美國
證券交易委員會 及交易所
華盛頓特區，20549
表單
（馬克 一）
1934年法案
截至每季結束的日期為：
或
1934年证券交易法
在過渡期從 股份數減少至
委員會
檔案號碼：
(根據公司章程所述的註冊人的正確名稱)
| (依據所在地或其他管轄區) 的註冊地或組織地點) |
（州或其他管轄區
的 識別號碼) |
| (主要行政辦公室的地址)（郵政編碼） |
| (註冊人電話號碼，包括區號) |
根據該法案第12(b)條註冊的證券
| 每個課程的標題 | 交易標的（s） | 在哪個交易所 已註冊 | ||
請打勾表示以下情況：登記申報人（1）在過去12個月（或者登記人需要遞交該等報告的較短時段）已按照1934年證券交易所法第13條或第15(d)條的規定提交了所有要求提交的報告，以及（2）在過去90天中一直受到該等報告要求的約束。
請以勾選方式指明登記人是否在前12個月內（或登記人需要提交此類文件的短期間內）已電子提交根據
規則405的S-t條例（本章節第232.405條）所要求提交的每一個互動數據文件。
請勾選以下選項，指明掛牌者是否為大型快速申報掛牌者、快速申報掛牌者、非快速申報掛牌者、較小型的報告公司或新興成長型公司。關於Exchange Act第1202條中「大型快速申報掛牌者」、「快速申報掛牌者」、「較小型報告公司」和「新興成長型公司」的定義，請參閱。
| 大型加速歸檔人 | ☐ | 加速歸檔人 | ☐ |
| ☒ | 小型報告公司 | ||
| 新興成長型企業 |
如果是新興成長性公司，請打勾表示申報人選擇不使用根據證券交易法第13(a)條提供的任何新的或修訂的財務會計準則的延長過渡期遵守的標誌。
請用勾選標示
註冊人是否為空殼公司（根據交易法第120億2條的定義）。 是。 ☐
截至2024年11月13日， 註冊公司已發行的普通股數量為 每股面值為$0.0001的普通股（「普通股」）共計。
利佩拉 製藥公司。
文件 10-Q
2024年9月30日
目 錄
| 頁面 | ||
| 第一部分 | 財務信息 | 1 |
| 項目 1 | 基本報表。 | 1 |
| 2024年9月30日壓縮資產負債表（未經審核）及2023年12月31日 | 1 | |
| 2024年9月30日止三個月和九個月未經審核的營運簡明報表，與2023年。 | 2 | |
| 2024年9月30日止三個月和九個月未經審核的股東權益（赤字）變動簡明報表，與2023年。 | 3 | |
| 未經審核的截至2024年9月30日和2023年9月30日期間之現金流量簡表 | 4 | |
| 摘要的財務報表附註（未經審計） | 5 | |
| 事項 2. | 管理層對財務狀況和營運結果的討論和分析。 | 14 |
| 項目 3。 | 市場風險的定量和定性披露。 | 24 |
| 項目 4。 | 控制項和程序。 | 24 |
| 第二部分。 | 其他資訊 | 26 |
| 項目1。 | 法律訴訟。 | 26 |
| 项目1A。 | 風險因素。 | 26 |
| 事項2。 | 未註冊出售權益證券和資金用途。 | 26 |
| 項目 3。 | 違約資訊。 | 26 |
| 項目 4。 | 礦業安全披露。 | 26 |
| 项目5。 | 其他信息。 | 27 |
| 第6項。 | 展覽品。 | 27 |
| 簽名 | 28 |
本季度財務報告中提到的“公司”，“Lipella”，“我們”，“我們”，或“我們”的意思是Lipella Pharmaceuticals Inc.，除非另有明確說明或上下文表明其他。
i
第一部分 財務資訊
項目 1. 基本報表。
利佩拉 製藥公司。
總賬表
九月 30, 2024 (未經查核) |
2023年12月31日 |
|||||||
| 資產 | ||||||||
| 流動資產 | ||||||||
| 現金及現金等價物 | $ | $ | ||||||
| 應收補助款 | ||||||||
| 預付費用 | ||||||||
| 所有流動資产總額 | ||||||||
| 資產及設備 | ||||||||
| 家具、固定裝置及設備 | ||||||||
| 傢具、固定裝置及設備（累計 折舊） | ( |
) | ( |
) | ||||
| 傢具和固定裝置，淨額 | ||||||||
| 其他資產 | ||||||||
| 營業租賃權利資產 | ||||||||
| 總資產 | ||||||||
| 550,714 | ||||||||
| 流動負債 | ||||||||
| 應付帳款 | ||||||||
| 應計費用 | ||||||||
| 營業租賃負債 | ||||||||
| 工資負債 | ||||||||
| 全部流动负债 | ||||||||
| 經營租賃負債，扣除當前 部分 | ||||||||
| 總負債 | ||||||||
| 股東權益： | ||||||||
| 優先股，面額$0.01，授權股數為5,000,000股，發行且流通股數為截至2024年6月30日和2023年12月31日之184,668,188股和181,364,180股。 面值; 已授權股份數：-- 截至2024年9月30日及2023年12月31日發行及流通的股份 | $ | $ | ||||||
| 0.01 面值； 授權股份數， 截至2024年9月30日已發行 並流通的股份數 截至2023年12月31日已發行且流通的股份數 | ||||||||
| 資本公積額額外增資 | ||||||||
| 累積虧損 | ( |
) | ( |
) | ||||
| 股東權益總額 | ||||||||
| 負債總額和股東權益總額 | $ | $ | ||||||
附註為這些簡明基本報表的一部分。
1
利佩拉 製藥公司。
簡明的營運報表
（未經核數）
| 截至三個月結束 | 截至九個月結束的日期 | |||||||||||||||
| 2024年9月30日 | 2023年9月30日 | 2024年9月30日 | 2023年9月30日 | |||||||||||||
| 補助金收益 | $ | $ | $ | $ | ||||||||||||
| 總營業收入 | ||||||||||||||||
| 成本與費用 | ||||||||||||||||
| 研發 | ||||||||||||||||
| 一般及行政費用 | ||||||||||||||||
| 總費用及支出 | ||||||||||||||||
| 營業損失 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 其他收入（費用） | ||||||||||||||||
| 利息收益，淨額 | ||||||||||||||||
| 與相關方有關的利息費用 | ( | ) | ||||||||||||||
| 其他收入（支出）總額 | ||||||||||||||||
| 稅前損失 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 所得稅準備 | ||||||||||||||||
| 淨虧損 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 每股普通股損失 | ||||||||||||||||
| 基本 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 稀釋性 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 流通中的普通股加權平均股數： | ||||||||||||||||
| 基本的 | ||||||||||||||||
| 稀釋性 | ||||||||||||||||
附註內容是這些簡明基本報表的一部分。
2
利佩拉 製藥公司。
總結 報表 的 股東權益變動
（未經核數）
|
|
普通 股票 |
追加 實收 資本 |
累積 赤字 |
總計 | ||||||||||||||||
| 股票 | 金額 | |||||||||||||||||||
| 餘額， 2022年12月31日 | $ | $ | $ | ( |
) | $ | ||||||||||||||
| 淨虧損 | — | ( |
) | ( |
) | |||||||||||||||
| 以股票為基礎的薪酬 | — | |||||||||||||||||||
| 餘額， 2023年3月31日 | ( |
) | ||||||||||||||||||
| 淨損失 | — | ( |
) | ( |
) | |||||||||||||||
| 股票基礎 補償 | — | |||||||||||||||||||
| 餘額，2023年6月30日 | ( |
) | ||||||||||||||||||
| 淨損失 | — | ( |
) | ( |
) | |||||||||||||||
| 基於股票的 補償 | — | |||||||||||||||||||
| 發行為服務而發出的股份 | ||||||||||||||||||||
| 餘額， 2023年9月30日 | ( |
) | ||||||||||||||||||
| 餘額， 2023年12月31日 | ( |
) | ||||||||||||||||||
| 淨損失 | — | ( |
) | ( |
) | |||||||||||||||
| 基於股票的補償 | — | |||||||||||||||||||
| 已行使的預先資助warrants 換取普通股股份 | ( |
) | ||||||||||||||||||
| 普通股的發行 股票 | ||||||||||||||||||||
| 為服務發行的股份 | ||||||||||||||||||||
| 餘額， 2024年3月31日 | ( |
) | ||||||||||||||||||
| 淨虧損 | — | ( |
) | ( |
) | |||||||||||||||
| 基於股票的補償 | — | |||||||||||||||||||
| 預先資助的warrants 已行使以獲得普通股 | ( |
) | ||||||||||||||||||
| 餘額， 2024年6月30日 | $ | $ | $ | ( |
) | $ | ||||||||||||||
| 淨 虧損 | — | ( |
) | ( |
) | |||||||||||||||
| 發行
普通股及預付認股權證，扣除發行成本$ |
||||||||||||||||||||
| 以股票為基礎的補償 | — | |||||||||||||||||||
| 為普通股行使的預付認股權證 | ( |
) | ||||||||||||||||||
| 餘額， 2024年9月30日 | $ | $ | $ | ( |
) | $ | ||||||||||||||
附註內容是這些簡明基本報表的一部分。
3
利佩拉 製藥公司。
現金流量表摘要
（未經核數）
| 截至九個月結束的日期 | ||||||||
| 九月30日 | ||||||||
| 2024 | 2023 | |||||||
| 從營運活動中的現金流量: | ||||||||
| 淨損失 | $ | ( |
) | $ | ( |
) | ||
| 調整以調和淨虧損與經營活動所提供（使用）的淨現金： | ||||||||
| 折舊及攤銷 | ||||||||
| 股份發行用於服務 | ||||||||
| 非現金股票期權費用 | ||||||||
| 關聯方淨利息支出（非現金） | ||||||||
| 營運資產和負債的變化： | ||||||||
| 使用權資產 | ( |
) | ( |
) | ||||
| 應收補助款 | ||||||||
| 預付費用 | ( |
) | ||||||
| 應付帳款 | ( |
) | ||||||
| 應計費用 | ( |
) | ||||||
| 工資負債 | ||||||||
| 經營活動所用的淨現金 | ( |
) | ( |
) | ||||
| 來自投資 活動的現金流 | ||||||||
| 購置不動產、 廠房及設備 | ( |
) | ||||||
| 投資活動中使用的淨現金 | ( |
) | ||||||
| 來自融資活動的現金流量 | ||||||||
| 發行普通股及預資助warrants的收益，扣除發行成本 | ||||||||
| 償還應付票據 | ( |
) | ||||||
| 籌資活動提供的淨現金 | ( |
) | ||||||
| 現金及現金等價物的淨減少 | ( |
) | ( |
) | ||||
| 期初現金及現金等價物 | ||||||||
| 期末現金及現金等價物 | $ | $ | ||||||
| 現金流量資訊的補充披露： | ||||||||
| 支付利息 | $ | ( |
) | $ | ( |
) | ||
| 所得稅已支付金額 | ||||||||
| 現金流量資訊的補充披露： | ||||||||
| 發行普通股以免除關聯方票據 | ||||||||
| 發行普通股票期權以供諮詢服務 | ||||||||
附註內容是這些簡明基本報表的一部分。
4
利佩拉 製藥公司。
基本報表附註
（未經核數）
註1。 業務描述 及報表編製基礎
業務的性質
Lipella製藥公司（以下簡稱“本公司”、“我們”或“我們的”）是一家臨床階段的生物技術公司，專注於通過重新配製現有仿單藥物中的活性成分並對這些重新配製進行優化，以開發新藥品。我們的業務包括研究、臨床前開發和臨床開發活動，我們最先進的項目位於第2期臨床開發階段。自2005年成立以來，我們一直通過聯邦補助收入、授權收入、製造收入以及股權和債務融資來部分資助我們的業務。
報表說明基礎
公司的未經審計的簡縮基本報表已根據美國公認會計原則（"GAAP"）編製。這些註解中對適用指南的任何提及均旨在指向財務會計準則委員會（"FASB"）的會計準則編纂（"ASC"）和會計準則更新（"ASU"）中所找到的權威GAAP。
在管理層看來，隨附的未經審核的簡縮基本報表包括所有調整，包括正常的 經常性調整，這些調整是必要的，以公平地呈現公司的財務狀況、營運結果和 現金流量。期中營運結果不一定能反映整個財政年度可能發生的結果。根據美國證券交易委員會（“SEC”）的指示、規則和條例，某些通常包含在遵循GAAP 準則編製的基本報表中的信息和註腳披露已被簡化或省略。未經審核的簡縮期中基本報表應與我們於2024年2月27日向美國證券交易委員會（“SEC”）提交的截至2023年12月31日的10-K表格年度報告中的經審核基本報表及其註腳一同閱讀（我們的“年度報告”）。
於2024年11月7日，我們進行了每股8股反向股票拆分（“反向股票拆分”），涉及所有的普通股流通股份，$ 每股面值（“普通股”）。每股淨虧損及所有板塊數據已根據ASC 260-10-55-22，對所有呈現期間進行了追溯調整，以反映反向股票拆分，每股收益數據的重述。詳情請參見附註15。
5
備註 2。 經營概念
附帶的簡明基本報表已按照GAAP標準編製，該標準預計公司將作為持續經營的基礎。公司尚未確定充足的收入來支付其運營成本，將需要大量的額外資本來繼續其研究和開發計劃，包括推進臨床產品候選藥物走向商業化，以及為商業規模的製造和銷售作準備。
截至2024年9月30日和2023年12月31日止之九個月的淨虧損分別為$
如果 我們無法獲得額外資本（目前尚不確定），我們的長期業務計劃可能無法實現， 我們可能被迫縮減或停止運營。這些因素單獨和共同引發了關於 我們能否持續經營的重大質疑。隨附的未經審核的簡明基本報表不包括因這種不確定性而可能產生的任何調整。
筆記3。 重大會計政策摘要
公司的重大會計政策詳見2024年2月27日提交給美國證券交易委員會的公司年度報告第10-k表格中的第3項「會計政策」。在2024年9月30日結束的三個月期間內，除下述事項外，重大會計政策沒有重大變動。
估計的使用
根據GAAP準則編制基本報表需要管理層進行影響資產和負債金額報告以及對未來資產和負債的披露日期作出估計和假設。 實際結果可能與這些估計不同。
新會計準則的採納
截至2024年9月30日的三個月內，沒有發佈或生效的新會計公告，對我們的基本報表產生或預期會產生重大影響。
6
信用風險的集中度
公司的授權收入和應收授權款來自美國健康暨公共服務部下的國家衛生研究院（NIH）。公司相信應收金額可完全從該機構收回。合約收入為$
基本 普通股的每股淨損失是通過將該期間的淨損失除以該期間流通的普通股加權平均數計算得出的。稀釋後的普通股每股淨損失是考慮到所有稀釋性普通股等價物後計算的，包括期權和warrants。2024年和2023年截至9月30日的普通股稀釋後每股淨損失與基本每股淨損失相同，因為普通股等價物由於淨損失的影響而是反稀釋性的。
| 九月30日 | ||||||||
| 2024 | 2023 | |||||||
| 根據有效的股權激勵計劃可發行的普通股。 | ||||||||
| 根據執行warrants可發行的普通股。 | ||||||||
| 根據A系列優先股轉換可發行的普通股 。 | ||||||||
| 排除於稀釋後每股淨損中的普通股等價股。 | ||||||||
注意事項4。 公平價值 測量及可交易債務證券
根據ASC 820，"公允價值衡量和披露 （"ASC 820"），公司以公允價值計量其資產和負債。我們採用ASC 820中所述的三層估值層級，該層級是基於計量日期的輸入透明度。三層輸入的定義如下：
層級 1 評估方法論的輸入為在活躍市場上未經調整的相同資產或負債的報價。
等級 2 - 評價方法論的參數包括類似資產和負債在活躍市場中的報價價格，以及資產或負債的可觀察參數，不論是直接或間接，對財務工具的整個有效期都具有重要價值。
等級 3 - 評價方法的輸入是不可觀察的，並且對公允價值計量具有重要意義。
截至2024年9月30日及2023年12月31日，公司財務工具的主要組成包括：現金及現金等價物，應付賬款及應計負債。對於現金等價物、應付賬款及應計負債，這些財務工具截至2024年9月30日及2023年12月31日的帳面金額被認為代表其公允價值，因其為短期到期。
7
截至2024年9月30日及2023年12月31日，公司並未持有任何可上市證券。 截至2024年9月30日 及2023年12月31日，現金等價物的公允價值輸入級別如下摘要：
| 2024年9月30日 | 第1級 | 第2級 | 第3級 | 總計 | ||||||||||||
| 現金等價物（到期少於90天） | ||||||||||||||||
| 商業票據 | $ | $ | $ | $ | ||||||||||||
| 美國政府 | ||||||||||||||||
| 貨幣市場基金 | ||||||||||||||||
| 總現金等價物 | ||||||||||||||||
| 有價證券 | ||||||||||||||||
| 總現金等價物和可變現證券 | $ | $ | $ | $ | ||||||||||||
| 二零三年十二月三十一日 | 等級一 | 第二級 | 等級 3 | 總計 | ||||||||||||
| 現金等值 (到期少於 90 天) | ||||||||||||||||
| 商業紙 | $ | $ | $ | $ | ||||||||||||
| 美国政府 | ||||||||||||||||
| 貨幣市場基金 | ||||||||||||||||
| 現金等值總額 | ||||||||||||||||
| 可交易證券 | ||||||||||||||||
| 現金等值及可交易證券總計 | $ | $ | $ | $ | ||||||||||||
附注5。 預付費用
在
2024 年 9 月 30 日，預付費用為 $
注6。 應計費用
在2024年9月30日，應計費用為$
注7。 應付票據 - 關聯方
有
五百零二萬五千五百零五股Sonnet BioTherapeutics Holdings，Inc.的每股股份已發行和流通，截至2024年8月14日。
8
注意 8. 信用狀
公司與銀行有一封信用證，可供申索的總金額為$
本公司有兩個股票激勵計劃（每個稱為「股票期權計劃」，合稱為「股票期權計劃」）， 每個計劃均提供激勵股票期權及非合格股票期權的授予。根據股票期權計劃的條款，最多可發行的普通股股份數量為 在回溯應用反向股票分割的影響後，為 來自2008年股票期權計劃的已發行及在外流通（未過期）股票期權，以及 可能根據2020年股票期權計劃發放的期權獎勵的普通股股份。激勵股票期權的行使價格由本公司的董事會（「董事會」）決定。 該等期權的歸屬條款，包括終止，依股票期權計劃及其各自的獎勵協議所規定。此類股票期權一般在 授予日期起計算，最多可持續 的未確認薪酬成本，與已授予的未完全取得股份基礎的薪酬安排有關，將在剩餘的歸屬期內確認，少於 年計算第b系列優先股在浮動利率期間應支付的分配。
該公司於2024年6月30日結束於收入聲明總表上承認ITC分配相關的其他收入（2023年6月30日：$ and $ 截至2024年9月30日及2023年9月30日三個月內，與股票期權歸屬相關的補償成本。公司確認了$ 截至2024年9月30日的九個月內，公司的補償成本為$， 截至2023年9月30日的九個月內，公司的補償成本為$。
| 股票 | 加權 平均 行使 每股發售價格 每股($) |
加權 平均值 剩餘 合約上的 條款 (以年計) |
總計 內在的 價值（美元） |
|||||||||||||
| 至2022年12月31日止的未決清償 | $ | $ | ||||||||||||||
| 已授予 | $ | $ | — | |||||||||||||
| 已到期 | ||||||||||||||||
| 已取消 | ( |
) | $ | |||||||||||||
| 已行使 | ||||||||||||||||
| 截至2023年12月31日未清偿 | $ | $ | ||||||||||||||
| 已授予 | $ | $ | — | |||||||||||||
| 已過期 | ||||||||||||||||
| 已取消 | ||||||||||||||||
| 已行使 | ||||||||||||||||
| 截至2024年3月31日止尚未解除 | $ | $ | ||||||||||||||
| 已授予 | ||||||||||||||||
| 已過期 | ||||||||||||||||
| 已取消 | ||||||||||||||||
| 已行使 | ||||||||||||||||
| 截至2024年6月30日的未解除股票總數 | $ | $ | ||||||||||||||
| 已授予 | ||||||||||||||||
| 已過期 | ||||||||||||||||
| 已取消 | ||||||||||||||||
| 已行使 | ||||||||||||||||
| 截至2024年9月30日未清偿 | $ | $ | ||||||||||||||
| 截至2024年9月30日獲授權 | ||||||||||||||||
| 2024年9月30日可行使 | ||||||||||||||||
| 至2023年12月31日止可行使 | ||||||||||||||||
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| 持有數量 期權 |
加權- 平均公平價 賦予價值 日期 |
|||||||
| 2022年12月31日非授權 | $ | |||||||
| 已授予 | ||||||||
| 已歸屬 | ( |
) | ||||||
| 已過期 | ||||||||
| 2023年9月30日止尚未取得的股份 | $ | |||||||
| 2023年12月31日時的未發放股票 | $ | |||||||
| 已授予 | ||||||||
| 已歸屬 | ( |
) | ||||||
| 已過期 | ||||||||
| 2024年9月30日的尚未授予股份 | $ | |||||||
2024年9月30日至2023年9月30日期間，公司按以下描述授予期權。
股票 期權授予- 於2024年3月15日，公司授予 股票期權，行使價為$ ，分步賦權如下： 授予的三分之一於2024年4月1日賦權，授予的三分之一於2024年7月1日賦權，以及授予的三分之一於2024年10月1日賦權。
在2023年6月16日，公司發行了 股票期權，行使價為$ 行使價格，發行時立即生效。
| 截至九月三十日止九個月 | 2024 | 2023 | ||||||
| 授予期權的加權平均公允價值 | $ | $ | ||||||
| 預期波動率 | % | % | ||||||
| 預期壽命（以年為單位） | ||||||||
| 無風險利率（區間） | % | % | ||||||
| 預期股息率 | $ | $ | ||||||
注10. 此優先股
公司的公司章程授權一定數量的優先股，每股面值為$ 每股（“優先股”），可不時以一個或多個系列發行。截至2024年9月30日或2023年12月31日止的九個月期間，公司並沒有任何未償還的優先股。 每股（“優先股”），可不時以一個或多個系列發行。截至2024年9月30日或2023年12月31日止的九個月期間，公司並沒有任何未償還的優先股。
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截至2022年12月31日，本公司的所有系列A可轉換優先股份，面值$ 每股（「系列A優先股份」）均按1:1的比例轉換為普通股。至2023年12月31日或2024年9月30日，沒有未償付的系列A優先股份。系列A優先股份於2024年4月11日被本公司取消並終止。
公司的第二次修訂及重述的成立證書，經修訂後（以下稱「成立證書」），授權發行 普通股的股份。在考慮到反向拆分的影響後，至 2024年9月30日，已發行普通股股份為 截至2023年12月31日的已發行股份為。
在 2024年8月1日，我們向一位機構投資者發行了 股普通股，發售價格為$ 每股， 連同209,625個預資助warrants以購買相同數量的普通股。詳情請參見附註12關於預資助warrants的內容。
於2024年8月16日，普通股發行了 於2024年9月17日，普通股發行了 於2024年9月24日，普通股發行了 於2024年9月26日，另發行了相同數量的預資助權證，為普通股則發行了相同數量的預資助權證 於2024年9月26日，另發行了相同數量的預資助權證，為普通股則發行了相同數量的預資助權證
未能滿足納斯達克最低買盤價格要求的通知
根據公司於2024年4月19日向證券交易委員會提交的8-k表格披露，在2024年4月17日，公司收到了納斯達克上市資格部門（“Staff”）發出的書面通知（“四月納斯達克函”），通知公司根據最近30個連續業務日的普通股收盤買盤價，公司未符合維持每股普通股最低1.00美元的最低買盤價要求，該要求規定於納斯達克上市規則5550(a)(2)中（“最低買盤價要求”）。四月納斯達克函對普通股的上市沒有立即影響，普通股繼續在納斯達克資本市場交易。
納斯達克給予公司180天的日歷時間，直到2024年10月14日，以重新符合 最低買盤價格要求。
根據公司在2024年8月23日向證券交易委員會提交的第一季度報告書中披露，公司於2024年8月21日收到工作人員的信函，指出公司未遵守納斯達克上市規則5550(b)(1)的條款，該條款要求在納斯達克資本市場上市的公司須保持至少$2,500,000的股東權益以繼續上市（即“股東權益要求”）。公司在其截至2024年6月30日的季度報告書10-Q中報告了$1,703,798的股東權益，因此未遵守股東權益要求。
根據我們於2024年10月18日向美國證券交易委員會提交的8-K表格中披露，工作人員於2024年10月16日通知公司，即將自納斯達克資本市場除牌普通股，對此，公司及時向納斯達克聽證會（“委員會”）提出上訴。納斯達克聽證會日期已訂於2024年12月12日舉行。在上訴程序仍在進行中時，納斯達克資本市場對普通股的交易暫停將繼續停留，直到聽證程序結束並委員會作出決定。另請參見附註15，後續事項，以獲取有關逆向股票拆分的更多資訊。
附註 12. 認股權證
2024年8月1日，公司進行了2024年8月份的優先發行。相關地，公司發行了預先資助的認股權證，以購買最多 每股 $
11
註13. 承諾 和條件
經營 租約
營運 租賃作為使用權（“ROU”）資產和租賃負債記錄在資產負債表上。ROU資產代表我們在租賃期間使用租賃資產的權利，而租賃負債則代表我們支付租金的義務。 營運租賃ROU資產和負債在開始日期根據租賃期限內租金的現值進行確認。由於公司的大多數租賃未提供隱含利率，因此公司在開始日期使用其估算的增量借款利率來判斷租金的現值。營運租賃ROU資產還包括已支付的任何租金，不包括租賃激勵。
公司於2020年7月1日開始一份租賃協議，租用了位於賓夕法尼亞州匹茲堡蘇斯克哈納街7800號五樓的公司總部，其中包括辦公空間和無菌製造業務（「租賃」）。租賃期為五年，包括續約選項，但這種續約選項不確定且被排除在使用權計算之外。2023年7月26日，公司另外簽署了第二份租賃協議，租用了同一建築物四樓的額外空間（「四樓租賃」），租期自2023年8月1日起至2025年9月30日，與現有租賃同時到期。隨後，於2024年1月1日生效，公司同房東互相同意提前終止了四樓租賃，沒有任何懲罰，並以取得鄰近我們現有辦公室的額外空間的租賃替換之（「504套房租賃」，連同「租賃」合稱「租賃」）。504套房租賃的租賃期與租賃同時到期。 截至2024年9月30日，根據租賃協議，未來最低租金支付如下:
| 截至年末 | ||||
| 2024年（截至2024年9月30日還剩三個月） | $ | |||
| 2025 | $ | |||
| 租賃最低支付款總額 | $ | |||
| 减：利息費用 | $ | ( |
) | |
| 最低租賃付款的現值 | $ | |||
租賃契約按照ROU（租賃負債與資產）進行會計。截至2024年9月30日，公司擁有$
截至2024年9月30日和2023年9月30日止三個月的租金費用分別為$
合約 承諾
公司在正常的業務過程中，與醫藥外包概念（“CROs”）、合同製造組織、高校及其他第三方簽訂合同，以進行臨床前研究、臨床試驗和測試及製造服務。這些合同通常不包含最低採購承諾，我們可以在提前書面通知後取消，但臨床材料的採購訂單通常不可取消。取消時應支付的款項僅包括已提供服務或已產生的費用，包括我們服務供應商的不可取消義務，直到取消日期或在完成製造業運行時。
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注意 14. 所得稅
截至2024年和2023年9月30日的三個和九個月的所得稅撥備為$0，導致有效所得稅率為
本公司定期評估其遞延稅務資產的可實現性，並建立評估備抵，若某些或全部遞延稅務資產不太可能被利用的話。由於我們的累積虧損，截至2024年9月30日和2023年12月31日，幾乎所有的遞延稅務資產都已被評估備抵完全抵銷。我們尚未支付2023年12月31日結束的年度的所得稅。2024年9月30日結束的三個月和九個月的虧損所得稅費用，與按照美國聯邦法定稅率計算的金額有所不同。
| 法定聯邦所得稅率 | % | |||
| 州税，减去联邦福利 | % | |||
| 估值減損變化 | - |
% | ||
| 有效稅率 | % |
公司的2019年至2023納稅年度仍然受到內部稅務局針對聯邦稅目的審查及賓夕法尼亞州針對州稅目的審查。
備註 15. 隨後的事件
截至未經審核的簡化基本報表發佈日，後續事件已被評估，且未發現重大事件，除非以下所揭示的。
在2024年10月15日， 預先資助的warrants被行使並兌換為相同數量的普通股。
於2024年11月7日，公司根據2024年9月10日股東年度會議授權的權限，在特拉華州州務大臣處提交了一份修訂證書（“修訂章程”），以在2024年11月7日實現逆向股票拆分。由於逆向股票拆分，每八（8）股普通股交換為一（1）股普通股。這些普通股在2024年11月8日交易開始時，根據調整後的拆分基準在納斯達克資本市場上交易。逆向股票拆分並未影響公司授權發行的總股本數，包括普通股，在修訂章程中所列數量保持不變。逆向股票拆分還對公司截至逆向股票拆分生效日仍持有的所有其他期權和warrants產生了比例效應。
每股淨虧損和所有股份數據 截至2024年9月30日和2023年已經進行追溯調整，以反映根據ASC 260-10-55-12進行的股票 逆向股票分割，EPS數據重述。
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項目 2. 管理層對財務狀況和營運結果的分析與討論。
以下對我們截至2024年9月30日的三個月和九個月的財務狀況和業務運作的討論與分析應與我們的未經審計的簡明基本報表及相關附註一起閱讀，這些基本報表包含在本季度報告第I部分第1項中，該季度報告的截止日期為2024年9月30日（本「表格10-Q」），以及經審計的基本報表及相關附註，還有截至2023年12月31日的財務狀況和業務運作的管理層討論與分析，這些內容包含在我們的2023年年度報告（表格10-K）中，該報告已於2024年2月27日向美國證券交易委員會（SEC）提交，以及本文件及上述報告中披露的所有風險因素。這種討論包括根據經修訂的1933年證券法第27A條（“證券法”）和經修訂的1934年證券交易法第21E條（“交易所法”）的定義所做的前瞻性聲明，以及有關我們的業務的信息，這些信息反映了我們管理層對業務、策略、產品、未來結果和事件以及財務表現的當前看法、期望和假設，這些都面臨著可能使我們或我們的行業的實際結果、活動水平、表現或成就與任何未來結果、活動水平、表現或成就存在重大差異的風險和不確定性。這些前瞻性聲明僅在本表格10-Q日期的時候成立。雖然我們相信這些前瞻性聲明中反映的期望是合理的，但我們無法保證未來的結果、活動水平或成就，或我們的基本假設將被證明正確。除非法律要求，包括美國的證券法，我們明確放棄任何義務或承諾，以傳播任何此類前瞻性聲明的更新或修訂，以反映我們對此的期望的任何變化，或使這些前瞻性聲明符合實際結果。在本表格10-Q中做出的陳述，除了歷史事實的陳述之外，還涉及我們管理層預期或預計將在未來發生的業務表現、事件或發展的陳述，以及與預期或預測的增長、收入、盈利能力、新產品、業務運作資金充足性相關的陳述、表達對未來業務結果的總體樂觀的陳述和其他非歷史信息，均為前瞻性聲明。尤其是，“可能”、“將”、“預期”、“預計”、“旨在”、“潛在”、“未來”、“打算”、“計劃”、“相信”、“估計”、“繼續”、“很可能”及類似詞語的變體識別了前瞻性聲明，但這些詞並不是識別此類前瞻性聲明的唯一方式，且其缺失不一定意味著該聲明不是前瞻性的。
Overview
我們是一家臨床階段的生物技術公司，專注於通過重新配方現有仿製藥中的有效成分來開發新藥，並優化這些重新配方以用於新應用。我們相信這一策略結合了使用現有仿製藥所帶來的多種成本效率和風險降低，並為我們的專有配方提供潛在的專利保護；這一策略使我們能夠加速、保護和變現我們的產品候選者。此外，我們保持對於尚未有經批准藥物療法的疾病的治療專注，這些疾病具有顯著的未滿足的 morbidity 和 mortality。我們相信這一專注可以幫助降低獲取市場批准的成本、時間和風險。
LP-10 是我們針對他克莫司（已獲批准的通用活性成分）進行再製的開發名稱，特別優化以便於局部投放到膀胱腔內表面，使用我們已開發的專有藥物傳遞平台，我們稱之為我們的亞穩定脂質體藥物傳遞平台（我們的「平台」）。我們正在開發LP-10和我們的平台，據我們所知，這可能是第一個能成功治療發生出血性膀胱炎的癌症倖存者的藥物候選人和藥物傳遞科技。我們已獲得美國食品藥品監督管理局（「FDA」）對LP-10的「孤兒藥」認定，並計劃在取得LP-10臨床試驗的合格結果時申請額外的監管認證。在美國及其他獲得公司產品的監管批准的管轄區，市場數據專屬性可能可用，無論專利狀態如何。
LP-10的安全性和療效在一項針對13名受試者的開放標籤、多中心、劑量遞增、第二期臨床試驗中進行評估，該試驗針對的患者經歷與一種罕見但高度致病的疾病相關的併發症，該疾病稱為「放射誘發性出血性膀胱炎」或「放射膀胱炎」。這項第二期臨床試驗於2021年2月15日開始，我們在2023年第一季度報告了試驗的摘要結果。我們在2023年第四季度與FDA會面，討論LP-10的臨床試驗結果，並於2024年4月3日，FDA批准了我們關於第二期b臨床試驗設計的C類會議請求，以評估LP-10。我們已向FDA提交了一項完整的第二期多中心前瞻性雙盲安慰劑對照試驗，並準備開始。
目前尚無FDA批准的藥物療法可供輻射性膀胱炎患者使用，這些患者都是接受過盆腔放射療法以治療實性盆腔腫瘤（包括前列腺癌和卵巢癌）的癌症倖存者，現在正面對與治療相關的併發症，包括尿液出血（輻射性膀胱炎的症狀）。LP-10的活性成分是他克莫司，其藥理學和毒理學均為人所知，能有效減少（或停止）無法控制的尿液出血。
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2023年第四季，我們收到FDA針對LP-310的IND批准，這是我們用於治療口腔苔癬（“OLP”）的產品。我們已經開始LP-310的臨床試驗過程，並在2024年第二季啟動了第一個臨床研究站點。目前已有三位病人完成了試驗，我們預計在2024年底前得出初步結果。OLP是一種慢性細胞介導的自體免疫口腔黏膜疾病，LP-310含有可抑制T淋巴細胞活化的他克莫司。截至目前，通過評估相關FDA公共數據資源中關於已批准藥物和生物製品的信息，我們尚未意識到有其他使用脂質體治療此類疾病的產品。
2024年第一季，我們獲得FDA對LP-410的IND批准，這是我們的第1/2a階段產品，用於口腔移植物抗宿主病（“GVHD”）的治療。LP-410是口腔漱口劑，與LP-310類似，但將具有不同的封裝系統。造血幹細胞移植（“HCT”）用於治療廣泛範圍的惡性腫瘤、血液學和免疫缺陷狀態，以及自體免疫性疾病。GVHD是一種臨床綜合症，供者衍生的免疫活性t細胞直接反應對患者組織，或在HCT後通過誇張的炎症反應作用。Lipella為將LP-410直接投遞到口腔表面而開發了該產品。LP-410針對口腔GVHD的潛在機制，可能為受影響的個體提供安全有效的治療選擇。Lipella於2023年11月11日獲得羅氏“孤兒藥”指定批准，用於口腔GVHD的他克莫司治療。
自2005年成立以來，我們主要專注於業務規劃和推進我們的主要產品候選者，包括推進LP-10通過臨床開發，籌集資金，組織並配置公司的職位。 在2022年12月22日，我們完成了首次公開募股（“IPO”），並發行了152,174股普通股，價格為每股46美元，經過反向拆分的追溯調整後。 IPO的總淨收益約為500萬美元，扣除承銷折扣和約630,000美元的佣金以及約116萬美元的發行費用後。
最新動態
Nasdaq Notifications
如先前所披露，於2024年4月17日及2024年8月21日，公司收到納斯達克上市資格工作人員（“工作人員”）來自納斯達克證券市場有限責任公司（「納斯達克」）的信件，指出該公司不符合納斯達克上市規則5550(a)(2)（“最低買盤價格要求”）及納斯達克上市規則5550(b)(1)（“股東權益要求”）。於2024年10月16日，公司收到一封信件（“十月信”），信中指出雖然公司於2024年10月4日提交了恢復符合股東權益要求的計劃，但普通股將會從納斯達克資本市場除牌，除非該決定在2024年10月23日之前上訴至納斯達克聽證小組（“小組”）。於2024年10月17日，公司要求在小組面前舉行聽證會以上訴該決定，聽證會已定於2024年12月12日舉行。在上訴過程待決定之際，普通股在納斯達克資本市場的交易暫停將繼續延遲，直到聽證過程結束並且小組作出決定。
Reverse Stock Split
On November 7, 2024, the Company executed a 1-for-8 reverse stock-split of the Company’s outstanding shares of Common Stock (the “Reverse Stock Split”), whereby every 8 shares of Common Stock was consolidated into 1 share of Common Stock following the Reverse Stock Split. See “Note 15 – Subsequent Events” of the notes to the Company’s unaudited condensed financial statements in this Form 10-Q as well as the Current Report on Form 8-K filed by the Company with the SEC on November 7, 2024 for more information regarding the Reverse Stock Split.
Results of Operations
Comparison of 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 (in thousands):
| 三個月內 年終 | ||||||||||||
| 九月三十日， | 增加 | |||||||||||
| 2024 | 2023 | (減少) | ||||||||||
| （以千為單位) | ||||||||||||
| 營業收入 | $ | 80 | $ | 104 | $ | (24 | ) | |||||
| 營運費用： | ||||||||||||
| 研究和開發（“ R＆D”） | 1,047 | 833 | 213 | |||||||||
| 一般及行政費用 | 493 | 628 | (135 | ) | ||||||||
| 營業費用總額 | 1,540 | 1,461 | 79 | |||||||||
| 營運虧損 | (1,460 | ) | (1,357 | ) | (103 | ) | ||||||
| 其他收入 | 15 | 33 | (18 | ) | ||||||||
| 淨損失 | $ | (1,445 | ) | $ | (1,324 | ) | $ | (121 | ) | |||
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補助金和其他 營業收入
我們 尚未將任何產品商業化，並且預計在幾年內不會從任何產品候選者的銷售中產生營業收入。截止至2024年和2023年9月30日的三個月內，我們確認了來自國立衛生研究院（“NIH”）於2022年9月頒發的補助金（“2022 NIH 補助金”）的營業收入，該補助金的總額為673,000美元。 NIH於2023年6月批准了2022 NIH補助金的額外一年的資金，將2022 NIH補助金下的總資金增加至1,353,000美元。
我們 在相關成本產生且支付權利實現時，確認來自補助金的營業收入。截至2024年9月30日的三個月內，我們因2022年NIH補助金賺取了80,000美元，這被確認為營業收入，而與2023年9月30日結束的三個月相比則是104,000美元的營業收入。年補助金收入減少24,000美元是由於補助金工作中的分包商成本降低所驅動。
Operating Expenses
Our operating expenses consist of (i) R&D expenses and (ii) general and administrative expenses.
Research and Development Expenses
研發費用主要包括與顧問和材料、生物儲存、第三方CRO成本和合約開發及製造費用、薪金和其他與人員相關的費用有關的直接成本。研發費用在發生時予以支出。更具體地說，這些費用包括:
| ● | 為第三方進行研究、開發以及代表我們進行非臨床和臨床活動而進行的研究資金成本； |
| ● | 製造業藥品供應和藥品產品的成本； |
| ● | 進行我們產品候選品的非臨床研究和臨床試驗的成本； |
| ● | 與研究和開發相關的諮詢費用和專業費用，包括對非員工的股權報酬； |
| ● | 與遵守臨床監管要求相關的成本； 以及 |
| ● | 員工相關開支，包括薪資、福利以及 我們研究和開發人員的以股票為基礎的薪酬開支。 |
成本 某些活動的成本根據對特定任務完成進度的評估而認列，使用的數據包括我們供應商提供的信息，以及分析我們的非臨床和臨床研究或其他服務的進展。在確定任何報告期間末的應計費用餘額時，需要進行重大判斷和估計。我們未來為研發活動所需的商品或服務所支付的預付款項，記為預付費用。這些金額在商品交付或相關服務執行時認列為費用，或者直到不再預期商品會被交付或服務會被提供為止。
We expect that our R&D expenses will increase substantially in connection with our clinical development activities for our LP-10 and LP-310 programs. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of, or obtain regulatory approval for, any of our current or future product candidates. This is due to the numerous risks and uncertainties associated with product development and commercialization, including the specific factors set forth in the section of our Annual Report titled “Risk Factors.” If any events described in the applicable risk factors included in the section of our Annual Report titled “Risk Factors” occur, then the costs and timing associated with the development of any of our product candidates could significantly change. We may never succeed in obtaining regulatory approval for, of commercialization of, LP-10, LP-310, or any of our other product candidates.
R&D expenses increased by approximately $213,000, to $1,047,000, for the three months ended September 30, 2024, compared to $833,000 for the three months ended September 30, 2023. The increase in R&D expenses was attributable to an increase in stock option expense of $40,000, related to partial vesting of the March 2024 option grants, as well as an increase in outside services of $131,000 for clinical study trials. In the three months ended September 30, 2024, personnel costs increased by $16,000, and indirect costs related to operational overhead and employee benefits increased $12,000, and supplies for lab and clinical trial work increased by approximately $14,000, as compared to the three months ended September 30, 2023.
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General and Administrative Expenses
General and administrative expenses consist primarily of management and business consultants and other related costs, including stock-based compensation. General and administrative expenses also include board of directors’ expenses and professional fees for legal, patent, consulting, accounting, auditing, tax services and insurance costs.
There were $493,000 of general and administrative expenses for the three months ended September 30, 2024, compared to $628,000 for the three months ended September 30, 2023, a decrease of $135,000. Outside services, including legal and investor relations services, decreased by approximately $56,000, and Board compensation decreased by $125,000 as compared to the quarter ended September 30, 2023. This was offset by an increase in stock option expense of $41,000 compared to the three months ended September 30, 2023, related to the partial vesting of the March 2024 option grants.
Net Other Income (Expense)
Net other income for the three months ended September 30, 2024 was $15,000, as compared to $33,000 for the three months ended September 30, 2023. The change reflected an approximately $18,000 decrease in interest income on the Company’s short term investment portfolio, driven by lower investment balances.
Comparison of 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 (in thousands):
| Nine Months Ended | ||||||||||||
| September 30, | Increase | |||||||||||
| 2024 | 2023 | (Decrease) | ||||||||||
| (in thousands) | ||||||||||||
| Revenue | $ | 363 | $ | 329 | $ | 34 | ||||||
| Operating expenses: | ||||||||||||
| R&D | 2,551 | 2,585 | (34 | ) | ||||||||
| General and administrative | 1,441 | 1,760 | (319 | ) | ||||||||
| Total operating expenses | 3,992 | 4,345 | (353 | ) | ||||||||
| Loss from operations | (3,629 | ) | (4,016 | ) | 387 | |||||||
| Other income (expense) | 55 | 86 | (31 | ) | ||||||||
| Net loss | $ | (3,574 | ) | $ | (3,930 | ) | $ | 356 | ||||
Grants and Other Revenue
For the nine months ended September 30, 2024, we earned $363,000 in connection with a grant from the NIH, recognized as revenue. We received $329,000 in revenue for the nine months ended September 30, 2023. The increase in annual grant revenue from 2023 to 2024 of $34,000 is related to both the amount of time spent on the grant project, as well as increased salaries and overhead costs associated.
Operating Expenses
Research and Development Expenses
The following table summarizes our R&D expenses for the nine months ended September 30, 2024 and 2023 (in thousands):
| Nine Months Ended | ||||||||||||
| September 30, | Increase | |||||||||||
| (in thousands) | 2024 | 2023 | (Decrease) | |||||||||
| Direct R&D expenses for the LP-10 product candidate program: | ||||||||||||
| Employee-related costs | $ | 60,000 | $ | 133,000 | $ | (73,000 | ) | |||||
| Employee stock option expense | 56,000 | 220,000 | (164,000 | ) | ||||||||
| Outsourced R&D | 95,000 | 140,000 | (45,000 | ) | ||||||||
| Facility-related costs | 37,000 | 67,000 | (30,000 | ) | ||||||||
| Platform development, early-stage research and unallocated expenses: | ||||||||||||
| Employee-related costs | 619,000 | 448,000 | 171,000 | |||||||||
| Employee stock option expense | 529,000 | 796,000 | (267,000 | ) | ||||||||
| Outsourced R&D | 802,000 | 534,000 | 268,000 | |||||||||
| Facility-related costs | 353,000 | 247,000 | 105,000 | |||||||||
| Total research and development expenses | $ | 2,551,000 | $ | 2,585,000 | $ | (34,000 | ) | |||||
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R&D expenses decreased by approximately $34,000, with expenses of $2,551,000 for the nine months ended September 30, 2024, versus $2,585,000 for the nine months ended September 30, 2023. The decrease in R&D expenses was primarily attributable to a decrease in stock option expense versus the prior year by $431,000. This was offset by increases in 2024 of indirect overhead costs of $144,000, including employee benefits, overhead and facility related costs, office and lab expenses and supplies. There was also an increase in outside services of $233,000 during the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023, related to planning and launching our current clinical trial.
General and Administrative Expenses
General and administrative expenses were approximately $1,441,000 for the nine months ended September 30, 2024, compared to $1,760,000 for the nine months ended September 30, 2023. General and administrative expenses decreased by approximately $319,000, including a decrease in stock option expense of $256,000, with higher costs in the prior year related to our June 2023 option grants to employees and directors. Simultaneously, board compensation decreased by $125,000, and there was an increase in outside services of $270,000, which includes investor relations and other shareholder services, offset by a decrease in legal fees of $205,000.
Net Other Income (Expense)
Net other income for the nine months ended September 30, 2024 was approximately $55,000, as compared to $86,000 for the nine months ended September 30, 2023. This balance primarily included (i) cash interest income, (ii) unrealized loss on investments, and (iii) non-cash interest expense on related party notes in 2023. A higher cash investment balance in 2023 resulted in a decrease of $42,000 in interest on short term investments in the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023. This was offset by a decrease in interest expense on related party notes of $11,000, due to a reduction in the balance of debt outstanding. See Note 7 of the notes to our unaudited condensed financial statements in this Form 10-Q as well as Note 7 of the notes to our financial statements in our Annual Report for details of such related party notes and accrued interest at the respective periods.
Liquidity and Capital Resources
Sources of Liquidity
We have not yet commercialized any products, and we do not expect to generate revenue from sales of any product candidates for several years, if at all. Cash and cash equivalents totaled $1,353,734 as of September 30, 2024. We consider all highly liquid investments that mature in 90 days or less when purchased to be cash equivalents.
We have incurred operating losses and experienced negative operating cash flows for the nine months ended September 30, 2024 and the year ended December 31, 2023, and we anticipate that we will continue to incur losses for the foreseeable future. Our net loss totaled $3,574,592 and $3,930,081 for the nine months ended September 30, 2024 and 2023 respectively, and $4,618,965 for the year ended December 31, 2023.
Historically, we have financed our operations through a combination of grant revenue and equity financing, however our goals for the foreseeable future will likely require significant equity financing. Our ability to achieve significant profitability depends on our ability to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, LP-10 and/or our other product candidates, which may not occur for several years, if ever. The net losses we incur may fluctuate significantly from quarter to quarter.
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Cash Flows
The following table provides information regarding our cash flows for each of the periods presented (in thousands):
| For the Nine Months Ended | ||||||||
| September 30, | ||||||||
| Dollars in thousands | 2024 | 2023 | ||||||
| Net cash (used) provided by operating activities | $ | (2,960 | ) | $ | (2,423 | ) | ||
| Net cash (used) provided by investing activities | -- | (14 | ) | |||||
| Net cash (used) provided by financing activities | 1,020 | (275 | ) | |||||
| Net increase (decrease) in cash and cash equivalents | $ | (1,940 | ) | $ | (2,712 | ) | ||
Net Cash (Used) Provided in Operating Activities
Net cash used in operating activities for the nine months ended September 30, 2024 was approximately $2,960,000. This comprised a net loss for the period of approximately $3,574,000, and increased prepaid expenses (primarily insurance policies, outside services, and clinical trial operations services) of $592,000, offset by increased operating liabilities of $333,000. There were also non-cash adjustments reducing the net loss by $669,000 in stock option expense and $200,000 in shares of Common Stock issued for services.
Net cash used in operating activities for the nine months ended September 30, 2023 was approximately $2,423,000. This comprised a net loss for the period of approximately $3,930,000, and decreased operating liabilities of $383,000, offset by decreases in the following assets: grants receivable of $60,000 and prepaid expenses (primarily insurance policies and consulting services) of $356,000. There were also and noncash adjustments to net loss of $1,355,000 in stock option expense.
Net Cash (Used) Provided by Investing Activities
There was no cash used in investing activities for the nine month period ended September 30, 2024. In the nine months ended September 30, 2023, cash of $14,000 was invested in the purchase of laboratory equipment.
Net Cash (Used) Provided by Financing Activities
Net cash provided by financing activities for the nine months ended September 30, 2024 was approximately $1,020,000, received for the issuance of Common Stock. Net cash used in financing activities for the nine months ended September 30, 2023 was $275,000 in cash, of which $25,000 was used to fully repay a line of credit and $250,000 was used to fully repay a related party note.
Funding Requirements
We expect our expenses to increase substantially in connection with our ongoing R&D activities, particularly as we continue R&D, advance clinical trials of LP-10 and advance the preclinical development of our other programs, including LP-310. In addition, we expect to incur additional costs associated with operating as a public company. As a result, we expect to incur substantial operating losses and negative operating cash flows for the foreseeable future.
Based on our current operating plan, we believe that our existing cash and cash equivalents will be sufficient to fund our operations and capital expenses into 2025. However, we have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than we expect.
Because of the numerous risks and uncertainties associated with research, development and commercialization of LP-10, LP-310 and our other and future product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on, and could increase significantly as a result of, many factors, including, but not limited to, those referenced above in “— Results of Operations — Operating Expenses — Research and Development Expenses”.
Going Concern
The unaudited condensed financial statements of the Company have been prepared on a going concern basis, which contemplates the realization of assets and the discharge of liabilities in the normal course of business. We have generated losses from operations since inception. The Company expects operating losses to continue in the foreseeable future because of additional costs and expenses related to research and development activities, plans to expand its product portfolio, and increasing its market share. The Company’s ability to transition attaining profitable operations is dependent upon achieving a level of revenues adequate to support its cost structure. The timing and amount of our actual expenditures will be based on many factors, including cash flows from operations and the anticipated growth of our business.
Management of the Company may raise additional funds through the issuance of equity securities or debt. There can be no assurance that such financing will be available at terms acceptable to the Company, if at all. Failure to generate sufficient cash flows from operations and raise additional capital could have a material adverse effect on the Company’s ability to achieve its intended business objectives. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited condensed financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
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Off-Balance Sheet Arrangements
We did not have during the nine months ended September 30, 2024, or the year ended December 31, 2023, and we do not currently have, any off-balance sheet arrangements, as defined under applicable SEC rules.
Contractual Obligations
We did not have during the nine months ended September 30, 2024 or the year ended December 31, 2023, and we do not currently have, any material contractual obligations, such as license agreements or similar arrangements, other than as described below and in the financial notes to our unaudited condensed financial statements included in this Form 10-Q and in our Annual Report.
Employment Agreements
We are party to employment agreements with each of Drs. Kaufman and Chancellor and Mr. Johnston, executive officers of the Company, the material terms of each of which are described in the section entitled “Executive Compensation – Executive Employment Agreements” of our Annual Report, which descriptions are supplemented by the disclosure of the August 2023 amendments to our agreements with Drs. Kaufman and Chancellor contained in our Current Report on Form 8-K filed with the SEC on August 8, 2023, and as described in our Annual Report.
Lease Agreement
We are party to a lease agreement, dated June 1, 2019, with Bridgeway Development Corporation (“Bridgeway”), as amended, for the lease of 2,690 square feet of office and lab and manufacturing space in Pittsburgh, Pennsylvania commencing on July 1, 2020 (the “Lease”). The Lease term expires on September 30, 2025 and we have the right to exercise a one-time option to extend the Lease term for an additional five-year term. The annual base rent under the Lease is approximately $66,000. On July 26, 2023, the Company entered into a second lease for additional space on the fourth floor of the same building (the “Fourth Floor Lease,” and together with the Lease, the “Leases”), commencing August 1, 2023 and co-terminating with the Lease on June 30, 2025. Annual rent under the Fourth Floor Lease was approximately $28,000. As space became available in the immediate proximity to our existing offices at the beginning of 2024, we terminated the Fourth Floor Lease upon mutual agreement with the landlord and replaced it with a lease for Suite 504 (“the Suite 504 Lease”). The Suite 504 Lease is effective January 1, 2024 and the term co-terminates with the Lease. The annual base rent for the current year for the Suite 504 Lease is approximately $29,000. See Note 13 of the notes to our unaudited condensed financial statements included in this Form 10-Q for more details.
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Service Agreements
We enter into service agreements in the normal course of business with CROs and for clinical trials, preclinical research studies and testing, manufacturing, and other services and products for operating purposes. These contracts do not contain any minimum purchase commitments. Certain agreements provide for termination rights subject to termination fees or wind down costs. Under such agreements, we are contractually obligated to make certain payments to vendors, mainly to reimburse them for their unrecoverable outlays incurred prior to cancellation. The exact amounts of such obligations are dependent on the timing of termination, and the exact terms of the relevant agreement and cannot be reasonably estimated. The expense we incurred pursuant to these agreements for the nine months ended September 30, 2024 was approximately $694,000, which was an increase of approximately $93,000 over the $601,000 expense incurred for the nine months ended September 30, 2023. The spending was primarily attributable to expenses relating to our ongoing research and development work, and costs related to our clinical trials for LP-310 in 2024. in During the nine months ended September 30, 2023, spending was primarily related to oral toxicology testing for LP-310, along with FDA and grant writing support expenses.
Critical Accounting Policies and Significant Judgments and Estimates
This management’s discussion and analysis is based on our unaudited condensed financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make judgments and estimates that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the unaudited condensed financial statements and the reported amounts of expenses during the reported periods. We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts and experience. The effects of material revisions in estimates, if any, will be reflected in the financial statements prospectively from the date of change in estimates.
While our accounting policies are described in more detail in the notes to our financial statements included in our Annual Report, we believe the following accounting policies used in the preparation of our financial statements require the most significant judgments and estimates. See Note 3 of the notes to our financial statements in our Annual Report for a description of our other significant accounting policies.
Accrued Expenses
As part of the process of preparing our financial statements, we are required to estimate our accrued third-party R&D expenses as of each balance sheet date. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf, and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make estimates of our accrued expenses as of each balance sheet date based on facts and circumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service providers and make adjustments if necessary. The significant estimates in our accrued R&D expenses include the costs incurred for services performed by our vendors in connection with R&D activities for which we have not yet been invoiced.
We base our expenses related to R&D activities on our estimates of the services received and efforts expended pursuant to quotes and contracts with vendors that conduct R&D activities on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the R&D expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaid balance accordingly. Non-refundable advance payments for goods and services that will be used in future R&D activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.
Although we do not expect our estimates to be materially different from amounts incurred, if our estimates of the status and timing of services performed differ from the actual status and timing of services performed, it could result in us reporting amounts that are too high or too low in any particular period. To date, there have been no material differences between our estimates of such expenses and the amounts incurred.
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Stock-Based Compensation
We measure stock-based compensation based on the grant date fair value of the stock-based awards and recognize stock-based compensation expense on a straight-line basis over the requisite service period of the awards, which is generally the vesting period of the respective award. For non-employee awards, compensation expense is recognized as the services are provided, which is generally ratably over the vesting period. We account for forfeitures as they occur. On January 1, 2018, we adopted, using the modified retroactive approach, the guidance of Accounting Standard Update 2018-07, Compensation — Stock Compensation (Topic 718) — Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”), and account for awards to non-employees using the grant date fair value without subsequent periodic remeasurement. The adoption of ASU 2018-07 did not have a material effect on our financial statements.
We classify stock-based compensation expense in our statements of operations in the same manner in which the award recipient’s salary and related costs are classified or in which the award recipient’s service payments are classified. In future periods, we expect stock-based compensation expense to increase, due in part to our existing unrecognized stock-based compensation expense and as we grant additional stock-based awards to continue to attract and retain our employees.
We determine the fair value of restricted Common Stock awards granted based on the fair value of our Common Stock. We have historically determined the fair value of the underlying Common Stock based on input from management and the board of directors and the Company’s enterprise value determined utilizing various methods, including the “back-solve” method. The total enterprise value, determined from the back-solve method, is historically then allocated to the various outstanding equity instruments, including the underlying Common Stock, utilizing the option pricing method (“OPM”) or a hybrid of the probability-weighted expected return method (“PWERM”) and the OPM.
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that approximates the expected term of the option, and our expected dividend yield. As the public market for our Common Stock has been limited and prior to the IPO there was no such public market, we have historically determined the volatility for awards granted based on an analysis of reported data for a group of guideline companies that issued options with substantially similar terms. The expected volatility has been determined using a weighted-average of the historical volatility measures of this group of guideline companies along with our own. We expect to continue estimating expected volatility based on the group of guideline companies until we have adequate historical data regarding the volatility of our own traded stock price. The expected term of our stock options granted to employees and non-employees has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. We have not paid, and do not anticipate paying, dividends on our Common Stock; therefore, the expected dividend yield is assumed to be zero.
As there was no public market for our Common Stock prior to the IPO, the estimated fair value of our Common Stock prior to our IPO had been approved by our board of directors, with input from management, as of the date of each award grant, considering our most recently available independent third-party valuations of our Common Stock and any additional objective and subjective factors that we believed were relevant and which may have changed from the date of the most recent valuation through the date of each award grant. We estimated the value of our equity using the market approach and a precedent transaction method which “back-solves” the equity value that yielded a specific value for our Series A Stock. We allocated the equity value to our Common Stock and shares of our Series A Stock using either an OPM or a hybrid method, which is a hybrid between the OPM and the PWERM. The hybrid method we utilized estimated the probability-weighted value across multiple scenarios but used the OPM to estimate the allocation of value within at least one of the scenarios. In addition to the OPM, the hybrid method considered the IPO scenario in which the shares of our Series A Preferred Stock converted to Common Stock. The future value of the Common Stock in the IPO scenario was discounted back to the valuation date at an appropriate risk adjusted discount rate. In the hybrid method, the present value indicated for each scenario was probability weighted to arrive at an indication of value for our Common Stock.
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In addition to considering the results of the valuations, management considered various objective and subjective factors to determine the fair value of our Common Stock as of each grant date, which may be a date later than the most recent third-party valuation date, including:
| ● | the prices of our Series A Preferred Stock sold to or exchanged between outside investors in arm’s length transactions, if any, and the rights, preferences and privileges of our Series A Preferred Stock as compared to those of our Common Stock, including the liquidation preferences of our Series A Preferred Stock; | |
| ● | the progress of our R&D efforts, including the status of preclinical studies; | |
| ● | the lack of liquidity of our equity as a private company; | |
| ● | our stage of development and business strategy and the material risks related to our business and industry; | |
| ● | the achievement of enterprise milestones; | |
| ● | the valuation of publicly traded companies in the life sciences and biotechnology sectors, as well as recently completed mergers and acquisitions of peer companies; | |
| ● | any external market conditions affecting the biotechnology industry, and trends within the biotechnology industry; | |
| ● | the likelihood of achieving a liquidity event for the holders of our Series A Preferred Stock and Common Stock, such as an IPO, or a sale of the Company, given prevailing market conditions; and | |
| ● | the analysis of IPOs and the market performance of similar companies in the biopharmaceutical industry. |
There are significant judgments and estimates inherent in these valuations. These judgments and estimates included assumptions regarding our future operating performance, the stage of development of our programs, the timing of a potential offering, or other liquidity event, and the determination of the appropriate valuation methodology at each valuation date. The assumptions underlying these valuations represented management’s best estimates, which involve inherent uncertainties and the application of management judgment. As a result, if factors or expected outcomes change and we use significantly different assumptions or estimates, our stock-based compensation expense could be materially different. Subsequent to the completion of the IPO, the fair value of our Common Stock has been determined based on the market price of our Common Stock on Nasdaq.
With respect to stock options granted during the nine months ended September 30, 2024 and 2023, the following table sets forth by grant date the (i) number of shares of our Common Stock issuable upon exercise of such stock options, (ii) per share exercise price of such options and (iii) estimated fair value per share of our Common Stock on each such date. We did not grant any shares of restricted Common Stock during this period.
| Grant date |
Number of shares
of Common Stock issuable upon exercise of stock options granted |
Exercise price
per share of Common Stock |
Estimated fair
value per share of Common Stock at grant date |
|||||||||
| 03/15/24 | 55,000 | $ | 6.16 | $ | 4.40 | |||||||
| 06/16/23 | 53,000 | $ | 17.52 | $ | 12.00 | |||||||
The per share values at each such grant date, which we applied to determine the per share estimated fair value of the respective awards for accounting purposes, were based upon the calculations described above used to determine the fair value of our Common Stock as of each grant date.
Emerging Growth Company Status
In April 2012, the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” may take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Therefore, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected to avail ourselves of this extended transition period and, as a result, we will not be required to adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.
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In addition, as an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include, among other things:
| ● | reduced disclosure about the compensation paid to our executive officers; | |
| ● | not being required to submit to our stockholders’ advisory votes on executive compensation or golden parachute arrangements; | |
| ● | an exemption from the auditor attestation requirement in the pursuant to the Sarbanes-Oxley Act of 2002; and | |
| ● | an exemption from compliance with any new requirements adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation. |
We may take advantage of these exemptions until such time that we are no longer an emerging growth company. We would cease to be an emerging growth company upon the earliest of
| ● | the last day of the fiscal year on which we have $1.235 billion or more in annual revenue; | |
| ● | the date on which we become a “large accelerated filer” (i.e., as of our fiscal year end, the total market value of our common equity securities held by non-affiliates is $700 million or more as of September 30); | |
| ● | the date on which we issue more than $1.0 billion of non-convertible debt over a three-year period; or | |
| ● | the last day of our fiscal year following the fifth anniversary of the date of the completion of the IPO. |
We may choose to take advantage of some but not all of these exemptions.
Recent Accounting Pronouncements
We have reviewed all recently issued accounting pronouncements and have determined that, other than as disclosed in Note 3 to our unaudited condensed financial statements included in this Report, such standards will not have a material impact on our financial statements or do not otherwise apply to our operations.
Item 3. Quantitative and Qualitative Disclosures about Market Risk.
As a smaller reporting company, as defined in Item 10(f)(1) of Regulation S-K, we are not required to provide the information required by this Item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including the Chief Executive Officer and Chief Financial Officer, the Company conducted an evaluation of the effectiveness of its disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of the end of the period covered by this report. Disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports the Company files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to management, including the Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure. Based on this evaluation, the Company’s management, including the Chief Executive Officer and Chief Financial Officer, concluded that its disclosure controls and procedures were effective as of September 30, 2024.
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Changes in Internal Controls
There were no changes in the Company’s internal control over financial reporting that occurred during the three months ended September 30, 2024, that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.
Limitations of the Effectiveness of Controls
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include, but are not limited to, the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple errors. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
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第二部分 其他資訊
項目 1. 法律訴訟。
時常，我們可能成為法律訴訟、索賠或訴訟的對象，這些是業務運作中常見的情況。目前根據我們管理層的意見，我們並未成為任何法律訴訟的一方，如果有利於我們，將對我們的業務、營運結果、財務狀況或現金流產生重大不利影響。
項目 1A. 風險因素。
我們的業務、財務狀況和營運成果受許多風險因素影響，包括我們已知的和下文標明的風險，以及不時可能出現的其他風險。這些風險和不確定因素並非我們面臨的唯一風險，我們現在還不知道的或目前認為不重要的其他風險和不確定因素也可能損害我們的業務營運。這些風險因素可能導致我們的實際結果與本報告以及其他地方所建議的前瞻性陳述有實質不同的情況，並可能不利影響我們的業務、財務狀況或營運成果。如果任何這些風險因素發生，此外，我們的普通股交易價格可能下跌，我們的普通股投資者可能會損失全部或部分投資。這些風險因素以及本報告中包含的其他信息應仔細考慮，以評估我們的前景。
我們 已收到納斯達克的通知，指出我們未能符合某些持續上市要求；如果我們無法恢復符合所有適用的持續上市要求及納斯達克的標準，我們的普通股可能會被從納斯達克退市。
我們的普通股目前在納斯達克資本市場上市。為了維持該上市地位，我們必須滿足最低金融和其他持續上市要求及標準，包括關於董事獨立和獨立委員會要求、最低股東權益、最低股價和某些公司治理要求的規定。
根據我們於2024年4月19日向美國證券交易委員會（SEC）提交的8-k表格，我們在2024年4月17日收到一份書面通知人員，告知我們未能達到最低買盤價格要求，因為我們的普通股收盤買盤價格連續三十（30）個業務日低於每股1.00美元。
根據我們於2024年8月23日向美國證券交易委員會提交的8-K表格當前報告中透露的資訊，我們於2024年8月21日收到來自主管機構的信件，表示我們未能符合股東權益要求。我们在截至2024年6月30日的季度的10-Q表格季度報告中報告的股東權益為1,703,798美元，因此我們未能符合股東權益要求。
正如我們在2024年10月18日向美國證券交易委員會（SEC）提交的8-k表格的當前報告中披露的，工作人員於2024年10月16日通知我們， 將從納斯達克資本市場除牌普通股，對此我們迅速對該通知提出了上訴請求。 納斯達克聽證會日期定於2024年12月12日。在上訴過程尚未結束之前，普通股在納斯達克資本市場的交易暫停將持續生效， 直到聽證過程結束且小組發出決定為止。公司正在努力恢復對最低買盤價格要求及股東權益要求的符合性。
目前無法保證我們能再次達到最低買盤價要求或股東權益要求，如果日後我們再次達到最低買盤價要求或股東權益 要求，則不能保證我們將能夠繼續遵守所有適用的納斯達克上市要求，無論現在還是將來。如果我們無法遵守這些納斯達克 的要求，我們的普通股將從納斯達克資本市場摘牌。
如果我們的普通股因未能遵守最低買盤價格要求或股東權益要求，而被納斯達克資本市場退市，或由於我們未能持續遵守納斯達克資本市場的任何其他持續上市要求，而不符合在其他交易所上市的資格，那麼我們的普通股在場外交易市場或設立的電子公告板上進行交易的可能性就會增加，這些市場如粉紅市場或其他由場外交易市場集團運營的場外市場。在這種情況下，處置我們的普通股或獲得準確的價格報價可能會變得更加困難，而且可能更難獲得證券分析師和資訊媒體的報導，這可能會導致我們的普通股價格進一步下跌。此外，如果我們未在國家交易所上市，則可能會難以籌集額外資本。
項目 2. 未註冊的股票出售和籌集資金用途。
無。
項目 3. 違約處理
無。
Item 4. Mine Safety Disclosures.
Not applicable.
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Item 5. Other Information.
None.
Item 6. Exhibits.
In accordance with SEC Release 33-8238, Exhibits 32.1 and 32.2 are being furnished and not filed.
| * | Filed herewith. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Lipella Pharmaceuticals Inc. | ||
| Date: November 14, 2024 | By: | /s/ Jonathan Kaufman |
| Jonathan Kaufman | ||
| President and Chief Executive Officer | ||
| (Duly Authorized Officer and Principal Executive Officer) | ||
| Date: November 14, 2024 | By: | /s/ Douglas Johnston |
| Douglas Johnston | ||
| Chief Financial Officer | ||
| (Duly Authorized Officer and Principal Financial and Accounting Officer) | ||
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