due and payable with the interest rate on the outstanding principal amount of the Bridge Loan increasing to 12% per annum.

 

For more information regarding the Asset Sale Transaction (including the Revised PRN Transaction Terms, the APA Amendment and the Bridge Loan) and the Dissolution, please see the Company’s Current Reports on Form 8-K filed with the SEC on September 20, 2024, October 29, 2024 and November 6, 2024 and the Special Meeting Proxy Statement and related supplements.

 

 

 

ITEM 2.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

This discussion contains forward-looking statements that involve risks and uncertainties. The following discussion of our financial condition and results of operations should be read together with our unaudited condensed consolidated financial statements and related notes included in Part I, Item 1 of this report, and with our consolidated financial statements and related notes, and Managements Discussion and Analysis of Financial Condition and Results of Operations, included in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the Securities and Exchange Commission (the SEC) on March 26, 2024, as amended on March 29, 2024 (the 2023 Annual Report). Words such as expects, anticipated, will, may,” “goals, plans, believes, estimates, concludes, determines, variations of these words, and similar expressions are intended to identify these forward-looking statements. As a result of many factors, including those set forth under the section entitled Risk Factors of this report, our 2023 Annual Report and our Special Meeting Proxy Statement (as defined below), as well as in other sections in our SEC filings, our actual results may differ materially from those anticipated in these forward-looking statements. Readers are cautioned that these forward-looking statements are only predictions based upon assumptions made that we believed to be reasonable at the time and are subject to risks and uncertainties. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Except as required by law, we undertake no obligation to revise or update publicly any forward-looking statements after the date of this report, even if new information becomes available in the future.

 

Overview 

 

We are a company focused on the development and sale of scientifically-created and clinically-proven eyecare and wound care products. Our leading product, Avenova® Antimicrobial Lid and Lash Solution, or Avenova Spray, is proven in laboratory testing to have broad antimicrobial properties as it removes foreign material including microorganisms and debris from the skin around the eye, including the eyelid. Avenova Spray is formulated with our proprietary, stable and pure form of hypochlorous acid and is cleared by the Food and Drug Administration (the “FDA”) for sale in the United States. Avenova Spray is available direct to consumers, primarily through online distribution channels, and is also available by prescription and dispensed by eyecare professionals for blepharitis and dry eye disease. Because dry eye is a complex condition, we offer a complementary portfolio of scientifically-developed products for each step of the standard at-home treatment regimen, including the Avenova Lubricating Eye Drops for instant relief, NovaWipes by Avenova, Avenova Warm Eye Compress to soothe the eyes, and the i-Chek by Avenova to monitor physical eyelid health.

 

We also manufacture and sell our proprietary form of hypochlorous acid for the wound care market through our NeutroPhase and PhaseOne branded products. NeutroPhase and PhaseOne are used for cleansing and irrigation as part of surgical procedures, as well as treating wounds, burns, ulcers and other injuries. The Company currently sells these products through distributors.

 

Through our former subsidiary DERMAdoctor, LLC (“DERMAdoctor”), the Company offered over 30 dermatologist-developed products targeting common skin concerns, ranging from aging and blemishes to dry skin, perspiration and keratosis pilaris. On March 25, 2024, we announced the closing of the sale of DERMAdoctor (the “DERMAdoctor Divestiture”). We acquired DERMAdoctor in November 2021 in order to achieve overall revenue growth, cost reductions and profitability. We were unable to achieve those objectives with DERMAdoctor. Therefore, we determined to divest DERMAdoctor and consummate the DERMAdoctor Divestiture, having incurred historical losses including the loss of $124 thousand for the nine months ended September 30, 2024. The DERMAdoctor Divestiture streamlined our business by reducing our cash burn and allowing us to focus on our core business.

 

Recent Developments

 

Potential Asset Sale Transaction and Dissolution

 

On September 19, 2024, the Company entered into an Asset Purchase Agreement (the “Original Purchase Agreement”) with PRN Physician Recommended Nutriceuticals, LLC, a Delaware limited liability company (“PRN”), pursuant to which PRN will acquire the Company’s eyecare products sold under the Avenova brand and the related assets (the “Avenova Assets”) (collectively, the “Asset Sale Transaction”). On November 5, 2024, the Company entered into an amendment to the Original Purchase Agreement (the “APA Amendment,” and together with the Original Purchase Agreement, the “Purchase Agreement”) that provides for, among other terms, an increase in the base purchase price to $11.5 million from $9.5 million and for PRN to provide the Company with a $1.0 million secured promissory note (the “Bridge Loan”). Pursuant to the Purchase Agreement, the Asset Sale Transaction is subject to certain closing conditions, including stockholder approval. Assuming stockholder approval is received and other closing conditions are met, the Company expects to close the Asset Sale Transaction in the fourth quarter of 2024.

 

The Asset Sale Transaction would constitute substantially all of the Company’s revenue generating and operating assets; however, PRN would not purchase any of the Company’s other products and assets, including those that relate to the Company’s wound care, urology or dermatology businesses. The Board unanimously approved the Asset Sale Transaction and further determined that, if the Asset Sale Transaction is completed, the best opportunity available to optimize value to our stockholders is to wind-up the Company’s affairs and pursue a liquidation and dissolution pursuant to the Plan of Dissolution under Delaware law that may result in distributions to our stockholders of our remaining asset value (the “Dissolution”). If the Asset Sale Transaction and/or the Dissolution are not completed, we will continue our corporate existence and the Board will continue to explore its options to secure immediate funding for ongoing operations due to significantly reduced available capital and liquidity, the strategic alternatives available to the Company including to return capital to stockholders or, to the extent funding or any other viable alternatives are not available, then the Company may need to file for bankruptcy protection or commence a similar state law proceeding.

 

-46-

 

The Company has called a special meeting of stockholders (the “Special Meeting”) on November 22, 2024 to approve (1) the Asset Sale Transaction and (2) the Dissolution subject to the Board’s discretion to proceed with the Dissolution.

 

On October 29, 2024, the Company announced that the Board determined that an unsolicited and non-binding acquisition proposal from Refresh Acquisitions BidCo LLC (“Refresh”) to purchase the Avenova Assets (the “Refresh Unsolicited Offer”) was a “Superior Proposal” (as defined in the Purchase Agreement). As a result, the Company notified PRN of the Board’s determination and the Company’s intention to terminate the Purchase Agreement pursuant to its terms, unless the Company received a revised proposal from PRN such that the Board determined the Refresh Unsolicited Offer was no longer a Superior Proposal, all in accordance with the process provided in the Purchase Agreement.

 

Subsequent to this Board determination, in accordance with the process in the Purchase Agreement, the Company negotiated in good faith with PRN, and, as a result of these negotiations, PRN proposed amending the  terms of the Original Purchase Agreement by entering into the APA Amendment, which provides for the following primary revisions to the Original Purchase Agreement: (i) an increase in the base purchase price to $11.5 million from $9.5 million; (ii) the removal of debt financing contingencies and related PRN representations, while adding a new PRN representation that it has sufficient funding for the $11.5 million purchase price; (iii) PRN providing the Company with the Bridge Loan; and (iv) PRN providing the Company with an equity funding commitment letter (the “Equity Commitment Letter”) from Roundtable Healthcare Partners V, L.P. that provides for up to $13.0 million in financing to be used by PRN’s parent company, Acumen Intermediate Holdings, LLC, and contributed to PRN for payment of the purchase price at the closing of the Asset Sale Transaction (with such updated terms, the “Revised PRN Transaction Terms”). On November 4, 2024, after considering the Revised PRN Transaction Terms, the Board determined that the Refresh Unsolicited Offer was no longer a “Superior Proposal” and that it was advisable and in the best interests of stockholders to enter into the APA Amendment and the Bridge Loan.

 

On November 5, 2024, the Company entered into the APA Amendment and the Bridge Loan. The Bridge Loan provides for the Company to receive a secured loan of up to $1.0 million from PRN as lender that will be funded in two tranches of $0.5 million each upon the Company providing written notice to PRN on or after November 22, 2024 and on or after December 6, 2024. The amounts borrowed under the Bridge Loan are required to be used for working capital purposes, will bear interest at a rate of 10% per annum and be secured by all of the Company’s assets as collateral. The Bridge Loan is to be repaid upon the earlier of the closing of the Asset Sale Transaction (to be repaid from the purchase price), immediately upon termination of the Purchase Agreement or February 28, 2025. If the Asset Sale Transaction is not consummated, the Purchase Agreement is terminated and the Company is required to repay the full amount borrowed pursuant to the Bridge Loan, the Company may not have the necessary capital resources available at the time to repay the Bridge Loan absent the Company raising additional capital.

 

For more information regarding the Asset Sale Transaction (including the Revised PRN Transaction Terms, the APA Amendment and the Bridge Loan) and the Dissolution, please see the Company’s Current Reports on Form 8-K filed with the SEC on September 20, 2024, October 29, 2024 and November 6, 2024 and the Company’s Definitive Proxy Statement on Schedule 14A filed with the SEC on October 16, 2024 (as may be supplemented, the “Special Meeting Proxy Statement”).

 

2024 Public Offering

 

On July 26, 2024, the Company entered into the Underwriting Agreement with Ladenburg, as the sole underwriter, relating to the issuance and sale in a public offering (the “2024 Public Offering”) of: (i) 1,158,566 shares of common stock and 2,041,814 July 2024 Pre-Funded Warrants, in lieu of shares of common stock, (ii) 3,200,380 Series F-1 Warrants, (iii) 3,200,380 Series F-2 Warrants, and (iv) 3,200,380 Series F-3 Warrants. The 2024 Public Offering closed on July 29, 2024, and the Company received gross proceeds of $3.9 million, without taking into account any underwriting discounts and commissions. A portion of the proceeds were used towards repaying the Secured Convertible Notes, which were repaid in full during the third quarter of 2024.

 

DERMAdoctor Divestiture

 

On March 12, 2024, we entered into a Membership Unit Purchase Agreement (the “DERMAdoctor Purchase Agreement”) by and among: (i) New Age Investments, LLC; (ii) DERMAdoctor; and (iii) the Company that provided for the sale of 100% of the membership units (the “Membership Units”) of DERMAdoctor.

 

Upon the closing of the DERMAdoctor Divestiture on March 25, 2024 as contemplated by the DERMAdoctor Purchase Agreement, the Company sold the Membership Units to New Age Investments, LLC for a purchase price of $1.1 million. For additional information regarding the DERMAdoctor Divestiture, see also Note 18, “Divestiture and Discontinued Operations” in the Notes to the Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this report.

 

-47-

 

Amendment to the Security Agreement and Consent to Terminate the Subsidiary Guarantee

 

The closing of the DERMAdoctor Divestiture was subject to certain conditions, which included the Company obtaining the consent of the holders (the “Secured Parties”) of the Company’s Original Discount Senior Secured Convertible Debentures due November 1, 2024 (see Note 10, “Convertible Notes”), to (i) amend the Security Agreement, dated April 27, 2023 (the “Security Agreement”), to remove the Membership Units and any assets of DERMAdoctor as collateral for the Company’s obligations pursuant to the Secured Convertible Notes and for DERMAdoctor to be removed as a party to the Security Agreement and (ii) terminate the Subsidiary Guarantee, dated April 27, 2023, which DERMAdoctor entered into in connection with the issuance of the Secured Convertible Notes.

 

On March 24, 2024, the Company and the Secured Parties entered into a First Amendment to the Security Agreement to effect the Security Agreement Amendment, and a Consent and Release to effect the 2024 Subsidiary Guarantee Termination. As consideration for the Secured Parties executing and delivering the First Amendment and the Subsidiary Guarantee Consent, which reduced the collateral available to secure the obligations under the Secured Convertible Notes, the Company provided each Secured Party the option, at the Secured Party’s election, to receive upon the closing of the DERMAdoctor Divestiture either: (i) a new Series D common stock purchase warrant (the “March 2024 Warrant”), or (ii) a new unsecured convertible note convertible into shares of common stock (the “Unsecured Convertible Notes”).  Based on the Secured Parties’ elections and as a result of the closing of the DERMAdoctor Divestiture, the Company issued: (A) a March 2024 Warrant to a Secured Party that is exercisable for an aggregate of 1,000,000 shares of common stock (28,572 shares post-Reverse Stock Split) and (B) Unsecured Convertible Notes to four (4) Secured Parties that have an aggregate principal amount of $525,000 or will be convertible into an aggregate of 3,750,000 shares of common stock (107,146 shares post-Reverse Stock Split).

 

The Company incurred total issuance costs of $130 thousand in conjunction with the 2024 Subsidiary Guarantee Termination. The Company allocated $19 thousand of the issuance costs to the Unsecured Convertible Notes which was recorded as a discount in the Company’s unaudited condensed consolidated balance sheet as of September 30, 2024. The remaining $111 thousand was allocated to the embedded derivative liability and warrant liability and expensed as “Other expense, net” in the Company’s unaudited condensed consolidated statements of operations, during the nine months ended September 30, 2024. For additional information regarding the March 2024 Warrant and the Unsecured Convertible Notes that we issued, see also Notes 9, “Financing Activities”; 10, “Convertible Notes”; 11, “Common Stock Warrants”; and 12, “Stockholders’ Equity” in the Notes to the Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this report.

 

NYSE American Notices

 

On April 18, 2024, the Company received a notification (“Initial Deficiency Letter”) from the NYSE American LLC Exchange (“NYSE American”) stating that the Company is not in compliance with Section 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide (requiring stockholders’ equity of $4.0 million or more if the Company has reported losses from continuing operations and/or net losses in three of the four most recent fiscal years and $6.0 million or more if the Company has reported losses from continuing operations and/or net losses in its five most recent fiscal years, respectively).

 

On May 28, 2024, the Company received a letter (“Additional Deficiency Letter”) from NYSE American stating that the Company is not in compliance with the minimum stockholders’ equity requirements of Section 1003(a)(i) of the NYSE American Company Guide. Section 1003(a)(i) of the NYSE American Company Guide requires a listed company to maintain stockholders’ equity of $2.0 million or more if the listed company has reported losses from continuing operations and/or net losses in two of its three most recent fiscal years. The Company reported stockholders’ equity of $160 thousand as of March 31, 2024 and has had losses from continuing operations and net losses in each of the last three fiscal years.

 

Therefore, the Company has become subject to the procedures and requirements of Section 1009 of the NYSE American Company Guide and was required to submit a plan of compliance by May 18, 2024 addressing how it intends to regain compliance with Section 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide by October 18, 2025. On June 4, 2024, the Company received notice from the NYSE American that it had accepted the Company’s plan of compliance and granted a plan period through October 18, 2025. During the plan period, the Company will be subject to quarterly monitoring for compliance with the plan. If the Company does not regain compliance with the NYSE American’s listing standards by October 18, 2025, or if the Company does not make progress consistent with its plan, then the NYSE American may initiate delisting procedures.

 

Additionally, the Asset Sale Transaction (to the extent completed) may cause the NYSE American to delist our shares of common stock and the Company may not meet NYSE American’s continued listing requirements. To the extent the NYSE American does not delist our shares after completion of the Asset Sale Transaction and the Board determines to effect the Dissolution, the Company plans to request that our common stock stop trading on the NYSE American on the effective date of the Dissolution or as soon thereafter as is reasonably practicable.

 

-48-

 

Financial Overview and Outlook

 

We have incurred net losses and generated negative cash flows from operations since inception and expect to incur losses in the future as we continue to commercialize our products. Our net losses were $2.2 million and $1.8 million for the three months ended September 30, 2024 and 2023, respectively. In addition, our net losses were $7.4 million and $7.5 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $182.2 million, total current assets of $2.3 million and total assets of $3.9 million.

 

To date, our plan to grow commercial sales of Avenova branded products primarily through an expansion of domestic market penetration of our online channels as well expanded product offerings through partnerships with other eyecare product providers has been unsuccessful. However, in an effort to maximize stockholder value, our Board unanimously determined to pursue the Asset Sale Transaction and the Dissolution, both of which are subject to stockholder approval at the Special Meeting. See “Potential Asset Sale Transaction and Dissolution” above for additional information regarding the Asset Sale Transaction and the Dissolution.

 

Critical Accounting Estimates

 

Our unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the reported revenues and expenses during the reporting periods. In preparing these unaudited condensed consolidated financial statements, management has made its best estimates and judgments of certain amounts, giving due consideration to materiality. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results may differ from these estimates.

 

-49-

 

While our significant accounting policies are more fully described in Note 2, “Summary of Significant Accounting Policies” in the Notes to Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this report, we believe that the following accounting estimates are most critical to fully understanding and evaluating our reported financial results as discussed in this Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

Impairment of Goodwill, Indefinite-Lived Intangible Assets and Long-Lived Assets

 

We review goodwill, indefinite-lived intangible assets and long-lived assets for impairment at least annually or whenever events or changes in business circumstances indicate that any such asset may be impaired, that the carrying amount of any such asset may not be fully recoverable or that the useful life of the asset, if applicable, is no longer appropriate. Management uses judgement in making critical assumptions and estimates in determining when an impairment assessment should be recorded, if more frequent than annually, or in the completion of any such assessment. This includes cash flow projections that look several years into the future and assumptions on variables such as future sales and operating margin growth rates, economic conditions, probability of success, market competition, inflation and discount rates. Changes in judgments with respect to these assumptions and estimates could impact any such impairments recorded such as those recorded in the fourth quarter of 2023 as further described in Note 2, “Summary of Significant Accounting Policies” included in our 2023 Annual Report.

 

Valuation of Contingent Consideration Resulting from a Business Combination

 

We revalue any outstanding contingent obligations to pay future consideration related to business combinations at the end of each quarter and record increases or decreases in their fair value within our unaudited condensed consolidated statements of operations. Increases or decreases in fair value of the contingent consideration liabilities can result from updates to assumptions such as the expected timing or probability of achieving the specified milestones. Significant judgment is employed in determining these assumptions as of the acquisition date and for each subsequent period. Updates to assumptions could have a significant impact on our results of operations in any given period. See additional information in Note 2, “Summary of Significant Accounting Policies” in the Notes to Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this report.

 

Estimates of Future Product Returns

 

The Company records revenue in an amount that reflects the consideration which the Company expects to receive. Accordingly, revenue is reduced for estimated future product returns. The Company’s estimates for returns are updated quarterly based on historical data of actual returns. Actual future returns experience may differ significantly from historical data and could result in significant future adjustments, including a reduction of revenue recognized.

 

Common Stock Warrant Liabilities

 

For warrants that are classified as liabilities, the Company records the fair value of the warrants upon issuance and at each balance sheet date with changes in the estimated fair value recorded as a non-cash gain or loss in the unaudited condensed consolidated statements of operations. The fair values of these warrants are determined using the Black Scholes option pricing model. These values are subject to a significant degree of management’s judgment.

 

Results of Operations

 

Comparison of the Three Months Ended September 30, 2024 and 2023 (dollars in thousands)

 

   

Three Months Ended

September 30,

   

Dollar

   

Percent

 
   

2024

   

2023

   

Change

   

Change

 

Statement of Operations

                               

Sales:

                               

Product revenue, net

  $ 2,424     $ 2,471     $ (47 )     (2 )%

Other revenue, net

    17       10       7       70 %

Total sales, net

    2,441       2,481       (40 )     (2 )%
                                 

Cost of goods sold

    848       819       29       4 %

Gross profit

    1,593       1,662       (69 )     (4 )%

Operating expenses

                               

Research and development

    4       4             0 %

Sales and marketing

    947       1,263       (316 )     (25 )%

General and administrative

    1,703       1,093       610       56 %

Total operating expenses

    2,654       2,360       294       12 %

Operating loss

    (1,061 )     (698 )     (363 )     52 %
                                 

Accretion of interest and amortization of discounts on convertible notes

    (138 )     (655 )     517       (79 )%

Extinguishment of Secured Convertible Notes

    (13 )           (13 )     (100 )%

Net loss from continuing operations

    (1,212 )     (1,353 )     141       (10 )%
                                 

Net loss from discontinued operations

          (404 )     404       (100 )%

Net loss

  $ (1,212 )   $ (1,757 )   $ 545       (31 )%

 

-50-

 

Impact of DERMAdoctor Divestiture

 

The financial results of DERMAdoctor beginning from January 1, 2024 through the closing of the DERMAdoctor Divestiture on March 25, 2024 in the table above and as set forth in this report have been aggregated in the captions entitled “Loss on divestiture of subsidiary” and “Net loss from discontinued operations” for the nine months ended September 30, 2024 (see Note 18, “Divestiture and Discontinued Operations” in the Notes to the Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this report). The discussions below and throughout this section apply only to results from continuing operations except as otherwise noted.

 

Total Net Sales and Cost of Goods Sold

 

Product revenue, net, decreased $0.1 million, or 2%, to $2.4 million for the three months ended September 30, 2024, from $2.5 million for the three months ended September 30, 2023.

 

Revenue from eyecare products, including Avenova Spray, was $2.4 million for both the three months ended September 30, 2024 and September 30, 2023.

 

Revenue from the Company’s wound care products decreased to a nominal amount for the three months ended September 30, 2024, from $0.1 million for the three months ended September 30, 2023.

 

Cost of goods sold remained consistent for the three months ended September 30, 2024 and September 30, 2023 at $0.8 million.

 

Sales and marketing

 

Sales and marketing expenses decreased $0.4 million, or 25%, to $0.9 million for the three months ended September 30, 2024, from $1.3 million for the three months ended September 30, 2023. The decrease was due primarily to continued digital marketing efficiencies and a decrease in related consulting costs incurred in the three months ended September 30, 2024 compared to the three months ended September 30, 2023.

 

General and administrative 

 

General and administrative expenses increased $0.6 million, or 56%, to $1.7 million for the three months ended September 30, 2024, from $1.1 million for the three months ended September 30, 2023, due primarily to an increase in legal costs related to non-recurring strategic initiatives, including the 2024 Public Offering, the Asset Sale Transaction and the Dissolution, ongoing during the three months ended September 30, 2024.

 

Accretion of interest and amortization of discounts on convertible notes

 

Accretion of interest and amortization of discounts on convertible notes was $0.1 million for the three months ended September 30, 2024 and $0.7 million for the three months ended September 30, 2023.

 

Extinguishment of Secured Convertible Notes

 

Extinguishment of Secured Convertible Notes was $13 thousand for the three months ended September 30, 2024, with no comparable activity for the three months ended September 30, 2023.

 

-51-

 

Comparison of the Nine Months Ended September 30, 2024 and 2023 (dollars in thousands)

 

   

Nine Months Ended

September 30,

   

Dollar

   

Percent

 
   

2024

   

2023

   

Change

   

Change

 

Statement of Operations

                               

Sales:

                               

Product revenue, net

  $ 7,435     $ 8,326     $ (891 )     (11 )%

Other revenue, net

    37       28       9       32 %

Total sales, net

    7,472       8,354       (882 )     (11 )%
                                 

Cost of goods sold

    2,493       3,353       (860 )     (26 )%

Gross profit

    4,979       5,001       (22 )     * %

Operating expenses

                               

Research and development

    32       36       (4 )     (11 )%

Sales and marketing

    3,021       3,674       (653 )     (18 )%

General and administrative

    5,611       4,385       1,226       28 %

Loss on divestiture of subsidiary

    865             865       100 %

Total operating expenses

    9,529       8,095       1,434       18 %

Operating loss

    (4,550 )     (3,094 )     (1,456 )     47 %
                                 

Non-cash gain on changes in fair value of warrant liabilities

    114       216       (102 )     (47 )%

Non-cash (loss) gain on change in fair value of embedded derivative liability

    (18 )     40       (58 )     (145 )%

Accretion of interest and amortization of discounts on convertible notes

    (871 )     (1,156 )     285       (25 )%

Extinguishment of Secured Convertible Notes

    (13 )           (13 )     (100 )%

Other expense, net

    (549 )     (432 )     (117 )     27 %

Net loss from continuing operations

    (5,887 )     (4,426 )     (1,461 )     33 %
                                 

Net loss from discontinued operations

    (124 )     (1,106 )     982       (89 %)

Net loss

  $ (6,011 )   $ (5,532 )   $ (479 )     9 %

 

*Less than 1%.

 

Impact of DERMAdoctor Divestiture

 

The financial results of DERMAdoctor beginning from January 1, 2024 through the closing of the DERMAdoctor Divestiture on March 25, 2024 in the table above and as set forth in this report have been aggregated in the captions entitled “Loss on divestiture of subsidiary” and “Net loss from discontinued operations” for the nine months ended September 30, 2024 (see Note 18, “Divestiture and Discontinued Operations” in the Notes to the Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this report). The discussions below and throughout this section apply only to results from continuing operations except as otherwise noted.

 

Total Net Sales and Cost of Goods Sold

 

Product revenue, net, decreased $0.9 million, or 11%, to $7.4 million for the nine months ended September 30, 2024, from $8.3 million for the nine months ended September 30, 2023.

 

Revenue from eyecare products, including Avenova Spray, increased $0.5 million to $7.2 million for the nine months ended September 30, 2024, from $6.7 million for the nine months ended September 30, 2023. The increase was due to an overall increase in Avenova branded products sold through online channels.

 

Revenue from the Company’s wound care products decreased $1.3 million to $0.3 million for the nine months ended September 30, 2024, from $1.6 million for the nine months ended September 30, 2023. The decrease was due primarily to a large one-time order of the NeutroPhase branded wound care product in the nine months ended September 30, 2023, with no comparable order in the nine months ended September 30, 2024.

 

-52-

 

Cost of goods sold decreased $0.9 million, or 26%, to $2.5 million for the nine months ended September 30, 2024, from $3.4 million for the nine months ended September 30, 2023. Such decrease was due primarily to the decrease in wound care products (which has lower margins) slightly offset by an increase in eyecare products (which has higher margins) sold during the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023.

 

Sales and marketing

 

Sales and marketing expenses decreased $0.7 million, or 18%, to $3.0 million for the nine months ended September 30, 2024, from $3.7 million for the nine months ended September 30, 2023. The decrease was due primarily to continued digital advertising efficiencies and a decrease in related consulting costs incurred in the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023.

 

General and administrative 

 

General and administrative expenses increased $1.2 million, or 28%, to $5.6 million for the nine months ended September 30, 2024, from $4.4 million for the nine months ended September 30, 2023, was due primarily to an increase in legal costs primarily related to non-recurring strategic initiatives, including the DERMAdoctor Divestiture, the 2024 Public Offering, the Asset Sale Transaction and the Dissolution, ongoing during the nine months ended September 30, 2024.

 

Loss on divestiture of subsidiary

 

As a result of the closing of the DERMAdoctor Divestiture on March 25, 2024, we incurred a loss of $0.9 million for the nine months ended September 30, 2024 with no comparable activity for the nine months ended September 30, 2023. For additional information regarding the loss on divestiture of this subsidiary, please see Note 18, “Divestiture and Discontinued Operations”, in the Notes to Unaudited Condensed Consolidated Financial Statements, in Part I, Item 1 of this report.

 

Non-cash gain on change in fair value of warrant liabilities

 

Adjustments to the fair value of warrant liabilities resulted in a gain of $114 thousand for the nine months ended September 30, 2024 and $216 thousand for the nine months ended September 30, 2023. The warrant liabilities for the December 2023 Warrants and the March 2024 Warrant were reclassified to equity during the nine months ended September 30, 2024, and will no longer require fair value adjustments which will impact our results of operations. For additional information regarding warrant liabilities and their valuation, please see Note 11, “Common Stock Warrants”, in the Notes to Unaudited Condensed Consolidated Financial Statements, in Part I, Item 1 of this report.

 

Non-cash (loss) gain on changes in fair value of embedded derivative liability

 

Adjustments to the fair value of embedded derivative liability resulted in a loss of $18 thousand for the nine months ended September 30, 2024 and gain of $40 thousand for the nine months ended September 30, 2023. For additional information regarding the embedded derivative liability and its valuation, please see Note 3, “Fair Value Measurements”.

 

Accretion of interest and amortization of discounts on convertible notes

 

Accretion of interest and amortization of discounts on convertible notes was $0.9 million for the nine months ended September 30, 2024 and $1.2 million for the nine months ended September 30, 2023.

 

Extinguishment of Secured Convertible Notes

 

Extinguishment of Secured Convertible Notes was $13 thousand for the nine months ended September 30, 2024, with no comparable activity for the nine months ended September 30, 2023.

 

Other expense, net

 

Other expense, net was $0.5 million for the nine months ended September 30, 2024 and $0.4 million for the nine months ended September 30, 2023. Expenses were related primarily to separate and unrelated financing events recorded during the respective periods.

 

-53-

 

Financial Condition, Liquidity and Capital Resources 

 

As of September 30, 2024, our cash and cash equivalents were $0.8 million, compared to $2.9 million as of December 31, 2023. Our cash and cash equivalents as of September 30, 2024 includes $2.9 million of net proceeds from the 2024 Public Offering, $0.2 million of net proceeds from the 2024 Warrant Reprice Transaction and $1.1 million of net proceeds from the DERMAdoctor Divestiture. Our cash and cash equivalents as of December 31, 2023 includes $0.6 million of net proceeds from the 2023 Warrant Reprice Transaction and $2.8 million of net proceeds from the 2023 Private Placement (both as defined in the Notes to the Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this report). Under the terms of the Secured Convertible Notes issued in the 2023 Private Placement, we were required to make a monthly redemption of the principal amount of the Secured Convertible Notes (“Monthly Redemption”) over an 18-month period, which began on June 1, 2023 in an amount equal to $193 thousand per month, unless such Monthly Redemption is eligible under the terms of the Secured Convertible Notes to instead be settled through the issuance of our common stock. We paid the Monthly Redemption in cash every month until the Secured Convertible Notes were repaid in full during the third quarter of 2024.

 

On March 25, 2024, the Company issued Unsecured Convertible Notes to four (4) Secured Parties that have an aggregate principal amount of $525,000 or will be convertible into an aggregate of 3,750,000 shares of common stock (107,146 shares post-Reverse Stock Split). The principal amount of the Unsecured Convertible Notes does not accrue interest and is payable to the Secured Parties upon maturity in March 2026, unless earlier converted into common stock. For additional information regarding the 2023 Private Placement, the Secured Convertible Notes and the Unsecured Convertible Notes, see Note 9 “Financing Activities, Note 10 “Convertible Notes,” and Note 12 “Stockholders’ Equity” in the Notes to the Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this report.

 

On September 16, 2024, the Board unanimously approved the Asset Sale Transaction and Dissolution, both of which are subject to the approval of the Company’s stockholders. On November 5, 2024, the Company entered into the APA Amendment that provides for, among other terms, an increase in the base purchase price to $11.5 million from $9.5 million and for PRN to provide the Company with the Bridge Loan. The Bridge Loan provides for the Company to receive funding in two tranches of $0.5 million each upon the Company providing written notice to PRN on or after November 22, 2024 and on or after December 6, 2024. The amounts borrowed under the Bridge Loan are required to be used by the Company for working capital purposes, will bear interest at a rate of 10% per annum and be secured by all of the Company’s assets as collateral. The Bridge Loan is a short term secured loan which is to be repaid upon the earlier of the closing of the Asset Sale Transaction (to be repaid from the purchase price), immediately upon termination of the Purchase Agreement or February 28, 2025. The Company is holding the Special Meeting on November 22, 2024 to obtain stockholder approval of the Asset Sale Transaction and the Dissolution, pursuant to the Special Meeting Proxy Statement.

 

Based primarily on the funds available on September 30, 2024, the Company believes that the Company’s existing cash and cash equivalents and cash flows generated from product sales will be sufficient to fund its existing operations and meet its planned operating expenses into at least the first quarter of 2025. The Company has sustained operating losses for the majority of its corporate history and expects that its 2024 expenses will exceed its 2024 revenues. Additionally, the Company expects to continue incurring operating losses and negative cash flows. Accordingly, the Company has determined that its planned operations raise substantial doubt about its ability to continue as a going concern for a period of at least twelve months from the date of issuance of these unaudited condensed consolidated financial statements. Additionally, changing circumstances may cause the Company to expend cash significantly faster than currently anticipated, and the Company may need to spend more cash than currently expected because of circumstances beyond its control that impact the broader economy such as periods of inflation, supply chain issues, global pandemics and international conflicts (e.g., the conflicts between Israel and Hamas, Russia and Ukraine, and China and Taiwan).

 

-54-

 

To address the Company’s current liquidity and near term capital needs, the Company has and continues to evaluate different plans and strategic transactions to fund operations, including: (1) raising additional capital through debt and equity financings or from other sources; (2) reducing spending on operations, including reducing spending on one or more of its sales and marketing programs or restructuring operations to change its overhead structure; and/or (3) the divestiture of certain business or product lines and related assets such as the Asset Sale Transaction and the DERMAdoctor Divestiture. If the Asset Sale Transaction and/or the Dissolution are not completed, we will continue our corporate existence and the Board will continue to explore its options to secure immediate funding for ongoing operations due to significantly reduced available capital, the strategic and alternatives available to the Company, including returning capital to stockholders or, to the extent any funding or other viable alternatives are not available or there is not sufficient capital remaining at the time to fund operations, then, the Company may need to file for bankruptcy protection or commence a similar state law proceeding. In connection with such strategic options, the Company may issue securities, including common stock, preferred stock, convertible debt securities and warrants through additional private placement transactions or registered public offerings, which may require the filing of a Form S-1 or Form S-3 registration statement with the SEC. While the Company believes that the proceeds from the 2024 Public Offering and the DERMAdoctor Divestiture improved the Company’s liquidity in the first nine months of 2024, there is no assurance that the Company will be successful in completing the Asset Sale Transaction and/or the Dissolution or otherwise executing on alternative capital-raising strategies at levels necessary to address the Company’s ongoing and future cash flow and liquidity needs. The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. These unaudited condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts of liabilities that may result from uncertainty related to its ability to continue as a going concern. If the Company’s stockholders approve the Dissolution, the Company would consider liquidation to be imminent and apply liquidation basis of accounting pursuant to U.S. GAAP.

 

Cash Used in Operating Activities

 

Net cash used in operating activities from continuing operations was $4.2 million for the nine months ended September 30, 2024, which consisted primarily of a net loss from continuing operations of $6.0 million, adjusted by depreciation and amortization expenses of $32 thousand, stock-based compensation expenses related to employee and director stock awards of $0.1 million, non-cash loss on divestiture of $0.9 million, non-cash expense for consent of Secured Convertible Note holders of $0.4 million, non-cash loss on modifications of warrants of $69 thousand, non-cash gain on changes in fair value of warrant liabilities of $0.1 million, non-cash loss on changes in fair value of embedded derivative liability of $18 thousand, non-cash right-of-use amortization of $0.3 million, accretion of interest and amortization of debt discounts on convertibles notes of $0.9 million, and a net decrease of $0.8 million in our net operating assets and liabilities of continuing operations.

 

Net cash used in operating activities from continuing operations was $3.5 million for the nine months ended September 30, 2023, which consisted primarily of a net loss from continuing operations of $5.5 million, adjusted by depreciation and amortization expenses of $39 thousand, stock-based compensation expenses of $0.2 million, non-cash loss on modifications of warrants of $0.3 million, non-cash gain on changes in fair value of warrant liabilities of $0.2 million, non-cash gain on changes in fair value of embedded derivative liability of $40 thousand, non-cash right-of-use amortization of $0.2 million, accretion of interest and amortization of debt discounts on convertibles notes of $1.1 million, and a net decrease of $0.7 million in our net operating assets and liabilities of continuing operations.

 

Cash Provided by (Used in) Investing Activities

 

Net cash provided by investing activities from continuing operations was $1.1 million for the nine months ended September 30, 2024, which included the DERMAdoctor Divestiture proceeds of $1.1 million and purchase of property and equipment in a nominal amount. Net cash used in investing activities for the purchase of property and equipment from continuing operations was $16 thousand for the nine months ended September 30, 2023.

 

-55-

 

Cash Provided by Financing Activities

 

Net cash provided by financing activities from continuing operations was $1.0 million for the nine months ended September 30, 2024, which included repayment of $2.0 million for the Secured Convertible Notes through September 30, 2024, net proceeds of $2.9 million from the 2024 Public Offering transaction, and the net proceeds of $0.2 million from the 2024 Warrant Repice transaction.

 

Net cash provided by financing activities from continuing operations was $1.9 million for the nine months ended September 30, 2023, which included the net proceeds of $2.8 million received in the 2023 Private Placement of the Secured Convertible Notes and the May 2023 Warrants and repayment of $0.8 million for the Monthly Redemption through September 30, 2023 on the Secured Convertible Notes.

 

Net Operating Losses and Tax Credit Carryforwards

 

As of December 31, 2023, we had net operating loss carryforwards for federal and state income tax purposes of $139.3 million and $117.4 million, respectively. The federal net operating loss carryforwards consist of $94.9 million generated before January 1, 2018, which will begin to expire in 2024 and $44.4 million that will carry forward indefinitely but are subject to an 80% limitation for years following December 31, 2021. The state net operating loss carryforwards will begin to expire in 2028. As of December 31, 2023, we also had tax credit carryforwards of $0.5 million for federal income tax purposes and $0.1 million for state tax purposes. If not utilized, the federal tax credits will begin expiring in 2031. The state tax credits have an indefinite carryover period.

 

Current federal and California tax laws include substantial restrictions on the utilization of net operating loss carryforwards in the event of an ownership change of a corporation. Accordingly, our ability to utilize net operating loss carryforwards may be limited as a result of such ownership changes. Such a limitation could result in the expiration of carryforwards before they are utilized.

 

Inflation

 

Our costs are subject to fluctuations, particularly due to changes in the price of raw and packing materials and the cost of labor, transportation and operating supplies. Therefore, our business results depend, in part, on our continued ability to manage these fluctuations through pricing actions, cost-saving projects and sourcing decisions, while maintaining and improving margins and market share. Failure to manage these fluctuations could adversely impact our results of operations or cash flows.

 

Off-Balance Sheet Arrangements

 

We did not have any off-balance sheet arrangements at September 30, 2024 or December 31, 2023 as defined in Item 303(a)(4)(ii) of Regulation S-K.

 

Seasonality

 

Avenova Branded Products

 

Consistent with our peers in the United States pharmaceutical industry, prescriptions for Avenova Spray experience seasonality with the first quarter of each year typically being the lowest revenue quarter. This annual phenomenon is due to consumers facing the need to satisfy health insurance deductibles and changes to copays as each new insurance year begins. Sales of Avenova Spray through non-prescription channels, along with the other Avenova branded products, experience less seasonality with demands, with more consistent sales throughout the year.

 

NeutroPhase and PhaseOne Branded Wound Care Products

 

Our NeutroPhase and PhaseOne branded products are sold through wholesale distribution relationships with third parties such as Chongqing Pioneer Pharma Holdings Limited and Phase One Health; therefore, we receive periodic large orders that result in large chunks of revenue that are received in irregular intervals during the year.

 

Contractual Obligations

 

In the normal course of business, we enter into contracts and commitments that obligate us to make payments in the future. Information regarding our obligations under lease and convertible note arrangements are provided in Note 8 “Commitments and Contingencies,” and Note 10 “Convertible Notes” in the Notes to the Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this report.

 

-56-

 

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Our market risk consists principally of interest rate risk on our cash and cash equivalents. Our exposure to market risk is limited primarily to interest income sensitivity, which is affected by changes in interest rates, particularly because our current liquid assets at September 30, 2024 were held in cash and cash equivalents.

 

Our investment policy restricts our investments to high-quality investments and limits the amounts invested with any one issuer, industry, or geographic area. The goals of our investment policy are as follows: preservation of capital, assurance of liquidity needs, best available return on invested capital, and minimization of capital taxation. Some of the securities in which we invest may be subject to market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate. For example, if we hold a security that was issued with an interest rate fixed at the then-prevailing rate and the prevailing interest rate later rises, the principal amount of our investment will probably decline. To minimize this risk, in accordance with our investment policy, we maintain our cash and cash equivalents in short-term marketable securities, including money market mutual funds, Treasury bills, Treasury notes, certificates of deposit, commercial paper, and corporate and municipal bonds. The risk associated with fluctuating interest rates is limited to our investment portfolio. Due to the short-term nature of our investment portfolio, we believe we have minimal interest rate risk arising from our investments. As of September 30, 2024 and December 31, 2023, a 10% change in interest rates would have had an immaterial effect on the value of our investment portfolio. We do not use derivative financial instruments in our investment portfolio. We do not hold any instruments for trading purposes.

 

With most of our focus on the domestic U.S. market, we have not had any material exposure to foreign currency rate fluctuations.

 

ITEM 4.

CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Interim Chief Financial Officer, of the effectiveness of our disclosure controls and procedures pursuant to Rule 13a-15 and 15d-15 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

 

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Assessing the costs and benefits of such controls and procedures necessarily involves the exercise of judgment by management. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.

 

Based upon that evaluation at September 30, 2024, our Chief Executive Officer and our Interim Chief Financial Officer concluded that our disclosure controls and procedures were effective to ensure, at the reasonable assurance level, that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms and were effective in ensuring that information required to be disclosed by us in the reports that we file or submit under the Exchange Act was accumulated and communicated to our management, including our Chief Executive Officer and Interim Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

 

Changes in Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting during the current quarter which has materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

-57-

 

PART II. OTHER INFORMATION

 

ITEM 1.

LEGAL PROCEEDINGS

 

From time to time, the Company may be involved in various legal proceedings arising in the ordinary course of business. As of September 30, 2024, there were no matters that, in the opinion of management, would ultimately result in liability that would have a material adverse effect on the Company’s financial position, results of operations or cash flows.

 

ITEM 1A.

RISK FACTORS

 

For information regarding factors that could affect our business, results of operations, financial condition and liquidity, see the risk factors discussed under Part I, Item 1A included in our 2023 Annual Report, under Part II, Item 1A included in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, which was filed with the SEC on May 9, 2024, and in the risk factors related to the Asset Sale Transaction and the Dissolution in the Special Meeting Proxy Statement (as may be supplemented). We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and, as such, are not required to provide updated quarterly information under this Item. 

 

-58-

 

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

None.

 

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4.

MINE SAFETY DISCLOSURES

 

Not Applicable. 

 

 

ITEM 5.

OTHER INFORMATION

 

Rule 10b5-1 Trading Arrangements

 

During the nine months ended September 30, 2024, none of our directors or Section 16 officers adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each such term is defined in Item 408 of Regulation S-K.

 

 

-59-

 

ITEM 6.

EXHIBITS

 

The following exhibits are filed with or incorporated by reference into this report.

 

EXHIBIT INDEX

 

 

Incorporation by Reference

Filed

Herewith

Exhibit

Number

Exhibit Description

Form

File

Number

Exhibit/

Form 8-K

Item

Reference

Filing

Date

 

2.1

Membership Unit Purchase Agreement dated September 27, 2021, by and among the Company, DERMAdoctor, the Founders and the Sellers (as defined therein)

8-K

001-3678

2.1

9/28/2021

 

2.2

Membership Unit Purchase Agreement, dated March 12, 2024, by and among the Company, DERMAdoctor, the Founders and New Age Investments

8-K

001-33678

2.1

3/14/2024

 

2.3

Asset Purchase Agreement, dated September 19, 2024, by and among NovaBay Pharmaceuticals , Inc. and PRN Physicians Recommended Nutriceuticals, LLC

8-K

001-33678

2.1

9/20/2024

 
2.4 Amendment No. 1 to Asset Purchase Agreement, dated as of November 5, 2024, between PRN Physician Recommended Nutriceuticals, LLC and NovaBay Pharmaceuticals, Inc. 8-K 001-33678 2.1 11/6/2024  

2.5

Plan of Complete Liquidation and Dissolution of NovaBay Pharmaceuticals, Inc.

8-K

001-33678

2.2

9/20/2024

 

3.1

Amended and Restated Certificate of Incorporation of NovaBay Pharmaceuticals, Inc.

10-K

001-33678

3.1

3/21/2018

 

3.2

Amendment to the Amended and Restated Certificate of Incorporation, dated June 4, 2018

8-K

001-33678

3.1

6/4/2018

 

3.3

Amendment to the Amended and Restated Certificate of Incorporation, as amended, dated May 27, 2020

8-K

001-33678

3.1

5/28/2020

 

3.4

Amendment to the Amended and Restated Certificate of Incorporation, as amended, dated May 24, 2021

8-K

001-33678

3.1

5/24/2021

 

3.5

Amendment to the Amended and Restated Certificate of Incorporation, as amended, dated January 31, 2022

8-K

001-33678

3.1

2/1/2022

 

3.6

Amendment to Amended and Restated Certificate of Incorporation, as amended, dated November 14, 2022

8-K

001-33678

3.1

11/18/2022

 

3.7

Amendment to Amended and Restated Certificate of Incorporation, as amended, dated May 30, 2024

8-K

001-33678

3.1

5/31/2024

 

3.8

Certificate of Designation for the Series B Preferred Stock

8-K

001-33678

3.1

11/1/2021

 

3.9

Certificate of Designation for the Series C Preferred Stock

8-K

001-33678

3.2

11/18/2022

 

3.10

Bylaws, as amended and restated effective June 13, 2023

8-K

001-33678

3.1

6/14/2023

 

4.1

Form of Warrant pursuant to the Services Agreement with TLF Bio Innovation Lab, LLC, dated May 13, 2020

8-K

001-33678

4.1

5/18/2020

 

4.2

Form of July 2020 Warrant

8-K

001-33678

4.1

7/21/2020

 

4.3

Form of Amended July 2020 Warrant

8-K

001-33678

4.1

9/13/2022

 

4.4

Form of Amended November 2021 Warrant

8-K

001-33678

4.2

9/13/2022

 

4.5

Form of September 2022 Warrant (2020 participants)

8-K

001-33678

4.3

9/13/2022

 

4.6

Form of September 2022 Warrant (2021 participants)

8-K

001-33678

4.4

9/13/2022

 

4.7

Form of Series A-1 Long-Term Warrant

8-K

001-33678

4.5

9/13/2022

 

4.8

Form of Original Issue Discount Secured Senior Convertible Debenture

8-K

007-33678

4.1

4/27/2023

 

4.9

Form of Series B-1 Long-Term Warrant

8-K

001-33678

4.2

4/27/2023

 

4.10

Form of Series B-2 Short-Term Warrant

8-K

001-33678

4.3

4/27/2023

 

4.11

Form of Warrant Amendment Agreement

8-K

001-33678

4.4

4/27/2023

 

4.12

Form of Series C Common Stock Warrant

8-K

001-33678

4.1

12/21/2023

 

4.13

Form of Series D Common Stock Warrant

8-K

001-33678

4.2

3/25/2024

 

4.14

Form of Series E Common Stock Warrant

8-K

001-33678

4.1

6/14/2024

 

4.15

Form of Unsecured Convertible Notes

8-K

001-33678

4.3

3/25/2024

 

4.16

Form of Pre-Funded Common Stock Warrant

8-K

001-33678

4.4

3/25/2024

 

4.17

Form of Series F-1 Common Stock Warrant

8-K

001-33678

4.1

7/29/2024

 

4.18

Form of Series F-2 Common Stock Warrant

8-K

001-33678

4.2

7/29/2024

 

4.19

Form of Series F-3 Common Stock Warrant

8-K

001-33678

4.3

7/29/2024

 

10.1

Underwriting Agreement, dated July 26, 2024, by and between the Company and Ladenburg Thalmann & Co., Inc.

8-K

001-33678

4.3

7/29/2024

 

10.2

Warrant Agency Agreement, dated July 29, 2024, by and between the Company and Equinti Trust Company, LLC

8-K

001-33678

10.1

7/29/2024

 
10.3 Secured Promissory Note, dated as of November 5, 2024, between NovaBay Pharmaceuticals, Inc., as borrower, and PRN Physician Recommended Nutriceuticals, as lender. 8-K 001-33678 10.1 11/6/2024  

31.1

Certification of the Principal Executive Officer of NovaBay Pharmaceuticals, Inc., as required by Rule 13a-14(a) or Rule 15d-14(a)

       

X

 

-60-

 

31.2

Certification of the Principal Financial Officer of NovaBay Pharmaceuticals, Inc., as required by Rule 13a-14(a) or Rule 15d-14(a)

       

X

32.1

Certification by the Chief Executive Officer of NovaBay Pharmaceuticals, Inc., as required by Rule 13a-14(b) or 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350)

       

X

32.2

Certification by the Chief Financial Officer of NovaBay Pharmaceuticals, Inc., as required by Rule 13a-14(b) or 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350)

       

X

101.INS

Inline XBRL Instance Document

       

X

101.SCH

Inline XBRL Taxonomy Extension Schema Document 

       

X

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

       

X

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase

       

X

101.LAB

Inline XBRL Taxonomy Extension Labels Linkbase Document

       

X

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

       

X

104

The Cover Page Interactive Data File, formatted in Inline XBRL (included within the Exhibit 101 attachments)

       

X

 

-61-

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report on Form 10-Q to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Date: November 7, 2024

 
 

By:

/s/   Justin Hall 

   

Justin Hall 

Chief Executive Officer, General Counsel and Director

(principal executive officer)

 

Date: November 7, 2024

 
 

By:

/s/   Tommy Law

   

Tommy Law

Interim Chief Financial Officer

(principal financial officer)

 

-62-