美國
證券交易委員會
華盛頓特區20549
表格
（標記一）
截至季度結束日期的財務報告
或者
過渡期間 對
委員會文件號
(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 公司成立或組織） |
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（IRS僱主 唯一識別號碼） |
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，（主要行政辦公地址） |
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(郵政編碼) |
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(註冊人電話號碼，包括區號)
在法案第12(b)條的規定下注冊的證券：
每種類別的證券 |
交易代碼 |
名稱爲每個註冊的交易所: |
請在以下方框內打勾，以指示註冊人是否（1）已在過去12個月內（或在註冊人需要提交此類報告的較短期間內）提交了交易所法案第13或15（d）條規定的所有要求提交的報告，並且（2）在過去90天內一直需要遵守提交要求。
☑ 否 ☐
請在勾選標誌處表示註冊人是否已經在過去12個月內（或者在註冊人要求提交這些文件的較短時期內）按照規則405 of協議S-T（本章節的§232.405）提交了每個交互式數據文件。 ☒ 沒有 ☐
發行普通股以供股票計劃、員工購股計劃
大型加速報告人 |
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加速文件提交人 |
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較小的報告公司 |
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新興成長公司 |
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如果是成長型企業，請在複選框中表示註冊人是否選擇不使用延長過渡期來符合根據1934年交易所法第13(a)條提供的任何新的或修訂的財務會計準則。
請在以下方框內打勾，以指示註冊人是否爲殼公司（如交易所法規第12b-2條規定）。 是 ☐ 否
截至2024年11月1日，有
思延喜斯股份有限公司。
10-Q表格季度報告
截至2024年9月30日季度結束
T能夠 內容
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頁面 |
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第 1 項。 |
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2 |
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3 |
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4 |
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第 2 項。 |
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第 3 項。 |
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26 |
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第 4 項。 |
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第 1 項。 |
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第 1A 項。 |
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第 6 項。 |
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28 |
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29 |
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第一部分. 財務財務信息
項目 1. 財務財務報表。
思延喜斯股份有限公司。
未經審計的簡明資產負債表彙編的合併資產負債表
（以千爲單位，除股份數和每股數據外）
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2024年9月30日 |
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2023年12月31日 |
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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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$ |
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$ |
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短期投資 |
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預付費用和其他流動資產 |
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許可協議應收款 |
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許可協議合同資產 |
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受限現金 |
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總流動資產 |
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投資 |
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延遲募資成本 |
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受限現金 |
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經營租賃使用權資產（見注7） |
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資產總額 |
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$ |
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$ |
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負債和股東權益 |
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流動負債: |
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應付賬款 |
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$ |
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$ |
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應計費用 |
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遞延收入，當期部分 |
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經營租賃負債，流動部分（詳見註釋7） |
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認股權負債 |
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可轉換債務和衍生負債（詳見註釋6） |
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流動負債合計 |
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遞延收入 |
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認股權負債 |
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可轉換債務和衍生負債（見註釋6） |
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經營租賃負債（見註釋7） |
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負債合計 |
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股東權益: |
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優先股，$0.0001 |
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普通股，每股面值爲 $0.0001； |
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額外實收資本 |
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累積赤字 |
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股東權益總額 |
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負債和股東權益總額 |
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$ |
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$ |
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財務報表的附註是不可或缺的組成部分。
1
思延喜斯股份有限公司。
未經審計的簡明合併財務報表損益表
（以千爲單位，除股份數和每股數據外）
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截至9月30日的三個月 |
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截至9月30日的九個月 |
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2024 |
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2023 |
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2024 |
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2023 |
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營業收入： |
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產品（損失）營業收入，淨額 |
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$ |
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許可協議營業收入 |
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總收入 |
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營業費用： |
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產品營業成本 |
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研發 |
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銷售、一般及行政費用 |
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營業費用總計 |
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（損失）營業利潤 |
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其他收入/費用： |
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債務發行成本和折扣攤銷 |
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利息收入 |
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利息支出 |
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權證負債公允值調整 |
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衍生負債公允價值調整 |
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其他費用(收益)合計 |
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稅前(損失)收入 |
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所得稅(受益)費用 |
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淨（虧損）利潤 |
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$ |
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$ |
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$ |
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$ |
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每股普通股股東應占基本淨（虧損）收益 |
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基本每股淨(損)利潤 |
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$ |
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每股攤薄後歸屬於普通股股東的淨（損益）收入 |
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攤薄每股淨(損)利潤 |
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$ |
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$ |
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$ |
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基本和稀釋普通股股份平均持有量 |
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Basic |
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Diluted |
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財務報表的附註是不可或缺的組成部分。
2
思延喜斯股份有限公司。
未經審計的簡明合併財務報表現金流量表
（以千爲單位）
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截至9月30日的九個月 |
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2024 |
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2023 |
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經營活動現金流量： |
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淨（虧損）利潤 |
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$ |
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重分類和其他項目 |
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折舊和攤銷 |
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股票補償費用 |
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投資折現的漸增 |
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債務發行成本和折扣攤銷 |
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權證負債公允價值變動 |
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衍生負債公允價值變動 |
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租賃資產的非現金營業租金支出 |
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註銷因承諾費用的遞延資產 |
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爲應付貸款支付的預付費 |
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經營性資產和負債變動: |
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預付費用、其他資產、延期費用及其他 |
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許可協議應收款 |
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許可協議合同資產 |
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應收賬款 |
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庫存 |
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應付賬款 |
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應計費用 |
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遞延收入 |
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其他負債和其他 |
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經營活動中提供的淨現金流量（流出） |
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投資活動現金流量： |
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投資購買 |
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投資到期收回 |
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投資活動產生的淨現金流量 |
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籌集資金的現金流量： |
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支付遞延發行成本 |
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貸款應付款項支付 |
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貸款應付款項預付費 |
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來自員工股票購買計劃發行的收益 |
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回購股份以支付稅款扣繳 |
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籌集資金的淨現金流量 |
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現金、現金等價物和限制性現金的淨減少額 |
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期初現金、現金等價物和受限制的現金餘額 |
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期末現金、現金等價物和受限制的現金餘額 |
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$ |
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補充現金流量信息： |
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支付的利息現金 |
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$ |
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獲得的利息現金 |
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$ |
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$ |
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非現金融資和投資活動: |
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包含在應付帳款中的推遲發行費用 |
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財務報表的附註是不可或缺的組成部分。
3
思延喜斯股份有限公司。
簡明財務報表註解
(未經審計)
1. 業務描述和準備基礎
組織形式
scynexis公司（"scynexis"或"公司"）是一家成立於1999年11月4日的特拉華州公司。scynexis是一家生物技術公司，總部設在新澤西州澤西市，致力於開發創新藥物以克服和預防難治性和耐藥性感染。該公司正在開發其專有的恩富馬氟吡嗪衍生抗真菌化合物類（"fungerps"），作爲廣譜、全身性抗真菌藥物，用於多種真菌感染指徵。ibrexafungerp是這一新型抗真菌藥物類別的第一個代表，還有來自"fungerp"家族的其他資產，包括處於臨床前階段的SCY-247。2021年6月，美國食品藥品監督管理局（"FDA"）批准了BREXAFEMME（ibrexafungerp片劑），用於治療女性陰道念珠菌病（"VVC"），又稱陰道酵母感染；2022年12月，該公司宣佈FDA批准了BREXAFEMME的第二適應症，用於減少復發陰道念珠菌病（"RVVC"）的發生率。
公司與葛蘭素史克知識產權（No. 3）有限公司（"GSK"）於2023年3月簽訂了許可協議（"GSK許可協議"），在該協議中，公司授予GSK獨家（包括對公司及其關聯公司的）可轉讓的專利許可，用於ibrexafungerp的開發和商業化，包括已批准的產品BREXAFEMME，適用於所有指徵，除了大中華及已授權給第三方的某些其他國家。
在GSK審核製造ibrexafungerp藥物物質的供應商的製造過程和設備後，公司得知，使用通用於製造ibrexafungerp的製造過程的設備製造了一種非抗菌β-內酰胺藥物物質。目前FDA的草案指南建議將製造非抗菌β-內酰胺化合物與其他化合物分開，因爲β-內酰胺化合物有潛在作爲致敏劑的可能性，可能會引發某些人的過敏或過敏反應。在缺乏建議的分離情況下，存在交叉污染的風險。目前尚不清楚ibrexafungerp是否受到β-內酰胺化合物的污染，公司也未收到由於可能的β-內酰胺交叉污染而導致的任何不良事件報告。儘管如此，出於謹慎起見，並遵循GSK的建議，公司已從市場上召回了BREXAFEMME®（ibrexafungerp片劑），並對包括第3期MARIO研究在內的ibrexafungerp的臨床研究進行了暫時保留。
臨床暫停和召回影響公司的兩項正在進行中的臨床研究：第3期MARIO研究和第1期哺乳研究。暫停不會影響已完成的FURI、CARES、VANQUISH和SCYNERGIA臨床研究。 FDA確定了ibrexafungerp的慈善使用計劃，該計劃爲患有有限或無其他治療選擇的患者提供ibrexafungerp，只要患者的治療醫生得出有利的效益-風險評估結論，並告知患者並同意風險即可繼續。這適用於目前在項目中的患者，以及新患者，在供應確認後可繼續。公司的臨床前階段化合物SCY-247不受這些變化影響。
患者級別和臨床產品召回仍在進行中，公司正在與經驗豐富的供應商合作管理這一過程。 2023年9月，在公司宣佈自願臨床暫停之後，FDA同意了公司的自願暫停並下令暫停。 公司正在解決此問題，並預計在FDA解除臨床暫停後，在2025年第一季度重新啓動MARIO研究。
公司截至2024年9月30日積累的赤字爲 $
4
changes to its operating plan. The accompanying unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. Intercompany balances and transactions are eliminated in consolidation.
Use of Estimates
The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates and judgments include: revenue recognition including gross to net estimates and the identification of performance obligations in licensing arrangements; estimates for the relative standalone selling price and measure of progress under the input method for the GSK License Agreement; estimates for product recall reserves; determination of the fair value of stock-based compensation grants; the estimate of services and effort expended by third-party research and development service providers used to recognize research and development expense; and the estimates and assumptions utilized in measuring the fair values of the warrant and derivative liabilities each reporting period.
Unaudited Condensed Consolidated Financial Information
The accompanying unaudited condensed consolidated financial statements and notes have been prepared in accordance with accounting principles generally accepted in the United States (“US GAAP”), as contained in the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (the “Codification” or “ASC”) for interim financial information. In the opinion of management, the interim financial information includes all adjustments of a normal recurring nature necessary for a fair presentation of the results of operations, financial position, and cash flows. The results of operations for the three and nine months ended September 30, 2024, are not necessarily indicative of the results for the full year or the results for any future periods. These unaudited condensed consolidated financial statements should be read in conjunction with the financial statements and notes set forth in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 28, 2024.
2. Summary of Significant Accounting Policies
The accompanying unaudited condensed consolidated financial statements and notes follow the same significant accounting policies as those described in the notes to the audited consolidated financial statements of the Company for the year ended December 31, 2023, except as described below.
Basic and Diluted Net (Loss) Income per Share of Common Stock
The Company calculates net (loss) income per common share in accordance with ASC 260, Earnings Per Share. Basic net (loss) income per common share for the three and nine months ended September 30, 2024 and 2023 was determined by dividing net (loss) income applicable to common stockholders by the weighted average number of common shares outstanding during the period. Per ASC 260, Earnings Per Share, the weighted average number of common shares outstanding utilized for determining the basic net (loss) income per common share for the three and nine months ended September 30, 2024 and 2023 includes the outstanding prefunded warrants to purchase
|
Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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||||
Net (loss) income allocated to common shares |
$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
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Dilutive effect of convertible debt |
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Net (loss) income allocated to common shares |
$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
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Weighted average common shares outstanding – basic |
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Dilutive effect of convertible debt |
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Dilutive effect of restricted stock units |
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Weighted average common shares outstanding – diluted |
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||||
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||||
Net (loss) income per share – diluted |
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
5
The following potentially dilutive shares of common stock and outstanding restricted stock units that contain certain performance contingencies have not been included in the computation of diluted net (loss) income per share for the three and nine months ended September 30, 2024 and 2023, as the result would be anti-dilutive or the performance contingencies have not been met:
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
2024 |
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2023 |
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2024 |
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2023 |
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||||
Outstanding stock options |
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Outstanding restricted stock units |
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Warrants to purchase common stock associated with December 2020 public offering - Series 2 |
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Warrants to purchase common stock associated with April 2022 public offering |
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Warrants to purchase common stock associated with Loan Agreement |
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Common stock associated with March 2019 Notes |
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Warrants to purchase common stock associated with Danforth |
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Total |
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Reclassification of Prior Year Amounts
Certain prior year amounts within the changes in operating assets and liabilities on the unaudited condensed consolidated statement of cash flows and certain prior year accrued expenses have been reclassified for consistency with the current year presentation.
Recently Adopted Accounting Pronouncements
In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options and Derivatives and Hedging—Contracts in Entity’s Own Equity: Accounting for Convertible Instruments and Contracts in and Entity’s Own Equity (“ASU 2020-06”). The amendments in ASU 2020-06 reduce the number of accounting models for convertible debt instruments and revises certain guidance relating to the derivative scope exception and earnings per share. The amendments in ASU 2020-06 are effective for public business entities that meet the definition of a SEC filer and a smaller reporting company for fiscal years beginning after December 15, 2023, and interim periods within those years. The Company
Recently Issued Accounting Pronouncements
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures, which introduced new guidance on disclosures for reportable segments and significant segment expenses, including for entities with a single reportable segment. This guidance is effective for the Company for annual reporting periods beginning January 1, 2024 and interim periods beginning January 1, 2025. As a smaller reporting company, the Company is currently evaluating the impact ASU 2023-07 will have on its consolidated financial statements.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740), Improvements to Income Tax Disclosures, which introduced new guidance on disclosures for income taxes, including enhancements to the rate reconciliation and income taxes paid disclosures. This guidance is effective for the Company for annual reporting periods beginning January 1, 2025. As a smaller reporting company, the Company is currently evaluating the impact ASU 2023-09 will have on its consolidated financial statements.
3. Investments
The following table summarizes the investments at September 30, 2024 (in thousands):
6
|
|
Amortized |
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Unrealized |
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Unrealized |
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Fair Value |
|
||||
As of September 30, 2024 |
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||||
Maturities < 1 Year |
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||||
Corporate bonds |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Agency bonds |
|
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||||
Total short-term investments |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
|
|
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|
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||||
Maturities > 1 Year |
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|
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|
||||
Corporate bonds |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Total investments |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
|
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||||
As of December 31, 2023 |
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||||
Maturities < 1 Year |
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||||
Corporate bonds |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Agency bonds |
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|
||||
Total short-term investments |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
|
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||||
Maturities > 1 Year |
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|
||||
Corporate bonds |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Total investments |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
4. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
||
Prepaid research and development services |
|
$ |
|
|
$ |
|
||
Prepaid insurance |
|
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||
Other prepaid expenses |
|
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|
||
Other current assets |
|
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|
||
Total prepaid expenses and other current assets |
|
$ |
|
|
$ |
|
||
5. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
||
Accrued research and development expenses |
|
$ |
|
|
$ |
|
||
Accrued employee bonus compensation |
|
|
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|
||
Other accrued expenses |
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|
||
Accrued product recall |
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|
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|
||
Total accrued expenses |
|
$ |
|
|
$ |
|
||
7
6. Borrowings
Loan Agreement
On May 13, 2021 (the “Closing Date”), the Company entered into the Loan and Security Agreement (the "Loan Agreement") with Hercules Capital, Inc. and Silicon Valley Bridge Bank, N.A. (as successor to Silicon Valley Bank) (the "Lenders") for an aggregate principal amount of $
In connection with the entering into of the GSK License Agreement, the Company entered into a First Amendment and Consent to Loan and Security Agreement with the Lenders pursuant to which the Lenders consented to the Company entering into the GSK License Agreement and the Company agreed to pay to the Lenders an amount equal to the sum of (i) all outstanding principal plus all accrued and unpaid interest with respect to the amounts loaned under the Loan Agreement (approximately $
March 2019 Note Purchase Agreement
On
As of September 30, 2024 and December 31, 2023, the Company’s March 2019 Notes consist of the convertible debt balance of $
7. Commitments and Contingencies
8
Leases
On March 1, 2018, the Company entered into a long-term lease agreement for approximately
The following table summarizes certain quantitative information associated with the amounts recognized in the unaudited condensed consolidated financial statements for the Lease (dollars in thousands):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Operating lease cost |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Variable lease cost |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total operating lease expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash paid for amounts included in the measurement of operating lease liability |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
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|
||||
|
|
|
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|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
||||
Remaining Lease term (years) |
|
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|
||||
Discount rate |
|
|
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|
|
|
|
|
% |
|
|
% |
||||
Future minimum lease payments for the Lease as of September 30, 2024 are as follows (in thousands):
|
|
September 30, 2024 |
|
|
2024 |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
2027 |
|
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|
2028 |
|
|
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Thereafter |
|
|
|
|
Total |
|
$ |
|
|
The presentations of the operating lease liability as of September 30, 2024 are as follows (in thousands):
|
|
September 30, 2024 |
|
|
Present value of future minimum lease payments |
|
$ |
|
|
|
|
|
|
|
Operating lease liability, current portion |
|
$ |
|
|
Operating lease liability, long-term portion |
|
|
|
|
Total operating lease liability |
|
$ |
|
|
|
|
|
|
|
Difference between future minimum lease payments and discounted cash flows |
|
$ |
|
|
License Arrangement with Potential Future Expenditures
As of September 30, 2024, the Company had a license arrangement with Merck Sharp & Dohme Corp., or Merck, as amended, that involves potential future expenditures. Under the license arrangement, executed in May 2013, the Company exclusively licensed from Merck its rights to ibrexafungerp in the field of human health. In January 2014, Merck assigned the patents related to ibrexafungerp that it had exclusively licensed to the Company. Ibrexafungerp is the Company's lead product candidate. Pursuant to the terms of the license agreement, Merck was originally eligible to receive milestone payments from the Company that could total $
9
drug application, and marketing approvals in each of the U.S., major European markets, and Japan. In addition, Merck is eligible to receive tiered royalties from the Company based on a percentage of worldwide net sales of ibrexafungerp. The aggregate royalties are mid- to high-single digits.
In December 2014, the Company and Merck entered into an amendment to the license agreement that deferred the remittance of a milestone payment due to Merck, such that no amount would be due upon initiation of the first Phase 2 clinical trial of a product containing the ibrexafungerp compound (the “Deferred Milestone”). The amendment also increased, in an amount equal to the Deferred Milestone, the milestone payment that would be due upon initiation of the first Phase 3 clinical trial of a product containing the ibrexafungerp compound. In December 2016 and January 2018, the Company entered into second and third amendments to the license agreement with Merck which clarified what would constitute the initiation of a Phase 3 clinical trial for the purpose of milestone payment. In January 2019, a milestone payment became due to Merck as a result of the initiation of the VANISH Phase 3 VVC program and was paid in March 2019. On December 2, 2020, the Company entered into a fourth amendment to the license agreement with Merck. The amendment eliminates two cash milestone payments that the Company would have paid to Merck upon the first filing of an NDA, triggered by the FDA acceptance for filing of the Company’s NDA for ibrexafungerp for the treatment of VVC, and first marketing approval in the U.S. Such cash milestone payments would have been creditable against future royalties owed to Merck on net sales of ibrexafungerp. With the amendment, these milestones will not be paid in cash and, accordingly, credits will not accrue. Pursuant to the amendment, the Company will also forfeit the credits against future royalties that it had accrued from a prior milestone payment already paid to Merck. All other key terms of the license agreement are unchanged.
Legal Proceedings
On November 7, 2023, a securities class action was filed by Brian Feldman against the Company and certain of the Company's executives in the United States District Court, District of New Jersey, alleging that, during the period from March 31, 2023 to September 22, 2023, the Company made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects, alleging specifically that the Company failed to disclose to investors: (1) that the equipment used to manufacture ibrexafungerp was also used to manufacture a non-antibacterial beta-lactam drug substance, presenting a risk of cross-contamination; (2) that the Company did not have effective internal controls and procedures, as well as adequate internal oversight policies to ensure that its vendor complied with current Good Manufacturing Practices (cGMP); (3) that, due to the substantial risk of cross-contamination, the Company were reasonably likely to recall its ibrexafungerp tablets and halt its clinical studies; and (4) as a result of the foregoing, the Company's statements about its business, operations, and prospects were materially misleading and/or lacked a reasonable basis. The complaint seeks unspecified damages, interest, fees and costs on behalf of all persons and entities who purchased and/or acquired shares of the Company's common stock between March 31, 2023 to September 22, 2023. On May 1, 2024, and again on June 4, 2024, purported shareholder derivative complaints were filed in the United States District Court, District of New Jersey. The complaints name the Company’s directors and certain of its officers and assert state and federal claims based on the same alleged misstatements as the securities class action complaint. The Company disagrees with the allegations and intends to defend these litigations vigorously and the Company has not recognized any expense for these contingencies.
8. Stockholders’ Equity
Authorized, Issued, and Outstanding Common Stock
The Company’s authorized common stock has a par value of $
10
The following table summarizes common stock share activity for the three and nine months ended September 30, 2024 and 2023 (dollars in thousands):
|
|
Three Months Ended September 30, 2024 |
|
|||||||||||||||||
|
|
Shares of |
|
|
Common |
|
|
Additional |
|
|
Accumulated |
|
|
Total |
|
|||||
Balance, June 30, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Net loss |
|
|
— |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
||
Stock-based compensation expense |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Common stock issued through employee stock purchase plan |
|
|
|
|
|
|
|
|
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|
|||||
Common stock issued for vested restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Balance, September 30, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
|
|
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|
|||||
|
|
Three Months Ended September 30, 2023 |
|
|||||||||||||||||
|
|
Shares of |
|
|
Common |
|
|
Additional |
|
|
Accumulated |
|
|
Total |
|
|||||
Balance, June 30, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Net loss |
|
|
— |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
||
Stock-based compensation expense |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Common stock issued through employee stock purchase plan |
|
|
|
|
|
|
|
|
|
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|
|
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|
|||||
Common stock issued for vested restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Balance, September 30, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
|
Nine Months Ended September 30, 2024 |
|
|||||||||||||||||
|
|
Shares of |
|
|
Common |
|
|
Additional |
|
|
Accumulated |
|
|
Total |
|
|||||
Balance, December 31, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Net loss |
|
|
— |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
||
Stock-based compensation expense |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Common stock issued through employee stock purchase plan |
|
|
|
|
|
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|
|
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|
|||||
Common stock issued for vested restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Balance, September 30, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
|
Nine Months Ended September 30, 2023 |
|
|||||||||||||||||
|
|
Shares of |
|
|
Common |
|
|
Additional |
|
|
Accumulated |
|
|
Total |
|
|||||
Balance, December 31, 2022 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Net income |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stock-based compensation expense |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Common stock issued through employee stock purchase plan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Common stock issued, net of expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Common stock issued for vested restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Balance, September 30, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
11
Shares Reserved for Future Issuance
The Company had reserved shares of common stock for future issuance as follows:
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
||
Outstanding stock options |
|
|
|
|
|
|
||
Outstanding restricted stock units |
|
|
|
|
|
|
||
Warrants to purchase common stock associated with December 2020 public offering - Series 2 |
|
|
|
|
|
|
||
Prefunded warrants to purchase common stock associated with December 2020 public offering |
|
|
|
|
|
|
||
Warrants to purchase common stock associated with April 2022 public offering |
|
|
|
|
|
|
||
Prefunded warrants to purchase common stock associated with April 2022 public offering |
|
|
|
|
|
|
||
Warrants to purchase common stock associated with Loan Agreement |
|
|
|
|
|
|
||
Warrant to purchase common stock associated with Danforth |
|
|
|
|
|
|
||
For possible future issuance for the conversion of the March 2019 Notes |
|
|
|
|
|
|
||
For possible future issuance under 2024 Plan (Note 9) |
|
|
|
|
|
|
||
For possible future issuance under employee stock purchase plan |
|
|
|
|
|
|
||
For possible future issuance under 2015 Plan (Note 9) |
|
|
|
|
|
|
||
Total common shares reserved for future issuance |
|
|
|
|
|
|
||
Warrants Associated with the December 2020 and April 2022 Public Offerings
The outstanding warrants associated with the December 2020 public offering contains a provision where the warrant holder has the option to receive cash, equal to the Black-Scholes fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). Due to this provision, ASC 480, Distinguishing Liabilities from Equity, requires that these warrants be classified as liabilities. The fair values of these warrants have been determined using the Black-Scholes valuation model, and the changes in the fair value are recorded in the accompanying unaudited condensed consolidated statements of operations. The outstanding warrants associated with the April 2022 public offering meet the definition of a derivative pursuant to ASC 815, Derivatives and Hedging, and do not meet the derivative scope exception given the warrants do not qualify under the indexation guidance. As a result, the April 2022 public offering warrants were initially recognized as liabilities and measured at fair value using the Black-Scholes valuation model. For the three months ended September 30, 2024 and 2023, the Company recognized gains of $
9. Stock-based Compensation
Pursuant to the terms of the Company’s 2014 Equity Incentive Plan (“2014 Plan”), on January 1, 2024 and 2023, the Company automatically added
2024 Equity Incentive Plan
In April 2024, the Company’s board of directors adopted the 2024 Equity Incentive Plan (“2024 Plan”), which was subsequently approved by the Company’s stockholders and became effective on June 19, 2024. The 2024 Plan is the successor to the 2014 Plan. The 2014 Plan terminated on February 11, 2024 and no new grants may be made under the 2014 Plan after that date, although all outstanding awards granted under the 2014 Plan will continue to be subject to the terms and conditions as set forth in the agreements evidencing such awards and the terms of the 2014 Plan. The purpose of the 2024 Plan is to allow the Company to utilize equity incentives in order to secure and retain the services of the Company's employees, directors, and consultants, and to provide long-term incentives that align the interests of the Company's employees, directors, and consultants with the interests of the Company's stockholders.
The aggregate number of shares of the Company's common stock that may be issued under the 2024 Plan will not exceed the sum of (i)
12
2015 Inducement Award Plan
As of September 30, 2024, there were
The activity for the Company’s 2024 Plan, 2014 Plan, and 2015 Plan, for the nine months ended September 30, 2024, is summarized as follows:
|
|
Number of |
|
|
Weighted- |
|
|
Weighted- |
|
|
Aggregate |
|
||||
Outstanding — December 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Forfeited/Cancelled |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Outstanding — September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable — September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested or expected to vest — September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Restricted stock unit (“RSU”) activity under the 2024 Plan, 2014 Plan, and 2015 Plan for the nine months ended September 30, 2024, is summarized as follows:
|
|
Number of |
|
|
Weighted |
|
||
Non-vested at December 31, 2023 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
$ |
|
||
Vested |
|
|
( |
) |
|
$ |
|
|
Forfeited |
|
|
( |
) |
|
$ |
|
|
Non-vested at September 30, 2024 |
|
|
|
|
$ |
|
||
The fair value of RSUs is based on the market price of the Company’s common stock on the date of grant. RSUs generally vest
Compensation Cost
The compensation cost that has been charged against income for stock awards was $
Stock-based compensation expense related to stock options is included in the following line items in the accompanying unaudited condensed consolidated statements of operations (in thousands):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Selling, general and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
13
10. Fair Value Measurements
The carrying amounts of certain financial instruments, including cash and cash equivalents, restricted cash, investments, accounts receivable, prepaid expenses and other current assets, accounts payable, and accrued expenses approximate their respective fair values due to the short-term nature of such instruments.
Assets and Liabilities Measured at Fair Value on a Recurring Basis
The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them for each reporting period. This determination requires significant judgments to be made.
|
|
|
|
|
Fair Value Hierarchy Classification |
|
||||||||||
|
|
Balance |
|
|
Quoted |
|
|
Significant |
|
|
Significant |
|
||||
September 30, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash |
|
$ |
|
|
$ |
|
|
|
|
|
|
|
||||
Restricted cash |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total assets |
|
$ |
|
|
$ |
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liabilities |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
||||
Total liabilities |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
December 31, 2023 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash |
|
$ |
|
|
$ |
|
|
|
|
|
|
|
||||
Restricted cash |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total assets |
|
$ |
|
|
$ |
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liabilities |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
||||
Derivative liability |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total liabilities |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
||||
The Company measures cash equivalents at fair value on a recurring basis. The fair value of cash equivalents is determined based on “Level 1” inputs, which consist of quoted prices in active markets for identical assets. As of September 30, 2024, the cash and cash equivalents of $
Level 3 financial liabilities consist of the warrant liabilities for which there is no current market such that the determination of fair value requires significant judgment or estimation. Changes in fair value measurements categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded as appropriate. The Company uses the Black-Scholes option valuation model to value the Level 3 warrant liabilities at inception and on subsequent valuation dates. This model incorporates transaction details such as the Company’s stock price, contractual terms, maturity, risk free rates, as well as volatility. The unobservable input for all of the Level 3 warrant liabilities includes volatility. The historical and implied volatility of the Company, using its closing common stock prices and market data, is utilized to reflect future volatility over the expected term of the warrants. At September 30, 2024, the Level 3 volatility utilized in the Black-Scholes model to fair value the warrant liability was
The Company uses the binomial lattice valuation model to value the Level 3 derivative liabilities at inception and on subsequent valuation dates. This model incorporates transaction details such as the Company’s stock price, contractual terms, dividend yield, risk-free rate, adjusted equity volatility, credit rating, market credit spread, and estimated effective yield. The unobservable inputs associated with the Level 3 derivative liabilities are adjusted equity volatility, market credit spread, and
14
estimated yield. As of December 31, 2023, these inputs were
A reconciliation of the beginning and ending balances for liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands):
|
|
|
Warrant Liabilities |
|
|
Balance – December 31, 2023 |
|
|
$ |
|
|
Gain adjustment to fair value |
|
|
|
( |
) |
Balance – September 30, 2024 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
Derivative Liability |
|
|
Balance – December 31, 2023 |
|
|
$ |
|
|
Gain adjustment to fair value |
|
|
|
( |
) |
Balance – September 30, 2024 |
|
|
$ |
|
|
11. Revenue
Product (Loss) Revenue, Net
Net product (loss) revenue was
The following table summarizes activity in each of the Company’s product revenue provision and allowance categories as of September 30, 2024 and 2023 (in thousands):
|
|
Discounts and Chargebacks (1) |
|
|
Product Returns (2) |
|
|
Rebates and Incentives (3) |
|
|
Product Recall (4) |
|
|
Total |
|
|||||
Balance as of December 31, 2023 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|||||
Provision related to current period revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Changes in estimate related to prior period revenue |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
||||
Credit/payments |
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
||
Balance as of September 30, 2024 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
|
Discounts and Chargebacks (1) |
|
|
Product Returns (2) |
|
|
Rebates and Incentives (3) |
|
|
Product Recall (4) |
|
|
Total |
|
|||||
Balance as of December 31, 2022 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|||||
Provision related to current period revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Changes in estimate related to prior period revenue |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
Credit/payments |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
Balance as of September 30, 2023 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|||||
15
License Agreement with GSK
On March 30, 2023, the Company entered into the GSK License Agreement. Pursuant to the terms of the GSK License Agreement, the Company granted GSK an exclusive (even as to the Company and its affiliates), royalty-bearing, sublicensable license for the development, manufacture, and commercialization of ibrexafungerp, including the approved product BREXAFEMME, for all indications, in all countries other than Greater China and certain other countries already licensed to third parties (the “GSK Territory”). If the existing licenses granted to or agreements with third parties are terminated with respect to any country, GSK will have an exclusive first right to negotiate with the Company to add those additional countries to the GSK Territory. The parties closed the transactions contemplated by the GSK License Agreement in May 2023.
As previously disclosed, the Company became aware that a non-antibacterial beta-lactam drug substance was manufactured using equipment common to the manufacturing process for ibrexafungerp. Current FDA draft guidance recommends segregating the manufacture of non-antibacterial beta-lactam compounds from other compounds since beta-lactam compounds have the potential to act as sensitizing agents that may trigger hypersensitivity or an allergic reaction in some people. In the absence of the recommended segregation, there is a risk of cross contamination. It is not known whether any ibrexafungerp has been contaminated with a beta-lactam compound. Nonetheless, in light of this risk and out of an abundance of caution, BREXAFEMME (ibrexafungerp tablets) was recalled from the market and clinical studies of ibrexafungerp were placed on temporary hold.
On December 26, 2023, the Company and GSK entered into a binding memorandum of understanding ("Binding MOU") for amendment to the GSK License Agreement. The GSK License Agreement was amended in connection with the delay in the commercialization of BREXAFEMME and further clinical development of ibrexafungerp associated with this event. Under the terms of the updated GSK License Agreement, as amended by Binding MOU, the Company is now eligible to receive potential:
•regulatory approval milestone payments of up to $
•commercial milestone payments of up to $
•and sales milestone payments of up to $
These milestones are based on annual net sales in the GSK Territory, with a total of $
The Company will continue to be responsible for the execution and costs of the ongoing clinical studies of ibrexafungerp but will have the potential to receive up to $
The Company evaluated the GSK License Agreement in accordance with ASC 606 as it includes a customer-vendor relationship as defined under ASC 606 and meets the criteria to be considered a contract. The Company assessed the terms of the GSK License Agreement and identified the following performance obligations which include: (1) the license for the development, manufacture, and commercialization of ibrexafungerp, including the approved product BREXAFEMME, in the GSK Territory, (2) the research and development activities for the MARIO study, and (3) performance obligations for the remaining research and development activities for the ongoing clinical and preclinical studies of ibrexafungerp. As of June 30, 2023, the Company provided all necessary information to GSK for it to benefit from the license under the license term.
16
Accordingly, for the nine months ended September 30, 2023, the Company recognized $
As of September 30, 2024 and December 31, 2023, the Company maintains a contract asset of $
The Company recognizes the revenue associated with the MARIO study and the remaining ongoing clinical and preclinical studies of ibrexafungerp over time using an input method. The input method is based on the actual costs incurred as a percentage of total budgeted costs towards satisfying the performance obligation as this method provides the most faithful depiction of the Company’s performance in transferring control of the services promised to GSK and represents the Company’s best estimate of the period of the obligation.
For the three months ended September 30, 2024 and 2023, the Company recognized $
License Agreement with Hansoh
In February 2021, the Company entered into an Exclusive License and Collaboration Agreement (the “Hansoh Agreement”) with Hansoh (Shanghai) Health Technology Co., Ltd., and Jiangsu Hansoh Pharmaceutical Group Company Limited (collectively, “Hansoh”), pursuant to which the Company granted to Hansoh an exclusive license to research, develop and commercialize ibrexafungerp in the Greater China region, including mainland China, Hong Kong, Macau, and Taiwan (the “Territory”). The Company also granted to Hansoh a non-exclusive license to manufacture ibrexafungerp solely for development and commercialization in the Territory. For the three and nine months ended September 30, 2024 and 2023, there was
17
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Operating results for the three and nine months ended September 30, 2024, are not necessarily indicative of results that may occur in future interim periods or future fiscal years. Some of the statements in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” are forward-looking statements. These forward-looking statements are based on management’s beliefs and assumptions and on information currently available to our management and involve significant elements of subjective judgment and analysis. Words such as “expects,” “will,” “anticipate,” “target,” “goal,” “intend,” “plan,” “seek,” “estimate,” “potential,” “should,” “could,” variations of such words, and similar expressions are intended to identify forward-looking statements. Our actual results and the timing of events may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a difference include those discussed under the heading “Risk Factors” in Item 1A of Part I of our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 28, 2024, and in Part II, Item 1A of this Quarterly Report on Form 10-Q. These and many other factors could affect our future financial and operating results. We undertake no obligation to update any forward-looking statement to reflect events after the date of this Quarterly Report on Form 10-Q. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this Quarterly Report on Form 10-Q. While we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into or review of, all relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely on these statements.
Overview
SCYNEXIS, Inc. is pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections. We are developing our proprietary antifungal platform “fungerps”, a novel class of antifungal agents called triterpenoids, that are a structurally distinct glucan synthase inhibitors and have generally shown in vitro and in vivo activity against a broad range of human fungal pathogens such as Candida and Aspergillus genera, including multidrug-resistant strains, as well as Pneumocystis, Coccidioides, Histoplasma and Blastomyces genera and in vivo activity against most common mucorales species.
Ibrexafungerp is the first representative of this novel class of antifungals. In June 2021 and December 2022, we announced that the United States (U.S.) Food and Drug Administration (FDA) approved BREXAFEMME (ibrexafungerp tablets) for treatment of patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection, and for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC), respectively. Oral ibrexafungerp is also under development for other systemic fungal diseases. SCY-247, a second-generation antifungal compound from this novel class, is in preclinical development stage. We anticipate initiating a Phase 1 study for SCY-247 in the fourth quarter of 2024.
The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to ibrexafungerp for the indications of VVC (including the prevention of recurrent VVC), invasive candidiasis (IC) (including candidemia), and invasive aspergillosis (IA), and has granted Orphan Drug designations for the IC and IA indications. The European Medicines Agency has granted Orphan Medicinal Product designation to ibrexafungerp for IC. We anticipate that the FDA may grant QIDP and Fast Track designations for the IV and oral formulations of SCY-247. These designations may provide us with additional market exclusivity and expedited regulatory paths.
In March 2023, we entered into a license agreement (the GSK License Agreement) with GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK) in which we granted GSK an exclusive (even as to us and our affiliates), royalty-bearing, sublicensable license for the development and commercialization of ibrexafungerp, including the approved product BREXAFEMME, for all indications, in all countries other than Greater China and certain other countries already licensed to third parties. In July 2024, we delivered to GSK the final clinical study reports for the completed FURI, CARES, and NATURE clinical studies and we received a $10.0 million development milestone in the third quarter of 2024. As of September 30, 2024, we have received $125.0 million in upfront and development milestones under the GSK License Agreement. See further details of the GSK License Agreement, including financial terms, as described in Note 11 of Item 1 on this Quarterly Report on Form 10-Q.
Product Recall and Clinical Hold
Following a review by GSK of the manufacturing process and equipment at the vendor that manufactures the ibrexafungerp drug substance, we became aware that a non-antibacterial beta-lactam drug substance was manufactured using equipment common to the manufacturing process for ibrexafungerp. Current FDA draft guidance recommends segregating the manufacture of non-antibacterial beta-lactam compounds from other compounds since beta-lactam compounds have the potential to act as sensitizing agents that may trigger hypersensitivity or an allergic reaction in some people. In the absence of the recommended segregation, there is a risk of cross contamination. It is not known whether any ibrexafungerp has been contaminated with a beta-lactam compound and we have not received any reports of adverse events due to the possible
18
beta-lactam cross contamination. Nonetheless, out of an abundance of caution and in line with GSK’s recommendation, we have recalled BREXAFEMME (ibrexafungerp tablets) from the market and placed a temporary hold on clinical studies of ibrexafungerp, including the Phase 3 MARIO study.
The patient-level and clinical product recall is ongoing and we are working with an experienced vendor to manage the process. In September 2023, after we announced our voluntary clinical hold, the FDA concurred with our voluntary hold and placed a clinical hold. We are working with the FDA to discuss paths for resolution of this issue. The clinical hold and recall affected two ongoing clinical studies: the Phase 3 MARIO study and a Phase 1 lactation study. The clinical hold does not impact the completed FURI, CARES, VANQUISH and SCYNERGIA clinical studies. The NATURE study, which is an observational study in patients with IC treated with standard of care antifungals (not ibrexafungerp), is also not affected by this hold. The FDA determined that the compassionate use program for ibrexafungerp, which provides ibrexafungerp to patients with limited or no other treatment options, can continue provided the patient’s treating physician concludes a favorable benefit-risk assessment and the patient is made aware of and consents to the risk. This applies to patients currently in the program as well as for new patients, pending confirmation of available supply. Our preclinical stage compound, SCY-247, is not affected by these developments.
In response to the hold on clinical studies of ibrexafungerp by the FDA due to possible beta-lactam cross contamination, we have entered into certain new manufacturing agreements with third-party contract manufacturers to begin producing new batches of ibrexafungerp which we believe will allow us to lift the clinical hold and restart our impacted clinical studies, the Phase 3 MARIO study and a Phase 1 lactation study. We are working on the resolution of this issue and we anticipate the restart of the MARIO study, after FDA's lifting of the clinical hold, in the first quarter of 2025.
Legal Proceedings
On November 7, 2023, a securities class action was filed by Brian Feldman against us and certain of our executives in the United States District Court, District of New Jersey, alleging that, during the period from March 31, 2023 to September 22, 2023, we made materially false and/or misleading statements, as well as failed to disclose material adverse facts about our business, operations, and prospects, alleging specifically that we failed to disclose to investors: (1) that the equipment used to manufacture ibrexafungerp was also used to manufacture a non-antibacterial beta-lactam drug substance, presenting a risk of cross-contamination; (2) that we did not have effective internal controls and procedures, as well as adequate internal oversight policies to ensure that its vendor complied with current Good Manufacturing Practices (cGMP); (3) that, due to the substantial risk of cross-contamination, we were reasonably likely to recall its ibrexafungerp tablets and halt its clinical studies; and (4) as a result of the foregoing, our statements about our business, operations, and prospects were materially misleading and/or lacked a reasonable basis. The complaint seeks unspecified damages, interest, fees and costs on behalf of all persons and entities who purchased and/or acquired shares of our common stock between March 31, 2023 to September 22, 2023. On May 1, 2024, and again on June 4, 2024, purported shareholder derivative complaints were filed in the United States District Court, District of New Jersey. The complaints name our directors and certain of our officers and assert state and federal claims based on the same alleged misstatements as the securities class action complaint. We disagree with the allegations and intend to defend these litigations vigorously.
Repaid Loan Agreement
We, Hercules Capital, Inc. (Hercules Capital) and Silicon Valley Bridge Bank, N.A. (now a division of First Citizens Bank, SVB) were parties to a Loan and Security Agreement dated as of May 13, 2021 (the Loan Agreement), pursuant to which Hercules Capital, SVB and each of the other lenders from time-to-time party to the Loan Agreement (collectively, the Lenders) loaned to us $35 million. In connection with the entering into of the License Agreement, we entered into a First Amendment and Consent to Loan and Security Agreement with the Lenders pursuant to which the Lenders consented to us entering into the License Agreement and we agreed to pay to the Lenders an amount equal to the sum of (i) all outstanding principal plus all accrued and unpaid interest with respect to the amounts loaned under the Loan Agreement (approximately $35.4 million), (ii) the prepayment fee payable under Loan Agreement ($262,500), (iii) the final payment payable under Loan Agreement ($1,382,500), and (iv) all other sums, if any, that shall have become due and payable with respect to loan advances under the Loan Agreement. These payments became due upon the earliest of (A) one business day following receipt by us of the $90 million upfront payment payable to us under the License Agreement, (B) June 1, 2023, or (C) the termination of the License Agreement.
Following the closing of the transactions under the GSK License Agreement, in May 2023, we received the upfront payment pursuant to the terms of the GSK License Agreement, which triggered the obligation of us to repay the amounts due under the terms of the First Amendment. In connection with the repayment of those amounts due, in May 2023, we and the Lenders executed a payoff letter confirming the amounts due under the First Amendment, and our confirmation that the Loan Agreement, as amended by the First Amendment, was terminated.
19
Liquidity
We have operated as a public entity since we completed our initial public offering in May 2014, which we refer to as our IPO. We also completed a follow-on public offering of our common stock in April 2015 and public offerings of our common stock and warrants in June 2016, March 2018, December 2019, December 2020, and April 2022. Our principal source of liquidity is cash, cash equivalents, and investments which totaled $84.9 million as of September 30, 2024.
As of September 30, 2024, our accumulated deficit was $372.1 million. We expect we will continue to incur significant research and development expense as we continue to execute our research and drug development strategy. Consistent with our operating plan, we also expect that we will continue to incur significant selling, general and administrative expenses to support our public reporting company operations and ongoing operations. As a result, we will need additional capital to fund our operations, which we may obtain through one or more of equity offerings, debt financings, other non-dilutive third-party funding (e.g., grants), strategic alliances and licensing or collaboration arrangements. We may offer shares of our common stock pursuant to our effective shelf registration statements.
Collaborations and Licensing Agreements
We are party to a number of licensing and collaboration agreements with partners in human health, including: (1) GSK, a pharmaceutical company, which we exclusively (even as to us and our affiliates) provide a, royalty-bearing, sublicensable license for the development, manufacture, and commercialization of ibrexafungerp, including the approved product BREXAFEMME, for all indications, in the GSK Territory; (2) Merck, a pharmaceutical company, under which we exclusively licensed the rights to ibrexafungerp in the field of human health, and agreed to pay Merck milestones upon the occurrence of specified events as well as tiered royalties based on worldwide sales of ibrexafungerp when and if it is approved (in 2014, Merck assigned to us the patents related to ibrexafungerp that it had exclusively licensed to us and, as contemplated by the agreement, we will continue to pay milestones and royalties); (3) Hansoh, a pharmaceutical company, which we exclusively provide a license from us to research, develop and commercialize ibrexafungerp in the Greater China region, including mainland China, Hong Kong, Macau, and Taiwan, under which we are entitled to receive development and commercial milestones and royalties; (4) R-Pharm, CJSC, or "R-Pharm," a leading supplier of hospital drugs in Russia, granting it exclusive rights in the field of human health to develop and commercialize ibrexafungerp in Russia and several non-core markets, under which we are entitled to receive potential milestones and royalties and reimbursement for certain development costs incurred by us (this agreement is not material to our unaudited condensed consolidated balance sheets, statements of operations, or statements of cash flows); (5) Waterstone, an international pharmaceutical business, granting Waterstone exclusive worldwide rights to development and commercialization of SCY-635 for the treatment of viral diseases in humans, under which we are entitled to receive potential milestones and royalties; and (6) Cypralis Limited, or "Cypralis," a life sciences company, transferring to it certain cyclophilin inhibitor assets of ours, under which we are eligible to receive milestone payments upon the successful progression of certain Cypralis clinical candidates into later stage clinical studies and royalties payable upon product commercialization.
Components of Operating Results
Revenue
Revenue consists of license agreement revenue associated with GSK and product sales of BREXAFEMME. For the three and nine months ended September 30, 2023, our product (loss) revenue, net comprised of sales of BREXAFEMME that we sold as principal given we control BREXAFEMME product until delivery to our wholesalers at which point control is transferred.
Cost of Product Revenue
Cost of product revenue consists primarily of distribution, freight expenses, royalties due to Merck, and other manufacturing costs associated with BREXAFEMME.
Research and Development Expense
Research and development expense consists of expenses incurred while performing research and development activities to discover, develop, or improve potential product candidates we seek to develop. This includes conducting preclinical studies and clinical trials, manufacturing and other development efforts, and activities related to regulatory filings for product candidates. We recognize research and development expenses as they are incurred. Our research and development expense primarily consists of:
20
Ibrexafungerp and SCY-247 were the only key research and development project during the periods presented. We expect to continue to incur significant research and development expense for the foreseeable future as we continue our effort to develop ibrexafungerp and SCY-247, and to potentially develop our other product candidates, subject to the availability of additional funding.
The successful development of product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs required to complete the remaining development of any product candidates. This is due to the numerous risks and uncertainties associated with the development of product candidates.
Selling, General and Administrative Expense
Selling, general and administrative expense consists primarily of salaries and personnel-related costs, including employee benefits and any stock-based compensation. This includes personnel in executive, finance, human resources, business development, medical affairs, marketing and commercial, and administrative support functions. Other expenses include facility-related costs not otherwise allocated to research and development expense, professional fees for accounting, auditing, tax and legal services, consulting costs for general and administrative purposes, information systems and marketing efforts.
Other Expense (Income)
All of our other expense (income) recognized in the three and nine months ended September 30, 2024 and 2023, consists of amortization of debt issuance costs and discount, interest income, interest expense, the warrant liabilities fair value adjustment, and the derivative liabilities fair value adjustment.
Income Tax (Benefit) Expense
For the three and nine months ended September 30, 2024, our income tax (benefit) expense recognized consists primarily of a (benefit) expense for U.S. federal income tax.
Results of Operations for the Three Months Ended September 30, 2024 and 2023
The following table summarizes our results of operations for the three months ended September 30, 2024 and 2023, together with the changes in those items in dollars and percentage (dollars in thousands):
|
|
Three Months Ended September 30, |
|
|
|||||||||||||
|
|
2024 |
|
|
2023 |
|
|
Period-to-Period Change |
|
|
|||||||
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product (loss) revenue, net |
|
$ |
— |
|
|
$ |
(614 |
) |
|
$ |
614 |
|
|
|
(100.0 |
) |
% |
License agreement revenue |
|
|
660 |
|
|
|
2,375 |
|
|
|
(1,715 |
) |
|
|
(72.2 |
) |
% |
Total revenue |
|
|
660 |
|
|
|
1,761 |
|
|
|
(1,101 |
) |
|
|
(62.5 |
) |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of product revenue |
|
|
— |
|
|
|
379 |
|
|
|
(379 |
) |
|
|
(100.0 |
) |
% |
Research and development |
|
|
8,073 |
|
|
|
6,466 |
|
|
|
1,607 |
|
|
|
24.9 |
|
% |
Selling, general and administrative |
|
|
2,907 |
|
|
|
5,014 |
|
|
|
(2,107 |
) |
|
|
(42.0 |
) |
% |
Total operating expenses |
|
|
10,980 |
|
|
|
11,859 |
|
|
|
(879 |
) |
|
|
(7.4 |
) |
% |
Loss from operations |
|
|
(10,320 |
) |
|
|
(10,098 |
) |
|
|
(222 |
) |
|
|
2.2 |
|
% |
Other (income) expense: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Amortization of debt issuance costs and discount |
|
|
441 |
|
|
|
360 |
|
|
|
81 |
|
|
|
22.5 |
|
% |
Interest income |
|
|
(1,020 |
) |
|
|
(1,263 |
) |
|
|
243 |
|
|
|
(19.2 |
) |
% |
Interest expense |
|
|
213 |
|
|
|
212 |
|
|
|
1 |
|
|
|
0.5 |
|
% |
Warrant liabilities fair value adjustment |
|
|
(6,751 |
) |
|
|
(7,468 |
) |
|
|
717 |
|
|
|
(9.6 |
) |
% |
Derivative liabilities fair value adjustment |
|
|
— |
|
|
|
(182 |
) |
|
|
182 |
|
|
|
(100.0 |
) |
% |
Total other income |
|
|
(7,117 |
) |
|
|
(8,341 |
) |
|
|
1,224 |
|
|
|
(14.7 |
) |
% |
Loss before taxes |
|
|
(3,203 |
) |
|
|
(1,757 |
) |
|
|
(1,446 |
) |
|
|
82.3 |
|
% |
Income tax benefit |
|
|
(395 |
) |
|
|
— |
|
|
|
(395 |
) |
|
|
— |
|
% |
Net loss |
|
$ |
(2,808 |
) |
|
$ |
(1,757 |
) |
|
$ |
(1,051 |
) |
|
|
59.8 |
|
% |
21
Revenue. For the three months ended September 30, 2024 and 2023, revenue primarily consists of $0.7 million and $2.4 million, respectively, in license agreement revenue associated with the GSK License Agreement.
Cost of Product Revenue. Cost of product revenue for the three months ended September 30, 2023 consists primarily of distribution, freight, and royalty costs associated with BREXAFEMME.
Research and Development. For the three months ended September 30, 2024, research and development expenses increased to $8.1 million compared to $6.5 million for the three months ended September 30, 2023. The increase of $1.6 million, or 25%, for the three months ended September 30, 2024, was primarily driven by an increase of $2.2 million in chemistry, manufacturing, and controls (CMC) expense, an increase of $0.9 million in preclinical expense, and a net increase in other research and development expense of $0.4 million, offset in part by a decrease of $1.6 million in clinical expense and a decrease of $0.3 million in salaries primarily associated with medical affairs.
The $2.2 million increase in CMC expense is primarily associated with a $2.1 million increase in expense associated with the manufacturing of drug product for SCY-247 and ibrexafungerp. The $0.9 million increase in preclinical expense was primarily associated with certain preclinical costs associated with the continued development of SCY-247. The $1.6 million decrease in clinical expense was primarily due to a $1.4 million decrease in clinical expense for the Phase 3 MARIO study and a $0.2 million decrease in clinical expense associated with the Phase 1 lactation study.
Selling, General & Administrative. For the three months ended September 30, 2024, selling, general and administrative expenses decreased to $2.9 million from $5.0 million for the three months ended September 30, 2023. The decrease of $2.1 million, or 42%, for the three months ended September 30, 2024, was primarily driven by a decrease of $1.5 million in professional fees and a decrease of $0.5 million in commercial expense due to the costs incurred in the prior period associated with BREXAFEMME. The $1.5 million decrease in professional fees was primarily due to a $0.8 million nonrecurring legal expense incurred in the prior period.
Amortization of Debt Issuance Costs and Discount. For both the three months ended September 30, 2024 and 2023, we recognized $0.4 million in amortization of debt issuance costs and discount. The debt issuance costs and discount for our March 2019 convertible notes primarily consisted of an allocated portion of advisory fees and other issuance costs and the initial fair value of the derivative liability.
Interest Income. For the three months ended September 30, 2024 and 2023, we recognized $1.0 million and $1.3 million, respectively, in interest income on our money market funds and investments.
Interest Expense. For both the three months ended September 30, 2024 and 2023, we recognized $0.2 million in interest expense on our March 2019 convertible notes.
Warrant Liabilities Fair Value Adjustment. For the three months ended September 30, 2024 and 2023, we recognized gains of $6.8 million and $7.5 million, respectively, in the fair value adjustment related to the warrant liabilities primarily due to the decrease in our stock price during the periods.
Derivative Liabilities Fair Value Adjustment. For the three months ended September 30, 2023, we recognized a gain of $0.2 million in the fair value adjustment related to the derivative liability primarily due to the decrease in our stock price during the period.
Income Tax Benefit. For the three months ended September 30, 2024, we recognized a $0.4 million income tax benefit for U.S. federal income tax.
22
Results of Operations for the Nine Months Ended September 30, 2024 and 2023
The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023, together with the changes in those items in dollars and percentage (dollars in thousands):
|
|
Nine Months Ended September 30, |
|
|
|||||||||||||
|
|
2024 |
|
|
2023 |
|
|
Period-to-Period Change |
|
|
|||||||
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product revenue, net |
|
$ |
— |
|
|
$ |
984 |
|
|
$ |
(984 |
) |
|
|
(100.0 |
) |
% |
License agreement revenue |
|
|
2,769 |
|
|
|
133,360 |
|
|
|
(130,591 |
) |
|
|
(97.9 |
) |
% |
Total revenue |
|
|
2,769 |
|
|
|
134,344 |
|
|
|
(131,575 |
) |
|
|
(97.9 |
) |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of product revenue |
|
|
— |
|
|
|
940 |
|
|
|
(940 |
) |
|
|
(100.0 |
) |
% |
Research and development |
|
|
22,091 |
|
|
|
20,342 |
|
|
|
1,749 |
|
|
|
8.6 |
|
% |
Selling, general and administrative |
|
|
9,742 |
|
|
|
17,328 |
|
|
|
(7,586 |
) |
|
|
(43.8 |
) |
% |
Total operating expenses |
|
|
31,833 |
|
|
|
38,610 |
|
|
|
(6,777 |
) |
|
|
(17.6 |
) |
% |
(Loss) income from operations |
|
|
(29,064 |
) |
|
|
95,734 |
|
|
|
(124,798 |
) |
|
|
(130.4 |
) |
% |
Other expense (income): |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Amortization of debt issuance costs and discount |
|
|
1,262 |
|
|
|
2,616 |
|
|
|
(1,354 |
) |
|
|
(51.8 |
) |
% |
Interest income |
|
|
(3,422 |
) |
|
|
(2,590 |
) |
|
|
(832 |
) |
|
|
32.1 |
|
% |
Interest expense |
|
|
617 |
|
|
|
2,908 |
|
|
|
(2,291 |
) |
|
|
(78.8 |
) |
% |
Warrant liabilities fair value adjustment |
|
|
(10,598 |
) |
|
|
5,991 |
|
|
|
(16,589 |
) |
|
|
(276.9 |
) |
% |
Derivative liabilities fair value adjustment |
|
|
(196 |
) |
|
|
182 |
|
|
|
(378 |
) |
|
|
(207.7 |
) |
% |
Total other (income) expense |
|
|
(12,337 |
) |
|
|
9,107 |
|
|
|
(21,444 |
) |
|
|
(235.5 |
) |
% |
(Loss) income before taxes |
|
|
(16,727 |
) |
|
|
86,627 |
|
|
|
(103,354 |
) |
|
|
(119.3 |
) |
% |
Income tax expense |
|
|
128 |
|
|
|
— |
|
|
|
128 |
|
|
|
— |
|
% |
Net (loss) income |
|
$ |
(16,855 |
) |
|
$ |
86,627 |
|
|
$ |
(103,482 |
) |
|
|
(119.5 |
) |
% |
Revenue. For the nine months ended September 30, 2024, revenue consists of the $2.8 million in license agreement revenue associated with the GSK License Agreement. For the nine months ended September 30, 2023, revenue primarily consists of the $130.1 million recognized upon the transfer of the license associated with the GSK License Agreement in May 2023.
Cost of Product Revenue. Cost of product revenue for the nine months ended September 30, 2023 consists primarily of distribution, freight, and royalty costs associated with BREXAFEMME.
Research and Development. For the nine months ended September 30, 2024, research and development expenses increased to $22.1 million compared to $20.3 million for the nine months ended September 30, 2023. The increase of $1.7 million, or 9%, for the nine months ended September 30, 2024, was primarily driven by an increase of $4.4 million in CMC expense and an increase of $1.8 million in preclinical expense, offset in part by a decrease of $3.5 million in clinical expense and a decrease of $1.0 million in salaries primarily associated with medical affairs.
The $4.4 million increase in CMC expense is primarily associated with a $1.5 million expense for drug product purchased in the current period and a $2.6 million increase in expense associated with the manufacturing of drug product for SCY-247 and ibrexafungerp. The $1.8 million increase in preclinical expense was primarily associated with certain preclinical costs associated with the continued development of SCY-247. The $3.5 million decrease in clinical expense was primarily due to a $2.2 million decrease in clinical expense for the Phase 3 MARIO study, a $0.8 million decrease in expense associated with a Phase 1 study of oral ibrexafungerp that was substantially completed in the prior period and is intended to support the potential NDA filing for the treatment of IC, and a $0.6 million decrease in clinical expense associated with the Phase 1 lactation study.
Selling, General & Administrative. For the nine months ended September 30, 2024, selling, general and administrative expenses decreased to $9.7 million from $17.3 million for the nine months ended September 30, 2023. The decrease of $7.6 million, or 44%, for the nine months ended September 30, 2024, was primarily driven by a decrease of $5.7 million in professional fees, a decrease of $1.2 million in commercial expense due to the costs incurred in the prior period associated with BREXAFEMME, and a net decrease of $0.7 million in other selling, general, and administrative expense. The $5.7 million decrease in professional fees was primarily due to a $3.1 million expense incurred during the prior period for business development associated with the GSK License Agreement, a $0.8 million nonrecurring legal expense incurred in the prior period, a $0.7 million decrease in legal costs associated with the GSK License Agreement, and a $0.5 million expense recognized in the prior period to write off a deferred asset for certain commitment fees associated with the Loan Agreement.
Amortization of Debt Issuance Costs and Discount. For the nine months ended September 30, 2024 and 2023, we recognized $1.3 million and $2.6 million in amortization of debt issuance costs and discount. The decrease of $1.4 million, or
23
52%, was primarily driven by the recognition, in the prior period, of $2.0 million in amortization for the remaining debt issuance costs and discount associated with the Loan Agreement which was fully paid in May 2023. The debt issuance costs and discount for our March 2019 convertible notes primarily consisted of an allocated portion of advisory fees and other issuance costs and the initial fair value of the derivative liability.
Interest Income. For the nine months ended September 30, 2024 and 2023, we recognized $3.4 million and $2.6 million in interest income, respectively. The increase was primarily due to the interest income being earned on our money market funds and investments for the full period in 2024.
Interest Expense. For the nine months ended September 30, 2024 and 2023, we recognized $0.6 million and $2.9 million in interest expense, respectively. The decrease in interest expense was primarily due to the repayment of the Loan Agreement in May 2023.
Warrant Liabilities Fair Value Adjustment. For the nine months ended September 30, 2024 and 2023, we recognized a gain of $10.6 million and a loss of $6.0 million, respectively, in the fair value adjustment related to the warrant liabilities primarily due to the decrease and increase in our stock price during the periods, respectively.
Derivative Liabilities Fair Value Adjustment. For the nine months ended September 30, 2024 and 2023, we recognized a gain of $0.2 million and a loss of $0.2 million, respectively, in the fair value adjustment related to the derivative liabilities primarily due to the decrease and increase in our stock price during the periods, respectively.
Income Tax Expense. For the nine months ended September 30, 2024, we recognized a $0.1 million income tax expense for U.S. federal income tax.
Liquidity and Capital Resources
Sources of Liquidity
As of September 30, 2024, we had cash and cash equivalents and investments of $84.9 million, compared to cash and cash equivalents and short-term investments of $98.0 million as of December 31, 2023. We believe our capital resources are sufficient to fund our on-going operations for a period of at least 12 months subsequent to the issuance of the accompanying unaudited condensed consolidated financial statements. As of September 30, 2024, our accumulated deficit was $372.1 million.
Consistent with our operating plan, we expect to incur significant research and development expenses and selling, general and administrative expenses. As a result of our continued significant expenses, we may need additional capital to fund our operations, which we may obtain through one or more of equity offerings, debt financings, or other non-dilutive third-party funding, strategic alliances and licensing or collaboration arrangements.
Cash Flows
The following table sets forth the significant sources and uses of cash for the nine months ended September 30, 2024 and 2023 (in thousands):
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Cash, cash equivalents, and restricted cash, January 1 |
|
$ |
34,593 |
|
|
$ |
46,032 |
|
Net cash (used in) provided by operating activities |
|
|
(14,102 |
) |
|
|
67,894 |
|
Net cash provided by (used in) investing activities |
|
|
8,767 |
|
|
|
(32,725 |
) |
Net cash provided by (used in) financing activities |
|
|
16 |
|
|
|
(36,586 |
) |
Net decrease in cash, cash equivalents, and restricted cash |
|
|
(5,319 |
) |
|
|
(1,417 |
) |
Cash, cash equivalents, and restricted cash, September 30 |
|
$ |
29,274 |
|
|
$ |
44,615 |
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Operating Activities
The $82.0 million decrease in net cash (used in) provided by operating activities for the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023 was primarily due to the $115.0 million in upfront and development milestones received under the GSK License Agreement in the prior period and the continued development costs associated with SCY-247 and ibrexafungerp in the current period, offset in part by the $10.0 million development milestone received under the GSK License Agreement in the current period.
Net cash used in operating activities of $14.1 million for the nine months ended September 30, 2024, primarily consisted of the $16.9 million net loss adjusted for non-cash charges that included the gain on change in fair value of the warrant liabilities of $10.6 million, stock-based compensation expense of $2.4 million, and amortization of debt issuance costs and discount of $1.3 million, partially offset by a net favorable change in operating assets and liabilities of $10.8 million. The net favorable change in operating assets and liabilities of $10.8 million is due to a favorable change of $16.2 million due to the
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decrease in operating assets, offset by an unfavorable change of $5.4 million due to the decrease in operating liabilities The net $16.2 million decrease in operating assets is primarily due to a decrease of $9.9 million in the license agreement contract asset given the receipt of the $10.0 million development milestone associated with the GSK License Agreement in the current period, a $2.3 million decrease in the license agreement receivable associated with the GSK License Agreement which was collected in the current period, and a $4.0 million decrease in prepaid expenses, other assets, deferred costs, and other. The $4.0 million decrease in prepaid expenses, other assets, deferred costs, and other was primarily due to the collection of a $4.4 million unbilled receivable in the current period from GSK. The net unfavorable change of $5.4 million in operating liabilities is primarily due to the $2.2 million decrease in accounts payable and a $2.0 million decrease in accrued expenses primarily due to the $1.0 million decrease in accrued research and development expenses.
Net cash provided by operating activities of $67.9 million for the nine months ended September 30, 2023, primarily consisted of the $86.6 million net income adjusted for non-cash charges that included the loss on change in fair value of the warrant liabilities of $6.0 million, stock-based compensation expense of $2.1 million, and amortization of debt issuance costs and discount of $2.6 million, partially offset by a net unfavorable change in operating assets and liabilities of $30.3 million. The net unfavorable change in operating assets and liabilities was due to a net decrease in operating liabilities of $0.4 million and by a net increase of $30.0 million in operating assets. The net $30.0 million increase in operating assets is primarily due to a $19.3 million increase in license agreement contract asset associated with the GSK License Agreement, a $7.4 million increase in inventory for raw material purchased in the current period, and an increase in accounts receivable and license agreement receivable of $2.5 million. The $0.4 million decrease in accounts payable, accrued expenses, deferred revenue, other liabilities, and other was primarily due to the decrease of $5.8 million in other liabilities associated with the deferred fees due to Amplity that were fully paid as of February 2023 and a decrease of $2.5 million in accounts payable, offset primarily by a $4.1 million increase in deferred revenue associated with the GSK License Agreement and a $3.9 million increase in accrued expenses due to the $3.5 million increase in expense for product recall.
Investing Activities
Net cash provided by investing activities of $8.8 million for the nine months ended September 30, 2024 consisted of purchases and maturities of investments of $28.0 million and $36.8 million, respectively.
Net cash used in investing activities of $32.7 million for the nine months ended September 30, 2023 consisted of purchases and maturities of investments of $73.3 million and $40.6 million, respectively.
Financing Activities
Net cash provided by financing activities of $16,000 for the nine months ended September 30, 2024, consisted primarily of the proceeds from employee stock purchase plan issuances.
Net cash used in financing activities of $36.6 million for the nine months ended September 30, 2023, consisted primarily of the full repayment of the Loan Agreement with Hercules and SVB in May 2023.
Future Funding Requirements
We expect to incur expenses in connection with our efforts to further development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for, product candidates. We anticipate that we will need substantial additional funding in connection with our continuing future operations.
We are continually evaluating our operating plan and assessing the optimal cash utilization for our SCY-247 and ibrexafungerp development strategy. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenses necessary to complete the development of product candidates.
Our future capital requirements will depend on many factors, including:
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Until such time, if ever, as we can generate substantial revenue from product sales, we expect to finance our cash needs through a combination of net proceeds from equity offerings, debt financings, or other non-dilutive third-party funding (e.g., grants), strategic alliances and licensing arrangements, in particular the GSK License Agreement. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, similar to our Loan Agreement or the convertible senior notes we sold in March 2019 and April 2020, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through sales of assets, other third-party funding, strategic alliances and licensing or collaboration arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.
Significant Estimates and Judgments
Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which we have prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of our condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our condensed consolidated financial statements, as well as the reported revenues and expenses during the reported periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on 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.
Our critical estimates and judgments are described within Item 7 to our Annual Report on Form 10-K for the year ended December 31, 2023.
Item 3. Quantitative and Qualitative Disclosure about Market Risk.
This item is not applicable to smaller reporting companies.
Item 4. Controls and Procedures.
Management’s Evaluation of our Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Securities Exchange Act of 1934, as amended (the "Exchange Act") is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure.
As of September 30, 2024, our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our principal executive officer and principal financial officer have concluded based upon the evaluation described above that, as of September 30, 2024, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control Over Financial Reporting
During the three months ended September 30, 2024, there have been no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15(d)-15(f) promulgated under the Exchange Act, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
On November 7, 2023, a securities class action was filed by Brian Feldman against us and certain of our executives in the United States District Court, District of New Jersey, alleging that, during the period from March 31, 2023 to September 22, 2023, we made materially false and/or misleading statements, as well as failed to disclose material adverse facts about our business, operations, and prospects, alleging specifically that we failed to disclose to investors: (1) that the equipment used to manufacture ibrexafungerp was also used to manufacture a non-antibacterial beta-lactam drug substance, presenting a risk of cross-contamination; (2) that we did not have effective internal controls and procedures, as well as adequate internal oversight policies to ensure that its vendor complied with current Good Manufacturing Practices (cGMP); (3) that, due to the substantial risk of cross-contamination, we were reasonably likely to recall its ibrexafungerp tablets and halt its clinical studies; and (4) as a result of the foregoing, our statements about our business, operations, and prospects were materially misleading and/or lacked a reasonable basis. The complaint seeks unspecified damages, interest, fees and costs on behalf of all persons and entities who purchased and/or acquired shares of our common stock between March 31, 2023 to September 22, 2023. On May 1, 2024, and again on June 4, 2024, purported shareholder derivative complaints were filed in the United States District Court, District of New Jersey. The complaints name our directors and certain of our officers and assert state and federal claims based on the same alleged misstatements as the securities class action complaint. We disagree with the allegations and intend to defend these litigations vigorously.
Item 1A. Risk Factors.
Our operations and financial results are subject to various risks and uncertainties, including those described in Part I, Item 1A, "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023.
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Item 6. Exhibits.
Exhibit Number |
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Description of Document |
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3.1 |
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3.2 |
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3.3 |
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3.4 |
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3.5 |
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4.1 |
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31.1* |
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31.2* |
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32.1** |
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101.INS |
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Inline XBRL Instance Document |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents. |
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104 |
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Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
* Filed herewith.
** Furnished herewith. Exhibit 32.1 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall such exhibit be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise specifically stated in such filing.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SCYNEXIS, INC. |
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By: |
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/s/ David Angulo, M.D. |
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David Angulo, M.D. |
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Chief Executive Officer (Principal Executive Officer) |
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Date: |
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November 5, 2024 |
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By: |
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/s/ Ivor Macleod |
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Ivor Macleod |
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Chief Financial Officer (Principal Financial and Accounting Officer) |
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Date: |
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November 5, 2024 |
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