113. ****
美國
證券交易委員會
華盛頓特區20549
表格
(標記一個)
根據1934年證券交易法第13或15(d)條款的季度報告。 |
截至2024年6月30日季度結束
或
根據1934年證券交易法第13或15(d)條款的過渡報告 |
過渡期從___________到___________
委員會檔案編號：
（根據其章程所指定的正式名稱）
(依據所在地或其他管轄區) 的註冊地或組織地點) |
(國稅局雇主識別號碼) |
(總部辦公地址) |
（郵政編碼） |
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(註冊人電話號碼，包括區號)
根據法案第12(b)條規定註冊的證券：
每個班級的標題 |
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交易 符號 |
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每個註冊的交易所的名稱 |
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請在核對標記上打勾，確認申報人（1）已在前12個月（或申報人被要求提交此類申報的縮短期間）內提交證券交易所法案第13條或第15(d)條要求申報的所有報告，以及（2）過去90天一直處於此類申報要求的範圍內。
在過去十二個月內，註冊人是否已經以電子方式提交所有根據《規例 S-t》第 405 條（本章第 232.405 條）所需提交的互動數據檔案（或在較短的時間內，註冊人須提交該等檔案），以勾選標記表示。
勾選表示登記人是大型加速申報人、加速申報人、非加速申報人、較小型申報公司或新興成長公司。詳細定義請參閱《交易所法》第1202條中“大型加速申報人”、“加速申報人”、“較小型申報公司”和“新興成長公司”的定義。
大型加速歸檔人 |
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加速歸檔人 |
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小型報告公司 |
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新興成長型企業 |
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如果一家新興成長型公司，請用勾選標記表示該申報人已選擇不使用根據證交所法案13(a)條款提供的任何新的或修訂過的財務會計準則的延長過渡期。
請用勾選標記指示，註冊人是否屬於外殼公司（交易所法規定的第120億2條）。 是 ☐ 否
截至2024年11月1日，登記人持有
目錄
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第一部分 |
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項目一。 |
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項目二。 |
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第三項目。 |
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第四項。 |
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第二部分 |
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項目一。 |
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項目 1A。 |
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項目二。 |
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第三項目。 |
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第四項。 |
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第五項。 |
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第六項 |
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我們業務相關的重大風險摘要
我們的業務受到許多重大和其他風險的影響，在您對我們的證券做出投資決定之前，您應該注意這些風險。這些風險在我們截至2023年12月31日的年度報告Form 10-K的第一部分第1A項中更詳細地描述。這些風險包括但不限於以下內容（這不是所有這類風險的詳盡列表）：
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我們是一家擁有有限營業歷史的精準腫瘤公司。我們尚未獲得任何產品的商業批准，也尚未從產品銷售中產生任何營業收入，可能永遠無法盈利。此外，我們面臨着激烈的競爭，這可能導致其他公司在我們之前或比我們更成功地發現、開發或商品化產品。 |
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自我們成立以來，我們已經遭受了重大的淨虧損，並預計在可預見的未來我們將繼續出現虧損。隨着我們業務的發展，我們預計未來的營運結果將出現顯著波動。 |
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我們將需要籌集大量額外資金。如果我們無法在需要時籌集資本，或者不能接受我們可以接受的條件，我們可能被迫推遲、減少或取消一些產品開發計劃或商業化工作。籌集額外資本可能會對我們的股東造成稀釋，限制我們的運營，或要求我們放棄對我們的技術或產品候選人的權利。 |
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我們從未成功完成任何臨床試驗，對我們開發的任何產品候選者也許無法如期進行。我們的部分項目仍處於臨床前開發階段，可能永遠不會進展到臨床開發階段。 |
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我們的項目專注於爲患有基因定義或生物標誌驅動癌症的患者開發腫瘤治療藥物，這是一個快速發展的科學領域，我們採取的藥物發現和開發方法是新穎的，可能永遠不會導致獲批或上市的產品。 |
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如果我們無法成功驗證、開發並獲得對我們的產品候選者進行篩選測試和伴隨診斷測試所需或會在商業上受益的批准，或者在這方面遇到重大延遲，我們可能無法實現這些產品候選者的完整商業潛力。我們還將依賴第三方進行篩查，以尋找能夠爲臨床試驗選擇病人的生物標誌物。 |
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臨床產品開發涉及漫長而昂貴的過程，結果不確定。此外，我們目前的和潛在未來的合作可能無法實現預期的益處。 |
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我們不時宣佈或發佈的臨床試驗的初步、過渡和主要數據可能會隨着更多患者數據的出現而出現變化，並且需要經過確認、審核和驗證程序，可能導致最終數據發生重大變化。 |
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我們項目和產品候選藥物此前臨床前研究的結果，不一定能預示我們後期臨床前研究和臨床試驗的結果。如果我們無法複製我們項目和產品候選藥物此前臨床前研究的結果於後期臨床前研究和臨床試驗中，可能會無法成功開發、獲得監管批准並商業化我們的產品候選藥物。 |
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如果我們在臨床試驗中遇到啓動、招募或患者服藥方面的延誤或困難，臨床試驗結果的公佈以及我們獲取必要的監管批准（如果有的話）可能會被推遲或阻止。 |
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我們的臨床試驗或我們當前或未來的合作伙伴的試驗可能會揭示在我們的臨床前或非臨床研究中未見的重大不良事件，並可能導致安全性概況可能限制任何產品候選藥物的監管批准或市場接受度。 |
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我們一些產品候選物可能調節目前沒有批准或有效療法的通路，並利用新穎的結合位點，這可能導致更高的研究和開發費用，可能有監管問題會延遲或阻止批准，或發現未知或意外的不良反應。 |
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如果我們無法獲得或者獲得所需的監管批准出現延遲，我們將無法商業化，或者將被延遲商業化，我們的營業收入能力將受到重大損害。 |
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公共衛生危機可能會對我們的業務和財務結果產生重大不利影響，並可能導致產品候選物的開發以及臨床試驗的啓動和完成中斷。 |
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我們目前依賴並預計將繼續依賴第三方進行我們的臨床試驗，以及我們產品候選品的研究員贊助的臨床試驗（如果有的話）。如果這些第三方不能成功履行其合同責任，遵守監管要求或滿足預期的截止日期，我們可能無法獲得產品候選品的監管批准或商業化，並且我們的業務可能會受到嚴重損害。 |
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我們與第三方簽訂合同，委託他們爲我們的候選藥物進行臨床前開發和臨床試驗，預計未來繼續如此進行臨床測試和商業化（如果獲得批准）。對第三方的依賴增加了我們可能無法獲得足夠數量的候選藥物或產品，或以可接受的成本獲得這些數量的風險，這可能會延遲、阻止或損害我們的開發或商業化努力。 |
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我們依賴極少量的第三方公司供應用於我們產品候選品中的原料藥和藥品（用於我們所有臨床試驗產品的原料藥，藥明康德的附屬公司是所有這些供應的唯一來源），而藥明康德最近成爲擬議中的國會立法的對象，如果獲得批准，可能會嚴重限制我們與藥明康德的業務往來，並獲取原料藥，任何供應商的喪失，包括藥明康德，都可能嚴重損害我們的業務。 |
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如果我們無法獲得新專利，維護我們現有的專利並保護商業機密和其他知識產權的保密性和專有性，我們的業務和競爭地位可能會受到損害。 |
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如果我們被發現侵犯第三方專利，我們可能被迫賠償專利持有人，並/或取得許可繼續製造、銷售或開發我們的產品。如果我們無法取得許可，我們可能會被禁止製造、銷售或開發我們的產品或候選產品，這可能會對我們的業務產生不利影響。 |
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開發聯合療法可能會帶來比單一藥物治療更多或不同的挑戰。 |
關於前瞻性聲明的說明
本Form 10-Q季度報告包含根據1933年修正案第27條和1934年修正案第21條（「交易所法」）的明示或暗示的前瞻性陳述。諸如"預測"，"繼續"，"可能"，"可能"，"預測"，"預計"，"打算"，"有可能"，"相信"，"尋找"，"估計"，"預測"，"目標"等詞及類似表達用於識別此類前瞻性陳述，儘管並非所有前瞻性陳述都包含這些識別詞。前瞻性陳述不是未來績效的保證，並且存在難以預測的某些風險、不確定性和假設；因此，實際結果可能與這些陳述中表達或預測的結果有實質性差異。此類前瞻性陳述基於關於我們所處行業和業務、管理層的信念以及我們管理層做出的某些假設的當前期待、估計和投射，可能包括但不限於以下聲明：
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我們的研發計劃及研發項目的啓動、時間安排、進展、結果和成本，以及我們當前和未來的臨床前研究、臨床試驗和聯合臨床試驗，包括關於IND申請和接受的時間安排，臨床試驗的主動招募（包括聯合臨床試驗），臨床試驗的給藥，劑量擴展的未來計劃，研究或臨床試驗的啓動和完成以及相關的準備工作的陳述，以及臨床試驗結果可用的期間（如預計2025年獲得正在進行的TNG462臨床試驗的額外臨床數據）。 |
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我們能夠有效地發現和開發候選產品的能力（包括按照確定的時間表推進開發候選產品的能力，以及確定並與臨床試驗網站和調查員簽訂合同，以便在試驗中使用我們的候選產品）； |
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我們有能力和潛力（或第三方有能力和潛力）成功地製造我們的藥品、藥物成分和產品候選者，供臨床前使用、臨床試驗以及經批准後供商業使用。 |
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我們第三方戰略合作伙伴授權並繼續進行與我們開發候選藥物和產品候選藥物相關的研究和開發活動的能力和意願; |
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我們有能力獲得資金來支持我們完成進一步的研究、開發和商業化產品候選人的運營，同時現有的現金、現金等價物和可市場化證券將至少支持我們的營業費用和資本支出需求直至2026年第三季度。 |
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我們有能力獲得並且，如果獲准，維持我們產品候選品的監管批准（以及我們產品候選品的篩查測試和伴隨診斷測試的批准），以及TNG462在結合治療的第一線設置獲批的潛在途徑; |
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如果獲得批准，我們有能力將產品商業化； |
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如果獲批准，產品候選物的定價和報銷； |
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我們業務模式的實施，以及針對我們業務和產品候選者的戰略計劃； |
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我們能夠建立和維護覆蓋我們產品候選品的知識產權的保護範圍以及執行我們的知識產權的能力； |
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關於我們未來支出、資本需求和需額外融資的估計； |
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戰略合作協議的潛在好處，我們進行戰略合作或安排的能力，以及我們吸引具有開發、監管和商業化專業知識的合作夥伴的能力; |
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與第三方在商業化產品候選品（如獲批准）以及任何其他獲批准產品方面的未來協議； |
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我們產品候選藥物的市場大小和增長潛力，以及我們服務這些市場的能力； |
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我們的財務表現，包括我們將繼續承擔營運損失和負現金流的預期； |
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如果獲批准，我們產品候選品市場接受程度和速度。 |
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美國和外國的監管發展，包括產品批准要求以及由美國監管機構（如醫療保險與醫療衛生服務中心）和外國監管機構制定的定價規定； |
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我們與第三方供應商和製造商簽訂合同的能力以及他們的適當履行能力； |
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我們（或我們與之簽約的第三方）製造產品或產品候選者的能力，以具有優勢的交貨時間或製造成本; |
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我們能夠提供深度、持久的目標抑制，以優化腫瘤反應和臨床效果，這是因為合成致命性靶向的獨特能力可以避免對正常細胞造成損害，以及競爭療法的成功，這些療法已經存在或可能推出。 |
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我們吸引和留住重要科學或管理人員的能力； |
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法律和法規的影響; |
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與我們的競爭對手和行業板塊相關的發展； |
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公共健康危機對我們業務運營的影響，包括但不限於我們的前臨床研究和臨床試驗，以及任何將來的研究或試驗； |
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我們認為，在患者中使用我們的藥物作為單一療法和/或聯合用藥的預期好處，包括我們相信TNG260可能是首批能夠利用基因基礎患者篩選（STK11突變）的腫瘤學分子之一，並配合檢查點抑制劑治療。 |
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其他風險和不確定性，包括本季度報告表格10-Q中第II部分第1A項和截至2023年12月31日年度年報表格10-k中第I部分第1A項中確定的那些風險， 在這兩種情況下，請參見標題為"風險因素"的部分。 |
所述年度年結日為2023年12月31日的年度報告第一部分第1A項目和本季度10-Q報告第2部分第1A項目中所含的前瞻性聲明，乃基於對未來發展及其對我們可能產生的影響之目前期望和信念。未來對我們產生影響的發展是否符合我們的預期並不得而知。這些前瞻性聲明涉及眾多風險、不確定性（其中部分超出我們的控制範圍）或其他可能使實際結果或表現與這些前瞻性聲明所表達或暗示的大相逕庭的假設。這些風險和不確定性包括但不限於在所述年度年結日為2023年12月31日的年度報告第一部分第1A項目下所述的「風險因素」之因素。若其中一項或多項這些風險或不確定性成真，或任何我們的假設被證明不正確，則實際結果可能大幅異於這些前瞻性聲明所預測的。可能有我們目前認為不重要或未知的附加風險。無法預測或識別所有此類風險。我們不會承擔任何義務更新或修訂任何前瞻性聲明，除非根據適用的證券法律所要求。
在本季度十分報告表格10-Q中所使用的定義術語
除非本季度報告表格10-Q（截至2024年9月30日止）另有要求，否則我們使用以下定義術語：
企業信息
我們以前被稱為BCTG Acquisition Corp.（“BCTG”），並於2020年5月在特拉華州成立為一家專門用途的收購公司，旨在實現合併、資本股票交易、資產收購、股份購買、重組或其他類似業務組合。2021年8月10日，我們根據2021年4月13日簽署的《合併協議及合併計劃》完成了合併，當事人包括BCTG、BCTG Merger Sub Inc.和Tango Therapeutics Sub, Inc. 合併完成後，我們將名稱更改為Tango Therapeutics, Inc。
v
我們根據1934年修訂的證券交易法案（Exchange Act）第13(a)、14和15(d)條的規定提交的或提供的我們的年度10-k表格、季度10-Q表格、當前8-k表格，包括展示品、代理和信息披露，以及對這些報告的修訂，會在我們的網站“投資者”部分免費提供，並且在我們向證券交易委員會（“SEC”）電子提交或提供此類材料後合理可行的時間內提供。 W我們還會免費在我們的網站上提供我們的執行官、董事和持有公司10%股份的人根據《Exchange Act》第16條提交給SEC的報告，並在這些報告被這些人提供給我們後合理可行的時間內提供。f在這些報告的副本由這些人提供給我們之後。. A因此，投資者應監控公司網站的相應部分，除了關注公司的新聞稿、SEC的文件和公開的電話會議和網絡廣播（如有）。 我們網站上的信息不應視為被引用或屬於本10-Q季度報告或我們其他證券文件的一部分，除非明確在此處引用，不應依靠該信息來決定是否購買我們的普通股。我們與SEC的提交可通過SEC的互動數據電子應用系統網站http://www.sec.gov進行訪問。所有我們的證券文件中所做的陳述，包括所有展望性陳述或信息，均是根據所包含陳述的文件的日期發布，我們不會假定或承擔任何更新這些陳述或文件的義務，除非法律要求我們這樣做。
此外，公司打算使用其網站http://www.tangotx.com 作為披露重要非公開信息的手段，並遵守SEC規定FD下的披露義務。這些披露將包含在公司網站的“投資者”標題下。因此，投資者應該監控公司網站的這些部分，除了關注公司的新聞發佈、SEC提交和公開會議呼叫和網絡廣播（如果有）。包含在該網站上，或通過該網站可能訪問的信息，並非本季度報告10-Q的一部分，也不被納入其中。
我們的首席執行辦公室位於201 Brookline Avenue，901室，馬薩諸塞州波士頓02215。
vi
第一部分—財務信息
項目1.基本報表。
TANGO治療公司，股份有限公司。
簡明綜合資產負債表資產負債表
（以千爲單位，除股份數量和每股金額外）
（未經審計）
|
|
九月三十日， |
|
|
12月31日, |
|
||
資產 |
|
|
|
|
|
|
||
流動資產： |
|
|
|
|
|
|
||
現金及現金等價物 |
|
$ |
|
|
$ |
|
||
有價證券 |
|
|
|
|
|
|
||
受限現金 |
|
|
— |
|
|
|
|
|
預付費用和其他流動資產 |
|
|
|
|
|
|
||
總流動資產 |
|
|
|
|
|
|
||
資產和設備，淨值 |
|
|
|
|
|
|
||
經營租賃權使用資產 |
|
|
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|
|
|
||
限制性現金，減去當前部分 |
|
|
|
|
|
|
||
其他 |
|
|
|
|
|
|
||
資產總額 |
|
$ |
|
|
$ |
|
||
負債和股東權益 |
|
|
|
|
|
|
||
流動負債: |
|
|
|
|
|
|
||
應付賬款 |
|
$ |
|
|
$ |
|
||
應計費用及其他流動負債 |
|
|
|
|
|
|
||
經營租賃負債 |
|
|
|
|
|
|
||
遞延收入 |
|
|
|
|
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|
||
流動負債合計 |
|
|
|
|
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|
||
經營租賃負債，淨值超過流動資產 |
|
|
|
|
|
|
||
遞延收入，減去當前部分淨額 |
|
|
|
|
|
|
||
負債合計 |
|
|
|
|
|
|
||
|
|
|
|
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|
|||
優先股，$0.0001 |
|
|
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|
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|
||
股東權益: |
|
|
|
|
|
|
||
普通股，每股面值爲 $0.0001； |
|
|
|
|
|
|
||
額外實收資本 |
|
|
|
|
|
|
||
累計其他綜合收益 |
|
|
|
|
|
|
||
累積赤字 |
|
|
( |
) |
|
|
( |
) |
股東權益總額 |
|
|
|
|
|
|
||
負債和股東權益總額 |
|
$ |
|
|
$ |
|
||
附註是未經審計的簡明合併財務報表的一部分。
1
TANGO治療公司，股份有限公司。
綜合損益簡明綜合損益表綜合損失
(以千爲單位，除每股數據外)
（未經審計）
|
|
截至9月30日的三個月 |
|
|
截至9月30日的九個月 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
協作收入 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
許可證收入 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
總收入 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
運營費用： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
研究和開發 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
一般和行政 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
運營費用總額 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
運營損失 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
其他收入： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
利息收入 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
其他收入，淨額 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
其他收入總額，淨額 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
所得稅前虧損 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
所得稅準備金 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
淨虧損 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
每股普通股淨虧損——基本虧損和攤薄後 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
已發行普通股的加權平均數量——基本股和攤薄後 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
淨虧損 |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
|
( |
) |
其他綜合收入： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
有價證券的未實現收益 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
綜合損失 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
附註是未經審計的簡明合併財務報表的一部分。
2
TANGO治療公司，股份有限公司。
壓縮綜合財務報表: 股東權益
（以千爲單位，除股份數量外）
(未經查核)
|
|
|
|
|
|
|
|
額外的 |
|
|
留存 |
|
|
|
|
|
總計 |
|
||||||
|
|
普通股 |
|
|
實收資本 |
|
|
綜合 |
|
|
累計 |
|
|
股東权益 |
|
|||||||||
|
|
股份 |
|
|
金額 |
|
|
資本 |
|
|
（虧損）收益 |
|
|
赤字累計 |
|
|
股權 |
|
||||||
2023年12月31日餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||
股票計畫下發行普通股 |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
市場賣出，扣除發行成本淨額 |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
以股份為基礎之報酬支出 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
其他全面損失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
淨損失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
2024年3月31日止結餘 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
股票計畫下發行普通股 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
以股份為基礎之報酬支出 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
其他全面損失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
淨損失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
2024年6月30日餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
根據股票計劃發行普通股 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
以股份為基礎之報酬支出 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
其他綜合收益 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
淨損失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
2024年9月30日結餘 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||
|
|
|
|
|
|
|
|
Additional |
|
|
Accumulated |
|
|
|
|
|
Total |
|
||||||
|
|
Common Stock |
|
|
Paid-in |
|
|
Comprehensive |
|
|
Accumulated |
|
|
Stockholders’ |
|
|||||||||
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Loss |
|
|
Deficit |
|
|
Equity |
|
||||||
Balance at December 31, 2022 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of common stock under stock plans |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Other comprehensive income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance at March 31, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of common stock under stock plans |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Other comprehensive income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance at June 30, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of common stock under stock plans |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of common stock from private placement financing, net |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Other comprehensive income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance at September 30, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
3
TANGO THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Cash flows from operating activities |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash from |
|
|
|
|
|
|
||
Depreciation |
|
|
|
|
|
|
||
Noncash operating lease expense |
|
|
|
|
|
|
||
Stock-based compensation |
|
|
|
|
|
|
||
Accretion on marketable securities |
|
|
( |
) |
|
|
( |
) |
Other, net |
|
|
|
|
|
|
||
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Accounts receivable |
|
|
— |
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
|
|
|
( |
) |
|
Other long-term assets |
|
|
|
|
|
( |
) |
|
Accounts payable |
|
|
|
|
|
( |
) |
|
Accrued expenses and other liabilities |
|
|
( |
) |
|
|
( |
) |
Operating lease liabilities |
|
|
( |
) |
|
|
( |
) |
Deferred revenue |
|
|
( |
) |
|
|
( |
) |
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
Cash flows from investing activities |
|
|
|
|
|
|
||
Purchase of property and equipment |
|
|
( |
) |
|
|
( |
) |
Sales and maturities of marketable securities |
|
|
|
|
|
|
||
Purchases of marketable securities |
|
|
( |
) |
|
|
( |
) |
Net cash provided by investing activities |
|
|
|
|
|
|
||
Cash flows from financing activities |
|
|
|
|
|
|
||
Proceeds from at-the-market offerings, net of issuance costs |
|
|
|
|
|
— |
|
|
Proceeds from issuance of common stock and pre-funded warrants, net of issuance costs |
|
|
— |
|
|
|
|
|
Proceeds from issuance of common stock upon exercise of stock options and purchase of shares under ESPP |
|
|
|
|
|
|
||
Net cash provided by financing activities |
|
|
|
|
|
|
||
Net change in cash, cash equivalents and restricted cash |
|
|
( |
) |
|
|
( |
) |
Cash, cash equivalents and restricted cash, beginning of period |
|
|
|
|
|
|
||
Cash, cash equivalents and restricted cash, end of period |
|
$ |
|
|
$ |
|
||
Supplemental cash flow information: |
|
|
|
|
|
|
||
Cash paid for leases |
|
$ |
|
|
$ |
|
||
Supplemental disclosure of noncash investing and financing activity: |
|
|
|
|
|
|
||
Revaluation of right-of-use asset and lease liability upon lease remeasurement |
|
$ |
|
|
$ |
( |
) |
|
Financing offering costs included in accounts payable and accrued expenses |
|
$ |
— |
|
|
$ |
|
|
Capital expenditures included in accounts payable and accrued expenses |
|
$ |
|
|
$ |
— |
|
|
Operating lease liabilities from obtaining right-of-use assets |
|
$ |
|
|
$ |
— |
|
|
The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
4
TANGO THERAPEUTICS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Tango Therapeutics, Inc.是一家致力於在具有高度未滿醫療需求的確定患者人群中發現和開發新型藥物的精密腫瘤學公司。
Tango Therapeutics, Inc.（連同其合併子公司Tango或公司），前身為BCTG Acquisition Corp.（BCTG），於2020年5月21日在特拉華州成立。 BCTG是一家專門用途的收購公司（SPAC），旨在實現合併、資本股票交易、資產收購、股票購買、重組或類似業務組合。
與市場情況相關的股票發行
2022年9月，公司與Jefferies LLC（Jefferies）簽署了一項銷售協議（銷售協議），允許公司不時按其選擇通過Jefferies最多出售$
在2024年1月，公司賣出了
報告基礎
附帶的未經審核的簡明綜合財務報表已按照美利堅合眾國通用會計準則（U.S. GAAP）的規定準備。年末資產負債表數據源於經過審核的財務報表，但不包括U.S. GAAP所要求的所有披露。附帶的未經審核的簡明綜合財務報表反映了Tango及其全資子公司的運營情況。所有公司內部帳戶和交易均已予以消除。公司及其子公司的功能性和報告貨幣為美元。
據管理層看法，為了公正陳述財務資訊，對於報告期間內的財務資訊進行了所有必要的調整，這些調整屬於正常且經常性質。截至2024年9月30日和2023年三個月和九個月的營運結果並不一定能反映2024年12月31日結束時的結果，也不一定能反映任何其他中間時期的結果，亦不一定能反映任何未來年度或時期的結果。截至2024年9月30日和2023年9月30日三個月和九個月的未經審核簡明綜合財務報表已按照相同基礎準備，應與包括在公司於2023年12月31日 ended的年度10-K表格中的已審核綜合財務報表和附註一起閱讀。 已於2024年3月18日向美國證券交易委員會提交的文件。
重大會計政策在附註2中披露，並沒有發生重大變化。 重要會計政策摘要除下文描述外，合併財務報表及附註收錄於截至2023年12月31日的公司年度10-k表格中，並無重大變化。
估計的使用
編製合併財務報表需要公司作出可能影響資產、負債、權益、營業收入和費用及相關披露的估計、判斷和假設。合併財務報表中作出的重大估計和假設包括但不限於從合作協議認列的營業收入，股份感謝權的估值以及研究和發展費用的應計。公司持續評估其估計、判斷和方法。公司的估計是基於歷史經驗和其他合理假設，其結果形成對資產、負債和權益以及營業收入和費用的計量基礎和判斷的根據。截至合併財務報表發布日期，公司尚不知道任何需要更新估計、判斷或修訂資產或負債帳面價值的具體事件或情況。實際結果可能在不同假設或條件下與這些估計不同。估計變更將反映在變為已知的時間段中的報告結果中。
5
資產及設備
資產和設備以成本減去累計折舊和攤銷額列示。折舊和攤銷費用採用直線法，在每項資產的預估使用壽命內確認。定期評估預估使用壽命，以判斷變更是否適當。
資產 |
|
預估使用壽命 |
計算機設備 |
|
|
計算機軟體 |
|
|
傢具和裝置 |
|
|
實驗室設備 |
|
|
租賃改良 |
|
當公司審核長期資產，如不動產和設備，出現事件或情況變更表明資產的帳面價值可能無法收回時，將進行減損審核。如果出現減損指標，將通過比較資產的帳面金額與預計未來現金流的折現現值，以判斷資產是否可能收回。如果預期現金流小於資產組的帳面價值，則認為該資產組受損，其帳面價值將下調至公平價值，基於相關預估折現未來現金流。截至目前，未記錄任何此類減值虧損。
未投入使用的資產成本按照施工中成本資本化，一旦投入使用，按照上述使用年限折舊或攤銷。退休或出售時，相關成本和累計折舊和攤銷從賬面中移除，而任何因此產生的利得或損失均包括在綜合營運報表中。維修和保養成本按發生時支出。
最近公佈的會計準則
公司依據指定的生效日期採納由財務會計準則委員會（FASB）或其他標準制定機構發布的新會計聲明。除非在下文另有說明，否則公司認為最新發布的標準的採納對其綜合財務報表和披露沒有或可能沒有實質影響。
2023 年 11 月，FASB 發布了ASU 2023-07，《分割報告（課題 280）：改進可報告部門披露。》該標準旨在通過要求公開實體按年度和中期基礎披露增量部門信息，從而使投資者能夠進行更具決策價值的財務分析。該標準自 2023 年 12 月 15 日後開始的財政年度和 2024 年 12 月 15 日後開始的財政年度內中期生效。採納後，該標準應對財務報表中呈現的所有過去期間進行追溯應用。公司正在評估此採納對綜合財務報表和相關披露的潛在影響。2023 年 12 月，FASB 發布了ASU 2023-09，《》 該標準旨在通過要求公開實體按年度和中期基礎披露增量部門信息，從而使投資者能夠進行更具決策價值的財務分析。該標準自 2023 年 12 月 15 日後開始的財政年度和 2024 年 12 月 15 日後開始的財政年度內中期生效。採納後，該標準應對財務報表中呈現的所有過去期間進行追溯應用。公司正在評估此採納對綜合財務報表和相關披露的潛在影響。
為何Corcept Therapeutics股票今天飆升？》所得稅（740主題）：所得稅披露的改進該標準旨在加強現有的所得稅披露，以提供信息，更好地評估實體的營運和相關稅務風險，稅務規劃和營運機會如何影響其稅率和未來現金流的前景。該標準於2024年12月15日後開始之年度期間生效。採納後，該標準應適用於前瞻性，儘管允許追溯應用。允許提前採納。公司正在評估採納該標準對合併財務報表和相關披露可能產生的影響。
2024年11月，FASB發布了ASU 2024-03，《利潤及損失表-報告綜合收入-支出分解披露（分項220-40）：利潤及損失表支出分解》。該標準旨在要求對財務報表上呈報的特定費用類別（包括員工報酬、折舊和攤銷）進行更詳細的披露。ASU將於2026年12月15日後開始的經年期間生效，並於2027年12月15日後開始的經年期間內的中期期間生效。允許提前採納。修訂應用方式為（1）前瞻性應用於此ASU生效日期之後發布的財務報表，或（2）追溯性應用於財務報表中呈報的所有先前期間。公司正在評估採納該標準對合併財務報表和相關披露可能產生的影響。
6
2018 年 10 月，該公司與吉利亞德科學有限公司（吉利亞德）簽訂了研究合作和許可協議（2018 年吉利亞德協議）。根據 2018 年吉利亞德協議的條款，公司收到首次預付款為 $
2020 年 8 月，該公司和吉利亞德簽訂了修訂的研究合作和許可協議（吉利亞德協議），該協議取代並取代了 2018 年吉利亞德協議。吉利亞德協議代表了根據 2018 年吉利亞德協議所開始的初始目標發現和驗證研究和開發工作的繼續。根據吉利亞德協議：
該公司有資格獲得高達 $
2020 年 8 月，吉利亞德還進行了 $ 的股權投資
吉利亞德合作的會計
吉利亞德協議根據 ASC 606 進行帳目。該公司根據《吉利亞德協議》確定了一項單一合併履行責任，包括研究服務和在研究期內繼續參與聯合指導委員會。就研究選項延長費用而言，該公司確定與持續研究服務相關的額外商品和服務與在進行的研究計劃下已承諾給 Gilead 的早期研究服務並不分別。與每項研究選項延長相關的費用，按一定的付款時間表，以等於按季度分期付款支付予本公司。 根據《吉利亞德協議》下的交易價格中，研究期權延長考慮額會加入。由於本公司沒有持續參與本計劃的推進，Gilead 可以自行從授權中受益，而且許可證可與研究服務分開識別，許可證費將立即被視為收入。
吉利亞德收入已確認
根據吉利亞德協議下的合併履行義務所分配的交易價格總額為 $
7
公司重新評估交易價格和預計於每個報告期滿後需要承擔的總預估成本，並在不確定事件解決或公司負責的某些研究和開發活動的預期時間和成本發生變化或其他環境變化時。截至2024年9月30日和2023年12月31日，公司短期的透過賬收入分別為$
在2024年6月，吉利德授權一項藥物發現計劃，收取了$
尚未收到的公司應收款項按照應收賬款記錄，尚未確認為營業收入的收到的金額則按照公司的簡明合併賬表記錄為預收收入。
根據吉利德條款和2018年吉利德協議所產生的成本被記錄為研究和發展費用。
以下表格提供了有關公司按照重複性基礎計量的財務資產的公平價值信息：
|
|
公平市值衡量 |
|
|||||||||||||
|
|
一級 |
|
|
二級 |
|
|
等級 3 |
|
|
總計 |
|
||||
|
|
（以千為單位） |
|
|||||||||||||
現金等價物： |
|
|
|
|
|
|
|
|
|
|
|
|
||||
貨幣市場基金 |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
有價證券資產: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
美國政府機構債券 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
資產總額 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
|
|
公允市值衡量 |
|
|||||||||||||
|
|
一級 |
|
|
二級 |
|
|
等級 3 |
|
|
總計 |
|
||||
|
|
（以千為單位） |
|
|||||||||||||
現金等價物 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
貨幣市場基金 |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
美國國庫券 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
可銷負債證券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
美國政府機構債券 |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
資產總額 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
在2023和2024年6月30日結束的三個和六個月中，有資產減損處理記錄。更新計算公司進行中的研究和開發資產（“IPR&D”）公平價值所使用的關鍵假設可能會改變公司未來短期內回收IPR&D資產的帶值估計。
公司使用獨立定價服務評估其有交易價格的有價證券，通常這些服務根據最近報告的相同或類似證券的交易價格，並根據重要的可觀察交易進行調整。在每個資產負債表日，可觀察的市場輸入可能包括交易信息、經紀人或交易商報價、買賣價或這些數據來源的組合。
8
以下表格彙總了公司的具市場價值的債務證券，歸為可供出售：
|
|
公允價值衡量 |
|
|||||||||||||
|
|
攤銷後成本 |
|
|
總計 |
|
|
總計 |
|
|
公正的 |
|
||||
|
|
（以千為單位） |
|
|||||||||||||
有價證券資產: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
美國國庫券 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
美國政府機構債券 |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
|
|
公允價值衡量 |
|
|||||||||||||
|
|
攤銷後成本 |
|
|
總計 |
|
|
總計 |
|
|
公平價值 |
|
||||
|
|
（以千為單位） |
|
|||||||||||||
有價證券資產: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
美國國庫券 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
美國政府機構債券 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
公司持有具有總合公平價值的有價證券
以下表格總結了按類別和單一證券處於未實現虧損位階的時長而分類的公平值和毛未實現虧損：
|
2024年9月30日 |
|
|||||||||||||||||||||
|
少於十二個月 |
|
|
超過十二個月 |
|
|
總計 |
|
|||||||||||||||
|
公允價值 |
|
|
未實現虧損 |
|
|
公允價值 |
|
|
未實現虧損 |
|
|
公允價值 |
|
|
未實現虧損 |
|
||||||
|
（以千為單位） |
|
|||||||||||||||||||||
美國國庫券 |
$ |
|
|
$ |
( |
) |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
|
|
$ |
( |
) |
||
|
$ |
|
|
$ |
( |
) |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
|
|
$ |
( |
) |
||
|
2023年12月31日 |
|
|||||||||||||||||||||
|
少於十二個月 |
|
|
超過十二個月 |
|
|
總計 |
|
|||||||||||||||
|
公允價值 |
|
|
未實現虧損 |
|
|
公允價值 |
|
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未實現虧損 |
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公允價值 |
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未實現虧損 |
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（以千為單位） |
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美國國庫券 |
$ |
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$ |
( |
) |
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$ |
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$ |
( |
) |
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$ |
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$ |
( |
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美國政府機構債券 |
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( |
) |
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( |
) |
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( |
) |
|||
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$ |
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$ |
( |
) |
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$ |
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$ |
( |
) |
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$ |
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$ |
( |
) |
|||
公司持有投資級別的可銷售證券，被視為處於未實現虧損狀態。儘管這些可銷售證券在2024年9月30日時處於未實現虧損狀態，公司並不打算在這些證券的價值得到恢復之前出售這些可銷售證券，公司已得出結論，在證券出售前證券成本基準價值可能會得到恢復且不存在任何狀況或事件可能要求公司在成本基準得以恢復之前出售證券。此外，公司已經
9
資產和設備
淨物業和設備包括以下內容：
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九月三十日， |
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12月31日, |
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（以千爲單位） |
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|||||
實驗室設備 |
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$ |
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$ |
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計算機設備 |
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計算機-半導體軟件 |
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2,551 |
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租賃改良 |
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施工進度 |
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減：累計折舊 |
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( |
) |
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( |
) |
資產和設備，淨值 |
|
$ |
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|
$ |
|
||
折舊費用爲$
應計費用及其他流動負債包括以下方面：
應計費用和其他流動負債包括以下內容：
|
|
九月三十日， |
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12月31日, |
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||
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|
（以千爲單位） |
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|||||
工資和與僱員相關的成本 |
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$ |
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$ |
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||
研究開發費用 |
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其他 |
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累計費用及其他流動負債總計 |
|
$ |
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|
$ |
|
||
限制性現金
截至2024年9月30日和2023年，公司分別保留了$ 的限制性現金餘額。
|
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九月三十日， |
|
|
九月三十日， |
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||
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（以千爲單位） |
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|||||
現金及現金等價物 |
|
$ |
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|
$ |
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||
受限現金 |
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現金、現金等價物和受限制的現金 |
|
$ |
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$ |
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||
授權協議
2024年6月，公司與Sesame Therapeutics, Inc. (Sesame)達成授權協議，根據該協議，公司向Sesame授予與預臨床研究相關的某些專有技術的非獨家許可（Sesame Agreement）。根據Sesame協議，公司於2024年6月收取了一筆不可退款的＄
根據Sesame協議的條款，公司有資格在未來的臨床、監管和商業里程碑活動中最高可獲得＄
10
公司根據ASC 606評估了芝麻協議。公司在協議書下確定了以下承諾：(1) 非排他性許可和(2) 初始專有技術轉讓，並確定這些承諾是無關緊要的，因為合同起始時的預付許可金額微不足道。初始的預付許可金已被記錄為授權收入，整合損益表在2024年6月30日結束的期間內。
所有潛在的未來里程碑支付均視為變量收入，已從交易價格中排除。所有潛在的臨床和監管里程碑成就的收入將在相關里程碑達成時或當發生與里程碑事件相關的收入金額發生重大逆轉的概率不大時予以確認。公司或被許可方無法控制的里程碑支付，例如監管批准，直到收到這些批准之前都不被認為可能達成。此外，與潛在銷售里程碑和授權產品銷售的權利金相關的收入將在相關銷售發生時確認。
由於管理層成員和董事會之間存在共同關係，與Sesame的上述交易屬於相關方交易。
臨床試驗協作和供應協議
2024年11月，公司與Revolution Medicines, Inc. (RevMed)簽署了臨床試驗協作和供應協議。協議規定RevMed將免費提供兩種其RAS抑制劑供公司用於包括這些組合在內的試驗。公司將成為任何組合試驗的贊助商並承擔相應費用。每家公司將保留其各自化合物的商業權，協議是互不排他的。由於管理層成員和董事會之間存在共同關係，此交易為相關方交易。
其他資助承諾
截至2024年9月30日，公司正在進行預臨床和臨床研究。公司在正常業務過程中與醫藥外包概念簽訂合同，以準備和控制臨床試驗的運作，聘請專業顧問提供專業意見，與其他供應商簽訂合同，以提供臨床供應製造或其他預臨床和臨床服務。這些合同通常可由公司選擇取消，並在通知後生效，並不會造成重大取消懲罰。
保證
公司在業務過程中與其他方訂立某些協議，其中包括賠償條款。這些通常包括與董事和高管、業務夥伴、承包商、房東、施工公司、醫藥外包概念、臨床試驗基地和其他方訂立的協議。根據這些規定，公司通常為受保護方在合同條款下蒙受的損失提供賠償並使其免受損害。這些賠償條款通常在基礎協議終止後仍然有效。公司在這些賠償條款下可能需要承擔的未來付款的最大潛在金額是無限的。不過，迄今為止，公司尚未因捍衛訴訟或解決與這些賠償條款相關的索賠而產生重大成本。因此，這些義務的預估公平價值很小。
訴訟
公司可能會不時參與與業務有關的訴訟。截至2024年9月30日，公司未受任何重大法律訴訟影響，目前也沒有任何重大法律訴訟正在進行或威脅進行。由於與索賠、訴訟和訴訟相關的不確定性，潛在責任的評估基於公司在評估時可獲得的信息的最佳估計。定期，隨著額外信息的獲得，或根據特定事件如訴訟結果、法院裁決或索賠解決（和和解提議），公司可能會重新評估與這些事項相關的潛在責任，並可能修改這些預估，這可能對公司的營運結果產生重大不利影響。參與訴訟的相關成本在產生時認列費用。無論事實如何，這類訴訟的結果都具有固有的不確定性。如果公司無法在這類訴訟中取得勝利，公司的財務狀況、經營成果和未來現金流可能受到重大影韁。.
未指定優先股
11
公司的公司章程，經修訂並重述，授權公司發行面值為$的優先股。
股票激勵計劃
2017年3月，公司股東批准了2017年股票期權和授予計劃（2017計劃），根據該計劃向符合條件的員工、高級職員、董事、顧問或向公司提供服務的其他重要人士授予了期權和受限股票獎勵。2017計劃下的這些發行取決於董事會於發行時認為適當的授予、沽出和其他限制。
2021年8月，公司股東批准了2021年股票期權和激勵計劃（2021計劃），根據該計劃向符合條件的員工、高級職員、董事、顧問或向公司提供服務的其他重要人士授予了期權、受限股票單位（RSUs）和其他以權益為基礎的獎勵，或以上述任何組合進行授予。這些發行取決於董事會於發行時認為適當的授予、沽出和其他限制。截至2024年9月30日本公司截至此時擁有現金及現金等價物，包括有自然存續期限在一個月或以下的貨幣市場帳戶和可供銷售投資，以及有自然存續期限在一年或以下的可供銷售投資，總金額為
2023年2月，公司董事會批准了2023年招聘激勵計劃（招聘激勵計劃）。招聘激勵計劃允許公司向以前未曾擔任公司員工或董事的個人進行股權和以股權為基礎的激勵獎勵。截至2024年9月30日本公司截至此時擁有現金及現金等價物，包括有自然存續期限在一個月或以下的貨幣市場帳戶和可供銷售投資，以及有自然存續期限在一年或以下的可供銷售投資，總金額為
公司在其隨附的簡明綜合綜合損益表中記錄了以下費用類別的股份報酬支出：
|
|
截至9月30日的三個月 |
|
|
截至9月30日的九個月 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
|
|
（以千為單位） |
|
|
（以千為單位） |
|
||||||||||
研發費用 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
總務與行政 |
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||||
總計 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
期權活動
下表概括了股票期權活動。 nine months ended September 30, 2024:
|
|
數量 |
|
|
期權 |
|
|
期權 |
|
|
總計 |
|
||||
|
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|
|
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(按年計算) |
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||||
截至2023年12月31日的期權未行使 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
已授予股份 |
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|
$ |
|
|
|
|
|
|
|
||||
行使 |
|
|
( |
) |
|
$ |
|
|
|
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|
|||
已取消 |
|
|
( |
) |
|
$ |
|
|
|
|
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|||
截至2024年9月30日的期權未行使 |
|
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|
|
$ |
|
|
|
|
|
$ |
|
||||
截至2024年9月30日可以行使的期權 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
截至2024年9月30日，與期權相關的未確認總酬勞費用百萬美元
限制性股票單位活動
12
以下表格概述了該份RSU截至2023年12月31日的活動情況。 nine months ended September 30, 2024:
|
|
數量 |
|
|
加權平均 |
|
||
未投資和未解決的截至2023年12月31日。 |
|
|
|
|
$ |
|
||
已授予股份 |
|
|
|
|
|
|
||
已行使股票數 |
|
|
( |
) |
|
|
|
|
已棄權股份 |
|
|
( |
) |
|
|
|
|
截至2024年9月30日，未實現並未發行股份。 |
|
|
|
|
$ |
|
||
截至2024年9月30日，與RSUs相關的未承認總補償費用。為$
2021員工股票購買計劃
2021員工股票購買計劃（2021 ESPP）已獲公司董事會和公司股東批准並在業務組合關閉後生效。截至2024年9月30日結束的九個月期間，公司已發行
基本和稀釋後每股淨虧損歸屬於普通股股東的計算如下：
|
|
截至9月30日的三個月 |
|
|
截至9月30日的九個月 |
|
||||||||||
|
|
(以千為單位，每股數據除外) |
|
|
(以千為單位，每股數據除外) |
|
||||||||||
|
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2024 |
|
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2023 |
|
|
2024 |
|
|
2023 |
|
||||
分子: |
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|
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|
|
|
|
||||
淨損失 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
分母: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
基本和稀釋每股基本股份的加權平均數 |
|
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|
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|
|
|
|
|
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|
||||
每股普通股基本和稀釋后淨損失 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
2023年8月，公司完成了一項定向增發，其中
公司的潛在稀釋證券，包括普通股期權和未發放的限制性普通股單位，已被排除在計算每股稀釋淨虧損中，因為其影響將使每股淨虧損減少。因此，用於計算歸屬於普通股東的基本和稀釋每股淨虧損的加權平均普通股份數是相同的。
|
|
九月三十日， |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
購買普通股的期權 |
|
|
|
|
|
|
||
未投資的受限制普通股單位 |
|
|
|
|
|
|
||
總計 |
|
|
|
|
|
|
||
13
The Company’s effective income tax rate was -
The effective income tax rate for the three and nine months ended September 30, 2024 and 2023 differed from the
14
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and related notes for the year ended December 31, 2023 included in our Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis.
Overview
Tango Therapeutics was founded with a clear mission: discover the next generation of precision medicines to help patients with cancer through addressing the specific genetic alterations that fuel the cancer. We leverage our state-of-the-art target discovery platform to identify novel targets and develop new drugs directed at tumor suppressor gene loss in defined patient populations with high unmet medical need. Tumor suppressor gene loss remains a largely unaddressed target space specifically because these genetic events cannot be directly targeted. Our novel small molecules are designed to be selectively active in cancer cells with specific tumor suppressor gene loss, killing those cancer cells while sparing normal cells. We also are extending this target space beyond the classic, cell-autonomous effects of tumor suppressor gene loss to include the discovery of novel targets that reverse the effects of tumor suppressor gene loss that prevent the immune system from recognizing and killing cancer cells (immune evasion). We believe our approach will provide the ability to deliver the deep, sustained target inhibition necessary to optimize tumor response and clinical benefit as a result of the unique ability of synthetic lethal targeting to spare normal cells.
We are developing multiple MTA-cooperative PRMT5 inhibitors that are designed to work selectively in cancer cells with an MTAP deletion. MTAP-deletion occurs in approximately 10% to 15% of all human tumors, including NSCLC and pancreatic cancer.
In November 2024, we announced that, based on data from our ongoing Phase 1/2 clinical trial, we plan to move TNG462, a MTA-cooperative PRMT5 inhibitor, into the next stage of development. The investigational new drug (IND) application for TNG462 was cleared by the U.S. Food and Drug Administration (FDA) in the first quarter of 2023 and we announced the first patient in the Phase 1/2 clinical trial was dosed in July 2023. In the ongoing Phase 1/2 clinical trial, TNG462 has demonstrated durable clinical activity across multiple tumor types, including NSCLC and pancreatic cancer, and has a good tolerability and safety profile. We continue to evaluate TNG462 efficacy and tolerability at 200 mg, 250 mg and 300 mg daily, predominantly in NSCLC and pancreatic cancer. We plan to provide further clinical updates on TNG462 in 2025. Additionally, we plan to enroll patients in multiple combination clinical trials with TNG462 in the first half of 2025, including targeted combinations with (i) two RAS(ON) inhibitors, (RAS(ON) multi-selective inhibitor, RMC-6236, and RAS(ON) G12D-selective inhibitor RMC-9805, both from Revolution Medicines, Inc.), (ii) osimertinib (AstraZeneca), and (iii) pembrolizumab (Merck & Co., Inc.). Combinations of TNG462 and standard of care chemotherapy for NSCLC and pancreatic cancer also are being planned as potential paths to approval in the first line setting. We are initiating conversations with the FDA in preparation for multiple registrational studies.
In November 2024, we announced that we are stopping enrollment of TNG908, a brain-penetrant MTA-cooperative inhibitor of PRMT5, to resource to our other programs, TNG462 and TNG456. Data from our Phase 1/2 clinical trial demonstrated that TNG908 is clinically active and well-tolerated in non-central nervous system solid tumors (including NSCLC and pancreatic cancer). No partial responses by RANO criteria were observed in the 23 evaluable GBM patients who were treated at active doses.
We plan to enroll patients in a Phase 1/2 clinical trial for TNG456, a next-generation brain-penetrant MTA-cooperative PRMT5 inhibitor, in the first half of 2025. We plan to evaluate TNG456 as a monotherapy and in combination with the brain-penetrant CDK4/6 inhibitor, abemaciclib (Lilly), in GBM, NSCLC and selected other solid tumors. Preclinical studies suggest that TNG456 has increased selectivity and potency compared to TNG908.
Discovered as part of our immune evasion target discovery platform, TNG260 is a first-in-class CoREST inhibitor, which reverses the immune evasion effect of STK11 loss-of-function mutations. STK11 loss-of-function mutations are present in approximately 15% of NSCLC, 15% of cervical cancers, 10% of carcinoma of unknown primary, 5% of breast cancers and 3% of pancreatic cancers. In syngeneic models with an STK11 mutation and an intact immune system, the combination of TNG260 with an anti-PD-1 antibody resulted in sustained complete tumor regressions and the induction of immune memory against re-implantation of tumors. These preclinical data demonstrate that TNG260 in combination with an anti-PD-1 antibody is active in cancers with STK11 mutation, a setting where an anti-PD-1 antibody alone is inactive. In the first quarter of 2023, the FDA cleared the TNG260 IND and we announced the first patient in the Phase 1/2 clinical trial was dosed in July 2023. The TNG260 Phase 1/2 clinical trial is ongoing,
15
evaluating the safety, pharmacokinetics, PD and efficacy of TNG260 in combination with pembrolizumab, with a one cycle single agent run-in phase to evaluate the safety and PK of TNG260, in patients with locally advanced or metastatic solid tumors with an STK11 loss-of-function mutation. To date, the safety, tolerability and pharmacokinetics profiles are favorable. Clinical data from the ongoing trial are expected in 2025. We believe that TNG260 could be among the first oncology molecules to leverage the benefits of genetically-based patient selection (STK11-mutation) with checkpoint inhibitor therapy.
In May 2024, we announced the discontinuation of TNG348, a USP1 inhibitor, due to toxicity observed in the dose escalation portion of our phase 1/2 clinical trial. The phase 1/2 clinical trial was evaluating TNG348 in BRCA1/2-mutant and other HRD+ cancers for safety, pharmacokinetics, pharmacodynamics and efficacy.
Financial Overview
Since the Company's inception, we have focused primarily on organizing and staffing our company, business planning, raising capital, discovering product candidates, securing related intellectual property, and conducting research and development activities for our programs. To date, we have funded our operations primarily through equity financings and from the proceeds received from our collaboration agreement with Gilead. Since inception, we have raised an aggregate of $166.9 million of gross proceeds from the sale of our preferred shares, $342.1 million in gross proceeds through the closing of the Business Combination and simultaneous financing transactions, $237.1 million through our collaboration with Gilead and $123.0 million of gross proceeds through (i) $80.0 million from the private placement of common shares and pre-funded warrants to purchase common shares in August 2023 and (ii) $43.0 million from our "at-the-market" stock offering program.
We expect that our existing cash, cash equivalents and marketable securities on hand as of September 30, 2024 of $293.3 million will enable us to fund our operating expenses and capital expenditure requirements at least into the third quarter of 2026. Since inception, we have incurred significant operating losses. For the nine months ended September 30, 2024 and 2023, our net losses were $92.6 million and $71.0 million, respectively. We had an accumulated deficit of $463.9 million as of September 30, 2024. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our product candidates through preclinical and clinical development and seek regulatory approvals, manufacture drug product and drug supply, and maintain and expand our intellectual property portfolio. We also expect to hire additional personnel, pay for accounting, audit, legal, regulatory and consulting services, and pay costs associated with maintaining compliance with Nasdaq listing rules and the requirements of the U.S. Securities and Exchange Commission, director and officer liability insurance, investor and public relations activities and other expenses associated with operating as a public company. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our preclinical studies, our clinical trials, and our expenditures on other research and development activities.
We do not have any product candidates approved for sale and have not generated any revenue from product sales. We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates, if ever. In addition, if we obtain regulatory approval for our product candidates and do not enter into a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing and distribution activities. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all. Our failure to raise capital or enter into such agreements as, and when needed, could have a negative effect on our business, results of operations and financial condition.
Because of the numerous risks and uncertainties associated with pharmaceutical development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate revenues from the sale of our therapies, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce our operations.
At-the-Market Stock Offering
In September 2022, we entered into a sales agreement (the Sales Agreement) with Jefferies LLC (Jefferies), which permits us to sell from time to time, at our option, up to an aggregate of $100.0 million of shares of common stock through Jefferies, as sales agent. Sales of the common stock, if any, will be made by methods deemed to be "at-the-market" stock offerings. The Sales Agreement will terminate upon the earliest of: (a) the sale of $100.0 million of shares of our common stock or (b) the termination of the Sales Agreement by us or Jefferies.
16
In January 2024, the Company sold 4,001,200 shares of common stock under this program for gross proceeds of $43.0 million.
Revenue
To date, we have not recognized any revenue from product sales, and we do not expect to generate any revenue from the sale of products in the next several years. If our development efforts for our product candidates are successful and result in regulatory approval, or license agreements with third parties, we may generate revenue in the future from product sales. However, there can be no assurance as to when we will generate such revenue, if at all.
Collaboration Agreements with Gilead Sciences
In October 2018, we entered into a collaboration agreement (the 2018 Gilead Agreement) with Gilead Sciences, Inc. (Gilead). Pursuant to the terms of the 2018 Gilead Agreement, we received an initial upfront payment of $50.0 million. The upfront payment was initially recorded as deferred revenue on our balance sheet and is recognized as revenue as or when the performance obligation under the contract is satisfied. In August 2020, the 2018 Gilead Agreement was expanded into a broader collaboration via an amended and restated research collaboration and license agreement (the Gilead Agreement). Pursuant to the terms of the Gilead Agreement, we received an upfront payment of $125.0 million. Consistent with the treatment of the previously received upfront payment, this upfront payment was recorded as deferred revenue on our balance sheet and is recognized as revenue as or when the performance obligation under the contract is satisfied. In 2020 and 2021, Gilead elected to extend two programs for research extension fees totaling $24.0 million, which was added to our estimate of the transaction price to total $199.0 million. In June 2024, Gilead licensed a program for a $12.0 million fee, which was recognized as license revenue in the second quarter of 2024.
As of September 30, 2024, $132.5 million has been recognized as collaboration revenue related to the upfront and research option-extension payments from the Gilead Agreement and the 2018 Gilead Agreement (the Gilead Agreements).
During the three months ended September 30, 2024 and 2023, we recognized $11.6 million and $10.7 million, respectively, and during the nine months ended September 30, 2024 and 2023, we recognized $25.9 million and $26.1 million, respectively, of collaboration revenue associated with the Gilead Agreements based on performance completed during each period.
Refer to Note 2 and Note 3 to our unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements and related notes for the year ended December 31, 2023 included in our Annual Report on Form 10-K for additional information regarding our revenue recognition accounting policy and our collaboration agreement with Gilead.
Operating Expenses
Research and Development Expenses
Research and development expenses consist primarily of costs incurred for our drug discovery efforts and the development of our product candidates. We expense research and development costs as incurred, which include:
Costs for certain activities are recognized based on an evaluation of the progress to completion of specific tasks using data such as information provided to us by our vendors and analyzing the progress of our preclinical studies or other services performed. Significant judgment and estimates are made in determining the accrued expense balances at the end of any reporting period.
17
Our direct external research and development expenses consist primarily of fees paid to CROs and outside consultants in connection with our preclinical and clinical development and manufacturing activities. Our direct external research and development expenses also include fees incurred under license agreements. We track these external research and development costs on a program-by-program basis once we have identified a product candidate.
We do not allocate employee costs, costs associated with our target discovery efforts, laboratory supplies, and facilities, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We characterize research and development costs incurred prior to the identification of a product candidate as discovery costs. We use internal resources primarily to conduct our research and discovery activities as well as for managing our preclinical, development and manufacturing activities.
The following table summarizes our research and development expenses:
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
|
|
(in thousands) |
|
|
(in thousands) |
|
||||||||||
TNG908 direct program expenses |
|
$ |
3,259 |
|
|
$ |
3,165 |
|
|
$ |
10,776 |
|
|
$ |
7,353 |
|
TNG462 direct program expenses |
|
|
3,119 |
|
|
|
1,795 |
|
|
|
12,162 |
|
|
|
6,969 |
|
TNG260 direct program expenses |
|
|
1,947 |
|
|
|
1,565 |
|
|
|
7,946 |
|
|
|
5,731 |
|
TNG348 direct program expenses |
|
|
590 |
|
|
|
922 |
|
|
|
5,531 |
|
|
|
4,454 |
|
Discovery direct program expenses |
|
|
6,898 |
|
|
|
5,206 |
|
|
|
19,923 |
|
|
|
17,804 |
|
Unallocated research and development expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Personnel-related expenses |
|
|
12,403 |
|
|
|
9,598 |
|
|
|
38,309 |
|
|
|
28,347 |
|
Facilities and other related expenses |
|
|
5,047 |
|
|
|
4,898 |
|
|
|
15,334 |
|
|
|
13,201 |
|
Total research and development expenses |
|
$ |
33,263 |
|
|
$ |
27,149 |
|
|
$ |
109,981 |
|
|
$ |
83,859 |
|
The successful development of our product candidates is highly uncertain. We plan to substantially increase our research and development expenses for the foreseeable future as we continue the development of our product candidates and manufacturing processes and conduct discovery and research activities for our preclinical programs. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates or the timing of regulatory filings in connection with clinical trials or regulatory approval, due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments and our ongoing assessments as to each product candidate’s commercial potential. Our clinical development costs have, and are expected to increase significantly with the commencement and continuation of our clinical trials. We anticipate that our expenses will increase substantially, particularly due to the numerous risks and uncertainties associated with developing product candidates, including the uncertainty of:
Any changes in the outcome of any of these variables with respect to the development of our product candidates in preclinical and clinical development could mean a significant change in the costs and timing associated with the development of these product
18
candidates. We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on other product candidates.
General and Administrative Expenses
General and administrative expenses consist primarily of employee related costs, including salaries, bonuses, benefits, stock-based compensation and other related costs. General and administrative expense also includes professional services, including legal, accounting and audit services and other consulting fees as well as facility costs not otherwise included in research and development expenses, insurance and other general administrative expenses.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and development of our product candidates. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs as well as investor and public relations expenses associated with operating as a public company.
Other Income, Net
Interest Income
Interest income consists of income earned and losses incurred in connection with our investments in money market funds, U.S. Treasury bills and U.S. government agency bonds.
Other Income, Net
Other income, net consists of miscellaneous income and expense unrelated to our core operations.
Provision for Income Taxes
Our provision for income tax consists of an estimate for U.S. federal and state income taxes based on enacted rates, as adjusted for allowable credits, deductions, uncertain tax positions, changes in deferred tax assets and liabilities and changes in tax law. We recorded an insignificant provision for income taxes for each of the three and nine months ended September 30, 2024 and 2023.
19
Results of Operations
Comparison of the three months ended September 30, 2024 and 2023
The following table summarizes our results of operations for the three months ended September 30, 2024 and 2023:
|
|
Three Months Ended September 30, |
|
|
|
|
||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
|
|
(in thousands) |
|
|||||||||
Collaboration revenue |
|
$ |
11,607 |
|
|
$ |
10,732 |
|
|
$ |
875 |
|
Total revenue |
|
|
11,607 |
|
|
|
10,732 |
|
|
|
875 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
|
33,263 |
|
|
|
27,149 |
|
|
|
6,114 |
|
General and administrative |
|
|
11,222 |
|
|
|
9,209 |
|
|
|
2,013 |
|
Total operating expenses |
|
|
44,485 |
|
|
|
36,358 |
|
|
|
8,127 |
|
Loss from operations |
|
|
(32,878 |
) |
|
|
(25,626 |
) |
|
|
(7,252 |
) |
Other income: |
|
|
|
|
|
|
|
|
|
|||
Interest income |
|
|
1,809 |
|
|
|
1,872 |
|
|
|
(63 |
) |
Other income, net |
|
|
1,956 |
|
|
|
1,514 |
|
|
|
442 |
|
Total other income, net |
|
|
3,765 |
|
|
|
3,386 |
|
|
|
379 |
|
Loss before income taxes |
|
|
(29,113 |
) |
|
|
(22,240 |
) |
|
|
(6,873 |
) |
Provision for income taxes |
|
|
(54 |
) |
|
|
(23 |
) |
|
|
(31 |
) |
Net loss |
|
$ |
(29,167 |
) |
|
$ |
(22,263 |
) |
|
$ |
(6,904 |
) |
Collaboration Revenue
Collaboration revenue of $11.6 million and $10.7 million for the three months ended September 30, 2024 and 2023, respectively, was derived from the Gilead collaboration. Collaboration revenue increased due to changes to estimated costs expected to be incurred under the collaboration.
Research and Development Expenses
Research and development expense was $33.3 million for the three months ended September 30, 2024 compared to $27.1 million for the three months ended September 30, 2023. The increase of $6.1 million was primarily due to a $3.0 million increase relating to the advancement of TNG462 and our preclinical programs. Additionally, the increase was also due to $2.8 million in personnel-related costs, including share-based compensation expense and additional headcount to support our research and development activities.
General and Administrative Expenses
General and administrative expense was $11.2 million for the three months ended September 30, 2024 compared to $9.2 million for the three months ended September 30, 2023. The increase of $2.0 million was primarily due to $1.5 million in personnel-related costs, including share-based compensation expense and additional headcount.
Interest Income
Interest income was $1.8 million for the three months ended September 30, 2024 compared to $1.9 million for the three months ended September 30, 2023, with the decrease attributed to a decrease in marketable securities balance in 2024 as compared to 2023.
Other Income, Net
Other income, net was $2.0 million for the three months ended September 30, 2024 compared to other income, net of $1.5 million for the three months ended September 30, 2023, with the increase attributed to accretion on investments purchased at a discount.
20
Provision for Income Taxes
Provision for income taxes was $0.1 million for the three months ended September 30, 2024 and $0.1 million for the three months ended September 30, 2023. The income tax provision amount for the period ended September 30, 2024 is primarily attributable to state taxes on interest income earned on marketable securities.
Comparison of the nine months ended September 30, 2024 and 2023
The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023:
|
|
Nine Months Ended September 30, |
|
|
|
|
||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
|
|
(in thousands) |
|
|||||||||
Collaboration revenue |
|
$ |
25,852 |
|
|
$ |
26,096 |
|
|
$ |
(244 |
) |
License revenue |
|
|
12,100 |
|
|
|
5,000 |
|
|
|
7,100 |
|
Total revenue |
|
|
37,952 |
|
|
|
31,096 |
|
|
|
6,856 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
|
109,981 |
|
|
|
83,859 |
|
|
|
26,122 |
|
General and administrative |
|
|
32,656 |
|
|
|
26,397 |
|
|
|
6,259 |
|
Total operating expenses |
|
|
142,637 |
|
|
|
110,256 |
|
|
|
32,381 |
|
Loss from operations |
|
|
(104,685 |
) |
|
|
(79,160 |
) |
|
|
(25,525 |
) |
Other income: |
|
|
|
|
|
|
|
|
|
|||
Interest income |
|
|
6,077 |
|
|
|
4,383 |
|
|
|
1,694 |
|
Other income, net |
|
|
6,135 |
|
|
|
3,883 |
|
|
|
2,252 |
|
Total other income, net |
|
|
12,212 |
|
|
|
8,266 |
|
|
|
3,946 |
|
Loss before income taxes |
|
|
(92,473 |
) |
|
|
(70,894 |
) |
|
|
(21,579 |
) |
Provision for income taxes |
|
|
(159 |
) |
|
|
(87 |
) |
|
|
(72 |
) |
Net loss |
|
$ |
(92,632 |
) |
|
$ |
(70,981 |
) |
|
|
(21,651 |
) |
Collaboration Revenue
Collaboration revenue of $25.9 million and $26.1 million for the nine months ended September 30, 2024 and 2023, respectively, was derived from the Gilead collaboration. Research costs incurred under the collaboration were lower during the nine months ended September 30, 2024 which resulted in lower collaboration revenue amounts recognized.
License Revenue
License revenue was $12.1 million for the nine months ended September 30, 2024, compared to $5.0 million for the nine months ended September 30, 2023. The increase is primarily due to licensing a program to Gilead for $12.0 million during the second quarter of 2024 as compared to Gilead licensing a program for $5.0 million during the second quarter of 2023.
Research and Development Expenses
Research and development expense was $110.0 million for the nine months ended September 30, 2024 compared to $83.9 million for the nine months ended September 30, 2023. The increase of $26.1 million was primarily due to a $14.0 million increase relating to the advancement of our clinical and preclinical programs. Additionally, the increase was also due to $10.0 million in personnel-related costs, including share-based compensation expense and additional headcount to support our research and development activities.
General and Administrative Expenses
General and administrative expense was $32.7 million for the nine months ended September 30, 2024 compared to $26.4 million for the nine months ended September 30, 2023. The increase of $6.3 million was primarily due to $5.5 million in personnel-related costs, including share-based compensation expense and additional headcount.
21
Interest Income
Interest income was $6.1 million for the nine months ended September 30, 2024 compared to $4.4 million for the nine months ended September 30, 2023, with the increase attributed to an increase in interest rates in 2024 as compared to 2023.
Other Income, Net
Other income, net was $6.1 million for the nine months ended September 30, 2024 compared to other income, net of $3.9 million for the nine months ended September 30, 2023, with the increase attributed to accretion on investments purchased at a discount.
Provision for Income Taxes
Provision for income taxes was $0.2 million for the nine months ended September 30, 2024 and $0.1 million for the nine months ended September 30, 2023. The income tax provision amount for the period ended September 30, 2024 is primarily attributable to state taxes on interest income earned on marketable securities.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have generated recurring net losses. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. To date, we have funded our operations primarily through equity financings and from the proceeds received from our collaboration agreement with Gilead. Since inception, we have raised an aggregate of $166.9 million of gross proceeds from the sale of our preferred shares, $342.1 million in gross proceeds from the Business Combination and simultaneous financing transactions, $123.0 million of gross proceeds through (i) the $80.0 million private placement of common shares and pre-funded warrants to purchase common shares in August 2023 and (ii) the $43.0 million from our "at-the-market" stock offering program, and another $237.1 million through our collaboration with Gilead. As of September 30, 2024, we had cash and cash equivalents and marketable securities of $293.3 million.
Funding Requirements
We expect that our existing cash, cash equivalents and marketable securities on hand as of September 30, 2024 of $293.3 million will enable us to fund our operating expenses and capital expenditure requirements at least into the third quarter of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could expend our capital resources sooner than we expect.
Cash Flows
Comparison of the nine months ended September 30, 2024 and 2023
The following table summarizes our cash flows for each of the nine month periods presented:
|
|
Nine Months Ended September 30, |
|
|
|
|
||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
|
|
(in thousands) |
|
|
|
|
||||||
Net cash used in operating activities |
|
$ |
(94,854 |
) |
|
$ |
(90,515 |
) |
|
$ |
(4,339 |
) |
Net cash provided by investing activities |
|
|
34,066 |
|
|
|
7,574 |
|
|
|
26,492 |
|
Net cash provided by financing activities |
|
|
46,695 |
|
|
|
80,939 |
|
|
|
(34,244 |
) |
Net decrease in cash, cash equivalents and restricted cash |
|
$ |
(14,093 |
) |
|
$ |
(2,002 |
) |
|
$ |
(12,091 |
) |
Operating Activities
Net cash used in operating activities was $94.9 million for the nine months ended September 30, 2024 compared to net cash used in operating activities of $90.5 million for the nine months ended September 30, 2023. The increase in net cash used in operating activities for the nine months ended September 30, 2024 was primarily due to an increase to the net loss as a result of higher operating expenses related to the advancement of our programs and personnel-related costs. The increase was partially offset by changes in operating assets and liabilities and higher non-cash expenses, including stock compensation.
22
Investing Activities
Net cash provided by investing activities was $34.1 million for the nine months ended September 30, 2024 compared to net cash provided by investing activities of $7.6 million for the nine months ended September 30, 2023. The change was primarily due to a decrease in purchases of marketable securities as compared to the nine months ended September 30, 2023, which was partially offset by a decrease in sales and maturities of marketable securities as compared to the nine months ended September 30, 2023.
Financing Activities
Net cash provided by financing activities was $46.7 million for the nine months ended September 30, 2024 compared to net cash provided by financing activities of $80.9 million for the nine months ended September 30, 2023. The cash provided by financing activities for the nine months ended September 30, 2024 consisted of the $41.7 million in net proceeds received from our "at-the-market" stock offering program in January 2024, as well as the cash provided from the exercises of stock options and ESPP purchases. The cash provided by financing activities for the nine months ended September 30, 2023 consisted of the net proceeds received from our private placement financing transaction in August 2023 of $79.8 million, as well as the cash provided from the exercises of stock options and ESPP purchases.
Contractual Obligations and Commitments
The following table summarizes our contractual obligations at September 30, 2024 and the effects that such obligations are expected to have on our liquidity and cash flows in future periods:
|
|
Payments Due by Period |
|
|||||||||||||||||
|
|
Total |
|
|
Less than |
|
|
1 – 3 Years |
|
|
3 – 5 Years |
|
|
More than |
|
|||||
|
|
(in thousands) |
|
|||||||||||||||||
Operating lease commitments |
|
$ |
51,973 |
|
|
$ |
5,732 |
|
|
$ |
11,640 |
|
|
$ |
12,349 |
|
|
$ |
22,252 |
|
Total |
|
$ |
51,973 |
|
|
$ |
5,732 |
|
|
$ |
11,640 |
|
|
$ |
12,349 |
|
|
$ |
22,252 |
|
The commitment amounts in the table above primarily reflect the minimum payments due under our amended operating lease for office and laboratory space at our 201 Brookline Avenue, Boston, Massachusetts location. These commitments are also recognized as operating lease liabilities in our balance sheet at September 30, 2024. Refer to Note 7 to our audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2023 for additional discussion of the lease.
Purchase Obligations
In the normal course of business, we enter into contracts with third parties for preclinical studies, clinical operations, manufacturing and research and development supplies. These contracts generally do not contain minimum purchase commitments and generally provide for termination on notice, and therefore are cancellable contracts. These payments are not included in the table above as the amount and timing of such payments are not known as of September 30, 2024.
License Agreement Obligations
We have also entered into a license agreement under which we may be obligated to make milestone and royalty payments. We have not included future milestone or royalty payments under the agreement in the table above since the payment obligations are contingent upon future events, such as achieving certain development, regulatory, and commercial milestones or generating product sales. As of September 30, 2024 and December 31, 2023, we were unable to estimate the timing or likelihood of achieving these milestones or generating future product sales. Refer to Note 8 to our audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2023 for a description of our license agreement.
Critical Accounting Policies and Significant Judgments and Estimates
Our consolidated financial statements have been prepared in accordance with U.S. GAAP. The preparation of these consolidated financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances and at the time these estimates are made, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Some of the
23
judgments and estimates we make can be subjective and complex. Our actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, and experience. The effects of material revisions in estimates, if any, will be reflected in the consolidated financial statements prospectively from the date of change in estimates.
While our significant accounting policies are described in more detail in Note 2 to our audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2023, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Revenue Recognition
The terms of our collaboration agreements may include consideration such as non-refundable up-front payments, license fees, research extension fees, and clinical, regulatory and sales-based milestones and royalties on product sales.
We recognize revenue under ASC Topic 606, Revenue from Contracts with Customers, or ASC 606, which applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. ASC 606 provides a five-step framework whereby revenue is recognized when control of promised goods or services is transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of the revenue standard, we perform the following five steps: (i) identify the promised goods or services in the contract; (ii) determine whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measure the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations; and (v) recognize revenue when (or as) we satisfy each performance obligation. We only apply the five-step model to contracts when collectability of the consideration to which we are entitled in exchange for the goods or services we transfer to the customer is determined to be likely. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess whether the goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services until a distinct bundle is identified. We then allocate the transaction price (the amount of consideration we expect to be entitled to from a customer in exchange for the promised goods or services) to each performance obligation and recognize the associated revenue when (or as) each performance obligation is satisfied. Our estimate of the transaction price for each contract includes all variable consideration to which we expect to be entitled.
We recognize the transaction price allocated to license payments as revenue upon delivery of the license to the customer and resulting ability of the customer to use and benefit from the license, if the license is determined to be distinct from the other performance obligations identified in the contract. If the license is considered to not be distinct from other performance obligations, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied (i) at a point in time, but only for licenses determined to be distinct from other performance obligations in the contract, or (ii) over time; and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from license payments. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
We evaluate whether it is probable that the consideration associated with each milestone payment will not be subject to a significant reversal in the cumulative amount of revenue recognized. Amounts that meet this threshold are included in the transaction price using the most likely amount method, whereas amounts that do not meet this threshold are considered constrained and excluded from the transaction price until they meet this threshold. Milestones tied to regulatory approval, and therefore not within our control, are considered constrained until such approval is received. Upfront and ongoing development milestones under our collaboration agreements are not subject to refund if the development activities are not successful. At the end of each subsequent reporting period, we re-evaluate the probability of a significant reversal of the cumulative revenue recognized for the milestones, and, if necessary, adjust the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues from collaborators in the period of adjustment. We exclude sales-based milestone payments and royalties from the transaction price until the sale occurs (or, if later, until the underlying performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied), because the license to our intellectual property is deemed to be the predominant item to which the royalties relate as it is the primary driver of value.
ASC 606 requires us to allocate the arrangement consideration on a relative standalone selling price basis for each performance obligation after determining the transaction price of the contract and identifying the performance obligations to which that amount should be allocated. The relative standalone selling price is defined in ASC 606 as the price at which an entity would sell a promised good or service separately to a customer. If other observable transactions in which we have sold the same performance obligation separately are not available, we are required to estimate the standalone selling price of each performance obligation. Key assumptions
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to determine the standalone selling price may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success.
Whenever we determine that multiple promises to a customer are not distinct and comprise a combined performance obligation that includes services, we recognize revenue over time using the cost-to-cost input method, based on the total estimated cost to fulfill the obligation. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which we are expected to complete our performance obligations under an arrangement.
Consideration that does not meet the requirements to satisfy the above revenue recognition criteria is a contract liability and is recorded as deferred revenue in the consolidated balance sheets. We have recorded short-term and long-term deferred revenue on our consolidated balance sheets based on our best estimate of when such revenue will be recognized. Short-term deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that we expect will not be recognized within the next 12 months are classified as long-term deferred revenue.
In certain instances, the timing of and total costs of satisfying these obligations under our collaboration agreement can be difficult to estimate. Accordingly, our estimates may change in the future. If these estimates and judgments change over the course of these agreements, it may affect the timing and amount of revenue that we will recognize and record in future periods.
Under ASC 606, we will recognize revenue when we fulfill our performance obligations under the agreements with customers. As the required performance obligation is satisfied, we will recognize revenue for the portion satisfied and record a receivable for any fees that have not been received. Amounts are recorded as short-term collaboration receivables when our right to consideration is unconditional. A contract liability is recognized when a customer prepays consideration or owes payment to an entity in advance of our performance according to a contract. We do not assess whether a contract has a significant financing component if the expectation at contract inception is that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. We expense incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that we would have recognized is one year or less or the amount is immaterial.
Accrued Research and Development Expenses
As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. This process involves estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments, which would be recorded as a prepaid expense in other assets, or if there is the right of offset, offset against our liability balance with the counterparty. We make estimates of our accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known to us at that time. At each period end, we corroborate the accuracy of these estimates with the service providers and make adjustments, if necessary.
We record the expense and accrual related to research and development activities performed by our vendors based on our estimates of the services received and efforts expended considering a number of factors, including our knowledge of the progress towards completion of the research and development activities; invoicing to date under the contracts; communication from the vendors of any actual costs incurred during the period that have not yet been invoiced; and the costs included in the contracts and purchase orders. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or prepaid expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses.
Recently Adopted Accounting Pronouncements
A description of recently issued and adopted accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed within Note 2 of our unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and also in Note 2 to our audited consolidated financial statements and related notes in our Annual Report on Form 10-K for the year ended December 31, 2023.
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Emerging Growth Company and Smaller Reporting Company Status
We are an “emerging growth company,” under the JOBS Act. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of delayed adoption of new or revised accounting standards and, therefore, we will be subject to the same requirements to adopt new or revised accounting standards as private entities. As an emerging growth company, we may take advantage of certain exemptions and reduced reporting requirements under the JOBS Act. Subject to certain conditions, as an emerging growth company:
We will remain an emerging growth company until the earliest of (i) December 31, 2025, (ii) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more, (iii) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year, provided we have been subject to the Exchange Act for at least 12 calendar months and have filed at least one annual report pursuant to the Exchange Act or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. We may choose to take advantage of some but not all of these exemptions.
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
On the last business day of our second quarter in 2024, the aggregate market value of our shares of common stock held by non-affiliates exceeded $700 million. As a result, as of December 31, 2024, we will be considered a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, and we will cease to be an “emerging growth company” as defined in the JOBS Act. We will no longer be exempt from the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, and our independent registered public accounting firm will evaluate and report on the effectiveness of internal control over financial reporting. The Company will also no longer be permitted to take advantage of reduced reporting requirements for smaller reporting companies.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
There were no material changes to our market risks from those described in Part II Item 7A. Quantitative and qualitative disclosures about market risk in our Annual Report on Form 10-K for the year ended December 31, 2023.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Quarterly Report on Form 10-Q. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure
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that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives. Our disclosure controls and procedures have been designed to provide reasonable assurance of achieving their objectives. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of September 30, 2024.
Changes in Internal Controls Over Financial Reporting
There were no changes in the Company’s internal control over financial reporting identified in connection with the evaluation required by paragraph (d) of Exchange Act Rules 13a-15 or 15d-15 that occurred during the quarter ended September 30, 2024 that materially affected, or were reasonably likely to materially affect, the Company’s internal control over financial reporting.
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PART II—OTHER INFORMATION
項目1 控件1. 法律訴訟。
我們可能不時捲入訴訟或其他法律訴訟。無論結果如何，訴訟都可能對我們的業務、財務狀況、經營業績和前景產生不利影響，這是因爲軍工股和解決費用、管理資源分散以及其他因素。
我們目前並非在任何訴訟或法律訴訟中當事方，該訴訟據我們管理層認爲存在可能對我們業務產生重大不利影響。
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第1A項。風險因素。
投資我們的證券涉及高風險程度。除了《本季度10-Q表格》中提供的其他信息外，還應仔細考慮我們截至2023年12月31日年度10-K年度報告中第1A項「風險因素」中討論的風險因素，這可能會對我們的業務、財務狀況和/或未來業績產生重大影響。我們年度報告中描述的風險不是我們所面臨的唯一風險。我們目前不知道的額外風險和不被視爲重要的不確定性也可能對我們的業務、財務狀況和/或經營業績產生重大不利影響。
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項目1 控件M2.未註冊股票的銷售和款項的使用。
無。
項目1 控件M 3. 高級證券的違約。
無。
項目1 控件第四條. 礦山安全披露。
不適用。
項目1 控件第5節：其他信息。
內部人員不斷採用或終止交易安排
2024年9月30日結束的財政季度，我們的任何董事或高管都沒有告訴我們
項目1 控件第6號展品。
展示文件 數量 |
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Description |
3.1 |
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Tango Therapeutics, Inc.修訂後的第二份證明和修訂總公司規程，經修訂。（參照提交給美國證券交易委員會的2024年8月7日提交的第10-Q表的附件3.1）。 |
3.2 |
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Tango Therapeutics, Inc.修訂和重新規定的公司章程（參照提交給美國證券交易委員會的2021年10月14日提交的S-8表的附件4.2）。 |
31.1* |
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根據《證券交易法》第13a-14(a)和15d-14(a)條的規定，信安金融首席財務官的認證書，該規定根據2002年《薩班斯-奧克斯利法》第302條的規定採納。 |
31.2* |
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根據《證券交易法》第13a-14(a)條和第15d-14(a)條規定文件，信安金融主要財務負責人的認證，根據《薩班斯-奧克斯利法案》第302條通過。 |
32.1** |
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根據2002年薩班斯 - 豪利法案第906條，主要執行官的認證（根據18 U.S.C. Section 1350進行），豪利奧克斯利應用第32.1(a)項（第906條）的採納。 |
32.2** |
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101.INS |
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Inline XBRL實例文檔 - 該實例文檔未出現在交互式數據文件中，因爲XBRL標籤嵌入在Inline XBRL文檔中。 |
Inline XBRL擴展架構文檔 |
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內聯XBRL補充架構，帶有嵌入式鏈接基礎文檔。 |
104* |
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交易所頁面互動數據文件（以內聯XBRL格式，其中包含101號附錄中適用的分類目錄擴展信息） |
* 隨附文件。
** 本季度報告表格10-Q中附上的32.1號和32.2號展示的證明文件被視爲隨本報告一併提供，並不被視爲根據1934年修訂版證券交易法第18條目的「提交」，除非註冊人明確參考。
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SIG自然
根據1934年的證券交易法的要求，註冊人已經指定代表簽署本報告。
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特定拉藥物有限公司 |
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日期: 2024年11月6日 |
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通過： |
巴巴拉·魏伯 |
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巴巴拉·魏伯，醫生 |
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總裁兼首席執行官 |
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簽名：/s/ Ian Lee |
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Tango Therapeutics, Inc. |
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By: |
/s/ Daniella Beckman |
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Daniella Beckman |
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Chief Financial Officer |
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(Principal Financial Officer) |
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