美國
證券交易委員會
華盛頓特區20549
格式
（標記一）
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根據SECTION進行的季度報告 13或15(d) 證券交易所法案的 1934 |
截至季度結束日期的財務報告
or
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依據SECTION的過渡報告 13或15(d) 證券交易所法案的 1934 |
委託文件編號：001-39866
(根據其章程規定的註冊人準確名稱)
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（國家或其他管轄區的 |
（IRS僱主 |
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公司成立或組織） |
（標識號碼） |
（總部地址及郵政編碼）
(
（包括區號的電話號碼）
在法案第12(b)條的規定下注冊的證券：
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每個標題 |
交易 |
註冊交易所的名稱： |
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The |
請勾選以下選項以指示註冊人是否在過去12個月內(或在註冊人需要提交此類報告的較短時間內)已提交證券交易法1934年第13或15(d)條所要求提交的所有報告，並且在過去90天內已受到此類報告提交要求的影響。
請在以下複選框內表明註冊者是否已在過去的12個月內（或註冊者被要求提交這些文件的較短期間內）提交了根據規則405 of Regulation S-T所需提交的每個交互式數據文件。
請勾選符合註冊人是大型加速申報人、加速申報人、非加速申報人、小型報告公司還是新興成長型公司的選項。「大型加速申報人」、「加速申報人」、「小型報告公司」和「新興成長型公司」的定義請參見交易所法120億.2號規定。
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大型加速量申報人 ☐ |
加速量申報人 ☐ |
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小型報告公司 |
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新興成長公司 |
如果是新興成長型公司，在選中複選標記的同時，如果公司已選擇不使用根據證券交易法第13(a)條提供的任何新的或修訂後的財務會計準則的延長過渡期來符合新的或修訂後的財務會計準則，則表明該公司已選擇不使用根據證券交易法第13(a)條提供的任何新的或修訂後的財務會計準則的延長過渡期來符合新的或修訂後的財務會計準則。☐
勾選表示註冊人是否爲無實質業務的公司（根據法規12b-2條規定）。 是
截至2024年11月4日，註冊公司普通股的流通股數量爲每股面值0.001美元。
有關前瞻性聲明的特別說明
本季度報告中包含關於我們業務、運營、財務表現和狀況的前瞻性陳述，以及我們對業務、運營、財務表現和狀況的計劃、目標和期望。本文件中包含的任何非歷史事實的陳述可能被視爲前瞻性陳述。在某些情況下，您可以通過類似「預期」、「假設」、「相信」、「考慮」、「繼續」、「可能」、「受到」、「估計」、「期望」、「目標」、「打算」、「可能」、「計劃」、「預測」、「潛力」、「定位」、「尋求」、「應該」、「目標」、「將」、「將會」等詞彙辨別出前瞻性陳述，這些詞彙表明或預測未來事件和未來趨勢，或者這些術語的否定形式或其他類似術語。這些前瞻性陳述包括但不限於以下內容：
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我們能夠繼續作爲聚焦公司的能力; |
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我們有能力恢復並保持納斯達克資本市場的掛牌要求。 |
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我們目前臨床研究的結果和預期，以及我們開始的任何額外臨床研究。 |
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我們計劃修改我們當前的產品，或開發新產品，以滿足其他適應症； |
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我們通過未來的股權或債務融資能力。 |
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美國食品和藥物管理局（"FDA"）批准的510(k)的預期時間可能包括但不限於Pantheris，Ocelot，Tigereye和Lightbox的其他版本； |
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● |
預計向FDA提交510(k)申請的時間，以及FDA頒發的相關營銷許可，可能包括但不限於Pantheris、Ocelot、Tigereye和Lightbox的其他版本。 |
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我們能夠從與Zylox-Tonbridge的許可和合作協議中實現利益。 |
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我們業務和組織的預期增長； |
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我們對政府和第三方付款方覆蓋範圍和報銷情況的期望，包括Pantheris有資格獲得其他切膜產品使用的報銷代碼; |
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我們保留和招聘關鍵人員的能力，包括持續發展我們的銷售和營銷製造行業； |
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我們獲取和維護產品的知識產權保護的能力; |
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我們對支出、持續虧損、未來營業收入、資本需求以及對額外融資需求或獲取能力的估計。 |
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我們對營業收入、營業成本、毛利率和費用的預期，包括研發費用以及銷售、一般和管理費用。 |
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我們識別和開發新產品及計劃產品以及獲取新產品的能力，包括冠狀市場的產品。 |
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我們的財務表現; |
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我們保持遵守目前適用於我們業務的法律和法規的能力，包括在美國和國際上的法律法規; |
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有關我們競爭對手或我們行業板塊的發展和預測。 |
我們認爲向投資者傳達我們的未來預期是重要的。然而，未來可能會發生一些我們無法準確預測或控制的事件，這可能導致我們的實際結果與我們在前瞻性陳述中描述的預期出現重大差異。這些前瞻性陳述基於管理層目前對我們業務和所處行業的預期、估計、預測和展望，以及管理層的信念和假設，並不保證未來的表現或發展，可能涉及已知和未知的風險、不確定性以及其他某些情況下超出我們控制範圍的因素。因此，我們在本季度報告（表格10-Q）中的任何或所有前瞻性陳述可能會被證明是不準確的。造成實際結果與當前預期出現重大差異的因素包括，除其他事項外，在本季度報告（表格10-Q）和我們於2024年3月20日向證券交易委員會提交的年度報告（表格10-K）中的「風險因素」部分及其他地方列出的因素。我們敦促您在評估這些前瞻性陳述時仔細考慮這些因素。這些前瞻性陳述僅在本季度報告（表格10-Q）之日期有效。我們不承擔任何更新或修訂這些前瞻性陳述的義務，即使未來有新信息可用。
您不應將前瞻性陳述視爲對未來事件的預測。儘管我們相信前瞻性陳述中反映的期望是合理的，但我們無法保證前瞻性陳述中反映的未來結果、活動水平、表現或事件與情況會實現或發生。除法律要求外，我們沒有義務在本季度10-Q報告日期之後因任何原因公開更新任何前瞻性陳述，以使這些陳述符合實際結果或我們期望的變化。
您應閱讀此10-Q季度報告以及我們在該季度報告中提及的文件，並已作爲展品向美國證券交易委員會（「SEC」）提交，理解我們的實際未來結果、活動水平、業績及事件和情況可能與我們的預期有重大不同。
Avinger, 公司。
截至2024年9月30日的季度期間
目錄
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頁 |
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部分 I |
財務信息 |
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項目 1. |
未經審計的基本財務報表 |
1 |
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簡明資產負債表 |
1 |
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簡明運營和全面損失報表 |
2 |
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簡明股東權益報表 |
3 |
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現金流量表簡明報表 |
5 |
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基本財務報表附註。 |
6 |
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項目 2. |
管理層對控件和經營結果的討論與分析 |
23 |
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項目 3。 |
關於市場風險的定量和定性披露 |
38 |
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項目 4。 |
控制和程序 |
38 |
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部分 II |
其他信息 |
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項目 1. |
法律訴訟 |
38 |
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項目1A. |
Risk Factors |
39 |
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項目 2. |
未註冊的股票證券銷售及收益使用 |
43 |
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項目3。 |
高級證券的缺省 |
43 |
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項目4。 |
礦業安全披露 |
43 |
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項目5。 |
其他信息 |
43 |
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項目6。 |
展覽品 |
44 |
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簽名 |
45 |
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「Avinger」、「Pantheris」、「Lumivascular」和「Tigereye」是我們公司的商標。我們在這份10-Q季度報告中出現的標誌以及其他商號、商標和服務標記都是我們的財產。在這份10-Q季度報告中出現的其他商號、商標和服務標記是其各自所有者的財產。爲了方便起見，我們在這份10-Q季度報告中提到的商標和商號沒有使用™符號，但這些引用並不意味着我們不會根據適用法律以最大程度主張我們的權利，或相關許可方對這些商標和商號的權利。
部分 I. 財務信息
項目 1。 未經審計的基本報表
Avinger, 公司。
簡明資產負債表
(未經審計)
(單位爲千，除股份和每股數據外)
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九月三十日 |
12月31日 |
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2024 |
2023 |
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資產 |
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流動資產： |
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現金及現金等價物 |
$ | $ | ||||||
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應收賬款，扣除$的壞賬準備 |
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存貨，淨額 |
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預付款項及其他流動資產 |
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總流動資產 |
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使用權資產 |
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物業及設備（淨額） |
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其他資產 |
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總資產 |
$ | $ | ||||||
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負債和股東’ 權益（赤字） |
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流動負債： |
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應付賬款 |
$ | $ | ||||||
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應計補償 |
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優先股股息應付 |
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應計費用和其他流動負債 |
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租賃負債，流動部分 |
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借款 |
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總流動負債 |
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租賃負債，長期部分 |
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其他長期負債 |
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總負債 |
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承諾和或可能負債（附註6） |
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股東’ 股東權益（赤字）： |
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可按系列發行的優先股，面值$ |
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授權股份： |
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已發行和流通股份： |
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普通股，面值$ |
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授權股份： |
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已發行及流通股份： |
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額外實收資本 |
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累計虧損 |
( |
) |
( |
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股東權益（赤字）總額 |
( |
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總負債和股東權益（赤字） |
$ | $ | ||||||
Avinger, 公司。
綜合損益和全面損失的精簡報表
(未經審計)
(以千爲單位，除每股數據外)
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截止三個月 九月三十日 |
截止九個月 九月三十日 |
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2024 |
2023 |
2024 |
2023 |
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營業收入 |
$ | $ | $ | $ | ||||||||||||
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營業成本 |
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毛利潤 |
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營業費用： |
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研究和開發 |
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銷售、一般和行政 |
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總營業費用 |
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運營損失 |
( |
) |
( |
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( |
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利息費用，淨額 |
( |
) |
( |
) |
( |
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其他收入（費用），淨額 |
( |
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淨虧損和全面虧損 |
( |
) |
( |
) |
( |
) | ( |
) | ||||||||
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優先股股息的增值 |
( |
) | ( |
) | ||||||||||||
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將A系列轉換爲A-1系列優先股的收益 |
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適用於普通股股東的淨虧損 |
$ | ( |
) |
$ | ( |
) |
$ | ( |
) | $ | ( |
) | ||||
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歸屬於普通股股東的每股淨虧損，基本和攤薄 |
$ | ( |
) |
$ | ( |
) |
$ | ( |
) | $ | ( |
) | ||||
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用於計算每股淨虧損的加權平均普通股股數，基本和攤薄 |
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Avinger, 公司。
股東簡明報表’ 股本（赤字）
(未經審計)
（以千爲單位，除股票數據外）
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可轉換的 優先股 |
普通股 |
額外實收資本 |
累積的 |
股東總權益 |
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股份 |
金額 |
股份 |
金額 |
資本 |
赤字 |
股權 |
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截至2023年6月30日的餘額 |
$ | $ | $ | $ | ( |
) |
$ | ( |
) | |||||||||||||||||||
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公共發行中普通股的發行，扣除佣金和發行成本 |
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將CRG貸款本金轉換爲E系列可轉換優先股 |
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員工股票薪酬 |
— | — | ||||||||||||||||||||||||||
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由於反向拆分對碎股的影響而進行的重分類和調整 |
( |
) | ||||||||||||||||||||||||||
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放棄系列A優先股送轉 |
— | — | ||||||||||||||||||||||||||
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淨損失及綜合損失 |
— | — | ( |
) |
( |
) |
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至2023年9月30日的餘額 |
$ | $ | $ | $ | ( |
) |
$ | ( |
) | |||||||||||||||||||
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可轉換的 優先股 |
普通股 |
額外實收資本 |
累計的 |
股東總權益 |
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股份 |
金額 |
股份 |
金額 |
資本 |
赤字 |
股權 |
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截至2024年6月30日的餘額 |
$ | $ | $ | $ | ( |
) |
$ | |||||||||||||||||||||
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公開發行普通股，扣除佣金和發行成本 |
— | — | ( |
) | ( |
) | ||||||||||||||||||||||
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將CRG貸款本金轉換爲H系列可轉換優先股 |
||||||||||||||||||||||||||||
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預付認股權證行使普通股 |
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員工股票基礎補償 |
— | — | ||||||||||||||||||||||||||
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優先股股息的增值 |
— | — | ( |
) | ( |
) | ||||||||||||||||||||||
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淨損失和綜合損失 |
— | — | ( |
) | ( |
) | ||||||||||||||||||||||
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截至2024年9月30日的餘額 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||||||
Avinger, 公司。
股東的簡明財務報表’ 股本（虧損）（續）
(未經審計)
（以千爲單位，除股票數據外）
|
可轉換的 優先股 |
普通股 |
額外實收資本 |
累計的 |
股東總權益 |
||||||||||||||||||||||||
|
股份 |
金額 |
股份 |
金額 |
資本 |
赤字 |
股本（赤字） |
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截至2022年12月31日的餘額 |
$ | $ | $ | $ | ( |
) |
$ | |||||||||||||||||||||
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公開發行普通股，扣除佣金和發行費用 |
||||||||||||||||||||||||||||
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將CRG貸款本金轉換爲E系列可轉換優先股 |
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行使預融資Warrants以獲取普通股 |
( |
) | ( |
) | ||||||||||||||||||||||||
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因限制性股票單位的歸屬而發行普通股 |
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員工股票優先補償 |
— | — | ||||||||||||||||||||||||||
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由於反向拆股對碎股的影響而導致的重新分類和調整 |
( |
) | ||||||||||||||||||||||||||
| 淨損失和綜合損失 | — | — | — | — | — | ( |
) | (13,296 | ) | |||||||||||||||||||
|
截至2023年9月30日的餘額 |
$ | $ | $ | $ | ( |
) |
$ | ( |
) | |||||||||||||||||||
|
可轉換的 優先股 |
普通股 |
額外實收資本 |
累積的 |
股東總權益 |
||||||||||||||||||||||||
|
股份 |
金額 |
股份 |
金額 |
資本 |
赤字 |
權益（赤字） |
||||||||||||||||||||||
|
截至2023年12月31日的餘額 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||
|
在定向增發中發行普通股和F系列優先股，扣除佣金和發行成本 |
||||||||||||||||||||||||||||
|
在定向增發中發放普通股Warrants |
||||||||||||||||||||||||||||
| 預先分配的Warrants轉換爲普通股 | ||||||||||||||||||||||||||||
|
公開發行普通股，扣除佣金和發行費用後 |
||||||||||||||||||||||||||||
|
將CRG貸款本金轉換爲H系列可轉換優先股 |
||||||||||||||||||||||||||||
|
取消A系列優先股 |
( |
) | ||||||||||||||||||||||||||
|
發行A-1系列優先股，扣除佣金和發行費用後 |
— | — | ||||||||||||||||||||||||||
|
根據限制性股票獎勵的歸屬情況發行普通股 |
||||||||||||||||||||||||||||
|
限制性股票獎勵的淨股票結算以滿足稅務義務 |
( |
) | ( |
) | ( |
) | ||||||||||||||||||||||
|
員工股票基礎補償 |
— | — | ||||||||||||||||||||||||||
|
優先股股息的增值 |
— | — | ( |
) | ( |
) | ||||||||||||||||||||||
|
淨損失和綜合損失 |
— | — | ( |
) | ( |
) | ||||||||||||||||||||||
|
截至2024年9月30日的餘額 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||||||
Avinger, 公司。
現金流量簡表
(未經審計)
(以千計)
|
截至9月30日的九個月 |
||||||||
|
2024 |
2023 |
|||||||
|
經營活動產生的現金流 |
||||||||
|
淨損失 |
$ | ( |
) | $ | ( |
) | ||
|
調整淨虧損與經營活動使用的現金的折算： |
— | — | ||||||
|
折舊和攤銷 |
||||||||
|
債務發行成本和債務折扣的攤銷 |
||||||||
|
基於股票的補償 |
||||||||
|
非現金利息費用及其他費用 |
||||||||
|
使用權資產的變動 |
||||||||
|
過剩和過時庫存的準備 |
||||||||
|
其他非現金費用 |
( |
) | ||||||
|
經營資產和負債的變動： |
— | — | ||||||
|
應收賬款 |
||||||||
|
存貨 |
( |
) | ||||||
|
預付款項及其他流動資產 |
( |
) | ( |
) | ||||
|
其他資產 |
( |
) | ||||||
|
應付賬款 |
( |
) | ||||||
|
應計補償 |
( |
) | ( |
) | ||||
|
應計費用和其他流動負債 |
( |
) | ||||||
|
其他長期負債 |
( |
) | ||||||
|
淨現金流出活動 |
( |
) | ( |
) | ||||
| 投資活動產生的現金流量 | ||||||||
| 購買房地產和設備 | ( |
) | ||||||
| 投資活動中使用的淨現金 | ( |
) | ||||||
|
融資活動產生的現金流 |
||||||||
|
在定向增發中發行普通股和可轉換優先股的收益，扣除佣金和發行費用 |
||||||||
|
根據認購權證行使而發行普通股的收益 |
||||||||
|
通過公開發行發行普通股的收益，扣除佣金和發行費用 |
||||||||
|
通過限制性股票獎勵的淨股票結算以滿足稅務義務 |
( |
) | ||||||
|
融資活動提供的淨現金 |
||||||||
|
現金及現金等價物淨變動額 |
( |
) | ||||||
|
期初現金及現金等價物 |
||||||||
|
期末現金及現金等價物 |
$ | $ | ||||||
|
現金流信息的補充披露 |
||||||||
|
非現金投資及融資活動： |
||||||||
|
因租賃修訂而增加的使用權資產和租賃負債 |
$ | $ | ||||||
|
將CRG貸款本金及應計利息轉換爲H系列可轉債優先股 |
$ | $ | ||||||
|
優先股股息的增值 |
$ | $ | ||||||
|
將其他長期負債重新分類爲應計薪酬 |
$ | $ | ||||||
|
庫存與物業及設備之間的轉賬 |
$ | $ | ||||||
See accompanying notes.
AVINGER, INC.
Notes to Condensed Financial Statements
1. Organization
Organization, Nature of Business
Avinger, Inc. (the “Company”), a Delaware corporation, was incorporated in March 2007. The Company designs, manufactures and sells image-guided, catheter-based systems that are used by physicians to treat patients with peripheral artery disease (“PAD”). Patients with PAD have a build-up of plaque in the arteries that supply blood to areas away from the heart, particularly the pelvis and legs. The Company manufactures and sells a suite of products in the United States (“U.S.”) and in select international markets. The Company has developed its Lumivascular platform, which integrates optical coherence tomography (“OCT”) visualization with interventional catheters and is the industry’s only system that provides real-time intravascular imaging during the treatment portion of PAD procedures. The Company’s Lumivascular platform consists of a capital component, Lightbox consoles, as well as a variety of disposable catheter products. The Company’s current catheter products include Ocelot, Tigereye and Tigereye ST, which are designed to allow physicians to penetrate a total blockage in an artery, known as a chronic total occlusion (“CTO”). The Company also has image-guided atherectomy products, Pantheris, Pantheris SV and Pantheris LV, which are designed to allow physicians to precisely remove arterial plaque in PAD patients. The Company is in the process of developing next-generation CTO crossing devices to target coronary CTO markets. The Company is located in Redwood City, California.
Liquidity Matters
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) No. 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40) requires the Company to make certain disclosures if it concludes that there is substantial doubt about the entity’s ability to continue as a going concern within one year from the date of the issuance of these financial statements.
In the course of its activities, the Company has incurred losses and negative cash flows from operations since its inception. As of September 30, 2024, the Company had an accumulated deficit of $
The Company can provide no assurance that it will be successful in raising funds pursuant to additional equity or debt financings or that such funds will be raised at prices that do not create substantial dilution for its existing stockholders. Given the volatility in the Company’s stock price, any financing that the Company may undertake in the next twelve months could cause substantial dilution to its existing stockholders, and there can be no assurance that the Company will be successful in acquiring additional funding at levels sufficient to fund its various endeavors. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. In addition, the macroeconomic environment has in the past resulted in and could continue to result in reduced consumer and investor confidence, instability in the credit and financial markets, volatile corporate profits and reduced business and consumer spending, which could increase the cost of capital and/or limit the availability of capital to the Company.
If the Company is unable to raise additional capital in sufficient amounts or on terms acceptable to it, the Company may have to significantly reduce its operations or delay, scale back or discontinue the development and sale of one or more of its products. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company’s ultimate success will largely depend on its continued development of innovative medical technologies, its ability to successfully commercialize its products and its ability to raise significant additional funding.
Additionally, due to the substantial doubt about the Company’s ability to continue operating as a going concern and the “Material Adverse Change” clause in the Loan Agreement with CRG Partners III L.P. and certain of its affiliated funds (collectively “CRG”), the entire amount of outstanding borrowings at September 30, 2024 and December 31, 2023 has been classified as current in these financial statements. CRG has not purported that an Event of Default (as defined in the Loan Agreement) has occurred due to a Material Adverse Change.
Currently substantially all of the Company’s cash and cash equivalents are held at a single financial institution. The Company’s previous banking partner was acquired by another financial institution in 2023 following closure by state regulators. The Company has regained access to its accounts with the new institution and is currently reviewing its banking relationships. Potential future disruptions to financial institutions where the Company holds accounts or has credit arrangements, or more widespread disruptions in the financial services industry, could negatively impact the Company’s access to cash and cash equivalents.
If the Company is unable to access its cash and cash equivalents as needed, its financial position and ability to operate its business will be adversely affected.
Public Offerings
June 2024 Offering
On June 13, 2024, the Company entered into a securities purchase agreement with two institutional investors for the issuance and sale of
As a result, the Company issued (i)
In addition, the Company issued to the investors in the Offering (i) Series A-1 warrants (the “Series A-1 Warrants”) to purchase up to an aggregate of
The Series A-1 Warrants expire on the earlier of August 12, 2029 and
Pursuant to an engagement letter (the “Engagement Letter”) with H.C. Wainwright & Co., LLC (the “Placement Agent”), the Company, in connection with the Offering, issued warrants to designees of the Placement Agent (the “Placement Agent Warrants”) to purchase up to an aggregate of
At The Market Offering Agreement
On May 20, 2022, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (the “Agent”), as sales agent, pursuant to which the Company may offer and sell shares of common stock, par value $
Other than the ATM Agreement, the Company currently does not have any commitments to obtain additional funds.
Strategic Partnership and Private Placement
On March 4, 2024, the Company entered into a License and Distribution Agreement (the “License Agreement”) with Zylox-Tonbridge effective as of the Initial Closing (defined below), pursuant to which the Company will license and distribute certain of the Company’s products (including consumables) in the Greater China region, including mainland China, Hong Kong, Macao, and Taiwan (the “Territory”). Zylox-Tonbridge will lead all regulatory activities for the registration of the Avinger products in the Territory. Avinger will also license its intellectual property and know-how related to Avinger products to Zylox-Tonbridge so that Zylox-Tonbridge can manufacture the localized products in the Territory. Avinger will supply Avinger products to Zylox-Tonbridge until Zylox-Tonbridge’s manufacturing capability has been established and Zylox-Tonbridge has obtained the regulatory approval of the localized products manufactured by Zylox-Tonbridge. All sales of Avinger products locally manufactured by Zylox-Tonbridge with regulatory approval by the regulatory authorities in the Territory and commercialized in the Territory will be royalty bearing to Avinger at a rate from a mid-single to high-single digit percentage depending on the amount of gross revenue as defined in the License Agreement, with certain increases depending on the amount of product gross margin. The License Agreement has an initial term of
In connection with the License Agreement, on March 4, 2024, the Company and Zylox-Tonbridge also entered into a Strategic Cooperation and Framework Agreement in conjunction with the Initial Closing (the “Collaboration Agreement” and, together with the License Agreement, the “Strategic Collaboration”), which provides the opportunity for the Company to access certain Zylox-Tonbridge peripheral vascular products for distribution in the U.S. and Germany. The agreement also provides the option for Avinger to source finished goods inventory from Zylox-Tonbridge following registration of Zylox-Tonbridge’s manufacturing facility with the FDA.
Private Placement
On March 4, 2024, in connection with the Strategic Collaboration, the Company and Zylox-Tonbridge Medical Limited, a wholly-owned subsidiary of Zylox-Tonbridge (the “Purchaser”), entered into a Securities Purchase Agreement (the “Purchase Agreement”), pursuant to which the Purchaser agreed to purchase, in two tranches, up to an aggregate of $
Each share of Series F Preferred Stock has a stated value of $
Upon completion of the following as mutually agreed upon by the Company and the Purchaser: (i) the successful registration and listing under 21 CFR part 807 with the FDA of the Purchaser and one of its designated affiliates to manufacture Avinger’s products, and (ii) the Company achieving an aggregate of $
On May 22, 2024, the Company held a special meeting of stockholders to vote on the following proposals resulting from the Private Placement (i) accept conversion of the shares of Series F Preferred Stock in excess of
The Company engaged two financial advisors in connection with the Private Placement and agreed to pay them an aggregate cash fee equal to
Series A Preferred Stock Exchange
On March 5, 2024, the Company entered into a Securities Purchase Agreement (the “A-1 Securities Purchase Agreement”) with CRG to exchange all outstanding shares of Series A preferred stock for
CRG Loan Amendment
Also on March 5, 2024, the Company entered into Amendment No. 9 to Loan Agreement effective as of the Initial Closing (the “Amendment”) with CRG, which amends the Loan Agreement to, among other things:
| - |
extend the interest-only period through December 31, 2026; |
| - |
provide that interest payable through December 31, 2026 may be payable in kind rather than in cash; and |
| - |
permit the payment of dividends on the preferred stock issued or issuable to the Purchaser. |
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and pursuant to the rules and regulations of the SEC. The accompanying unaudited condensed interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the Company’s financial information. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024, or for any other interim period or for any future year. The December 31, 2023 condensed balance sheet data has been derived from audited financial statements. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to SEC rules and regulations relating to interim financial statements. These unaudited condensed financial statements and notes should be read in conjunction with the financial statements included in the Company’s Form 10-K for the fiscal year ended December 31, 2023, which was filed with the SEC on March 20, 2024. The Company’s significant accounting policies are more fully described in Note 2 of the Notes to Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements. Management uses significant judgment when making estimates related to its stock-based compensation, accruals related to compensation, the valuation of the common stock warrants, provisions for doubtful accounts receivable and excess and obsolete inventories, clinical trial accruals, and its reserves for sales returns and warranty costs. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions.
Concentration of Credit Risk, and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents and accounts receivable to the extent of the amounts recorded on the balance sheets.
The Company’s policy is to invest in cash and cash equivalents, consisting of money market funds. These financial instruments are held in Company accounts at one financial institution, First Citizens Bank, which acquired the Company’s prior banking partner, Silicon Valley Bank, in March 2023. The counterparties to the agreements relating to the Company’s investments consist of financial institutions of high credit standing. The Company provides for uncollectible amounts when specific credit problems arise. Management’s estimates for uncollectible amounts have been adequate, and management believes that all significant credit risks have been identified at September 30, 2024 and December 31, 2023. The Company’s previous banking partner was acquired by another financial institution in 2023 following closure by state regulators. Although the Company has regained access to its accounts with this institution, now a division of the acquiring bank, and is currently reviewing its banking relationships, potential future disruptions to financial institutions where the Company holds accounts or has credit arrangements, or more widespread disruptions in the financial services industry, could negatively impact the Company’s access to cash and cash equivalents.
The Company’s accounts receivable are due from a variety of healthcare organizations in the United States and select international markets. The Company provides for uncollectible amounts when specific credit problems arise. Management’s estimates for uncollectible amounts have been adequate, and management believes that all significant credit risks have been identified at September 30, 2024 and December 31, 2023. At September 30, 2024, there was customer that represented
Product Warranty Costs
The Company typically offers a -year warranty on its products commencing upon the transfer of title and risk of loss to the customer. The Company accrues for the estimated cost of product warranties upon invoicing its customers, based on historical results. Warranty costs are reflected in the statement of operations and comprehensive loss as a cost of revenues. The warranty obligation is affected by product failure rates, material usage and service delivery costs incurred in correcting a product failure. Should actual product failure rates, material usage or service delivery costs differ from these estimates, revisions to the estimated warranty liability would be required. Periodically the Company assesses the adequacy of its recorded warranty liabilities and adjusts the amounts, as necessary. Warranty provisions and claims are summarized as follows (in thousands):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
|
2024 |
2023 |
2024 |
2023 |
|||||||||||||
|
Beginning balance |
$ | $ | $ | $ | ||||||||||||
|
Warranty provision |
||||||||||||||||
|
Usage/Release |
( |
) |
( |
) |
( |
) | ( |
) | ||||||||
|
Ending balance |
$ | $ | $ | $ | ||||||||||||
Net Loss per Share Attributable to Common Stockholders
Basic net loss per share attributable to common stockholders is computed by dividing the net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the period, without consideration for potential dilutive common shares. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss applicable to common stockholders by the weighted average number of shares of common stock and dilutive potential shares of common stock outstanding during the period. Any common stock shares subject to repurchase are excluded from the calculations as the continued vesting of such shares is contingent upon the holders’ continued service to the Company. As of September 30, 2024 and 2023, there were shares subject to repurchase. Since the Company was in a loss position for all periods presented, basic net loss per share attributable to common stockholders is the same as diluted net loss per share attributable to common stockholders as the inclusion of all potentially dilutive common shares would have been anti-dilutive.
Net loss per share applicable to common stockholders was determined as follows (in thousands, except per share data):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
|
2024 |
2023 |
2024 |
2023 |
|||||||||||||
|
Net loss applicable to common stockholders |
$ | ( |
) |
$ | ( |
) |
$ | ( |
) | $ | ( |
) | ||||
|
Weighted average common stock outstanding, basic and diluted |
||||||||||||||||
|
Net loss per share attributable to common stockholders, basic and diluted |
$ | ( |
) |
$ | ( |
) |
$ | ( |
) | $ | ( |
) | ||||
The following potentially dilutive securities outstanding have been excluded from the computations of diluted weighted average shares outstanding because such securities have an anti-dilutive impact due to losses reported:
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
|
2024 |
2023 |
2024 |
2023 |
|||||||||||||
|
Common stock warrants equivalents |
||||||||||||||||
|
Common stock options |
||||||||||||||||
|
Convertible preferred stock |
||||||||||||||||
|
Unvested restricted stock units |
||||||||||||||||
Segment and Geographical Information
The Company operates and manages its business as reportable and operating segment. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. Primarily all of the Company’s long-lived assets, which are comprised of property and equipment, are based in the United States. For the three months ended September 30, 2024 and 2023,
Fair Value Measurements
As of September 30, 2024 and December 31, 2023, cash equivalents were all categorized as Level 1 and consisted of money market funds. As of September 30, 2024 and December 31, 2023, there were no financial assets and liabilities categorized as Level 2 or 3. There were no transfers between fair value hierarchy levels during the three or nine months ended September 30, 2024 and September 30, 2023.
Recent Accounting Pronouncements
Recent accounting standards not yet adopted
In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which among other things, simplifies the accounting models for the allocation of proceeds attributable to the issuance of a convertible debt instrument. As a result, after adopting the ASU’s guidance, entities will not separately present in equity an embedded conversion feature in such debt. Instead, they will account for a convertible debt instrument wholly as debt, and for convertible preferred stock wholly as preferred stock (i.e., as a single unit of account), unless (i) a convertible instrument contains features that require bifurcation as a derivative under Accounting Standards Codification (“ASC”) 815 or (ii) a convertible debt instrument was issued at a substantial premium. The ASU becomes effective for the Company, as a smaller reporting company as defined by the SEC, in the first quarter of 2024. The Company has not yet adopted this standard. This new standard is not expected to have a material impact on the Company’s financial statements.
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures. This ASU requires that a public entity provide additional segment disclosures on an interim and annual basis. The amendments in this ASU should be applied retrospectively to all prior periods presented in the financial statements unless impracticable. Upon transition, the segment expense categories and amounts disclosed in the prior periods should be based on the significant segment expense categories identified and disclosed in the period of adoption. The ASU is effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. The Company has not yet adopted this standard. This new standard is not expected to have a material impact on the Company’s financial statements.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which will require the Company to disclose specified additional information in its income tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. ASU No. 2023-09 will also require the Company to disaggregate its income taxes paid disclosure by federal, state and foreign taxes, if any, with further disaggregation required for significant individual jurisdictions. The ASU is effective for the Company for fiscal years beginning after December 15. ASU No. 2023-09 allows for adoption using either a prospective or retrospective transition method. This new standard is not expected to have a material impact on the Company’s financial statements.
3. Inventories
Inventories consisted of the following (in thousands):
|
September 30, |
December 31, |
|||||||
|
2024 |
2023 |
|||||||
|
Raw materials |
$ | $ | ||||||
|
Work-in-process |
||||||||
|
Finished products |
||||||||
|
Total inventories |
$ | $ | ||||||
4. Borrowings
CRG
On September 22, 2015, the Company entered into a Term Loan Agreement, as amended (the “Loan Agreement”) with CRG under which, subject to certain conditions, the Company had the right to borrow up to $
On February 14, 2018, the Company and CRG further amended the Loan Agreement concurrent with the conversion of $
On August 2, 2023, the Company and CRG entered into a Securities Purchase Agreement (“Series E Purchase Agreement”) pursuant to which the Company issued
On May 16, 2024, the Company and CRG entered into another Securities Purchase Agreement (“Series H Purchase Agreement”) pursuant to which the Company issued
The Company has entered into several amendments to the Loan Agreement (the “Amendments”) with CRG since September 2015. The Amendments, among other things: (1) extended the interest-only period through December 31, 2026; (2) extended the period during which the Company may elect to pay a portion of interest in payment-in-kind (“PIK”), interest payments through December 31, 2026 so long as no Default (as defined in the Loan Agreement) has occurred and is continuing; (3) permitted the Company to make the entire interest payments in PIK interest payments through December 31, 2026 so long as no Default has occurred and is continuing; (4) extended the Stated Maturity Date (as defined in the Loan Agreement) to December 31, 2028; (5) reduced the minimum liquidity covenant to $
On January 26, 2024, the Company entered into Amendment No. 8 to the Loan Agreement with CRG, which reduced the minimum liquidity requirement of the Loan Agreement from $
On March 5, 2024, the Company entered into Amendment No. 9 to the Loan Agreement with CRG, which (1) extended the interest-only period through December 31, 2026; (2) extended the period during which the Company may elect to pay a portion of interest in PIK interest payments through December 31, 2026 so long as no Default (as defined in the Loan Agreement) has occurred and is continuing; (3) permitted the Company to make the entire interest payments in PIK interest payments through December 31, 2026 so long as no Default has occurred and is continuing; and (4) permit the payment of dividends on the preferred stock issued or issuable to the Purchaser. The Company assessed Amendment No. 9 to the Loan Agreement and determined that this represented a loan modification. As such, the unamortized portion of previous issuance costs incurred will be amortized over the modified term, and costs incurred with third parties was expensed as incurred.
On June 5, 2024, the Company entered into Amendment No. 10 to the Loan Agreement with CRG, which reduced the minimum liquidity requirement of the Loan Agreement from $
Under the amended Loan Agreement, no cash payments for either principal or interest are required until the first quarter of 2027. The interest will be accrued and included in the debt balance based (to the extent not paid) on principal amounts outstanding at the beginning of the quarter at an interest rate of
The Company may voluntarily prepay the borrowings in full, with a prepayment premium beginning at
The Loan Agreement requires that the Company adheres to certain affirmative and negative covenants, including financial reporting requirements, certain minimum financial covenants for a pre-specified liquidity requirement and a prohibition against the incurrence of indebtedness, or creation of additional liens, other than as specifically permitted by the terms of the Loan Agreement. In particular, the covenants of the amended Loan Agreement included a covenant that the Company maintain a minimum of $
As of September 30, 2024, the Company was in compliance with all applicable covenants under the Loan Agreement.
As of September 30, 2024, principal, final facility fee and PIK payments under the Loan Agreement, as amended, were as follows (in thousands):
|
Year Ending December 31, |
||||
|
2024 (remaining three months of the year) |
$ | |||
|
2025 |
||||
|
2026 |
||||
|
2027 |
||||
|
2028 |
||||
|
Total |
||||
|
Less: Amount of PIK additions and final facility fee to be incurred subsequent to September 30, 2024 |
( |
) | ||
|
Less: Amount representing debt issuance costs |
( |
) | ||
|
Borrowings, current portion, as of September 30, 2024 |
$ |
In connection with drawdowns under the Loan Agreement, the Company recorded aggregate debt discounts of $
While, as of the date hereof, CRG has not purported that an Event of Default has resulted due to a Material Adverse Change (as those terms defined in the Loan Agreement), due to the substantial doubt about the Company’s ability to continue operating as a going concern, the entire outstanding amount of borrowings under the Loan Agreement and associated aggregate debt discount at September 30, 2024 and December 31, 2023 were classified as current in these financial statements.
5. Leases
The Company’s operating lease obligations primarily consist of leased office, laboratory, and manufacturing space under a non-cancelable operating lease. In addition to the minimum future lease commitments presented below, the lease requires the Company to pay property taxes, insurance, maintenance, and repair costs. The most recent amendment also provides an optional -year extension of the lease following the end of the current term on November 30, 2025, which was not included in the assessment of the lease term as it is not reasonably certain the Company will elect to exercise this option. Rent expense is recognized using the straight-line method over the term of the lease.
The current lease was to expire on November 30, 2024. On March 6, 2024, the Company entered into an amendment to the lease which extended the lease term for a period of one year, subsequent to the original expiration. As amended, the lease will expire on November 30, 2025. Under the terms of the amendment, the Company will be obligated to pay an additional $
In connection with the amendment the Company adjusted its right-of-use asset and lease liability to $
The Company’s operating lease expense, excluding variable maintenance fees and other expenses on a monthly basis, was approximately $
The following table presents the future operating lease payments and leasehold liability included on the balance sheet related to the Company’s operating lease as of September 30, 2024 (in thousands):
|
Year Ending December 31, |
||||
|
2024 (remaining three months of the year) |
$ | |||
|
2025 |
||||
|
Total |
||||
|
Less: Imputed interest |
( |
) |
||
|
Leasehold liability as of September 30, 2024 |
$ |
The following table shows ROU assets and lease liabilities, and the associated financial statement line items, as of September 30, 2024 and December 31, 2023 (in thousands):
| Lease-Related Assets and Liabilities |
Financial Statement Line Items |
September 30, 2024 |
December 31,
2023 |
|||||||
|
Right of use assets: |
||||||||||
|
Operating lease |
Right of use asset |
$ | $ | |||||||
|
Total right of use assets |
$ | 1,427 | $ | |||||||
|
Lease liabilities: |
||||||||||
|
Operating lease |
Leasehold liability, current portion |
$ | $ | |||||||
|
Leasehold liability, long-term portion |
||||||||||
|
Total lease liabilities |
$ | $ | ||||||||
6. Commitments and Contingencies
Purchase Obligations
Purchase obligations consist of agreements to purchase goods and services entered into in the ordinary course of business. The Company had non-cancelable commitments to suppliers for purchases totaling approximately $
Legal Proceedings
The Company is not currently involved in any pending legal proceedings that it believes could have a material adverse effect on our financial condition, results of operations or cash flows. From time to time, the Company may be involved in legal proceedings or investigations, which could harm our reputation, business and financial condition and divert the attention of our management from the operation of our business.
7. Stockholders’ Equity
Convertible Preferred Stock
As of September 30, 2024 and December 31, 2023, the Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue up to
Series A Preferred Stock Exchange
On March 5, 2024, the Company entered into the A-1 Securities Purchase Agreement with CRG to exchange all
The exchange was accounted for as a capital transaction constituting an extinguishment of the Series A preferred stock through the issuance of Series A-1 preferred stock with no net impact to stockholders’ deficit. At the time of the exchange, the Series A preferred stock had approximately $
Series A-1 Convertible Preferred Stock
Each share of Series A-1 preferred stock has a stated value of $
Series B Convertible Preferred Stock
The Series B preferred stock has a liquidation preference of $
Series E Convertible Preferred Stock
Each share of Series E preferred stock has a stated value of $
Series F Convertible Preferred Stock
On March 4, 2024, in connection with the Purchase Agreement (see Note 1), the Company issued
Series H Convertible Preferred Stock
On May 16, 2024, in connection with the Series H Purchase Agreement (see Note 4), the Company issued
Common Stock
As of September 30, 2024, the Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue up to
March 2024 Offering
On March 5, 2024, in connection with the Purchase Agreement (see Note 1), the Company issued
June 2024 Offering
On June 17, 2024, in connection with the June 2024 Offering (see Note 1), the Company issued
Common Stock Warrants
As of September 30, 2024, the Company had outstanding warrants to purchase common stock as follows:
|
Total Outstanding and Exercisable |
Underlying Shares of Common Stock |
Exercise Price per Share |
Expiration Date |
|||||||||||||
|
Series 1 Warrants issued in the February 2018 Series B financing |
$ |
February 2025 |
||||||||||||||
|
Series 2 Warrants issued in the February 2018 Series B financing |
$ |
February 2025 |
||||||||||||||
|
Placement agent warrants issued in the January 2022 financing |
$ |
January 2027 |
||||||||||||||
|
Warrants issued in the January 2022 financing |
$ |
July 2027 |
||||||||||||||
|
Series A Preferred Investment Options issued in August 2022 financing |
$ |
February 2028 |
||||||||||||||
|
Placement agent Preferred Investment Options issued in the August 2022 financing |
$ |
August 2027 |
||||||||||||||
|
Advisor Warrants issued in the March 2024 financing |
$ |
March 2029 |
||||||||||||||
|
Pre-Funded Warrants issued in the June 2024 financing |
$ | n/a | ||||||||||||||
|
Series A-1 Warrants issued in the June 2024 financing |
$ |
See note (1) |
||||||||||||||
|
Series A-2 Warrants issued in the June 2024 financing |
$ |
See note (2) |
||||||||||||||
|
Series A-3 Warrants issued in the June 2024 financing |
$ |
See note (3) |
||||||||||||||
|
Placement Agent Warrants issued in the June 2024 financing |
$ |
June 2029 |
||||||||||||||
|
Total as of September 30, 2024 |
||||||||||||||||
|
(1) |
The Series A-1 Warrants expire on the earlier of August 12, 2029 and |
|
(2) |
Series A-2 Warrants expire on the earlier of August 12, 2026 and |
|
(3) |
The Series A-3 Warrants expire on the earlier of May 12, 2025 and |
During the three months ended September 30, 2024, a total of
In accordance with their terms, the
As of December 31, 2023, the Company had outstanding warrants to purchase common stock as follows:
|
Total Outstanding and Exercisable |
Underlying Shares of Common Stock |
Exercise Price per Share |
Expiration Date |
||||||||||
|
Series 1 Warrants issued in the February 2018 Series B financing |
$ |
February 2025 |
|||||||||||
|
Series 2 Warrants issued in the February 2018 Series B financing |
$ |
February 2025 |
|||||||||||
|
Placement agent warrants issued in the January 2022 financing |
$ |
January 2027 |
|||||||||||
|
Warrants issued in the January 2022 financing |
$ |
July 2027 |
|||||||||||
|
Series A Preferred Investment Options issued in August 2022 financing |
$ |
February 2028 |
|||||||||||
|
Series B Preferred Investment Options issued in August 2022 financing |
$ |
August 2024 |
|||||||||||
|
Placement agent Preferred Investment Options issued in the August 2022 financing |
$ |
August 2027 |
|||||||||||
|
Total as of December 31, 2023 |
|||||||||||||
March 2024 Private Placement
On March 7, 2024, in connection with the closing of the Strategic Partnership and Private Placement, the Company issued Advisor Warrants at an exercise price of $
The exercise price and the number of shares of common stock issuable upon exercise of each Advisor Warrant are subject to appropriate adjustments in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock. In addition, in certain circumstances, upon a fundamental transaction, a holder of Advisor Warrants will be entitled to receive, upon exercise, the kind and amount of securities, cash or other property that such holder would have received had they exercised the Advisor Warrants prior to the fundamental transaction.
The Advisor Warrants can be exercised at the option of the holders at any time after they become exercisable provided that shares cannot be exercised into common stock if the applicable holder would beneficially own in excess of
June 2024 Offering
On June 13, 2024, the Company entered into a securities purchase agreement with two institutional investors resulting in the issuance of among other things, Pre-Funded Warrants in lieu of common stock to purchase up to an aggregate of
In addition, the Company issued to the investors in the Offering (i) Series A-1 Warrants to purchase up to an aggregate of
The Series A-1 Warrants expire on the earlier of August 12, 2029 and
In connection with the Offering, the Company also issued to the placement agent Placement Agent or its designees Placement Agent Warrants to purchase up to an aggregate of
The exercise price and the number of shares of common stock issuable upon exercise of each Pre-Funded Warrants, Series A-1 Warrants, Series A-2 Warrants, Series A-3 Warrants, and Placement Agent Warrants are subject to appropriate adjustments in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock. In addition, in certain circumstances, upon a fundamental transaction, a holder of Pre-Funded Warrants, Series A-1 Warrants, Series A-2 Warrants, Series A-3 Warrants, and Placement Agent Warrants will be entitled to receive, upon exercise, the kind and amount of securities, cash or other property that such holder would have received had they exercised the Pre-Funded Warrants, Series A-1 Warrants, Series A-2 Warrants, Series A-3 Warrants, and Placement Agent Warrants immediately prior to the fundamental transaction.
The Pre-Funded Warrants, Series A-1 Warrants, Series A-2 Warrants, Series A-3 Warrants, and Placement Agent Warrants can be exercised at the option of the holders at any time after they become exercisable provided that shares of the Pre-Funded Warrants, Series A-1 Warrants, Series A-2 Warrants, Series A-3 Warrants, and Placement Agent Warrants cannot be exercised into common stock if the applicable holder would beneficially own in excess of
In the event of a fundamental transaction in which the holders of our voting securities immediately prior to such fundamental transaction will not, following such fundamental transaction, directly or indirectly own more than 50% of the voting securities of the surviving entity or successor entity, and in which the Company is not the successor entity or does not continue as a reporting issuer under the Exchange Act, then, at the request of the holder, the Company or the successor entity shall purchase the unexercised portion of the Pre-Funded Warrants, Series A-1 Warrants, Series A-2 Warrants, Series A-3 Warrants, and Placement Agent Warrants from the holder by paying to the holder an amount, in cash, equal to the fair value of the remaining unexercised portion of the Pre-Funded Warrants, Series A-1 Warrants, Series A-2 Warrants, Series A-3 Warrants, and Placement Agent Warrants on the date of such fundamental transaction, subject to certain limitations in the event of a fundamental transaction not within our control.
8. Stock-Based Compensation
Stock Plans
In January 2015, the Board of Directors adopted and the Company’s stockholders approved the 2015 Equity Incentive Plan (“2015 Plan”). On December 22, 2023, the Company’s stockholders approved an additional
The Company’s RSUs and RSAs generally vest annually over two years in equal increments. RSAs and RSUs largely contain the same contractual terms except RSAs have the ability to vote along with common holders as an RSA is considered an outstanding security at the time of grant, subject to certain vesting and other restrictions. The Company measures the fair value of RSAs using the closing stock price of a share of the Company’s common stock on the grant date and is recognized as expense on a straight-line basis over the vesting period of the award. A summary of all RSA activity is presented below:
|
Number of Shares |
Weighted Average Grant Date Fair Value |
Weighted Average Remaining Contractual Term |
||||||||||
|
Awards outstanding at December 31, 2023 |
$ | |||||||||||
|
Awarded |
$ | — | ||||||||||
|
Released |
( |
) |
$ | — | ||||||||
|
Forfeited |
( |
) |
$ | — | ||||||||
|
Awards outstanding at September 30, 2024 |
$ | |||||||||||
As of September 30, 2024, there was $
Total noncash stock-based compensation expense relating to the Company’s RSAs recognized, before taxes, during the three and nine months ended September 30, 2024 and 2023, is as follows (in thousands):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
|
2024 |
2023 |
2024 |
2023 |
|||||||||||||
|
Cost of revenues |
$ | $ | $ | $ | ||||||||||||
|
Research and development expenses |
||||||||||||||||
|
Selling, general and administrative expenses |
||||||||||||||||
| $ | $ | $ | $ | |||||||||||||
9. Restructuring Charges and Expenses
In June 2024, the Company undertook an organizational realignment and cost reduction plan which included a reduction in force, lowering its total headcount by approximately
|
ITEM 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
You should read the following discussion and analysis of our financial condition and results of operations together with the unaudited financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. This discussion and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions, that are based on the beliefs of our management, as well as assumptions made by, and information currently available to, our management. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the sections of this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K filed with the SEC on March 20, 2024, titled “Risk Factors.”
Overview
We are a commercial-stage medical device company that designs, manufactures, and sells real-time high-definition image-guided, minimally invasive catheter-based systems that are used by physicians to treat patients with PAD. Patients with PAD have a build-up of plaque in the arteries that supply blood to areas away from the heart, particularly the pelvis and legs. Our mission is to significantly improve the treatment of vascular disease through the introduction of products based on our Lumivascular platform, the only intravascular real-time high-definition image-guided system available in this market.
We design, manufacture, and sell a suite of products in the United States and select international markets. We are located in Redwood City, California. Our current Lumivascular platform consists of products including our Lightbox imaging console, the Ocelot and Tigereye family of devices, which are image-guided devices designed to allow physicians to penetrate a total blockage in an artery, known as a CTO, and the Pantheris family of catheters, our image-guided atherectomy catheters which are designed to allow physicians to precisely remove arterial plaque in PAD patients.
We are in the process of developing CTO crossing devices to target the coronary CTO market. However, the market for medical devices in the coronary artery disease (“CAD”) space is highly competitive, dynamic, and marked by rapid and substantial technological development and product innovation and there is no guarantee that we will be successful in developing and commercializing any new CAD product. At this stage, we are working on understanding market requirements, and initiated the development process for the new CAD product, which we anticipate will require additional expenses.
We obtained CE Marking for our original Ocelot product in September 2011 and received from the U.S. FDA, 510(k) clearance in November 2012. We also received 510(k) clearance from the FDA for commercialization of Pantheris in October 2015. We received an additional 510(k) clearance for an enhanced version of Pantheris in March 2016 and commenced sales of Pantheris in the United States and select European countries promptly thereafter. In May 2018, we received 510(k) clearance from the FDA for our current next-generation version of Pantheris. In April 2019, we received 510(k) clearance from the FDA for our Pantheris Small Vessel (“SV”), a version of Pantheris targeting smaller vessels, and commenced sales in July 2019. In September 2020, we received 510(k) clearance for Tigereye, a next-generation CTO crossing system utilizing Avinger’s proprietary image-guided technology platform. Tigereye is a product line extension of Avinger’s Ocelot family of image-guided CTO crossing catheters. In January 2022, we received 510(k) clearance from the FDA for our Lightbox 3 imaging console, an advanced version of our Lightbox imaging console that allows for easy portability and offers significant reductions in size, weight, and production cost in comparison to the incumbent version.
In April 2023, we received 510(k) clearance from the FDA for Tigereye Spinning Tip (“ST”), a next-generation image-guided CTO crossing system. Tigereye ST is a line extension of our Ocelot and Tigereye family of CTO crossing catheters. This new image-guided catheter incorporates design upgrades to the tip configuration and catheter shaft to increase crossing power and procedural success in challenging lesions, as well as design enhancements for ease of image interpretation during the procedure. The low-profile Tigereye ST has a working length of 140 cm and 5 French sheath compatibility. We initiated a limited launch of Tigereye ST in the second quarter of 2023 and subsequently expanded to full commercial availability within the United States during the third quarter of 2023.
In June 2023, we received 510(k) clearance from the FDA for Pantheris Large Vessel (“LV”), a next generation image guided atherectomy system for the treatment of larger vessels, such as the superficial femoral artery (“SFA”) and popliteal arteries. Pantheris LV is a line extension of our Pantheris and Pantheris SV family of atherectomy products. This catheter offers higher speed plaque excision for efficient removal of challenging occlusive tissue and multiple features to streamline and simplify user-operation, including enhanced tissue packing and removal, a radiopaque gauge to measure volume of plaque excised during the procedure, and enhanced guidewire management. We initiated a limited launch of the Pantheris LV during the third quarter of 2023 and expect to expand to full commercial availability within the United States in the second half of 2024.
Current treatments for PAD, including bypass surgery, can be costly and may result in complications, high levels of post-surgery pain, and lengthy hospital stays and recovery times. Minimally invasive, or endovascular, treatments for PAD include stenting, angioplasty, and atherectomy, which is the use of a catheter-based device for the removal of plaque. These treatments all have limitations in their safety or efficacy profiles and frequently result in recurrence of the disease, also known as restenosis. We believe one of the main contributing factors to high restenosis rates for PAD patients treated with endovascular technologies is the amount of vascular injury that occurs during an intervention. Specifically, these treatments often disrupt the membrane between the outermost layers of the artery, which is referred to as the external elastic lamina (“EEL”).
We believe our Lumivascular platform is the only technology that offers radiation free, high-definition real-time visualization of the inside of the artery during PAD treatment through the use of OCT, a high resolution, light-based, radiation-free imaging technology. Our Lumivascular platform provides physicians with high-definition real-time OCT images from the inside of an artery, and we believe Ocelot and Pantheris are the first products to offer intravascular visualization during CTO crossing and atherectomy, respectively. We believe this approach will significantly improve patient outcomes by providing physicians with a clearer picture of the artery using radiation-free image guidance during treatment, enabling them to better differentiate between plaque and healthy arterial structures. Our Lumivascular platform is designed to improve patient safety by enabling physicians to direct treatment towards the plaque, while avoiding damage to healthy portions of the artery.
During the first quarter of 2015, we completed enrollment of patients in VISION, a clinical trial designed to support our August 2015 510(k) submission to the FDA for our Pantheris atherectomy device. VISION was designed to evaluate the safety and efficacy of Pantheris to perform atherectomy using intravascular imaging and successfully achieved all primary and secondary safety and efficacy endpoints. We believe the data from VISION allows us to demonstrate that avoiding damage to healthy arterial structures, and in particular disruption of the external elastic lamina, which is the membrane between the outermost layers of the artery, reduces the likelihood of restenosis, or re-narrowing, of the diseased artery. Although the original VISION study protocol was not designed to follow patients beyond six months, we worked with 18 of the VISION sites to re-solicit consent from previous clinical trial patients in order for them to evaluate patient outcomes through 12 and 24 months following initial treatment. Data collection for the remaining patients from participating sites was completed in May 2017, and we released the final 12- and 24-month results for a total of 89 patients in July 2017.
During the fourth quarter of 2017, we began enrolling patients in INSIGHT, a clinical trial designed to support a submission to the FDA to expand the indication for our Pantheris atherectomy device to include the treatment of in-stent restenosis. Patient enrollment began in October 2017 and was completed in July 2021. Patient outcomes were evaluated at thirty days, six months and one year following treatment. In November 2021, we received 510(k) clearance from the FDA for this new clinical indication for treating in-stent restenosis with Pantheris using the data collected and analyzed from INSIGHT. We expect this will expand our addressable market for Pantheris to include a high-incidence disease state for which there are few available indicated or effective treatment options.
We are pursuing additional clinical data programs including a post-market study, IMAGE-BTK, that is designed to evaluate the safety and efficacy of Pantheris SV in the treatment of PAD lesions below-the-knee. We completed enrollment in 2023. Patient outcomes are being evaluated at thirty days, six months and one year following treatment. We expect this will bolster the application of Pantheris SV as a primary interventional tool to address below-the-knee lesions for which there are few available effective treatment options.
We focus our direct sales force, marketing efforts and promotional activities on interventional cardiologists, vascular surgeons and interventional radiologists. We also work on developing strong relationships with physicians and hospitals that we have identified as key opinion leaders. Although our sales and marketing efforts are directed at these physicians because they are the primary users of our technology, we consider the hospitals and medical centers where the procedure is performed to be our customers, as they typically are responsible for purchasing our products. We are designing additional future products to be compatible with our Lumivascular platform, which we expect to enhance the value proposition for hospitals to invest in our technology. Pantheris qualifies for existing reimbursement codes currently utilized by other atherectomy products, further facilitating adoption of our products.
We have assembled a team with extensive medical device development and commercialization experience in both start-up and large, multi-national medical device companies. We assemble all of our catheter products at our manufacturing facility but certain critical processes, such as coating and sterilization, are performed by outside vendors. Our Lightbox 3 imaging console is assembled through a qualified contract manufacturer. We expect our current manufacturing facility in California will be sufficient through at least 2025.
We generated revenues of $10.1 million in 2021, $8.3 million in 2022 and $7.7 million in 2023. Revenues during these years were tangentially affected by COVID-19 as hospitals continued to defer elective procedures in certain jurisdictions while increasing volume to accommodate previously deferred procedures in others, which among other things, created unpredictability in case volume. This unpredictability created more volatility in our revenues which continued to affect our business in the aforementioned years. The decline in revenue in 2022 and 2023 was primarily attributable to the adverse effects of staffing shortages, resource constraints on our customers as hospitals deferred elective procedures, and the impact of a very competitive market for talent on the retention of our commercial team.
Recent Developments
Nasdaq Delisting Notice
On April 25, 2023, we received notice (the “Bid Price Deficiency Letter”) from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market, LLC (“Nasdaq”) notifying us that we were not in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Requirement”), as the minimum bid price for our listed securities was less than $1.00 for the previous 30 consecutive business days. We had a period of 180 calendar days, or until October 23, 2023, to regain compliance with the rule referred to in this paragraph. As part of our efforts to regain compliance with the aforementioned rule, we effected a 1-for-15 reverse stock split on September 12, 2023.
On September 27, 2023, we received a letter from Nasdaq notifying us that the Staff had determined that the closing bid price of our common stock had been at $1.00 per share or greater for at least 10 consecutive business days and, accordingly, that we had regained compliance with the Bid Price Requirement. While we have regained compliance with the Bid Price Requirement, there can be no assurance that we will be able to maintain compliance with the Bid Price Requirement, or other continued listing requirements of Nasdaq, in the future.
As of the date of this quarterly report, the minimum bid price for our common stock has been below $1.00 for the previous 23 consecutive business days.
On May 18, 2023, we received notice (the “Stockholders’ Equity Deficiency Letter”) from the Staff that we no longer satisfied the $2.5 million stockholders’ equity requirement for continued listing on The Nasdaq Capital Market, or the alternatives to that requirements – a $35 million market value of listed securities or $500,000 in net income in the most recent fiscal year or two of the last three fiscal years – as required by Nasdaq Listing Rule 5550(b) (the “Equity Requirement”).
As with the Bid Price Deficiency Letter, the Stockholders’ Equity Deficiency Letter had no immediate effect on our continued listing on The Nasdaq Capital Market. In accordance with the Nasdaq Listing Rules, we were provided 45 calendar days, or until July 3, 2023, to submit a plan to regain compliance with the Equity Requirement (the “Compliance Plan”). We submitted the Compliance Plan to Nasdaq on July 3, 2023. On July 31, 2023, we received a letter from Nasdaq notifying us that the Staff had determined to grant us an extension of 180 calendar days from the date of the Staff’s notice, or November 14, 2023, to regain compliance with the Equity Requirement.
On November 21, 2023, the Staff formally notified us that the Staff had determined that we were unable to demonstrate compliance with the Equity Requirement and that our securities would be delisted at the open of business on November 30, 2023, unless we timely requested a hearing before the Nasdaq Hearings Panel (the “Panel”). On November 28, 2023, we requested and were granted a hearing before the Panel which took place on February 20, 2024. At the hearing, we presented a plan to regain and sustain compliance with the Equity Requirement and requested an extension to do so. On March 14, 2024, the results from the hearing were rendered in which we were granted an extension by the Panel. This extension stayed any further action by Nasdaq with respect to our continued listing until May 20, 2024.
We took definitive steps pursuant to our plan as presented to the Panel to ensure our compliance with the Equity Requirement and all other applicable criteria for continued listing on Nasdaq. We undertook certain actions which included among other things (i) converting $11.0 million of outstanding indebtedness into equity in May 2024, (ii) issuing additional shares of capital stock, (iii) completing a public equity offering in June 2024 in which we received gross proceeds of $6.0 million through the issuance of a combination of common stock and pre-funded warrants and (iv) entring into a securities purchase agreement in March 2024 as part of a larger strategic partnership and collaboration transaction representing entry into a number of financing, licensing and other agreements in which we received gross proceeds of $7.5 million and expect to receive another $7.5 million upon the successful completion of certain milestones, discussed in more detail below. This financing transaction was an integral part of the plan presented to the Panel.
On May 29, 2024, we were formally notified by Nasdaq that we have regained compliance with the stockholders’ equity requirement set forth in Nasdaq Listing Rule 5550(b)(1) and evidenced compliance with all other applicable criteria for continued listing on The Nasdaq Capital Market. Accordingly, the listing matter, which was reviewed by the Panel has been closed.
We will be subject to a “Mandatory Panel Monitor” as that term is defined in Nasdaq Listing Rule 5815(d)(4)(B), through May 29, 2025. If within the monitoring period we fail to evidence compliance with the Equity Requirement, we would not be allowed to provide to the Staff a plan to regain compliance with the Equity Requirement; rather, the Staff would be required to issue a delist determination. We would in that case have the opportunity to request a new hearing before the Panel, which request would stay any further action by the Staff.
We anticipate we will need to issue additional shares of capital stock through various other financing transactions in order to maintain compliance with the Equity Requirement, the most recent of which occurred in June 2024 in a best efforts public offering resulting in gross proceeds of $6.0 million. However, we may not be successful in executing such future transactions on terms favorable to us, or at all, and may not be able to maintain compliance with Nasdaq’s listing requirements, including the Equity Requirement.
Global Supply Chain
We are closely monitoring the general economic conditions on global supply chain, manufacturing, and logistics operations. As inflationary pressures increase, we anticipate that our production and operating costs may similarly increase, including costs and availability of materials and labor. In addition, port closures and labor shortages have resulted in manufacturing and shipping constraints. While we have had sufficient inventory on-hand to meet our current production requirements and customer demand, we have experienced some constraints with respect to the availability of certain materials and extended lead times from certain key suppliers. We have also experienced some delays in shipping products to our customers. Any significant delay or interruption in our supply chain could impair our ability to meet the demands of our customers in the future and could harm our business.
We may need to identify and qualify new suppliers in response to disruptions and difficulties experienced by some of our current suppliers. The process of identifying and qualifying suppliers is lengthy with no guarantee of mitigating the current issues we are experiencing. This process can include but is not limited to delays in qualification, quality issues on components, and higher costs to source these components. All of these issues may impair our ability to meet the demands of our customers in the future.
Reverse Stock Split
On September 11, 2023, our board of directors approved an amendment to our amended and restated certificate of incorporation to effect a 1-for-15 reverse stock split of our issued and outstanding common stock. The reverse stock split became effective on September 12, 2023. The par value of the common stock was not adjusted as a result of the reverse stock split. All common stock, stock options, restricted stock units, and per share amounts in the financial statements have been retroactively adjusted for all periods presented to give effect to the reverse stock split.
Strategic Collaboration
On March 4, 2024, we entered into a License Agreement with Zylox-Tonbridge, pursuant to which we will license and distribute certain of our products (including consumables) in the Greater China region, including mainland China, Hong Kong, Macao, and Taiwan. Zylox-Tonbridge will lead all regulatory activities for the registration of our products in the Territory. We will also license our intellectual property and know-how related to our products to Zylox-Tonbridge so that Zylox-Tonbridge can manufacture the localized products in the Territory. All sales of our products locally manufactured by Zylox-Tonbridge with regulatory approval by the regulatory authorities in the Territory and commercialized in the Territory will be royalty bearing to us at varying percentages depending on the amount of gross revenue and product gross margin.
In connection with the License Agreement, we also entered into a Strategic Cooperation and Framework Agreement with Zylox-Tonbridge, which provides the opportunity for us to access certain Zylox-Tonbridge peripheral vascular products for distribution in the U.S. and Germany. The agreement also provides the option for us to source finished goods inventory from Zylox-Tonbridge following registration of Zylox-Tonbridge’s manufacturing facility with the FDA.
Financing Agreements
On March 4, 2024, in connection with the Strategic Collaboration, we and the Purchaser, entered into the Purchase Agreement, pursuant to which the Purchaser agreed to purchase, in two tranches, up to an aggregate of $15 million in shares of our common stock, and shares of two new series of our preferred stock. On March 5, 2024, we issued to the Purchaser 75,327 shares of the common stock at a purchase price per share of $3.664 (the “Purchase Price”), and 7,224 shares of Series F Preferred Stock at a purchase price per share of $1,000, for an aggregate purchase price of $7.5 million.
Each share of Series F Preferred Stock has a stated value of $1,000 and is initially convertible into approximately 273 shares of common stock at a conversion price equal to the Purchase Price, subject to the terms of Series F Certificate of Designation.
Upon completion of the Milestones, the Purchaser will invest an additional $7.5 million to purchase shares of Series G Preferred Stock. Each share of Series G Preferred Stock will have a stated value of $1,000 and will be convertible into shares of common stock at a conversion price of equal to the lowest of (x) the Purchase Price, (y) the closing price of the common stock on the date immediately preceding the Milestone Closing, and (z) the average closing price for the last five trading days preceding the Milestone Closing, provided that the conversion price will be no less than $0.20.
On May 22, 2024, we held a special meeting of stockholders to vote on the following proposals resulting from the Private Placement (i) accept conversion of the shares of Series F Preferred Stock in excess of 19.9% of our outstanding common stock, which may be deemed a “change of control” under Nasdaq Listing Rule 5635(b) and (ii) issue and sell shares of Series G Preferred Stock upon completion of the Milestones. Both proposals were approved by our stockholders. There were no conversions of Series F Preferred Stock during the three or nine months ended September 30, 2024.
Series A Preferred Stock Exchange
On March 5, 2024, we entered into the A-1 Securities Purchase Agreement to exchange all outstanding shares of Series A Preferred Stock for 10,000 shares of Series A-1 Preferred Stock. Among other things, the shares of Series A-1 Preferred Stock: (i) are convertible into an aggregate of approximately 2,729,257 shares of common stock at a conversion price equal to the Purchase Price, (ii) do not accrue or pay dividends payable solely on the Series A-1 Preferred Stock, (iii) will have no liquidation preference and (iv) will be junior in rank to shares of our Series E Preferred Stock, Series F Preferred Stock and Series G Preferred Stock.
CRG Loan Amendment
On March 5, 2024, we also entered into Amendment No. 9 to the Loan Agreement effective as of the Initial Closing with CRG, which amends the Loan Agreement to, among other things: (i) extend the interest-only period through December 31, 2026; (ii) provide that interest payable through December 31, 2026 may be payable in kind rather than in cash; and (iii) permit the payment of dividends on the preferred stock issued or issuable to the Purchaser.
Lease Extension
On March 6, 2024, we entered into an amendment to the lease which extended the lease term for a period of one year, subsequent to the original expiration of November 30, 2024. As amended, the lease will expire on November 30, 2025. Under the terms of the amendment, we will be obligated to pay approximately $1.3 million in base rent payments through November 2025, beginning on December 1, 2024. This amendment also provides an optional one year extension of the lease following the end of the current term, as amended.
Reduction in Force
In June 2024, we undertook a cost reduction plan and concurrent organizational realignment which included a company-wide reduction in force lowering our total headcount by 17 employees. This workforce reduction was designed to reduce operating expenses while continuing to support major product development and clinical initiatives related to our coronary product development program. Our sales personnel headcount dedicated to our peripheral business was reduced to 18, down from 27 as of March 31, 2024, a difference of 33%. The organizational realignment within sales was designed, in part, to focus our commercial efforts on driving catheter utilization in our strongest peripheral markets, around our most productive sales professionals. The strategic reduction in the field sales force and one individual in sales leadership was designed to maintain robust engagement with higher volume users of our Lumivascular technology and position us to maintain and support utilization of our catheters within our installed base of accounts leveraging our existing and next generation products, namely Pantheris LV and Tigereye ST.
Financing
During the three and nine months ended September 30, 2024, our net loss and comprehensive net loss was $3.7 million and $13.6 million, respectively; during the years ended December 31, 2023 and 2022, our net loss and comprehensive loss was $18.3 million and $17.6 million, respectively. We have not been profitable since inception, and as of September 30, 2024, our accumulated deficit was $434.3 million. Since inception, we have financed our operations primarily through private and public placements of our preferred and common securities and, to a lesser extent, debt financing arrangements.
In September 2015, we entered into the Loan Agreement with CRG, under which we were able to borrow up to $50.0 million on or before the end of the twenty-four (24) month period commencing on the first Borrowing Date (as defined in the Loan Agreement), subject to certain terms and conditions. Under the Loan Agreement we borrowed $30.0 million on September 22, 2015 and an additional $10.0 million on June 15, 2016. Contemporaneously with the execution of the Loan Agreement, we entered into a Securities Purchase Agreement with CRG (the “Securities Purchase Agreement”), pursuant to which CRG purchased 3 shares of our common stock on September 22, 2015 at a price of $1,678,920 per share, which represents the 10-day average of closing prices of our common stock ending on September 21, 2015. Pursuant to the Securities Purchase Agreement, we filed a registration statement covering the resale of the shares sold to CRG and must comply with certain affirmative covenants during the time that such registration statement remains in effect.
On February 14, 2018, we entered into a Series A preferred stock Purchase Agreement (the “Series A Purchase Agreement”) with CRG, pursuant to which it agreed to convert $38.0 million of the outstanding principal amount of its senior secured term loan (plus the back-end fee and prepayment premium applicable thereto) under the Loan Agreement into newly authorized Series A-1 preferred stock. In March 2024, all outstanding shares of Series A preferred stock were cancelled in exchange for the issuance of Series A-1 preferred stock. The Series A-1 preferred stock, which is immediately convertible, carries no liquidation preference or dividend rights.
We have entered into several amendments to the Loan Agreement with CRG since September 2015. The Amendments, among other things: (1) extended the interest-only period through December 31, 2026; (2) extended the period during which we may elect to pay a portion of interest in PIK, interest payments through December 31, 2026 so long as no Default (as defined in the Loan Agreement) has occurred and is continuing; (3) permitted us to make our entire interest payments in PIK interest payments through December 31, 2026 so long as no Default has occurred and is continuing; (4) extended the Stated Maturity Date (as defined in the Loan Agreement) to December 31, 2028; (5) reduced the minimum liquidity covenant to $3.5 million at all times; (6) eliminated the minimum revenue covenant for all years; (7) changed the date under the on-going stand-alone representation regarding no “Material Adverse Change” to December 31, 2020; (8) amended the on-going stand-alone representation and stand-alone Event of Default (as defined in the Loan Agreement) regarding Material Adverse Change such that any adverse change in or effect upon the revenue of us and our subsidiaries due to the outbreak of COVID-19 will not constitute a Material Adverse Change; (9) provided CRG with board observer rights; and (10) provide that the board observer may be appointed or removed by written notice from the Majority Lenders (as defined in the Loan Agreement).
On August 2, 2023, we entered into the Series E Purchase Agreement with CRG, pursuant to which we issued 1,920 shares of newly authorized Series E convertible preferred stock in exchange for CRG surrendering for cancellation $1.92 million of outstanding principal and accrued interest of the senior secured term loan. Each share of Series E preferred stock has a stated value of $1,000 per share and is convertible into 93 shares of our common stock at a conversion price of $10.725 per share. The Series E preferred stock is initially convertible into 178,560 shares of common stock subject to certain limitations contained in the Series E Purchase Agreement. Under the terms of the Series E Purchase Agreement, the holders of Series E preferred stock are entitled to receive annual accruing dividends at a rate of 8%, payable in additional shares of Series E preferred stock or cash, at our option. The shares of Series E preferred stock have full voting rights, on an as-converted basis, subject to certain limitations. The Series E preferred stock rank junior to Series H preferred stock and senior to all other classes and series of the Company’s equity in terms of repayment and certain other rights.
On September 29, 2023, the Company entered into the Waiver Agreement with CRG, who held all of the outstanding shares of the Company’s Series A and Series E preferred stock. Pursuant to the Waiver Agreement, CRG waived their rights to receive the Series A and Series E preferred dividends for the year ending December 31, 2023. Such waived preferred dividends were not cumulative or accrued.
On January 26, 2024, we entered into Amendment No. 8 to the Loan Agreement with CRG, which reduced the minimum liquidity requirement of the Loan Agreement from $3.5 million to $1.0 million until April 1, 2024. Thereafter, we would be subject to the minimum liquidity requirement of $3.5 million.
On May 16, 2024, we entered into the Series H Purchase Agreement with CRG pursuant to which we issued 11,000 shares of a newly authorized Series H convertible preferred stock in exchange for CRG surrendering for cancellation $11.0 million of outstanding principal and accrued interest of the senior secured term loan under the Loan Agreement. Each share of Series H preferred stock has a stated value of $1,000 per share and is convertible into 259 shares of our common stock at a conversion price of $3.86 per share. The Series H preferred stock is initially convertible into 2,849,000 shares of common stock subject to certain limitations contained in the Series H Purchase Agreement. Under the terms of the Series H Purchase Agreement, the holders of Series H preferred stock are entitled to receive annual accruing dividends at a rate of 8%, payable in additional shares of Series H preferred stock or cash, at our option. The shares of Series H preferred stock have full voting rights, on an as-converted basis, subject to certain limitations. The Series H preferred stock rank senior to all other classes and series of the Company’s equity in terms of repayment and certain other rights.
The shares of Series A-1 preferred stock, Series E preferred stock and Series H preferred stock cannot be converted into common stock to the extent the applicable holder would beneficially own in excess of 9.99% of the Company’s outstanding voting power and in no case will the beneficial ownership limitation exceed 19.99% of the Company’s outstanding voting power on a combined basis (as CRG collectively holds all of the issued and outstanding shares of the Company’s Series A-1 convertible preferred stock, Series E convertible preferred stock and Series H convertible preferred stock), unless approved by our stockholders in accordance with Nasdaq Listing Rule 5635(b).
As part of our Strategic Collaboration, we entered into Amendment No. 9 to the Loan Agreement with CRG, which amends the Loan Agreement to, among other things: (i) extend the interest-only period through December 31, 2026; (ii) provide that interest payable through December 31, 2026 may be payable in kind rather than in cash; and (iii) permit the payment of dividends on the preferred stock issued or issuable to the Purchaser. In addition, we completed the Private Placement for gross proceeds, before expenses, of $7.5 million.
On June 5, 2024, we entered into Amendment No. 10 to the Loan Agreement with CRG, which reduced the minimum liquidity requirement of the Loan Agreement from $3.5 million to $1.5 million for the period commencing June 1, 2024 and ending July 31, 2024. Thereafter, we will be subject to the minimum liquidity requirement of $3.5 million.
Critical Accounting Policies and Estimates
Management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenues, expenses and related disclosures of contingent assets and liabilities. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material. There have been no significant and material changes in our critical accounting policies during the three months ended September 30, 2024, as compared to those disclosed in “Management’s Discussion and Analysis of Financial Conditions and Results of Operations - Critical Accounting Policies and Significant Judgments and Estimates” in our most recent Annual Report on Form 10-K, as filed with the SEC on March 20, 2024.
Components of Our Results of Operations
Revenues
All of our revenues are currently derived from sales of our various PAD catheters in the United States and select international markets, Lightbox consoles, and related services. We expect our revenues to decrease in 2024 due to reductions in sales personnel resulting from reductions in force (“RIF”), attrition, competitive labor market, and other factors, partially offset by the expansion of market presence of our Tigereye ST and Pantheris LV products. There was one customer that represented 20% and 17% of revenues for each of the three and nine months ended September 30, 2024 respectively. For the three and nine months ended September 30, 2023, there was one customer that represented 22% and 17% of revenues, respectively.
Revenues may fluctuate from quarter to quarter due to a variety of factors including capital equipment purchasing patterns that are typically increased towards the end of the calendar year and decreased in the first quarter and our ability to have product available in light of supply chain challenges. In addition, during the first quarter, our results can be harmed by adverse weather and by resetting of annual patient healthcare insurance plan deductibles, both of which may cause patients to delay elective procedures. In the third quarter, the number of elective procedures nationwide is historically lower than other quarters throughout the year, which we believe is primarily attributable to the summer vacations of physicians and their patients. Additionally, we believe hospital capacity and resource staffing issues have had an adverse effect on our ability to generate sales in past periods due to the fluctuating and unpredictable levels of capacity medical providers have to perform procedures that require the use of our products.
Cost of Revenues and Gross Margin
Cost of revenues consists primarily of costs related to manufacturing overhead, materials and direct labor. We expense all warranty costs and inventory provisions as cost of revenues. We periodically write-down inventory for estimated excess, obsolete and non-sellable inventories based on assumptions about future demand, past usage, changes to manufacturing processes and overall market conditions. A significant portion of our cost of revenues currently consists of manufacturing overhead costs. These overhead costs include the cost of quality assurance, material procurement, inventory control, facilities, equipment and operations supervision and management. We expect overhead costs as a percentage of revenues to become less significant as our production volume increases. Cost of revenues also includes depreciation expense for production equipment, depreciation and related maintenance expense for placed Lightboxes held by customers and certain direct costs such as those incurred for shipping our products.
We calculate gross margin as gross profit divided by revenues. Our gross margin has been and will continue to be affected by a variety of factors, primarily production volumes, manufacturing costs, product yields, headcount, charges for excess and obsolete inventories and cost-reduction strategies. We intend to use our design, engineering and manufacturing capabilities to further advance and improve the efficiency of our manufacturing processes, which we believe will reduce costs and increase our gross margin. In the future, we may seek to manufacture certain of our products outside the United States to further reduce costs. Our gross margin will likely fluctuate from quarter to quarter as we continue to introduce new products and sales channels, and as we adopt new manufacturing processes and technologies.
Research and Development Expenses
Research and development (“R&D”), expenses consist primarily of engineering, product development, clinical and regulatory affairs, consulting services, materials, depreciation and other costs associated with products and technologies in development. These expenses include employee compensation, including stock-based compensation, supplies, materials, quality assurance expenses allocated to R&D programs, consulting, related travel expenses and facilities expenses. Clinical expenses include clinical trial design, clinical site reimbursement, data management, travel expenses and the cost of manufacturing products for clinical trials. We expect R&D expenses to vary over time depending on the level and timing of our new product development efforts, as well as our clinical development, clinical trial and other related activities.
Selling, General and Administrative Expenses
Selling, general and administrative (“SG&A”), expenses consist primarily of compensation for personnel, including stock-based compensation, selling and marketing functions, physician education programs, business development, finance, information technology and human resource functions. Other SG&A expenses include commissions, training, travel expenses, educational and promotional activities, marketing initiatives, market research and analysis, conferences and trade shows, professional services fees, including legal, audit and tax fees, insurance costs and general corporate expenses. We expect SG&A expenses to increase as we expand our commercial efforts and additional costs related to corporate matters.
Interest Expense, Net
Interest expense, net consists primarily of interest incurred on our outstanding indebtedness and non-cash interest related to the amortization of debt discount and issuance costs associated with our debt agreement.
Other Income (Expense), Net
Other income (expense), net primarily consists of gains and losses resulting from the remeasurement of foreign exchange transactions and other miscellaneous income and expenses.
Results of Operations:
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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2024 |
2023 |
2024 |
2023 |
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(in thousands, except percentages) |
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Revenues |
$ | 1,650 | $ | 1,817 | $ | 5,356 | $ | 5,746 | ||||||||
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Cost of revenues |
1,224 | 1,429 | 4,209 | 4,117 | ||||||||||||
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Gross profit |
426 | 388 | 1,147 | 1,629 | ||||||||||||
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Gross margin |
26 | % | 21 | % | 21 | % | 28 | % | ||||||||
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Operating expenses: |
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Research and development |
1,086 | 1,044 | 3,052 | 3,388 | ||||||||||||
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Selling, general and administrative |
3,009 | 3,377 | 10,980 | 10,261 | ||||||||||||
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Total operating expenses |
4,095 | 4,421 | 14,302 | 13,649 | ||||||||||||
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Loss from operations |
(3,669 | ) | (4,033 | ) | (12,885 | ) | (12,020 | ) | ||||||||
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Interest expense, net |
(48 | ) | (455 | ) | (698 | ) | (1,292 | ) | ||||||||
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Other (expense) income, net |
11 | 12 | (2 | ) | 16 | |||||||||||
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Net loss and comprehensive loss |
$ | (3,706 | ) | $ | (4,476 | ) | $ | (13,585 | ) | $ | (13,296 | ) | ||||
Comparison of Three Months Ended September 30, 2024 and 2023
Revenues.
For the three months ended September 30, 2024, revenues decreased by approximately $0.2 million or 9% compared to the three months ended September 30, 2023. Revenues related to sales of our disposable catheters decreased by 9% to $1.5 million while revenues related to our Lightbox imaging console and other revenues decreased by $0.1 million. The decreased revenues reflects the impact of the reduced size of our field sales force, as well as a strategic decision we made in June 2024 to realign the focus of our sales force on driving the utilization at our current active user base in our strongest markets rather than on building new active users in other peripheral markets.
Cost of Revenues and Gross Margin.
For the three months ended September 30, 2024, cost of revenues decreased by $0.2 million or 14% compared to the three months ended June 30, 2023. This decrease was primarily attributable to fluctuations in inventory production and other ancillary expenditures. Stock-based compensation expense within cost of revenues totaled $36,000 for each the three months ended September 30, 2024 and 2023.
Gross margin for the three months ended September 30, 2024 increased to 26%, compared to 21% during the three months ended September 30, 2023. The increase in gross margin was primarily due to the decrease in cost of revenues driven by fluctuations in inventory production and other ancillary expenditures.
Research and Development Expenses.
R&D expense for the three months ended September 30, 2024 increased by less than $0.1 million or 4% compared to the three months ended June 30, 2023. The increase is primarily due to completion of our development efforts of Tigereye ST and Pantheris LV occurring during 2023 and ongoing product development of our coronary device program. Stock-based compensation expense within R&D totaled approximately $42,000 and $24,000 for the three months ended September 30, 2024 and 2023, respectively. We expect R&D expense to fluctuate based on the ongoing product development of our coronary device.
Selling, General and Administrative Expenses.
SG&A expense for the three months ended September 30, 2024 decreased by $0.4 million or 11%, compared to the three months ended September 30, 2023. This decrease was primarily attributable to decreases in headcount related to reduction in force from June 2024, third-party professional services and other ancillary expenses related to the administration of the special proxy resulting from the closing of the Zylox-Tonbridge transaction and other corporate, activities partially offset by increases of quality assurance expenses related to regulatory and compliance activities. Stock-based compensation expense within SG&A totaled $145,000 and $159,000 for the three months ended September 30, 2024 and 2023, respectively. We expect SG&A expense to decline based on the impact of the reduced size of our field sales force deployed within the United States, and other cost reduction measures we undertook in the strategic realignment in June 2024, potentially offset by fluctuations in revenues and consequently variable compensation, and other corporate activities that we undertake.
Interest Expense, Net.
Interest expense, net is comprised of interest expense net of interest income. Interest Expense, net for the three months ended September 30, 2024 decreased by approximately $0.4 million or 89% compared to the three months ended September 30, 2023, which resulted from lower PIK interest due to a smaller CRG loan balance resulting from the conversion of $11.0 million of principal and accrued interest in May 2024. This was partially offset by a decrease in interest income due to a lower average cash balance.
Other Income (Expense), Net.
Other income (expense), net primarily consists of gains and losses resulting from the remeasurement of foreign exchange transactions, which are typically a small percentage of transaction volume, and other miscellaneous income and expenses. Other income (expense), net for the three months ended September 30, 2024 remained relatively flat in comparison to the three months ended September 30, 2023 as both periods consisted primarily of remeasurement gains and losses from foreign exchange transactions resulting in nominal changes between periods..
Comparison of Nine Months Ended September 30, 2024 and 2023
Revenues.
For the nine months ended September 30, 2024, revenue decreased by approximately $0.4 million or 7% compared to the nine months ended September 30, 2023. Revenues related to sales of our disposable catheters decreased by 7% to $4.9 million while revenues related to our Lightbox imaging consoles and other revenues decreased by less than 1% to less than $0.1 million. The decreased revenues reflects the impact of the reduced size of our field sales force, as well as a strategic decision we made in June 2024 to realign the focus of our sales force on driving the utilization at our current active user base in our strongest markets rather than on building new active users in other peripheral markets.
Cost of Revenues and Gross Margin.
For the nine months ended September 30, 2024, cost of revenues increased by $0.1 million or 2% compared to the nine months ended September 30, 2023. This increase was primarily attributable fluctuations in labor costs and inventory production, increased material costs and other ancillary expenditures. Stock-based compensation expense within cost of revenues totaled $228,000 and $99,000 for the nine months ended September 30, 2024 and 2023, respectively.
Gross margin for the nine months ended September 30, 2024 decreased to 21%, compared to 28% during the nine months ended September 30, 2023. There are significant amounts of overhead costs, specifically in the form of labor, associated with manufacturing and production of inventory embedded in cost of revenues that will typically fluctuate due to the levels of inventory being produced, production schedule changes, lead times and other factors. The decrease in gross margin was primarily due to the decrease in the production levels of inventory and rising costs of materials. This decrease was compounded by the decrease in revenues which resulted in a decline in economies of scale.
Research and Development Expenses.
R&D expense for the nine months ended September 30, 2024 decreased by approximately $0.3 million or 10% compared to the nine months ended September 30, 2023. The decrease is primarily due to our efforts to complete development of Tigereye ST and Pantheris LV occurring during 2023 and reduced headcount, partially offset by ongoing product development of our coronary device program. Stock-based compensation expense within R&D totaled approximately $397,000 and $158,000 for the nine months ended September 30, 2024 and 2023, respectively. We expect R&D expense to fluctuate based on the ongoing product development of our coronary device.
Selling, General and Administrative Expenses.
SG&A expense for the nine months ended September 30, 2024 increased by $0.7 million or 7%, compared to the nine months ended September 30, 2023. This increase was primarily attributable to increases in third-party professional services and other ancillary expenses related to the consummation of the Zylox-Tonbridge transaction administration, the special proxy resulting from the closing of the Zylox-Tonbridge transaction, increases in franchise and other taxes, and other corporate activities. There were also increased allocations of quality assurance expenses related to regulatory and compliance activities. Stock-based compensation expense within SG&A totaled $900,000 and $446,000 for the nine months ended September 30, 2024 and 2023, respectively. We expect SG&A expense to decline based on the impact of the reduced size of our field sales force deployed within the United States, and other cost reduction measures we undertook in the strategic realignment in June 2024, potentially offset by fluctuations in revenues and consequently variable compensation, and other corporate activities that we undertake.
Interest Expense, Net.
Interest expense, net is comprised of interest expense net of interest income. Interest Expense, net for the nine months ended September 30, 2024 decreased by approximately $0.6 million or 46% compared to the nine months ended September 30, 2023, which resulted from lower PIK interest due to a smaller CRG loan balance resulting from the conversion of $11.0 million of principal and accrued interest in May 2024. This was partially offset by a decrease in interest income due to a lower average cash balance.
Other Income (Expense), Net.
Other income (expense), net primarily consists of gains and losses resulting from the remeasurement of foreign exchange transactions, which are typically a small percentage of transaction volume, and other miscellaneous income and expenses. Other income (expense), net for the nine months ended September 30, 2024 remained relatively flat in comparison to the nine months ended September 30, 2023 as both periods consisted primarily of remeasurement gains and losses from foreign exchange transactions, resulting in nominal changes between periods.
Liquidity and Capital Resources
As of September 30, 2024, we had cash and cash equivalents of $5.9 million and an accumulated deficit of $434.3 million, compared to cash and cash equivalents of $5.3 million and an accumulated deficit of $420.7 million as of December 31, 2023. We expect to incur losses for the foreseeable future. We believe that our cash and cash equivalents of $5.9 million at September 30, 2024 and expected revenues, debt and financing activities and funds from operations will be sufficient to allow us to fund our current operations through the end of the fourth quarter of 2024.
To date, we have financed our operations primarily through net proceeds from the issuance of our preferred stock, common stock and debt financings, our “at-the-market” program, our initial public offering (“IPO”), our follow-on public offerings and warrant issuances. We do not know when or if our operations will generate sufficient cash to fund our ongoing operations. We will need to raise additional capital through future equity or debt financings in the near future to meet our operational needs and capital requirements for product development, clinical trials and commercialization. Additional debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. Any additional debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders and require significant debt service payments, which divert resources from other activities. Additional financing may not be available at all, or if available, may not be in amounts or on terms acceptable to us. If we are unable to obtain additional financing, we may be required to delay the development, commercialization and marketing of our products and we may be required to significantly scale back our business and operations. In the event we determine that additional sources of liquidity will not be available to us or will not allow us to meet our obligations as they become due, we may need to file a voluntary petition for relief under the United States Bankruptcy Code in order to implement a restructuring plan or liquidation. Our financial statements for the three and nine months ended September 30, 2024 do not include any adjustments that might result from the outcome of this uncertainty.
Currently substantially all of our cash and cash equivalents are held at a single financial institution, First Citizens Bank, which acquired our prior banking partner, Silicon Valley Bank, in March 2023. On March 10, 2023, the Federal Deposit Insurance Corporation announced that Silicon Valley Bank had been closed by the California Department of Financial Protection and Innovation. While we have regained access to our accounts at Silicon Valley Bank, now a division of First Citizens Bank, we are evaluating our banking relationships, future disruptions of financial institutions where we bank or have credit arrangements, or disruptions of the financial services industry in general, that could adversely affect our ability to access our cash and cash equivalents. If we are unable to access our cash and cash equivalents as needed, our financial position and ability to operate our business will be adversely affected.
Equity Financings
March 2024 Financing
In connection with our the Strategic Collaboration, we entered into the Purchase Agreement with the Purchaser, pursuant to which the Purchaser agreed to purchase, in two tranches, up to an aggregate of $15 million in shares of our common stock, and shares of two new series of our preferred stock. On March 5, 2024, we issued to the Purchaser 75,327 shares of the common stock at a purchase price per share of $3.664, and 7,224 shares of a newly authorized Series F convertible preferred stock, par value $0.001 per share, for an aggregate purchase price of $7.5 million. Each share of Series F Preferred Stock has a stated value of $1,000 and is initially convertible into approximately 273 shares of common stock at a conversion price equal to the Purchase Price, subject to the terms of the Series F Certificate of Designation.
Upon completion of the Milestones, the Purchaser will invest an additional $7.5 million to purchase shares of our new Series G Preferred Stock. Each share of Series G Preferred Stock will have a stated value of $1,000 and will be convertible into shares of common stock at a conversion price of equal to the lowest of (x) the Purchase Price, (y) the closing price of the common stock on the date immediately preceding the Milestone Closing, and (z) the average closing price for the last five trading days preceding the Milestone Closing, provided that the conversion price will be no less than $0.20. There can be no guarantee that such Milestone Closing will occur.
June 2024 Offering
On June 13, 2024, we entered into a securities purchase agreement with two institutional investors for the issuance and sale of 3,614,457 shares of its common stock in the Offering at a purchase price of $1.66 per share, or pre-funded warrants in lieu thereof. We received aggregate net proceeds of approximately $5.2 million after underwriting discounts, commissions, legal and accounting fees, and other ancillary expenses.
As a result, we issued (i) 330,000 shares of common stock, and (ii) and Pre-Funded Warrants in lieu of common stock to purchase up to an aggregate of 3,284,457 shares of common stock. As of September 30, 2024, 2,417,000 Pre-Funded Warrants remained outstanding. On October 3, 2024, holders of Pre-Funded Warrants opted to exercise a total of 306,000 of their warrants into common stock leaving 2,111,000 remaining.
In addition, we issued to the investors in the Offering (i) Series A-1 Warrants to purchase up to an aggregate of 3,614,457 shares of common stock, (ii) Series A-2 Warrants to purchase up to an aggregate of 3,614,457 shares of common stock, and (iii) Series A-3 Warrants to purchase up to an aggregate of 3,614,457 shares of common stock. Each share of common stock or Pre-Funded Warrant was sold together with one Series A-1 Warrant to purchase one share of common stock, one Series A-2 Warrant to purchase one share of common stock, and one Series A-3 Warrant to purchase one share of common stock. Each Warrant has an exercise price of $1.66 per share.
The Series A-1 Warrants expire on the earlier of August 12, 2029 60 days following the public announcement by us of us receiving FDA clearance of second image-guided coronary device with a therapeutic indication other than diagnostic imaging or coronary CTO crossing. The Series A-2 Warrants expire on the earlier of August 12, 2026 60 days following the date of the public announcement us of the occurrence of us receiving 510(k) clearance of image-guided Coronary CTO crossing device. The Series A-3 Warrants expire on May 5, 2025 and 60 days following the date of the public announcement by us of the occurrence of us receiving FDA approval of image-guided Coronary CTOIDE application.
Pursuant to the Engagement Letter with the Placement Agent, we, in connection with the Offering, agreed to issue to the Placement Agent or its designeesPlacement Agent Warrants to purchase up to an aggregate of 216,867 shares of common stock. The Placement Agent Warrants have substantially the same terms as the Warrants issued and sold in the Offering, except that the Placement Agent Warrants have an exercise price of $2.075 per share and expire on June 13, 2029.
At The Market Offering Agreement
On May 20, 2022, we entered into ATM Agreement with the Agent pursuant to which we may offer and sell shares of common stock, par value $0.001 per share up to an aggregate offering price of $7,000,000 from time to time, in an at the market public offering. Sales of the Shares are to be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent. The Agent will receive a commission from us of 3.0% of the gross proceeds of any Shares sold under the ATM Agreement. The Shares sold under the ATM Agreement are offered and sold pursuant to our shelf registration statement on Form S-3, which was initially filed with the SEC on March 29, 2022 and declared effective on April 7, 2022, and a prospectus supplement and the accompanying prospectus relating to the At The Market Offering filed with the SEC on May 20, 2022. On August 3, 2022, we suspended sales under the ATM Agreement. On March 17, 2023, we reactivated the ATM Agreement. During the year ended December 31, 2023, we sold 607,241 shares of common stock at an average price of $9.01 per share for aggregate proceeds of approximately $5.5 million, of which approximately $164,000 was paid in the form of commissions to the Agent. There were no sales under the ATM Agreement during the nine months ended September 30, 2024. On October 17, 2024, the Company reactivated the ATM Agreement. During October and part of November 2024, the Company sold 107,080 shares of common stock pursuant to the ATM Agreement at an average price of $0.82 per share for aggregate proceeds of approximately $88,000, of which approximately $2,600 was paid in the form of commissions to the Agent While we may attempt additional sales in the future, there can be no assurance that we will be successful in acquiring additional funding through these means.
Other than the ATM Agreement, we currently do not have any commitment to obtain additional funds.
Contractual Obligations
Our principal obligations consist of the operating lease for our facility, our Loan Agreement with CRG and non-cancelable purchase commitments. The following table sets out, as of September 30, 2024, our contractual obligations due by period (in thousands):
|
Payments Due by Period |
||||||||||||||||||||
|
Less Than |
2 - 3 |
4-5 Years |
More |
Total |
||||||||||||||||
|
Operating lease obligations (1) |
$ | 1,267 | $ | 212 | $ | — | $ | — | $ | 1,479 | ||||||||||
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CRG Loan (2) |
— | 1,653 | 4,584 | — | 6,237 | |||||||||||||||
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Non-cancelable purchase commitments (3) |
686 | 11 | — | — | 697 | |||||||||||||||
| $ | 1,953 | $ | 1,876 | $ | 4,584 | $ | — | $ | 8,413 | |||||||||||
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(1) |
Operating lease obligations primarily consist of leased office, laboratory, and manufacturing space under a non-cancelable operating lease. In addition to the minimum future lease commitments presented above, the lease requires the Company to pay property taxes, insurance, maintenance, and repair costs. The lease will expire on November 30, 2025. |
|
(2) |
The total CRG Loan amount, shown as borrowings on the balance sheet as of September 30, 2024, is $4.2 million. The contractual obligation in the table above of $6.2 million under the CRG Loan includes future interest to be accrued but not paid in cash as well as a $2.1 million back-end fee to be paid in December 2028 upon maturity of the CRG Loan which is being accreted. For more information, see Part I, Item 1 “Unaudited Financial Statements, Note 4. Borrowings.” |
|
(3) |
Non-cancelable purchase commitments consist of agreements to purchase goods and services entered into in the ordinary course of business. |
CRG Loan
We have entered into several amendments to the Loan Agreement with CRG since September 2015. The Amendments, among other things: (1) extended the interest-only period through December 31, 2026; (2) extended the period during which we may elect to pay a portion of interest in payment-in-kind, or PIK, interest payments through December 31, 2026 so long as no Default (as defined in the Loan Agreement) has occurred and is continuing; (3) permitted us to make the entire interest payments in PIK interest payments through December 31, 2026 so long as no Default has occurred and is continuing; (4) extended the Stated Maturity Date (as defined in the Loan Agreement) to December 31, 2028; (5) reduced the minimum liquidity covenant to $3.5 million at all times; (6) eliminated the minimum revenue covenant for all years; (7) changed the date under the on-going stand-alone representation regarding no “Material Adverse Change” to December 31, 2020; (8) amended the on-going stand-alone representation and stand-alone Event of Default (as defined in the Loan Agreement) regarding Material Adverse Change such that any adverse change in or effect upon the revenue of us and our subsidiaries due to the outbreak of COVID-19 will not constitute a Material Adverse Change; (9) provided CRG with board observer rights, and (10) provide that the board observer may be appointed or removed by written notice from the Majority Lenders (as defined in the Loan Agreement). The total Loan amount under the Loan Agreement (the “CRG Loan”), shown as short-term borrowings on the balance sheet as of September 30, 2024, is $4.2 million. However, upon maturity of the obligations under the Loan Agreement in December 2028, we will be obligated to pay $6.2 million under the Loan Agreement, which includes future interest to be accrued but not paid in cash as well as a $2.1 million back-end fee to be paid in December 2028 upon maturity of the CRG Loan which is being accreted to the maturity date. Due to the substantial doubt about our ability to continue operating as a going concern and the “Material Adverse Change” clause under the Loan Agreement, the entire amount of outstanding borrowings at September 30, 2024 and December 31, 2023 is classified as current. CRG has not purported that any Event of Default (as defined in the Loan Agreement) has occurred as a result a “Material Adverse Change” under the Loan Agreement. Refer to Part 1, Item 1, “Unaudited Financial Statements,” Note 4 for additional details.
On January 26, 2024, we entered into Amendment No. 8 to the Loan Agreement with CRG, which reduces the minimum liquidity requirement of the Loan Agreement from $3.5 million to $1.0 million until April 1, 2024. Thereafter, we will be subject to the minimum liquidity requirement of $3.5 million.
As part of our Strategic Collaboration, we entered into Amendment No. 9 to the Loan Agreement with CRG, which amends the Loan Agreement to, among other things: (i) extend the interest-only period through December 31, 2026; (ii) provide that interest payable through December 31, 2026 may be payable in kind rather than in cash; and (iii) permit the payment of dividends on the preferred stock issued or issuable to the Purchaser.
On June 5, 2024, we entered into Amendment No. 10 to the Loan Agreement with CRG, which reduced the minimum liquidity requirement of the Loan Agreement from $3.5 million to $1.5 million for the period commencing June 1, 2024 and ending July 31, 2024. Thereafter, we will be subject to the minimum liquidity requirement of $3.5 million.
Lease Agreements
Our operating lease obligations primarily consist of leased office, laboratory, and manufacturing space under a non-cancelable operating lease. In addition to the minimum future lease commitments presented above, the lease requires us to pay property taxes, insurance, maintenance, and repair costs. Rent expense is recognized using the straight-line method over the term of the lease.
The lease will expire on November 30, 2025. We are obligated to pay a total of approximately $7.1 million in base rent payments through November 2025. The weighted average remaining lease term as of September 30, 2024 is 1.2 years.
On March 6, 2024, we entered into an amendment to the lease which extended the lease term for a period of one year, subsequent to the original expiration of November 30, 2024. As amended, the lease will expire on November 30, 2025. Under the terms of the amendment, we will be obligated to pay approximately $1.3 million in base rent payments through November 2025, beginning on December 1, 2024. This amendment also provides an optional one year extension of the lease following the end of the current term, as amended.
Cash Flows
|
Nine Months Ended September 30, |
||||||||
|
2024 |
2023 |
|||||||
|
(in thousands) |
||||||||
|
Net cash (used in) provided by: |
||||||||
|
Operating activities |
$ | (11,163 | ) | $ | (11,043 | ) | ||
|
Investing activities |
— | (8 | ) | |||||
|
Financing activities |
11,789 | 5,173 | ||||||
|
Net change in cash and cash equivalents |
$ | 626 | $ | (5,878 | ) | |||
Net Cash Used in Operating Activities
Net cash used in operating activities for the nine months ended September 30, 2024 was $11.2 million, consisting primarily of a net loss of $13.6 million and an increase in net operating assets of $0.4 million, partially offset by non-cash charges of $2.8 million. Non-cash charges primarily related to non-cash interest expense of $0.8 million and stock-based compensation of $1.5 million. The increase in net operating assets was primarily due to the increase in prepaid expenses and other current assets due to annual renewals of certain expenses, including insurance coming due; decrease in accrued compensation as certain bonuses relating to retention of key individuals and company-wide bonuses were paid; and a decrease in long-term liabilities relating to certain retention bonuses being reclassified to accrued compensation as they became due within less than one year. These increases were partially offset by a decline in inventory which include components and labor, in an effort to optimize inventory levels in anticipation of forecasted demand in light of extended lead times and shifting product mix primarily related to new product introductions of Tigereye ST and Pantheris LV.
Net cash used in operating activities for the nine months ended September 30, 2023 was $11.0 million, consisting primarily of a net loss of $13.3 million and an increase in net operating assets of $0.6 million, partially offset by non-cash charges of $2.8 million. Non-cash charges largely related to non-cash interest expense of $1.5 million, excess and obsolete charges related to inventory of $0.4 million, and stock-based compensation of $0.7 million. The increase in net operating assets was primarily due to investments in inventory, which include components and labor, in anticipation of (i) forecasted demand in light of extended lead times and (ii) building inventory in anticipation of the Tigereye ST and Pantheris LV product launches in the second half of 2023 and first half of 2024. These increases were partially offset by the increase in other long-term liabilities as certain variable compensation continues to accrue.
Net Cash Provided by Financing Activities
Net cash provided by financing activities for the nine months ended September 30, 2024 of $11.8 million relates to $7.0 million of proceeds, net of commissions and various issuance costs, from the issuance of preferred stock and common stock in the Private Placement in March 2024 and $5.2 million of proceeds, net of commissions and various issuance costs from the issuance of a combination of common stock and pre-funded warrants in June 2024. This was partially offset by the payment of approximately $0.4 million in satisfaction of certain tax obligations related to net share settlement on restricted stock awards vesting during the quarter.
Net cash provided by financing activities for the nine months ended September 30, 2023 of $5.2 million primarily relates to proceeds of approximately $5.2 million from the sale of common stock pursuant to the ATM Agreement, net of commissions and various issuance costs.
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ITEM 3. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Interest Rate Risk
The risk associated with fluctuating interest rates is primarily limited to our cash equivalents, which are carried at quoted market prices. Due to the short-term maturities and low risk profile of our cash equivalents, an immediate 100 basis point change in interest rates would not have a material effect on the fair value of our cash equivalents. We do not currently use or plan to use financial derivatives in our investment portfolio.
Credit Risk
As of September 30, 2024, our cash and cash equivalents were maintained with one financial institution in the United States, and our current deposits are in excess of insured limits. We have reviewed the financial statements of this institution and believe it has sufficient assets and liquidity to conduct its operations in the ordinary course of business with little or no credit risk to us.
Our accounts receivable primarily relate to revenues from the sale of our Lumivascular platform products to hospitals and medical centers in the United States. At September 30, 2024, there was one customer that represented 38% of the Company’s accounts receivable. At December 31, 2023, there was one customer that represented 24% of the Company’s accounts receivable.
Foreign Currency Risk
Our business is primarily conducted in U.S. dollars. Any transactions that may be conducted in foreign currencies are not expected to have a material effect on our results of operations, financial position or cash flows.
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ITEM 4. |
CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Securities Exchange Act of 1934, as amended, or the Exchange Act, and the rules and regulations thereunder, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
As required by Rule 13a-15(b) under the Exchange Act, our management, under the supervision and with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2024. Based on such evaluation, our principal executive officer and principal financial officer have concluded that, as of September 30, 2024, our disclosure controls and procedures were effective.
Changes in Internal Control over Financial Reporting
There were no changes in our internal controls over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three months ended September 30, 2024 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. |
OTHER INFORMATION |
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|
|
|
ITEM 1. |
LEGAL PROCEEDINGS |
None.
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ITEM 1A. |
RISK FACTORS |
Except as described below, there have been no material changes from the risk factors previously disclosed in our Annual Report on Form 10-K filed with the SEC on March 20, 2024.The disclosure of risks identified below does not imply that the risk has not already materialized.
Nasdaq may delist our securities from its exchange, which could harm our business and limit our stockholders’ liquidity.
Our common stock is currently listed on the Nasdaq Capital Market, which has qualitative and quantitative listing criteria. However, we cannot assure you that our common stock will continue to be listed on Nasdaq in the future. In order to continue listing our common stock on Nasdaq, we must maintain certain financial, distribution and stock price levels. Generally, we must maintain a minimum amount in stockholders’ equity, a minimum number of holders of our common stock and a minimum bid price.
On April 25, 2023, we received the Bid Price Deficiency Letter from Staff of The Nasdaq notifying us that we were not in compliance with the Bid Price Requirement, as the minimum bid price for our listed securities was less than $1.00 for the previous 30 consecutive business days. We had a period of 180 calendar days, or until October 23, 2023, to regain compliance with the rule referred to in this paragraph. As part of our efforts to regain compliance with the aforementioned rule, we effected a 1-for-15 reverse stock split on September 12, 2023.
On September 27, 2023, we received a letter from Nasdaq notifying us that the Staff had determined that the closing bid price of our common stock had been at $1.00 per share or greater for at least 10 consecutive business days and, accordingly, that we had regained compliance with the Bid Price Requirement. While we have regained compliance with the Bid Price Requirement, there can be no assurance that we will be able to maintain compliance with the Bid Price Requirement, or other continued listing requirements of Nasdaq, in the future.
As of the date of this quarterly report, the minimum bid price for our common stock has been below $1.00 for the previous 23 consecutive business days.
On May 18, 2023, we received the Stockholders’ Equity Deficiency Letter from the Staff that we no longer satisfied the Equity Requirement.
As with the Bid Price Deficiency Letter, the Stockholders’ Equity Deficiency Letter had no immediate effect on our continued listing on The Nasdaq Capital Market. In accordance with the Nasdaq Listing Rules, we were provided 45 calendar days, or until July 3, 2023, to submit a plan to regain compliance with the Equity Requirement. We submitted the Compliance Plan to Nasdaq on July 3, 2023. On July 31, 2023, we received a letter from Nasdaq notifying us that the Staff had determined to grant us an extension of 180 calendar days from the date of the Staff’s notice, or November 14, 2023, to regain compliance with the Equity Requirement.
On November 21, 2023, the Staff formally notified us that the Staff had determined that we were unable to demonstrate compliance with the Equity Requirement and that our securities would be delisted at the open of business on November 30, 2023, unless we timely requested a hearing before the Panel. On November 28, 2023, we requested and were granted a hearing before the Panel which took place on February 20, 2024. At the hearing, we presented a plan to regain and sustain compliance with the Equity Requirement and requested an extension to do so. On March 14, 2024, the results from the hearing were rendered in which we were granted an extension by the Panel. This extension stayed any further action by Nasdaq with respect to our continued listing until May 20, 2024.
On May 29, 2024, we were formally notified by Nasdaq that we have regained compliance with the stockholders’ equity requirement set forth in Nasdaq Listing Rule 5550(b)(1) and evidenced compliance with all other applicable criteria for continued listing on The Nasdaq Capital Market. Accordingly, the listing matter, which was reviewed by the Panel has been closed.
We will be subject to a “Mandatory Panel Monitor” as that term is defined in Nasdaq Listing Rule 5815(d)(4)(B), through May 29, 2025. If within the monitoring period we fail to evidence compliance with the Equity Requirement, we would not be allowed to provide to the Staff a plan to regain compliance with the Equity Requirement; rather, the Staff would be required to issue a delist determination. We would in that case have the opportunity to request a new hearing before the Panel, which request would stay any further action by the Staff.
We anticipate we will need to issue additional shares of capital stock through various other financing transactions in order to maintain compliance with the Equity Requirement, the most recent of which occurred in June 2024 in a best efforts public offering resulting in gross proceeds of $6.0 million. However, we may not be successful in executing such future transactions on terms favorable to us, or at all. In addition, there can be no guarantee that such efforts will succeed in helping us maintain compliance with the Nasdaq Listing Rules.
If Nasdaq delists our common stock from trading on its exchange and we are not able to list our securities on another national securities exchange, we expect our securities could be quoted on an over-the-counter market. If this were to occur, we could face significant material adverse consequences, including:
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● |
a limited availability of market quotations for our securities; |
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● |
reduced liquidity for our securities; |
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● |
a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities; |
|
● |
a limited amount of news and analyst coverage; and |
|
● |
a decreased ability to issue additional securities or obtain additional financing in the future. |
The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” If our common stock continues to be listed on NASDAQ, our common stock will be a covered security. Although the states are preempted from regulating the sale of our securities, the federal statute does allow the states to investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent activity, then the states can regulate or bar the sale of covered securities in a particular case.
There is substantial doubt about our ability to continue as a going concern, and we will need additional financing to execute our business plan, to fund our operations and to continue as a going concern, and, if we are unable to obtain additional financing, may be required to pursue a reorganization proceeding under applicable bankruptcy or insolvency laws, including under Chapter 11 of the U.S. Bankruptcy Code.
Since inception, we have experienced recurring operating losses and negative cash flows and we expect to continue to generate operating losses and consume significant cash resources for the foreseeable future. There is substantial doubt regarding our ability to continue as a going concern. Our independent registered public accounting firm has expressed in its auditors’ report on our 2023 financial statements, included our Annual Report on Form 10-K filed on March 20, 2024, an emphasis of matter paragraph relating to our ability to continue as a “going concern,” meaning that our recurring losses from operations and negative cash flows from operations raise substantial doubt regarding our ability to continue as a going concern. We have prepared our financial statements on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. Our financial statements do not include any adjustment to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty, with the exception that all borrowings are classified as current on the balance sheets.
Under the Loan Agreement with CRG, a “Material Adverse Change” or “Material Adverse Effect” (each as defined in the Loan Agreement) is an “Event of Default” thereunder, which gives Majority Lenders (as defined in the Loan Agreement) the right to declare amounts outstanding under the Loan Agreement immediately due and payable. Due to the substantial doubt about our ability to continue operating as a going concern and the Event of Default that could result due to a Material Adverse Change under the Loan Agreement, the entire amount of borrowings at September 30, 2024 and December 31, 2023 are classified as current. In addition, we may not be able to generate sufficient liquidity or revenue to satisfy minimum liquidity and minimum revenue covenants under the Loan Agreement. If we fail to satisfy such requirements, we will be in default under the Loan Agreement and all outstanding amounts under the Loan Agreement will become immediately due.
Majority Lenders have not purported that an Event of Default has occurred as a result of a Material Adverse Change or breach of other financial covenants. However, there can be no guarantee that Majority Lenders will not invoke such Event of Default in the future, or that we will not experience other Material Adverse Changes or other Material Adverse Effects, or otherwise breach our financial or other covenants under the Loan Agreement, that could give rise to an Event of Default under the Loan Agreement.
If we are unable to generate sufficient revenue and liquidity to service our debt, we may be required to pursue a reorganization proceeding under applicable bankruptcy or insolvency laws, including protection (“Bankruptcy Protection”) under Chapters 7 or 11 of the U.S. Bankruptcy Code. Holders of our common stock will likely not receive any value or payments in a restructuring or similar scenario.
In the event we pursue Bankruptcy Protection, we will be subject to the risks and uncertainties associated with such proceedings.
In the event we file for relief under the United States Bankruptcy Code, our operations, our ability to develop and execute our business plan and our continuation as a going concern will be subject to the risks and uncertainties associated with bankruptcy proceedings, including, among others: our ability to execute, confirm and consummate a plan of reorganization; the high costs of bankruptcy proceedings and related fees; our ability to obtain sufficient financing to allow us to emerge from bankruptcy and execute our business plan post-emergence, and our ability to comply with terms and conditions of that financing; our ability to continue our operations in the ordinary course; our ability to maintain our relationships with our customers, business partners, counterparties, employees and other third parties; our ability to obtain, maintain or renew contracts that are critical to our operations on reasonably acceptable terms and conditions; our ability to attract, motivate and retain key employees; the ability of third parties to use certain limited safe harbor provisions of the United States Bankruptcy Code to terminate contracts without first seeking Bankruptcy Court approval; and the actions and decisions of our stakeholders and other third parties who have interests in our bankruptcy proceedings that may be inconsistent with our operational and strategic plans. Any delays in our bankruptcy proceedings would increase the risks of our being unable to reorganize our business and emerge from bankruptcy proceedings and may increase our costs associated with the bankruptcy process or result in prolonged operational disruption for us. Also, we would need the prior approval of the bankruptcy court for transactions outside the ordinary course of business during the course of any bankruptcy proceedings, which may limit our ability to respond timely to certain events or take advantage of certain opportunities. Because of the risks and uncertainties associated with any bankruptcy proceedings, we cannot accurately predict or quantify the ultimate impact of events that could occur during any such proceedings. There can be no guarantees that if we seek Bankruptcy Protection, we will emerge from Bankruptcy Protection as a going concern or that holders of our common stock will receive any recovery from any bankruptcy proceedings.
In the event we are unable to pursue Bankruptcy Protection under Chapter 11 of the United States Bankruptcy Code, or, if pursued, successfully emerge from such proceedings, it may be necessary to pursue Bankruptcy Protection under Chapter 7 of the United States Bankruptcy Code for all or a part of our businesses.
In the event we are unable to pursue Bankruptcy Protection under Chapter 11 of the United States Bankruptcy Code, or, if pursued, successfully emerge from such proceedings, it may be necessary for us to pursue Bankruptcy Protection under Chapter 7 of the United States Bankruptcy Code for all or a part of our businesses. In such event, a Chapter 7 trustee would be appointed or elected to liquidate our assets for distribution in accordance with the priorities established by the United States Bankruptcy Code. We believe that liquidation under Chapter 7 would result in significantly smaller distributions being made to our stakeholders than those we might obtain under Chapter 11 primarily because of the likelihood that the assets would have to be sold or otherwise disposed of in a distressed fashion over a short period of time rather than in a controlled manner and as a going concern.
We may not be able to secure additional financing on favorable terms, or at all, to meet our future capital needs and our failure to obtain additional financing when needed could force us to delay, reduce or eliminate our product development programs and commercialization efforts or cause us to become insolvent.
Even though we received net proceeds of approximately $7.0 million from the sale of our common stock and Series F Convertible Preferred Stock in the Private Placement in March 2024 and $5.2 million from the sale of a combination of our common stock and Pre-Funded Warrants in a public offering in June 2024, we believe that our cash and cash equivalents at September 30, 2024, together with the aforementioned financing, debt and other financing activities and expected revenues from operations, will not be sufficient to satisfy our capital requirements and fund our operations beyond the fourth quarter of 2024. We will need to raise additional funds through future equity or debt financings in the near future to meet our operational needs and capital requirements for product development, clinical trials and commercialization. We can provide no assurance that we will be successful in raising funds pursuant to additional equity or debt financings or that such funds will be raised at prices that do not create substantial dilution for our existing stockholders. Given the volatility of our stock price, any financing that we undertake could cause substantial dilution to our existing stockholders. Macroeconomic challenges and volatility in capital markets could further limit our ability to raise capital when needed on terms favorable to us, or at all. In addition, while we have been able to raise capital from the sale of shares under our at-the-market program, the limitations under instruction I.B.6 of Form S-3, as well as possible low volume of trading in our securities, will limit our ability to continue raising funds through such program.
To date, we have financed our operations primarily through sales of our products and net proceeds from the issuance of our preferred stock and debt financings, our IPO, private offerings, strategic investment, and our follow-on public offerings of our securities. We do not know when or if our operations will generate sufficient cash to fund our ongoing operations. We cannot be certain that additional capital will be available as needed on acceptable terms, or at all. In the future, we may require additional capital in order to (i) continue to conduct research and development activities, (ii) conduct post-market clinical studies, as well as clinical trials to obtain regulatory clearances and approvals necessary to commercialize our Lumivascular platform products, (iii) expand our sales and marketing infrastructure, (iv) acquire complementary businesses technologies or products; or (v) respond to business opportunities, challenges, a decline in sales, increased regulatory obligations or unforeseen circumstances. Our future capital requirements will depend on many factors, including:
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● |
the degree of success we experience in commercializing our Lumivascular platform products, particularly Pantheris, Ocelot, Tigereye and any future versions of such products; |
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● |
the costs, timing and outcomes of clinical trials and regulatory reviews associated with our future products; |
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the costs and expenses of maintaining or expanding our sales and marketing infrastructure and our manufacturing operations; |
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the costs and timing of developing variations of our Lumivascular platform products and, if necessary, obtaining FDA clearance of such variations; |
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the costs and timing of developing our Coronary products, timing and outcomes of clinical trials and regulatory reviews associated with this product and eventual timing and expenses related to obtaining FDA clearance; |
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● |
the extent to which our Lumivascular platform is adopted by hospitals for use by interventional cardiologists, vascular surgeons and interventional radiologists in the treatment of PAD; |
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● |
the number and types of future products we develop and commercialize; |
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● |
the costs of defending ourselves against future litigation; |
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● |
the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; and |
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● |
the extent and scope of our general and administrative expenses. |
We may attempt to raise additional funds in equity or debt financings or enter into credit facilities in order to access funds for our capital needs. Any debt financing obtained by us in the future would cause us to incur additional debt service expenses and could include restrictive covenants relating to our capital raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital and pursue business opportunities. In addition, due to our current level of debt, future equity investors may require that we convert all or a portion of our debt to equity, and our debtholders may not agree to such terms. If we raise additional funds through further issuances of equity or convertible debt securities, and/or if we convert all or a portion of our existing debt to equity, our existing stockholders could suffer significant dilution in their percentage ownership of our company, and any new equity securities we issue could have rights, preferences and privileges senior to those of holders of our common stock.
If we are unable to obtain adequate financing or financing on terms satisfactory to us when we require it, we may terminate or delay the development of one or more of our products, delay clinical trials necessary to market our products, delay establishment of sales and marketing capabilities or other activities necessary to commercialize our products, and significantly scale back our operations, or we may become insolvent. In addition, as described above under the risk factor “Nasdaq may delist our securities from its exchange, which could harm our business and limit our stockholders’ liquidity,” if we are unable to raise capital in a manner accretive to our stockholders’ equity, our common stock could be delisted from Nasdaq. If this were to occur, our ability to continue to grow and support our business and to respond to business challenges could be significantly limited.
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
10b5-1 Trading Plans
During the second quarter of 2024, of our directors or executive officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement” (as each term is defined in Item 408(a) of Regulation S-K).
ITEM 6. EXHIBITS
The following exhibits are filed as part of, or incorporated by reference into, this Quarterly Report on Form 10-Q:
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Exhibit |
Exhibit Title |
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31.1* |
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31.2* |
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32.1*# |
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101.INS |
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
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101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
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101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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104 |
Cover Page Interactive Data File - the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
| # |
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The certifications filed as Exhibits 32.1 are not deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of the Company under the Securities Exchange Act of 1933 or the Securities Exchange Act of 1934, whether made before or after the date hereof irrespective of any general incorporation by reference language contained in any such filing, except to the extent that the registrant specifically incorporates it by reference. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Avinger, Inc. |
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(Registrant) |
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Date: November 7, 2024 |
/s/ JEFFERY M. SOINSKI |
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Jeffrey M. Soinski |
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Chief Executive Officer |
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(Principal Executive Officer) |
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Date: November 7, 2024 |
/s/ NABEEL SUBAINATI |
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Nabeel Subainati |
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Vice President, Finance |
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(Principal Financial and Accounting Officer) |