美國
證券交易委員會
華盛頓特區，郵編：20549
形式
第1號修正案
(標記一)
根據1934年《證券交易法》第13或15(D)條規定的季度報告 |
截至本季度末
根據1934年證券交易法第13或15（d）條提交的過渡報告 |
由_至_的過渡期
委員會文件號：
(註冊人的確切姓名載於其章程)
這個 |
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(述明或其他司法管轄權 公司或組織) |
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不適用 |
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（主要行政辦公室地址） |
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(郵政編碼) |
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(註冊人的電話號碼，包括區號)
N/A
(前姓名、前地址和前財政年度，如果自上次報告以來發生變化)
根據該法第12(B)條登記的證券：
每個班級的標題 |
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交易 符號 |
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各交易所名稱 在其上註冊的 |
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用複選標記表示註冊人是否：(1)在過去12個月內(或註冊人被要求提交此類報告的較短時間內)提交了1934年《證券交易法》第13或15(D)節要求提交的所有報告，以及(2)在過去90天內一直遵守此類提交要求。
通過勾選標記檢查註冊人是否已在過去12個月內（或在註冊人被要求提交此類文件的較短期限內）以電子方式提交了根據S-t法規第405條（本章第232.405條）要求提交的所有交互數據文件。
用複選標記表示註冊人是大型加速申報公司、加速申報公司、非加速申報公司、較小的報告公司或新興成長型公司。請參閱《交易法》第12b-2條規則中「大型加速申報公司」、「加速申報公司」、「較小申報公司」和「新興成長型公司」的定義。
大型加速文件服務器 |
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加速文件管理器 |
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規模較小的報告公司 |
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新興成長型公司 |
如果是一家新興的成長型公司，用複選標記表示註冊人是否已選擇不使用延長的過渡期來遵守根據《交易所法》第13(A)節提供的任何新的或修訂的財務會計準則。
通過勾選標記檢查註冊人是否是空殼公司（定義見《交易法》第120億.2條）。 是的 沒有
截至2024年11月5日，登記人已
說明性說明
表格10-Q/A的本第1號修正案的唯一目的是修改ATAI Life Sciences NV表格10-Q季度報告中作爲附件31.3和附件32.1提交的證書（「公司」）於11月13日向美國證券交易委員會提交了截至2024年9月30日的季度報告，2024年（「原始文件」）糾正一致簽名的無意遺漏，並糾正附件31.2簽名塊標題行中的抄寫員錯誤，括號中指的是「聯席首席執行官」。 這些認證於2024年11月13日全面執行，並在原始備案時由公司擁有。 根據修訂後的1934年證券交易法第120億.15條，當前日期的證書已作爲附件31.1 - 31.3和附件32.1提供。
除上述規定外，本第1號修正案不會以任何方式修改、修改或更新原始備案中包含的財務或其他信息，本第1號修正案也不反映原始備案後可能發生的事件。本第1號修正案應與原始文件一起閱讀。
ATAI生命科學NV
表格10-問答
目錄
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頁面 |
1 |
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第一部分：財務信息 |
3 |
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項目1. |
3 |
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3 |
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4 |
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5 |
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6 |
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7 |
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8 |
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項目2. |
41 |
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項目3. |
60 |
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項目4. |
61 |
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第二部分。其他信息 |
62 |
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項目1. |
62 |
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第1A項。 |
62 |
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項目2. |
62 |
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項目3. |
62 |
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項目4. |
62 |
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第五項。 |
62 |
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第六項。 |
63 |
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65 |
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關於前方的注意事項ARD尋找聲明
這份截至2024年9月30日的10-Q/A表格季度報告(以下簡稱「季度報告」)包含符合「1995年私人證券訴訟改革法案」的前瞻性陳述。我們打算將這類前瞻性陳述納入修訂後的1933年《證券法》第27A節和修訂後的1934年《證券交易法》第21E節中關於前瞻性陳述的安全港條款。除歷史事實陳述外，本季度報告中包含的所有陳述均爲前瞻性陳述，包括但不限於以下陳述：我們未來的經營結果和財務狀況；我們候選產品的成功、成本和開發時機，包括非臨床、臨床前研究和臨床試驗及相關里程碑的進展；我們當前候選產品和我們可能確定並追求的任何其他候選產品的商業化，如果獲得批准，包括我們成功建立專業銷售隊伍和商業基礎設施以營銷我們當前的候選產品和我們可能確定和追求的任何其他候選產品的能力；獲得和維護監管部門批准的時機和能力；我們的業務戰略和計劃；潛在的收購、合作伙伴關係和其他戰略安排；從任何當前或未來的許可協議和其他戰略安排中產生收入的能力；我們的現金和現金等價物以及爲我們的業務提供資金的短期證券的充足程度；Hercules Capital，Inc.貸款安排下的可用資金；以及未來業務和資本支出的管理計劃和目標。「相信」、「可能」、「將會」、「估計」、「繼續」、「預期」、「打算」、「預期」、「可能」、「將會」、「計劃」、「可能」、「可能」、「初步」、「可能」以及類似的表達方式旨在識別前瞻性陳述。
這些前瞻性陳述主要基於我們目前對未來事件和趨勢的預期和預測，我們認爲這些事件和趨勢可能會影響我們的財務狀況、運營結果、業務戰略、短期和長期業務運營和目標，以及財務需求。這些前瞻性陳述既不是承諾，也不是保證，受一些重要因素的制約，這些因素可能導致實際結果與前瞻性陳述明示或暗示的任何未來結果、業績或成就大不相同，包括但不限於：我們是一家臨床階段的生物製藥公司，自成立以來已發生重大虧損，我們預計在可預見的未來將出現虧損，可能永遠不會盈利；如果我們無法在需要時以可接受的條件獲得資金，我們可能被迫推遲、限制或停止我們的候選產品開發工作；我們有限的運營歷史可能會使您很難評估我們業務的成功和評估我們未來的生存能力；我們依賴第三方協助進行臨床試驗以及我們研究和臨床前測試的某些方面；我們目前依賴在第三方臨床試驗地點工作的合格治療師在我們的臨床試驗中管理我們的某些候選產品，我們預計這將在我們當前或未來的候選產品獲得批准(如果有的話)後繼續進行，如果第三方網站未能招聘和保留足夠數量的治療師或未能有效管理他們的治療師，我們的業務、財務狀況和運營結果將受到實質性損害；我們的候選產品處於臨床前或臨床開發階段，這是一個漫長而昂貴的過程，結果不確定，我們不能保證我們的任何候選產品將成功開發和/或獲得監管批准，這是它們可以商業化之前所必需的；針對中樞神經系統(CNS)的藥物的研究和開發尤其困難，可能很難預測和理解爲什麼一種藥物對某些患者有積極影響，但對其他患者沒有積極影響，這可能會降低我們的產品候選產品最終獲得批准的可能性，因此可能對我們的業務和運營結果產生實質性的不利影響；我們的候選產品的生產和銷售可能被認爲是非法的，或者可能因爲使用受控物質而受到限制，這也可能對來自外國司法管轄區的投資的合法性產生影響，因此我們可能無法在這些司法管轄區成功地將我們的候選產品商業化，這將對我們的業務、財務狀況和運營結果產生不利影響；在技術和科學快速變化的環境中，我們面臨着激烈的競爭，我們的競爭對手有可能在我們之前獲得監管部門的批准，或者開發比我們更安全、更先進或更有效的療法，這可能會對我們成功營銷或商業化我們可能開發的任何候選產品的能力產生負面影響，並最終損害我們的財務狀況；如果我們無法爲我們現有的候選產品或我們可能確定的任何其他候選產品獲得並保持足夠的知識產權保護，或者如果我們目前擁有或未來獲得的知識產權保護範圍不夠廣泛，我們的競爭對手可能會開發和商業化與我們類似或相同的候選產品，我們成功將現有候選產品和我們可能追求的任何其他候選產品商業化的能力可能會受到損害；第三方可能會聲稱我們正在侵犯、挪用或以其他方式侵犯他們的知識產權，其結果將是不確定的，並可能阻止或推遲我們的開發和商業化努力；我們未來的成功取決於我們留住關鍵員工、董事、顧問和顧問的能力，以及吸引、留住和激勵合格人員的能力；由於我們與Hercules Capital，Inc.簽訂的貸款協議，我們的經營活動可能受到限制，如果我們違約或違約，我們可能需要償還未償債務，這可能對我們的業務產生重大不利影響；如果我們未能保持有效的披露控制和財務報告內部控制系統，我們編制及時準確財務報表或遵守適用法規的能力可能會受到損害；我們的業務受到與國際業務相關的經濟、政治、監管和其他風險的影響；大流行、流行病或傳染病的爆發，如新冠肺炎大流行，可能會對我們的業務產生實質性的不利影響，包括我們的臨床前研究、臨床試驗、試驗地點、我們所依賴的第三方、我們的供應鏈、我們籌集資金的能力、我們進行常規業務的能力和我們的財務業績，以及在截至12月31日的第一部分「管理層對財務狀況和運營結果的討論和分析」第1A部分中「風險因素」項下描述的其他風險、不確定性和假設，以及在截至12月31日的10-K表格中的其他部分。2023年(「10-K表格」)，在「管理層」中進一步更新
1
本季度報告第2項以及我們隨後向美國證券交易委員會（「SEC」）提交的文件中包含「財務狀況和經營業績的討論和分析」。
本文中做出的任何前瞻性陳述僅限於原始備案之日，您不應依賴前瞻性陳述作爲對未來事件的預測。儘管我們相信前瞻性陳述中反映的預期是合理的，但我們不能保證前瞻性陳述中反映的未來結果、業績或成就將會實現或將會發生。除適用法律要求外，我們沒有義務在原始提交日期後以任何原因更新任何這些前瞻性陳述，也沒有義務使這些陳述符合實際結果或修訂後的預期。
一般信息
除非上下文另有要求，否則本季度報告中所有提及的「我們」、「我們的」、「atai」或「公司」均指ATai Life Sciences NV及其合併子公司。本文中提到的「季度報告」是指截至2024年9月30日季度期間的10-Q/A表格季度報告，本文中提到的「10-K表格」和「年度報告」是指我們截至2023年12月31日財年的10-K表格年度報告。
我們向SEC提交的所有報告均可通過SEC網站www.sec.gov上的電子數據收集分析和檢索（EDGAR）系統免費下載。我們還通過我們的投資者關係網站免費下載報告的電子副本 ir.atai.life 在向SEC提交此類材料後，在合理可行的範圍內儘快提交。
我們可能會使用我們的投資者關係網站（網址： ir.atai.life.因此，除了關注我們向SEC提交的文件、網絡廣播、新聞稿和電話會議外，我們鼓勵投資者和其他對atai感興趣的人審查我們在我們網站上提供的信息。我們網站上包含的信息不包含在本季度報告中，也不構成本季度報告的一部分。
2
第一部分-財務信息
項目1. 財務報表
阿泰生命科學NV
凝結固型BARACE頁
(以千爲單位，不包括每股和每股)
(未經審計)
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9月30日， |
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12月31日， |
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2024 |
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2023 |
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資產 |
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流動資產： |
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現金及現金等價物 |
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以公允價值計價的證券 |
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用於其他投資的短期限制現金 |
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承諾投資資金 |
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預付費用和其他流動資產 |
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短期應收票據-關聯方，淨值 |
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流動資產總額 |
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財產和設備，淨額 |
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經營性租賃使用權資產淨額 |
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以公允價值持有的其他投資 |
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其他投資 |
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長期應收票據-關聯方，淨值 |
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其他資產 |
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總資產 |
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負債與股東權益 |
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流動負債： |
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應付賬款 |
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應計負債 |
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租賃負債的當期部分 |
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短期可轉換期票和衍生負債-關聯方 |
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短期可轉換期票和衍生負債 |
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其他流動負債 |
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流動負債總額 |
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或有對價負債-關聯方 |
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或有對價負債 |
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租賃負債的非流動部分 |
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可轉換期票和衍生負債-關聯方 |
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可轉換本票和衍生負債 |
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長期債務，淨額 |
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其他負債 |
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(Note 16） |
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股東權益： |
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普通股，歐元 |
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額外實收資本 |
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累計其他綜合損失 |
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累計赤字 |
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歸屬於ATAI生命科學NV股東的股東權益總額 |
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非控制性權益 |
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總負債和股東權益 |
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請參閱隨附的未經審計簡明綜合財務報表附註。
3
阿泰生命科學NV
濃縮合並聲明N運營TS
(以千爲單位，不包括每股和每股)
（未經審計）
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許可證收入 |
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( |
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|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
其他收入(費用)，淨額： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
利息收入 |
|
|
|
|
|
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|
|
|
|
|
||||
利息開支 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
受益於研發稅收抵免 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
資產和負債公允價值變動，淨額 |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
||
淨匯兌收益(虧損) |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|||
其他費用，淨額 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
其他收入(費用)合計，淨額 |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
||
所得稅前淨收益(虧損) |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
所得稅受益(撥備) |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
權益法投資對象投資損失，扣除稅款 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
淨利潤（虧損） |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
非控股權益應占淨虧損 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
歸屬於ATAI Life Sciences NV的淨利潤（虧損） |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
歸屬於ATAI Life Sciences NV的每股淨利潤（虧損） |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
歸屬於ATAI Life Sciences NV的每股淨利潤（虧損） |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
加權平均應占流通普通股 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
加權平均應占流通普通股 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
請參閱隨附的未經審計簡明綜合財務報表附註。
4
阿泰生命科學NV
壓縮合並報表收入（損失）
(金額以千爲單位)
（未經審計）
|
|
截至9月30日的三個月內， |
|
|
截至9月30日的9個月， |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
淨利潤（虧損） |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
其他全面收益(虧損)： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
外幣折算調整，稅後淨額 |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
||
綜合收益（損失） |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
非控股權益應占淨虧損 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
外幣兌換調整，扣除非控股權益應占稅款 |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
||
可歸屬於非控股權益的綜合損失 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
歸屬於ATAI生命科學的綜合收益（虧損） |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
請參閱隨附的未經審計簡明綜合財務報表附註。
5
阿泰生命科學NV
簡明合併股東權益報表
(以千爲單位的數額，但份額除外)
（未經審計）
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
總 |
|
|
|
|
|
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|
||||||||
|
|
|
|
|
|
|
|
|
|
|
積累 |
|
|
|
|
|
股東 |
|
|
|
|
|
|
|
||||||||
|
|
|
|
|
|
|
|
額外 |
|
|
其他 |
|
|
|
|
|
應占權益 |
|
|
|
|
|
總 |
|
||||||||
|
|
普通股 |
|
|
實收 |
|
|
全面 |
|
|
積累 |
|
|
ATAI生命科學NV |
|
|
非控制性 |
|
|
股東 |
|
|||||||||||
|
|
股份 |
|
|
量 |
|
|
資本 |
|
|
損失 |
|
|
赤字 |
|
|
股東 |
|
|
利益 |
|
|
股權 |
|
||||||||
2023年12月31日餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
||||||
限制性股票單位歸屬後發行股份 |
|
|
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
基於股票的補償費用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
外幣兌換調整，扣除稅 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
||||
淨虧損 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
2024年3月31日餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
||||||
限制性股票單位歸屬後發行股份 |
|
|
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
- |
|
|
|
— |
|
|
|
- |
|
||
行使股票期權後發行股票 |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||||
收購可變利益實體額外權益後對額外實繳資本的調整 |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
基於股票的補償費用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
債務修改後額外實繳資本的調整 |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
外幣兌換調整，扣除稅 |
|
|
— |
|
|
|
— |
|
|
|
- |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
淨虧損 |
|
|
— |
|
|
|
— |
|
|
|
- |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
2024年6月30日餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
||||||
行使股票期權後發行股票 |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||||
基於股票的補償費用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
外幣兌換調整，扣除稅 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
淨虧損 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
2024年9月30日餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
總 |
|
|
|
|
|
|
|
|||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
積累 |
|
|
|
|
|
股東 |
|
|
|
|
|
|
|
|||||||||
|
|
|
|
|
|
|
|
額外 |
|
|
分享 |
|
|
其他 |
|
|
|
|
|
應占權益 |
|
|
|
|
|
總 |
|
|||||||||
|
|
普通股 |
|
|
實收 |
|
|
訂費 |
|
|
全面 |
|
|
積累 |
|
|
ATAI生命科學NV |
|
|
非控制性 |
|
|
股東 |
|
||||||||||||
|
|
股份 |
|
|
量 |
|
|
資本 |
|
|
應收賬款 |
|
|
損失 |
|
|
赤字 |
|
|
股東 |
|
|
利益 |
|
|
股權 |
|
|||||||||
2022年12月31日的餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
||||||
行使股票期權後發行股票 |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||||
股票期權行使時股票發行的結算 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
基於股票的補償費用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
累計赤字調整（根據ASM 2016-13的採用） |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
外幣兌換調整，扣除稅 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
||||
淨虧損 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
2023年3月31日的餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||||
基於股票的補償費用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
外幣兌換調整，扣除稅 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
||||
淨虧損 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
2023年6月30日的餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||||
基於股票的補償費用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
收購可變利益實體額外權益後對額外實繳資本的調整 |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
外幣兌換調整，扣除稅 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
||||
淨利潤（虧損） |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
2023年9月30日餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||||
請參閱隨附的未經審計簡明綜合財務報表附註。
6
阿泰生命科學NV
CAS的濃縮合並報表H流
(金額以千爲單位)
（未經審計）
|
|
截至9月30日的9個月， |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
經營活動的現金流 |
|
|
|
|
|
|
||
淨虧損 |
|
$ |
( |
) |
|
$ |
( |
) |
對淨虧損與經營活動中使用的現金淨額進行的調整： |
|
|
|
|
|
|
||
長期資產的折舊和攤銷 |
|
|
|
|
|
|
||
非現金租賃費用 |
|
|
|
|
|
|
||
債務貼現攤銷 |
|
|
|
|
|
|
||
基於股票的補償費用 |
|
|
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請參閱隨附的註釋 未經審計的簡明合併財務報告灰褐色。
7
阿泰生命科學NV
簡明合併財務報表附註
（未經審計）
1.或業務的組織與描述
總部設在德國柏林的阿泰生命科學公司(「阿泰」或「公司」)是阿泰生命科學股份公司的母公司，與其子公司一起，是一家臨床階段的生物製藥公司，旨在改變精神健康障礙的治療方式。ATAI成立於2018年，是對心理健康治療領域重大的未得到滿足的需求和缺乏創新的回應，致力於高效地開發創新療法來治療抑鬱、焦慮、成癮和其他心理健康障礙。通過彙集資源和最佳實踐，ATAI旨在負責任地加快新藥的開發，以實現對精神健康患者具有臨床意義和持續的行爲改變。
該公司受到生物技術行業臨床階段公司常見的風險和不確定因素的影響，包括但不限於，競爭對手對新技術創新的開發，對關鍵人員、第三方臨床研究機構和製造商的依賴，對專有知識產權和技術的保護，對政府法規的遵守，以及獲得額外資本爲運營提供資金的能力。目前正在開發的候選治療藥物在商業化之前將需要大量額外的研究和開發努力，包括臨床前和臨床測試以及監管批准。這些努力需要大量資本、充足的人員和基礎設施以及廣泛的合規報告能力。即使該公司的治療開發努力取得成功，該公司何時(如果有的話)將從銷售中實現收入也是不確定的。
該公司將該業務作爲一個可報告的部門進行運營和管理，這是一項識別和推進精神健康創新的業務。本公司已確定其首席執行官爲首席運營決策者(「CODM」)。CODM審查合併的運營費用，以便根據公司的整體戰略和目標，決定將資源或資本分配給特定的化合物或項目。該公司主要在美國和德國的兩個地理區域開展業務。
流動資金和持續經營
自成立以來，該公司在運營中出現了重大虧損和負現金流。截至2024年9月30日，公司擁有現金和現金等價物#美元。
該公司目前預計，截至2024年9月30日的現有現金和現金等價物以及短期證券將爲自未經審核簡明綜合財務報表發出之日起至少12個月，足以支付其營運開支及資本開支需求。
2.重要會計政策的列報、彙總和彙總依據
陳述的基礎
隨附的未經審核簡明綜合財務報表乃根據美國公認會計原則(「美國公認會計原則」)編制，以提供中期財務資料，並符合美國證券交易委員會(「美國證券交易委員會」)對中期財務報告的要求。因此，這些未經審計的簡明合併財務報表並不包括美國公認會計原則要求的完整財務報表所需的所有信息和披露，因爲美國公認會計原則通常要求的某些腳註或其他財務信息可能被濃縮或省略。這些未經審計的簡明綜合財務報表應與公司已審計的綜合財務報表及其附註一併閱讀，這些報表及其附註包括在公司於2024年3月28日提交給美國證券交易委員會的截至2023年12月31日的10-k表格年度報告中。
未經審核的簡明綜合財務報表已按年度財務報表的相同基準編制，管理層認爲該等報表反映所有調整，其中只包括爲公平地反映本公司的財務狀況、其經營業績及全面虧損以及所呈報期間的現金流量所需的正常經常性調整。截至2024年9月30日的三個月和九個月的經營結果不一定表明截至2024年12月31日的一年或任何其他未來年度或中期的預期結果。
8
本附註中對適用會計準則的任何提及均指財務會計準則委員會(「FASB」)發佈的會計準則編纂(「ASC」)和「會計準則更新」(「ASU」)中包含的權威美國公認會計原則。
重新分類
對未經審計的簡明綜合財務報表和附註中的上期金額進行了某些重新分類，以符合本年度的列報方式，以便合併和簡化按公允價值持有的資產和負債變動的披露。
整固
該公司未經審計的簡明綜合財務報表包括安泰及其子公司的賬目。所有公司間餘額和交易均已在合併中沖銷。
該公司的政策是合併其通過擁有已發行有表決權股票的多數股權而控制的所有實體。此外，符合以ATAI爲主要受益人的可變利益實體(「VIE」)定義的實體被合併。主要受益人是有權指導對實體的經濟業績產生最重大影響的VIE活動的一方，並且有義務承擔該實體的損失，或有權從該實體獲得可能對該實體具有重大意義的利益。對於非全資擁有的合併實體，第三方持有的股權在公司未經審計的簡明綜合資產負債表和未經審計的簡明綜合股東權益表中作爲非控股權益列示。歸屬於非控股權益的淨收益部分在公司未經審計的簡明綜合經營報表中作爲歸屬於非控股權益的淨虧損列示。
重大會計政策
受限現金
該公司維持着某些現金餘額，限制在取款或使用方面。截至2024年9月30日的受限現金資產的唯一目的是額外購買貝克利心理科技有限公司的C系列股票。有關詳細信息，請參閱注5。
最近採用的會計公告
ASU 2016-13金融工具-信貸損失
2016年6月，FASB發佈了ASU 2016-13，金融工具-信貸損失。這一指導要求立即確認管理層對當前預期信貸損失的估計。在以前的模式下，只有當損失被認爲是可能的時才確認損失。新模型適用於大多數金融資產和某些其他工具，它們不是通過淨收入按公允價值計量的。
本公司使用未貼現的違約概率(PD)和給定違約損失(LGD)方法來估計其資產池的信貸損失，該資產池由對其他公司的貸款組成。在PD和LGD方法下，預期信貸損失百分比(或「損失率」)的計算方法是違約概率(即資產在給定時間範圍內違約的概率)乘以違約造成的損失(即由於違約而預計不會收回的資產的百分比)。爲了實施PD和LGD方法，本公司利用可隨時觀察到的來自期限匹配公共債務的市場信息，得出按標準普爾(「S」)信用評級等級分組的市場隱含當前預期信用損失(「MICECL」)。MICECL框架根據可公開獲得或估計的S信用評級，考慮資產池的風險特徵，爲資產池或資產組計算適當的信用損失準備金。
ASU 2016-13年度要求對自第一個報告期開始時起生效的財務狀況表進行累計效果調整。在……上面2023年1月1日，公司採用了該指南，並通過對採用後的保留收益進行累積效應調整，應用了修改後的追溯過渡方法。在過渡期間，新會計指南的採用導致
9
在……裏面累計赤字增加#美元
最近發佈的尚未採用的會計公告
2023年11月，財務會計準則委員會(「FASB」)發佈了新的指導意見，旨在改善可報告分部的披露要求，主要是通過加強對每個分部重大費用的披露。該指導意見適用於2023年12月15日之後開始的所有財政年度，以及2024年12月15日之後開始的過渡期。新標準必須在追溯的基礎上通過，並允許及早採用。該公司採用該標準的時間並不早。我們目前正在評估這一指導意見，以確定其對我們合併財務報表的影響。
2023年12月，財務會計準則委員會發布了新的指導意見，旨在改善所得稅披露要求，主要是通過在有效稅率調節中增加分類披露以及加強對已支付所得稅的披露。該指導意見適用於2024年12月15日之後的所有財政年度。新標準可以在預期的基礎上通過，並可選擇追溯通過，並允許及早採用。該公司採用該標準的時間並不早。我們目前正在評估這一指導意見，以確定其對我們合併財務報表的影響。
2024年11月，FASB發佈了新的指導意見，旨在改善損益表費用披露，主要是要求以表格形式披露新的財務報表，並將任何相關損益表標題下的指定類別的信息分類。該標準適用於2026年12月15日之後的財政年度和2027年12月15日之後的財政年度內的過渡期，並允許提前採用。新標準一經通過，可以前瞻性地或追溯地適用。本公司目前正在評估這一採用可能對其精簡綜合財務報表中的披露產生的影響。
3.收購和處置
2023年處置
西伯爾公司
2023年10月，公司與心理創辦人(以下簡稱「心理創建人」)簽訂了一項框架協議，根據協議，公司將其在心理創建人(「心理創建人」)的股權轉讓給創建人，以換取某些知識產權。
作爲出售的結果，本公司不再擁有Sprber的控制財務權益。該公司決定，它不再是主要受益者，不再有權力指導精神病者的重大活動，因此，解除整合的精神病者。T除保留的知識產權外，該公司從其合併資產負債表中取消確認了精神病的所有資產和負債，並確認了#美元的損失。
該公司得出的結論是，根據資源資本分配決定而取消合併Squber的決定並不代表重大的戰略轉變，不會對公司的運營和財務業績產生實質性影響。因此，在截至2023年12月31日的年度綜合經營報表中，公司沒有將解除合併前的經營業績作爲非持續經營列報。
TrypageniX，Inc.
2023年12月，公司與CB Treeutics，Inc.(「CBT」)敲定並簽訂了一項框架協議，根據該協議，公司將其在TrypageniX Inc.(「TrypageniX」)的股權轉讓給CBT，以換取某些知識產權以及修訂和重新簽署的開發服務和獨家許可協議。
作爲出售的結果，本公司不再擁有TrypageniX的控股權。該公司確定，它不再是主要受益人，不再有權指導TrypageniX的重大活動，因此，解除合併後的TrypageniX。該公司取消了對所有TrypageniX的識別從合併資產負債表中提取資產和負債，並確認收益#美元
該公司的結論是，取消合併TrypageniX的決定是基於資源資本分配決定，並不代表重大的戰略轉變，不會對公司的運營和財務業績產生實質性影響。因此，在截至2023年12月31日的年度綜合經營報表中，公司沒有將TrypageniX在解除合併前的業績作爲非持續業務列報。
10
4.可變權益實體
合併後的VIE
在每個報告期，本公司都會重新評估其是否仍是根據VIE模式合併的可變利益實體(「VIE」)的主要受益人。
本公司合併的實體由全資及部分擁有的實體組成，而本公司是VIE模式下的主要受益人，因爲本公司有權(I)有權指導對VIE的經濟表現有最重大影響的活動，及(Ii)有義務承擔可能對VIE造成重大損失的損失，或有權從VIE獲得可能對VIE產生重大利益的利益。合併實體的經營結果包括在公司自收購之日起至2024年9月30日的未經審計的簡明綜合財務報表中。
截至2024年9月30日和2023年12月31日，公司已將以下合併投資記爲VIE：
合併實體 |
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已獲取日期控件 |
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所有權百分比2024年9月30日 |
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所有權百分比2023年12月31日 |
感知神經科學控股公司。 |
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科爾斯股份有限公司 |
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認識生命科學公司。 |
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心理Protix公司 |
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截至2024年9月30日和2023年12月31日，合併後的VIE的資產只能用於償還各自VIE的債務。合併VIE的負債是各自VIE的債務，其債權人對ATAI的一般信貸或資產沒有追索權。
心理Protix公司
2021年2月3日，作爲本公司和Chymia(創辦人)的合資企業成立了SquProtix，Inc.(以下簡稱「QiProtix」)，其目的是使QiProtix成爲阿泰新成立的公司子公司。爲了探索和開發一種基於新陳代謝組學的精確精神病學方法而創建了QiProtix。根據該公司在收購時對交易的評估，該公司得出結論認爲，QiProtix不是一項業務，並將該公司的投資作爲對一項不屬於ASC 810規定的業務的VIE進行初步合併。
於2024年4月，本公司與Chymia訂立框架協議，導致本公司收購Chymia
下表列出了截至的所有VIE的資產和負債(不包括在合併中沖銷的公司間餘額)2024年9月30日（以千計）：
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感知 |
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Kures |
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淨化 |
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資產： |
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流動資產： |
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現金 |
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$ |
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應收賬款 |
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預付費用和其他流動資產 |
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流動資產總額 |
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總資產 |
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$ |
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$ |
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負債： |
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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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$ |
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應計負債 |
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其他流動負債 |
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流動負債總額 |
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總負債 |
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$ |
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$ |
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$ |
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11
下表列出了截至2023年12月31日所有合併VIE的資產和負債（不包括合併中抵消的公司間餘額）（單位：千）：
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感知 |
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Kures |
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淨化 |
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PsyProtix |
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資產： |
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流動資產： |
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現金 |
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$ |
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$ |
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$ |
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$ |
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應收賬款 |
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預付費用和其他流動資產 |
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流動資產總額 |
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長期應收票據 |
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其他資產 |
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總資產 |
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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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流動負債： |
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應付賬款 |
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$ |
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$ |
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$ |
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$ |
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應計負債 |
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其他流動負債 |
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流動負債總額 |
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總負債 |
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$ |
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$ |
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$ |
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$ |
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非控制性權益
公司確認與其合併VIE相關的非控股權益，並提供非控股權益餘額的結轉，具體如下（以千計）：
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感知 |
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Kures |
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淨化 |
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總 |
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截至2023年12月31日的餘額 |
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$ |
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$ |
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$ |
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$ |
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歸屬於非控股權益的淨虧損-優先 |
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( |
) |
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( |
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( |
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( |
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可歸屬於非控股權益的全面收益 |
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截至2024年3月31日餘額 |
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$ |
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$ |
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$ |
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$ |
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歸屬於非控股權益的淨虧損-優先 |
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( |
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( |
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( |
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可歸屬於非控股權益的綜合損失 |
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( |
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( |
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截至2024年6月30日餘額 |
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$ |
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$ |
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$ |
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$ |
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歸屬於非控股權益的淨虧損-優先 |
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可歸屬於非控股權益的綜合損失 |
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( |
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截至2024年9月30日餘額 |
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$ |
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$ |
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$ |
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$ |
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感知 |
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Kures |
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淨化 |
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總 |
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截至2022年12月31日的餘額 |
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$ |
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$ |
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$ |
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$ |
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可歸因於非控股權益的淨虧損-優先 |
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( |
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( |
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( |
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可歸屬於非控股權益的綜合損失 |
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截至2023年3月31日餘額 |
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$ |
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$ |
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$ |
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$ |
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可歸因於非控股權益的淨虧損-優先 |
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( |
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( |
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( |
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可歸屬於非控股權益的全面收益(虧損) |
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截至2023年6月30日的餘額 |
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$ |
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$ |
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$ |
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$ |
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可歸因於非控股權益的淨虧損-優先 |
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( |
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( |
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可歸屬於非控股權益的全面收益(虧損) |
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截至2023年9月30日的餘額 |
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$ |
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$ |
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$ |
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$ |
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非合併VIE
本公司評估其於InnoplexsAG(「InnoplexusAG」)、IntelGenx(定義見下文)及Beckley Squtech Limited(統稱爲「非綜合VIE」)的投資性質，並確定該等投資於本公司截至2024年9月30日的初始投資日期爲VIE。本公司並非非綜合VIE的主要受益人，因其無權指揮對投資經濟表現有最重大影響的活動，因此得出結論，截至2024年9月30日及2023年12月31日，其並無於每個需要合併的非綜合VIE擁有控股權。
在發生特定複議事件時，公司將重新評估投資是否符合VIE的定義。本公司按照權益法、公允價值期權或ASC 321中包含的計量替代方案對這些投資進行會計處理(見附註5)。截至2024年9月30日，公司對其非合併VIE的最大風險敞口爲$
截至2023年12月31日，公司對其非合併VIE的最大風險敞口爲$
12
5.投資
以公允價值持有的其他投資
COMPASS Pathways plc
Compass Path plc(「Compass」)是一家精神保健公司，致力於通過其產品COMP360率先開發裸蓋菇素治療的新模式。該公司於2018年12月首次收購了Compass的投資，並在2021年之前進行了額外投資，並在2023年8月之前根據權益法覈算了其投資。2023年8月，指南針完成了最近一輪融資，公司沒有參與，公司在指南針的所有權權益減少到
在2023年8月的融資後，本公司評估了其繼續對其投資施加重大影響的能力，並確定其不再具有重大影響，因此將按公允價值計入其根據ASC 321進行的指南針投資。本公司對COMPASS投資的任何公允價值變動將在其未經審計的簡明綜合經營報表中計入資產和負債公允價值變動淨額。
2024年9月，該公司出售了
根據所報市場價格，該公司擁有COMPASS的市值爲#美元
英特爾GenX技術公司
IntelGenX科技公司(「IntelGenx」)是一家新型藥物輸送公司，專注於爲醫藥市場開發和製造新型口腔薄膜產品。2021年3月，IntelGenx和公司簽訂了戰略發展協議和買方權利協議(PPA)，(如下所述)。2023年，IntelGenx和該公司簽訂了訂閱協議(如下所述)。
在IntelGenx SPA(定義如下)初始關閉後，公司舉行了
2024年5月，IntelGenx宣佈，其董事會授權IntelGenx向魁北克高等法院提出申請，根據《公司債權人安排法》(CCAA)尋求債權人保護，以便有時間審查其戰略選擇。IntelGenX根據一份初始訂單(「初始訂單」)獲得保護，該訂單還授權本公司提供臨時債務人佔有融資(「DIP融資」)，以允許IntelGenx在重組過程中繼續運營。隨後，IntelGenx獲得批准實施出售和投資徵集流程(《SISP》及批文，《SISP批准令》)。作爲SISP批准令的一部分，法院批准了IntelGenx與該公司之間的購銷協議，僅爲構成SISP下的「跟蹤馬投標」的目的。跟蹤馬投標爲向合格的利害關係方徵求更好的投標確立了一個基線價格和交易結構。
2024年7月，根據SISP批准令，SISP沒有產生替代的更好的投標。本公司與IntelGenx於2024年10月完成買賣交易。
在CCAA申請的同時，IntelGenx在多倫多證券交易所的普通股交易已暫停。截至2024年9月30日，考慮到相關事實和情況，本公司估計購買IntelGenx普通股和認購期權購買額外可轉換債券單位的各種權證的公允價值爲零。此外，本公司已根據擔保債務的相關抵押品的公允價值估計IntelGenx的各種應收票據的公允價值，詳情見下文附註6。
2021年證券購買協議
2021年5月，在獲得IntelGenx股東批准後，IntelGenx與公司簽署了一份證券購買協議(「IntelGenx SPA」)，根據該協議，IntelGenx向公司發行了普通股股份(「IntelGenx普通股」)和認股權證，價格約爲$
13
the Company has the right to purchase (in cash, or in certain circumstances, the Company’s equity) additional units for a period of three years from the closing of the initial investment (the “Additional Unit Warrants”). As of the March 15, 2024 expiration date, the Company had not exercised any of the Initial Warrants or the Additional Unit Warrants, which had a carrying value of
The Company qualified for and elected to account for its investment in the IntelGenx Common Shares under the fair value option. The Company believes that the fair value option better reflects the underlying economics of the IntelGenx Common Shares investment. The Initial Warrants and the Additional Unit Warrants were accounted for at fair value under ASC 321 and recorded in Other investments held at fair value on the consolidated balance sheets. The Company applied a calibrated model and determined that the initial aggregate fair value of its $
2023 Subscription Agreement, as amended
In August 2023, IntelGenx and the Company entered into a subscription agreement (the “Subscription Agreement”), under which the Company paid IntelGenx $
(i) $
(ii)
Pursuant to the Subscription Agreement, the Company agreed to subscribe for an additional
Effective September 30, 2023, IntelGenx and the Company amended the Subscription Agreement (the “Amended Subscription Agreement”), allowing the Company, subject to obtaining certain shareholder approvals, the "Call Option" to purchase up to an additional
The issuance of any Call Option Unit shall result in a corresponding reduction in the Company's remaining purchase right pursuant to the IntelGenx SPA executed in May 2021 (the “2021 Purchase Right”), with such right to be reduced by the maximum number of shares of common stock issuable in connection with such Call Option Units, and (ii) in the event that the 2021 Purchase Right has been fully or partially exercised such that the aggregate number of shares of common stock issued thereunder together with the number of shares of common stock issuable in accordance with the Call Option Units would exceed
There are limits over the conversion of the Initial Units, Subsequent Units, Call Options Units and the IntelGenx Term Loan (as defined below in Note 6) into common shares.
The Company qualified for and elected to account for its investment in the convertible debenture units and call option under the fair value option. The Company believes that the fair value option better reflects the underlying economics of the convertible debenture units and call option. The convertible promissory notes are accounted for at fair value under ASC 320 and recorded in Short-term convertible notes receivable - related party in the unaudited condensed consolidated balance sheet, as described further in Note 6. The warrants and call option are accounted for pursuant to the fair value option election and recorded in Other investments held at fair value in the unaudited condensed consolidated balance sheet.
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For the 2023 Initial Units, the Company determined that the initial aggregate fair value of its $
In November 2023, upon shareholder approval, the Company paid $
At December 31, 2023, the Call Option was recorded in Other investments held at fair value on the consolidated balance sheet with an estimated fair value of $
2024 Term Loan Warrants
In March 2024, the Company and IntelGenx entered into a third amendment to the amended and restated loan agreement (the "Third Amendment"), as further described in Note 6 below. In connection with the Third Amendment, the Company received warrants to purchase up to
Strategic Development Agreement
Pursuant to the Strategic Development Agreement, the Company engages IntelGenx to conduct research and development projects (“Development Project”) using IntelGenx’s proprietary oral thin film technology. Under the terms of the Strategic Development Agreement, the Company can select four (4) program products. As of the effective date of the Strategic Development Agreement, the Company nominated two (2) program products - DMT and Salvinorin A.
Other investments
The Company has accounted for its Other investments that do not have a readily determinable fair value under either the alternative measurement under ASC 321 or as an equity method investment. Under the measurement alternative, the Company measured its Other investments at cost, less any impairment, plus or minus, if any, observable price changes in orderly transactions for an identical or similar investment of the same issuer. For equity method investments where the Company has not elected the fair value option, it records gains (losses) from investments in equity method investees, net of tax, for its proportionate share of the underlying company’s net results until
15
the investment balance is adjusted to zero. If the Company makes subsequent additional investments in that same company, it may record additional gains (losses) based on changes to its investment basis and also may record additional income (loss) in equity method investments.
The Company’s investments in the preferred stock of Innoplexus, GABA, defined below, and Beckley Psytech Limited are not considered as in-substance common stock due to the existence of substantial liquidation preferences and therefore did not have subordination characteristics that were substantially similar to the common stock.
During the three and nine months ended September 30, 2024 and 2023, the Company evaluated all of its other investments to determine if certain events or changes in circumstance had a significant adverse effect on the fair value of any of its investments in non-consolidated entities. Based on this analysis, the Company did not note any impairment indicators associated with the Company’s Other investments.
During the three and nine months ended September 30, 2024 and 2023 there were no observable changes in price recorded related to the Company’s Other investments.
As of September 30, 2024 and December 31, 2023, the carrying values of Other investments, which consisted of investments in the investee’s preferred stock not in the scope of ASC 323 were as follows (in thousands):
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September 30, 2024 |
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December 31, 2023 |
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Beckley Psytech Limited |
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$ |
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$ |
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GABA Therapeutics, Inc. |
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Innoplexus AG |
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Total |
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$ |
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$ |
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Beckley Psytech Limited
Beckley Psytech Limited ("Beckley Psytech") is a clinical stage biotechnology company dedicated to improving the lives of people suffering from neuropsychiatric disorders by transforming psychedelics into effective and rapid-acting clinical medicines. Its most advanced programs are focused on the development of psychedelic-based medicines to treat people with treatment resistant depression and major depressive disorder.
Subscription and shareholders' agreement
On January 3, 2024, the Company entered into a subscription and shareholders' agreement with Beckley Psytech and certain other shareholders as identified in the agreement (the "SSA"). Pursuant to the terms of the SSA, the Company (a) has the right to acquire
In connection with the SSA, the Company acquired, pursuant to an equity warrant instrument between the Company and Beckley Psytech,
Also under the SSA, the Company will have the right to receive additional warrants to purchase Series C Shares in the event Beckley Psytech issues equity or equity linked securities pursuant to a deferred equity arrangement in connection with a prior acquisition made by Beckley Psytech, each such warrant is exercisable at an exercise price of $
Initial Subscription
On January 3, 2024, the Company made an initial payment of $
Secondary Sale
On January 18, 2024, the Company and Beckley Psytech entered into the Secondary Sale SPA pursuant to which the Company agreed to purchase
The Company paid a total of $
16
The Company determined that the Additional Warrants meet the definition of a derivative instrument under ASC 815 and recorded the $
The Company qualified for and elected to account for the remaining investment acquired per the SSA using the measurement alternative under ASC 321, and is included in Other Investments in the unaudited condensed consolidated balance sheet. The Company applied a calibrated model for the remaining $
Deferred Shares
On January 5, 2024, subject to the terms of the Escrow Agreement, the Company deposited $
As of September 30, 2024, Beckley Psytech has not made any draws against the escrow account. The Company reflects the $
Additional Warrants
In May 2024, Beckley Psytech issued equity pursuant to the deferred equity arrangement, and, per the SSA, the Company received
As of September 30, 2024, the Additional Warrants had a fair value of $
GABA Therapeutics, Inc.
GABA Therapeutics, Inc. ("GABA") is a California based biotechnology company focused on developing GRX-917 for anxiety, depression and a broad range of neurological disorders. The Company is deemed to have significant influence over GABA through its total ownership interest in GABA’s equity, including the Company’s investment in GABA’s preferred stock, and the Company’s noncontrolling representation on GABA’s board of directors.
Common Stock Investment
The Company’s investment in GABA’s common stock was accounted for in accordance with the equity method.
In November 2020 the Company exercised its option to purchase additional shares of common stock of GABA at a price of approximately $
The carrying value of the investment in GABA common stock was reduced to
The Company's ownership of GABA common stock was
Preferred Stock Investment
The Company’s investment in GABA’s preferred stock did not meet the criteria for in-substance common stock. As such, the investment in GABA’s preferred stock is accounted for under the measurement alternative under ASC 321.
In August 2019, GABA and the Company entered into the Preferred Stock Purchase Agreement (the “GABA PSPA”), whereby GABA issued shares of its Series A preferred stock to the Company at a price of approximately $
17
Pursuant to the GABA PSPA, the Company was obligated to purchase additional shares of Series A preferred stock for up to $
The completion of the Series A Preferred stock purchase in May 2021 was deemed to be a reconsideration event at which point GABA was no longer deemed a VIE as GABA now had sufficient equity at risk to finance its activities through the initial development period without additional subordinated financial support. Entities that do not qualify as a VIE are assessed for consolidation under the voting interest model (“VOE model”). Under the VOE model, the Company consolidates the entity if it determines that it, directly or indirectly, has greater than
In May 2021, GABA and the Company entered into an Amendment to Preferred Stock Purchase Agreement (the "Amended GABA PSPA”) under which the GABA PSPA was amended and shares of its Series A preferred stock were issued to the Company at a price of approximately $
As of September 30, 2024 the Company's remaining obligation to purchase additional shares of Series A preferred stock from GABA is for up to $
GABA’s net losses attributable to the Company were determined based on the Company’s ownership percentage of preferred stock in GABA and recorded to the Company’s investments in GABA preferred stock. During the three months ended September 30, 2024 and 2023, the Company recognized its proportionate share of GABA’s net loss of an immaterial amount and $
Innoplexus AG
Innoplexus is a technology company that provides “Data as a Service” and “Continuous Analytics as a Service” solutions that aims to help healthcare organizations leverage their technologies and expedite the drug development process across all stages—preclinical, clinical, regulatory and commercial. The Company first acquired investments in Innoplexus in August 2018.
As of December 31, 2020, the Company owned
In February 2021, the Company entered into a Share Purchase and Assignment Agreement (the “Innoplexus SPA”) to sell its shares of common and preferred stock held in Innoplexus to a current investor of Innoplexus (the “Purchaser”) in exchange for an initial purchase price of approximately $
Pursuant to the Innoplexus SPA, the Purchaser is required to hold a minimum number of shares equivalent to the number of shares purchased from the Company through
18
In addition, the Innoplexus SPA also provides the right for the Company to receive additional consideration with a maximum payment outcome of $
The carrying value of the Company’s investment in Innoplexus was zero as of September 30, 2024 and December 31, 2023.
The Company's ownership of Innoplexus common stock was
Summarized Financial Information
The following is a summary of financial data for investments accounted for under the equity method of accounting (in thousands):
Balance Sheets
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September 30, 2024 |
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December 31, 2023 |
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GABA |
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GABA |
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Current assets |
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$ |
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$ |
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Total assets |
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$ |
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$ |
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Current liabilities |
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$ |
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$ |
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Total liabilities |
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$ |
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$ |
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Statements of operations
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For the three months ended September 30, 2024 |
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For the three months ended September 30, 2023 |
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GABA |
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GABA |
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Loss from continuing operations |
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$ |
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$ |
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Net loss |
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$ |
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$ |
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For the nine months ended September 30, 2024 |
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For the nine months ended September 30, 2023 |
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GABA |
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GABA |
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Loss from continuing operations |
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$ |
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$ |
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Net loss |
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$ |
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$ |
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6. Notes Receivable
IntelGenx Technologies Corp.
As of September 30, 2024, considering relevant facts and circumstances, the Company has estimated the fair value of the various notes receivables with IntelGenx to be based on the fair value of the underlying collateral of the secured debt and the relative seniority of the debt. As the DIP Loan (as defined below) is the senior secured debt, the Company will apply the fair value of the underlying collateral first to the DIP loan with the residual fair value in excess of the DIP Loan (as defined below) principal and interest being applied to the IntelGenx Term Loan. The Initial Order is an event of default under the terms of the various notes receivables, and, accordingly, the notes receivables have all been reflected as short-term as of September 30, 2024.
IntelGenx Term Loan, as amended
In March 2021, the Company and IntelGenx entered into a loan agreement (the “Original Loan Agreement”) under which the Company provided a loan to IntelGenx for an aggregate principal amount of $
On January 1, 2023, the Company adopted ASU 2016-13, Financial Instruments – Credit Losses, as further discussed in Note 2, which resulted in a $
In August 2023, the Company and IntelGenx entered into the first amendment to the amended and restated loan agreement (the “First Amendment”) which, among other things, extended the maturity date from
19
Effective September 2023, the Company and IntelGenx entered into a second amendment to the amended and restated loan agreement (the “Second Amendment”) which, subject to obtaining certain shareholder approvals, entitles the Company to convert any portion of the outstanding and unpaid principal and accrued interest into common shares of IntelGenx at a conversion price per share of $
In November 2023, upon shareholder approval, the Conversion Feature was effective. The Company evaluated this modification subject to accounting guidance in ASU 2022-02, Financial Instruments – Credit Losses and determined the Conversion Feature was considered the addition of a substantive conversion option and the modification is more than minor. Therefore, the Second Amendment was treated as an extinguishment of the existing loan and the issuance of a new convertible debt instrument. The IntelGenx Term Loan, as amended, meets the definition of a security and was accounted for under ASC 320. Pursuant to the remeasurement event, the Company was eligible and has elected the fair value option to account for its investment in the IntelGenx Term Loan. The Company believes that the fair value option better reflects the underlying economics of the loan. The Company recorded the new convertible debt instrument at its fair value of $
In March 2024, the Company and IntelGenx entered into the Third Amendment (together with the Original Loan Agreement, the First Amendment, and the Second Amendment, the “IntelGenx Term Loan”) pursuant to which the Company immediately provided an additional $
In connection with the Third Amendment, the Company received warrants to purchase up to
As a result of the Third Amendment, the Company recorded the Tranche 1 Additional Term Loan principal of $
In May 2024, the Company paid the Tranche 2 Additional Term Loan and recorded the principal of $
As of September 30, 2024, the Company estimated that the fair value of the underlying collateral of the secured debt is less than the principal and interest of the DIP Loan (as defined below). Accordingly, the Company determined that the fair value of the IntelGenx Term Loan is zero as of September 30, 2024. As of December 31, 2023, the $
For the three months ended September 30, 2024 and 2023, the Company recognized
20
IntelGenx Convertible Notes
On August 30, 2023, the Company and IntelGenx entered into the Subscription Agreement (as defined in Note 5), under which the Company paid IntelGenx $
(i) $
(ii)
Pursuant to the Subscription Agreement, the Company agreed to subscribe for an additional
The Company qualified for and elected to account for its investment in the convertible debenture units and call option under the fair value option. The Company believes that the fair value option better reflects the underlying economics of the convertible debenture units and call option. The convertible promissory notes related to the debenture units are accounted for at fair value under ASC 320 and recorded in Short-term convertible notes receivable - related party in the unaudited condensed consolidated balance sheet. The Company will recognize unpaid interest and subsequent changes in fair value of the convertible promissory notes related to the debenture units as Change in fair value of assets and liabilities, net, a component of other income (expense), net in the unaudited condensed consolidated statements of operations.
The Company determined that the initial aggregate fair value of its $
In November 2023, upon shareholder approval, the Company paid $
As of September 30, 2024, the Company has estimated the fair value of various notes receivables with IntelGenx based on the fair value of the underlying collateral of the secured debt. As the 2023 Initial Notes and 2023 Subsequent Notes are not secured by underlying collateral, the Company has determined the fair value of the 2023 Initial Notes and 2023 Subsequent Notes are zero, respectively, as of September 30, 2024. As of December 31, 2023, the fair value of the 2023 Initial Notes and 2023 Subsequent Notes were $
For the three months ended September 30, 2024, the Company recognized $
Debtor-in-Possession Loan
In May 2024, pursuant to the Initial Order authorizing the DIP Financing, the Company and IntelGenx entered into a senior secured super-priority, interim, non-revolving multiple draw credit facility ("DIP Loan") up to a maximum of CDN
The Company qualified for and elected to account for the DIP Loan under the fair value option. The Company believes that the fair value option better reflects the underlying economics of the DIP Loan. The DIP Loan is accounted for at fair value under ASC 825 and recorded in Short term notes receivable - related party, net in the unaudited condensed consolidated balance sheet. The Company will recognize
21
unpaid interest and subsequent changes in fair value of the DIP Loan Note as Change in fair value of assets and liabilities, net, a component of other income (expense), net in the unaudited condensed consolidated statements of operations.
As of September 30, 2024, IntelGenx has drawn CDN $
The Company is committed to fund IntelGenx up to an additional CDN $
As of September 30, 2024, the fair value of the Subsequent DIP Loan Commitment was $
IntelGenx 2023 Term Loan Note
In December 2023, the Company and IntelGenx entered into a new term loan agreement under which the Company provided the aggregate principal amount of $
The Company qualified for and elected to account for the 2023 Term Loan Note under the fair value option. The Company believes that the fair value option better reflects the underlying economics of the 2023 Term Loan Note. The IntelGenx 2023 Term Loan Note is accounted for at fair value under ASC 825 and recorded in Short-term notes receivable - related party, net in the consolidated balance sheet. The Company will recognize unpaid interest and subsequent changes in fair value of the IntelGenx 2023 Term Loan Note as Change in fair value of assets and liabilities, net, a component of other income (expense), net in the consolidated statements of operations.
As of September 30, 2024, the Company has estimated the fair value of various notes receivables with IntelGenx based on the fair value of the underlying collateral of the secured debt. As the 2023 Term Loan Note is not secured by underlying collateral, the Company has determined the fair value of the 2023 Term Loan Note is
For the three and nine months ended September 30, 2024, the Company recognized a $
22
7. Fair Value Measurement
The following table presents information about the Company’s financial assets and liabilities that are measured at fair value on a recurring basis and indicates the fair value hierarchy of the valuation (in thousands):
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Fair Value Measurements as of |
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September 30, 2024 |
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Level 1 |
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Level 2 |
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Level 3 |
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Total |
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Assets: |
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Cash equivalents: |
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Money market funds |
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$ |
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$ |
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$ |
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$ |
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Investment in securities at fair value: |
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U.S. treasuries |
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U.S. government agencies |
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Other investments held at fair value |
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Short-term notes receivable - related party, net |
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$ |
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$ |
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$ |
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$ |
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Liabilities: |
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Other current liability |
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$ |
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$ |
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$ |
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$ |
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Contingent consideration liability - related parties |
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Contingent consideration liability |
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2018 convertible promissory note conversion option - related party |
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2018 convertible promissory note conversion option |
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$ |
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$ |
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$ |
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$ |
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Fair Value Measurements as of |
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December 31, 2023 |
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Level 1 |
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Level 2 |
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Level 3 |
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Total |
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Assets: |
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Cash equivalents: |
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Money market funds |
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$ |
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$ |
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$ |
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$ |
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Investment in securities at fair value: |
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U.S. treasuries |
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Corporate notes/bonds |
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U.S. government agencies |
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Other investments held at fair value |
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Convertible notes receivable - related party |
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$ |
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$ |
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$ |
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$ |
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Liabilities: |
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Contingent consideration liability - related parties |
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$ |
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$ |
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$ |
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$ |
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Contingent consideration liability |
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2018 convertible promissory note conversion option |
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$ |
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$ |
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$ |
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$ |
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Investment in securities at fair value
The Company elected the fair value option for the securities in the investment portfolio. The fair value is based on quoted market prices, when available. When a quoted market price is not readily available, the Company uses the market price from its last sale of similar assets. The cash and cash equivalents held by the Company are categorized as Level 1 investments as quoted market prices are readily available for these investments. All other investments in the investment portfolio are categorized as Level 2 investments as inputs utilized to fair value these securities are either directly or indirectly observable, such as the market price from the last sale of similar assets.
The Company purchases investment grade short-term debt securities which are rated by nationally recognized statistical credit rating organizations in accordance with its investment policy. This policy is designed to minimize the Company's exposure to credit losses and to ensure that adequate liquidity is maintained at all times to meet anticipated cash flow needs.
The unrealized gains and losses on the available-for-sale securities, represented by change in the fair value of the investment portfolio, is reported in other income (expense), net in the unaudited condensed consolidated statements of operations. Since the investment in the
23
available-for-sale securities are already measured at fair value, no separate credit losses would be recorded in the unaudited condensed consolidated financial statements.
For three months ended September 30, 2024 and 2023, the Company recognized a $
Other investments held at fair value
COMPASS Pathways plc
As described in Note 5 above, pursuant to the August 2023 financing, the Company determined that it no longer had significant influence and accounted for its COMPASS investment at fair value under ASC 321 with any changes in fair value recorded as a Change in fair value of assets and liabilities, net in its unaudited condensed consolidated statements of operations. The Company determines the fair value of its COMPASS investment by taking the publicly available share price as of the balance sheet date multiplied by the number of shares the Company holds. There are no non-observable inputs in determining the fair value. For the three and nine months ended September 30, 2024, the Company recorded $
IntelGenx
As described in Note 5, the Company's investment in IntelGenx includes common shares, 2023 Initial Warrants, 2023 Subsequent Warrants, and 2024 Warrants, (the 2023 Initial Warrants, 2023 Subsequent Warrants, and 2024 Warrants are collectively referred to as the “Warrants”), and Call Option. The Company determined that the Warrants and the Call Option do not meet the definition of a derivative instrument under ASC 815. The Company has classified the common shares as Level 2 assets and the Warrants and the Call Option as Level 3 assets in the fair value hierarchy. The Warrants and Call Option are measured at fair value on a quarterly basis and any changes in the fair value will be recorded as Change in fair value of assets and liabilities, net, a component of other income (expense), net in the consolidated statements of operations.
As of September 30, 2024, considering relevant facts and circumstances, the Company has estimated zero fair value for the Warrants and the Call Option (Note 5).
The fair value of IntelGenx Common Shares, which is included in Other investments held at fair value in the consolidated balance sheet, was also zero as of September 30, 2024 and December 31, 2023 (Note 5).
As of December 31, 2023, the Warrants and Call Option were recorded at fair value utilizing the Black-Scholes option pricing model. The Black Scholes option pricing model is based on the estimated market value of the underlying IntelGenx Common Shares at the valuation measurement date, the remaining contractual term of the Warrants and Call Option, risk-free interest rates, expected dividends, and expected volatility of the price of the underlying IntelGenx Common Shares. The expected volatility is based on a peer group volatility which is a Level 3 input within the fair value hierarchy.
As of September 30, 2024, the fair value of the 2023 Initial Warrants, 2023 Subsequent Warrants, 2024 Warrants and Call Option were all
The significant unobservable inputs that are included in the valuation of the Warrants and Call Option as of December 31, 2023 are (i) estimated market value of the underlying IntelGenx Common Shares of $
An additional significant unobservable input that is included in the valuation of the Call Option as of December 31, 2023 is discount rate of
IntelGenx notes receivable
As described in Note 6, the Company's notes receivable with IntelGenx include the IntelGenx Term Loan, the 2023 Initial Notes, the 2023 Subsequent Notes, the DIP Loan, and the 2023 Term Loan Note.
As of September 30, 2024, considering relevant facts and circumstances, the Company has estimated the fair value of the various notes receivables with IntelGenx based on the fair value of the underlying collateral of the secured debt and the relative seniority of the debt. As the DIP loan is the senior secured debt, the Company will apply the fair value of the underlying collateral first to the DIP loan with the residual fair value in excess of the DIP Loan principal and interest being applied to the IntelGenx Term Loan. The Company has estimated the fair value of the underlying collateral, which includes the fair value of the intangible assets which was determined based on probability
24
adjusted forecasted revenue and expenses and a discount rate of
IntelGenx subsequent DIP loan commitment
As described in Note 6, the Company is committed to fund up to an additional CDN $
Beckley Psytech
Under the Beckley Psytech SSA, the Company will have the right to receive Additional Warrants to purchase Series C Shares in the event Beckley Psytech issues equity or equity linked securities pursuant to a deferred equity arrangement in connection with a prior acquisition made by Beckley Psytech. The Company determined that the Additional Warrants meet the definition of a derivative instrument under ASC 815 and recorded the Additional Warrants at fair value with subsequent changes in fair value being reflected through the condensed consolidated statement of operations in the Change in fair value of assets and liabilities, net. The Additional Warrants have a fair value of $
The significant unobservable inputs that are included in the valuation of the Additional Warrants as of September 30, 2024 are (i) probability of issuances under the deferred equity arrangement of
Contingent consideration liability – related parties
The contingent consideration liability—related parties in the table above relates to milestone and royalty payments in connection with the 2018 acquisition of Perception Neuroscience Holdings, Inc. (“Perception”) and InnarisBio, Inc. ("InnarisBio"). The fair value of the contingent consideration liability—related parties was determined based on significant inputs not observable in the market, which represent Level 3 measurements within the fair value hierarchy. The fair value of the contingent milestone and royalty liabilities was estimated based on the discounted cash flow valuation technique. The technique considered the following unobservable inputs:
Perception
The fair value of the Perception contingent milestone and royalty liabilities could change in future periods depending on prospects for the outcome of R-Ketamine milestone meetings with the FDA or other regulatory authorities, and whether the Company realizes a significant increase or decrease in sales upon commercialization. The most significant assumptions in the discounted cash flow valuation technique that impacts the fair value of the milestone contingent consideration are the projected milestone timing and the probability of the milestone being met. Further, significant assumptions in the discounted cash flow that impacts the fair value of the royalty contingent consideration are the projected revenue over ten years, the timing of royalties on commercial revenue, and the probability of success rate for a commercial R-Ketamine product. The valuations as of September 30, 2024 and December 31, 2023, respectively, used inputs that were unobservable inputs with the most significant being the discount rates for royalties on projected commercial revenue and clinical milestones and probability of success estimates over the following ten years, which represent Level 3 measurements within the fair value hierarchy.
The fair value of the contingent milestone and royalty liabilities for Perception was estimated to be $
25
The fair value of the Perception contingent consideration liability – related parties was calculated using the following significant unobservable inputs:
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September 30, 2024 |
December 31, 2023 |
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Valuation Technique |
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Significant Unobservable Inputs |
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Input Range |
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Input Range |
Discounted cash flow |
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Milestone contingent consideration: |
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Discount rate |
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Probability of the milestone |
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Discounted cash flow with Scenario-Based Method |
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Royalty contingent consideration: |
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Discount rate for royalties |
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Discount rate for royalties on milestones |
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Probability of success rate |
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InnarisBio
The fair value of the contingent milestone and royalty liabilities for InnarisBio was immaterial as of September 30, 2024 and December 31, 2023, respectively.
Contingent Consideration Liability
The contingent consideration liability in the table above relates to milestone payments in connection with the acquisition of DemeRx IB and TryptageniX. The fair value of the contingent consideration liability was determined based on significant inputs not observable in the market, which represent Level 3 measurements within the fair value hierarchy. The fair value of the contingent milestone and royalty liabilities was estimated based on the discounted cash flow valuation technique. The technique considered the following unobservable inputs:
DemeRx
In October 2023, the Company and DemeRx, Inc. entered into a Stock Purchase and Framework Agreement which resulted in the Company's acquisition of DemeRx, Inc.’s equity ownership of DemeRx IB (the “Stock Purchase”), in exchange for consideration that included, among other items, earn-out consideration of up to an additional $
The fair value of the DemeRx contingent milestone could change in future periods depending on prospects for the outcome of ibogaine milestone meetings with the FDA or other regulatory authorities. The most significant assumptions in the discounted cash flow valuation technique that impacts the fair value of the milestone contingent consideration are the projected milestone timing and the probability of the milestone being met. The valuations as of September 30, 2024 and December 31, 2023 used inputs that were unobservable inputs with the most significant being the discount rates and the probability of success of certain clinical milestones, which represent Level 3 measurements within the fair value hierarchy.
The fair value of the contingent milestone for DemeRx was estimated to be $
The fair value of the DemeRx contingent consideration liability – related parties was calculated using the following significant unobservable inputs:
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September 30, 2024 |
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December 31, 2023 |
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Valuation Technique |
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Significant Unobservable Inputs |
Input Range |
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Input Range |
Discounted cash flow |
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Milestone contingent consideration: |
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Discount rate |
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Probability of the milestone |
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26
TryptageniX
The fair value of the contingent liability for TryptageniX was estimated to be $
Convertible Promissory Note
As described in Note 11, in December 2023 and April 2024, the Company entered into subscription agreements with each of a noteholder and a related party noteholder, respectively (together the "Subscription Agreement") whereby each of the noteholder and the related party noteholder exchanged their ATAI Life Sciences AG notes (the "Old AG Notes") into the same principal amount of new convertible notes issued by ATAI Life Sciences N.V. (the "New NV Notes"). The exchange resulted in the New NV Notes conversion option no longer meeting the equity classification criteria. Accordingly, at the time of the exchange modification, the Company bifurcated the conversion option and reclassified the conversion option fair value from equity to a liability and is included in Short-term convertible promissory notes and derivative liability and Short-term convertible promissory notes and derivative liability - related party, respectively, in the unaudited condensed consolidated balance sheets. The conversion option is measured at fair value on a quarterly basis and any changes in the fair value will be recorded as Change in fair value of assets and liabilities, net, a component of other income (expense), net in the unaudited condensed consolidated statements of operations. For the three and nine months ended September 30, 2024, the Company recognized a loss of $
The conversion option fair value was estimated utilizing the Black-Scholes option pricing model. The Black Scholes option pricing model is based on the estimated market value of the underlying common stock at the valuation measurement date, the remaining contractual term of the Conversion Feature, risk-free interest rates, expected dividends, and expected volatility of the price of the underlying common stock. The expected volatility is based upon the historical volatility of daily lognormal returns on atai shares, which is a Level 3 input within the fair value hierarchy.
The significant unobservable input that is included in the valuation of the Conversion Feature as of September 30, 2024 and December 31, 2023 is volatility of
The following table provides a roll forward of the aggregate fair values of the Company’s financial instruments described above, for which fair value is determined using Level 3 inputs (in thousands):
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IntelGenx Debt (1) |
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IntelGenx Investments Held at Fair Value (2) |
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IntelGenx Subsequent DIP Loan Commitment |
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Contingent |
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Contingent |
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New NV Notes Conversion Feature |
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Beckley Psytech Additional Warrants |
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Balance as of December 31, 2023 |
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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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Initial fair value of instrument |
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Change in fair value, including interest |
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( |
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Balance as of March 31, 2024 |
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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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Initial fair value of instrument |
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Change in fair value, including interest |
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( |
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( |
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( |
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( |
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Balance as of June 30, 2024 |
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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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Initial fair value of instrument |
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$ |
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|||||||
Additional Warrants received |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
||||||
Change in fair value, including interest |
|
$ |
( |
) |
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|||
Balance as of September 30, 2024 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|||||||
27
|
|
Convertible notes receivable - related party |
|
|
IntelGenx 2023 Initial Warrants |
|
|
Contingent |
|
|||
Balance as of December 31, 2022 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Initial fair value of instrument |
|
|
|
|
|
|
|
|
|
|||
Change in fair value |
|
|
|
|
|
|
|
|
( |
) |
||
Extinguishment of liability |
|
|
|
|
|
|
|
|
|
|||
Balance as of March 31, 2023 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Initial fair value of instrument |
|
|
|
|
|
|
|
|
|
|||
Change in fair value |
|
|
|
|
|
|
|
|
( |
) |
||
Extinguishment of liability |
|
|
|
|
|
|
|
|
|
|||
Balance as of June 30, 2023 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Initial fair value of instrument |
|
|
|
|
|
|
|
|
|
|||
Change in fair value, including interest |
|
|
|
|
|
|
|
|
|
|||
Extinguishment of liability |
|
|
|
|
|
|
|
|
|
|||
Balance as of September 30, 2023 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
8. Prepaid Expenses and Other Current Assets
Prepaid expenses consist of the following (in thousands):
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
||
Prepaid research and development related expenses |
|
$ |
|
|
$ |
|
||
Tax receivables |
|
|
|
|
|
|
||
Prepaid insurance |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
9. Accrued Liabilities
Accrued liabilities consist of the following (in thousands):
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
||
Accrued accounting, legal, and other professional fees |
|
$ |
|
|
$ |
|
||
Accrued external research and development expenses |
|
|
|
|
|
|
||
Accrued payroll |
|
|
|
|
|
|
||
Other liabilities |
|
|
|
|
|
|
||
Taxes payable |
|
|
|
|
|
|
||
Accrued restructuring costs |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
10. Leases
The Company leases certain office space under long-term operating leases that expire at various dates through 2028. The Company generally has options to renew lease terms on its facilities, which may be exercised at the Company's sole discretion. The Company evaluates renewal and termination options at the lease commencement date to determine if it is reasonably certain to exercise the option and has concluded on all operating leases that is it not reasonably certain that any options will be exercised. The weighted-average remaining lease term for the Company’s operating leases as of September 30, 2024 was
ROU assets and lease liabilities related to the Company’s operating leases are as follows (in thousands):
28
|
Balance Sheet Classification |
September 30, 2024 |
|
|
December 31, 2023 |
|
||
Right-of-use assets |
Operating lease right-of-use asset, net |
$ |
|
|
$ |
|
||
Current lease liabilities |
|
|
|
|
|
|||
Non-current lease liabilities |
|
|
|
|
|
|||
Expenses related to leases is recorded on a straight-line basis over the lease term.
|
|
|
|
For the Three Months Ended September 30, |
|
|
For the Nine Months Ended September 30, |
|
||||||||||
Lease Cost Components |
|
Statement of Operations Classification |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Operating lease cost |
|
Operating expenses: General and administrative |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Short-term lease cost |
|
Operating expenses: General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total lease cost |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Future minimum commitments under all non-cancelable operating leases are as follows (in thousands):
Year Ended |
|
|
|
|
2024 (excluding nine months ended September 30, 2024) |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
Total lease payments |
|
|
|
|
Less: Imputed interest |
|
|
( |
) |
Present value of lease liabilities |
|
$ |
|
|
Supplemental cash flow information related to the Company’s operating leases for the nine months ended September 30, 2024 and 2023 are as follows (in thousands):
|
|
2024 |
|
|
2023 |
|
||
Cash paid for amounts included in the measurement of lease liabilities: |
|
|
|
|
|
|
||
Operating cash flows from operating leases |
|
$ |
|
|
$ |
|
||
Right-of-use assets obtained in exchange for new operating lease liabilities |
|
$ |
|
|
$ |
|
||
11. Debt
Convertible Promissory Notes
2018 Convertible Promissory Notes—Related Parties
During November 2018 and October 2020, the Company executed a terms and conditions agreement (the “Convertible Note Agreement”) under which it would issue convertible promissory notes to investors. An investor would become a party to the Convertible Note Agreement and would be issued a convertible promissory note by executing and delivering a subscription form. In November 2018 and October 2020, certain investors subscribed to the Convertible Note Agreement and the Company issued convertible promissory notes in the aggregate principal amount of €
The Company concluded that both the embedded conversion feature, which is exercisable by the investor at any time during the maturity, and the contingent put option, which would trigger upon the occurrence of an event of default of the 2018 Convertible Notes, do not meet the criteria to be bifurcated and separately accounted for as derivatives and the notes were recorded net of discount and issuance costs, or a
29
reduction to the carrying value of the notes issued in November 2018, with a corresponding adjustment to additional paid in capital. The discount is being amortized using the effective interest method over the period from the respective date of issuance to the Maturity Date.
The Company determined that the October 2020 notes were issued in exchange for services previously provided by the Company’s founders and other shareholders and were fully vested and non-forfeitable upon issuance. These instruments were therefore considered stock-based compensation awards to non-employees, and the instruments were initially measured and recorded at their grant date fair value based on a Black-Scholes option pricing model. The fair value of the October 2020 notes exceeded the principal amount that will be due at maturity. Therefore, at initial recognition, the October 2020 notes were accounted for as convertible debt issued at a substantial premium, such that the face value of the note is recorded as a liability and the premium was recorded as paid-in capital.
Exchange of 2020 Convertible Promissory Notes
In November 2023 and April 2024, a noteholder and a related party noteholder, respectively, of the October 2020 notes and ATAI Life Sciences AG executed exchange agreements (together the "Exchange Agreements") where each noteholder agreed to exchange its 2020 convertible notes issued by ATAI Life Sciences AG ("Old AG Notes") into the same principal amount of new convertible notes issued by ATAI Life Sciences NV ("New NV Notes"). The New NV Notes are non-interest-bearing, unsecured and are due and payable on September 30, 2025, unless previously redeemed, converted, purchased or cancelled (the “Maturity Date”). Each New NV Note has a face value of €
In December 2023 and April 2024, the Company entered into subscription agreements with each of the noteholder and related party noteholder, respectively (together the "Subscription Agreements") and exchanged their respective Old AG Notes into New NV Notes. The Company determined that the note exchanges were modifications of the debt. The Exchange Agreements and Subscription Agreements resulted in the New NV Notes conversion option no longer meeting the equity classification criteria. Accordingly, at the time of the Exchange Agreements modification, the Company bifurcated the conversion option and reclassified the conversion option fair value from equity to a liability and is included in Convertible promissory notes and derivative liability in the unaudited condensed consolidated balance sheet. The conversion option is measured at fair value on a quarterly basis and any changes in the fair value will be recorded as Change in fair value of assets and liabilities, net, a component of other income (expense), net in the unaudited condensed consolidated statements of operations. For the three and nine months ended September 30, 2024, the Company recognized a gain of $
As of September 30, 2024 and December 31, 2023, the fair value of the Convertible promissory note and derivative liability was $
Term Loan
Hercules Loan and Security Agreement
In August 2022 (the “Closing Date”), the Company and certain subsidiaries, as guarantors, and Hercules Capital, Inc., a Maryland corporation (“Hercules”), entered into a Loan and Security Agreement the “Initial Hercules Loan Agreement”. The Initial Hercules Loan Agreement provides for term loans in an aggregate principal amount of up to $
On May 26, 2023, the Company, ATAI Life Sciences AG (“ATAI AG” and together with the Company, the “Borrowers”) and certain subsidiary guarantors of the Company (collectively, the “Subsidiary Guarantors”) entered into the Second Amendment with the several banks and other financial institutions or entities from time to time parties to the Hercules Loan Agreement, defined below, (collectively, the “Lenders”) and Hercules, in its capacity as administrative agent and collateral agent for itself and for the Lenders (the “Agent”) which amended that certain Loan and Security Agreement, dated August 9, 2022 (as amended by the First Amendment, the “Existing Loan Agreement,” and as amended by the Second Amendment, the “Hercules Loan Agreement”) to, among other things, (i) extend the availability of Tranche 1B of $
30
amend the Tranche 2 Draw Test, satisfaction of which is a condition to draw Tranche 2 under the Hercules Loan Agreement and (vii) extend the financial covenant commencement date, from the later of (x) July 1, 2023, and (y) the date that the outstanding debt under the facility is equal to or greater than $
On August 14, 2024 (the “Third Amendment Date”), the Borrowers and certain Subsidiary Guarantors” entered into the Third Amendment with the Lenders and Hercules, in its capacity as the Agent, which amended that certain Loan and Security Agreement, dated August 9, 2022 (as amended by the First Amendment, the Second Amendment and the Third Amendment, the “2022 Term Loan Agreement”) to, among other things, (i) provide Tranche 1B of $
The 2022 Term Loan Facility will mature on
The 2022 Term Loan Agreement contains customary closing and commitment fees, prepayment fees and provisions, events of default and representations, warranties and affirmative and negative covenants, including a financial covenant requiring the Company to maintain certain levels of cash in accounts subject to a control agreement in favor of the Agent (the “Qualified Cash”) at all times commencing from the Closing Date, which includes a cap on the amount of cash that can be held by, among others, certain of our foreign subsidiaries in Australia and the United Kingdom.
In addition, the Company is required to make a final payment fee (the “End of Term Charge”) upon the earlier of (i) the Maturity Date, (ii) the date that the Company prepays, in full or in part, the principal balance of the 2022 Term Loan Facility, or (iii) the date that the outstanding balance of the 2022 Term Loan Facility becomes due and payable. The End of Term Charge is
The Company may, at its option, prepay the term loans in full or in part, subject to a prepayment penalty equal to (i)
31
The Company incurred financing expenses related to the 2022 Term Loan Agreement, which are recorded as an offset to long-term debt on the Company's consolidated balance sheets. These deferred financing costs are being amortized over the term of the debt using the effective interest method, and are included in other income, net in the Company’s unaudited condensed consolidated statements of operations. During the three months ended September 30, 2024 and 2023, interest expense included $
Outstanding debt obligations are as follows (in thousands):
|
|
|
|
|
|
||
|
September 30, 2024 |
|
|
December 31, 2023 |
|
||
Principal amount |
$ |
|
|
$ |
|
||
End of the term charge |
|
|
|
|
|
||
Less: unamortized issuance discount |
|
( |
) |
|
|
( |
) |
Less: unamortized issuance costs |
|
( |
) |
|
|
( |
) |
Less: unamortized end of term charge |
|
( |
) |
|
|
( |
) |
Net carrying amount |
|
|
|
|
|
||
Less: current maturities |
|
|
|
|
|
||
Long-term debt, net of current maturities and unamortized debt discount and issuance costs |
$ |
|
|
$ |
|
||
The fair value of the outstanding debt obligations under the 2022 Term Loan Facility was $
12. Common Stock
All common shareholders have identical rights. Each common share entitles the holder to one vote on all matters submitted to the shareholders for a vote.
All holders of common shares are entitled to receive dividends, as may be declared by the Company’s board of supervisory directors. Upon liquidation, common shareholders will receive distribution on a pro rata basis. As of September 30, 2024 and December 31, 2023, no cash dividends have been declared or paid.
In November 2022, the Company entered into an Open Market Sale Agreement with Jefferies LLC (“Jefferies”), pursuant to which the Company may issue and sell its common shares, nominal value €
13. Stock-Based Compensation
atai Equity Incentive Plans
The Company has options and restricted stock units (“RSUs”) outstanding under various equity incentive plans, including the 2020 Incentive Plan, 2021 Incentive Plan, defined below, and HSOP Plan, which are further described in Note 13 of the Company’s audited consolidated financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2024.
As of September 30, 2024, there were
Shares that are expired, terminated, surrendered, or canceled without having been fully exercised will be available for future awards. As of September 30, 2024,
As of September 30, 2024,
Stock Option activity under 2020 Incentive Plan and 2021 Incentive Plan
The stock options outstanding noted below consist primarily of both service and performance-based options to purchase common stock. These stock options have a five-year or ten-year contractual term. These awards are subject to the risk of forfeiture until vested by virtue of continued employment or service to the Company.
32
The following is a summary of stock option activity from December 31, 2023 to September 30, 2024:
|
|
Number of |
|
|
Weighted- |
|
|
Weighted- |
|
|
Aggregate |
|
||||
Outstanding as of December 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
(1) |
|
|
|
|
— |
|
|
|
— |
|
||
Exercised |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
— |
|
|
Cancelled or forfeited |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
— |
|
|
Outstanding as of September 30, 2024 |
|
|
|
(2) |
$ |
|
|
|
|
|
$ |
|
||||
Options exercisable as of September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
The weighted-average grant-date fair value of options granted during the nine months ended September 30, 2024 was $
The Company estimates the fair value of each stock option using the Black-Scholes option-pricing model on the date of grant. During the nine months ended September 30, 2024, the assumptions used in the Black-Scholes option pricing model were as follows:
|
|
September 30, |
||
|
|
2024 |
|
2023 |
Weighted average expected term in years |
|
|
||
Weighted average expected stock price volatility |
|
|
||
Risk-free interest rate |
|
|
||
Expected dividend yield |
|
|
||
For the three months ended September 30, 2024 and 2023, the Company recorded stock-based compensation expense of $
As of September 30, 2024, total unrecognized compensation cost related to the unvested stock options was $
Restricted Stock Unit activity under the 2021 Incentive Plan
The restricted stock units noted below consist of service-based awards vesting over a two-year period, subject to the risk of forfeiture until vested by virtue of continued employment or service to the Company. The Company reflects restricted stock units as issued and outstanding common stock when vested and the shares have been delivered to the individual.
The following is a summary of restricted stock unit activity from December 31, 2023 to September 30, 2024:
|
|
Restricted Stock Units |
|
|
Weighted Average Grant Date Fair Value |
|
||
Unvested at December 31, 2023 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Vested |
|
|
|
|
|
|
||
Forfeited |
|
|
|
|
|
|
||
Unvested at September 30, 2024 |
|
|
|
|
$ |
|
||
33
For the three months ended September 30, 2024 and 2023, the Company recorded stock-based compensation expense of $
The total fair value of restricted stock units vested during the nine months ended September 30, 2024 was $
Stock Option activity under HSOP Plan
The HSOP Options outstanding noted below consist of service and performance-based options to request the distribution of HSOP Shares. These HSOP Options have a fifteen-year contractual term. These HSOP Options vest over a three to four-year service period. These awards are subject to the risk of forfeiture until vested by virtue of continued employment or service to the Company.
The following is a summary of stock option activity from December 31, 2023 to September 30, 2024:
|
|
Number of |
|
|
Weighted- |
|
|
Weighted- |
|
|
Aggregate |
|
||||
Outstanding as of December 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Exercised |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Cancelled or forfeited |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Outstanding as of September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
— |
|
|||
Options exercisable as of September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
— |
|
|||
For the three months ended September 30, 2024 and 2023, the Company recorded stock-based compensation expense of
As of September 30, 2024, there was
Subsidiary Equity Incentive Plans
Certain controlled subsidiaries of the Company adopted their own equity incentive plans (each, an “EIP”). Each EIP is generally structured so that the applicable subsidiary, and its affiliates’ employees, directors, officers and consultants are eligible to receive non-qualified and incentive stock options and restricted stock unit awards under their respective EIP. Standard option grants have time-based vesting requirements, generally vesting over a period of four years with a contractual term of ten years. Such time-based stock options use the Black-Scholes option pricing model to determine grant date fair value.
For the three months ended September 30, 2024 and 2023, the Company recorded stock-based compensation expense of an immaterial amount and $
Stock-Based Compensation
Stock-based compensation expense is allocated to either research and development or general and administrative expense on the unaudited condensed consolidated statements of operations based on the cost center to which the option holder belongs.
The following table summarizes the total stock-based compensation expense by function for the three and nine months ended September 30, 2024, which includes expense related to stock options and restricted stock unit awards (in thousands):
|
|
Three months ended September 30, 2024 |
|
|||||||||||||
|
|
atai 2020 and 2021 Incentive Plans |
|
|
atai |
|
|
Other Subsidiaries Equity Plan |
|
|
Total |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
$ |
|
||||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
34
|
|
For the nine months ended September 30, 2024 |
|
|||||||||||||
|
|
atai 2020 and 2021 Incentive Plans |
|
|
atai |
|
|
Other Subsidiaries Equity Plan |
|
|
Total |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
$ |
|
||||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The following table summarizes the total stock-based compensation expense by function for the three and nine months ended September 30, 2023, which includes expense related to stock options and restricted stock unit awards (in thousands):
|
|
Three months ended September 30, 2023 |
|
|||||||||||||
|
|
atai 2020 and 2021 Incentive Plans |
|
|
atai |
|
|
Other Subsidiaries Equity Plan |
|
|
Total |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
$ |
|
||||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
For the nine months ended September 30, 2023 |
|
|||||||||||||
|
|
atai 2020 and 2021 Incentive Plans |
|
|
atai |
|
|
Other Subsidiaries Equity Plan |
|
|
Total |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
$ |
|
||||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
14. Income Taxes
The Company records its quarterly income tax expense by utilizing an estimated annual effective tax rate applied to its period to date earnings as adjusted for any discrete items arising during the quarter. The tax effect for discrete items are recorded in the period in which they occur. The Company recorded a $
35
15. Net Loss Per Share
Basic and diluted net loss per share attributable to atai stockholders were calculated as follows (in thousands, except share and per share data):
|
|
For the three months ended September 30, |
|
|
For the nine months ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Basic EPS |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net income (loss) |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
Net loss attributable to noncontrolling interests |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Net income (loss) attributable to ATAI Life Sciences N.V. shareholders — basic (numerator) |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. Shareholders (denominator) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net income (loss) per common share attributable to ATAI Life Sciences N.V. Shareholders - basic |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
Diluted EPS |
|
|
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Net income (loss) |
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$ |
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$ |
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Net loss attributable to noncontrolling interests |
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Net income (loss) attributable to ATAI Life Sciences N.V. shareholders — diluted (numerator) |
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$ |
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$ |
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$ |
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$ |
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Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. Shareholders |
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Effect of dilutive securities: |
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Options to purchase common stock |
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Unvested restricted stock units |
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2018 Convertible Promissory Note - Related Parties (note 11) |
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Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. shareholders (denominator) |
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Net income (loss) per common share attributable to ATAI Life Sciences N.V. shareholders — diluted |
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$ |
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$ |
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$ |
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HSOP Shares issued to the Partnership and allocated to the HSOP Participants are not considered outstanding for accounting purposes and not included in the calculation of basic weighted average common shares outstanding in the table above because the HSOP Participants have a forfeitable right to distributions until the HSOP Options vest and are exercised, at which time the right becomes nonforfeitable.
36
The following also represents the maximum amount of outstanding shares of potentially dilutive securities that were excluded from the computation of diluted net loss per share attributable to common shareholders for the periods presented because including them would have been antidilutive:
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As of September 30, |
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2024 |
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2023 |
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HSOP options to purchase common stock |
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2018 short-term convertible promissory notes - related parties |
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2018 short-term convertible promissory notes |
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Unvested restricted stock units |
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16. Commitments and Contingencies
Research and Development Agreements
The Company may enter into contracts in the ordinary course of business with clinical research organizations for clinical trials, with contract manufacturing organizations for clinical supplies and with other vendors for preclinical studies, supplies and other services and products for operating purposes.
Indemnification
In the ordinary course of business, the Company may provide indemnifications of varying scope and terms to vendors, lessors, business partners, board members, officers and other parties with respect to certain matters, including, but not limited to, losses arising out of breach of such agreements, services to be provided by the Company, negligence or willful misconduct of the Company, violations of law by the Company, or intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with directors and certain officers and employees that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors, officers or employees. No demands have been made upon the Company to provide indemnification under such agreements, and thus, there are no claims that the Company is aware of that could have a material effect on the Company’s unaudited condensed consolidated financial statements.
The Company also maintains director and officer insurance, which may cover certain liabilities arising from its obligation to indemnify the Company’s directors. To date, the Company has not incurred any material costs and has not accrued any liabilities in the unaudited condensed consolidated financial statements as a result of these provisions.
Contingencies
From time to time, the Company may become involved in legal proceedings arising in the ordinary course of business. The Company is unable to predict the outcome of these matters or the ultimate legal and financial liability, and at this time cannot reasonably estimate the possible loss or range of loss and accordingly has not accrued a related liability. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company accrues a liability when a loss is considered probable and the amount can be reasonably estimated. When a material loss contingency is reasonably possible but not probable, the Company does not record a liability, but instead discloses the nature and the amount of the claim, and an estimate of the loss or range of loss, if such an estimate can be made. Legal fees are expensed as incurred.
17. License Agreements
Otsuka License and Collaboration Agreement
In March 2021, Perception entered into a license and collaboration agreement (the “Otsuka Agreement”) with Otsuka under which Perception granted exclusive rights to Otsuka to develop and commercialize products containing arketamine, known as PCN-101 in Japan for the treatment of any depression, including treatment-resistant depression, or major depressive disorder or any of their related symptoms or conditions at its own cost and expense. Perception retained all rights to PCN-101 outside of Japan.
With the execution of the Otsuka Agreement, Perception received an upfront, non-refundable payment of $
37
For the three and nine months ended September 30, 2024 and 2023, respectively, there were no milestones achieved under the Otsuka Agreement.
For the three months ended September 30, 2024 and 2023, respectively, the company recognized an immaterial amount and $
National University Corporation Chiba University License Agreement
In August 2017, Perception entered into a license agreement (the “CHIBA License”), with the National University Corporation Chiba University (“CHIBA”), relating to Perception’s drug discovery and development initiatives. Under the CHIBA License, Perception has been granted a worldwide exclusive license under certain patents and know-how of CHIBA to research, develop, manufacture, use and commercialize therapeutic products.
During the three and nine months ended September 30, 2024 and 2023, respectively, the Company made
Allergan License Agreement
In February 2020, Recognify entered into an amended and restated license agreement (the “Allergan License Agreement”), with Allergan Sales, LLC (“Allergan”), under which Allergan granted Recognify an exclusive (non-exclusive as to know-how), sublicensable and worldwide license under certain patent rights and know-how controlled by Allergan to develop, manufacture and commercialize certain products for use in all fields including the treatment of certain diseases and conditions of the central nervous system.
During the three and nine months ended September 30, 2024 and 2023, respectively, Recognify made
Columbia Stock Purchase and License Agreement
In June 2020, Kures, Inc. ("Kures") entered into a license agreement with Trustees of Columbia University (“Columbia”), pursuant to which, Kures obtained an exclusive license under certain patents and technical information to discover, develop, manufacture, use and commercialize such patents or other products in all uses and applications (“Columbia IP”). In addition, in consideration for the rights to the Columbia IP, Kures entered into a Stock Purchase Agreement (the “SPA”) with Columbia in contemplation of the license agreement. Pursuant to the SPA, Kures issued to Columbia certain shares of the Kures’ capital stock, representing
During the three and nine months ended September 30, 2024 and 2023, respectively, Kures made
Dalriada License Agreement
In December 2021, Invyxis, Inc. (“Invyxis”), a wholly owned subsidiary of the Company, entered into an exclusive services and license agreement (the “Invyxis ESLA”) with Dalriada Drug Discovery Inc. (“Dalriada”). Under the Invyxis ESLA, Dalriada is to exclusively collaborate with Invyxis to develop products, services and processes with the specific purpose of generating products consisting of new chemical entities. Invyxis will pay Dalriada up to $
In January 2022, in accordance with the Invyxis ESLA, Invyxis paid an upfront deposit of $
During the three months ended September 30, 2024 and 2023, respectively, the Company recorded an immaterial amount and $
38
18. Related Party Transactions
atai Formation
In connection with the formation of atai in 2018, the Company entered into a series of transactions with its shareholders, Apeiron, Galaxy Group Investments LLC. (“Galaxy”) and HCS Beteiligungsgesellschaft mbH (“HCS”) whereby these shareholders contributed their investments in COMPASS, Innoplexus and Juvenescence to the Company in exchange for the Company's common stock of equivalent value. Apeiron is the family office of the Company’s co-founder who owns
Directed Share Program
In connection with the Company's initial public offering, the underwriters reserved
Consulting Agreement with Mr. Angermayer
In January 2021, the Company entered into a consulting agreement, (the “Consulting Agreement”), with Mr. Angermayer, one of the Company’s co-founders and supervisory director. Apeiron is the family office and merchant banking business of Mr. Angermayer. Pursuant to the Consulting Agreement, Mr. Angermayer agreed to render services to the Company on business and financing strategies in exchange for
In January 2024, the Company and Mr. Angermayer entered into the Termination and New Consultancy Agreement (the “2024 Consultancy Agreement"). Pursuant to the 2024 Consultancy Agreement, the parties agreed to terminate the Consulting Agreement (as defined above) between ATAI AG and Mr. Angermayer dated January 16, 2021 (the “Original Consultancy Agreement”) and enter into a new consultancy agreement between the Company and Mr. Angermayer to, among other things, extend the term of the Original Consultancy Agreement to January 5, 2028, increase the services to include various business objectives (including related to business and finance, communication and investor relations), and provide for the grant of an option to purchase
As a result of the 2024 Consulting Agreement, for the three and nine months ended September 30, 2024, the Company recorded $
For the three and nine months ended September 30, 2024, the Company recorded an immaterial amount and $
19. Defined Contribution Plan
The Company has a defined contribution retirement savings plan under Section 401(k) of the Internal Revenue Code. This plan allows eligible employees to defer a portion of their annual compensation. Employees may make contributions by having the Company withhold a percentage of their salary up to the Internal Revenue Service annual limit. The Company recognized $
20. Corporate Restructuring
2024 Restructuring
In February 2024, the Company restructured its workforce and eliminated approximately
39
Restructuring expense related to the workforce reduction incurred during the nine months ended September 30, 2024, resulted in $
As of September 30, 2024, net restructuring liabilities totaled approximately $
2023 Restructuring
In February 2023, the Company restructured its workforce and eliminated approximately
Restructuring expense related to the workforce reduction incurred during the nine months ended September 30, 2023, resulted in $
As of September 30, 2023, all restructuring liabilities had been paid in full and there were no restructuring liabilities included in accrued expenses on the Company's unaudited condensed consolidated balance sheets.
A reconciliation of the restructuring charges and related payments for the nine months ended September 30, 2024 and 2023 is as follows:
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2024 |
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2023 |
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Restructuring costs expensed during the period |
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Non-cash impact of stock-based compensation |
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Cash payments of restructuring liabilities, net |
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Ending Restructuring liability |
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$ |
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$ |
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21. Subsequent Events
In October 2024, the Company acquired all of the issued and outstanding shares of IntelGenx Corp., a subsidiary of IntelGenx Technologies Corp., following the approval and vesting order obtained on September 30, 2024 from the Superior Court of Québec (Commercial Division) issued in connection with the proceedings instituted pursuant to the CCAA. No Company equity or cash was exchanged in connection with this transaction.
In October 2024, pursuant to the terms of the Beckley Psytech Escrow Agreement, Beckley Psytech, at its sole discretion, drew $
40
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes thereto included in this Quarterly Report and our audited consolidated financial statements and related notes thereto for the year ended December 31, 2023, included in our Form 10-K filed with the SEC on March 28, 2024 (the "Annual Report"). This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in the section titled "Risk Factors" in our Annual Report, and may be updated from time to time in our other filings with the SEC.
All references to years, unless otherwise noted, refer to our fiscal years, which end on December 31. Unless the context otherwise requires, all references in this subsection to “we,” “us,” “our,” “atai” or the “Company” refer to atai and its consolidated subsidiaries.
Business Overview
We are a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. We were founded in 2018 in response to the significant unmet need and lack of innovation in the mental health treatment landscape. We are dedicated to efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. By pooling resources and best practices, we aim to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained behavioral change in mental health patients.
We have a bold and ambitious vision: to heal mental health disorders so that everyone, everywhere can live a more fulfilled life.
Mental health disorders such as depression, substance use disorder, and anxiety, which are among our initial focus indications, are highly prevalent and estimated to affect more than one billion people globally. In addition, the total costs of mental health disorders are significant and expected to increase substantially. Between 2009 and 2019, spending on mental health care in the United States increased by more than 50%, reaching $225 billion, and a Lancet Commission report estimates the global economic cost will reach $16 trillion by 2030. While current treatments, such as selective serotonin reuptake inhibitors, or SSRIs, and serotonin-norepinephrine reuptake inhibitors, or SNRIs, are well established and effective for certain patients, a significant percentage of patients either respond inadequately or relapse, translating to a significant unmet patient need.
Since our inception in 2018, we have focused substantially all of our efforts and financial resources on acquiring and developing product and technology rights, establishing our platform, building our intellectual property portfolio and conducting research and development activities for our product candidates within our atai companies that we consolidate based on our controlling financial interest of such entities. We operate a decentralized model to enable scalable drug or technological development at our atai companies. Our atai companies drive the development of our programs and enabling technologies for which we have either acquired a controlling or significant interest in or created de novo. We believe that this model provides our development teams the support and incentives to rapidly advance their therapeutic candidates or technologies in a cost-efficient manner. We look to optimize deployment of our capital in order to maximize value for our stakeholders.
We provide our development teams with access to shared services including scientific, intellectual property, clinical, and regulatory support, as well as project management, research and development, market strategy, and development and corporate finance. Our global team of subject matter professionals provides deep domain expertise in areas such as mental health drug development and life sciences intellectual property. Development teams have access to relevant expertise specific to each stage of their development. We believe our knowledge and specialization in psychedelics and mental health continuously enhance the quality of the services we provide through the sharing of learnings and experiences across the teams.
We have incurred significant operating losses since our inception. Our net loss attributable to ATAI Life Sciences N.V. stockholders was $110.3 million and $21.9 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024 and December 31, 2023, our accumulated deficit was $661.3 million and $550.9 million, respectively. Our ability to generate product revenue sufficient to achieve profitability will depend substantially on the successful development and eventual commercialization of product candidates at our atai companies that we consolidate based on our controlling financial interest of such entities as determined under the variable interest entity model ("VIE model") or voting interest entity model ("VOE model"). We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.
Our historical losses resulted principally from costs incurred in connection with research and development activities, as well as general and administrative costs associated with our operations. In the future, we intend to continue to conduct research and development, preclinical testing, clinical trials, regulatory compliance, market access, commercialization and business development activities that, together with anticipated general and administrative expenses, will result in incurring further significant losses for at least the next several years. Our operating losses stem primarily from the development of our mental health research programs. Furthermore, we expect to incur additional costs associated with operating as a public company, including audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums, and investor relations costs. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our operations through a combination of
41
equity offerings, debt financings, strategic collaborations and alliances or licensing arrangements. Our inability to raise capital as and when needed could have a negative impact on our financial condition and our ability to pursue our business strategies. There can be no assurances, however, that our current operating plan will be achieved or that additional funding will be available on terms acceptable to us, or at all.
We do not have any products approved for sale and have not generated any revenue from product sales. We have funded our operations to date primarily with proceeds from the sale of our common shares, issuances of convertible notes and a term loan.
Capital Allocation and Strategic Value Capture
Consistent with our strategy, we provide the necessary funding and operational support to our programs to maximize their probability of success in clinical development and commercialization. We also regularly review the status of our programs to assess whether there are alternative forms of ownership, partnership or other forms of collaboration that would optimize our economic interests and the success of our programs. To that end, we are focusing on clinical phase programs and business development that we expect to generate meaningful data in the near term, and, therefore, prioritizing programs and opportunities that we believe have the highest return potential and value. As a result, in late 2023, we finalized and entered into agreements through which we disposed of our equity interests in Psyber, Inc. and TryptageniX Inc. In 2024, our strategic investment in Beckley Psytech Limited added more programs to our diverse portfolio of clinical-stage psychedelic candidates with multiple upcoming clinical readouts. We are also exploring other opportunities, including but not limited to seeking strategic partnership options, for example, with Recognify Life Sciences, Inc. and Perception Neuroscience Holdings, Inc.
In February 2023, we implemented a realignment initiative resulting in a reduction in force of approximately 30% of our global workforce in order to more effectively allocate our research and development and other resources supporting the revised business and program priorities and to reduce operational costs. In February 2024, we conducted a reduction in force of approximately 10% of our global workforce, predominantly reducing redundancy in our general & administrative functions to reduce operational costs. Refer to Note 20 in the Notes to condensed consolidated financial statements in Part I, Item 1 for further information.
Our Core Clinical Programs
Our pipeline currently consists of therapeutic candidates across multiple neuropsychiatric indications. The table below summarizes the status of our core product candidate portfolio as of the date of this Quarterly Report.
42
Clinical Pipeline Recent Advancements
RL-007: Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS)
Recent Advancements
VLS-01 (N,N-Dimethyltryptamine; (“DMT”) for Treatment-Resistant Depression ("TRD")
Recent Advancements:
EMP-01: R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for Social Anxiety Disorder (SAD)
Recent Advancements
IBX-210: Intravenous (IV)-Ibogaine for Opioid Use Disorder (OUD)
Recent Advancements
Novel 5-HT2A Receptor Agonists
Recent Advancements
43
Financial Overview
Since our inception in 2018, we have focused substantially all of our efforts and financial resources on acquiring and developing product and technology rights, establishing our platform, building our intellectual property portfolio and conducting research and development activities for our product candidates within our atai companies that we consolidate based on our controlling financial interest of such entities. We operate a decentralized model to enable scalable drug or technological development at our atai companies. Our atai companies drive the development of our programs and enabling technologies for which we have either acquired a controlling or significant interest in or created de novo. We believe that this model provides our development teams the support and incentives to rapidly advance their therapeutic candidates or technologies in a cost-efficient manner. We look to optimize deployment of our capital in order to maximize value for our stakeholders.
We do not have any products approved for sale and have not generated any revenue from product sales. We have funded our operations to date primarily with proceeds from the sale of our common shares, issuances of convertible notes, and a term loan.
Factors and Trends Affecting our Results of Operations
We believe that the most significant factors affecting our results of operations include:
Research and Development Expenses
We believe that our ability to successfully develop innovative product candidates through our programs will be the primary factor affecting our future growth. Our approach to the discovery and development of our product candidates is still being demonstrated. As such, we do not know whether we will be able to successfully develop any of our product candidates. Developing novel product candidates requires a significant investment of resources over a prolonged period of time, and a core part of our strategy is to continue making sustained investments in this area. We have chosen to leverage our platform to focus initially on advancing our product candidates in the area of mental health.
All of our product candidates are still in development stages, and we have incurred and will continue to incur significant research and development costs for preclinical studies and clinical trials. We expect that our research and development expenses will constitute the most significant part of our expenses in future periods in line with the advancement and expansion of the development of our product candidates.
Acquisitions/Investments
To continue to grow our business and to aid in the development of our various product candidates, we have strategically acquired and invested in companies that share our common goal towards advancing transformative treatments, including psychedelic compounds and digital therapeutics, for patients that suffer from mental health disorders.
Stock-Based Compensation
In August 2020, we adopted the 2020 Equity Incentive Plan (the “2020 Incentive Plan”) and the Hurdle Share Option Plan (the “HSOP Plan”), which allowed us to grant stock-based awards to executive officers, directors, employees and consultants.
Effective April 23, 2021, we adopted and our shareholders approved the atai Life Sciences N.V. 2021 Incentive Award Plan (the “2021 Incentive Plan”). The 2021 Incentive Plan enables us to grant incentive stock options or nonqualified stock options, restricted stock awards and other stock-based awards to our executive officers, directors and other employees and consultants. Any shares subject to outstanding options originally granted under the 2020 Incentive Plan that terminate, expire or lapse for any reason without the delivery of shares to the holder thereof shall become available for issuance pursuant to the 2021 Incentive Plan.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and follow the requirements of the United States Securities and Exchange Commission ("SEC"), and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of our financial position, results of operations and comprehensive loss, and cash flows for the periods presented.
Any reference in these notes to applicable accounting guidance is meant to refer to the authoritative U.S. GAAP included in the Accounting Standards Codification (“ASC”), and Accounting Standards Update (“ASU”) issued by the Financial Accounting Standards Board (“FASB”).
Consolidation
Since our inception, we have created wholly owned subsidiaries or made investments in certain controlled entities, including partially-owned subsidiaries for which we have majority voting interest under the VOE model or for which we are the primary beneficiary under the
44
VIE model, which we refer to collectively as our consolidated entities. Ownership interests in consolidated entities that are held by entities other than us are reported as noncontrolling interests in our unaudited condensed consolidated balance sheets and unaudited condensed consolidated statements of stockholders' equity. The portion of net earnings attributable to the noncontrolling interests is presented as Net loss attributable to noncontrolling interests in our unaudited condensed consolidated statements of operations. All intercompany balances and transactions have been eliminated in the consolidation.
Ownership interests in entities over which we have significant influence, but not a controlling financial interest, are accounted for under either the alternative measurement pursuant to ASC 321 or as an equity method investment. Investments eligible for the measurement alternative under ASC 321 are carried at its initial cost, with remeasurements to fair value upon impairment or upon a price change observed in an orderly transaction of the same or similar investments. For equity method investments where we have not elected the fair value option, we record gains (losses) from investments in equity method investees, net of tax, for our proportionate share of the underlying company’s net results until the investment balance is adjusted to zero. If we make subsequent additional investments in that same company, we may record additional gains (losses) based on changes to our investment basis and also may record additional income (loss) in equity method investments. If we have elected the fair value option for an equity investment, the fair value of the investments will be recognized upon acquisition and any changes in fair value will be recognized as a component of other income (expense), net.
Components of Our Results of Operations
License Revenue
On March 11, 2021, we entered into a license and collaboration agreement (the "Otsuka Agreement"), with Otsuka Pharmaceutical Co., LTD ("Otsuka"), under which we granted exclusive rights to Otsuka to develop and commercialize certain products containing arketamine in Japan for the treatment of depression and other select indications. We received an upfront, non-refundable payment of $20.0 million in June 2021 and we are also eligible to receive up to $35.0 million if certain development and regulatory milestones are achieved and up to $66.0 million in commercial milestones upon the achievement of certain commercial sales thresholds. We are eligible to receive tiered, royalties ranging from low-teens to high-teens on net sales of licensed products subject to reduction in certain circumstances.
For the foreseeable future, we may generate revenue from reimbursements of services under the Otsuka Agreement, as well as milestone payments under our current and/or future collaboration agreements. We do not expect to generate any revenue from the sale of products unless and until such time that our product candidates have advanced through clinical development and regulatory approval, if ever. We expect that any revenue we generate, if at all, will fluctuate from year-to-year as a result of the timing and amount of payments relating to such services and milestones and the extent to which any of our products are approved and successfully commercialized. Our ability to generate future revenues will also depend on our ability to complete preclinical and clinical development of product candidates or obtain regulatory approval for them.
Operating Expenses
Research and development expenses
Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts and the development of our product candidates, which include:
Research and development costs, including costs reimbursed under the Otsuka Agreement, are expensed as incurred, with reimbursements of such amounts being recognized as revenue. We account for nonrefundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received.
Our direct research and development expenses are tracked on a program-by-program basis for our product candidates and consist primarily of external costs, such as fees paid to outside consultants, CROs, contract manufacturing organizations (“CMOs”) and research laboratories in connection with our preclinical development, process development, manufacturing and clinical development activities. Our direct research and development expenses by program also include fees incurred under third-party license agreements.
45
Certain internal research and development expenses consisting of employee and contractor-related costs are not allocated to specific product candidate programs because these costs are deployed across multiple product candidate programs under research and development expense.
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will continue to increase for the foreseeable future in connection with our planned preclinical and clinical development activities in the near term and in the future.
The successful development of our product candidates is highly uncertain. As such, at this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the remainder of the development of these product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from our product candidates. This is due to the numerous risks and uncertainties associated with developing products, including the uncertainty of whether (i) any clinical trials will be conducted or progress as planned or completed on schedule, if at all, (ii) we obtain regulatory approval for our product candidates and (iii) we successfully commercialize product candidates.
General and administrative expenses
General and administrative ("G&A") expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive, finance, corporate and business development and administrative functions, professional fees for legal, patent, accounting, auditing, tax and consulting services, travel expenses and facility-related expenses, advertising, and information technology-related expenses.
We are actively controlling G&A spend and expect that our on-going G&A expenses will continue to decrease in the near future. We may add more general and administrative head count in the future to support the potential commercialization of our product candidates.
Other income (expense), net
Interest income
Interest income consists of interest earned on cash balances held in interest-bearing accounts and interest earned on notes receivable. We expect that our interest income will fluctuate based on the timing and ability to raise additional funds as well as the amount of expenditures for the research and development of our product candidates and ongoing business operations.
Interest expense
Interest expense consists primarily of interest expense incurred in connection with our 2022 Term Loan Facility, defined below.
Benefit from research and development tax credit
Benefit from research and development tax credit consists of tax credits received in Australia under the Research and Development Tax Incentive, or RDTI, program. Qualifying expenditures include employment costs for research staff, consumables, and relevant, permitted CRO costs incurred as part of research projects.
Change in fair value of assets and liabilities, net
The Company carries various assets and liabilities at fair value and subsequent remeasurements are recorded as a Change in fair value of assets and liabilities, net as a component of Other income (expense), net. Assets held at fair value include securities held at fair value, investments held at fair value, and convertible notes receivable. Liabilities held at fair value include contingent considerations, short-term convertible promissory notes and derivative liability, debtor-in-possession loan commitment, and warrant liability.
Change in fair value of securities carried at fair value
Change in fair value of securities consists of changes in fair value of our available for sale securities for which we have elected the fair value option.
Change in fair value of short-term notes receivable - related party, net
Change in fair value of short-term notes receivable - related party, net, consists of subsequent remeasurements of our notes receivable with IntelGenx for which we have elected the fair value option.
Change in fair value of short-term convertible notes receivable - related party
Change in fair value of short-term convertible notes receivable - related party, consists of subsequent remeasurements of our convertible notes receivable with IntelGenx for which we have elected the fair value option.
46
Change in fair value of other investments held at fair value
Change in fair value of other investments held at fair value consists of subsequent remeasurements of our investments held at fair value, including COMPASS Pathways plc ("COMPASS"), IntelGenx Technologies Corp. ("IntelGenx"), and Beckley Psytech Limited ("Beckley Psytech") for which we have elected the fair value option.
Change in fair value of contingent consideration liability - related parties
Change in fair value of contingent consideration liability - related parties, consists of subsequent remeasurements of our contingent consideration liability related to our acquisition of Perception Neuroscience Holdings, Inc. for which we record at fair value.
Change in fair value of contingent consideration liability
Change in fair value of contingent consideration liability, consists of subsequent remeasurements of our contingent consideration liability related to our acquisition of DemeRx IB, Inc. ("DemeRx IB") and TryptageniX, Inc. ("TryptageniX") for which we record at fair value.
Change in the fair value of short-term convertible promissory notes and derivative liability
Change in fair value of short-term convertible promissory notes and derivative liability consists of subsequent remeasurements of certain convertible notes issued in 2020.
Change in fair value of subsequent debtor-in-possession loan commitment
Change in fair value of subsequent debtor-in-possession loan commitment consists of subsequent remeasurements of our liability for the remaining balance of the credit facility between the Company and IntelGenx (the “DIP Loan”) for which we have elected the fair value option.
Gain on deconsolidation of a variable interest entity
Gain on deconsolidation of a variable interest entity is the result of removing assets and liabilities from our consolidated balance sheet following a loss of control or divestment of a variable interest entity.
Foreign exchange gain (loss), net
Foreign exchange gain (loss), net consists of the impact of changes in foreign currency exchange rates on our foreign exchange denominated assets and liabilities, relative to the U.S. dollar. The impact of foreign currency exchange rates on our results of operations fluctuates period over period based on our foreign currency exposures resulting from changes in applicable exchange rates associated with our foreign denominated assets and liabilities.
Other income (expense), net
Other income (expense), net consists principally of the impact of accounting adoptions, changes in the carrying values of our assets and liabilities, or net gains (losses) recognized on the sale of certain of our assets.
Benefit from (provision for) income taxes
For our consolidated entities, deferred income taxes are provided for the effects of temporary differences between the amounts of assets and liabilities recognized for financial reporting purposes and the amounts recognized for income tax purposes. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.
We regularly assess the need to record a valuation allowance against net deferred tax assets if, based upon the available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. Accordingly, we maintain a full valuation allowance against net deferred tax assets for all entities as of September 30, 2024. In assessing the realizability on deferred tax assets, we consider whether it is more-likely-than-not that some or all of deferred tax assets will not be realized. The future realization of deferred tax assets is subject to the existence of sufficient taxable income of the appropriate character (e.g., ordinary income or capital gain) as provided under the carryforward provisions of local tax law.
We consider the scheduled reversal of deferred tax liabilities (including the effect in available carryback and carryforward periods), future projected taxable income, including the character and jurisdiction of such income, and tax-planning strategies in making this assessment.
Unrecognized tax benefits arise when the estimated benefit recognized in the financial statements differs from the amounts taken or expected to be taken in a tax return because of the considerations described above. As of September 30, 2024, we had no additional unrecognized tax benefits and the Company accrued interest on the tax positions recognized in 2023 through September 30, 2024.
Losses from Investments in Equity Method Investees, Net of Tax
Losses from investments in equity method investees, net of tax consists of our share of equity method investees losses on the basis of our equity ownership percentage related to our equity method investments.
47
Net Loss Attributable to Noncontrolling Interests
Net loss attributable to noncontrolling interests in our unaudited condensed consolidated statements of operations is a result of our investments in certain of our consolidated VIEs and consists of the portion of the net loss of these consolidated entities that is not allocated to us. Net losses in consolidated VIEs are attributed to noncontrolling interests considering the liquidation preferences of the different classes of equity held by the shareholders in the VIE and their respective interests in the net assets of the consolidated VIE in the event of liquidation, and their pro rata ownership. Changes in the amount of net loss attributable to noncontrolling interests are directly impacted by changes in the net loss of our VIEs and our ownership percentage changes.
Results of Operations
Comparison of the Three Months Ended September 30, 2024 and 2023 (unaudited)
|
|
For the three months ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
$ Change |
|
|
% Change |
|
||||
|
|
(in thousands, except percentages) |
|
|||||||||||||
License revenue |
|
$ |
40 |
|
|
$ |
87 |
|
|
$ |
(47 |
) |
|
|
(54 |
%) |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
12,377 |
|
|
|
13,290 |
|
|
|
(913 |
) |
|
|
(7 |
%) |
General and administrative |
|
|
10,265 |
|
|
|
13,631 |
|
|
|
(3,366 |
) |
|
|
(25 |
%) |
Total operating expenses |
|
|
22,642 |
|
|
|
26,921 |
|
|
|
(4,279 |
) |
|
|
(16 |
%) |
Loss from operations |
|
|
(22,602 |
) |
|
|
(26,834 |
) |
|
|
4,232 |
|
|
|
(16 |
%) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
160 |
|
|
|
612 |
|
|
|
(452 |
) |
|
|
(74 |
%) |
Interest expense |
|
|
(783 |
) |
|
|
(686 |
) |
|
|
(97 |
) |
|
|
14 |
% |
Benefit from research and development tax credit |
|
|
31 |
|
|
|
— |
|
|
|
31 |
|
|
|
100 |
% |
Change in fair value of assets and liabilities, net |
|
|
(1,964 |
) |
|
|
70,810 |
|
|
|
(72,774 |
) |
|
|
(103 |
%) |
Foreign exchange gain, net |
|
|
770 |
|
|
|
253 |
|
|
|
517 |
|
|
|
204 |
% |
Other expense, net |
|
|
(2,075 |
) |
|
|
(308 |
) |
|
|
(1,767 |
) |
|
|
574 |
% |
Total other income (expense), net |
|
|
(3,861 |
) |
|
|
70,681 |
|
|
|
(74,542 |
) |
|
|
(105 |
%) |
Net income (loss) before income taxes |
|
|
(26,463 |
) |
|
|
43,847 |
|
|
|
(70,310 |
) |
|
|
(160 |
%) |
Benefit from (provision for) income taxes |
|
|
178 |
|
|
|
(238 |
) |
|
|
416 |
|
|
|
(175 |
%) |
Losses from investments in equity method investees, net of tax |
|
|
(26 |
) |
|
|
(238 |
) |
|
|
212 |
|
|
|
(89 |
%) |
Net loss |
|
$ |
(26,311 |
) |
|
$ |
43,371 |
|
|
$ |
(69,682 |
) |
|
|
(161 |
%) |
Net loss attributable to noncontrolling interests |
|
|
(25 |
) |
|
|
(873 |
) |
|
|
848 |
|
|
|
(97 |
%) |
Net loss attributable to ATAI Life Sciences N.V. stockholders |
|
$ |
(26,286 |
) |
|
$ |
44,244 |
|
|
$ |
(70,530 |
) |
|
|
(159 |
%) |
License Revenue
We recognized an immaterial amount and $0.1 million of license revenue for the three months ended September 30, 2024 and 2023, respectively, related to certain research and development services performed by the Company pursuant to the Otsuka Agreement.
48
Research and Development Expenses
The table and discussion below present research and development expenses for the three months ended September 30, 2024 and 2023:
|
|
Three months ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
$ Change |
|
|
% Change |
|
||||
|
|
(in thousands, except percentages) |
|
|||||||||||||
Direct research and development expenses by program: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Psychedelic Programs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
VLS-01 |
|
$ |
1,582 |
|
|
$ |
1,179 |
|
|
$ |
403 |
|
|
|
34 |
% |
IBX-210 & DMX-1002 |
|
|
1,247 |
|
|
|
368 |
|
|
|
879 |
|
|
|
239 |
% |
Novel 5-HT2A Receptor Agonists |
|
|
880 |
|
|
|
539 |
|
|
|
341 |
|
|
|
63 |
% |
EMP-01 |
|
|
355 |
|
|
|
556 |
|
|
|
(201 |
) |
|
|
(36 |
%) |
Non-Psychedelic Programs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
RL-007 |
|
|
3,953 |
|
|
|
2,418 |
|
|
|
1,535 |
|
|
|
63 |
% |
Other Programs |
|
|
80 |
|
|
|
803 |
|
|
|
(723 |
) |
|
|
(90 |
%) |
Enabling Technologies and Drug Discovery Platforms |
|
|
11 |
|
|
|
507 |
|
|
|
(496 |
) |
|
|
(98 |
%) |
Unallocated research and development expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Personnel expenses |
|
|
4,046 |
|
|
|
6,457 |
|
|
|
(2,411 |
) |
|
|
(37 |
%) |
Professional and consulting services |
|
|
93 |
|
|
|
363 |
|
|
|
(270 |
) |
|
|
(74 |
%) |
Other |
|
|
130 |
|
|
|
100 |
|
|
|
30 |
|
|
|
30 |
% |
Total research and development expenses |
|
$ |
12,377 |
|
|
$ |
13,290 |
|
|
$ |
(913 |
) |
|
|
(7 |
%) |
Research and development expenses were $12.4 million for the three months ended September 30, 2024, compared to $13.3 million for the three months ended September 30, 2023. The $0.9 million decrease was primarily attributable to $2.2 million increase of direct costs in our clinical programs as discussed below, mostly offset by $0.5 million decrease of costs related to our enabling technologies and drug discovery platform as discussed below, $2.4 million decrease in personnel expenses (inclusive of $1.3 million decrease in stock-based compensation), and a $0.2 million decrease in professional services costs and other costs.
Psychedelic Programs
VLS-01: N,N-dimethyltryptamine; (“DMT”) for Treatment Resistant Depression
The $0.4 million increase in direct costs for our VLS-01 program was primarily due to $1.1 million increase of clinical development costs related to our Phase 1b trial of VLS-01 designed to evaluate the efficacy, safety, tolerability, PK and PD of VLS-01 delivered using our proprietary OTF formulation as well as our upcoming randomized, double-blind, placebo-controlled Phase 2 study. These costs were partially offset by $0.5 million decrease in preclinical development costs and $0.2 million decrease in manufacturing costs.
IBX-210 & DMX-1002: Ibogaine for Opioid Use Disorder
The $0.9 million increase in direct costs was primarily due to $0.7 million of preclinical development costs, $0.3 million of clinical development costs, and $0.2 million of manufacturing costs related to the IBX-210 program in the third quarter of 2024, as compared to $0.2 million of clinical development costs, $0.1 million of manufacturing costs, and $0.1 million of personnel costs related to conduct our DMX-1002 Phase 1/2 trial in the third quarter of 2023.
Novel 5-HT2A Receptor Agonists
The $0.3 million increase in direct costs for novel 5-HT2A receptor agonists was primarily due to an increase of $0.6 million of preclinical development costs, partially offset by a $0.3 million decrease in manufacturing costs.
EMP-01: 3,4-methylenedioxy-methamphetamine (MDMA) derivative for Post Traumatic Stress Disorder
The $0.2 million decrease in direct costs for our EMP-01 program was primarily due to $0.3 million decrease in clinical development costs relating to our Phase 1 single ascending dose trial to assess the safety and tolerability of orally administered EMP-01. These were partially offset by $0.1 million increase in manufacturing costs.
Non-Psychedelic Programs
RL-007: Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia
The $1.5 million increase in direct costs for our RL-007 program was due to $1.5 million increase of clinical development costs relating to our Phase 2b proof-of-concept clinical trial for RL-007 in CIAS.
49
Other Programs
The $0.7 million decrease in direct costs for our other programs was primarily due to $0.7 million decrease in our PCN-101 program.
Enabling Technologies and Drug Discovery Platforms
The $0.5 million decrease in our enabling technologies and drug discovery platforms primarily relates to $0.5 million decreased costs in our Invyxis program.
General and Administrative Expenses
General and administrative expenses were $10.3 million for the three months ended September 30, 2024 compared to $13.6 million for the three months ended September 30, 2023. The decrease of $3.3 million was largely attributable to $3.5 million decrease in personnel related costs (inclusive of $1.8 million decrease in stock-based compensation), $0.7 million decrease in legal and professional service expenses, and $0.5 million decrease in insurance expenses. These were partially offset by a $1.3 million increase in VAT and non-income tax (due to non-recurring prior year refund) and an increase of $0.1 million in investor relations and public company compliance fees.
Other income (expense), net
Interest income
Interest income for the three months ended September 30, 2024 and 2023 primarily consisted of interest earned on our cash balances and notes receivable during these periods. We recognized interest income of $0.2 million and $0.6 million for the three months ended September 30, 2024 and 2023, respectively.
Interest expense
Interest expense for the three months ended September 30, 2024 and 2023 primarily consisted of interest expense incurred in connection with our 2022 Term Loan Facility, defined below. Interest expense was $0.8 million and $0.7 million for the three months ended September 30, 2024 and 2023, respectively.
Benefit from research and development tax credit
We recognized an immaterial amount of research and development tax credit from the Australian Tax Authorities for the three months ended September 30, 2024 and 2023.
Change in fair value of assets and liabilities, net:
Change in fair value of securities carried at fair value
Changes in fair value of securities consists of changes in the fair value of our available for sale securities for which we have elected the fair value option. During the three months ended September 30, 2024 and 2023 we recognized a gain of $0.9 million and $1.8 million, respectively, relating to the change in fair value of securities.
Change in fair value of short-term notes receivable - related party, net
Changes in fair value of short-term notes receivable - related party, net, including interest, consists of subsequent remeasurement of our notes receivable with IntelGenx for which we have elected the fair value option. During the three months ended September 30, 2024 we recognized an immaterial loss related to the change in the fair value. We recorded an immaterial change in fair value of short-term notes receivable - related party during the three months ended September 30, 2023. See Note 6 in the Notes to unaudited condensed consolidated financial statements in Part I, Item 1 for further information.
Change in fair value of short-term convertible notes receivable - related party
Changes in fair value of short-term convertible notes receivable - related party, including interest, consists of subsequent remeasurement of our convertible notes receivable with IntelGenx for which we have elected the fair value option. During the three months ended September 30, 2024 we recognized an $8.0 million loss related to the change in the fair value. An immaterial change in fair value of convertible notes receivable - related party was recognized during the three months ended September 30, 2023. See Note 6 in the Notes to unaudited condensed consolidated financial statements in Part I, Item 1 for further information.
Change in fair value of other investments held at fair value
Changes in fair value of other investments held at fair value consists of subsequent remeasurement of our investments held at fair value, including our ADS holding in COMPASS, IntelGenx related investments, and warrants issued by Beckley Psytech Limited. During the three months ended September 30, 2024, we recognized a $3.9 million gain related to our ADS holding in COMPASS and a $0.1 million loss related to our warrants issued by Beckley Psytech Limited. During the three months ended September 30, 2023, we recognized a $69.0
50
million non-cash change in fair value of other investments held at fair value related to an accounting method change for our ADS holdings in COMPASS resulting in our election of fair value accounting. See Note 5 in the Notes to unaudited condensed consolidated financial statements in Part I, Item 1 for further information.
Change in fair value of contingent consideration liability—related parties
The milestone and royalty payments in relation to the acquisition of Perception were recognized at the acquisition date, and are subsequently remeasured to fair value. For the three months ended September 30, 2024 and 2023 we recognized a $0.1 million loss and a $0.1 million loss, respectively.
Change in fair value of contingent consideration liability
In October 2023, we acquired the noncontrolling interest's shares of DemeRx IB making DemeRx IB a wholly owned subsidiary. An earn-out of up to $8.0 million was part of the consideration and was recognized at fair value at the transaction date and subsequently remeasured at fair value. For the three months ended September 30, 2024, we recognized an immaterial change in the fair value related to the DemeRx IB contingent consideration. In December 2023, we disposed of our equity interest in TryptageniX, but retained the contingent consideration liability, which is subsequently remeasured to fair value. For the three and nine months ended September 30, 2024 and 2023, we recognized an immaterial gain related to the TryptageniX contingent consideration.
Change in fair value of convertible promissory notes and derivative liability
In December 2023 and April 2024, certain 2020 convertible noteholders exchanged the 2020 convertible notes issued by ATAI Life Sciences AG for notes issued by ATAI Life Sciences NV, which are convertible into ATAI NV common shares. We determined that this was a modification to the convertible notes and record the fair value of the conversion option quarterly. For the three months ended September 30, 2024, we recognized a $0.9 million gain due to a change in the fair value of the conversion option of the convertible notes issued by ATAI Life Sciences NV.
Change in fair value of subsequent debtor-in-possession loan commitment
Change in fair value of subsequent debtor-in-possession loan commitment consists of subsequent remeasurements of our liability for the remaining balance of the DIP Loan for which we have elected the fair value option. During the three months ended September 30, 2024 we recognized $0.5 million gain related to the change in the fair value.
Foreign exchange gain, net
We recognized a gain of $0.8 million related to foreign currency exchange rates for the three months ended September 30, 2024 and a gain of $0.3 million related to foreign currency exchange rate for the three months ended September 30, 2023. This was due to the impact of fluctuations in the foreign currency exchange rate between the Euro and the U.S. dollar on our foreign denominated balances.
Other expense, net
We incurred a non-cash loss of $2.1 million on the sale of our ADS holdings in COMPASS during the three months ended September 30, 2024. We incurred a $0.3 million other expense, net for the three months ended September 30, 2023, which primarily consisted of a $0.3 million increase to the allowances on receivables, partially offset by a $0.1 million gain recognized on the Company divestment of it's investment in Juvenescence Limited ("Juvenescence").
Benefit from (provision for) income taxes
We incurred $0.2 million of current income tax benefit for the three months ended September 30, 2024 compared to a $0.2 million income tax expense for the three months ended September 30, 2023. The decrease in income tax expense in 2024 was primarily driven by a reduction in global earnings, a favorable return to provision from one of our Australian subsidiaries and the release of an uncertain tax liability associated with a 2021 tax return for one of our subsidiaries.
Losses from Investments in Equity Method Investees
Losses from investment in equity method investees for the three months ended September 30, 2024 and 2023 was immaterial and $0.2 million, respectively. Loss from investment in equity method investees represents our share of equity method investee losses on the basis of our equity ownership percentages or based on our proportionate share of the respective class of securities in our other investments in the event that the carrying amount of our equity method investments was zero.
51
Comparison of the Nine Months Ended September 30, 2024 and 2023 (unaudited)
|
|
For the nine months ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
$ Change |
|
|
% Change |
|
||||
|
|
(in thousands, except percentages) |
|
|||||||||||||
License revenue |
|
$ |
313 |
|
|
$ |
296 |
|
|
$ |
17 |
|
|
|
6 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
36,513 |
|
|
|
48,047 |
|
|
|
(11,534 |
) |
|
|
(24 |
%) |
General and administrative |
|
|
36,226 |
|
|
|
44,159 |
|
|
|
(7,933 |
) |
|
|
(18 |
%) |
Total operating expenses |
|
|
72,739 |
|
|
|
92,206 |
|
|
|
(19,467 |
) |
|
|
(21 |
%) |
Loss from operations |
|
|
(72,426 |
) |
|
|
(91,910 |
) |
|
|
19,484 |
|
|
|
(21 |
%) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
585 |
|
|
|
1,191 |
|
|
|
(606 |
) |
|
|
(51 |
%) |
Interest expense |
|
|
(2,172 |
) |
|
|
(1,965 |
) |
|
|
(207 |
) |
|
|
11 |
% |
Benefit from research and development tax credit |
|
|
617 |
|
|
|
— |
|
|
|
617 |
|
|
|
100 |
% |
Change in fair value of assets and liabilities, net |
|
|
(33,764 |
) |
|
|
72,411 |
|
|
|
(106,175 |
) |
|
|
(147 |
%) |
Foreign exchange gain (loss), net |
|
|
676 |
|
|
|
(593 |
) |
|
|
1,269 |
|
|
|
(214 |
%) |
Other expense, net |
|
|
(2,737 |
) |
|
|
(100 |
) |
|
|
(2,637 |
) |
|
|
2637 |
% |
Total other income (expense), net |
|
|
(36,795 |
) |
|
|
70,944 |
|
|
|
(107,739 |
) |
|
|
(152 |
%) |
Net loss before income taxes |
|
|
(109,221 |
) |
|
|
(20,966 |
) |
|
|
(88,255 |
) |
|
|
421 |
% |
Benefit from (provision for) income taxes |
|
|
163 |
|
|
|
(588 |
) |
|
|
751 |
|
|
|
(128 |
%) |
Losses from investments in equity method investees, net of tax |
|
|
(2,000 |
) |
|
|
(3,199 |
) |
|
|
1,199 |
|
|
|
(37 |
%) |
Net loss |
|
$ |
(111,058 |
) |
|
$ |
(24,753 |
) |
|
$ |
(86,305 |
) |
|
|
349 |
% |
Net loss attributable to noncontrolling interests |
|
|
(747 |
) |
|
|
(2,821 |
) |
|
|
2,074 |
|
|
|
(74 |
%) |
Net loss attributable to ATAI Life Sciences N.V. stockholders |
|
$ |
(110,311 |
) |
|
$ |
(21,932 |
) |
|
$ |
(88,379 |
) |
|
|
403 |
% |
License Revenue
We recognized $0.3 million and $0.3 million of license revenue for the nine months ended September 30, 2024 and 2023, respectively, related to certain research and development services performed by the Company pursuant to the Otsuka Agreement.
Research and Development Expenses
The table and discussion below present research and development expenses for the nine months ended September 30, 2024 and 2023:
|
|
Nine months ended September 30, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
$ Change |
|
|
% Change |
|
||||
|
|
(in thousands, except percentages) |
|
|||||||||||||
Direct research and development expenses by program: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Psychedelic Programs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
VLS-01 |
|
$ |
6,362 |
|
|
$ |
6,351 |
|
|
$ |
11 |
|
|
|
0 |
% |
IBX-210 & DMX-1002 |
|
|
3,224 |
|
|
|
1,324 |
|
|
|
1,899 |
|
|
|
143 |
% |
Novel 5-HT2A Receptor Agonists |
|
|
1,705 |
|
|
|
1,395 |
|
|
|
311 |
|
|
|
22 |
% |
EMP-01 |
|
|
622 |
|
|
|
2,124 |
|
|
|
(1,501 |
) |
|
|
(71 |
%) |
Non-Psychedelic Programs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
RL-007 |
|
|
8,452 |
|
|
|
5,797 |
|
|
|
2,655 |
|
|
|
46 |
% |
Other Programs |
|
|
550 |
|
|
|
6,122 |
|
|
|
(5,572 |
) |
|
|
(91 |
%) |
Enabling Technologies and Drug Discovery Platforms |
|
|
563 |
|
|
|
2,711 |
|
|
|
(2,149 |
) |
|
|
(79 |
%) |
Unallocated research and development expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Personnel expenses |
|
|
13,945 |
|
|
|
20,566 |
|
|
|
(6,621 |
) |
|
|
(32 |
%) |
Professional and consulting services |
|
|
765 |
|
|
|
1,279 |
|
|
|
(514 |
) |
|
|
(40 |
%) |
Other |
|
|
324 |
|
|
|
378 |
|
|
|
(54 |
) |
|
|
(14 |
%) |
Total research and development expenses |
|
$ |
36,513 |
|
|
$ |
48,047 |
|
|
$ |
(11,534 |
) |
|
|
(24 |
%) |
Research and development expenses were $36.5 million for the nine months ended September 30, 2024, compared to $48.0 million for the nine months ended September 30, 2023. The decrease of $11.5 million was primarily attributable to $2.2 million decrease of direct costs in our clinical programs as discussed below, $2.1 million decrease of costs related to our enabling technologies and drug discovery platform as discussed below, $6.6 million decrease in personnel expenses (inclusive of $3.2 million decrease in stock-based compensation and a $1.6 million decrease in restructuring costs), $0.5 million decrease in professional service costs, and a $0.1 million decrease in other expenses.
52
Psychedelic Programs
VLS-01: N,N-dimethyltryptamine; (“DMT”) for Treatment Resistant Depression
The direct costs for our VLS-01 program remained consistent for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023. This was primarily due to $1.0 million increase of clinical development costs and $0.2 million increase of preclinical development costs related to our Phase 1 three-part trial and Phase 1b trial of VLS-01 designed to evaluate the safety, tolerability, PK and PD of VLS-01 delivered by intravenous (IV) infusion and using our proprietary OTF formulation as well as our upcoming randomized, double-blind, placebo-controlled Phase 2 study. These increases were partially offset by a $1.2 million decrease in manufacturing costs.
IBX-210 & DMX-1002: Ibogaine for Opioid Use Disorder
The $1.9 million net increase in direct costs was primarily due to $1.6 million of preclinical development costs, $0.9 million of clinical development costs, and $0.7 million of manufacturing costs related to the IBX-210 program for the nine months ended September 30, 2024, as compared to $0.7 million of clinical development costs, $0.4 million of manufacturing costs, and $0.2 million of personnel costs related to the conduct our DMX-1002 Phase 1/2 trial for the nine months ended September 30, 2023.
Novel 5-HT2A Receptor Agonists
The $0.3 million increase in direct costs for novel 5-HT2A receptor agonists was primarily due to $0.3 million increase in preclinical development costs.
EMP-01: 3,4-methylenedioxy-methamphetamine (MDMA) derivative for Post Traumatic Stress Disorder
The $1.5 million decrease in direct costs for our EMP-01 program was primarily due to $1.2 million decrease in clinical development costs and $0.3 million decrease in preclinical development costs relating to our Phase 1 single ascending dose trial to assess the safety and tolerability of orally administered EMP-01.
Non-Psychedelic Programs
RL-007: Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia
The $2.7 million increase in direct costs for our RL-007 program was primarily due to an increase of $2.5 million in clinical development costs, $0.2 million of manufacturing costs, and $0.2 million in preclinical development costs, all relating to our Phase 2b proof-of-concept clinical trial for RL-007 in CIAS. These costs were partially offset by a decrease of $0.2 million in personnel costs.
Other Programs
The $5.6 million decrease in direct costs for our other programs was primarily due to $5.3 million decrease in our PCN-101 program, $0.2 million decrease in our KUR-101 program, and $0.1 million decrease in our RLS-01 program.
Enabling Technologies and Drug Discovery Platforms
The $2.1 million decrease in our enabling technologies and drug discovery platforms primarily relates to $1.1 million decrease in our Invyxis program, $0.4 million decrease in our TryptageniX program, $0.4 million decrease in our InnarisBio program, and $0.2 million decrease in our Psyber program.
General and Administrative Expenses
General and administrative expenses were $36.2 million for the nine months ended September 30, 2024 compared to $44.2 million for the nine months ended September 30, 2023. The decrease of $8.0 million was largely attributable to $8.3 million decrease in personnel related costs (inclusive of $5.1 million decrease in stock-based compensation and $0.4 million increase in restructuring costs), $2.3 million decrease in legal and professional services, and $1.1 million decrease in insurance costs, partially offset with $3.3 million increase in VAT and non-income tax (due to non-recurring prior year refund) and $0.4 million increase in investor relations and public company fees.
Other income (expense), net
Interest income
Interest income for the nine months ended September 30, 2024 and 2023 primarily consisted of interest earned on our cash balances and notes receivable during these periods. We recognized interest income of $0.6 million and $1.2 million for the nine months ended September 30, 2024 and 2023, respectively.
53
Interest expense
Interest expense for the nine months ended September 30, 2024 and 2023 primarily consisted of interest expense incurred in connection with our 2022 Term Loan Facility, defined below. Interest expense was $2.2 million and $2.0 million for the nine months ended September 30, 2024 and 2023, respectively.
Benefit from research and development tax credit
We recognized a research and development tax credit from the Australian Tax Authorities as a benefit of $0.6 million for the nine months ended September 30, 2024. We recognized an immaterial amount of research and development tax credit for the nine months ended September 30, 2023.
Change in fair value of assets and liabilities, net:
Change in fair value of securities carried at fair value
Changes in fair value of securities consists of changes in the fair value of our available for sale securities for which we have elected the fair value option. During the nine months ended September 30, 2024 and 2023, we recognized a gain of $3.2 million and $3.3 million, respectively, relating to the change in fair value of securities.
Change in fair value of short-term notes receivable - related party, net
Changes in fair value of short-term notes receivable - related party, net, including interest, consists of subsequent remeasurement of our short-term notes receivable with IntelGenx for which we have elected the fair value option. During the nine months ended September 30, 2024 we recognized a $0.5 million loss related to the change in the fair value. We recorded an immaterial change in fair value of short-term notes receivable - related party during the nine months ended September 30, 2023. See Note 6 in the Notes to unaudited condensed consolidated financial statements in Part I, Item 1 for further information.
Change in fair value of short-term convertible notes receivable - related party
Changes in fair value of short-term convertible notes receivable - related party, including interest, consists of subsequent remeasurement of our convertible notes receivable with IntelGenx for which we have elected the fair value option. During the nine months ended September 30, 2024 we recognized $13.2 million loss related to the change in the fair value. We recognized an immaterial change in fair value for our convertible notes receivable - related party during the nine months ended September 30, 2023. See Note 6 in the Notes to unaudited condensed consolidated financial statements in Part I, Item 1 for further information.
Change in fair value of other investments held at fair value
Changes in fair value of other investments held at fair value consists of subsequent remeasurement of our investments held at fair value, including our ADS holdings in COMPASS, IntelGenx related investments, and warrants issued by Beckley Psytech Limited. During the nine months ended September 30, 2024, we recognized a $22.0 million loss related to our ADS holdings in COMPASS, a $6.5 million loss related to our investments in IntelGenx, and a $0.6 million gain related to warrants issued by Beckley Psytech Limited. During the nine months ended September 30, 2023, we recognized a $69.0 million non-cash change in fair value of other investments held at fair value related to an accounting method change for our ADS holdings in COMPASS resulting in our election of fair value accounting. See Note 5 in the Notes to unaudited condensed consolidated financial statements in Part I, Item 1 for further information.
Change in fair value of contingent consideration liability—related parties
The milestone and royalty payments in relation to the acquisition of Perception were recognized at the acquisition date, and are subsequently remeasured to fair value. For the nine months ended September 30, 2024 and 2023 we recognized an immaterial loss and a $0.1 million loss, respectively.
Change in fair value of contingent consideration liability
In October 2023, we acquired the noncontrolling interest's shares of DemeRx IB making DemeRx IB a wholly owned subsidiary. An earn-out of up to $8.0 million was part of the consideration and was recognized at fair value at the transaction date and subsequently remeasured at fair value. For the nine months ended September 30, 2024, we recognized a $0.2 million gain related to the DemeRx IB contingent consideration. In December 2023, we disposed of our equity interest in TryptageniX, but retained the contingent consideration liability, which is subsequently remeasured to fair value. For the nine months ended September 30, 2024, we recognized an immaterial gain related to the TryptageniX contingent consideration.
Change in fair value of convertible promissory notes and derivative liability
In December 2023 and April 2024, certain 2020 convertible noteholders exchanged the 2020 convertible notes issued by ATAI Life Sciences AG for notes issued by ATAI Life Sciences NV, which are convertible into ATAI NV common shares. We determined that this was a modification to the convertible notes and record the fair value of the conversion option quarterly. For the nine months ended September 30, 2024, we recognized a $4.0 million gain due to a change in the fair value of the conversion option of the notes issued by ATAI Life Sciences NV.
54
Change in fair value of subsequent debtor-in-possession loan commitment
Change in fair value of subsequent debtor-in-possession loan commitment consists of subsequent remeasurements of our liability for the remaining balance of the DIP Loan for which we have elected the fair value option. During the nine months ended September 30, 2024 we recognized $0.5 million gain related to the change in the fair value.
Foreign exchange loss, net
We recognized a gain of $0.7 million related to foreign currency exchange rates for the nine months ended September 30, 2024 and a loss of $0.6 million related to foreign currency exchange rate for the nine months ended September 30, 2023. This was due to the impact of fluctuations in the foreign currency exchange rate between the Euro and the U.S. dollar on our foreign denominated balances.
Other expense, net
We incurred $2.7 million of other expense, net for the nine months ended September 30, 2024, which primarily relates to a non-cash loss of $2.1 million on the sale of our ADS holdings in COMPASS and our initial recognition of the IntelGenx subsequent debtor-in-possession loan commitment of $0.7. See Note 5 and Note 6 in the Notes to our unaudited condensed consolidated financial statements in Part I, Item 1 for further information.
We incurred $0.1 million of other expense, net of for the nine months ended September 30, 2023, which consists primarily of a $0.3 million increase to the allowances on receivables, partially offset by a $0.1 million gain recognized on our divestment of our investment in Juvenescence Limited ("Juvenescence") and $0.1 million of service revenue generated for general and administrative services performed by us on behalf of our platform companies.
Benefit from (provision for) income taxes
We incurred $0.2 million of current income tax benefit for the nine months ended September 30, 2024 compared to $0.6 million of income tax expense for the nine months ended September 30, 2023. The decrease in income tax expense shown in 2024 was primarily driven by a reduction in global earnings, a favorable return to provision from one of our Australian subsidiaries and the release of an uncertain tax liability associated with a 2021 subsidiary tax return.
Losses from Investments in Equity Method Investees
Losses from investment in equity method investees for the nine months ended September 30, 2024 and 2023 was $2.0 million and $3.2 million, respectively. Loss from investment in equity method investees represents our share of equity method investee losses on the basis of our equity ownership percentages or based on our proportionate share of the respective class of securities in our other investments in the event that the carrying amount of our equity method investments was zero.
Liquidity and Capital Resources
For the nine months ended September 30, 2024 and 2023, we had net losses attributable to ATAI Life Sciences N.V. stockholders of $110.3 million and $21.9 million, respectively. As of September 30, 2024 and December 31, 2023, our accumulated deficit was $661.3 million and $550.9 million, respectively. We expect to continue to incur losses and operating cash outflows for the foreseeable future as we continue working towards commercializing any of our product candidates. Our primary sources of liquidity are our cash and cash equivalents, short-term securities, convertible promissory notes, investments, sales of common shares under our at-the-market equity offering program, and the 2022 Term Loan Facility, as further described below. We maintain cash balances with financial institutions in excess of insured limits.
Our primary requirements for liquidity and capital are clinical trial costs, manufacturing costs, nonclinical and other research and development costs, funding of strategic investments, public company compliance costs and general corporate needs. Because our product candidates are in various stages of clinical and pre-clinical development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates or whether, or when, we may achieve profitability.
Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity or debt financings, collaboration arrangements, license agreements, other business development opportunities with third parties and government grants.
55
Sources of Liquidity
Convertible Promissory Notes
In November 2018, we issued an aggregate principal amount of $0.2 million of convertible notes (“2018 Convertible Notes”). The 2018 Convertible Notes are non-interest-bearing, unsecured and have a maturity date of September 30, 2025, unless previously redeemed, converted, purchased or cancelled. In October 2020, we issued an additional principal amount of $1.0 million of the 2018 Convertible Notes. Each note has a face value of €1 and is convertible into one ordinary share of ATAI Life Sciences AG upon the payment of €17.00.
In December 2023 and April 2024, respectively, a noteholder and a related party noteholder each entered into an agreement with us to exchange their respective 2020 Convertible Notes for new convertible notes issued by ATAI Life Sciences N.V. Each new note has a face value of €1 and is convertible into 16 common shares of ATAI Life Sciences N.V. upon the payment of €17.00. Conversion rights may be exercised by a noteholder at any time prior to maturity.
As of September 30, 2024 the new ATAI Life Sciences N.V. notes had a principal balance of $0.4 million. If all convertible notes were converted, the Company would receive proceeds of €6.6 million ($7.4 million) in the aggregate.
Investments
A significant potential source of liquidity resides in our investment in ADSs of COMPASS, subject to market conditions. Based on quoted market prices, the market value of our ownership in COMPASS was $43.5 million as of September 30, 2024.
In September 2024, the Company sold 2,660,000 ADSs of COMPASS at a price of $6.05 per ADS in an open market transaction, resulting in net proceeds received of $16.1 million.
ATM Agreement
In November 2022, we entered into an Open Market Sale Agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which we may issue and sell our common shares, having an aggregate offering price of up to $150,000,000, from time to time through an “at-the-market” equity offering program under which Jefferies will act as sales agent. Subject to the terms and conditions of the Sales Agreement, Jefferies could sell the common shares by any method deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. There have been no sales under the Sales Agreement through September 30, 2024.
Hercules Term Loan
In August 2022, we entered into a Loan and Security Agreement, with Hercules Capital, Inc., which was most recently amended in August 2024. See “ – Liquidity Risks – Indebtedness– Hercules Term Loan” for additional information.
Liquidity Risks
As of September 30, 2024, we had cash and cash equivalents of $30.0 million, restricted cash of $15.0 million, and short-term securities of $56.0 million. Based on our current operating plan, we estimate that our existing cash and cash equivalents, short-term securities, and committed term loan funding as of the date this Quarterly Report will be sufficient to fund our operating expenses and capital expenditure requirements for at least the next 12 months and we believe will be sufficient to fund our operations into 2026.
We expect to continue to incur substantial additional expenditures in the near term to support our ongoing activities. Additionally, we have incurred and expect to continue to incur additional costs as a result of operating as a public company. We expect to continue to incur net losses for the foreseeable future. Our ability to fund our product development and clinical operations as well as commercialization of our product candidates, will depend on the amount and timing of cash received from planned financings.
Our future capital requirements will depend on many factors, including:
56
A change in the outcome of any of these or other variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Further, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans. If we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity financings, debt financings, collaborations with other companies and other strategic transactions. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Further, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development activities. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated product development programs.
Cash Flows
The following table summarizes our cash flows for the nine months ended September 30, 2024 and 2023:
|
|
September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
|
|
(in thousands) |
|
|||||
Net cash used in operating activities |
|
$ |
(58,142 |
) |
|
$ |
(62,156 |
) |
Net cash provided by (used in) investing activities |
|
|
52,612 |
|
|
|
(52,472 |
) |
Net cash provided by financing activities |
|
|
5,220 |
|
|
|
106 |
|
Effect of foreign exchange rate changes on cash |
|
|
239 |
|
|
|
401 |
|
Net decrease in cash, cash equivalents and restricted cash |
|
$ |
(71 |
) |
|
$ |
(114,121 |
) |
Net Cash Used in Operating Activities
Net cash used in operating activities was $58.1 million for the nine months ended September 30, 2024, which consisted of a net loss of $111.1 million, adjusted by non-cash charges of $58.1 million and a net cash outflow of $5.2 million related to the change in operating assets and liabilities. The non-cash charges primarily consisted of $36.0 million loss related to the change in fair value of assets and liabilities, net, $17.1 million of stock-based compensation, $2.1 million loss from sale of investment held at fair value, $2.0 million of losses from our equity method investments, $1.0 million in other expenses, $0.3 million amortization of debt discount, $0.2 million in depreciation and amortization expense, and $0.2 million change in right-of-use asset, partially offset by a $0.8 million unrealized foreign exchange gain. The net cash outflows from the change in operating assets and liabilities were primarily due to a $3.8 million decrease in accrued liabilities and a $1.6 increase in prepaid expenses, partially offset by a $0.3 million increase in accounts payable .
Net cash used in operating activities was $62.2 million for the nine months ended September 30, 2023, which consisted of a net loss of $23.0 million, adjusted by non-cash charges of $43.9 million and a net cash outflow of $4.8 million related to the change in operating assets and liabilities. The non-cash benefit primarily consisted $69.0 million gain related to investments held at fair value and $3.3 million gain relating to the change in the fair value of our short-term securities, partially offset by $25.7 million of stock-based compensation, $3.2 million of losses from our equity method investments, $0.6 million of unrealized foreign exchange losses, $0.3 million change in right-of-use asset and $0.3 million amortization of debt discount. The net cash inflows from the change in operating assets and liabilities were primarily due to a decrease of $6.7 million in prepaid expenses and other current assets and a $3.1 million increase in accounts payable, partially offset by a $5.0 million decrease in accrued liabilities.
57
Net Cash Provided By (Used in) Investing Activities
Net cash provided by investing activities was $52.6 million for the nine months ended September 30, 2024, primarily driven by $54.3 million of proceeds from the sale and maturities of securities carried at fair value and $16.1 million of proceeds from the sale of other investment held at fair value, partially offset by $10.0 million cash paid for investments, $5.7 million of cash paid for short-term notes receivable – related party, net, and $2.0 million of cash paid for short-term convertible notes receivable and warrant – related party.
Net cash used in investing activities was $52.5 million for the nine months ended September 30, 2023, primarily driven by $177.0 million of cash paid for securities at fair value, $3.0 million of loans to related parties, $2.2 million cash paid for investments held at fair value, $0.5 million of cash paid for acquisition of variable interest entity, $0.3 million of capitalized internal-use software development costs, and $0.3 million of purchases of property plant and equipment, partially offset by $130.4 million of proceeds from the sale and maturities of securities carried at fair value and $0.5 million from the sale of other investments.
Net Cash Provided by Financing Activities
Net cash provided by financing activities was $5.2 million for the nine months ended September 30, 2024, due to $5.0 million of proceeds from debt financing and $0.4 million of proceeds from stock option exercises, partially offset by $0.2 million of financing costs paid.
Net cash provided by financing activities was $0.1 million for the nine months ended September 30, 2023, due to $0.2 million of proceeds from stock option exercises, partially offset by $0.1 million of financing costs paid.
Indebtedness
Convertible Notes
In November 2018, we issued an aggregate principal amount of $0.2 million of 2018 Convertible Notes. In October 2020, we issued an additional principal amount of $1.0 million of 2018 Convertible Notes. The 2018 Convertible Notes are non-interest-bearing and have a maturity date of September 30, 2025, unless previously redeemed, converted, purchased or cancelled. Each note has a face value of €1 and is convertible into one common share of ATAI Life Sciences AG upon the payment of €17.00. Conversion rights may be exercised by a noteholder at any time prior to maturity, except during certain periods subsequent to the consummation of the IPO.
In December 2023 and April 2024, respectively, a noteholder and a related party noteholder each entered into an agreement with us to exchange their respective 2018 Convertible Notes for new convertible notes issued by ATAI Life Sciences N.V. Each new note has a face value of €1 and is convertible into 16 common shares of ATAI Life Sciences N.V. upon the payment of €17.00. Conversion rights may be exercised by a noteholder at any time prior to maturity.
As of September 30, 2024, the new ATAI Life Sciences N.V. notes had a principal balance of $0.4 million. If all convertible notes were converted, the Company would receive proceeds of €6.6 million ($7.4 million).
Hercules Term Loan
On August 9, 2022 (the “Closing Date”), we, ATAI Life Sciences AG (“ATAI AG” and together with us, the “Borrowers”) and certain of our subsidiary guarantors (collectively, the “Subsidiary Guarantors”) entered into a Loan and Security Agreement (the “Initial Hercules Loan Agreement”). The Initial Hercules Loan Agreement provides for term loans in an aggregate principal amount of up to $175.0 million under multiple tranches (as amended by that certain First Amendment to Loan and Security Agreement, dated as of March 13, 2023, the “First Amendment,” that Second Amendment to Loan and Security Agreement, dated as of May 26, 2023, the “Second Amendment,” and that Third Amendment to Loan and Security Agreement, dated August 14, 2024, the “Third Amendment,” and collectively, the “2022 Term Loan Facility”).
On May 26, 2023, we, ATAI AG, and the Subsidiary Guarantors entered into the Second Amendment, with the several banks and other financial institutions or entities from time to time parties to the Hercules Loan Agreement, defined below, (collectively, the “Lenders”) and Hercules, in its capacity as administrative agent and collateral agent for itself and for the Lenders (the “Agent”) which amended that certain Loan and Security Agreement, dated August 9, 2022 (as amended by the First Amendment, the “Existing Loan Agreement” and as amended by the Second Amendment, the “Hercules Loan Agreement”) to, among other things, (i) extend the availability of Tranche 1B of $10.0 million, from May 1, 2023, under the Existing Loan Agreement, to November 15, 2024, (ii) extend the availability of Tranche 1C of $15.0 million, from December 15, 2023, under the Existing Loan Agreement, to December 15, 2024, (iii) provide Tranche 1D of $20.0 million, available upon the earlier of (x) the full draw of Tranche 1C and (y) the expiration of Tranche 1C availability, through February 15, 2025, (iv) extend the availability of Tranche 2 of $15.0 million, from June 30, 2024, under the Existing Loan Agreement, subject to certain conditions under the Hercules Loan Agreement, to the earlier of (x) the full draw of Tranche 1D and (y) the expiration of Tranche 1D availability, through March 15, 2025, subject to the Tranche 2 Draw Test, (v) extend the timeline to achieve the second amortization extension condition, from June 30, 2024, in the Existing Loan Agreement, to December 15, 2024, (vi) amend the Tranche 2 Draw Test, satisfaction of which is a condition to draw Tranche 2 under the Hercules Loan Agreement and (vii) extend the financial covenant commencement date, from the later of (x) July 1, 2023, and (y) the date that the outstanding debt under the facility is equal to or greater than $40.0 million, in the Existing Loan Agreement, to the later of (x) May 1, 2024, and (y) the date that the outstanding debt under the
58
facility is equal to or greater than $30.0 million, provided, that the financial covenant is waived if the Company has a market capitalization of at least $550.0 million.
On August 14, 2024 (the “Third Amendment Date”), the Borrowers and certain Subsidiary Guarantors entered into the Third Amendment with the Lenders and Hercules, in its capacity as the Agent, which amended that certain Loan and Security Agreement, dated August 9, 2022 (as amended by the First Amendment, the Second Amendment and the Third Amendment, the “2022 Term Loan Agreement”) to, among other things, (i) provide Tranche 1B of $5.0 million on the Third Amendment Date, (ii) reduce the remainder of available Tranche 1 to $25.0 million, and extend the availability thereof (x) with respect to Tranche 1C, to be available after the Third Amendment Date until March 31, 2025, and (y) with respect to Tranche 1D, to be available upon the earlier to occur of (1) March 31, 2025 and (2) full borrowing of Tranche 1C, until June 30, 2025, (iii) increase Tranche 2 to $30.0 million, and extend the availability thereof to be available upon the earlier to occur of (1) June 30, 2025, and (2) full borrowing of Tranche 1D, until September 30, 2025, subject to the Tranche 2 Draw Test, (iv) extend the availability of Tranche 3 of $100.0 million, through March 31, 2026, available subject to lender’s investment committee approval, (v) extend the amortization date to September 1, 2025, and extend the timeline to achieve the second amortization extension condition, to June 30, 2025, upon the occurrence of which the amortization date may be extended to March 1, 2026, (vi) amend the financial covenant to commence on October 1, 2024, and require that so long as our market capitalization is less than $550.0 million, Borrowers shall maintain qualified cash equal to at least 50% of the sum of (x) the amount of outstanding debt under the facility plus (y) Qualified Cash A/P Amount (as defined in the Agreement), or upon the occurrence of certain conditions, 70% of the sum of (x) the amount of outstanding debt under the facility plus (y) Qualified Cash A/P Amount, and (vii) reduce the interest rate to equal the greater of (x) 9.05% or (y) prime rate plus 4.30% (or, upon achieving certain conditions, (y) shall equal prime rate plus 4.05%).
We are permitted to engage in certain specified transactions (subject to mandatory prepayment in certain instances as well as certain limitations, including the pledge of equity interests of certain subsidiaries and VIEs), including but not limited to, (i) entering into non-exclusive and certain specified exclusive licensing arrangements with respect to intellectual property without the consent of the Lenders; and (ii) entering into certain permitted acquisitions.
The 2022 Term Loan Facility will mature on August 1, 2026 (the “Maturity Date”), which may be extended until February 1, 2027 if we raise at least $175.0 million of unrestricted new net cash proceeds from certain permitted sources after the Closing Date and prior to June 30, 2025, and satisfy certain other specified conditions (the “Extension Condition Two”). The outstanding principal balance of the 2022 Term Loan Facility bears interest at a floating interest rate per annum equal to the greater of either (i) the prime rate as reported in the Wall Street Journal plus 4.30% and (ii) 9.05%; provided, that if the Extension Condition Two is satisfied, the rate of interest in the foregoing clause (i) is prime rate as reported in The Wall Street Journal plus 4.05%. Accrued interest is payable monthly following the funding of each term loan advance. We may make payments of interest only, without any loan amortization payments until September 1, 2025, which date may be extended to March 1, 2026 if Extension Condition Two is achieved. At the end of the interest only period, we are required to begin repayment of the outstanding principal of the 2022 Term Loan Facility in equal monthly installments.
As collateral for the obligations under the 2022 Term Loan Facility, we have granted to the Agent for the benefit of the Lenders a senior security interest in substantially all of our cash and investment accounts and each Subsidiary Guarantor’s property (including a pledge of equity interests of certain subsidiaries and VIEs), exclusive of intellectual property, with certain limited exceptions set forth in the Hercules Loan Agreement.
The 2022 Term Loan Agreement contains customary closing and commitment fees, prepayment fees and provisions, events of default and representations, warranties and affirmative and negative covenants, including a financial covenant requiring us to maintain certain levels of cash in accounts subject to a control agreement in favor of the Agent (the “Qualified Cash”) at all times commencing from the Closing Date, which includes a cap on the amount of cash that can be held by, among others, certain of our foreign subsidiaries in Australia and the United Kingdom. In addition, the financial covenant under the 2022 Term Loan Agreement requires that beginning on October 1, 2024, we shall maintain Qualified Cash in an amount no less than the sum of (1) 50% of the outstanding amount under the 2022 Term Loan Facility, and (2) the amount of the Borrowers’ and Subsidiary Guarantors’ accounts payable that have not been paid within 180 days from the invoice date of the relevant account payable, subject to certain exceptions; provided, upon the occurrence of certain conditions, we shall at all times maintain Qualified Cash in an amount no less than the sum of (1) 70% of the outstanding amount under the 2022 Term Loan Facility, and (2) the amount of the Borrowers’ and Subsidiary Guarantors’ accounts payable that have not been paid within 180 days from the invoice date of the relevant account payable, subject to certain exceptions; provided, further, that the financial covenant shall not apply on any day that our market capitalization is at least $550.0 million measured on a consecutive 10-business day period immediately prior to such date of measurement and tested on a daily basis. Upon the occurrence of an event of default, including a material adverse effect, subject to certain exceptions, on our and ATAI AG’s, taken together, business, operations, properties, assets or financial condition, and subject to any specified cure periods, all amounts owed by us may be declared immediately due and payable by the Lenders. As of September 30, 2024, we were in compliance with all applicable covenants under the 2022 Term Loan Agreement.
In addition, we are required to make a final payment fee (the “End of Term Charge”) upon the earlier of (i) the Maturity Date, (ii) the date that we prepay, in full or in part, the principal balance of the 2022 Term Loan Facility, or (iii) the date that the outstanding balance of the 2022 Term Loan Facility becomes due and payable. The End of Term Charge is 6.95% of the aggregate original principal amount of the term loans so repaid or prepaid under the 2022 Term Loan Agreement.
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We may, at our option, prepay the term loans in full or in part, subject to a prepayment penalty equal to (i) 2.00% of the principal amount prepaid if the prepayment occurs on or prior to the first anniversary of the Closing Date, (ii) 1.0% of the principal amount prepaid if the prepayment occurs after the first anniversary and on or prior to the second anniversary of the Closing Date, and (iii) 0.5% of the principal amount prepaid if the prepayment occurs after the second anniversary and prior to the Maturity Date.
Material Cash Requirements from Known Contractual and Other Obligations and Commitments
We are a party to many contractual obligations involving commitments to make payments to third parties. These obligations impact our short-term and long-term liquidity and capital resource needs. Certain contractual obligations are reflected on the unaudited condensed consolidated balance sheet as of September 30, 2024, while others are considered future commitments. Our contractual obligations primarily consist of milestone payments under existing license agreements. For information regarding our other contractual obligations, refer to Note 10. Leases, Note 16. Commitments and Contingencies, and Note 17. License Agreements and Part II, Item 7 of our Form 10-K.
Recently Adopted Accounting Pronouncements
See Note 2, “Basis of Presentation, Consolidation and Summary of Significant Accounting Policies—Recently Adopted Accounting Pronouncements” to our unaudited condensed consolidated financial statements appearing under Part 1, Item 1 for more information.
Critical Accounting Policies and Estimates
Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates” in our Form 10-K and in Note 2 to our consolidated financial statements included in our Form 10-K. As disclosed in Note 2 to our consolidated financial statements included in our Form 10-K, the preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions about future events that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ significantly from those estimates. During the period covered by this Quarterly Report, there were no material changes to our critical accounting policies from those discussed in our Form 10-K other than those disclosed in Note 2 of this Quarterly Report.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are exposed to market risks in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates. Our market risk exposure is primarily the result of fluctuations in interest rates and foreign currency exchange rates. In addition, our portfolio of notes receivables is exposed to credit risk in the form of non-payment or non-performance. In mitigating our credit risk, we consider multiple factors, including the duration and terms of the note and the nature of and our relationship with the counterparty.
Interest Rate Sensitivity
Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. As of September 30, 2024 we had cash and cash equivalents of $30.0 million, restricted cash of $15.0 million, and short-term securities of $56.0 million. We generally hold our cash in interest-bearing demand deposit accounts and short-term securities. Due to the nature of our cash and investment portfolio, a hypothetical 100 basis point change in interest rates would not have a material effect on the fair value of our cash. Our cash is held for working capital purposes. We purchased investment grade short-term debt securities which are rated by nationally recognized statistical credit rating organizations in accordance with its investment policy. This policy is designed to minimize our exposure to credit losses and to ensure that the adequate liquidity is maintained at all times to meet anticipated cash flow needs.
As of September 30, 2024, we had $0.4 million in convertible promissory notes, which was comprised of non-interest-bearing borrowings under the 2018 Convertible Notes. Based on the principal amounts of the convertible promissory notes and the interest rate assigned to the convertible promissory notes, a hypothetical 10% change in interest rates would not have a material impact on our convertible promissory notes, financial position or results of operations.
As of September 30, 2024, the carrying amount of our short and long-term notes receivables was an aggregate amount of $5.7 million. Based on the principal amounts of the notes receivable and the interest rates assigned to each note receivable as per their respective contracts, a hypothetical 10% change in the interest rates would not have a material impact on our notes receivables, financial position or results of operations.
Foreign Currency Exchange Risk
Our reporting and functional currency is the U.S. dollar, and the functional currency of our foreign subsidiaries is generally the respective local currency. The assets and liabilities of each of our foreign subsidiaries are translated into U.S. dollars at exchange rates in effect at each balance sheet date. Adjustments resulting from translating foreign functional currency financial statements into U.S. dollars are recorded as a separate component on the unaudited Condensed Consolidated Statements of Comprehensive Loss. Equity transactions are
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translated using historical exchange rates. Expenses are translated using the average exchange rate during the previous month. Gains or losses due to transactions in foreign currencies are included in interest and other income (expense), net in our unaudited Condensed Consolidated Statements of Operations.
The volatility of exchange rates depends on many factors that we cannot forecast with reliable accuracy. We have experienced and will continue to experience fluctuations in foreign exchange gains and losses related to changes in foreign currency exchange rates. In the event our foreign currency denominated assets, liabilities, revenue, or expenses increase, our results of operations may be more greatly affected by fluctuations in the exchange rates of the currencies in which we do business, resulting in unrealized foreign exchange gains or losses. We have not engaged in the hedging of foreign currency transactions to date, although we may choose to do so in the future.
A hypothetical 10% change in the relative value of the U.S. dollar to other currencies during any of the periods presented would not have had a material effect on our unaudited condensed consolidated financial statements, but could result in significant unrealized foreign exchange gains or losses for any given period.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures (as that term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to ensure that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Co-Chief Executive Officers and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures. In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Our management, with the participation of our Co-Chief Executive Officers and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2024, the end of the period covered by this Quarterly Report. Based on this evaluation, our Co-Chief Executive Officers and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of September 30, 2024 at the reasonable assurance level.
Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial reporting (as that term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II- OTHER INFORMATION
Item 1. Legal Proceedings.
We are, from time to time, party to various claims and legal proceedings arising in the ordinary course of our business. See Part I, Item I “Financial Statements (Unaudited) – Note 16, Commitments and Contingencies” in this Quarterly Report, which are incorporated herein by reference.
Item lA. Risk Factors.
Investing in our common shares involves a high degree of risk. In addition to the other information set forth in this Quarterly Report and in other documents that we file with the SEC, you should carefully consider the factors described in the section titled "Risk Factors" in our Form 10-K. There have been no material changes to the risk factors described in Part I, Item 1A of our Form 10-K. If any of the risk factors described in the Form 10-K actually materializes, our business, financial condition and results of operations could be materially adversely affected. In such an event, the market price of our common shares could decline and you may lose all or part of your investment. We may disclose changes to such risk factors or disclose additional risk factors from time to time in our future filings with the SEC.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
None.
None.
During the three months ended September 30, 2024, no director or “officer” (as defined in Rule 16a-1(f) under the Exchange Act) of the Company
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Item 6. Exhibits.
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Incorporated by Reference |
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Exhibit Number |
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Description |
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Form |
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File No. |
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Exhibit |
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Filing |
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Filed/Furnished |
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3.1 |
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Articles of Association of ATAI Life Sciences N.V. (translated into English), currently in effect |
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S-3 |
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333-265970 |
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3.1 |
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7/01/2022 |
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3.2 |
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S-1/A |
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333- 255383 |
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3.2 |
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6/11/2021 |
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3.3 |
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S-1/A |
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333- 255383 |
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3.3 |
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6/11/2021 |
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10.1† |
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8-K |
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001-40493 |
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10.3 |
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8/14/2024 |
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31.1 |
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Certification of Co-Principal Executive Officer pursuant to Exchange Act Rule 13a-14(a) |
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* |
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31.2 |
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Certification of Co-Principal Executive Officer pursuant to Exchange Act Rule 13a-14(a) |
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* |
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31.3 |
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Certification of Principal Financial Officer pursuant to Exchange Act Rule 13a-14(a) |
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* |
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32.1 |
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** |
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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 its XBRL tags are embedded within the Inline XBRL document |
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* |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema Document |
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* |
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101.CAL |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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* |
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101.DEF |
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Inline XBRL Taxonomy Extension Definition Linkbase Document |
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* |
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101.LAB |
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Inline XBRL Taxonomy Extension Label Linkbase Document |
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* |
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101.PRE |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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* |
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104 |
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Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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* |
* Filed herewith.
** Furnished herewith.
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† Certain confidential portions (indicated by brackets and asterisks) have been omitted from this exhibit pursuant to Item 601(b)(10)(iv).
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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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ATAI LIFE SCIENCES N.V. |
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Date: November 14, 2024 |
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By: |
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/s/ Florian Brand |
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Florian Brand |
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Co-Chief Executive Officer (Co-Principal Executive Officer) |
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Date: November 14, 2024 |
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By: |
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/s/ Srinivas Rao |
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Srinivas Rao, M.D. |
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Co-Chief Executive Officer |
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(Co-Principal Executive Officer) |
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Date: November 14, 2024 |
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By: |
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/s/ Anne Johnson |
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Anne Johnson |
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Chief Financial Officer |
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(Principal Financial Officer) |
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