美國
證券交易委員會
華盛頓特區20549
表格
（標記一）
根據1934年證券交易法第13或15(d)節的季度報告 |
截至季度結束日期的財務報告
或者
根據1934年證券交易法第13或15(d)節的轉型報告書 |
第過渡期
委託文件編號：001-39866
(根據其章程規定的註冊人準確名稱)
（設立或組織的其他管轄區域） |
（納稅人識別號碼） |
，（主要行政辦公地址） |
(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：
每一類的名稱 |
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交易 符號: |
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在其上註冊的交易所的名稱 |
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請打勾表示該註冊機構（1）在過去的12個月內（或註冊機構需要提出此類報告的較短時期內）已提交所有根據1934年證券交易法第13或15（d）節規定需要提交的報告，(2)過去90天一直受到此類提交要求的影響。是 ☐
用複選標記註明註冊人是否在過去 12 個月（或要求註冊人提交此類文件的較短期限）內以電子方式提交了根據第 S-T 法規（本章第 232.405 節）第 405 條要求提交的每份交互式數據文件。是的 ☐
勾選以下選框，指示申報人是大型加速評估提交人、加速評估提交人、非加速評估提交人、小型報告公司或新興成長型公司。關於「大型加速評估提交人」、「加速評估提交人」、「小型報告公司」和「新興成長型公司」的定義，請參見《交易所法規》第12億.2條。
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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如果是新興成長型企業，請勾選複選標記，表明註冊者已選擇不使用延長過渡期來符合根據證券交易法第13(a)條規定提供的任何新財務會計準則。
請勾選「是」，如果報告人是外殼公司（定義見證券交易法規則12b-2）。是 ☐ 沒有
截至2024年11月4日，註冊人員已
目錄
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頁面 |
第一部分 |
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第 1 項。 |
1 |
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1 |
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2 |
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3 |
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4 |
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5 |
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第 2 項。 |
35 |
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第 3 項。 |
47 |
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第 4 項。 |
47 |
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第二部分。 |
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第 1 項。 |
49 |
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第 1A 項。 |
49 |
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第 2 項。 |
50 |
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第 3 項。 |
50 |
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第 4 項。 |
50 |
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第 5 項。 |
50 |
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第 6 項。 |
50 |
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52 |
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除非上下文另有說明，在本季度報告中提到「公司」、「Celularity」、「我們」、「我們」和類似術語指的是Celularity Inc.及其合併子公司。
Celularity標誌、Celularity IMPACt、Biovance、Interfyl、Lifebank、CentaFlex和Celularity Inc.在本季度報告中出現的其他商標或服務標誌均爲Celularity Inc.所有。此10-Q表中還包含其他公司的註冊商標、商標和商號。此處出現的所有其他商標、註冊商標和商號均爲其各自持有者所有
2024年2月28日，我們對我們的A類普通股進行了1比10的逆向股票拆分。除非本季度10-Q表中另有規定，所有股份和每股信息均已調整以反映逆向股票拆分。
i
有關前瞻性聲明之特別說明
本季度報告中包含的部分陳述，包括題爲「管理對財務狀況和經營結果的討論與分析」的部分，構成根據1933年修訂版證券法第27A條及證券法，以及1934年證券交易法第21E條的涉及的前瞻性陳述。前瞻性陳述涉及對期望、信念、投影、未來計劃和策略、預期事件或趨勢以及類似表達的事項的看法，這些事項並非歷史事實。這些陳述涉及我們未來的事件，包括我們預期的經營、研究、開發和商業化活動、臨床試驗、經營結果和財務狀況。這些前瞻性陳述涉及已知和未知的風險、不確定性和其他因素，這些因素可能導致我們的實際結果、業績或成就與前瞻性陳述中明示或暗示的任何未來結果、業績或成就大相徑庭。前瞻性陳述可能包括但不限於明示或暗示的有關:
這些前瞻性陳述基於本季度報告日期可獲得的信息，以及當前的預期、預測和假設，並涉及一系列風險和不確定性，這些風險和不確定性可能導致我們的實際結果、表現或成就與前瞻性陳述所揭示或暗示的任何未來結果、表現或成就大相徑庭。導致實際結果有所不同的一些因素包括：
ii
有關這些因素以及其他可能導致我們未來業績或交易與任何前瞻性聲明中所表達的結果顯著不同的進一步討論，請參閱我們於2024年7月30日向證券交易委員會提交的《2023年10-k表格》中標題爲「風險因素」的部分。鑑於這些風險，您不應過度依賴任何基於我們目前可獲得信息的前瞻性聲明。
iii
對於發表前瞻性聲明的第三方）。儘管前瞻性聲明反映了我們的真誠信念，但它們並非對未來業績的保證。除非適用法律要求的範圍，我們無需（並明確否認任何此類義務）更新或修訂其前瞻性聲明，無論是基於新信息、未來事件或其他原因。
iv
第一部分—財政財務信息
項目1。基本報表。
Celularity 公司。
精簡合併資產負債表簡明合併資產負債表
（以千爲單位，除股份數量和每股金額外）
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6月30日, |
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12月31日, |
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(未經審計) |
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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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應收賬款淨額爲 |
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應收票據 |
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庫存 |
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預付費用和其他流動資產 |
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總流動資產 |
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資產和設備，淨值 |
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商譽 |
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無形資產, 淨額 |
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租賃權-運營租賃資產 |
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受限現金 |
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存貨淨額（扣除流動部分） |
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其他長期資產 |
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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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應計費用及其他流動負債 |
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Accrued R&D software |
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Short-term debt - unaffiliated (includes debt measured at fair value of $ |
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Short-term debt - related parties |
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遞延收入 |
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流動負債合計 |
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遞延收入，減去當前部分淨額 |
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併購相關的應計對價 |
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非流動租賃負債-經營性 |
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認股權負債 |
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遞延所得稅負債 |
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其他負債 |
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負債合計 |
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股東權益 |
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優先股，$0.0001 |
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普通股，每股面值$ |
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額外實收資本 |
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累積赤字 |
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( |
) |
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( |
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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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隨附說明是這些簡明合併財務報表的一部分。
1
Celularity 公司。
壓縮的合併現金流量表損益及綜合損失表（未經審計）
（以千爲單位，除股份數量和每股金額外）
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截至6月30日的三個月 |
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截至6月30日的六個月 |
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2024 |
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2023 |
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2024 |
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2023 |
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收入 |
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產品銷售淨額 |
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$ |
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$ |
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$ |
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$ |
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服務 |
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許可、 版稅和其他 |
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總淨收入 |
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營業費用 |
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營業成本（不包括獲得的無形資產攤銷） |
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產品銷售 |
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服務 |
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許可，特許權和其他 |
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研發 |
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軟件停止使用成本 |
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銷售、一般及行政費用 |
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變動中的待收妥求值責任負債 |
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( |
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商譽減值 |
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知識產權研發（IPR&D）減值 |
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取得的無形資產攤銷 |
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營業費用總計 |
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經營虧損 |
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( |
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( |
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其他收入（支出）： |
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利息收入 |
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利息支出 |
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( |
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( |
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( |
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( |
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權證負債公允價值變動 |
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( |
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債務公允價值變動 |
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( |
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( |
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( |
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債務清償損失 |
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( |
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其他費用，淨額 |
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( |
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( |
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( |
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( |
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其他收入（支出）總額 |
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( |
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( |
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( |
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稅前虧損 |
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( |
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( |
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( |
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所得稅費用（收益） |
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淨損失 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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由於信用風險變化導致的債務公允價值變動，稅後淨額 |
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( |
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其他綜合收益 |
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綜合損失 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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股份信息： |
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基本和稀釋每股淨損失 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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基本和稀釋後的流通股數平均權重 |
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隨附說明是這些簡明合併財務報表的一部分。
2
Celularity 公司。
簡明合併股票報表持有人權益（未經審計）
（單位：千元，股份數量除外）
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普通股 |
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額外的 |
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累積的 |
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其他綜合收益累積額 |
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總計 |
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股份 |
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金額 |
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資本 |
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$ |
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收益（損失） |
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股權 |
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2024年1月1日餘額 |
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$ |
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$ |
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$ |
( |
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$ |
- |
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$ |
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發行普通股給Yorkville以延長債務和SEPA承諾費用 |
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- |
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- |
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- |
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發行和修改權證給RWI和C.V. Starr |
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- |
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- |
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- |
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- |
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PIPE融資發行普通股和開空，扣除發行費用淨額 |
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- |
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- |
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受限制股票單位解除限制 |
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- |
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- |
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- |
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- |
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限制性股票單位歸屬所得稅代扣 |
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( |
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- |
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( |
) |
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- |
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- |
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( |
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以普通股向palantir支付解決協議作爲對價 |
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- |
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- |
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- |
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與股票逆向拆分相關的股份養老 |
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( |
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- |
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- |
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- |
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- |
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- |
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股票補償費用 |
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- |
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- |
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- |
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- |
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淨損失 |
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- |
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- |
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- |
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( |
) |
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- |
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( |
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2024年3月31日的結餘 |
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( |
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- |
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作爲和解協議的補償發行給palantir的認股權證 |
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- |
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- |
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- |
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向RWI和C.V. Starr發行和修改認股權證 |
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- |
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- |
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( |
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- |
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|
- |
|
|
|
( |
) |
受限制股票單位解除限制 |
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
解禁受限制股份單位時的稅款代扣 |
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
股票補償費用 |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||
淨損失 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
2024年6月30日的餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
- |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
2023年1月1日的餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|||||
行使股票期權 |
|
|
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|||
根據短期債務轉換髮行普通股 |
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
( |
) |
|
|
|
||||
PIPE發行的普通股數量，扣除發行費用 |
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||||
發行用於研究開發的幹細胞的普通股 |
|
|
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|||
受限制股票單位解除限制 |
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
受限制股單位解鎖時的稅金代扣 |
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
( |
) |
根據ATM協議發行普通股 |
|
|
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|||
在高級擔保橋貸上發行認股權證 |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||
股票補償費用 |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||
由於信用風險變化導致債務公允價值變動，稅後 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
||
淨損失 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
2023年3月31日的餘額 |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|||||
行使股票期權 |
|
|
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|||
根據短期債務轉換髮行的普通股 |
|
|
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
( |
) |
|
|
|
|||
普通股在PIPE Offering中發行，扣除發行費用 |
|
|
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|||
普通股在Registered Direct Offering中發行，扣除發行費用 |
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||||
受限制股票單位解除限制 |
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
股票限制單位解禁時的稅收代扣 |
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
( |
) |
發行權證（C.V. Starr和RWI） |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||
股票補償費用 |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||
由於信用風險的變化導致債務公允價值的變動，扣除稅款後的淨值變化 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
淨損失 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
2023年6月30日的餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|||||
隨附說明是這些簡明合併財務報表的一部分。
3
Celularity 公司。
壓縮的合併現金流量表現金流量表（未經審計）
（以千計）
|
|
截至6月30日的六個月 |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
經營活動現金流量： |
|
|
|
|
|
|
||
淨損失 |
|
$ |
( |
) |
|
$ |
( |
) |
調整爲淨損失到經營活動現金流量淨使用： |
|
|
|
|
|
|
||
折舊和攤銷 |
|
|
|
|
|
|
||
非現金租賃費 |
|
|
|
|
|
( |
) |
|
應收賬款減值準備 |
|
|
|
|
|
|
||
存貨貶值準備 |
|
|
( |
) |
|
|
- |
|
權證負債公允價值變動 |
|
|
|
|
|
( |
) |
|
商譽減值 |
|
|
- |
|
|
|
|
|
知識產權研發（IPR&D）減值 |
|
|
- |
|
|
|
|
|
股票補償費用 |
|
|
|
|
|
|
||
應計可變對價公允價值變動 |
|
|
- |
|
|
|
( |
) |
收購的未完成研發項目 |
|
|
- |
|
|
|
|
|
發行普通股用於幹細胞研究和開發 |
|
|
- |
|
|
|
|
|
發行普通股給palantir作爲和解協議的考慮 |
|
|
|
|
|
- |
|
|
與Yorkville債務延期和SEPA承諾費相關的普通股發行 |
|
|
|
|
|
- |
|
|
因RWI貸款安排（關聯方）而產生的折扣 |
|
|
- |
|
|
|
|
|
待定股票考慮的公正價值變動 |
|
|
- |
|
|
|
( |
) |
債務清償損失 |
|
|
|
|
|
- |
|
|
債務公正價值變動 |
|
|
( |
) |
|
|
|
|
非現金利息支出 |
|
|
|
|
|
- |
|
|
其他，淨額 |
|
|
( |
) |
|
|
|
|
資產和負債變動： |
|
|
|
|
|
|
||
應收賬款 |
|
|
( |
) |
|
|
|
|
庫存 |
|
|
|
|
|
( |
) |
|
預付款項和其他資產 |
|
|
|
|
|
|
||
應付賬款 |
|
|
( |
) |
|
|
|
|
應計費用及其他負債 |
|
|
|
|
|
|
||
積累的研發&D軟件 |
|
|
( |
) |
|
|
|
|
租賃負債-經營 |
|
|
|
|
|
|
||
遞延收入 |
|
|
|
|
|
|
||
經營活動使用的淨現金流量 |
|
|
( |
) |
|
|
( |
) |
投資活動現金流量： |
|
|
|
|
|
|
||
資本支出 |
|
|
( |
) |
|
|
( |
) |
Sanuwave可轉換應收票據的收益 |
|
|
|
|
|
- |
|
|
購買已獲得的研發中的研究 |
|
|
- |
|
|
|
( |
) |
投資活動產生的淨現金流量 |
|
|
|
|
|
( |
) |
|
籌資活動產生的現金流量： |
|
|
|
|
|
|
||
來自warrants和短期債務-關聯方的收益 |
|
|
|
|
|
|
||
來自注冊直接發行的收益 |
|
|
- |
|
|
|
|
|
行使期權所得款項 |
|
|
- |
|
|
|
|
|
償還短期債務 - 與非關聯方 |
|
|
( |
) |
|
|
( |
) |
短期債務發行收益 - 與非關聯方 |
|
|
|
|
|
- |
|
|
支付SEPA承諾費用 |
|
|
( |
) |
|
|
- |
|
償還短期債務 - 與關聯方 |
|
|
( |
) |
|
|
- |
|
PIPE融資收益 |
|
|
|
|
|
|
||
在ATM發行中出售普通股的收益 |
|
|
- |
|
|
|
|
|
PIPE支付和其他發行成本 |
|
|
- |
|
|
|
( |
) |
限制性股票單位歸屬所得稅代扣 |
|
|
( |
) |
|
|
( |
) |
籌資活動產生的現金淨額 |
|
|
|
|
|
|
||
現金，現金等價物和受限現金淨增加（減少） |
|
|
|
|
|
( |
) |
|
期初現金、現金等價物及受限制的現金餘額 |
|
|
|
|
|
|
||
期末現金、現金等價物及受限制的現金餘額 |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
現金流量補充披露： |
|
|
|
|
|
|
||
支付的利息現金 |
|
$ |
|
|
$ |
|
||
補充非現金投融資活動: |
|
|
|
|
|
|
||
計入應付賬款和應計費用的固定資產 |
|
$ |
( |
) |
|
$ |
( |
) |
修改了C.V. Starr的warrants以配合寬限 |
|
$ |
|
|
$ |
- |
|
|
發行RWI的warrants以配合寬限 |
|
$ |
|
|
$ |
- |
|
|
發行了資產抵押橋貸的warrants |
|
$ |
- |
|
|
$ |
|
|
包括在應計費用中的PIPE相關發行成本 |
|
$ |
- |
|
|
$ |
( |
) |
爲短期債務轉換髮行的普通股 |
|
$ |
- |
|
|
$ |
|
|
在長期債務-關聯方中計入的資產抵押貸款利息 |
|
$ |
- |
|
|
$ |
( |
) |
隨附說明是這些簡明合併財務報表的一部分。
4
Celularity 公司。
未經審計的基本報表註釋未經審計的基本報表附註
(以千爲單位，除每股數據外)
Celularity公司（"Celularity”或"公司”），前身爲GX Acquisition Corp.（"GX”），是一家於2018年8月24日在特拉華州成立的空白支票公司。該公司成立的目的是通過與一家或多家公司進行合併、資本股票交易、資產收購、股份購買、重組或其他類似的業務組合。
2021年7月16日（"結束日期”），公司完成了根據2021年1月8日簽署的《合併協議和重組計劃》（"合併協議”）進行的先前宣佈的合併，該合併協議由GX、Alpha First Merger Sub, Inc.，一家特拉華州公司和GX的直接全資子公司（"First Merger Sub”）、Celularity LLC（前身爲Alpha Second Merger Sub LLC），一家特拉華州有限責任公司和GX的直接全資子公司（"Second Merger Sub”）以及以Celularity Inc.的名義成立的實體（以下簡稱"Legacy Celularity”）共同簽署。完成合並交易後，GX更名爲Celularity公司。
業務描述
Celularity是一家專注於解決與老齡化相關疾病的細胞療法和再生醫學公司，包括癌症和變性疾病。Celularity總部位於新澤西州弗洛姆帕克。傳統的Celularity於2017年8月從Celgene公司（與Bristol Myers Squibb公司合併的全球生物技術公司）收購了Anthrogenesis Corporation（「Anthrogenesis」）。此前，Anthrogenesis作爲Celgene細胞治療部門運營。
公司面臨着與生物技術行業初創公司常見的風險和不確定性，包括但不限於，競爭對手開發新技術創新，依賴關鍵人員，保護專有技術，遵守政府監管規定，以及獲得額外資金以資助業務。目前正在開發的藥物候選品在商業化之前將需要獲得重大的批准，包括廣泛的臨床和臨床前測試以及監管批准。這些工作需要大量額外的資本、足夠的人員和基礎設施，以及廣泛的合規報告能力。即使公司的藥物開發工作取得成功，公司何時能從細胞療法產品銷售中實現重要營業收入是不確定的。
企業持續經營評估
公司已經評估是否存在一系列條件和事件，綜合考慮，這些條件和事件對公司在發佈精簡合併財務報表後的一年內繼續作爲營業實體存在構成重大疑慮。
作爲一家新興的臨床階段生物技術公司，Celularity受到與企業發展相關的某些固有風險和不確定性的影響。在這方面，自公司成立以來，管理層的幾乎所有努力都致力於投資於基礎科學研究，包括胎盤來源異基因細胞的基礎科學研究，爲其當前和未來的細胞治療臨床項目提供支持的臨床前研究，以及其細胞項目的臨床開發以及支持其核心業務運營的設施、銷售、普通管理和行政開支（統稱爲「投資」），所有這些都是以公司短期盈利能力爲代價。公司歷來通過從生物庫存和退行性疾病業務產生的有限營收以及向公衆和私人投資者發行股權和債務證券（這些發行統稱爲「外部資本」）來資助這些投資。儘管有這些努力，管理層不能保證公司的研發和商業化工作將成功完成，也不能保證公司的知識產權能夠得到充分保護。即使這些努力取得成功，公司何時能夠產生顯著銷售或以盈利方式運營以維持公司的運營，而不需要繼續依賴外部資本仍然是不確定的。
截至附表中的簡明合併財務報表的發行日期，或者發行日期，管理層評估了以下不利條件和事件的重要性，以考慮其作爲持續經營實體的能力：
5
這些不確定性對公司繼續作爲持續經營者提出了重大疑慮。附帶的簡明綜合財務報表是在公司將繼續作爲持續經營者的基礎上編制的，這預示着公司將能夠在可預見的未來通過正常經營活動實現資產並償付債務和承諾。因此，附帶的簡明綜合財務報表不包括可能由於這些不確定性結果而導致的任何調整。
報告範圍
公司的未經審計的簡明綜合財務報表是根據美國通用會計準則（「GAAP」）編制的。未經審計的簡明綜合財務報表包括全資子公司的賬目，在清理完畢內部公司帳戶和交易後。此處呈現的未經審計的簡明綜合財務信息反映了所有管理層認爲對於以公平的方式表述所提供的財務狀況、經營成果和現金流量的期間所必要的財務信息。
公司的簡明綜合財務報表是根據美國證券交易委員會（「SEC」）有關中期財務報表呈現的規則編制的，這些規則允許對某些披露進行簡化或省略。這些財務報表應當結合公司截至2023年12月31日的年度財務報表閱讀，該財務報表包含在於2024年7月30日提交給SEC的Form 10-k年度報告中（「2023 Form 10-K」）。
管理層認爲，附帶的中期財務報表包括所有正常和經常性調整（主要由應計、估計和影響財務報表的假設構成）被認爲是必要的，以公平地呈現公司截至2024年6月30日的合併財務狀況，以及其合併經營成果和現金流量的六個月。
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截至 2024 年 6 月 30 日和 2023 年 6 月 30 日的月。截至2024年6月30日的三個月和六個月的經營業績不一定代表截至2024年12月31日的財年的預期業績.
估算值的使用
根據公認會計原則編制公司的簡明合併財務報表要求管理層做出估算和假設，這些估算和假設會影響報告的資產和負債金額、簡明合併財務報表發佈之日的或有資產和負債的披露以及報告期內報告的收入和支出金額。這些簡明合併財務報表中反映的重要估計和假設包括但不限於與公司的商譽和無形資產減值評估、增量借款利率的確定、研發費用的應計以及庫存、或有對價、短期債務、股票期權和股票認股權證的估值相關的假設。該公司的估計基於歷史經驗、已知趨勢以及其認爲在當時情況下合理的其他特定市場因素或其他相關因素。當情況、事實和經驗發生變化時，管理層會持續評估其估計。估計值的變化記錄在得知時期。實際結果可能與這些估計有所不同。
公允價值測量
根據公認會計原則，公司的某些資產和負債按公允價值記賬。公允價值的定義是，在計量之日，在市場參與者之間的有序交易中，資產或負債在本市或最有利的市場上爲轉移負債（退出價格）而獲得的交易所收取或爲轉移負債（退出價格）而支付的交易價格。用於衡量公允價值的估值技術必須最大限度地利用可觀察的投入，並最大限度地減少不可觀察投入的使用。按公允價值記賬的金融資產和負債應按公允價值層次結構的以下三個級別之一進行分類和披露，其中前兩個級別被認爲是可觀察的，最後一個被認爲是不可觀察的：
•級別1 —相同資產或負債在活躍市場的報價。
• 第 2 級 — 可觀察的輸入（不包括一級報價），例如活躍市場中類似資產或負債的報價、相同或相似資產或負債不活躍的市場的報價，或其他可觀察到或可觀測的市場數據可以證實的輸入。
• 第 3 級 — 幾乎沒有或根本沒有市場活動支持的不可觀察的投入，這些活動對確定資產或負債的公允價值具有重要意義，包括定價模型、貼現現金流方法和類似技術。
綜合收益（虧損）
綜合收益（虧損）是指根據公認會計原則包含在綜合收益（虧損）中，但不包括在淨收益（虧損）中的收入、支出、收益和虧損，因爲這些金額直接記錄爲累計其他綜合收益（虧損）的調整。公司其他綜合收益（虧損）的唯一組成部分由公允價值期權下的負債公允價值變動總額中可歸因於特定工具信用風險變化的部分組成。在截至2024年6月30日的六個月中，公司沒有其他綜合收益（虧損）的一部分。在截至2023年6月30日的六個月中，該公司記錄的特定工具信用風險收入爲美元
所得稅
公司使用資產負債法對所得稅進行入賬，該方法要求確認遞延所得稅資產和負債，以應對簡明合併財務報表或公司納稅申報表中確認的事件的預期未來稅收後果。遞延所得稅資產和負債是根據財務報表與資產負債的納稅基礎之間的差異確定的，使用預計差異將逆轉的年份的現行稅率。遞延所得稅資產和負債的變化記錄在所得稅準備金中。公司評估了從未來應納稅所得額中收回遞延所得稅資產的可能性，並根據現有證據的權重，認爲遞延所得稅資產的全部或部分可能無法變現，估值補貼是通過向所得稅支出扣除來確定的。通過估算預期的未來應納稅利潤並考慮謹慎可行的稅收籌劃策略，來評估遞延所得稅資產的回收潛力。在截至2024年6月30日和2023年6月30日的六個月中，沒有產生所得稅支出.
每股淨收益（虧損）
基本 普通股每股淨收益（虧損）的計算方法是將淨收益（虧損）除以每個時期已發行普通股的加權平均數。普通股的攤薄後每股淨收益（虧損）包括可能行使或轉換證券（例如可贖回可轉換優先股、可轉換債務、股票期權、限制性股票單位和認股權證）所產生的影響（如果有），這將導致普通股增量發行。但是，
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潛在 普通股股份在產生抗稀釋效應時被排除在外。公司出現淨虧損時，基礎每股淨虧損的加權平均普通股股份數與稀釋每股淨虧損相同，因爲當出現淨虧損時，抗稀釋效應的影響不會計入計算，因此會排除稀釋證券的影響。所有認股權證均爲參與證券，在董事會宣佈派息時，它們會以一比一的比例參與A類普通股的分紅分配。爲計算每股收益，認股權證被視爲參與公司收益的A類普通股。因此，公司使用兩類法計算每股收益，這是一種收益分配方法，用於確定普通股和參與證券的每股淨利潤（虧損）（在有收益時）。
在使用兩類法之前，以下潛在稀釋證券已從計算未稀釋權重平均流通A類普通股數中排除，因爲它們會產生抗稀釋效應：
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6月30日, |
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2024 |
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2023 |
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股票期權 |
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限制性股票單位 |
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權證 |
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可轉換債券 |
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分段信息
營運部門被定義爲企業的組成部分，針對這些部分，首席經營決策者或決策團隊可以獲得單獨的財務信息，以便在評估績效、決定如何分配資源時使用。公司通過評估其業務來進行經營，評估其
信用減值準備
隨着ASU 2016-13的採納， 金融工具——信用損失， 如下所示，公司根據前瞻性的預期信用損失承認信用損失。公司根據對各種因素的評估進行預期信用損失的估計，這些因素包括歷史收款經驗，應收賬款餘額的年齡，客戶的信用質量，當前經濟狀況，合理和可支持的未來經濟狀況預測，以及可能影響公司向客戶收款能力的其他因素。
信貸風險的集中度和重要客戶
潛在使公司面臨信用風險集中的金融工具主要包括現金、現金等價物和受限現金以及應收賬款。公司通常在金融機構的各個運營帳戶中保持餘額，管理層認爲這些金融機構具有高信用質量，金額可能超過聯邦保險限額。公司未經歷與其現金、現金等價物或受限現金相關的任何損失，並且並不認爲自己面臨除與商業銀行關係相關的正常信用風險之外的異常信用風險。
公司面臨與變性疾病產品銷售和生物庫服務相關的應收貿易賬款的信用風險。所有應收貿易賬款均源自於在美國進行的產品銷售和服務。截至2024年6月30日，公司的兩位客戶中，每位客戶單獨至少佔據了公司尚未收回的總帳戶應收款的
新興成長公司
Section 102(b)(1) of the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act”) exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class of securities registered under the Securities Exchange Act of 1934, as amended) are required to comply with the new or revised financial accounting standards. The JOBS Act provides that an emerging growth company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such an election to opt out is irrevocable. The Company has elected not to opt out of such extended transition period, which expires December 31, 2026 unless the Company is otherwise disqualified. Accordingly, when a standard is
8
當公司作為一家新興成長型公司時，如果已有不同適用日期的發行或修訂，公司可以在私人公司採用新的或修訂後的準則時採納新的或修訂後的準則。
這可能會使公司的簡明合併財務報表與其他既不是新興成長型公司也沒有選擇使用延長過渡期的新興成長型公司進行比較變得困難或不可能，因為可能存在使用的會計準則不同。
重新分類
某些之前的金額已經重新分類以符合本年度的呈現形式。在簡明合併資產負債表中，短期債務 - 約克維爾和其他短期債務已被重新分類為短期債務 - 未關聯，與短期債務 - 相關人士和短期債務 - 相關方 - C.V. Starr和RWI已被重新分類為短期債務 - 相關方。有關更多信息，請參見附註7。
最近採納的會計準則
2016年6月，財務會計準則委員會（"FASB"）發布了會計準則更新（"ASU"）2016-13， 金融工具-信貸損失 （"ASU 2016-13"），改變了對金融資產認列減損的會計處理方式。根據新的指導，對於某些類型的金融工具，信貸損失將基於預期損失進行估計。ASU 2016-13還修改了可供出售的債務證券和自起源以來信用惡化的購買的金融資產的減值模型。ASU 2016-13適用於2022年12月15日後開始的年度，（該公司的2023財年），以及這些期間內的中期，可以提前採用。公司
最近公佈的會計準則
2023年11月，FASb發布了ASU 2023-07，旨在改善可報告的部門披露，以及增強有關顯著可報告的部門費用的披露。此指引將於我們的年度報告開始生效，即2024年12月31日結束的財政年度及其後的中期期間，并要求對所有已呈報的前期期間進行追溯應用。由於這些修訂不改變營運部門的識別方法，營運部門的匯總或定量門檻的應用以確定可報告的部門，我們不認為此指引對我們的財務狀況或經營業績產生實質影響。 分節報告（TOPIC 280）：改進報告的分節披露 ("ASU 2023-07")，要求每年和季度性披露增量段階資訊。本公告將於2023年12月15日後開始的財政年度和2024年12月15日後開始的財政年度內的季度期間以追溯方式生效。公司目前正在評估該公告對其披露的影響。
2023年12月，FASB發布了ASU 2023-09「 所得稅（740主題）：所得稅披露的改進 ("ASU 2023-09")，擴大了所需的所得稅披露。本公告將於2025年12月15日後開始的財政年度生效，可提早適用。修訂應以前瞻性方式應用，而允許追溯應用。公司目前正在評估該公告對其披露的影響。
以下表格提供了有關公司金融資產和負債的信息，這些資產和負債按照公平價值定期衡量，並指示了用於判斷這些公平價值的公平價值層級。
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截至2024年6月30日的公允價值衡量 |
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一級 |
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二級 |
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等級 3 |
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總計 |
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負債： |
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併購相關的有條件支付義務 |
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$ |
— |
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$ |
— |
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$ |
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$ |
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股份的有條件支付 |
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— |
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— |
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短期借款 - Yorkville可轉換票據 |
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— |
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— |
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認股權責任 - 2023年7月註冊直接認股權 |
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— |
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— |
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認股權責任 - 2023年4月註冊直接認股權 |
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— |
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— |
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認股權責任 - 2022年5月PIPE認股權 |
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— |
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— |
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認股權責任 - 2024年1月橋梁貸款 - Tranche＃2認股權 |
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— |
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— |
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認股權責任 - 贊助商認股權 |
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— |
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— |
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warrants 負債 - 公開認股權證 |
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— |
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— |
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$ |
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$ |
— |
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$ |
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$ |
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9
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2023年12月31日的公平值測量 |
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一級 |
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二級 |
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等級 3 |
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總計 |
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資產： |
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可轉換債券應收款項 |
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$ |
— |
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$ |
— |
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$ |
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$ |
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$ |
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$ |
— |
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$ |
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$ |
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負債： |
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與收購相關的有條件出資負債 |
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$ |
— |
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$ |
— |
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$ |
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$ |
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有條件的股份考量 |
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— |
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— |
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短期債務 - Yorkville |
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— |
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— |
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控制項負債 - 2023年7月註冊直接認股權證 |
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— |
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— |
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控制項負債 - 2023年4月註冊直接認股權證 |
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— |
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— |
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控制項負債 - 2022年5月PIPE認股權證 |
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— |
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— |
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控制項負債 - 贊助人認股權證 |
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— |
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— |
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控制項負債 - 公眾認股權證 |
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— |
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— |
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$ |
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$ |
— |
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$ |
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$ |
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和，到期時有
因這些工具的短期性質，在附帶的簡明綜合財務報表中，其他流動負債的攜帶值接近公平價值。
可轉換票據應收款項的估值
可轉換票據應收款項是因2020年出售UltraMIST/MISt業務而收到的。在2021年1月1日或之後的任何時候，由公司獨立決定，可將未清可轉換票據應收款項（包括應計利息）按一定匯率轉換為Sanuwave普通股。可轉換票據應收款項應在2021年8月6日或之前支付。
於2023年12月18日，公司與Sanuwave（“Sanuwave寬限協議”）簽訂了一項寬限協議。根據Sanuwave寬限協議，從2023年12月18日至最早的（i）2024年2月28日，（ii）根據美國破產法，針對Sanuwave開始破產程序，（iii）發生除支付違約以外的違約事件，或（iv）Sanuwave未遵守寬限協議中列明的任何條件、情況或約定之一時，公司同意在可轉換票據應收款項下不行使其可用的任何救濟措施，但不包括增加利率權利。作為對Palantir Technologies, Inc.（“Palantir”）所欠款的抵押品，公司在違約情況下將Sanuwave可轉換票據應收款項分配給Palantir（見註9）。於2024年5月10日，公司與Sanuwave簽署了一封信函協議，將寬限期延長至
下表介紹了使用Level 3資料進行定期基礎計算的可轉換備忘錄應收款項調解。 已實現的總體內在價值（單位：年）
|
|
至截至日期結餘 |
|
|
淨值 |
|
|
Purchases, |
|
|
公允價值 |
|
|
截至2024年6月30日的餘額 |
|
|||||
資產： |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
可轉換應收票據 |
|
$ |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
— |
|
|
在2023年12月31日，該筆票據的公平價值是基於一個採用信用違約模型的債券評估。公司採用了基於默認、償還和票據轉換結果的機率加權模型的Level 3輸入。評估是基於公司自身假設支持的不可觀察輸入，基本上沒有市場活動。
10
可轉換票據估值模型的重要輸入如下：
|
|
12月31日， |
|
|
面值 |
$ |
|
|
|
債券利率 |
|
|
||
股票價格 |
$ |
|
|
|
期限（年） |
|
|
||
無風險利率 |
|
|
% |
|
波動率 |
|
n/a |
|
|
未來可變對價值估價
對可變對價值義務的公平值評估採用三級輸入來確定，並基於概率加權收益法。 該評估基於未觀察到的輸入，並且根據公司自己的假設，這些輸入受到少量或沒有市場活動的支持。
以下表格呈現以三級輸入為基礎定期衡量的可變對價值義務調解 已實現的總體內在價值（單位：年）
|
|
至截至日期結餘 |
|
|
淨值 |
|
|
購買, |
|
|
公允價值 |
|
|
至截至日期結餘 |
|
|||||
負債： |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
併購相關的待辦體現負債 |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
在每個報告日期，公司估計未來里程碑和業績支付的負債的公平價值，部分基於第三方估值的結果，該估值使用基於各種假設的折現現金流分析，包括實現特定事件的概率、折扣率，以及業績支付應支付的時間和觸發里程碑支付的條件。待辦體現的實際結算可能與基於實際發生這些特定事件的當前估計有所不同。
在每個報告日期，公司重新評估待辦體現負債的估計公平價值，並將公平價值的變動記錄為公司財務報表和綜合損益表中的收入或費用。待辦體現負債的公平價值變動可能源自折扣期限和利率的變化、收入估計的時間和金額變化，以及關於實現各種待辦體現負債概率假設的變化。截至2024年6月30日六個月，待辦體現負債的公平價值變動微不足道。公司將所有待辦體現負債歸類為2024年6月30日和2023年12月31日簡明合併資產負債表上的長期負債。有關待辦體現負債的更多信息，請參見附註9。
待辦股票酬勞的估值
到2024年6月30日為止的條件股份考慮負債，是由根據截至2021年12月31日一年的和解協議向CariCord參與股東潛在未來發行A類普通股的公平價值組成。條件股份考慮負債的公平價值計量是使用第3級輸入確定的，並基於概率加權預期回報方法（"PWERM"）。該計量主要基於不可觀察的輸入支持，這些輸入幾乎沒有或沒有市場活動，是基於該公司自己的假設。
以下表格顯示了採用第3級輸入定期計量的條件股份考慮負債的協調，截至2024年6月30日為止： 截至2024年6月30日的六個月的轉讓：
|
|
至截至日期結餘 |
|
|
淨值 |
|
|
購買, |
|
|
公允價值 |
|
|
至截至日期結餘 |
|
|||||
負債： |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
待定股份考量 |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
公司在每個報告日使用基於各種輸入和假設的PWER模型，包括公司普通股價格、折扣率和其他因素，評估未來發行A類普通股的負債的公平價值。
11
達到特定未來運營目標的概率。或有股票對價的實際結算可能會根據這些特定目標的實際實現情況以及公司普通股股價的波動與當前估計不同。
在每個報告日，公司重新估值或有股票對價義務的公允價值，並將公允價值的變動記錄爲公司簡明合併運營和綜合損益表中的收入或費用。或有股票對價義務的公允價值的變動可能源於折現率的變化、公司普通股股價的變化以及與實現特定運營目標的可能性假設有關的概率假設的變化。在截至2024年6月30日的六個月期間內，或有股票對價義務的公允價值變動微乎其微。根據2024年6月30日和2023年12月31日的簡明合併資產負債表，公司已將所有或有股票對價列爲流動負債。
短期債務的評估 - Yorkville
公司選擇公允價值選項來計量2022年9月15日簽署的Yorkville PPA（見註釋7）。截至2023年12月31日，由於債務的短期性質，Yorkville PPA的公允價值大致等於結算金額，結算金額已於2024年1月17日完全支付。公司還選擇公允價值選項來計量2024年3月13日簽署的Yorkville可轉債券（見註釋7）。債務的公允價值計量是使用市場上不可觀察的第3級輸入和假設確定的。以公允價值計量的債務的公允價值變動，包括相關的應計利息費用，將在附帶的簡明合併運營和綜合損益表中作爲債務公允價值變動的收益或損失呈現。與工具特定信用風險的變化相關的公允價值的總變動部分是通過定期變化的折現率假設的具體測量確定的，且不包括基礎市場變化，並作爲附帶的簡明合併運營和綜合損益表中的綜合損失組成部分進行展示。短期債務的實際結算可能會根據Yorkville何時以及是否選擇將金額轉換爲普通股、公司在到期前的潛在現金償還以及公司普通股股價的波動與當前估計不同。
下表提供了基於三級輸入，對短期債務義務進行的重新調整。 現金支付
負債： |
|
|
|
|
截至2024年1月1日的餘額 |
|
$ |
|
|
本金償還 |
|
|
( |
) |
發行可轉換本票 |
|
|
|
|
公允價值調整通過 |
|
|
( |
) |
截至2024年6月30日的餘額 |
|
$ |
|
|
Yorkville可轉換期票的公允價值是基於採用蒙特卡洛模型和信用違約模型的估值。公司在基於違約、還款和票據轉換的結果的概率加權模型中使用了第3級輸入。該測量是基於不可觀察的輸入，並且根據公司的假設，支持的市場活動很少或沒有。 在2024年3月13日，發行日期，Yorkville可轉換期票的公允價值爲$
Yorkville可轉換期票估值模型的重要輸入如下：
|
|
6月30日 |
|
|
3月13日， |
|
||
|
|
|
|
|
(發行) |
|
||
普通分享價格 |
$ |
|
|
$ |
|
|
||
信用利差 |
|
|
% |
|
|
% |
||
股息收益率 |
|
|
% |
|
|
% |
||
期限（年） |
|
|
|
|
|
|
||
無風險利率 |
|
|
% |
|
|
% |
||
波動率 |
|
|
% |
|
|
% |
||
權證負債的估值
截至2024年6月30日的權證負債由購買A類普通股的權證的公允價值組成。公共權證根據期末公開聲明的收盤價以公允價值記錄，這是一個一級輸入。2024年1月的橋接貸款 - 第二批權證根據蒙特卡洛模擬模型以公允價值記錄，而註冊直接融資、PIPE和贊助商權證則根據使用以下輸入的黑-舒爾斯期權定價模型在各自的收盤日期的公允價值上記錄：(i) 基礎資產的價值，(ii) 行使價格，(iii) 無風險利率，(iv) 基礎資產的波動率。
12
資產、(v) 基礎資產的股息收益率和 (vi) 到期日，這些是三級輸入。Black-Scholes期權定價模型確定權證負債的公允價值時主要的不可觀察輸入是A類普通股的預期波動性。在合併前，傳統Celularity是一傢俬人公司，缺乏其股票的公司特定歷史和引伸波幅信息。因此，公司估計其預期股價波動性，使用自合併以來的波動性以及公開交易的同行公司的歷史波動性。無風險利率是通過參考與權證預計剩餘期限大致相等的美國國債收益率曲線來確定的。權證的Monte Carlo和Black-Scholes期權定價模型的輸入在每個報告期更新以反映公允價值。
下表展示了使用三級輸入定期進行測量的權證負債的調節。 現金支付
截至2024年1月1日的餘額 |
|
$ |
|
|
2024年1月橋接貸款-第2批次權證發行 |
|
|
|
|
認可收益中確認的公允價值變動 |
|
|
|
|
截至2024年6月30日的餘額 |
|
$ |
|
2022年5月PIPE權證和2023年直接註冊權證的重要輸入如下：
|
|
6月30日 |
|
|
2023年12月31日, |
|
||
普通股價格 |
$ |
|
$ |
|
|
|||
行使價格 |
$ |
|
$ |
|
||||
股息收益率 |
|
|
% |
|
|
% |
||
期限（年） |
|
|
|
|
||||
無風險利率 |
|
|
|
|
% |
|||
波動率 |
|
|
|
|
||||
2024年1月橋貸第2期認股權重要輸入如下：
|
|
6月30日 |
|
|
1月16日， |
|
||
|
|
|
|
|
（發行） |
|
||
普通股價格 |
$ |
|
|
$ |
|
|
||
有效行使日期的期限（年）(1) |
|
|
|
|
|
|
||
股息收益率 |
|
|
% |
|
|
% |
||
期限（年） |
|
|
|
|
|
|
||
無風險利率 |
|
|
% |
|
|
% |
||
波動率 |
|
|
% |
|
|
% |
||
(1) 正如在註釋7中進一步討論的，認股權證在滿足一定條件之前不得行使，行使價格也未確定。
贊助商認股權證的重要輸入如下：
|
|
6月30日 |
|
|
2023年12月31日, |
|
||
普通股價格 |
$ |
|
|
$ |
|
|
||
行使價格 |
$ |
|
|
$ |
|
|
||
股息收益率 |
|
|
% |
|
|
% |
||
期限（年） |
|
|
|
|
|
|
||
無風險利率 |
|
|
% |
|
|
% |
||
波動率 |
|
|
% |
|
|
% |
||
13
公司的主要庫存類別如下：
|
|
6月30日 |
|
|
2023年12月31日, |
|
||
原材料 |
|
$ |
|
|
$ |
|
||
進行中的工作 |
|
|
|
|
|
|
||
成品 |
|
|
|
|
|
|
||
庫存總額 |
|
|
|
|
|
|
||
減少：存貨準備 |
|
|
( |
) |
|
|
( |
) |
存貨淨額 |
|
$ |
|
|
$ |
|
||
資產負債表分類： |
|
|
|
|
|
|
||
存貨 |
|
$ |
|
|
$ |
|
||
存貨淨額（扣除流動部分） |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
||
存貨淨額中包括預計會留在手頭超過每個資產負債表日期一年的存貨。
淨固定資產包括以下內容:
|
|
6月30日 |
|
|
2023年12月31日, |
|
||
租賃改良 |
|
$ |
|
|
$ |
|
||
實驗室和生產設備 |
|
|
|
|
|
|
||
機械、設備和固定資產 |
|
|
|
|
|
|
||
建設中的工程 |
|
|
|
|
|
|
||
物業及設備 |
|
|
|
|
|
|
||
減：累計折舊及攤銷 |
|
|
( |
) |
|
|
( |
) |
物業和設備，淨值 |
|
$ |
|
|
$ |
|
||
折舊和攤銷費用分別爲$，其中包括2024年3月31日和2023年3月31日的三個月。
商譽
截至2023年6月30日止六個月內，公司股價持續下跌，致使市值低於其組合報告單位的賬面價值。公司得出結論，股價持續下跌，加上決定停止某些細胞治療臨床試驗，這兩者在本季度均構成觸發事件，並對商譽和已取得的知識產權與研發資產進行了定量減值測試。根據減值分析的結果，公司確認了截至2023年6月30日止六個月的商譽減值損失爲$
14
無形資產淨值
無形資產，淨值包括以下內容：
|
|
6月30日 |
|
|
2023年12月31日, |
|
|
預估 |
||
可攤銷的無形資產： |
|
|
|
|
|
|
|
|
||
開發的科技 |
|
$ |
|
|
$ |
|
|
|||
客戶關係 |
|
|
|
|
|
|
|
|||
交易名稱與商標 |
|
|
|
|
|
|
|
|||
重新獲得的權利 |
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
||
減：累計攤銷 |
|
|
|
|
|
|
|
|
||
開發的科技 |
|
|
( |
) |
|
|
( |
) |
|
|
客戶關係 |
|
|
( |
) |
|
|
( |
) |
|
|
交易名稱與商標 |
|
|
( |
) |
|
|
( |
) |
|
|
重新獲得的權利 |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
可攤銷無形資產淨額 |
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
||
未攤銷的無形資產 |
|
|
|
|
|
|
|
|
||
獲得的知識產權與開發產品權利 |
|
|
|
|
|
|
|
|||
|
|
$ |
|
|
$ |
|
|
|
||
截至2024年6月30日和2023年6月30日的三個月中，無形資產的攤銷費用爲$
負債包括以下：
|
|
6月30日 |
|
|
2023年12月31日, |
|
||
短期債務 - 非關聯方 |
|
|
|
|
|
|
||
Yorkville - PPA（按公允價值計量） |
|
$ |
- |
|
|
$ |
|
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Yorkville - 可轉換債務票據（按公允價值計量） |
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- |
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短期債務 - 其他 |
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總短期債務 - 非關聯方 |
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短期債務 - 關聯方： |
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C.V. Starr橋貸款，扣除折扣後 |
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RWI橋貸款，扣除折扣後 |
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首席執行官 Promissory note |
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總短期債務 - 關聯方 |
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總債務 |
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$ |
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$ |
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Yorkville PPA
2022年9月15日，公司與YA II PN, Ltd.（"Yorkville"）簽署了一份預付款協議（"PPA"），根據該協議，公司可以向Yorkville請求最高達$的現金預付款（或雙方協商一致的更大金額）（每筆稱爲"預付款"），在一段期限內，累計限制爲$。
15
未支付的 利息和
關於簽署PPA，公司收到了最初的預付款項 $
在2022年第四季度，Yorkville選擇將 $
2024年1月12日，公司與Yorkville簽署了一項寬容協議（"寬容協議"），根據該協議，Yorkville同意在寬容期內限制執行其因違約事件而享有的權利和救濟。寬容期將持續至2024年1月19日之前或公司全額償還PPA下所有到期金額的日期（"寬容期"）。在寬容期內，利息按每年
2024年3月13日，公司與Yorkville簽署了一項備用股權購買協議（"SEPA"）（見註釋10）。
約克維爾可轉換票據
在進入SEPA後，公司向約克維爾發行了一張$
公司確認可轉換票據中包含嵌入式衍生品，這些衍生品將需要拆分爲衍生負債，且無論債務工具還是嵌入特徵均不需要分類爲股權。因此，在開始時，公司選擇根據ASC 825的規定，將包含債務主機和嵌入式衍生負債的可轉換本票按公允價值持續計量。 金融工具. Changes in fair value caused by changes in the instrument-specific credit risk are reported in other comprehensive income, and the remaining change in fair value is reported in earnings (i.e., as a component of other income/expense). Interest expense is a component of the change in fair value of the notes and, therefore, is not separately recorded. As a result of the fair value election, the original issue discount of $
Short-Term Debt - Other and CEO Promissory Note
16
在2023年8月21日，公司與其主席兼首席執行官羅伯特·哈里里博士及兩名無關聯的貸款人簽署了一項貸款協議，總貸款本金金額爲$
爲進一步滿足公司的即時營運資本需求，哈里里博士與公司於2023年10月12日簽署了一份承諾票據，金額爲$
截至2024年6月30日，其他短期債務及首席執行官承諾票據的賬面價值（包括應計利息）爲$
短期債務 – 相關方 - C.V. Starr和RWI
C.V. Starr & Co., Inc
2023年3月17日，公司與C.V. Starr & Co., Inc.（"C.V. Starr"），公司的股東，簽訂了一份貸款協議（"Starr橋貸款"），總本金金額爲$
在2023年6月，與修訂的RWI貸款（如下所定義）相關， 公司授予C.V. Starr額外的warrants，累計最多可獲取
根據斯塔橋貸款的條款，公司同意遵循通常的負面契約，限制其償還債務、向股東支付分紅派息、償還或產生其他債務的能力（其他未被允許的）、在公司的資產上授予或存在安防-半導體權益（其他未被允許的），或持有現金及現金等價物少於 $
在2024年1月12日，公司簽署了一項修正案，終止了最低 $
On March 13, 2024, the Company and C.V. Starr entered into a forbearance agreement ("Starr Forbearance Agreement") with respect to the Starr Bridge Loan. Under the Starr Forbearance Agreement, (i) C.V. Starr agreed not to exercise its rights and remedies upon the occurrence of any default under the Starr Bridge Loan until the Company's obligations in respect of the Yorkville convertible promissory note have been indefeasibly paid in full, (ii) C.V. Starr consented to the Company's incurrence of indebtedness under the Yorkville convertible promissory note, (iii) C.V. Starr consented to cash payments required to be made under the SEPA and the Yorkville convertible promissory note, (iv) the Company agreed to increase the interest rate on the loan outstanding under the Starr Bridge Loan by
17
失敗 爲了在到期時支付某些利息，公司開始按默認利率累計利息
截至2024年6月30日和2023年12月31日，Starr Bridge貸款的賬面價值（包括應計利息和扣除折扣後）爲美元
名勝世界私人有限公司
2023年5月16日，經約克維爾書面同意，公司與Resorts World Inc. Pte Ltd（「RWI」）簽訂了優先擔保貸款協議（「RWI Bridge Loan」），規定初始貸款本金總額爲美元
2023年6月21日，公司完成了經修訂和重述的優先擔保貸款協議（「經修訂的RWI貸款」），以全面修改和重申先前的優先擔保貸款協議。修訂後的RWI貸款規定了額外的貸款，本金總額爲$
根據經修訂的RWI貸款的條款，公司必須將淨收益用於支付根據PPA應付給約克維爾的觸發付款。此外，公司同意按慣例簽訂負面契約，限制其償還債務、向股東支付股息、償還或承擔除允許以外的其他債務、授予或承受其任何資產的擔保權益（除非允許）或持有少於美元的現金和現金等價物的能力
該公司根據ASC 470-20對修訂後的RWI貸款進行了覈算， 帶轉換和其他選項的債務 還有 ASC 815， 衍生品和套期保值。經修訂的RWI貸款和RWI認股權證的淨收益按公允價值入賬，總折扣爲美元
2024年1月12日，公司簽訂了第二份經修訂和重述的優先擔保貸款協議（「RWI第二修正過橋貸款」），以全面修改和重述先前宣佈的截至2023年5月16日與RWI簽訂的優先擔保貸款協議，該協議於2023年6月20日修訂。RWI第二修正過橋貸款規定了額外的貸款，本金總額爲 $
根據RWI第二修正過橋貸款的條款，公司必須將額外貸款的收益（i）用於全額支付根據PPA欠約克維爾的所有未清款項，（ii）用於支付某些關鍵供應商的發票，（iii）用於支付欠Palantir的第一筆和解付款（見附註9），以及（iv）用於營運資金和RWI預先批准的其他用途。根據RWI第二修正過橋貸款的條款，公司同意了慣常的負面契約，限制其向股東支付股息、償還或承擔除允許以外的其他債務的能力，或者授予或承受公司任何資產的擔保權益的能力，除非允許。此外，公司同意將通過銷售與關聯方雲頂創新私人有限公司（「雲頂創新」）簽訂的分銷和製造協議相關或相關的產品/服務所獲得的淨收入作爲貸款的預付款。
18
由於現金流變化超過10％，RWI第二修正過橋貸款導致修正後的RWI貸款失效。因此，公司記錄的失效損失等於 (i) 新貸款與 Pranche #1 和 #2 認股權證的公允價值和 (ii) 經修訂的RWI貸款先前的賬面金額之間的差額，即美元
該公司和RWI還簽訂了截至2024年1月12日的投資者權利協議。投資者權利協議爲RWI提供了某些信息和審計權，以及與Tranche #1 Warter和Tranche #2 認股權證相關的股票的註冊權，包括承諾在提交2023年10-k表格後的45天內提交註冊聲明、「搭便車」 註冊權，以及每年申請最多三次承銷發行的需求權的權利；在每種情況下，均需按慣例進行 「承銷商削減」” 措辭以及證券交易所提出的任何異議納入證券的佣金。如果初始註冊聲明不是在2024年5月15日當天或之前提交的，則投資者權利協議規定的部分違約金等於
2024年3月13日，公司與RWI簽訂了第二份寬容協議（「RWI第二份寬容協議」）。根據RWI第二份寬容協議，（i）RWI同意在RWI第二修正過橋貸款發生任何違約時不行使其權利和補救措施，直到公司與約克維爾可轉換期票有關的債務得到不可避免的全額償還或2025年3月13日，以兩者中發生者爲準，（ii）RWI同意公司根據約克維爾可轉換承諾承擔債務（iii）RWI同意根據SEPA和約克維爾可轉換期票支付所需的現金付款，(iv) 公司同意通過以下方式提高RWI貸款協議下未償貸款的利率
截至2024年6月30日和2023年12月31日，RWI第二修正過橋貸款和經修訂的RWI貸款的賬面價值（包括利息和扣除折扣後）爲美元
租賃協議
ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The Company’s lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the present value of lease payments, the Company uses its incremental borrowing rate based on the information available at the lease commencement date to determine the appropriate discount rate by multiple asset classes. Variable lease payments that are not based on an index or that result from changes to an index subsequent to the initial measurement of the corresponding lease liability are not included in the measurement of lease ROU assets or liabilities and instead are recognized in earnings in the period in which the obligation for those payments is incurred. Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise any such options. Lease expense is recognized on a straight‐line basis over the expected lease term. Rent expense was $
在2019年3月13日，Legacy Celularity簽訂了一份租賃協議，
19
2023 年 9 月 14 日，公司就該公司在新澤西州弗洛勒姆公園設施進行租約修訂，以將信用證減少約 $
本公司租賃成本的組成部分在其簡明綜合營運報表和綜合損失中分類如下：
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三個月結束 |
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六個月結束 |
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2024 |
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2023 |
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2024 |
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2023 |
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營運租賃成本 |
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$ |
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$ |
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$ |
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$ |
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可變租賃成本 |
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營運租賃總成本 |
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$ |
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$ |
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$ |
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$ |
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下表顯示本公司在期內租賃負債有關的現金及非現金活動：
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截至六月三十日止六個月 |
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2024 |
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2023 |
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與租賃負債相關的現金支付： |
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營運租賃的營運現金流 |
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$ |
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$ |
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截至 2024 年 6 月 30 日，本公司營運租賃負債的到期如下：
2024 年（剩餘六個月） |
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$ |
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2025 |
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2026 |
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2027 |
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2028 |
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之後 |
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租賃付款總額 |
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減少計算利息 |
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( |
) |
總計 |
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$ |
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截至 2024 年 6 月 30 日，本公司營運租賃期的加權平均剩餘租賃期為
與企業合併有關的可定代價
有關 Legacy Celularity 於 2017 年收購 HLI 細胞治療有限公司和人類生成有限公司，該公司已同意在達成某些監管和商業里程碑時向賣家支付未來的考慮。因此，公司錄得了 $
賠償協議
在一般業務中，本公司可能就某些事項，包括但不限於因違反此等協議或由第三方提出的知識產權侵權聲明而引致的損失，向供應商、租賃人、業務合作夥伴和其他方提供不同範圍和條款的賠償。此外，本公司已與其董事會成員及其執行官員簽訂賠償協議，該協議將要求本公司除其他事項之外，就他們因其身為董事或主管的身份或服務而產生的某些責任，賠償他們。根據這些賠償協議，本公司可能需要支付的未來付款額的最高可能金額為：
20
在許多情況下，沒有限制。 截至2024年6月30日，公司尚未因此類補償產生任何重大成本。 公司目前沒有意識到任何補償要求，並未在其2024年6月30日或2023年12月31日的簡明合併財務報表中計提與此類義務相關的任何負債。
與palantir技術公司的協議。
2021年5月5日，Legacy Celularity簽署了與palantir達成的主訂閱協議（「Palantir MSA」），根據協議，Legacy Celularity同意支付$
Sirion 許可協議
2021年12月，公司與Sirion Biotech GmbH（以下簡稱「Sirion」）簽訂了一項許可協議（「Sirion許可協議」）。根據Sirion許可協議，Sirion授予公司與聚乙二醇聚氧乙烯醚（「受許可產品」）相關的專利權和專利技術許可。作爲Sirion許可協議的一部分，公司向Sirion支付了$
法律訴訟
在每個報告日期，公司評估潛在損失金額或潛在損失區間是否可能並且是否可合理估計，根據處理會計事務的權威指南的規定。公司根據發生的費用費用有關這類法律訴訟的成本。
民事調查要求
公司收到2022年8月14日的「東部賓夕法尼亞地區聯邦檢察官辦公室」根據《虛假索賠法》第31 U.S.C. §3729號發出的民事調查要求（「要求」）。該要求要求提供有關提交給醫療保險、醫療補助或其他聯邦保險商的關於涉及從羊膜液或出生組織提取的注射式人體組織療法產品的服務或程序的索賠的文件和信息，包括Interfyl，一種生物材料產品。公司正在配合要求並與處理要求的美國助理檢察官進行持續對話。此事仍處於初步階段，不確定該要求是否會導致任何責任。
Arbitration Demand from Palantir Technologies Inc.
On April 20, 2023, Palantir commenced an arbitration with JAMS Arbitration asserting claims for declaratory relief and breach of contract relating to the Palantir MSA, seeking damages in an amount equal to the full value of the contract. The Company responded to the arbitration demand and asserted counterclaims for breach of contract, breach of warranty, fraudulent inducement, violation of California’s Unfair Competition Law, amongst others, in relation to the Palantir MSA.
On December 21, 2023, the Company and Palantir entered into the Palantir Settlement Agreement to resolve the JAMS Arbitration. The Palantir Settlement Agreement was subsequently amended on January 10, 2024 and May 6, 2024. Both parties agreed to dismiss the arbitration proceeding and dispute and provide for mutual releases upon the Company's satisfaction of a settlement payment obligation. Through June 3, 2024, the Company made total settlement payments of $
21
權利根據該公司的義務，向palantir發行的A類普通股股份附帶跟隨註冊權利。該類股份由palantir出售的轉售將被納入公司未來提交的任何註冊聲明中。
Celularity Inc.訴Evolution Biologyx，LLC等
2023年4月17日，公司在新澤西州聯邦地區法院對Evolution Biologyx，LLC，Saleem S. Saab及其個人，以及Encyte，LLC（合稱「Evolution」）提起訴訟，以追討其生物材料產品銷售款項（約爲$）未付的發票金額
TargetCW訴Celularity Inc.
2024年3月27日，WMBE Payrolling，Inc.，亦稱TCWGlobal，在加利福尼亞州南區聯邦地區法院提起訴訟，聲稱違反合同和帳戶聲明，涉及2020年5月4日簽署的主服務協議，或稱TCWGlobal MSA，用於向我們提供特定僱員的租賃工作人員提供服務。訴訟指稱公司未能支付一些僱員服務的特定發票而違背了TCWGlobal MSA。2024年5月7日，公司與TCWGlobal達成了和解協議及相互解除協議，公司同意支付$
Common Stock
As of June 30, 2024 and December 31, 2023, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue
Voting Power
Except as otherwise required by law or as otherwise provided in any certificate of designation for any series of preferred stock, the holders of common stock possess all voting power for the election of the Company’s directors and all other matters requiring stockholder action. Holders of
Dividends
Holders of Class A common stock will be entitled to receive such dividends, if any, as may be declared from time to time by the Company’s board of directors in its discretion out of funds legally available therefor. In no event will any stock dividends or stock splits or combinations of stock be declared or made on common stock unless the shares of common stock at the time outstanding are treated equally and identically.
Liquidation, Dissolution and Winding Up
In the event of the Company’s voluntary or involuntary liquidation, dissolution, distribution of assets or winding-up, the holders of the common stock will be entitled to receive an equal amount per share of all of the Company’s assets of whatever kind available for distribution to stockholders, after the rights of the holders of the preferred stock have been satisfied.
Preemptive or Other Rights
The Company’s stockholders have no preemptive or other subscription rights and there are no sinking fund or redemption provisions applicable to common stock.
Election of Directors
The Company’s board of directors is divided into three classes, Class I, Class II and Class III, with only one class of directors being elected in each year and each class serving a three-year term, except with respect to the election of directors at the special meeting held in connection with the merger with GX, Class I directors are elected to an initial one-year term (and three-year terms subsequently), the Class II directors are elected to an initial two-year term (and three-year terms subsequently) and the Class III directors are elected to an initial three-year term (and three-year terms subsequently). There is no cumulative voting with respect to the election of directors, with the result that the holders of more than
22
Preferred Stock
The Company’s Certificate of Incorporation authorized
ATM Agreement
On September 8, 2022, the Company entered into an At-the-Market Sales Agreement (the “ATM Agreement”) with BTIG, LLC, Oppenheimer & Co. Inc. and B. Riley Securities, Inc., acting as sales agents and/or principals, pursuant to which the Company may offer and sell, from time to time in its sole discretion, shares of its common stock, having an aggregate offering price of up to $
Any shares offered and sold in the at-the-market offering will be issued pursuant to the Company’s shelf registration statement on Form S-3 and the related prospectus supplement. Under the ATM Agreement, the sales agents may sell shares of common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933. The Company will pay the sales agents a commission rate of up to
During the six months ended June 30, 2023, the Company received net proceeds of $
March 2023 PIPE
On March 20, 2023, the Company entered into a securities purchase agreement with two accredited investors, including its Chairman and Chief Executive Officer, Dr. Robert Hariri, providing for the private placement of (i)
The Company accounted for the March 2023 PIPE Warrants and common stock as a single non-arm's length transaction. The Company applied the guidance for this transaction in accordance with ASU 2020-06, (Subtopic 470-20): Debt - Debt with Conversion and Other Options, ASC 815 Derivatives and Hedging, and ASC 480 Distinguishing Liabilities from Equity. Accordingly, the net proceeds were allocated between common stock and the March 2023 PIPE warrants at their respective fair value, which resulted in a net premium of $
Registered Direct Offering
On April 10, 2023, the Company closed on a registered direct offering of
23
placement agent commissions and other estimated offering expenses. The Registered Direct Warrants had an exercise price of $
Upon the closing of the registered direct offering on April 10, 2023, the Company amended the existing May 2022 PIPE Warrants, to reduce the exercise price from $
May 2023 PIPE
On May 18, 2023, the Company closed on a securities purchase agreement with a group of accredited investors, providing for the private placement of an aggregate (i)
January 2024 PIPE
On January 12, 2024, the Company entered into a securities purchase agreement with an existing investor, Dragasac Limited ("Dragasac"), providing for the private placement of (i)
The Company accounted for the January 2024 PIPE Warrant and common stock as a single non-arm's length transaction recognized in equity. The Company applied the guidance for this transaction in accordance with ASU 2020-06, (Subtopic 470-20): Debt - Debt with Conversion and Other Options, ASC 815 Derivatives and Hedging, and ASC 480 Distinguishing Liabilities from Equity. Accordingly, the net proceeds were allocated between common stock and the January 2024 PIPE Warrant at their respective fair values, which resulted in proceeds of $
In connection with the execution of the securities purchase agreement, the Company also entered into an investor rights agreement with Dragasac dated as of January 12, 2024. The investor rights agreement provides Dragasac certain information and audit rights, as
24
well as registration rights with respect to the shares (and shares underlying the January 2024 PIPE Warrant), including both the undertaking to file a registration statement within 45 days of filing of the 2023 Form 10-K, "piggyback” registration rights, as well as the right to request up to three demand rights for underwritten offerings per year; in each case subject to customary "underwriter cutback” language as well as any objections raised by the SEC to inclusion of securities. If the initial registration statement was not filed on or prior to May 15, 2024, the investor rights agreement provides for partial liquidating damages equal to
Effective February 16, 2024, in order to comply with Section 4.15(a) of the securities purchase agreement, the Company entered into an amended employment agreement with its Chief Administrative Officer ("CAO"), whereby the CAO agreed to decrease his base salary from $
Warrant Modifications
On January 12, 2024, in connection with the January 2024 PIPE, the Company agreed to amend the exercise price of legacy warrants held by Dragasac to purchase
Standby Equity Purchase Agreement
On March 13, 2024, the Company and Yorkville entered into a SEPA. Under the SEPA, the Company has the right to sell to Yorkville up to $
Upon the satisfaction of the conditions precedent in the SEPA, which include having a resale shelf for shares of common stock issued to Yorkville declared effective, the Company has the right to direct Yorkville to purchase a specified number of shares of common stock by delivering written notice ("Advance"). An Advance may not exceed
Yorkville will generally purchase shares pursuant to an Advance at a price per share equal to
The SEPA will automatically terminate on the earliest to occur of (i) the first day of the month next following the 36-month anniversary of the date of the SEPA or (ii) the date on which Yorkville shall have made payment for shares of common stock equal to $
As consideration for Yorkville’s commitment to purchase the shares of common stock pursuant to the SEPA, the Company paid Yorkville a $
In connection with the entry into the SEPA, on March 13, 2024, the Company entered into a registration rights agreement with Yorkville, pursuant to which the Company agreed to file with the SEC no later than May 3, 2024, a registration statement for the resale by Yorkville of the shares of common stock issued under the SEPA (including the commitment fee shares). The Company agreed to use commercially reasonable efforts to have such registration statement declared effective within 45 days of such filing and to maintain the effectiveness of such registration statement during the 36-month commitment period. The Company will not have the ability to request any Advances under the SEPA (nor may Yorkville convert the Initial Advance into common stock) until such resale registration statement is declared effective by the SEC. The Company has not yet filed a registration statement with the SEC for the resale by
25
Yorkville of the shares of common stock issued under the SEPA, which is deemed an event of default under the SEPA and as a result, the interest rate on the on the Yorkville convertible promissory note (see Note 7) increased to
The Company determined that the SEPA should be accounted for as a derivative measured at fair value, with changes in the fair value recognized in earnings. Because the Company has not yet filed a registration statement and no shares can currently be issued under the SEPA, the SEPA is deemed to have no value as of the issuance date and as of June 30, 2024.
Warrants
As of June 30, 2024, the Company had
|
|
Number of |
|
|
Exercise |
|
|
|
Expiration |
||
Dragasac Warrant(1) |
|
|
|
|
$ |
|
|
|
|||
Public Warrants(2) |
|
|
|
|
$ |
|
|
|
|||
Sponsor Warrants(2) |
|
|
|
|
$ |
|
|
|
|||
May 2022 PIPE Warrants |
|
|
|
|
$ |
|
|
|
|||
March 2023 PIPE Warrants |
|
|
|
|
$ |
|
|
|
|||
March 2023 PIPE Warrants (modified) |
|
|
|
|
$ |
|
|
|
|||
March 2023 Loan Warrants(3) |
|
|
|
|
$ |
|
|
|
|||
April 2023 Registered Direct Warrants |
|
|
|
|
$ |
|
|
|
|||
April 2023 Registered Direct Warrants (modified) |
|
|
|
|
$ |
|
|
|
|||
May 2023 PIPE Warrants |
|
|
|
|
$ |
|
|
|
|||
June 2023 Warrants(3) |
|
|
|
|
$ |
|
|
|
|||
June 2023 Loan Warrants |
|
|
|
|
$ |
|
|
|
|||
July 2023 Registered Direct Warrants |
|
|
|
|
$ |
|
|
|
|||
January 2024 PIPE Warrants |
|
|
|
|
$ |
|
|
|
|||
January 2024 Bridge Loan - Tranche #1 Warrants |
|
|
|
|
$ |
|
|
|
|||
January 2024 Bridge Loan - Tranche #2 Warrants |
|
|
|
|
$ |
|
|
|
|||
March 2024 RWI Forbearance Warrants |
|
|
|
|
$ |
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
||
(1)
(2)
(3)
2021 Equity Incentive Plan
In July 2021, the Company’s board of directors adopted, and the Company’s stockholders approved the 2021 Equity Incentive Plan (the “2021 Plan”). The 2021 Plan provides for the grant of incentive stock options (“ISOs”) to employees and for the grant of nonstatutory stock options (“NSOs”), stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other forms of stock awards to employees, directors and consultants.
The number of shares of Class A Common Stock initially reserved for issuance under the 2021 Plan is
26
of shares as may be determined by the Company’s board of directors. Shares subject to stock awards granted under the 2021 Plan that expire or terminate without being exercised in full, or that are paid out in cash rather than in shares, will not reduce the number of shares available for issuance under the 2021 Plan. Additionally, shares issued pursuant to stock awards under the 2021 Plan that are repurchased or forfeited, as well as shares that are reacquired as consideration for the exercise or purchase price of a stock award or to satisfy tax withholding obligations related to a stock award, will become available for future grant under the 2021 Plan.
The 2021 Plan is administered by the Company’s board of directors. The Company’s board of directors, or a duly authorized committee thereof, may delegate to one or more officers the authority to (i) designate employees other than officers to receive specified stock awards and (ii) determine the number of shares to be subject to such stock awards. Subject to the terms of the 2021 Plan, the plan administrator has the authority to determine the terms of awards, including recipients, the exercise price or strike price of stock awards, if any, the number of shares subject to each stock award, the fair market value of a share, the vesting schedule applicable to the awards, together with any vesting acceleration, the form of consideration, if any, payable upon exercise or settlement of the stock award and the terms and conditions of the award agreements for use under the 2021 Plan. The plan administrator has the power to modify outstanding awards under the 2021 Plan. Subject to the terms of the 2021 Plan and in connection with a corporate transaction or capitalization adjustment, the plan administrator may not reprice or cancel and regrant any award at a lower exercise price, strike price or purchase price or cancel any award with an exercise price, strike price or purchase price in exchange for cash, property or other awards without first obtaining the approval of the Company’s stockholders.
2017 Equity Incentive Plan
The 2017 Equity Incentive Plan (the “2017 Plan”) adopted by Legacy Celularity’s board of directors and approved by Legacy Celularity’s stockholders provided for Legacy Celularity to grant stock options to employees, directors and consultants of Legacy Celularity. In connection with the closing of the merger and effectiveness of the 2021 Plan, no further grants will be made under the 2017 Plan.
The total number of stock options that could have been issued under the 2017 Plan was
The 2017 Plan is administered by the Company’s board of directors or, at the discretion of the Company’s board of directors, by a committee of the board of directors. The exercise prices, vesting and other restrictions were determined at the discretion of Legacy Celularity’s board of directors, or its committee if so delegated, except that the exercise price per share of stock options could not be less than
Stock Option Valuation
Awards with Service Conditions
The fair value of each option is estimated on the date of grant using a Black-Scholes option pricing model that takes into account inputs such as the exercise price, the estimated fair value of the underlying common stock at grant date, expected term, expected stock price volatility, risk-free interest rate, and dividend yield. The fair value of each grant of stock options was determined by the Company using the methods and assumptions discussed below. Certain of these inputs are subjective and generally require judgment to determine.
27
The following table presents, on a weighted average basis, the assumptions used in the Black-Scholes option-pricing model to determine the grant-date fair value of stock options granted during the six months ended June 30, 2024 and 2023:
|
|
Six Months Ended June 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Risk-free interest rate |
|
|
% |
|
|
% |
||
Expected term (in years) |
|
|
|
|
|
|
||
Expected volatility |
|
|
% |
|
|
% |
||
Expected dividend yield |
|
|
% |
|
|
% |
||
The weighted average grant-date fair value per share of stock options granted during the six months ended June 30, 2024 and 2023 was $
The following table summarizes option activity with service conditions under the 2021 Plan and the 2017 Plan:
|
|
Options |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
Outstanding at January 1, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Forfeited |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding at June 30, 2024* |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested and expected to vest June 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable at June 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
* Options outstanding at June 30, 2024 under the 2021 Plan and 2017 Plan were
The aggregate intrinsic value of options is calculated as the difference between the exercise price of the stock options and the fair value of the Company's Class A common stock for those options that had exercise prices lower than the fair value of Class A common stock.
The Company recorded stock-based compensation expense relating to option awards with service conditions of $
Awards with Performance Conditions
In connection with the advisory agreement signed with Robin L. Smith, MD (see Note 15), the Company awarded options under the 2021 Plan to acquire a total of
Awards with Market Conditions
In September 2021, the Company awarded options to acquire a total of
28
Restricted Stock Units
The Company issues restricted stock units (“RSUs”) to employees that generally vest over a
The following table summarizes activity related to RSU stock-based payment awards under the 2021 Plan:
|
|
Number of Shares |
|
|
Weighted |
|
||
Outstanding at January 1, 2024 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Vested |
|
|
( |
) |
|
|
|
|
Forfeited |
|
|
( |
) |
|
|
|
|
Outstanding at June 30, 2024 |
|
|
|
|
$ |
|
||
The Company recorded stock-based compensation expense of $
Performance Stock Units
In July 2023, the Company granted
Stock-Based Compensation Expense
The Company recorded stock-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive loss:
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Cost of revenues |
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
||||
Selling, general and administrative |
|
|
|
|
|
|
|
|
|
|
|
||||
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The following table provides information about disaggregated revenue by product and services:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Product sales, net |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Services |
|
|
|
|
|
|
|
|
|
|
|
|
||||
License, royalty and other |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total net revenues |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
29
The following table provides changes in deferred revenue from contract liabilities:
|
|
2024 |
|
|
2023 |
|
||
Balance at January 1 |
|
$ |
|
|
$ |
|
||
Deferral of revenue(1) |
|
|
|
|
|
|
||
Recognition of unearned revenue(2) |
|
|
( |
) |
|
|
( |
) |
Balance at June 30 |
|
$ |
|
|
$ |
|
||
Regeneron Research Collaboration Services Agreement
On August 25, 2023, the Company entered into a multi-year research collaboration services agreement with Regeneron Pharmaceuticals, Inc. ("Regeneron"), pursuant to which the Company will support the research effort of Regeneron's allogeneic cell therapy candidates (the "Regeneron Services Agreement"). The Regeneron Services Agreement’s initial focus is the research on a targeted allogeneic gamma delta chimeric antigen receptor (CAR) T-cell therapy owned by Regeneron designed to enhance proliferation and potency against solid tumors. Payments to the Company under the Regeneron Services Agreement included a non-refundable up-front payment and payments based upon the achievement of defined milestones according to written statements of work. The Regeneron Services Agreement will expire
The Regeneron Services Agreement grants Regeneron a royalty-free, fully-paid up, worldwide, non-exclusive license, with the right to grant sublicenses, to the Company’s intellectual property ("IP”) to the extent that any such license is necessary for Regeneron to fully use the Company’s research services. The Company determined that the (1) research licenses and (2) the research activities performed by the Company represent a single combined performance obligation under the Regeneron Services Agreement. The Company determined that Regeneron cannot benefit from the licenses separately from the research activities because these services are specialized and rely on the Company’s expertise such that these activities are highly interrelated and therefore not distinct. Accordingly, the promised goods and services represent one combined performance obligation and the entire transaction price was allocated to that single combined performance obligation. The performance obligation will be satisfied over the research term as the Company performs the research activities.
The upfront payment of $
Sorrento Therapeutics, Inc. License and Transfer Agreement
The Company and Sorrento Therapeutics, Inc. ("Sorrento"), a related party through September 30, 2023, are party to a License and Transfer Agreement for the exclusive worldwide license to CD19 CAR-T constructs for use in placenta-derived cells and/or cord blood-derived cells for the treatment of any disease or disorder (the "2020 Sorrento License Agreement”). The Company retains the right to sublicense the rights granted under the agreement with Sorrento’s prior written consent. As consideration for the license, the Company is obligated to pay Sorrento a royalty equal to low single-digit percentage of net sales (as defined within the agreement) and a royalty equal to low double-digit percentage of all sublicensing revenues (as defined within the agreement). The 2020 Sorrento License Agreement will remain in effect until terminated by either the Company or Sorrento for uncured material breach upon 90 days written notice or, after the first anniversary of the effective date of the 2020 Sorrento License Agreement, by the Company for convenience upon six months’ written notice to Sorrento. On October 19, 2023, Sorrento filed a Plan of Reorganization under Chapter 11 of the U.S.
30
Bankruptcy Code in the U.S. Bankruptcy Court for the Southern District of Texas which plan contemplates a liquidation of the debtor. If the Plan is confirmed by the Bankruptcy Court, the Company believes that Sorrento will not be able to perform under the license and that any rights the Company might have under the license would be unenforceable. After assessing the status of the IND to determine an optional path forward for the program, the Company elected to terminate development of CYCART-19 for B-cell malignancies during the third quarter of 2023. The Company may continue pre-clinical development of other T-cell candidates.
Genting Innovation PTE LTD Distribution Agreement
On May 4, 2018, concurrently with Dragasac’s equity investment in Legacy Celularity, Legacy Celularity entered into a distribution agreement with Genting Innovation pursuant to which Genting Innovation was granted supply and distribution rights to certain Company products in select Asia markets (the "Genting Agreement”). The Genting Agreement grants Genting Innovation limited distribution rights to the Company’s then-current portfolio of degenerative disease products and provides for the automatic rights to future products developed by or on behalf of the Company.
The term of the Genting Agreement was renewed on January 31, 2023, and automatically renews for successive 12 month terms unless: Genting provides written notice of its intention not to renew at least three months prior to a renewal term or the Genting Agreement is otherwise terminated by either party for cause.
Genting Innovation and Dragasac are both direct subsidiaries of Genting Berhad, a public limited liability company incorporated and domiciled in Malaysia.
On June 14, 2023, the Genting Agreement was amended and restated to include manufacturing rights in the territories covered under the agreement, expanded to include two new countries, and a commitment by the Company to provide technology transfer pursuant to the plan established by a Joint Steering Committee. On January 17, 2024, the Company further amended the Genting Agreement to include distribution and manufacturing rights to certain of the Company’s cell therapy products, including PSC-100, PDA-001, PDA-002, pEXO-001, APPL-001 and CYNK-001.
Celgene Corporation License Agreement
The Company is party to a license agreement with Celgene (the “Celgene Agreement”) pursuant to which the Company granted Celgene two separate licenses to certain intellectual property. The Celgene Agreement grants Celgene a royalty-free, fully-paid up, worldwide, non-exclusive license to the certain intellectual property (“IP”) for pre-clinical research purposes in all fields and a royalty-free, fully-paid up, worldwide license, with the right to grant sublicenses, for the development, manufacture, commercialization and exploitation of products in the field of the construction of any CAR, the modification of any T-lymphocyte or NK cell to express such a CAR, and/or the use of such CARs or T-lymphocytes or NK cells for any purpose, including prophylactic, diagnostic, and/or therapeutic uses thereof. The Celgene Agreement will remain in effect until its termination by either party for cause.
Pulthera, LLC Binding Term Sheet
Concurrent with the entry into the securities purchase agreement for the private placement described in Note 7 above, the Company executed a binding term sheet to negotiate and enter into a sublicense agreement of certain assets from an affiliate of Pulthera, LLC (the "sublicensor"). Pursuant to the binding term sheet, the Company paid sublicensor $
License Agreement with BioCellgraft, Inc.
On December 11, 2023, the Company and BioCellgraft, Inc. ("BioCellgraft") entered into a license agreement whereby the Company granted an exclusive license to BioCellgraft, with the right to sublicense, to develop and commercialize certain licensed products to the dental market in the United States over an initial
The Company regularly reviews its segments and the approach used by management to evaluate performance and allocate resources. The Company manages its operations through an evaluation of
31
The reportable segments were determined based on the distinct nature of the activities performed by each segment. Cell Therapy broadly refers to therapies the Company is researching and developing. Therapies being researched are unproven and in various phases of development. Degenerative Disease produces, sells and licenses products used in surgical and wound care markets. BioBanking collects stem cells from umbilical cords and placentas and provides storage of such cells on behalf of individuals for future use.
The Company manages its assets on a total company basis, not by operating segment. Therefore, the chief operating decision maker does not regularly review any asset information or related income statement effects by operating segment and, accordingly, asset information is not reported by operating segment. Total assets were $
Financial information by segment for the three months ended June 30, 2024 and 2023 is as follows:
|
|
2024年6月30日為止的三個月 |
|
|||||||||||||||||
|
|
Cell |
|
|
生物銀行 |
|
|
退化性 |
|
|
其他 |
|
|
總計 |
|
|||||
淨收入 |
|
$ |
- |
|
|
$ |
|
|
$ |
|
|
$ |
- |
|
|
$ |
|
|||
營收成本（不包括取得之無形資產攤銷） |
|
|
- |
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
|||
直接費用 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
部門貢獻 |
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||
間接費用 |
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
|
|||||
營運虧損 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
( |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
(a) 其他元件的組成 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
攤銷 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
其他總計 |
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
|
|||||
|
|
2023年6月30日結束的三個月 |
|
|||||||||||||||||
|
|
電芯 |
|
|
生物庫存 |
|
|
退化性 |
|
|
其他 |
|
|
總計 |
|
|||||
淨收入 |
|
$ |
- |
|
|
$ |
|
|
$ |
|
|
$ |
- |
|
|
$ |
|
|||
營業成本（不包括取得無形資產之攤銷） |
|
|
- |
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
|||
直接費用 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
分部貢獻 |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
間接費用 |
|
|
|
|
|
|
|
|
|
|
|
|
(b) |
|
|
|||||
營運虧損 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
( |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
（b）其他的元件 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
待付股份收購金額之公允價值變動損益 |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
||||
變動股份條件交易公允價值的變動 |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
||||
研究與發展資產減損 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
攤銷 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
其他總計 |
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
|
|||||
2024年6月30日和2023年結束後六個月的各部門財務資訊如下：
|
|
2024年6月30日止半年度 |
|
|||||||||||||||||
|
|
電芯 |
|
|
生物資料庫 |
|
|
退化性 |
|
|
其他 |
|
|
總計 |
|
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32
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2023年6月30日結束的六個月 |
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待付股份收購金額之公允價值變動損益 |
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變動的應計股票對價公平值 |
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研究與開發不動產、廠房及設備的減損 |
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與羅伯特·哈里里博士的修訂和重新訂僱傭協議
2023 年 1 月 25 日，為了解決公司目前的營運資本要求，公司董事長兼行政總裁博士羅伯特哈里萬 .D. 同意根據僱傭協議暫時將其薪酬調低至最低工資水平，剩餘工資延期至 2023 年 12 月 31 日。截至二零二四年六月三十日, $
為符合日期的證券購買協議
二零二三年三月管道
2023 年 3 月 20 日，公司與兩名認可投資者（包括其主席兼行政總裁 Robert Hariri 博士）簽訂證券購買協議，總購買價為 $
與羅伯特·哈里里博士的貸款協議
二零二三年八月二十一日，該公司簽訂美元
2023 年 10 月 12 日，為進一步解決公司立即營運資本要求，公司董事長兼行政總裁博士羅伯特哈里萬 .D. 與本公司簽署美元債券
與安德魯·佩科拉博士的諮詢和諮詢協議
33
of $
Advisory Agreement with Robin L. Smith MD
On August 16, 2022, the Company entered into an advisory agreement with Robin L. Smith, MD, a then member of the Company’s board of directors, to receive $
COTA, Inc
In November 2020, Legacy Celularity and COTA, Inc. (“COTA”) entered into an Order Schedule (the “Order Schedule No. 2”), to the Master Data License Agreement between Legacy Celularity and COTA, dated October 29, 2018, pursuant to which COTA will provide the licensed data in connection with AML patients. The COTA Order Schedule No. 2 will terminate on the one-year anniversary following the final licensed data deliverable described therein. Andrew Pecora, M.D., Celularity’s former President, is the Founder and Chairman of the Board of COTA and Dr. Robin L. Smith, a former member of the Company’s board of directors, is an investor in COTA. The Company did
Cryoport Systems, Inc
During the six months ended June 30, 2024 and 2023, the Company made payments totaling $
C.V. Starr Loan
On March 17, 2023 the Company entered into a $
Employment of an Immediate Family Member
Alexandra Hariri, the daughter of Robert J. Hariri, M.D., Ph.D., Celularity's Chairman and Chief Executive Officer, is employed by Celularity as an Executive Director, Corporate Strategy & Business Development. Ms. Hariri’s annual base salary for 2024 and 2023 was $
On October 9, 2024, the Company entered into an asset purchase agreement with Sequence LifeScience, Inc. ("Sequence") to acquire Sequence’s Rebound™ full thickness placental-derived allograft matrix product and certain related assets. The aggregate consideration paid for the assets was $
Concurrently with the execution of the asset purchase agreement, the Company entered into an exclusive supply agreement with Sequence for the manufacture and supply of Rebound for a minimum period of six months. Celularity retains the right to manufacture Rebound internally and intends to commence a technology transfer as soon as practicable.
There are no additional items that have not previously been mentioned elsewhere (see Notes 1, 7, 10 and 15) requiring disclosure.
34
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion of our financial condition and results of operations together with the unaudited interim condensed consolidated financial statements and the notes thereto included elsewhere in this report and other financial information included in this report. The following discussion may contain predictions, estimates and other forward-looking statements. See “Special Note Regarding Forward-Looking Statements.” These forward-looking statements involve a number of risks and uncertainties, including those discussed in this report and under “Part I — Item 1A. Risk Factors” in the 2023 Form 10-K. These risks could cause our actual results to differ materially from any future performance suggested below.
Overview
We are a regenerative and cellular medicines company focused on addressing aging related diseases including cancer and degenerative diseases. Our goal is to ensure all individuals have the opportunity to live healthier longer. We develop and market off-the-shelf placental-derived allogeneic advanced biomaterial products including allografts and connective tissue matrices for soft tissue repair and reconstructive procedures in the treatment of degenerative disorders and diseases including those associated with aging. When we are sufficiently capitalized, we plan to resume development of a pipeline of off-the-shelf placental-derived allogeneic cell therapy product candidates including T cells engineered with a chimeric antigen receptor, or CAR, natural killer, or NK cells, mesenchymal-like adherent stromal cells, or MLASCs, and exosomes. These therapeutic candidates may potentially target indications across cancer, infectious and degenerative diseases. We believe that by harnessing the placenta’s unique biology and ready availability, we will be able to develop therapeutic solutions that address a significant unmet global need for effective, accessible and affordable therapeutics. Our advanced biomaterials business today is comprised primarily of the sale of our Biovance 3L products, directly or through our distribution network. Biovance 3L is a tri-layer decellularized, dehydrated human amniotic membrane derived from the placenta of a healthy, full-term pregnancy. It is an intact, natural extracellular matrix that provides a foundation for the wound regeneration process and acts as a scaffold for restoration of functional tissue. We are developing new placental biomaterial products to deepen the biomaterials commercial pipeline. We also plan to leverage our core expertise in cellular therapeutic development and manufacturing to generate revenues by providing contract manufacturing and development services to third parties. The initial focus of this new service offering will be to assist development stage cell therapy companies with the development and manufacturing of their therapeutic candidates for clinical trials.
Our Celularity IMPACT platform capitalizes on the benefits of placenta-derived cells to target multiple diseases, and provides seamless integration, from bio sourcing through manufacturing cryopreserved and packaged allogeneic cells, in our purpose-built U.S.- based 147,215 square foot facility. We believe the use of placental-derived cells, sourced from the placentas of full-term healthy informed consent donors, has potential inherent advantages, from a scientific and an economic perspective. First, relative to adult-derived cells, placental-derived cells demonstrate greater stemness, meaning the ability to expand and persist. Second, placental-derived cells are immunologically naïve, meaning the cells have never been exposed to a specific antigen, and suggesting the potential for less toxicity and for low or no graft-versus-host disease, or GvHD, in transplant. Third, our placental-derived cells are allogeneic, meaning they are intended for use in any patient, as compared to autologous cells, which are derived from an individual patient for that patient’s sole use. We believe this is a key difference that will enable readily available off-the-shelf treatments that can be delivered faster, more reliably, at greater scale and to more patients.
From a single source material, the postpartum human placenta, we derive four allogeneic cell or extracellular vesicle types: T cells, NK cells, MLASCs and exosomes, which have the potential to support multiple therapeutic programs. In 2022, we had active and approved clinical trials under development utilizing CYNK-001, a placental derived unmodified NK cell, for the treatment of acute myeloid leukemia, or AML, a blood cancer, and for glioblastoma multiforme, or GBM, a solid tumor cancer. We also had an active clinical trial utilizing CYNK-101, a genetically modified NK cell, for the treatment of HER2+ Gastric cancer. Due to a need to prioritize corporate resources, in January 2023 we announced our intention to cease recruitment in the GBM and the HER2+ gastric trials. In addition, in April 2023, we announced based on the preliminary results of the Phase 1 trial data of CYNK-001, the AML trial would be closed to further enrollment and completed follow up. We are not actively investigating CYNK-001 for any indication. During the second quarter of 2023, we fully impaired the in-process research and development, or IPR&D, assets associated with CYNK-001. In the first quarter of 2022, we submitted an IND to investigate CYCART-19, a placental-derived CAR-T cell therapy targeting the cluster of differentiation 19, for the treatment of B-cell malignancies. In late May 2022, we received formal written communication from FDA requesting additional information before we could proceed with the Phase 1/2 clinical trial. After assessing the status of the IND to determine an optimal path forward for the CYCART-19 program, we elected to terminate development of CYCART-19 for B-cell malignancies during the third quarter of 2023. We may continue pre-clinical development of other T-cell candidates. APPL-001 is a placenta-derived MLASC being developed for the treatment of Crohn’s disease, and other degenerative diseases. Due to an internal alignment of corporate resources, we paused development in exosomes to focus on other priorities.
Our Celularity IMPACT manufacturing process is a seamless, fully integrated process designed to optimize speed and scalability from the sourcing of placentas from full-term healthy informed consent donors through the use of proprietary processing methods, cell selection, product-specific chemistry, manufacturing and controls, or CMC, advanced cell manufacturing and cryopreservation. The result is a suite of allogeneic inventory-ready, on demand placental-derived cell therapy products. We also operate and manage a
35
commercial biobanking business that includes the collection, processing and cryogenic storage of certain birth byproducts for third-parties.
Our current science is the product of the cumulative background and effort over two decades of our seasoned and experienced management team. We have our roots in Anthrogenesis Corporation, or Anthrogenesis, a company founded under the name Lifebank in 1998 by Robert J. Hariri, M.D., Ph.D., our founder and Chief Executive Officer, and acquired in 2002 by Celgene Corporation, or Celgene. The team continued to hone their expertise in the field of placental-derived technology at Celgene through August 2017, when we acquired Anthrogenesis. We have a robust global intellectual property portfolio comprised of over 350 patents and patent applications protecting our Celularity IMPACT platform, our processes, technologies and current key cell therapy programs. We believe this know-how, expertise and intellectual property will drive the rapid development and, if approved, commercialization of these potentially lifesaving therapies for patients with unmet medical needs.
Recent Developments
Private Placement
On January 12, 2024, we entered into a securities purchase agreement with an existing investor, Dragasac Limited, or Dragasac, providing for the private placement of (i) 2,141,098 shares of our Class A common stock and (ii) accompanying warrants to purchase up to 535,274 shares of our Class A common stock, or the January 2024 PIPE Warrant, for $2.4898 per share and $1.25 per accompanying January 2024 PIPE Warrant, for an aggregate purchase price of approximately $6.0 million. The closing of the private placement occurred on January 16, 2024. The securities were issued pursuant to an exemption from registration provided for under Section 4(a)(2) of the Securities Act, and Regulation D promulgated thereunder. Each January 2024 PIPE Warrant has an exercise price of $2.4898 per share, is immediately exercisable, will expire on January 16, 2029 (five years from the date of issuance), and is subject to customary adjustments for certain transactions affecting our capitalization.
Pursuant to the terms of the securities purchase agreement, we applied the net proceeds to the payment due to YA II PN, Ltd., or Yorkville, pursuant to the Pre-Paid Advance Agreement dated September 15, 2022, or PPA.
In connection with the execution of the securities purchase agreement, we also entered into an investor rights agreement with Dragasac dated as of January 12, 2024. The investor rights agreement provides Dragasac certain information and audit rights, as well as registration rights with respect to the shares (and shares underlying the January 2024 PIPE Warrant), including both the undertaking to file a registration statement within 45 days of filing of the 2023 Form 10-K, "piggyback” registration rights, as well as the right to request up to three demand rights for underwritten offerings per year; in each case subject to customary "underwriter cutback” language as well as any objections raised by the Securities and Exchange Commission, or SEC, to inclusion of securities. If the initial registration statement is not filed on or prior to May 15, 2024, the investor rights agreement provides for partial liquidating damages equal to 1% of the subscription amount each month, up to a maximum of 6%, plus interest thereon accruing daily at a rate of 18% per annum. We began to accrue partial liquidating damages and interest as of May 22, 2024. As a condition to closing, we entered into an amendment to an amended and restated distribution and manufacturing agreement with an affiliate of Dragasac to add cell therapy products in clinical development, investigational stage and/or in near-term commercial use to the list of products under the scope of the exclusive distribution and manufacturing licenses (including unmodified natural killer cells (such as CYNK-001) for aging and other non-oncology indications, PSC-100, PDA-001, PDA-002, pEXO and APPL-001 for regenerative indications).
2024 Warrant Modifications
On January 12, 2024, in connection with the execution of the securities purchase agreement described above, we agreed to reprice legacy warrants to acquire 652,981 shares of our Class A common stock held by Dragasac that expire upon the earliest to occur of (i) March 16, 2025 or (ii) consummation of a change in control of our company, with a previous exercise price of $67.70 to a new exercise price of $2.4898. On March 13, 2024, in connection with the RWI Forbearance Agreement described below, we agreed to issue RWI a warrant to acquire up to 300,000 shares of common stock, which expires June 20, 2028 and has an exercise price of $5.895 per share. Additionally, on March 13, 2024, in connection with the Starr Forbearance Agreement described below, we agreed to amend the exercise price of the 75,000 March 2023 Loan Warrants expiring March 17, 2028 from $7.10 per share to $5.895 per share (the "Minimum Price" as determined pursuant to Nasdaq 5635(d) on March 13, 2024) and the 50,000 June 2023 Warrants expiring June 20, 2028 from $8.10 per share to $5.895 per share, each of which are held by C.V. Starr.
Senior Secured Bridge Loan
On January 12, 2024, we entered into a second amended and restated senior secured loan agreement, or the RWI Second Amended Bridge Loan, with Resorts World Inc Pte Ltd, or RWI, to amend and restate the previously announced senior secured loan agreement with RWI dated as of May 16, 2023, as amended on June 20, 2023, in its entirety. The RWI Second Amended Bridge Loan provided for an additional loan in the aggregate principal amount of $15.0 million net of an original issue discount of $3.75 million, which bears interest at a rate of 12.5% per year, with the first year of interest being paid in kind on the last day of each month, and matures July 16, 2025. In addition, the RWI Second Amended Bridge Loan provides for the issuance of a 5-year immediately exercisable warrant to
36
acquire up to 1,650,000 shares of our Class A common stock, or the Tranche #1 Warrant, and a warrant to acquire up to 1,350,000 shares of our Class A common stock, which will only be exercisable upon the later of (x) stockholder approval for Nasdaq purposes of its exercise price, (y) CFIUS clearance and (z) six months from issuance date, or the Tranche #2 Warrant, and will expire 5 years after it becomes exercisable. The Tranche #1 Warrant and Tranche #2 Warrant were each issued on January 16, 2024, and the Tranche #1 Warrant has an exercise price of $2.4898 per share, and the Tranche #2 Warrant will have an exercise price equal to "Minimum Price” (as determined pursuant to Nasdaq 5635(d)) on the date it becomes exercisable. We closed the RWI Second Amended Bridge Loan and the sale and purchase of the Tranche #1 Warrant and Tranche #2 Warrant on January 16, 2024. The Tranche #2 Warrant initial exercise date was determined to be July 17, 2024 (i.e., six months from the issuance date) and the exercise price was set at $3.076 based on the 5-day trailing average stock price.
Pursuant to the terms of the RWI Second Amended Bridge Loan, we were required to apply the proceeds of the additional loan (i) to the payment in full of all outstanding amounts owed to Yorkville under the PPA, (ii) to the payment of invoices of certain critical vendors, (iii) to the first settlement payment owed to Palantir Technologies, Inc., and (iv) for working capital and other purposes pre-approved by RWI. Pursuant to the terms of the RWI Second Amended Bridge Loan, we agreed to customary negative covenants restricting its ability to pay dividends to stockholders, repay or incur other indebtedness other than as permitted, or grant or suffer to exist a security interest in any of our assets, other than as permitted. In addition, we agreed to apply net revenues received through the sale of our products/provision of services in connection with or related to our distribution and manufacturing agreement with Genting Innovation Pte Ltd, a related party, as a prepayment towards the loan. The RWI Second Amended Bridge Loan includes customary events of default.
We also entered into an investor rights agreement with RWI dated as of January 12, 2024. The investor rights agreement provides RWI certain information and audit rights, as well as registration rights with respect to the shares underlying the Tranche #1 Warrant and Tranche #2 Warrant, including both the undertaking to file a registration statement within 45 days of filing of the 2023 Form 10-K, "piggyback” registration rights, as well as the right to request up to three demand rights for underwritten offerings per year; in each case subject to customary "underwriter cutback” language as well as any objections raised by the SEC to inclusion of securities. If the initial registration statement is not filed on or prior to May 15, 2024, the investor rights agreement provides for partial liquidating damages equal to 1% of the purchase price of the Tranche #1 and Tranche #2 Warrants amount each month, up to a maximum of 6%, plus interest thereon accruing daily at a rate of 18% per annum.
Standby Equity Purchase Agreement
On March 13, 2024, we entered into a Standby Equity Purchase Agreement, or the SEPA, with Yorkville. Under the SEPA, we have the right to sell to Yorkville up to $10.0 million of our Class A common stock, subject to certain limitations and conditions set forth in the SEPA, from time to time, over a 36-month period. Sales of our Class A common stock to Yorkville under the SEPA, and the timing of any such sales, are at our option, and we are under no obligation to sell any shares of our Class A common stock to Yorkville under the SEPA except in connection with notices that may be submitted by Yorkville, in certain circumstances as described below. Upon the satisfaction of the conditions precedent in the SEPA, which include having a resale shelf for shares of our Class A common stock issued to Yorkville declared effective, we have the right to direct Yorkville to purchase a specified number of shares of our Class A common stock by delivering written notice. Such purchase is referred to as an "Advance.” An Advance may not exceed 100% of the average of the daily trading volume of our Class A common stock on The Nasdaq Capital Market, or Nasdaq, during the five consecutive trading days immediately preceding the written notice. Yorkville will generally purchase shares of our Class A common stock pursuant to an Advance at a price per share equal to 97% of the lowest daily volume weighted average price, or VWAP, on Nasdaq during the three consecutive trading days commencing on the date of the delivery of the written notice (unless we specify a minimum acceptable price or there is no VWAP on the subject trading day).
Upon entry into the SEPA, we issued Yorkville a $3.15 million convertible promissory note for $2.99 million in cash (after a 5% original issue discount), or the Initial Advance. The note bears interest at an annual rate equal to 8% (increased to 18% in the event of default as provided in the note), and matures March 13, 2025. Yorkville may convert the note into shares of our Class A common stock at a price per share equal to $6.3171, provided however, on the earlier of (a) the fifth trading day following the effective date of the resale shelf, or (b) September 13, 2024, the conversion price will be the average VWAP of our Class A common stock on Nasdaq during the five consecutive trading days immediately prior to the conversion price reset date, subject to a floor price of $2.4898 per share. Upon the occurrence and during the continuation of an event of default (as defined in the note), the note (including accrued interest) will become immediately due and payable. The issuance of our Class A common stock upon conversion of the note and otherwise under the SEPA is capped at 19.99% of our outstanding Class A common stock as of March 13, 2024 in order to comply with applicable Nasdaq rules. Further, the note and SEPA include a beneficial ownership blocker for Yorkville such that Yorkville may not be deemed the beneficial owner of more than 4.99% of our Class A common stock.
The SEPA will automatically terminate on the earliest to occur of (i) the first day of the month next following the 36-month anniversary of the date of the SEPA or (ii) the date on which Yorkville shall have made payment for shares of our Class A common stock equal to $10.0 million. We have the right to terminate the SEPA at no cost or penalty upon five trading days’ prior written notice to Yorkville, provided that there are no outstanding advances for which shares of our Class A common stock need to be issued and the convertible note (Initial Advance) has been paid in full. We and Yorkville may also agree to terminate the SEPA by mutual written
37
consent. As consideration for Yorkville’s commitment to purchase the shares of our Class A common stock pursuant to the SEPA, we paid Yorkville a $25 thousand cash due diligence fee and a commitment fee equal to 16,964 shares of our Class A common stock.
In connection with the entry into the SEPA, on March 13, 2024, we entered into a registration rights agreement with Yorkville, pursuant to which we agreed to file with the SEC no later than May 3, 2024, a registration statement for the resale by Yorkville of the shares of our Class A common stock issued under the SEPA (including the commitment fee shares). We agreed to use commercially reasonable efforts to have such registration statement declared effective within 45 days of such filing and to maintain the effectiveness of such registration statement during the 36-month commitment period. We will not have the ability to request any Advances under the SEPA (nor may Yorkville convert the Initial Advance into our Class A common stock) until such resale registration statement is declared effective by the SEC. As of the filing date of this Form 10-Q, we have not filed a registration statement with the SEC. As a result of our failure to file our Annual Report on Form 10-K for the year ended December 31, 2023, by April 30, 2024 (i.e., a deemed Event of Default under the convertible promissory note), we began accruing interest at the default rate of 18% as of May 1, 2024. A further event of default occurred as a result of our failure to file a registration statement with the SEC for the resale by Yorkville of the shares of Class A common stock issuable under the SEPA by May 3, 2024. Because we have not yet filed a registration statement no shares can currently be issued under the SEPA.
Forbearance Agreements
On March 13, 2024,we entered into a second forbearance agreement with RWI, or RWI 2nd Forbearance Agreement. Under the RWI 2nd Forbearance Agreement, (i) RWI agreed not to exercise its rights and remedies upon the occurrence of any default under the RWI Second Bridge Loan until our obligations in respect of the Yorkville convertible promissory note have been indefeasibly paid in full or March 13, 2025, whichever occurs first, (ii) RWI consented to our incurrence of indebtedness under the Yorkville convertible promissory note, (iii) RWI consented to cash payments required to be made under the SEPA and the Yorkville convertible promissory note, (iv) we agreed to increase the interest rate on the loan outstanding under the RWI Loan Agreement by 100 basis points, or from 12.5% to 13.5% per annum, and (v) we agreed to issue RWI a warrant to acquire up to 300,000 shares of Class A common stock, which expires June 20, 2028 and has an exercise price of $5.895 per share. Due to our failure to make certain interest payments when due, we began accruing interest on the loan at the default rate of 16.5% as of August 5, 2024.
On March 13, 2024, we entered into a forbearance agreement with C.V. Starr, or Starr Forbearance Agreement, with respect to the Starr Bridge Loan. Under the Starr Forbearance Agreement, (i) C.V. Starr agreed not to exercise its rights and remedies upon the occurrence of any default under the Starr Bridge Loan until our obligations in respect of the Yorkville convertible promissory note have been indefeasibly paid in full, (ii) C.V. Starr consented to our incurrence of indebtedness under the Yorkville convertible promissory note, (iii) C.V. Starr consented to cash payments required to be made under the SEPA and the Yorkville convertible promissory note, (iv) we agreed to increase the interest rate on the loan outstanding under the Starr Bridge Loan by 100 basis points and (v) we agreed to amend the exercise price of (x) that certain warrant to acquire 75,000 shares of our Class A common stock for $7.10 per share, expiring March 17, 2028, and (y) that certain warrant to acquire 50,000 shares of Class A common stock for $8.10 per share expiring June 20, 2028, each of which are held by C.V. Starr, such that the exercise price of each such warrant in (x) and (y) is $5.895 per share. In addition, the interest rate of the Starr Bridge Loan was increased to 13% per annum. Due to our failure to make certain interest payments when due, we began accruing interest on the Starr Bridge Loan at the default rate of 16% as of April 5, 2024.
Short-Term Debt - Other and CEO Promissory Note
The maturity date of the August 21, 2023, loan agreement with Dr. Robert Hariri, our CEO and two unaffiliated lenders, was extended to December 31, 2024. Additionally, on September 30, 2024, Dr. Robert Hariri assumed the full loan in exchange for repayment of the other lender’s respective principal loan amount, plus accrued interest.
Failure to comply with Nasdaq Listing Rule 5250(c)(1)
On August 22, 2024, Nasdaq provided formal notice to us that as a result of our failure to timely file our quarterly reports on Form 10-Q for the periods ended March 31, 2024 (Q1 2024 Form 10-Q) and June 30, 2024 (Q2 2024 Form 10-Q), we were not in compliance with the continued listing requirements under Nasdaq Listing Rule 5250(c)(1). On September 5, 2024, we submitted an updated compliance plan to Nasdaq, and Nasdaq subsequently granted us an extension until October 14, 2024, to file our Q1 2024 Form 10-Q and Q2 2024 Form 10-Q. On October 16, 2024, upon filing the Q1 2024 Form 10-Q, Nasdaq notified us that, as the Q2 2024 Form 10-Q had not been filed, we would be suspended from trading on October 25, 2024, unless we appealed Nasdaq's determination by October 23, 2024. On October 23, 2024, we filed an appeal requesting an oral hearing with a Nasdaq Hearings Panel pursuant to the procedures set forth in the Nasdaq Listing Rule 5800 Series. On October 25, 2024, Nasdaq notified us that the oral hearing date has been set for December 11, 2024, and that the delisting action has been stayed through November 7, 2024, unless the Nasdaq Hearings Panel grants us an extension of the stay, pending the hearing. There can be no assurance that the Nasdaq Hearings Panel will grant us an extension of the stay, that the appeal will be successful, or that we will maintain compliance with the Nasdaq listing requirements. If relief is not granted by the Nasdaq Hearings Panel or we are unable maintain compliance, our securities will be delisted from the Nasdaq, which such delisting could have a materially adverse effect on our ability to continue as a going concern.
38
Going Concern
In accordance with Accounting Standards Update ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), or ASU 205-40, we evaluated whether there are certain conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the unaudited condensed consolidated financial statements are issued.
As an emerging clinical-stage biotechnology company, we are subject to certain inherent risks and uncertainties associated with the development of an enterprise. In this regard, since our inception, substantially all of management’s efforts have been devoted to making investments in research and development including basic scientific research into placentally-derived allogeneic cells, pre-clinical studies to support our current and future clinical programs in cellular therapeutics, and clinical development of our cell programs as well as facilities and selling, general and administrative expenses that support our core business operations (collectively the “investments”), all at the expense of our short-term profitability. We have historically funded these investments through limited revenues generated from our biobanking and degenerative disease businesses and issuances of equity and debt securities to public and private investors (these issuances are collectively referred to as “outside capital”). Notwithstanding these efforts, management can provide no assurance that our research and development and commercialization efforts will be successfully completed, or that adequate protection of our intellectual property will be adequately maintained. Even if these efforts are successful, it is uncertain when, if ever, we will generate significant sales or operate in a profitable manner to sustain our operations without needing to continue to rely on outside capital. Continued decline in our share price could result in impairment of goodwill or long-lived assets in a future period.
As of the date the accompanying unaudited condensed consolidated financial statements were issued, or the issuance date, management evaluated the significance of the following adverse conditions and events in accordance with ASU 205-40:
39
These uncertainties raise substantial doubt about our ability to continue as a going concern. The accompanying unaudited condensed consolidated financial statements have been prepared on the basis that we will continue to operate as a going concern, which contemplates that we will be able to realize assets and settle liabilities and commitments in the normal course of business for the foreseeable future. Accordingly, the accompanying unaudited condensed consolidated financial statements do not include any adjustments that may result from the outcome of these uncertainties.
Business Segments
We manage our operations through an evaluation of three distinct business segments: Cell Therapy, Degenerative Disease, and BioBanking. The reportable segments were determined based on the distinct nature of the activities performed by each segment. Cell Therapy broadly refers to cellular therapies we are researching and developing, which are unproven and in various phases of development. All of the cell therapy programs fall into the Cell Therapy segment. We have no approved cell therapy product and have not generated revenue from the sale of cellular therapies to date. Degenerative Disease produces, sells and licenses products used in surgical and wound care markets, such as Biovance, Biovance 3L, Interfyl and CentaFlex. We sell products in this segment using independent sales representatives as well as distributors. We are developing additional tissue-based products for the Degenerative Disease segment. BioBanking collects stem cells from umbilical cords and placentas and provides storage of such cells on behalf of individuals for future use. We operate in the biobanking business primarily under the LifebankUSA brand. For more information about our reportable business segments refer to Note 14, "Segment Information” of our accompanying unaudited condensed consolidated financial statements included elsewhere in this quarterly report on Form 10-Q.
Acquisitions and Divestitures
Our current operations reflect the following strategic acquisitions that we have made since formation.
In May 2017, we acquired HLI Cellular Therapeutics, LLC, or HLI CT, from Human Longevity Inc. HLI CT operated LifebankUSA, a private umbilical cord blood stem cell and cord tissue bank that offers parents the option to collect, process and cryogenically preserve newborn umbilical cord blood stem cells and cord tissue units. The HLI CT acquisition also provided us with rights to a portfolio of biomaterial assets, including Biovance and Interfyl. At the time of the HLI CT acquisition, Biovance and Interfyl were subject to an exclusive distribution arrangement with Alliqua Biomedical, Inc., or Alliqua. In May 2018, we acquired certain assets from Alliqua, including Alliqua’s biologic wound care business, which included the marketing and distribution rights to Biovance and Interfyl.
In August 2017, we acquired Anthrogenesis, a wholly-owned subsidiary of Celgene. The Anthrogenesis acquisition included a portfolio of pre-clinical and clinical stage assets, including key cellular therapeutic assets that we continue to develop. The Anthrogenesis acquisition gives us access to Anthrogenesis’ proprietary technologies and processes for the recovery of large quantities of high-potential stem cells and cellular therapeutic products derived from postpartum human placentas, each an Anthrogenesis Product. As part of the Anthrogenesis acquisition, some of the inventors of the Anthrogenesis Products and other key members of the Anthrogenesis Product development team joined us.
Licensing Agreements
In the ordinary course of business, we license intellectual property and other rights from third parties and have also out-licensed our intellectual property and other rights, including in connection with our acquisitions and divestitures, described above. Additional details regarding our licensing agreements can be found in Note 13, "License and Distribution Agreements” to our unaudited condensed consolidated financial statements included elsewhere in this quarterly report on Form 10-Q.
In August 2017, in connection with the Anthrogenesis acquisition, we entered into a license agreement, or the Celgene License, with Celgene, which has since been acquired by Bristol Meyers Squibb. Pursuant to the Celgene License, we granted Celgene a worldwide, royalty-free, fully-paid up, non-exclusive license, without the right to grant sublicenses (other than to its affiliates), under Anthrogenesis’ intellectual property in existence as of the date of the Celgene License or as developed by Celgene in connection with any transition services activities related to the merger for non-commercial pre-clinical research purposes, as well as to develop, manufacture, commercialize and fully exploit products and services that relate to the construction of any CAR, the modification of any T-cell or NK cell to express such a CAR, and/or the use of such CARs or T-cells or NK cells for any purpose, which commercial license is sublicensable. Either party may terminate the Celgene License upon an uncured material breach of the agreement by the other party or insolvency of the other party.
In August 2017, Legacy Celularity also issued shares of its Series X Preferred Stock to Celgene as merger consideration and entered into a contingent value rights agreement, or the CVR Agreement, with Celgene pursuant to which Legacy Celularity issued one contingent value right or CVR, in respect of each share of Legacy Celularity Series X Preferred Stock issued to Celgene in connection with the Anthrogenesis acquisition. The CVR Agreement entitles the holders of the CVRs to an aggregate amount, on a per program basis, of $50.0 million in regulatory milestones and an aggregate $125.0 million in commercial milestone payments with respect to certain of our investigational therapeutic programs. In addition, with respect to each such program and calendar year, the CVR holders will be entitled to receive a royalty equal to a mid-teen percentage of the annual net sales for such program’s therapeutics from the date
40
of the first commercial sale of such program’s therapeutic in a particular country until the latest to occur of the expiration of the last to expire of any valid patent claim covering such program therapeutic in such country, the expiration of marketing exclusivity with respect to such therapeutic in such country, and August 2027 (i.e., the tenth anniversary of the closing of the acquisition of Anthrogenesis). No payments under the CVR Agreement have been made to date. We estimate the liability associated with the CVR quarterly. Changes to that liability include but are not limited to changes in our clinical programs, assumptions about the commercial value of those programs and the time value of money.
On December 11, 2023, we entered into a license agreement with BioCellgraft, Inc. whereby we granted an exclusive license to BioCellgraft, with the right to sublicense, to develop and commercialize certain licensed products to the dental market in the United States over an initial four year term, which license agreement will automatically renew for an additional two years unless either party provides written notice of termination. BioCellgraft agreed to pay us total license fees of $5.0 million over a two year period. Upon execution of the agreement, we received an initial $0.3 million payment towards the first year of the two year period.
Components of Operating Results
Net revenues
Net revenues include: (i) sales of biomaterial products, including Biovance, Biovance 3L, Interfyl, and CentaFlex of which our direct sales are included in Product Sales while sales through our network of distribution partners are included in License, royalty and other; and (ii) the collection, processing and storage of umbilical cord and placental blood and tissue after full-term pregnancies, collectively, Services.
Cost of revenues
成本包括與我們兩個現有商業業務部門（生物儲存和退化性疾病）有關的勞動力、物料和間接成本。 生物儲存成本包括新儲存材料的存儲和運輸套件成本，以及銀行保存的凍結胎盤和其他單位的槽和設施間接成本。 退化性疾病成本包括採購胎盤、質化胎床材料以及將胎床組織加工成可銷售產品所需的成本。 退化性疾病部門的成本包括與Biovance、Biovance 3L、Interfyl和CentaFlex產品線生產相關的勞動力和間接成本。 與直接銷售相關的成本列入產品銷售項目，而與通過我們的分銷合作夥伴銷售相關的成本則納入許可、特許權和其他項目。
研究和開發費用
我們的研究與開發支出主要涉及基礎科學研究，是有關胎盤源性異基因電芯、為支持目前及未來細胞醫學臨床計畫的臨床之前研究、我們的Nk電芯計畫與設施的臨床開發、由於研究與開發活動而產生的折舊及其他直接及分攤開支。我們支出用於研究科學家人員支出、用於進行生物研究的專用化學品和試劑支出、第三方測試和驗證支出、以及包括租金和設施維護支出在內的各種間接支出。基礎研究、與合作夥伴相關的研究合作、旨在成功提出監管機構申請的研究，對我們目前和未來細胞治療的成功至關重要。我們的研究與開發支出金額將取決於眾多因素，包括臨床試驗的時間安排、臨床試驗中有效性的初步證據以及我們選擇追求的適應症數量。
一般及行政費用
銷售、一般及行政費用主要包括支持我們核心業務運營的專業人員費用，包括薪水、獎金、股票報酬和福利。執行管理、財務、法務、人力資源和信息科技是銷售、一般及行政費用的關鍵元件，這些費用將在發生時予以承認。我們期望通過重新排列優先順序的努力，近期將看到銷售、一般及行政成本的下降。銷售、一般及行政成本的規模和時間取決於臨床試驗的進展、任何獲批治療方案的商業化努力，包括在退化疾病研究組合中推出新產品、監管環境的變化或支持我們業務策略所需的人員。
待付股份收購金額之公允價值變動損益
由於購併Celgene和HLI Ct的Anthrogenesis列為業務組合，我們根據會計的收購方法在資產負債表中承認了與收購相關的條件性支付。有關業務組合相關條件性支付的更多信息，請參見附註9“與業務組合相關的條件性支付”。條件性支付負債的公允價值是基於機率加權的收入方法和關於實現監管和商業里程碑義務以及版稅義務的概率評估而確定的。與收購相關的條件性支付的公允價值在每個報告期重新衡量，其變動金額記錄在簡明綜合損益表中。條件性支付公允價值估計的變動導致我們的條件性支付義務增加或減少，並對營運結果產生對應的支出或減少。條件性支付的關鍵元素
41
考慮的是監管里程碑支付、銷售里程碑支付和版稅支付。監管支付應在美國和歐盟對某些細胞類型的監管批准後支付。監管里程碑支付是一次性的，但應在特定指標的細胞類型有潛在商業成功之前支付。版稅支付是淨銷售額的百分比。銷售里程碑支付應在達到特定總銷售閾值時支付。管理層在評估條件支付的價值時必須做出重大判斷。管理層使用的估計包括但不限於：（i）我們可能基於預臨床數據質量而追求的臨床項目的數量和類型，（ii）進行臨床試驗所需的時間，（iii）該試驗的監管成功的機會，（iv）我們在成功的情況下可以治療的患者數量和（v）實現商業地位的治療定價。所有這些領域都涉及管理層的重大判斷，且本質上是不確定的。
Results of Operations
Comparison of Three Months Ended June 30, 2024 to June 30, 2023
|
|
截至六月三十日的三個月 |
|
|
|
|
|
百分比 |
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
增加 |
|
|
增加 |
|
||||
收入： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
產品銷售淨額 |
|
$ |
9,963 |
|
|
$ |
906 |
|
|
$ |
9,057 |
|
|
|
999.7 |
% |
服務 |
|
|
1,278 |
|
|
|
1,278 |
|
|
|
- |
|
|
|
— |
% |
許可、版稅和其他 |
|
|
870 |
|
|
|
754 |
|
|
|
116 |
|
|
|
15.4 |
% |
總凈收益 |
|
|
12,111 |
|
|
|
2,938 |
|
|
|
9,173 |
|
|
|
312.2 |
% |
營業費用： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
營業費用（不包括已取得無形資產攤銷成本 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
產品銷售 |
|
|
1,119 |
|
|
|
207 |
|
|
|
912 |
|
|
|
440.6 |
% |
服務 |
|
|
537 |
|
|
|
485 |
|
|
|
52 |
|
|
|
10.7 |
% |
許可、權利金及其他 |
|
|
467 |
|
|
|
110 |
|
|
|
357 |
|
|
|
324.5 |
% |
研發費用 |
|
|
3,800 |
|
|
|
8,604 |
|
|
|
(4,804 |
) |
|
|
(55.8 |
)% |
軟體停用成本 |
|
|
— |
|
|
|
243 |
|
|
|
(243 |
) |
|
|
(100.0 |
)% |
銷售，一般及行政費用 |
|
|
15,907 |
|
|
|
12,826 |
|
|
|
3,081 |
|
|
|
24.0 |
% |
待付股份收購金額之公允價值變動損益 |
|
|
— |
|
|
|
(85,407 |
) |
|
|
85,407 |
|
|
|
100.0 |
% |
研究與發展費用和其他無形資產減損 |
|
|
— |
|
|
|
107,800 |
|
|
|
(107,800 |
) |
|
|
(100.0 |
)% |
取得無形資產攤銷 |
|
|
456 |
|
|
|
546 |
|
|
|
(90 |
) |
|
|
(16.5 |
)% |
總營業費用 |
|
|
22,286 |
|
|
|
45,414 |
|
|
|
(23,128 |
) |
|
|
(50.9 |
)% |
營運虧損 |
|
$ |
(10,175 |
) |
|
$ |
(42,476 |
) |
|
$ |
(32,301 |
) |
|
|
(76.0 |
)% |
網絡收入和營收成本
截至2024年6月30日止三個月的凈收入為1210萬美元，較去年同期增加920萬美元，增幅達312.2％。這一增長主要是由於產品銷售增加910萬美元，這是由於對Biovance 3L需求增加所致。
2024年6月30日結束的三個月內，收入成本為210萬美元，較前一年同期增加130萬美元，增幅為164.7%。增加主要是由於產品銷售成本增加90萬美元，主要是由於Biovance 3L直接面向客戶銷售的增加，以及部分程度上，由於透過經銷商銷售生物材料產品的成本增加40萬美元所致。就收入比例而言，2024年6月30日結束的三個月內，與前一年同期相比，收入成本下降至18%，而前一年同期為27%，這是由於Biovance 3L銷售增加，其毛利率高於其他生物材料產品。
研發費用
Research and development expenses for the three months ended June 30, 2024 were $3.8 million, a decrease of $4.8 million, or 55.8% compared to the prior year period. The decrease was primarily due to lower personnel costs resulting from our March 2023 reduction in force, lower clinical trial costs as a result of discontinuing certain clinical trials of our cell therapy candidates and lower allocated indirect overhead costs.
Software Cease-Use Costs
There were no software cease-use costs for the three months ended June 30, 2024, a decrease of $0.2 million, or 100%, from the prior year period, which reflected the recognition of the remaining contract value associated with the Palantir platform fees in connection with our cease of use of the platform. We subsequently reached a settlement with Palantir and no software cease-use costs were incurred
42
在本期間。有關Palantir協議的詳細資訊，請參見我們這份未經審計的簡明合併基本報表中其他地方包含的第9號附註「承諾與條件」。
銷售、一般及管理費用
2024年6月30日止三個月的銷售、一般和行政費用為1590萬美元，較上年同期增加310萬美元，增長24%。增加主要是由於銷售費用增加，部分抵消了人員費用的降低。
未來條件支付責任公允價值變動
截至2024年6月30日三個月結束時，與前一年同期的8540萬美元負責任條款公平價值相比，並未出現任何變化。我們在2023年停止了我們的電芯治療臨床試驗。因此，今年期間負責任條款公平價值出現微小變化。截至2023年6月30日三個月結束時，市場假設和基礎預測的變化導致負責任條款公平價值下降（有關負責任條款公平價值變化的更多信息請參見附在本季度報告10-Q表格中其他地方包含的我們未經審計的簡明綜合財務報表中的第3號附註，“金融資產和負債的公允價值”）
IPR&D 償債減損
2024年6月30日結束的三個月內，與去年同期因電芯治療業務的临床试验中止以及我們策略和管線的变化导致未来收入預測下降而產生的10780萬美元費用相比，未出現任何知识产权研发 impairment。
其他收益（費用）
|
|
截至六月三十日的三個月 |
|
|
|
|
|
百分比 |
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
變動 |
|
|
變動 |
|
||||
利息收入 |
|
$ |
67 |
|
|
$ |
66 |
|
|
$ |
1 |
|
|
|
1.5 |
% |
利息費用 |
|
|
(1,552 |
) |
|
|
(1,104 |
) |
|
|
(448 |
) |
|
|
40.6 |
% |
公允價值變動 |
|
|
7,005 |
|
|
|
(134 |
) |
|
|
7,139 |
|
|
|
(5327.6 |
)% |
債務公允價值的變動 |
|
|
(67 |
) |
|
|
(1,077 |
) |
|
|
1,010 |
|
|
|
(93.8 |
)% |
其他費用，淨額 |
|
|
(1,766 |
) |
|
|
(3,224 |
) |
|
|
1,458 |
|
|
|
(45.2 |
)% |
其他收益（費用）合計 |
|
$ |
3,687 |
|
|
$ |
(5,473 |
) |
|
$ |
9,160 |
|
|
|
(167.4 |
)% |
For the three months ended June 30, 2024, other income was $3.7 million compared to $5.5 million of expense in the prior year period. The $9.2 million change was primarily related to a change in the fair value of the warrant liabilities due to a decrease in the price of our Class A common stock during the quarter ended June 30, 2024 (see Note 3, “Fair Value of Financial Assets and Liabilities” in our unaudited condensed consolidated financial statements included elsewhere in this quarterly report on Form 10-Q). Included in the three months ended June 30, 2023 was expense of $1.1 million for changes in fair value of debt related to the September 15, 2022 Yorkville Pre-Paid Advance Agreement, or Yorkville PPA, which we elected to account for at fair value. The Yorkville PPA was subsequently repaid in full on January 17, 2024. Other expense, net included a loss of $2.2 million in the three months ended June 30, 2023 related to the RWI Loan and RWI Warrant transactions (see Note 7, "Debt" in our unaudited condensed consolidated financial statements included elsewhere in this quarterly report on Form 10-Q). This loss is not present in the comparable period for 2024, highlighting the year-over-year change.
43
Comparison of Six Months Ended June 30, 2024 to June 30, 2023
|
|
截至六月三十日之半年度財報 |
|
|
|
|
|
百分比 |
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
增加 |
|
|
增加 |
|
||||
收入： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
產品銷售淨額 |
|
$ |
22,806 |
|
|
$ |
1,949 |
|
|
$ |
20,857 |
|
|
|
1,070.1 |
% |
服務 |
|
|
2,565 |
|
|
|
2,635 |
|
|
|
(70 |
) |
|
|
(2.7 |
)% |
許可、版稅及其他 |
|
|
1,421 |
|
|
|
2,289 |
|
|
|
(868 |
) |
|
|
(37.9 |
)% |
總凈收益 |
|
|
26,792 |
|
|
|
6,873 |
|
|
|
19,919 |
|
|
|
289.8 |
% |
營業費用： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
營業成本（不包括取得無形資產攤銷） |
|
|
|
|
|
|
|
|
|
|
|
|
||||
產品銷售 |
|
|
2,341 |
|
|
|
929 |
|
|
|
1,412 |
|
|
|
152.0 |
% |
服務 |
|
|
714 |
|
|
|
957 |
|
|
|
(243 |
) |
|
|
(25.4 |
)% |
許可證、版稅及其他 |
|
|
708 |
|
|
|
919 |
|
|
|
(211 |
) |
|
|
(23.0 |
)% |
研發費用 |
|
|
9,643 |
|
|
|
25,555 |
|
|
|
(15,912 |
) |
|
|
(62.3 |
)% |
軟體停用成本 |
|
|
— |
|
|
|
23,918 |
|
|
|
(23,918 |
) |
|
|
(100.0 |
)% |
銷售，一般及行政費用 |
|
|
29,935 |
|
|
|
26,760 |
|
|
|
3,175 |
|
|
|
11.9 |
% |
待付股份收購金額之公允價值變動損益 |
|
|
— |
|
|
|
(104,339 |
) |
|
|
104,339 |
|
|
|
100.0 |
% |
商譽減損 |
|
|
— |
|
|
|
29,633 |
|
|
|
(29,633 |
) |
|
|
(100.0 |
)% |
研究與開發不動產、廠房及設備的減損 |
|
|
— |
|
|
|
107,800 |
|
|
|
(107,800 |
) |
|
|
(100.0 |
)% |
取得無形資產攤銷 |
|
|
1,002 |
|
|
|
1,087 |
|
|
|
(85 |
) |
|
|
(7.8 |
)% |
總營業費用 |
|
|
44,343 |
|
|
|
113,219 |
|
|
|
(68,876 |
) |
|
|
(60.8 |
)% |
營運虧損 |
|
$ |
(17,551 |
) |
|
$ |
(106,346 |
) |
|
$ |
(88,795 |
) |
|
|
(83.5 |
)% |
網絡收入和營收成本
2024年6月30日結束的六個月淨收入為2680萬美元，較去年同期增加1990萬美元，增長率為289.8%。這主要是由於產品銷售增加了2090萬美元，主要是由於對Biovance 3L需求增加，部分抵消了授權、版稅和其他收入減少了90萬美元，主要是因為分銷商銷售減少。
截至2024年6月30日，成本收入為380萬美元，較去年同期增加100萬美元，增幅為34.2%。增加主要是由於產品銷售成本增加140萬美元，主要是由於Biovance 3L直接對客戶銷售增加，部分抵消了透過分銷商和生物庫集貯處理和儲存費用的生物材料產品銷售成本降低。與收入相比，截至2024年6月30日的成本收入佔比下降至14%，而去年同期為41%，這是由於Biovance 3L的銷售增加，其毛利潤率比其他生物材料產品高。
Research and Development Expenses
Research and development expenses for the six months ended June 30, 2024 were $9.6 million, a decrease of $15.9 million, or 62.3% compared to the prior year period. The decrease was primarily due to $3.1 million lower personnel costs resulting from our March 2023 reduction in force, $3.7 million lower clinical trial costs as a result of discontinuing certain clinical trials of our cell therapy candidates, $5.6 million lower allocated indirect overhead costs and the inclusion of $3.0 million of acquired IPR&D expense in the prior year period associated with an option fee paid to Pulthera, LLC for stem-cells inventory to be used in research and development.
Software Cease-Use Costs
截至2024年6月30日止六個月，我們未發生任何關於軟體停用成本，相較於去年同期的2390萬美元，後者反映我們在與palantir平台費用有關的剩餘合同價值認知因為我們停用該平台。我們隨後與palantir達成和解，在當期未發生任何軟體停用成本。有關palantir協議的相關信息請參見我們本季度報告表10-Q的未經審核的簡明合併財務報表中其他位置包含的附註9，“承諾和附帶條件”。
銷售、一般及管理費用
截至2024年6月30日的前六個月，銷售、一般及管理開支為2,990萬美元，較去年同期增加320萬美元，增幅為11.9%。增加主要是由於銷售開支增加，部分抵銷了由於我們於2023年3月裁員而導致的人員開支降低。
44
未來條件支付責任公允價值變動
有關2024年6月30日結束後的六個月，相較於前一年度10430萬美元的貸方，應計負債的公允價值並無變化。我們於2023年終止了我們的電芯治療臨床試驗。因此，當前一年期間，應計負債的公允價值只有微小變化。截至2023年6月30日結束的六個月，基於市場假設和基礎預測的改變導致應計負債的公允價值下降（有關應計負債公允價值變化的更多信息，請參閱我們未經審計的簡明綜合財務報表中第10-Q表格的本次季度報告其他地方包含的註釋3“金融資產和負債的公允價值”）。
商譽和研究開發費用減值
截至2024年6月30日的六個月內未有任何減值費用。截至2023年6月30日的六個月內，由於終止臨床試驗及業務策略和產品組合的調整，細胞治療業務未來營業收入預測下降，分別出現了2960萬美元和10780萬美元的商譽和研發投資減值費用。
其他收益（費用）
|
|
截至六月三十日止六個月 |
|
|
|
|
|
百分比 |
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
變更 |
|
|
變更 |
|
||||
利息收入 |
|
$ |
177 |
|
|
$ |
182 |
|
|
$ |
(5 |
) |
|
|
(2.7 |
)% |
利息支出 |
|
|
(2,700 |
) |
|
|
(1,381 |
) |
|
|
(1,319 |
) |
|
|
95.5 |
% |
認股證負債公平價值變動 |
|
|
(1,870 |
) |
|
|
1,601 |
|
|
|
(3,471 |
) |
|
|
(216.8 |
)% |
債務公平價值變化 |
|
|
14 |
|
|
|
(2,357 |
) |
|
|
2,371 |
|
|
|
(100.6 |
)% |
償還債務損失 |
|
|
(3,908 |
) |
|
|
— |
|
|
|
(3,908 |
) |
|
|
100.0 |
% |
其他費用（淨額） |
|
|
(2,663 |
) |
|
|
(3,665 |
) |
|
|
1,002 |
|
|
|
(27.3 |
)% |
其他費用總計 |
|
$ |
(10,950 |
) |
|
$ |
(5,620 |
) |
|
$ |
(5,330 |
) |
|
|
94.8 |
% |
For the six months ended June 30, 2024, other expense increased by $5.3 million compared to the prior year period. The increase was primarily related to a $3.5 million change in the fair value of the warrant liabilities (see Note 3, “Fair Value of Financial Assets and Liabilities” in our unaudited condensed consolidated financial statements included elsewhere in this quarterly report on Form 10-Q). Included in the six months ended June 30, 2024 was a $3.9 million loss on debt extinguishment recorded in connection with the January 12, 2024 RWI Second Amended Bridge Loan (for more information about the RWI Second Amended Bridge Loan refer to Note 7, “Debt” in our unaudited condensed consolidated financial statements included elsewhere in this quarterly report on Form 10-Q). Included in the six months ended June 30, 2023, was expense of $2.4 million for changes in fair value of debt related to the Yorkville PPA, which we elected to account for at fair value. The Yorkville PPA was subsequently repaid in full on January 17, 2024.
Liquidity and Capital Resources
As of June 30, 2024, we had $0.5 million of unrestricted cash and cash equivalents and an accumulated deficit of $870.3 million. Our primary use of our capital resources is funding our operating expenses, which consist primarily of funding selling, general and administrative expenses, and to a lesser extent, the research and development of our cellular therapeutic candidates.
On January 12, 2024, we entered into a securities purchase agreement with Dragasac, providing for the private placement of (i) 2,141,098 shares of our Class A common stock for $2.4898 per share and (ii) accompanying warrants to purchase up to 535,274 shares of Class A common stock for $1.25 per warrant. Total proceeds from the financing were approximately $6.0 million. Additionally, on January 12, 2024, we entered into the RWI Second Amended Bridge Loan, which provided for an additional loan in the aggregate principal amount of $15.0 million net of an original issue discount of $3.75 million.
Pursuant to the terms of the January 12, 2024 security purchase agreement with Dragasac and the RWI Second Amended Bridge Loan, we were required to apply the aggregate proceeds to: (i) payment in full of all outstanding amounts owed Yorkville under the September 15, 2022 PPA, (ii) payment of invoices of certain critical vendors, (iii) the first settlement payment owed to Palantir, and (iv) for working capital and other purposes pre-approved by RWI.
On March 13, 2024, we entered into a Standby Equity Purchase Agreement, or SEPA, with Yorkville. Upon entry into the SEPA, we issued Yorkville a $3.15 million convertible promissory note for $2.99 million in cash (after a 5% original issue discount). Refer to the Standby Equity Purchase Agreement section above for further details. Proceeds from the note were used for working capital purposes, including payment of invoices of certain critical vendors.
As of the issuance date, we had insufficient unrestricted cash and cash equivalents available to fund our operations and no available additional sources of outside capital to sustain our operations for a period of 12 months beyond the issuance date. These uncertainties raise substantial doubt about our ability to continue as a going concern. Refer to the Going Concern section above for further details.
45
To date, we have not had any cellular therapeutics approved for sale and have not generated any revenues from the sale of our cellular therapeutics and we are not actively developing any cellular therapeutics in our pipeline given our liquidity. We do not expect to generate any revenues from cellular therapeutic product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our therapeutic candidates, which we expect will take a number of years. If we obtain regulatory approval for any of our therapeutic candidates, we expect to incur significant commercialization expenses related to therapeutic sales, marketing, manufacturing and distribution as our current commercialization efforts are limited to our biobanking and degenerative disease businesses. As a result, until such time, if ever, as we can generate sufficient revenues to fund operations, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including commercial sales of our biomaterials products, as well as potentially collaborations, licenses and other similar arrangements for our cellular therapeutic candidates. We continue to explore licensing and collaboration arrangements for our cellular therapeutics as well as distribution arrangements for our degenerative disease business. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. Failure to obtain this necessary capital or address our liquidity needs may force us to delay, limit or terminate our operations, make further reductions in our workforce, discontinue our commercialization efforts for our biomaterials products as well as other clinical trial programs, liquidate all or a portion of our assets or pursue other strategic alternatives, and/or seek protection under the provisions of the U.S. Bankruptcy Code.
We expect to incur substantial expenses in the foreseeable future for the expansion of our degenerative disease business and ongoing internal research and development programs. We will require substantial additional funding in the future to build the sales, marketing and distribution infrastructure that will be necessary to commercialize our biomaterials products.
To date, inflation has not had a significant impact on our business. However, any significant increase in inflation and interest rates could have a significant effect on the economy in general and, thereby, could affect our future operating results.
Cash Flows
The following table summarizes our cash flows for the six months ended June 30, 2024 and 2023:
|
|
Six Months Ended June 30, |
|
|
|
|
||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Cash (used in)/provided by |
|
|
|
|
|
|
|
|
|
|||
Operating activities |
|
$ |
(7,851 |
) |
|
$ |
(26,022 |
) |
|
$ |
18,171 |
|
Investing activities |
|
|
2,105 |
|
|
|
(3,240 |
) |
|
|
5,345 |
|
Financing activities |
|
|
6,137 |
|
|
|
18,369 |
|
|
|
(12,232 |
) |
Net change in cash, cash equivalents and restricted cash |
|
$ |
391 |
|
|
$ |
(10,893 |
) |
|
$ |
11,284 |
|
Operating Activities
Net cash used in operations for the six months ended June 30, 2024 was $18.2 million lower than the prior year period, primarily due to higher net revenues, partially offset by an increase in accounts receivable and lower operating expenses mainly due to our March 2023 reduction in force and lower clinical trial costs from discontinuation of certain clinical trials of our cell therapy candidates.
Investing Activities
We received $2.1 million and used $3.2 million of net cash in investing activities for the six months ended June 30, 2024 and 2023, respectively. Net cash provided by investing activities for the six months ended June 30, 2024 included the $2.2 million settlement of the convertible note receivable from Sanuwave, offset by $0.1 million of capital expenditures. Net cash used in investing activities for the six months ended June 30, 2023, included $0.2 million of capital expenditures and $3.0 million used to acquire in-process research and development.
Financing Activities
Net cash provided by financing activities was $6.1 million for the six months ended June 30, 2024, which consisted of $15.0 million from the RWI second amended and restated senior secured loan agreement entered into on January 12, 2024, $6.0 million from the January 2024 private placement agreement with Dragasac and $3.0 million, net from the March 13, 2024 convertible promissory note issued to Yorkville, partially offset by $17.4 million for the payment in full of the Yorkville PPA. For the six months ended June 30, 2023 we generated $18.4 million of net cash from financing activities, which consisted primarily of $12.4 million from the March 2023 and May 2023 private placements, $5.0 million of proceeds from the Starr Bridge Loan, $12.8 million of proceeds from the RWI Loans, $6.0 million from the April 2023 registered direct offering, offset by principal repayments on the Yorkville PPA of $16.8 million and $1.4 million of issuance costs.
46
Critical Accounting Policies
Our significant accounting policies are summarized in Note 2, “Summary of Significant Accounting Policies” included within the Notes to our unaudited condensed consolidated financial statements included elsewhere in this quarterly report on Form 10-Q and in Note 2 to our audited annual financial statements included in the 2023 Form 10-K.
There have been no significant changes in our critical accounting policies during the six months ended June 30, 2024 as compared with those previously disclosed in the 2023 Form 10-K.
Recent Accounting Pronouncements
See Note 2 to our unaudited condensed consolidated financial statements included herein and Note 2 to our audited annual financial statements for the year ended December 31, 2023 included in the 2023 Form 10-K for information about recent accounting pronouncements, the timing of their adoption, and our assessment, to the extent we have made one, of their potential impact on our financial condition and results of operations.
JOBS Act Accounting Election
We are an “emerging growth company,” as defined in the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies.
We have elected to use this extended transition period to enable us to comply with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not applicable.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures,” as defined under Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it 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. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Because there are inherent limitations in all control systems, a control system, no matter how well conceived and operated, can provide only reasonable, as opposed to absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. 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. 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.
Our management, with the participation of our Principal Executive Officer and Principal Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered in this quarterly report on Form 10-Q. Based on that evaluation, management concluded that the disclosure controls and procedures were not effective, at the reasonable assurance level, as of the end of the period covered by this quarterly report on Form 10-Q, as a result of the material weaknesses in internal control over financial reporting discussed below as well as our inability to timely file this quarterly report on Form 10-Q, as well as our annual report on Form 10-K for the year ended December 31, 2023, which had not been filed until July 30, 2024.
We previously identified the following material weaknesses in our internal control over financial reporting:
47
We are currently implementing our remediation plan to address the material weaknesses identified above. Such measures include:
Remediation of the identified material weaknesses and strengthening our internal control environment will require a substantial effort throughout 2024 and beyond, as necessary. We will test the ongoing operating effectiveness of the new and existing controls in future periods. The material weaknesses cannot be considered completely remediated until the applicable controls have operated for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively.
Changes in Internal Control over Financial Reporting
Other than in connection with executing upon the continued implementation of the remediation measures referenced above, there were no changes in our internal controls over financial reporting that occurred during our fiscal quarter ended June 30, 2024 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
48
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in litigation or other legal proceedings. Except as set forth below, we are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact because of defense and settlement costs, diversion of management resources and other factors.
Arbitration Demand from Palantir Technologies Inc.
On April 20, 2023, Palantir Technologies Inc., or Palantir, commenced an arbitration with JAMS Arbitration, or JAMS, asserting claims for declaratory relief and breach of contract relating to the May 5, 2021 Master Subscription Agreement, or Palantir MSA, seeking damages in an amount equal to the full value of the contract. We responded to the arbitration demand and asserted counterclaims for breach of contract, breach of warranty, fraudulent inducement, violation of California’s Unfair Competition Law, amongst others, in relation to the Palantir MSA. On December 21, 2023, we entered into a settlement and release agreement, or Palantir Settlement Agreement, to resolve the JAMS Arbitration. The Palantir Settlement Agreement was subsequently amended on January 10, 2024 and May 6, 2024. Both parties agreed to dismiss the arbitration proceeding and dispute and provide for mutual releases upon satisfaction of a settlement payment obligation. Through June 3, 2024, we made total settlement payments of $3.5 million and issued Palantir an aggregate of 60,584 shares of our Class A common stock as consideration for further amendments to the Palantir Settlement Agreement. On June 4, 2024, the parties dismissed all claims and counterclaims. The Palantir MSA is now fully terminated and neither party has any further rights or obligations thereunder. The shares of our Class A common stock issued to Palantir were issued with piggyback registration rights. Resale of such shares by Palantir shall be included on any future registration statement we file.
Celularity Inc. v. Evolution Biologyx, LLC, et al.
On April 17, 2023, we filed a complaint against Evolution Biologyx, LLC, Saleem S. Saab, individually, and Encyte, LLC, (collectively, Evolution), in the U.S. District Court for the District of New Jersey to recover unpaid invoice amounts for the sale of our biomaterial products in the amount of approximately $2.35 million, plus interest. In September 2021, we executed a distribution agreement with Evolution, whereupon Evolution purchased biomaterial products from us for sale through Evolution’s distribution channels. We fulfilled Evolution’s orders and otherwise performed each of our obligations under the distribution agreement. Despite attempts to recover the outstanding invoices and Evolution’s promise to pay, Evolution has refused to pay any of the invoices and has materially breached its obligations under the distribution agreement. Our complaint asserts claims of breach of contract and fraudulent inducement, amongst others. We intend to vigorously pursue the matter to recover the outstanding payments owed by Evolution, as well as interest and reasonable attorney's fees, but there can be no assurance as to the outcome of the litigation.
Civil Investigative Demand
We received a Civil Investigative Demand, or Demand, under the False Claims Act, 31 U.S.C. § 3729, dated August 14, 2022, from the U.S. Attorney’s Office for the Eastern District of Pennsylvania. The Demand requests documents and information relating to claims submitted to Medicare, Medicaid, or other federal insurers for services or procedures involving injectable human tissue therapy products derived from amniotic fluid or birth tissue and includes Interfyl. We are cooperating with the request and are engaged in an ongoing dialogue with the Assistant U.S. Attorneys handling the Demand. The matter is still in preliminary stages and there is uncertainty as to whether the Demand will result in any liability.
TargetCW v. Celularity Inc.
On March 27, 2024, WMBE Payrolling, Inc., dba TCWGlobal, filed a complaint in the United States District Court for the Southern District of California alleging a breach of contract and account stated claims relating to a Master Services Agreement dated May 4, 2020, or the TCWGlobal MSA, for the provision of certain leased workers to perform services on our behalf. The complaint alleges that we breached the TCWGlobal MSA by failing to make payments on certain invoices for the services of the leased workers. On May 7, 2024, we entered into a settlement agreement and mutual release with TCWGlobal whereupon we agreed to pay $0.5 million in tiered monthly installments, with the last payment due and payable on May 1, 2025, in exchange for a dismissal of the complaint and full release of all claims.
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 filed with the SEC on July 30, 2024.
49
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
On January 10, 2024, we issued 20,000 shares of our Class A common stock, par value $0.0001 per share to Palantir Technologies Inc., or Palantir, pursuant to a Confidential Letter Agreement by and among us and Palantir dated January 10, 2024. The shares, which have not been registered, were issued pursuant to the exemption requirements provided in Section 4(a)(2) of the Securities Act of 1933, as amended.
On May 6, 2024, we issued 40,584 shares of our Class A common stock, par value $0.0001 per share to Palantir, pursuant to a Confidential Letter Amendment to the Palantir Settlement Agreement by and among us and Palantir dated December 21, 2023. The shares, which have not been registered, were issued pursuant to the exemption requirements provided in Section 4(a)(2) of the Securities Act of 1933, as amended.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
None of our directors or “officers,” as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934,
Item 6. Exhibits.
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Exhibit Number |
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Description |
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3.1 |
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3.2 |
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3.3 |
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10.1+ |
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10.2 |
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10.3 |
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10.4 |
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10.5 |
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10.6 |
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10.7 |
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10.8 |
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10.9 |
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10.10 |
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Standby Equity Purchase Agreement, dated March 13, 2024, between Celularity, Inc. and YA II PN, Ltd. (incorporated by reference to Exhibit 10.1 to the current report on Form 8-K, filed with the Commission on March 15, 2024). |
10.11 |
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10.12 |
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10.13 |
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10.14 |
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10.15 |
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10.16# |
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10.17# |
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10.18# |
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10.19# |
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10.20# |
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10.21# |
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10.22 |
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31.1 |
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31.2 |
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32.1* |
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32.2* |
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101.INS |
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Inline XBRL Instance Document- the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document |
101.SCH |
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Inline XBRL Taxonomy Extension Schema Document |
101.CAL |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF |
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Inline XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB |
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Inline XBRL Taxonomy Extension Label Linkbase Document |
101.PRE |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document |
104 |
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The cover page for the Company’s quarterly report on Form 10-Q has been formatted in Inline XBRL and contained in Exhibit 101 |
# Indicates a management contract or any compensatory plan, contract or arrangement.
* The certifications attached as Exhibits 32.1 and 32.2 accompanying this report are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Celularity Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this report, irrespective of any general incorporation language contained in such filing.
+ Celularity Inc. has omitted certain schedules and exhibits pursuant to Item 601(a)(5) of Regulation S-K and shall furnish supplementally to the Securities and Exchange Commission copies of any of the omitted schedules and exhibits upon request by the SEC.
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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.
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CELULARITY INC. |
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Date: November 6, 2024 |
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By: |
/s/ Robert J. Hariri |
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Robert J. Hariri, M.D., Ph.D. |
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Chief Executive Officer |
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(Principal Executive Officer) |
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Date: November 6, 2024 |
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By: |
/s/ David C. Beers |
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David C. Beers |
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Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
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