美國

證券和交易委員會

華盛頓特區20549

表格10-Q

☒ 根據1934年證券交易法第13或15(d)節的季度報告

截至季度結束日期的財務報告2024年9月30日

或者

☐ 根據1934年證券交易法第13或15（d)條的轉型報告

過渡期從至

委員會檔案號 001-37368

ADAPTIMMUNE THERAPEUTICS PLC

（根據其章程規定的準確名稱）


英格蘭和威爾士	Not Applicable
（設立或組織的其他管轄區域）	(美國國稅局僱主識別號.)

60 千禧業工藝大道，米爾頓公園

阿賓登，牛津郡 OX14 4RX

英國

，（主要行政辦公地址）

(44) 1235 430000

(註冊人電話號碼，包括區號)

在法案第12(b)條的規定下注冊的證券：


每一類的名稱	交易代碼	在其上註冊的交易所的名稱

美國存託憑證，每股代表 6股普通股，每股普通股價值 £0.001	ADAP	該納斯達克全球貨幣選擇市場

請用勾號勾選以下內容：（1）在過去的12個月內（或者c註冊人所需要提交此類報告的更短期限內），c註冊人已經提交了根據1934年證券交易法第13或第15（d）條規定需要提交的全部報告；和（2）c註冊人在過去的90天內一直需要遵守此類提交要求。⌧ 是 ◻ 否

請通過勾選，指明註冊人是否在過去12個月內（或者在註冊人必須提交此類文件的較短時期內）提交了根據規則405的S-t條例（本章第232.405條）要求提交的每個互動數據文件。 ⌧ 是 ◻ 否

請通過勾選，指明註冊人是大型加速報告者、加速報告者、非加速報告者、較小報告公司還是新興成長公司。請參閱《交易所法》第120億.2條中對「大型加速報告者」、「加速報告者」、「較小報告公司」和「新興成長公司」的定義。


大型加速歸檔人◻	加速報告人◻
非加速文件提交人x	小型報告公司x
	新興成長公司☐

如果是新興成長公司，請勾選註冊人是否選擇不使用根據交易所法第13(a)節規定的任何新的或修訂的財務會計標準的延長過渡期。 ◻

請用勾號勾選以下內容：c註冊人是否是一個空殼公司（根據證券交易法規則12b-2中的定義）。☐ 是的 ⌧ 不是

截至2024年11月12日，註冊公司的每股面值爲£0.001的普通股未償還數量爲 1,535,299,242.


第一部分——財務信息		4

項目 1。	基本報表:	4

	截至2024年9月30日和2023年12月31日的未經審計的簡約合併資產負債表	4

	2024年和2023年截至9月30日的未經審計合併基本報表	5

	截至2024年和2023年9月30日的未經審計合併綜合收益/損失簡要報表（第三季度及九個月）	6

	截至2024年和2023年9月30日的未經審計合併股權變動簡要報表（第三季度及九個月）	7

	2024年9月30日和2023年的九個月未經審計的簡明現金流量表	9

	未經審計的簡明合併財務報表附註。	10

項目 2。	分銷計劃	27

項目 3。	有關市場風險的定量和定性披露	41

項目 4。	控制和程序	41

第二部分——其他信息		41

項目1。	法律訴訟	41

項目1A。	風險因素	41

項目 2.	未註冊的股票股權銷售和籌款用途	48

項目3。	對優先證券的違約	48

項目4.	礦山安全披露	48

項目5。	其他信息	49

項目6。	展示資料	49

簽名		50

基本信息

根據本表10-Q季度報告（「季度報告」），「Adaptimmune」，「集團」，「公司」，「我們」，「我們」和「我們」指的是Adaptimmune Therapeutics plc及其合併子公司，除非上下文另有要求。

關於前瞻性聲明的信息

這款電動三輪車提供了卓越的舒適度和支撐作用，減輕了騎手的背部和關節的壓力。它是尋求輕鬆騎行體驗而不影響性能和效率的人的絕佳選擇。後置電機可以在加減速時更好地控制和操縱，而前叉懸掛可最小化不平的路面對車輛的衝擊。此三輪車還配備了5英寸液晶屏、EB 2.0照明系統、可摺疊車把、胖胎、後差速器和停車剎車。此外，它還有一個拖車管，可以輕鬆地搬運大貨物。還有一個適用於身材較矮的騎手的Mini版本。季度報告包含涉及風險和不確定因素的前瞻性聲明，以及假設，如果這些假設從未實現或被證明不正確，可能導致我們的結果與這些前瞻性聲明所表達或暗示的結果大相徑庭。我們根據1995年《私人證券訴訟改革法案》和其他聯邦證券法的庇護規定作出這些前瞻性聲明。本季度報告中除了歷史事實陳述之外的所有陳述均爲前瞻性聲明。在某些情況下，您可以通過諸如「相信」，「可能」，「將」，「估計」，「持續」，「預期」，「期待」等詞來識別前瞻性聲明或這些詞的否定形式或其他類似術語。

本季度報告中的任何前瞻性陳述反映了我們對未來事件或未來財務業績的當前看法，涉及已知和未知風險、不確定性和其他因素，可能導致我們的實際結果、業績或成就與這些前瞻性陳述中表達或暗示的任何未來結果、業績或成就有實質差異。可能導致實際結果與當前預期有實質差異的因素包括，但不限於，我們在2023年12月31日止的年度10-K表格的第I部分第1A條「風險因素」中討論的事項。規定在2024年3月6日向證券交易委員會（「SEC」）提交。鑑於這些不確定性，您不應過度依賴這些前瞻性陳述。除非法律要求，我們不承擔因任何原因更新或修訂這些前瞻性陳述的義務，即使將來有新信息可用。

本季度本季度報告還包含有關我們行業、業務和某些疾病市場的估計、預測和其他信息，包括關於這些市場的估計規模、某些醫療狀況的發病率和流行率的數據。基於估計、預測、投影、市場研究或類似方法的信息固有地受到不確定性的影響，實際事件或情況可能與此信息反映的事件和情況有實質差異。除非另有明確聲明，我們獲得此行業、業務、市場和其他數據的來源包括第三方準備的報告、研究調查、研究以及類似數據，行業、醫療和一般出版物、政府數據和類似來源。

第一部分 — 財務信息

項目1.基本報表。

ADAPTIMMUNE THERAPEUTICS PLC

未經審計的簡明合併資產負債表

（單位：千美元，以股份數據爲單位）


	9月30日，		十二月31日，
	2024		2023
資產
流動資產
現金及現金等價物	$	116,741	$	143,991
可交易證券 - 可供出售的債務證券（攤餘成本爲$69,293 和 $2,940) 淨額減去預計信貸損失的準備金爲$0 和 $0		69,349		2,947
應收賬款，減預期信貸損失後的淨額爲$0 和$0		12,500		821
存貨淨額		1,874		—
其他流動資產和預付費用		43,750		59,793
總流動資產		244,214		207,552

Restricted cash		2,681		3,026
其他非流動資產		968		—
運營租賃使用權資產，扣除累計攤銷$17,243 和$13,220		20,494		20,762
不動產、廠房及設備，扣除累計折舊$55,697 和$46,020		44,796		50,946
無形資產淨額（攤銷數累計$89.5）5,525 和$5,155		4,283		330
總資產	$	317,436	$	282,616

負債和股東權益
流動負債
應付賬款	$	9,069	$	8,128
經營租賃負債，流動負債		4,175		5,384
應計費用及其他流動負債		31,504		30,303
遞延收入，流動		18,709		28,973
流動負債合計		63,457		72,788

非流動經營租賃負債		20,455		19,851
遞延收入，非流動		98,731		149,060
非流動借款		49,865		—
其他非流動負債		4,939		1,404
總負債		237,447		243,103

股東權益
普通股 - 普通股面值£0.001, 2,039,252,874授權和1,534,889,490 發行和未清償的 (2023: 1,702,760,280 授權並 1,363,008,102 發行並流通中)		2,084		1,865
股票認購應收款項。		1,102,813		1,064,569
其他綜合收益累計		(5,136)		(3,748)
累積赤字		(1,019,772)		(1,023,173)
股東權益合計		79,989		39,513

負債和股東權益總額	$	317,436	$	282,616

請參見附註的未經審計的簡明合併財務報表。

ADAPTIMMUNE THERAPEUTICS PLC

未經審計的摘要合併利潤表

(單位：千美元，除每股數據外)



	結束於三個月				截至九個月
	9月30日，				2023年9月30日
	2024		2023		2024		2023
營業收入	$	40,901	$	7,319	$	174,810	$	60,050
營業費用
研發		(34,304)		(37,788)		(109,959)		(93,301)
銷售、總務和管理費用		(21,277)		(16,164)		(60,092)		(56,634)
總營業費用		(55,581)		(53,952)		(170,051)		(149,935)
營運(虧損)/利潤		(14,680)		(46,633)		4,759		(89,885)
利息收入		2,096		2,149		4,817		4,368
利息支出		(1,109)		—		(1,635)		—
減價收購利得		—		(106)		—		22,049
其他收入（費用），淨額		(3,093)		(324)		(2,657)		(494)
所得稅費用前的（虧損）/利潤		(16,786)		(44,914)		5,284		(63,962)
所得稅費用		(831)		(687)		(1,883)		(1,992)
歸屬於普通股東的淨（損失）/利潤	$	(17,617)	$	(45,601)	$	3,401	$	(65,954)

每普通股的淨（損失）/利潤
基本	$	(0.01)	$	(0.03)	$	0.00	$	(0.06)
稀釋	$	(0.01)	$	(0.03)	$	0.00	$	(0.06)


加權平均股數：
基本		1,534,613,977		1,357,849,656		1,506,565,234		1,153,791,567
稀釋		1,534,613,977		1,357,849,656		1,537,021,778		1,153,791,567

請參見附註的未經審計的簡明合併財務報表。

ADAPTIMMUNE THERAPEUTICS PLC

未經審計的綜合收益/損失簡明綜合彙報表

(以千爲單位)



	結束於三個月				截至九個月
	2023年9月30日				九月30日
	2024		2023		2024		2023
淨虧損/利潤	$	(17,617)	$	(45,601)	$	3,401	$	(65,954)
其他綜合損益（稅後），淨額
外幣翻譯調整，淨稅後$0，和$0		(43,558)		24,359		(38,835)		(4,830)
長期投資性質的跨公司貸款貨幣兌換盈虧，稅後淨額爲$0，和 $0		41,777		(21,321)		37,396		4,794
可供出售債券的未實現持有收益（虧損），稅後$0，和$0		57		69		51		926
可供出售債務證券的收益再分類調整，稅後淨損失中已包含$0, $0，以及$0		—		87		—		87
本期的綜合(虧損)/利潤總額	$	(19,341)	$	(42,407)	$	2,013	$	(64,977)

請參見附註的未經審計的簡明合併財務報表。

ADAPTIMMUNE THERAPEUTICS PLC

未經審計的綜合股東權益變動表

（單位：千美元，以股份數據爲單位）


						累計的
						其他
						全面				總計
	常見	Common		額外		（虧損）。		積累的		股東權益
	股票	股票		資本溢價		收入		赤字		普通股及限制性股票單位進入
2024年1月1日的餘額	1,363,008,102	$	1,865	$	1,064,569	$	(3,748)	$	(1,023,173)	$	39,513

淨損失	—		—		—		—		(48,503)		(48,503)
其他綜合收益	—		—		—		1,028		—		1,028
股票期權行權發行的股票	6,297,720		8		66		—		—		74
根據市場銷售協議發行股票，扣除佣金和費用	163,669,056		208		28,953		—		—		29,161
基於股份的薪酬費用	—		—		3,102		—		—		3,102
截至2024年3月31日的餘額	1,532,974,878	$	2,081	$	1,096,690	$	(2,720)	$	(1,071,676)	$	24,375
淨利潤	—		—		—		—		69,521		69,521
其他綜合損失	—		—		—		(692)		—		(692)
股票期權行權發行的股票	1,245,726		2		—		—		—		2
根據市場銷售協議發行股票，扣除佣金和費用	—		—		10		—		—		10
基於股份的薪酬費用	—		—		3,058		—		—		3,058
截至2024年6月30日的餘額	1,534,220,604	$	2,083	$	1,099,758	$	(3,412)	$	(1,002,155)	$	96,274
淨損失	—		—		—		—		(17,617)		(17,617)
其他綜合損失	—		—		—		(1,724)		—		(1,724)
股票期權行使後股份發行	668,886		1		—		—		—		1
基於股份的薪酬支出	—		—		3,055		—		—		3,055
2024年9月30日的餘額	1,534,889,490	$	2,084	$	1,102,813	$	(5,136)	$	(1,019,772)	$	79,989

請參見附註的未經審計的簡明合併財務報表。

ADAPTIMMUNE THERAPEUTICS PLC

未經審計的簡明合併權益變動表

（單位：千美元，以股份數據爲單位）


						累計的
						其他
						全面				總計
	常見	Common		額外		（虧損）。		Accumulated		股東權益
	股票	股票		股本		收入		赤字		普通股及限制性股票單位進入
2023年1月1日餘額	987,109,890	$	1,399	$	990,656	$	(875)	$	(909,302)	$	81,878

淨利潤	—		—		—		—		1,036		1,036
其他綜合損失	—		—		—		(910)		—		(910)
股票期權行權發行的股票	6,035,574		7		1		—		—		8
公開發行完成後發行股份，扣除發行成本淨額	554,496		1		187		—		—		188
基於股份的薪酬費用	—		—		1,676		—		—		1,676
截至2023年3月31日的餘額	993,699,960	$	1,407	$	992,520	$	(1,785)	$	(908,266)	$	83,876
淨損失	—		—		—		—		(21,389)		(21,389)
其他全面虧損	—		—		—		(1,307)		—		(1,307)
股票期權行權發行的股票	698,778		1		13		—		—		14
在收購TCR時發行股票²	357,429,306		443		60,320		—		—		60,763
基於股份的薪酬費用	—		—		4,694		—		—		4,694
截至2023年6月30日的餘額	1,351,828,044	$	1,851	$	1,057,547	$	(3,092)	$	(929,655)	$	126,651
淨損失	—		—		—		—		(45,601)		(45,601)
行使股票期權後發行股份	—		—		—		3,194		—		3,194
根據市場銷售協議發行股票，減去佣金和費用	6,466,992		9		152		—		—		161
其他綜合收益	3,300,000		3		432		—		—		435
基於股票的報酬支出	—		—		3,289		—		—		3,289
截至2023年9月30日的餘額	1,361,595,036	$	1,863	$	1,061,420	$	102	$	(975,256)	$	88,129

請參見附註的未經審計的簡明合併財務報表。

ADAPTIMMUNE THAREUTICS

未經審計的簡明合併現金流量表

（以千計）


	九個月已經結束
	九月三十日
	2024		2023
經營活動產生的現金流
淨利潤/（虧損）	$	3,401	$	(65,954)
爲使淨虧損與經營活動中使用的淨現金相一致而進行的調整：
折舊		8,156		6,647
攤銷		234		322
特價購買的收益		—		(22,049)
基於股份的薪酬支出		9,215		8,692
未實現的外匯損失		3,164		709
可供出售債務證券的增加		(544)		(1,595)
其他		(104)		253
運營資產和負債的變化：
應收賬款和其他運營資產減少/（增加）		5,426		(709)
庫存增加		(1,869)		—
應付賬款和其他流動負債的增加/（減少）		1,173		(7,792)
非流動資產的增加		(926)		—
借款和其他非流動負債的增加		1,480		—
遞延收入減少		(67,808)		(44,728)
用於經營活動的淨現金		(39,002)		(126,204)

來自投資活動的現金流
購置財產、廠房和設備		(667)		(3,854)
收購無形資產		(880)		(199)
收購 TCR2 Therapeutics Inc. 產生的現金		—		45,264
有價證券的到期或贖回		—		139,243
投資有價證券		(65,701)		(73,026)
其他		129		913
淨現金（用於）/由投資活動提供		(67,119)		108,341

來自融資活動的現金流
發放借款所得的收益，扣除折扣		49,500		—
發行普通股的收益，扣除佣金和發行成本		29,171		623
行使股票期權的收益		77		183
融資活動提供的淨現金		78,748		806

貨幣匯率變動對現金、現金等價物和限制性現金的影響		(222)		527
現金、現金等價物和限制性現金淨減少		(27,595)		(16,530)
期初的現金、現金等價物和限制性現金		147,017		109,602
期末現金、現金等價物和限制性現金	$	119,422	$	93,072

見隨附的未經審計的簡明合併財務報表附註。

ADAPTIMMUNE THERAPEUTICS PLC

未經審計的縮編合併財務報表附註

註釋1—概述

adaptimmune therapeutics plc在英格蘭和威爾士註冊。其註冊辦公地址位於英國牛津郡阿賓登密爾頓公園千禧大道60號，郵編OX14 4RX。adaptimmune therapeutics plc及其子公司（統稱爲「Adaptimmune」或「公司」）是一家主要致力於應用電芯療法治療實體腫瘤癌症的商業化生物製藥公司。該公司獨有的平台使其能夠識別癌症靶點，找到並開發針對這些靶點有效的療法候選者，並生產治療候選者供患者使用。

公司面臨着許多與其他生物製藥公司在臨床開發階段類似的風險，包括但不限於：需要獲得足夠的額外資金、可能失敗的臨床前項目或臨床項目、需要爲其療法獲得上市批准、競爭對手正在開發新的技術創新、需要成功商業化並獲得市場接受其療法、需要開發可靠的商業化製造過程、需要商業化可能獲得上市批准的任何療法以及保護專有技術。如果公司無法成功商業化其任何療法，將無法產生產品收入或實現盈利能力。截至2024年9月30日，公司累計赤字爲 $1,019,772,000 。

注2— 重大會計政策摘要

(a) 報告基礎

Adaptimmune Therapeutics plc及其子公司的簡明合併財務報表及本季度報告中包含的其他財務信息是未經審計的，並按照美國通用會計準則（「U.S. GAAP」）編制，以美元表示。所有公司和子公司之間的重要公司間帳戶和交易在合併時已予以消除。

本季度報告中提供的未經審計的簡明合併財務報表應與公司2023年年度報告中包括的合併財務報表及附表一起閱讀。截至2023年12月31日的資產負債表來源於包括在公司2023年年度報告中的經審計合併財務報表，但不包括U.S. GAAP要求的所有披露。公司的重要會計政策在那些合併財務報表的附註2中有所描述。

根據U.S. GAAP編制的財務報表通常包括的某些信息和腳註披露已在這些中期財務報表中進行了簡化或省略。然而，這些中期財務報表包含了所有調整，僅包括在管理層看來必要的一般性回顧調整，以公正陳述中期期間的結果。中間結果未必預示全年業績。

(b) 使用中期財務報表中的估計

依據U.S. GAAP及SEC規定編制中期財務報表要求管理層進行估計和假設，這些對中期財務報表報告的資產和負債的金額，披露中期財務報表日期的或附條件的資產和負債的金額以及報告期內收入和支出的金額產生影響。在各個領域，包括遞延稅項的減值準備，收入確認，收購的資產的公允價值，承擔的負債以及商業組合中轉讓的代價，並且對於營運租賃的增量借款利率的估計中進行了估計和假設。如果實際結果與公司的估計有所不同，或者這些估計在未來期間進行調整，公司的運營結果可能受益，或者受到任何估計變化的不利影響。

(c) 公允價值計量

公司需披露所有以公允價值報告的資產和負債的信息，以便評估用於確定報告的公允價值的輸入。公允價值層級根據這些輸入的可觀察性質對估值輸入進行優先排序。該層級定義了三種估值輸入的級別：

一級 - 在活躍市場上，相同資產或負債的報價

2級 - 除了包含在1級的報價價格之外，還可觀察到的資產或負債的輸入，無論是直接還是間接

3級 - 不可觀察的輸入，反映公司對市場參與者在定價資產或負債時將使用的假設的自身假設

公司的現金及現金等價物、限制性現金、應收賬款、應付賬款和應計費用的賬面金額因這些工具的短期性質而接近公允價值。以公允價值計量的可交易證券的公允價值，每個報告期均有詳細說明，請參見附註6，公允價值計量。

(d) 重大信用風險集中

截至2024年9月30日，公司持有現金及現金等價物$116,741,000, 可流通證券$69,349,000 以及限制性現金$2,681,000 現金及現金等價物和限制性現金存放在多家銀行，公司監控這些銀行的信用評級。公司保持的現金餘額超過由美國聯邦存款保險公司保險的金額和英國金融服務賠償計劃的金額。公司的投資政策將投資限制於某些類型的工具，如貨幣市場工具、公司債務證券和商業票據，規定了到期限制和按類型及發行人集中度的限制，並指定了所有投資的最低信用評級和投資組合的平均信用質量。

公司three 截至2024年9月30日，客戶包括galapagos NV（「galapagos」）、基因泰克公司（Genentech, Inc.）和F.霍夫曼-拉羅氏有限公司（F. Hoffmann-La Roche Ltd）（統稱爲「基因泰克」）以及GSk。應收賬款爲$12,500,000 截至2024年9月30日爲$821,000 截至2023年12月31日。公司自2024年以來與galapagos進行交易，自2021年以來與Genentech交易，自2014年以來與GSk交易，在此期間未確認任何信用損失。截至2024年9月30日，沒有預期信用損失的準備金是基於截至2024年9月30日，關於其應收款項可能發生信用損失的可能性被認爲是微乎其微的。截止2024年9月30日，沒有來自Genentech的應收賬款，無論是應計還是開票，在2024年4月終止與Genentech的合作及許可協議（「Genentech合作協議」）後均不再可回收，該協議於2024年9月23日生效。

管理層分析當前和逾期帳戶，並根據收款經驗、客戶的信用評級以及其他相關信息確定是否需要計提信用損失準備。估計不可收回賬款的過程涉及假設和判斷，最終的不可收回應收款項金額可能超過所計提的金額。

(e) 新的會計準則

在當前期間採用

報告業務板塊披露的改進

2023年11月，財務會計準則委員會發布了ASU 2023-07 - 分部報告（主題280）- 可報告分部披露的改進，該項改進優化了分部披露的要求，主要通過增強重要分部費用的披露要求。改進後的披露要求適用於所有需要報告分部信息的公衆實體，包括僅有一個可報告分部的實體。一股已發行和流通的普通股。由於反向股票拆分，沒有發行任何零碎股份。相反，任何因拆分而產生的零碎股份將被向上調整至下一個整數。反向股票拆分對所有股東均有影響，並不會改變任何股東在中國製藥公司已發行普通股中的百分比權益，除了可能因零碎股份處理而導致的調整。所有股份和每股金額在隨附的未經審計的簡明合併財務報表中已追溯重述。公司在2024年1月1日開始的財年中採用了該指導原則。對公司已識別的可報告分部沒有影響，並已在附註15中包含了額外的披露要求。

在2024年3月，FASB發佈了ASU 2024-02 - 編纂改進——修訂以刪除對概念聲明的引用，包含了對編纂的修訂，移除了對各種FASB概念聲明的引用。該修訂適用於受影響會計指導範圍內的所有報告實體，並且對於在2024年12月15日之後開始的財政年度，公共商業實體必須遵守，允許所有實體提前採用。公司在2024年1月1日開始的財政年度中採用了該指導，該指導對公司的基本報表沒有影響。

將在未來期間採用

所得稅披露改進

在2023年12月，FASB發佈了ASU 2023-09 – 所得稅（主題740） – 所得稅披露的改進，主要改進了與稅率調解和已支付所得稅信息相關的所得稅披露。這包括使用百分比和報告貨幣金額的表格調解，涵蓋各種稅收和調解項目，以及對期間內已支付所得稅的分項摘要。對於公共商業實體，該指導對於在2024年12月15日之後開始的年度期間生效，允許提前採用。公司計劃在2025年1月1日開始的財政年度中採用該指導。公司目前正在評估該指導對其合併基本報表的影響。

(f) 貸款

公司僅認識以固定或可確定的日期到期的合同支付構成的貸款，這些貸款僅以現金等於其票面價值的形式發行，以票面價值入賬，票面金額與發行時收到的收益之間的差額作爲折扣或溢價列示。

這些票據隨後採用利息法計量，利息總額是公司實際收到的現金金額與約定償還的總金額之間的差額。某一期間的利息費用基於有效利率，該利率是根據合同現金流隱含的利率。票據的折扣或溢價在票據的生命週期內作爲利息費用攤銷，以產生恒定的利率。

(g) 存貨

公司在獲得監管批准或認爲可能會獲得批准後開始對存貨進行資本化。在此之前，公司將所有相關成本當作研發費用支出。公司資本化在其商業產品生產中發生的材料成本、勞務和相關間接費用。

公司以成本或可實現淨值中的較低者對存貨進行計量，採用先進先出法。公司每個報告期審查存貨的可回收性，以判斷由於存貨過剩、滯銷或過時而導致的可實現淨值的變化。如果可實現淨值低於成本，則存貨將被減記至可實現淨值，並將在營業成本中確認減值費用。

可以用於臨床或商業目的的存貨初步分類爲存貨。隨後指定用於臨床試驗並不再可用於商業產品的存貨，自其專門用於臨床用途時起，將作爲研發支出進行費用化。

《營收確認，與客戶的合同》註釋3 — 營業收入

該公司通過與客戶的合作協議產生開發營業收入。該公司在截至2024年9月30日的三個月和九個月內有 three 營業收入合同與客戶相比於兩截至2023年9月30日的三個月內客戶情況，以及三截至2023年9月30日的九個月內客戶情況：與GSk簽訂的終止和轉讓協議，該協議於2023年4月6日簽署（「終止和轉讓協議」）、與galapagos於2024年5月30日簽署的合作和許可協議（「galapagos合作協議」）、Genentech合作協議，以及與安斯泰萊製藥（adr）簽訂的合作協議（「安斯泰萊製藥合作協議」）已

自2023年3月6日起終止。基因泰克合作協議於2024年4月終止，隨後於2024年9月23日生效。

營業收入包括以下類別（以千爲單位）：


	截至三個月的時間				截至九個月的時間
	2023年9月30日，				2023年9月30日，
	2024		2023		2024		2023

開發營業收入	$	40,901	$	7,319	$	174,810	$	60,050
	$	40,901	$	7,319	$	174,810	$	60,050

No 截至2024年9月30日的三個月和九個月期間，營業收入來自於商業銷售。

遞延收入減少了$60,593,000 來自 $178,033,000 截至2023年12月31日減少至$117,440,000 截至2024年9月30日共有$ revenue recognized during the period，該收入在2023年12月31日的遞延收入中被包含。161,007,000 另外，減少了$9,130,000 由於英鎊與美元之間的匯率變動，從£1.00變動至$1.27 截至2023年12月31日，匯率爲£1.00至$1.34 截至2024年9月30日，匯率爲£1.00至$。這部分被$的支付所抵消。85,000,000 來自galapagos和多項里程碑，總計$9,673,000 來自GSk的款項在截至2024年9月30日的九個月內滿足並支付。

截至2024年9月30日，分配給根據協議未滿足或部分滿足的履行義務的交易價格的總金額爲$128,150,000.

galapagos合作與獨家許可協議

2024年5月30日，公司簽署了galapagos合作協議，一項與galapagos的臨床合作協議。該galapagos合作協議包括一個選項，允許galapagos獨家許可在galapagos去中心化製造平台上生產的TCR電芯治療候選藥物uza-cel，用於頭頸癌和未來潛在的實體瘤適應症。根據該galapagos合作協議，我們將進行臨床概念驗證試驗（「POC試驗」），評估在galapagos去中心化製造平台上生產的uza-cel在頭頸癌患者中的安全性和有效性。

公司將收到初始支付$100 百萬美元，包括$70 百萬的預付款和$30 百萬的研究和開發資金，其中 $15 百萬的預付款和$15 百萬將在首位患者在POC試驗中注射時到期，期權行使費用最高可達$100 百萬（該金額取決於行使選項的指示數量），額外的開發和銷售里程碑付款最高可達$465 百萬，以及淨銷售額的分級版稅。$70 百萬的預付款和$15 百萬的預先研究和開發資金於2024年6月收到。

公司確定galapagos是一個客戶，並在ASC 606下對協議進行了會計處理。 Revenue from Contracts with Customers公司已識別出與完成POC試驗所需的各種活動相關的履約義務，以及與專有許可選項相關的重大權利。

galapagos合作協議成立時的總體交易價格爲$100,000,000 包含$70,000,000 預付費和$30,000,000 研發資金。專有許可選項行使費和開發里程碑付款在2024年9月30日時不被視爲可能，因此未包含在交易價格中。療法未來銷售的銷售里程碑和版稅在2024年9月30日時未包含在交易價格中，因爲它們是基於銷售的，並將於後續銷售發生時確認。

總體交易價格根據履約義務的相對獨立銷售價格分配給履約義務。在確定相對獨立銷售價格的最佳估計時，公司考慮了其在談判合同中使用的內部定價目標，以及有關預計成本和這些成本的標準利潤的內部數據，用於完成POC試驗。由於公司以前沒有單獨銷售uza-cel，因此使用剩餘法來評估與專有許可選項相關的重大權利，並且尚未爲uza-cel確定價格。

公司預計會根據試驗的完成情況，逐步履行POC試驗義務，該完成基於對試驗已發生成本佔預期總成本的比例估算。分配給與獨家許可期權相關的實質權益的營業收入將從期權行使並將控制權交給galapagos或期權過期的時間點開始確認。

2024年9月30日，分配給未實現或部分實現的履約義務的交易價格金額爲$99,836,000，其中有44,236,000 分配給POC試驗履約義務的金額爲$55,600,000 分配給獨家期權的實質權益的金額爲$

Genentech合作與許可協議

2024年4月12日，公司宣佈終止Genentech合作協議，該協議由公司全資子公司Adaptimmune Limited簽署，涉及癌症靶向異基因T細胞療法的研究、開發和商業化，原定自2024年10月7日生效。終止按累積回顧法會計處理。終止沒有改變已確認的履約義務的性質，但導致交易價格減少，因爲在2024年10月7日後本已應收的額外付款和變量考慮現在將不會收到。

公司最初預計將滿足與初始的「現貨」合作目標和個性化療法相關的履約義務，並根據項目完成的百分比的估計來確認營業收入，該百分比是基於項目的成本佔項目總預期成本的百分比確定的。公司預計將滿足與指定額外「現貨」合作目標的材料權利相關的履約義務，從期權可能會被行使的時間點開始，然後隨着開發的進行，與最初的「現貨」合作目標保持一致，或在權利到期時。公司預計將滿足與延長研究期限的材料權利相關的履約義務，從期權可能會被行使的時間點開始，然後在延長期間內，或在權利到期時。

截至終止日期尚未確認的剩餘交易價格爲$146,301,000 ，其中包括截至變更日期尚未確認的剩餘遞延收入和有效終止日期之前將要收取的與合作相關的可變收入，仍被認爲是可能發生的。終止導致截至終止日期的累積回顧調整爲$101,348,000 以及進一步的$20,741,000 營收已在2024年第二季度確認。

2024年9月23日，Adaptimmune有限公司與Genentech簽署了一份相互解除和解決協議（「相互解除協議」）。該協議解決並釋放雙方與Genentech合作協議相關的任何歷史、現在和未來的爭端、索賠、要求和訴因，無論已知或未知。根據相互解除協議的條款，Genentech將向公司支付$12.5 Genentech合作協議一經終止，即於2024年9月23日立即生效。

相互解除協議導致所有剩餘履行義務已完全履行，剩餘的待確認營收爲25,298,000 和額外支付的12,500,000 均確認爲總營業收入$37,798,000 在2024年第三季度。

GSk終止和轉讓協議

2023年4月6日，公司與GSk簽署了終止和轉讓協議，涉及返回包括PRAME和 NY-ESO細胞療法項目在內的權利和材料。雙方將共同努力確保維持作爲 NY-ESO細胞療法項目一部分的進行中的lete-cel臨床試驗的患者的持續性。

作爲終止和轉讓協議的一部分，與NY-ESO細胞療法項目相關的IGNYTE和長期隨訪（LTFU）試驗的贊助和責任將轉讓給公司。作爲回報，公司將獲得一筆預付款£7.5 在2023年6月，在協議簽署後，和1,000萬英鎊的里程碑付款3 1,000萬英鎊12 1,000萬英鎊6 百萬英鎊1.5 在2023年9月和12月，以及2024年6月和8月，分別爲1,000萬英鎊。根據終止和轉讓協議，GSK無需支付其他費用。

公司確定葛蘭素史克是客戶，並已根據ASC 606考慮了終止和轉讓協議 與客戶簽訂合同的收入。終止和轉讓協議作爲一份獨立於與 GsK 簽訂的原始合作和許可協議的合同進行覈算。該協議於2022年10月終止，終止於2022年12月23日生效。公司已根據終止和轉讓協議確定了以下履約義務：（i）接管IGNYTE試驗的贊助以及（ii）接管LTFU試驗的贊助。

協議開始時的總交易價格爲美元37,335,000 包括總計 £30,000,000 預付款和里程碑付款。沒有將任何價值歸因於非現金對價，也沒有確定可變對價。根據履約義務的相對獨立銷售價格，將總交易價格分配給履約義務。在確定相對獨立銷售價格的最佳估計值時，該公司考慮了在合同談判中使用的內部定價目標，以及有關預期成本和這些成本的標準利潤率的內部數據，以完成試驗。分配給履約義務的交易價格金額在公司履行履約義務時予以確認。

公司預計，從贊助構成試驗的活躍試驗之日起，再到試驗完成期間，根據在給定期末轉診且迄今仍在積極註冊的患者人數與預計試驗持續時間內的活躍患者入組總期相比，公司希望在一段時間內履行業績義務。

該公司認爲，這描述了根據終止和轉移協議完成試驗的進展情況，因爲該試驗中患者的狀況不受公司可能做出的與自己開發NY-ESO細胞療法計劃有關的決定的直接影響。

截至2024年9月30日，分配給協議中未履行或部分履行的履約義務的交易價格金額爲美元28,314,000，其中 $11,744,000 分配給 IGNYTE 履約義務和 $16,570,000 分配給 LTFU 履約義務。

安斯泰來合作協議

公司和環球電池共同同意自2023年3月6日（「終止日期」）起終止安斯泰來合作協議。與終止有關的是，根據安斯泰來合作協議授予任何一方的所有許可和分許可自終止之日起終止。沒有與解僱相關的解僱處罰；但是，公司仍有權獲得在終止之日起30天內開展的研發工作的報銷。

終止是按累計補交計算的合同修改算作的。修改後未確定任何履約義務，因爲公司沒有提供更多的商品或服務，而且修改導致合作項下剩餘未履行和部分履行的履約義務得到充分履行。合約修改的總交易價格爲美元42,365,000 其中包括截至修改之日尚未被確認爲收入的剩餘遞延收入，以及將在生效之日後的30天期限結束時根據合作開具的剩餘報銷收入的可變對價。修改的交易價格已於2023年3月得到全額確認，並且有不分配給未履行或部分履行的履約義務的剩餘交易價格，不截至2024年9月30日，與安斯泰來合作協議相關的剩餘遞延收益以及不收入已於 2024 年確認。

注意事項 4 — 每股（虧損）/利潤

下表協調了基本計算和攤薄（虧損）/每股利潤（以千計）計算中的分子和分母：


	截至三個月的時間				截至九個月的時間
	2023年9月30日，				9月30日，
	2024		2023		2024		2023
基本和稀釋每股收益的分子
歸屬於普通股東的淨（虧損）/利潤	$	(17,617)	$	(45,601)	$	3,401	$	(65,954)
歸屬於普通股股東的淨利潤/虧損，用於基本和稀釋每股盈利/虧損	$	(17,617)	$	(45,601)	$	3,401	$	(65,954)


	截至三個月的時間結束		截至九個月的時間結束
	9月30日		9月30日，
	2024	2023	2024	2023
基本每股（虧損）/盈利的分母-加權平均股數	1,534,613,977	1,357,849,656	1,506,565,234	1,153,791,567
攤薄效應:
員工股票期權	—	—	30,456,544	—
每股稀釋（虧損）/利潤的分母	1,534,613,977	1,357,849,656	1,537,021,778	1,153,791,567

The dilutive effect of 132,452,050 和 259,677,864 weighted stock options outstanding for the three and nine months ended September 30, 2024 respectively, and 200,370,627 for the three and nine months ended September 30, 2023 have been excluded from the diluted (loss)/profit per share calculation for the three and nine months ended September 30, 2024 and 2023 because they would have an antidilutive effect on the (loss)/profit per share for the period.

注意事項 5 — Accumulated other comprehensive (loss)/income

The Company reports foreign currency translation adjustments and the foreign exchange gain or losses arising on the revaluation of intercompany loans of a long-term investment nature within Other comprehensive (loss) income. Unrealized gains and losses on available-for-sale debt securities are also reported within Other comprehensive (loss) income until a gain or loss is realized, at which point they are reclassified to Other (expense) income, net in the Condensed Consolidated Statement of Operations.

以下表格顯示累積其他全面（虧損）收入的變化情況（以千爲單位）：


	累計		累積			總計
	外國的		未實現的			累積
	貨幣翻譯(b)		(虧損)盈利 on			其他
	翻譯		可供出售			全面
	調整		債務證券			（虧損）收入

2024年1月1日的餘額	$	(3,754)	$	6	$	(3,748)
外幣換算調整		6,815		—		6,815
長期投資性質的公司間貸款外幣收益，稅後淨額爲$0		(5,782)		—		(5,782)
未實現的可供出售債務證券持有收益，稅後金額爲$0		—		(5)		(5)
2024年3月31日結存餘額	$	(2,721)	$	1	$	(2,720)
外幣翻譯調整		(2,091)		—		(2,091)
長期投資性質的公司間貸款外幣收益，稅後淨額爲$0		1,400		—		1,400
可供出售債務證券的未實現持有收益，稅後淨額爲0		—		(1)		(1)
2024年6月30日餘額	$	(3,412)	$	—	$	(3,412)
外幣翻譯調整		(43,558)		—		(43,558)
長期投資性質公司間貸款的外幣匯兌損失，扣稅淨額爲$0		41,777		—		41,777
可供出售債務證券未實現持有盈利，扣稅淨額爲$0		—		57		57
截至2024年9月30日的餘額	$	(5,193)	$	57	$	(5,136)

	累計		累計		總計
	外國的		未實現的		已經累積
	貨幣		（虧損）在		其他
	翻譯		可供出售		綜合
	調整		債務證券		(損失) 收入

2023年1月1日的餘額	$	55	$	(930)		(875)
外幣翻譯調整		(16,908)		—		(16,908)
長期投資性質的跨公司貸款的外匯收益，稅後淨額爲$0		15,526		—		15,526
可供出售債務證券的未實現持有收益，稅後開多$0		—		472		472
2023年3月31日的餘額	$	(1,327)	$	(458)	$	(1,785)
外幣換算調整		(12,281)		—		(12,281)
長期投資性質的跨公司貸款外匯損失，稅後淨額爲$0		10,590		—		10,590
未實現的可供出售債務證券持有損失，稅後金額爲$0		—		385		385
2023年6月30日的餘額	$	(3,018)	$	(73)	$	(3,091)
外幣翻譯調整		24,359		—		24,359
長期投資性質的公司間貸款外幣損失，稅後淨額爲$0		(21,321)		—		(21,321)
重新分類計入綜合收益的可供出售債務證券收益，在稅後淨損失中淨額。 $0		—		69		69
可供出售債務證券的未實現持有收益，稅後淨額爲$0		—		87		87
2023年9月30日的餘額	$	19	$	83	$	102

注6 — 公允價值衡量

截至2024年9月30日，按第1級、第2級和第3級公允價值計量標準，經常性公允價值計量的資產和負債如下（以千計）：


			公允價值計量使用
	2023年9月30日，		一級水平		2級		三級
	2024
被歸類爲現金等價物的資產：
美國國債	$	3,996	$	—	$	3,996	$	—

分類爲可供出售債務證券的資產：
機構債券	$	17,015	$	—	$	17,015	$	—
公司債務證券		17,172		17,172
美國國債證券		35,162		—		35,162		—
	$	69,349	$	17,172	$	52,177	$	—

公司利用第三方估值服務來估算可供出售債務證券的公允價值，該服務每天使用來自第三方提供者的實際交易和指示性價格來估算公允價值。如果沒有可觀察的市場價格（例如短期到期且二級市場交易不頻繁的證券），則使用最大化可觀察輸入的估值模型爲這些證券定價，包括市場利率期貨。

註釋 7 — 可流通證券 – 可供出售的債務證券

截至2024年9月30日，公司在可流通證券方面的投資如下（單位：千元）：


				毛		毛總		彙總
	剩餘	攤銷		未實現的		未實現		預計
	21. 分類合同到期	成本		收益		損失		公允價值
現金及現金等價物：
美國國債證券	少於3個月	$	3,996	$	—	$	—	$	3,996
		$	3,996	$	—	$	—	$	3,996

可供出售的債務證券：
代理債券	少於三個月	$	10,072	$	9	$	—	$	10,081
公司債務證券	少於3個月		15,172		3		(1)		15,174
美國國債	少於 3個月		18,867		13		—		18,880
機構債券	三個月至 1年		6,926		9		—		6,935
企業債務證券	3個月至 1年		1,994		3		—		1,997
美國國債	3個月至 1年		16,262		20		—		16,282
		$	69,293	$	57	$	(1)	$	69,349

截至2024年9月30日和2023年12月31日，公司持有的證券（包括現金等價物類別）處於未實現損失位置的總公允價值（以千計）和數量如下：



	2024年9月30日						2023年12月31日
	未實現虧損頭寸的投資公允市場價值		持有未實現損失頭寸的投資數量		未實現損失		持有未實現損失頭寸的投資的公允市場價值		持有未實現損失頭寸的投資數量		未實現損失
持續虧損不足12個月的可交易證券:
企業債券	$	1,481		1	$	—	$	1,600		1	$	(1)
	$	1,481		1	$	—	$	1,600		1	$	(1)

截至2024年9月30日，沒有已確認關於安防-半導體處於未實現損失位置的準備金。原因是未實現損失不嚴重，不佔投資總公允市場價值的重要比例，且該安防-半導體具有投資級信用評級。此外，公司無意出售處於未實現損失位置的債務證券，相信有能力持有債務證券直至到期，並且目前公司不太可能需要在攤銷成本恢復之前出售此安防-半導體。

Note 8 — 其他流動資產

其他流動資產如下（以千元爲單位）：


	2023年9月30日，		十二月31日，
	2024		2023
研發積分應收款	$	24,905	$	46,098
預付款項		14,164		9,954
臨床材料		97		1,329
增值稅應收款項		1,209		—
其他流動資產		3,375		2,412
	$	43,750	$	59,793

2024年1月19日，從HMRC收到了一份有關研究與開發稅收抵免的英鎊收據24.2一千一百萬美元（1,100,000美元，減$1000美元的返還盡職調查費用）30.8 百萬英鎊）與研究與開發稅收抵免相關的款項已收到。

Note 9 — 經營租賃

公司在辦公室、製造業和研發設施方面存在經營租賃。.

以下表格顯示了截至2024年9月30日和2023年的九個月的租賃成本，以及2024年和2023年9月30日時的加權平均剩餘租期和加權平均折扣率：


	截至九個月
	九月三十日，
	2024		2023
租金成本:
營運租賃成本	$	5,114	$	4,168
短期租賃成本		98		643
	$	5,212	$	4,811

	九月三十日，
	2024		2023

加權平均剩餘租期 - 經營租賃	6.9 年		5.6 年
經營租賃加權平均貼現率	10.1%		8.5%

2024年9月30日以及之后的營運租賃負債到期時間如下（以千元計算）：


	經營租約

2024	$	1,678
2025		5,715
2026		4,503
2027		4,335
2028		4,387
2028年後		12,306
總租賃付款		32,924
減：推算利息		(8,294)
租賃負債的現值	$	24,630

未啟動終止期權的最長租賃期為至2041年。

解決方案框架於2023年9月6日生效，截至2024年1月31日，原始約33億美元的解決方案責任和其他和解款項的大部分已經支付，詳情請參閱會計報表附註10。 — 應計費用和其他當前負債

應計費用及其他流動負債包括以下項目（千元）：


	九月三十日		十二月三十一日
	2024		2023
累積的臨床和研發支出	$	13,281	$	12,351
應付員工費用		11,276		13,226
應付增值稅		—		1,398
其他應計支出		5,780		3,277
其他		1,167		51
	$	31,504	$	30,303

注意 11 — 以股份為基礎的補償

下表顯示了未經審核的合併經營報表中包含的總以股份為基礎的補償費用（以千為單位）：


		截至三個月結束			截至九個月
		九月三十日，			九月三十日，
	2024		2023		2024		2023
研究與開發	$	1,069	$	789	$	2,878	$	2,190
銷售、一般及行政		1,985		2,394		6,337		6,506
	$	3,054	$	3,183	$	9,215	$	8,696

下表顯示了有關期權和具有名義行使價格的期權（類似於限制性股票單位(RSUs)）的資訊：


		截至三個月			截至九個月
		截至九月三十日			九月三十日，
	2024		2023		2024		2023
授予普通股的期權數量		10,856,580		7,082,892		54,839,004		59,070,294
普通股期權的加權平均公平價值	$	0.13	$	0.12	$	0.12	$	0.12
額外授予的名義行使價的期權數量		3,001,032		465,960		33,656,856		26,480,652
期權的加權平均公允價值，名義行使價為	$	0.16	$	0.15	$	0.15	$	0.27

附註12 — 股東權益

在2022年4月8日，公司與Cowen簽訂了一份銷售協議（"銷售協議"），根據該協議，我們可以不時通過Cowen以"市價"發行和出售美國預托股份（ADSs），總募集金額不超過$200 百萬。在截至2024年9月30日的九個月內，公司根據銷售協議出售了 27,278,176 ADSs，代表 163,669,056 普通股，為公司帶來淨收益$29,155,317 ，扣除根據銷售協議應支付的佣金和發行成本。截至2024年9月30日，約$156,228,841 尚可在銷售協議下出售。

注意 13 – 業務合併

在2023年3月6日，公司宣布進入一項最終協議，根據該協議將與TCR² Therapeutics Inc.（“TCR²”)以全股交易的方式創建一家專注於治療實體腫瘤的卓越電芯療法公司。TCR² 是一家位於美國麻薩諸塞州的T細胞療法公司，專注於治療實體腫瘤，擁有進行臨床試驗的臨床領域和前期管道。該組合為臨床開發和產品交付提供了大量好處，並得到互補科技平台的支持。

該交易於2023年5月30日獲得公司股東和TCR股東的批准，並於2023年6月1日生效。² 公司發行了 357,429,306 股份給予TCR²股東作為回報 100% 的TCR²的股票。因此，TCR² 及所有板塊內的TCR² 集團，成為該公司的全資子公司。在交易完成後，前TCR² 股東持有約 25% 的公司股份，而該公司原有的股東持有約 75%.

該公司被確定為收購方，TCR² 則為被收購方，2023年6月1日被確定為收購日期。

Table of Contents

The consideration transferred for TCR² includes the shares issued by the Company to former TCR² shareholders, plus the fair value of replacement awards of the Company granted to TCR² grantholders attributable to pre-combination vesting. The table below summarizes the consideration transferred and the amounts of the assets acquired and liabilities assumed recognized at the acquisition date:


Consideration transferred:
Fair value of 357,429,306 ordinary shares issued	$	60,763
Fair value of replacement options and RSU-style options granted attributable to pre-combination service:		963
Purchase consideration	$	61,726

Identifiable assets acquired and liabilities assumed:

Assets acquired
Cash and cash equivalents	$	43,610
Restricted cash		1,654
Marketable securities - available-for-sale debt securities		39,532
Other current assets and prepaid expenses		6,029
Property, plant and equipment		2,712
Operating lease right-of-use assets		5,145
Intangible assets		58
Total assets acquired	$	98,740

Liabilities assumed
Accounts payable		(6,210)
Accrued expenses and other current liabilities		(4,537)
Operating lease liabilities, current		(1,974)
Operating lease liabilities, non-current		(2,244)
Total liabilities assumed	$	(14,965)

Net assets acquired and liabilities assumed	$	83,775

The fair value of the 357,429,306 ordinary shares issued to TCR² stockholders of $60,763,000 was determined on the basis of the closing market price of $1.02 ($0.17 per ordinary share) of the Company’s ADSs as of May 31, 2023.

The assets acquired and liabilities assumed were measured based on management’s estimates of the fair value as of the acquisition date, excluding leases.

The lease contracts acquired by the Company relate to the rental of office and manufacturing spaces in which TCR² was the lessee. The Company retained TCR²’s previous classification of acquired leases as operating leases as there were no lease modifications as a result of the combination, with the exception of leases with a remaining lease term of 12 months or less at the acquisition date, for which no assets or liabilities were recognized at the acquisition date. The lease liabilities were measured at the present value of the remaining lease payments as if the leases were a new lease as of June 1, 2023, discounted using the incremental borrowing rate. The right-of-use assets were measured at the same amount as the lease liabilities, with adjustments to reflect favorable or unfavorable terms compared to market terms. No intangible assets were identified in relation to lease contracts acquired.

The table below summarises the calculation for the gain on bargain purchase, recognized in the Gain on bargain purchase line in the Consolidated Statement of Operations:


Gain on bargain purchase

Purchase consideration	$	(61,726)
Net assets acquired and liabilities assumed		83,775
Gain on bargain purchase	$	22,049

Table of Contents

The gain on bargain purchase above includes the impact of a $106,000 reduction recognized in the third quarter of 2023 following finalization of provisional amounts relating to replacement awards.

The transaction resulted in a gain on bargain purchase as the purchase consideration included in the agreement on March 6, 2023 comprising Company ADSs was based on a fixed ratio of 1.5117 of the Company’s ADSs to be issued for each TCR² stock acquired. As the transaction was an all-stock transaction, the value of the consideration was highly sensitive to changes in the Company’s ADS price. The price of a Company ADS fell from a closing price of $1.32 on March 6, 2023 compared to a closing price of $1.02 on May 31, 2023.

The amount of revenue and earnings of the combined entity for the nine months ended September 30, 2023, had the acquisition date been January 1, 2022, would be as follows:


	Nine months ended
	September 30, 2023
Revenue	$	60,050
Net loss		(129,684)

The supplemental pro forma earnings for the nine months ended September 30, 2023 were adjusted to exclude the $22.0 million Gain on bargain purchase, $7.3 million of acquisition-related costs recognized by the Company, as detailed below, and the $9.0 million of acquisition-related costs incurred by TCR² during that period. The supplemental pro forma earnings was adjusted to include the impact of replacement options issued, as if these had been issued as of January 1, 2022. Accordingly, the share-based compensation expense recognized by TCR² in the five months ended May 31, 2023 prior to the acquisition by the Company, of $1.0 million were excluded from the pro forma earnings.

TCR² did not generate revenue in the period from January 1, 2023 to June 30, 2023, as it had no contracts with customers, so there was no impact on the revenue included in the Company’s Consolidated Statement of Operations or in the supplemental pro forma revenue and earnings presented above.

The Company incurred the following acquisition-related costs that were recognized as an expense in 2023:


	Total
	acquisition-related
	costs
Legal, professional and accounting fees	$	5,174
Bankers' fees		2,172
Total acquisition-related costs	$	7,346

All acquisition-related costs that were recognized as an expense were recognized in General and administrative expenses in the Consolidated Statement of Operations. No issuance costs were incurred relating to the issuance of shares to TCR² stockholders.

Note 14 – Borrowings

On May 14, 2024 (the “Closing Date”), we entered into a Loan and Security Agreement (the “Loan Agreement”), with several banks and other financial institutions or entities and Hercules Capital, Inc. (“Hercules Capital”), for a term loan facility of up to $125.0 million (the “Term Loan”), consisting of a term loan advance in the aggregate principal amount equal to $25.0 million on the Closing Date (the “Tranche 1 Advance”), and three further term loan advances available to the Company subject to certain terms and conditions in aggregate principal amounts of $25.0 million, $5.0 million and $30.0 million, respectively, and a term loan advance available in the sole discretion of the lenders and subject to certain terms and conditions in the aggregate principal amount of $40.0 million. The proceeds of the Term Loan will be used solely to repay related fees and expenses in connection with the Loan Agreement and for working capital and general corporate purposes.

Table of Contents

The Term Loan attracts interest on the outstanding principal in the form of both cash and payment-in-kind (“PIK”) interest. The cash interest rate is the greater of the Prime Rate plus 1.15% and 9.65% and is paid monthly in arrears. The PIK interest rate is 2% per annum. The outstanding principal used to determine both the cash and PIK interest is inclusive of capitalized PIK interest. The Term Loan also attracts an End of Term Charge of 5.85% payable on maturity which is based on the aggregate original principal amount (i.e. excluding capitalized PIK interest).

The Term Loan matures on June 1, 2029 and payments are interest-only until the June 1, 2027 (the “Amortization Date”) after which the monthly payments include repayments of both principal and interest. The Amortization Date can be extended if certain criteria are met and the Company chooses to extend the date. The final Term Loan Maturity Date cannot be extended.

The Term Loan is secured by a lien on substantially all of Borrower’s existing or after-acquired assets, including intellectual property, subject to customary exceptions. In addition, the 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 Hercules Capital (the “Qualified Cash”) during the period commencing on January 1, 2025 (which initial commencement date is subject to adjustment if certain performance milestones are met) and at all times thereafter, provided that if the Company has achieved certain performance milestones, the amount of Qualified Cash is subject to certain reductions. The Loan Agreement also includes customary events of default, including payment defaults, breaches of covenants following any applicable cure period, the occurrence of certain events that could reasonably be expected to have a “material adverse effect” as set forth in the Loan Agreement, cross acceleration to third-party indebtedness and certain events relating to bankruptcy or insolvency.

Each loan tranche has been identified as a separate unit of account within the scope of ASC 835-30 Imputation of interest, with the Tranche 1 Advance constituting a debt instrument and the remaining tranches being loan commitments.

On May 14, 2024, the Company drew down the Tranche 1 Advance of $25,000,000 and received proceeds of $24,500,000 after charges payable to Hercules Capital. The Tranche 1 Advance was initially recognized at $24,750,000. On August 13, 2024, the Company drew down the Tranche 2 Advance of $25,000,000 (the “Tranche 2 Advance,” and, together with the Tranche 1 Advance, “Tranches” and each a “Tranche”) and received proceeds of $25,000,000. The Tranche 2 Advance was initially recognized at $24,750,000. At September 30, 2024 the face value of the outstanding principal (including capitalized PIK interest) on the Term Loan (including both Tranches) was $50,263,000, less unamortized discount of $485,000 and plus accreted value of the End of Term Charge of $87,000 based on the imputed interest rate of 13.7%. No qualifying debt issuance costs were incurred in relation to either Tranche.

At September 30, 2024, the fair value of the Term Loan is a Level 2 measurement considered to approximate its book value of $50.3 million due to the short period of time since the Term Loan was entered into and the interest rates upon which the terms of the Term Loan were based, notably the Prime Rate, have not changed significantly since the Tranches were drawn.

The aggregate maturity of the term loan for the next five years from September 30, 2024 is as follows:


	Maturity
2024	$	—
2025		—
2026		—
2027		12,767
2028		23,601
2029		17,909
Total principal repayments	$	54,277

Composition of principal repayments
Original principal	$	50,000
Capitalized PIK interest		4,277
Total principal repayments	$	54,277

The payments included in the table include capitalized PIK interest, as this forms part of the principal balance to be repaid once incurred. Payments relating to cash interest and the End of Term Charge are excluded as they do not constitute repayments of the principal.

Table of Contents

Note 15 – Segment reporting

The Company has one reportable segment relating to the research, development and commercialization of its novel cell therapies. The segment derives its current revenues from research and development collaborations.

The Company’s Chief Operating Decision Maker (the “CODM”), its Chief Executive Officer and the senior leadership team (comprising the Executive Team members and three senior vice presidents), manages the Company’s operations on an integrated basis for the purposes of allocating resources. When evaluating the Company’s financial performance, the CODM regularly reviews total revenues, total expenses and expenses by function and the CODM makes decisions using this information on a global basis.

The table below is a summary of the segment profit or loss, including significant segment expenses (in thousands):


	Three months ended				Nine months ended
	September 30,				September 30,
	2024		2023		2024		2023
Revenue	$	40,901	$	7,319	$	174,810	$	60,050
Less:
Research		(2,954)		(4,197)		(10,392)		(9,570)
CMC and Quality		(15,073)		(17,350)		(44,006)		(43,958)
Biomarkers		(1,196)		(980)		(6,482)		(3,432)
Development and Compliance		(11,279)		(13,128)		(38,765)		(32,165)
Infrastructure management and Facilities		(7,951)		(7,491)		(23,779)		(20,981)
Commercial		(4,404)		(550)		(10,849)		(1,976)
Support functions		(9,247)		(8,643)		(30,321)		(37,278)
Other segment expenses^(a)		(3,479)		(1,613)		(5,458)		(575)
Total operating expenses		(55,581)		(53,952)		(170,051)		(149,935)
Operating (loss)/profit		(14,680)		(46,633)		4,759		(89,885)

Interest income		2,096		2,149		4,817		4,368
Interest expense		(1,109)		—		(1,635)		—
Gain on bargain purchase		—		(106)		—		22,049
Other income (expense), net		(3,093)		(324)		(2,657)		(494)
Income tax expense		(831)		(687)		(1,883)		(1,992)
Segment and consolidated net (loss)/profit	$	(17,617)	$	(45,601)	$	3,401	$	(65,954)

^(a)Other segment expenses includes reimbursements receivable for research and development tax and expenditure credits, depreciation, amortization and share-based compensation expenses.

Note 16 – Inventories

On August 1, 2024, the Company received U.S. Food and Drug Administration (“FDA”) approval for TECELRA® (afamitresgene autoleucel) (“Tecelra”) for the treatment of advanced MAGE-A4+ synovial sarcoma in adults with certain HLA types who have received prior chemotherapy, and commenced capitalization of inventory from this date.

Prior to August 1, 2024, regulatory approval and subsequent commercialization of Tecelra, and thus the possibility of future economic benefits from Tecelra sales, were not considered probable and inventory-related costs were expensed as incurred; as such, the inventory recognized on the balance sheet does not included any pre-launch inventory. At September 30, 2024, the gross value of pre-launch inventory held but not recognized was $11,478,000, which includes inventory that could be used for either clinical or commercial purposes.

Table of Contents

The components of inventory are as follows:


	September 30,
	2024
Raw materials	$	1,741
Work-in-progress		132
Finished goods		—
Total inventory, net	$	1,874

In addition to the above, the Company recognized an asset of $1,866,000 at September 30, 2024 relating to pre-purchases of raw materials that are still under production and have not yet been delivered.

Note 17 – Subsequent events

On November 13, 2024 the Company announced a restructuring plan that aims to prioritize its commercial sarcoma franchise and certain research and development programs. As part of this restructuring, the Company is planning a 33% reduction in workforce. The planned reduction in workforce is subject to consultation with employee representatives in the UK regarding the plan. The Company anticipates that the majority of the reduction in workforce will be completed during the first quarter of 2025. The Company estimates that the pre-tax costs of such reduction in workforce relating to employee severance and other employee-related costs may be in the region of $9-11 million with the majority of such costs being incurred in the first quarter of 2025. It will provide further updates as it progresses through the restructuring process and once the costs and expenses of such restructuring are known.

Table of Contents

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 in conjunction with our unaudited consolidated financial statements and related notes appearing elsewhere in this Quarterly Report and the audited consolidated financial statements and notes thereto and management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2023, included in our Annual Report on Form 10-K that was filed with the SEC on March 6, 2024. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, 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 and our Annual Report on Form 10-K for the year ended December 31, 2023, our actual results could differ materially from the results described in, or implied by, these forward-looking statements.

Overview

We are a commercial-stage biopharmaceutical company working to redefine the treatment of solid tumor cancers with cell therapies. With the approval by the U.S. Food and Drug Administration (“FDA”) of our first biologics license application (“BLA”) for Tecelra® (afamitresgene autoleucel) (“Tecelra”), which is the first engineered cell therapy for a solid tumor cancer approved in the U.S., we are now focused on its launch and commercialization. Tecelra is a genetically modified autologous T-cell immunotherapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. This indication is approved under the FDA’s accelerated approval based on overall response rate (“ORR”) and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits from a confirmatory trial.

We are focussing on a strategic business plan and restructuring to prioritize our commercial sarcoma franchise and pre-clinical programs (PRAME and CD-70 programs) which we believe have the highest potential for return on invested capital and transformational benefit to patients. We remain commited to our collaboration with Galapagos for uza-cel. We are ceasing further investment in all non-core programs, including the SURPASS-3 trial in ovarian cancer. As a result of this re-focussing we are undertaking a reduction of headcount and expenses. We anticipate a reduction in headcount of approximately 33% with the majority of the headcount restructuring to be completed by the end of the first quarter of 2025.

Tecelra

We are focused on the launch and commercialization of Tecelra for the treatment of advanced synovial sarcoma and for which we received FDA approval on August 1, 2024. Nine Authorized Treatment Centers (“ATCs”) are available to initiate the treatment journey for our patients. The first patient has been apheresed and manufacture of Tecelra is underway. We are confident that the full network of approximately 30 ATCs will be active by the end of 2025, covering an estimated 80% of patients treated in sarcoma centers of excellence.

The approval of Tecelra was based on results of the SPEARHEAD-1 (Cohort 1) trial, which included 44 patients. The major efficacy outcome was ORR determined by independent review and supported by duration of response. Tecelra treatment resulted in an ORR of 43% with a complete response rate of 4.5%. The median duration of response was six months (95% CI: 4.6, not reached). Among patients who were responsive to the treatment, 39% had a duration of response of twelve months or longer.

Lete-cel

Lete-cel targets the NY-ESO antigen and has been in clinical trials (the IGNYTE-ESO trial) for people with synovial sarcoma and myxoid round cell liposarcoma (MRCLS). Final data for the IGNYTE-ESO trial were reported at the Connective Tissue Oncology Society Annual Meeting (“CTOS”) in November 2024 with an ORR of 42% across both synovial sarcoma and myxoid round cell liposarcoma (MRCLS) patients and with six patients having a complete response (6/64) as their best overall response. The median duration of response was just over a year. These data will form part of our planned rolling BLA submission for lete-cel, starting in 2025.

Table of Contents

Clinical and Pre-clinical Pipeline

*Synovial sarcoma, Malignant Peripheral Nerve Sheath Tumor (MPNST), Neuroblastoma, Osteosarcoma, Temporary suspension of enrolment as per protocol in SPEARHEAD-3 trial

**uzatresgene autoleucel, formerly ADP-A2M4CD8; SURPASS Ph 1 and SURPASS-3 trials are no longer enrolling. Adaptimmune and Galapagos to conduct a clinical proof-of- concept trial to evaluate the safety and efficacy of uza-cel produced on Galapagos’ decentralized manufacturing platform in patients with

head & neck cancer

We have a pediatric trial ongoing in the US in tumors expressing the MAGE-A4 antigen. Enrollment in this trial has been temporarily suspended as per protocol. Enrollment in our other ongoing clinical trials has ceased or been closed including the SURPASS-3 Phase 2 Trial in ovarian cancer.

We are currently focusing our preclinical pipeline on the development of T-cell therapies directed to PRAME (ADP-600) and CD70 (ADP-520).

●

PRAME is highly expressed across a broad range of solid tumors including ovarian, endometrial, lung and breast cancers. We are developing TCR T-cells directed to PRAME, with the initial candidate (ADP-600) currently in preclinical testing and next-generation candidates being developed over the longer term.

●

The CD70 program targets the CD70 antigen which is expressed across a range of hematological malignancies (acute myeloid leukemia and lymphoma) and solid tumors (renal cell carcinoma). We are using TRuC technology to develop a T-cell therapy (ADP-520) against CD70, with membrane bound IL-15 to enhance persistence. ADP-520 is currently in pre-clinical testing.

Corporate News

On September 23, 2024, we announced the entry into the Mutual Release Agreement between Adaptimmune and Genentech Inc and F. Hoffmann-La Roche Ltd. This Agreement amongst other things resolves and releases each party from any and all past, present and future disputes, claims, demands and causes of action, whether known or unknown, related to the Genentech Collaboration Agreement in any way. Under the terms of the Mutual Release Agreement the Collaboration Agreement is terminated and Genentech will pay $12.5 million.

On May 14, 2024, we entered into the Loan Agreement with several banks and other financial institutions or entities and Hercules Capital for a Term Loan of up to $125.0 million. The Tranche 1 advance of $25.0 million was drawn on the closing date of the Loan Agreement. The Tranche 2 advance was received on August 13, 2024 following the receipt of FDA approval for Tecelra.

Table of Contents

We are focussed on the prioritization of our commercial sarcoma franchise and certain research and development programs. As a result the Company is planning a 33% reduction in workforce. The planned reduction in workforce is subject to consultation with employee representatives in the UK regarding the plan. The Company anticipates that the majority of the reduction in workforce will be completed during the first quarter of 2025. The Company estimates that the pre-tax costs of such reduction in workforce relating to employee severance and other employee-related costs may be in the region of $9-11 million with the majority of such costs being incurred in the first quarter of 2025. It will provide further updates as it progresses through the restructuring process and once the costs and expenses of such restructuring are known.

Financial Operations Overview

Revenue

The Company had three customers in the three and nine months ended September 30, 2024, two customers in the three months ended September 30, 2023, and three customers in the nine months ended September 30, 2023: the Astellas Collaboration Agreement (until March 6, 2023), the Galapagos Collaboration Agreement (from May 30, 2024), the Genentech Collaboration Agreement and the GSK Termination and Transfer Agreement (from April 11, 2023).

The Astellas Collaboration Agreement

In January 2020, the Company entered into the Astellas Collaboration Agreement. The Company received $50.0 million as an upfront payment after entering into the Astellas Collaboration Agreement. Under the Astellas Collaboration Agreement the parties would agree on up to three targets and would co-develop T-cell therapies directed to those targets pursuant to an agreed research plan. For each target, Astellas would fund co-development up until completion of a Phase 1 trial for products directed to such target. In addition, Astellas was also granted the right to develop, independently of the Company, allogeneic T-cell therapy candidates directed to two targets selected by Astellas. Astellas would have sole rights to develop and commercialize products resulting from these two targets.

The Astellas Collaboration Agreement consisted of the following performance obligations: (i) research services and rights granted under the co-exclusive license for each of the three co-development targets and (ii) the rights granted for each of the two independent Astellas targets. The revenue allocated to the co-development targets was recognized as the development of products directed to the targets progressed up until completion of a Phase 1 trial. The revenue allocated to each of the research licenses for the targets being independently developed by Astellas was to be recognized when the associated license commenced, which was upon designation of a target by Astellas.

The Company and Universal Cells mutually agreed to terminate the Astellas Collaboration Agreement as of the Termination Date. In connection with the termination, all licenses and sublicenses granted to either party pursuant to the Collaboration Agreement ceased as of the Termination Date. There were no termination penalties in connection with the termination, however the Company was still entitled to receive reimbursement for research and development work performed up to and including a period of 30 days after the Termination Date.

The termination was accounted for as a contract modification and the modification resulted in the remaining unsatisfied and partially satisfied performance obligations under the collaboration becoming fully satisfied. The aggregate transaction price of the contract modification was $42.4 million, which was primarily comprised of deferred income relating to the third co-development target and the two independent targets, and was recognized in full in March 2023. No revenue was recognized for Astellas in 2024.

The Genentech Collaboration Agreement

On September 3, 2021, Adaptimmune Limited, a wholly-owned subsidiary of the Company, entered into the Genentech Collaboration Agreement. The collaboration has two components:

development of allogeneic T-cell therapies for up to five shared cancer targets; and

development of personalized allogeneic T-cell therapies utilizing αβ T-cell receptors (TCRs) isolated from a patient, with such therapies being administered to the same patient.

The parties would collaborate to perform a research program, initially during an eight-year period (which may be extended for up to two additional two-year terms at Genentech’s election upon payment of an extension fee for each two-year term), to develop the cell therapies, following which Genentech would determine whether to further develop and commercialize such therapies. The Company

Table of Contents

received an upfront payment of $150 million in October 2021 and milestone payments of $20 million and $15 million in December 2022 and 2023, respectively.

The Company identified the following performance obligations under the Genentech Collaboration Agreement: (i) research services and rights granted under the licenses for each of the initial “off-the-shelf” collaboration targets, (ii) research services and rights granted under the licenses for the personalized therapies, (iii) material rights relating to the option to designate additional “off-the-shelf” collaboration targets and (iv) material rights relating to the two options to extend the research term. The revenue allocated to the initial “off-the-shelf” collaboration targets and the personalized therapies was recognized as development progressed. The revenue allocated to the material rights to designate additional ‘off-the-shelf’ collaboration targets would have been recognized from the point that the options were exercised and then as development progressed, in line with the initial “off-the-shelf” collaboration targets, or at the point in time that the rights expired. The revenue from the material rights to extend the research term would have been recognized from the point that the options were exercised and then over the period of the extension, or at the point in time that the options expired.

On April 12, 2024, we announced the termination of the Genentech Collaboration Agreement. The termination was accounted for as a contract modification on a cumulative catch-up basis. The termination did not change the nature the performance obligations identified but resulted in a reduction of the transaction price as the additional payments and variable consideration that would have been due in periods after October 7, 2024 will now never be received. The termination resulted in a cumulative catch-up adjustment to revenue recognized at the date of the termination of $101.3 million.

On September 23, 2024, Adaptimmune Limited entered into a Mutual Release Agreement with Genentech. The Mutual Release Agreement, among other things, resolved and released each party from any and all past, present and future disputes, claims, demands and causes of action, whether known or unknown, related to the Genentech Collaboration Agreement in any way. Under the terms of the Mutual Release Agreement, Genentech will pay $12.5 million, upon which the Genentech Collaboration Agreement will be terminated. The Mutual Release Agreement was effective immediately as of September 23, 2024. The Mutual Release Agreement resulted in all remaining performance obligations being fully satisfied and the remaining deferred revenue and the additional payment were both recognized as total revenue of $37.8 million in the third quarter of 2024.

The GSK Termination and Transfer Agreement

On April 11, 2023, the Company announced its entry into the Termination and Transfer Agreement with GSK regarding the return to the Company of rights and materials comprised within the PRAME and NY-ESO cell therapy programs. The parties will work collaboratively to ensure continuity for patients in ongoing lete-cel clinical trials forming part of the NY-ESO cell therapy program.

As part of the Termination and Transfer Agreement, sponsorship of the ongoing IGNYTE and LTFU trials relating to the NY-ESO cell therapy program will transfer to the Company. In return for this, the Company received an upfront payment of £7.5 million in June 2023 following the execution of the Termination and Transfer Agreement and further milestone payments of £3 million, £12 million, £6 million and £1.5 million to the Company in September and December 2023 and June and August 2024, respectively. No further payments are due from GSK under the Termination and Transfer Agreement.

The Company has identified the following performance obligations under the Termination and Transfer Agreement: (i) to take over sponsorship and complete the IGNYTE trial and (ii) to take over sponsorship and complete the LTFU trial. The revenue allocated to both obligations is recognized over time from the point that sponsorship of the active trials that make up the trial transfer, based on the number of patients transferred and still actively enrolled to date on the trial at a given period-end relative to the total estimated periods of active patient enrollment over the estimated duration of the trial.

The Galapagos Collaboration and Exclusive License Agreement

On May 30, 2024, the Company entered into a the Galapagos Collaboration Agreement. The Galapagos Collaboration Agreement includes an option for Galapagos to exclusively license the TCR T-cell therapy candidate uza-cel, manufactured on Galapagos’s decentralized manufacturing platform, in head and neck cancer and potential future solid tumor indications. Under the Galapagos Collaboration Agreement, we will conduct a clinical proof-of-concept trial to evaluate the safety and efficacy of uza-cel produced on Galapagos’ decentralized manufacturing platform in patients with head and neck cancer.

Table of Contents

The Company will receive initial payments of $100 million, comprising $70 million upfront and $30 million of research and development funding, option exercise fees of up to $100 million (the amount depending on the number of indications in relation to which the option is exercised), additional development and sales milestone payments of up to a maximum of $465 million, plus tiered royalties on net sales. The $70 million upfront payment and $15 million of upfront research and development funding was received in June 2024.

The Company has identified a performance obligation relating to the various activities required to complete the POC trial and a material right associated with the exclusive license option. The Company expects to satisfy the POC Trial obligation over time over the period that the trial is completed, based on an estimate of the percentage of completion of the trial determined based on the costs incurred on the trial as a percentage of the total expected costs. The revenue allocated to the material right associated with the exclusive licence option will be recognized from the point that the option is either exercised and control of the license has passed to Galapagos or the option lapses.

Research and Development Expenses

Research and development expenditures are expensed as incurred. Research and development expenses consist principally of the following:

●

salaries for research and development staff and related expenses, including benefits;

●

costs for production of preclinical compounds and drug substances by contract manufacturers;

●

fees and other costs paid to contract research organizations in connection with additional preclinical testing and the performance of clinical trials;

●

costs associated with the development of a process to manufacture and supply our lentiviral vector and cell therapies for use in clinical trials;

●

costs to develop manufacturing capability at our U.S. facility for manufacture of cell therapies for use in clinical trials;

●

costs relating to facilities, materials and equipment used in research and development;

●

costs of acquired or in-licensed research and development which does not have alternative future use;

●

costs of developing assays and diagnostics;

●

an allocation of indirect costs clearly related to research and development;

●

amortization and depreciation of property, plant and equipment and intangible assets used to develop our cells therapies; and

●

share-based compensation expenses.

These expenses are partially offset by:

●

reimbursable tax and expenditure credits from the U.K. government.

Research and development expenditure is presented net of reimbursements from reimbursable tax and expenditure credits from the U.K. government.

As a company that carries out extensive research and development activities, we benefit from the U.K. research and development tax credit regime for small and medium sized companies (“SME R&D Tax Credit Scheme”), whereby our principal research subsidiary company, Adaptimmune Limited, is able to surrender the trading losses that arise from its research and development activities for a payable tax credit of up to approximately 18.6% of eligible research and development expenditures. Qualifying expenditures largely comprise employment costs for research staff, consumables and certain internal overhead costs incurred as part of research projects for which we do not receive income. Subcontracted research expenditures are eligible for a cash rebate of up to approximately 12.1%. A large

Table of Contents

proportion of costs in relation to our pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by Adaptimmune Limited, are eligible for inclusion within these tax credit cash rebate claims.

Expenditures incurred in conjunction with our collaboration agreements are not qualifying expenditures under the SME R&D Tax Credit Scheme but certain of these expenditures can be reimbursed through the U.K. research and development expenditure credit scheme (the “RDEC Scheme”). Under the RDEC Scheme tax relief is given at 20% of allowable research and development costs, which may result in a payable tax credit at an effective rate of approximately 15% of qualifying expenditure for the year ended December 31, 2024.

On July 18, 2023, the U.K. Government released draft legislation on proposed changes to the U.K. research and development regimes which was subsequently enacted on February 22, 2024. These changes include combining the current SME R&D Tax Credit Scheme and RDEC Schemes with a single 20% gross rate applying to all claims with an exception for R&D Intensive SMEs. For entities which qualify as R&D Intensive SMEs, a higher effective cash tax benefit of 27% will be available. The legislation also includes changes to other rules and types of qualifying expenditure, such as the treatment of subcontracted and overseas costs.

Our research and development expenses may vary substantially from period to period based on the timing of our research and development activities, which depends upon the timing of initiation of clinical trials and the rate of enrollment of patients in clinical trials. The duration, costs, and timing of clinical trials and development of our cell therapies will depend on a variety of factors, including:

●

the scope, rate of progress, and expense of our ongoing as well as any additional clinical trials and other research and development activities;

●

uncertainties in clinical trial enrollment rates;

●

future clinical trial results;

●

significant and changing government regulation;

●

the timing and receipt of any regulatory approvals; and

●

supply and manufacture of lentiviral vector and cell therapies for clinical trials.

A change in the outcome of any of these variables may significantly change the costs and timing associated with the development of that cell therapy. For example, if the FDA, or another regulatory authority, requires us to conduct clinical trials beyond those that we currently anticipate will be required for regulatory approval, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.

Selling, General and Administrative Expenses

Our general and administrative expenses consist principally of:

●

salaries for employees other than research and development staff, including benefits;

●

business development expenses, including travel expenses;

●

professional fees for auditors, lawyers and other consulting expenses;

●

selling and other costs relating to our commercial product;

●

costs of facilities, communication, and office expenses;

●

cost of establishing commercial operations;

●

information technology expenses;

●

amortization and depreciation of property, plant and equipment and intangible assets not related to research and development activities; and

Table of Contents

●

share-based compensation expenses.

Interest Income

Interest income primarily comprises interest on cash, cash equivalents and marketable securities.

Interest Expense

Interest expense primarily comprises loan interest on the Hercules Capital loan facility.

Other Income (Expense), Net

Other income (expense), net primarily comprises foreign exchange gains (losses). We are exposed to foreign exchange rate risk because we currently operate facilities in the United Kingdom and United States. Our expenses are generally denominated in the currency in which our operations are located, which are the United Kingdom and United States. However, our U.K.-based subsidiary incurs significant research and development costs in U.S. dollars and, to a lesser extent, Euros. Our U.K. subsidiary has an intercompany loan balance in U.S. dollars payable to the Comapny. Since July 1, 2019, the intercompany loan has been considered as being a long-term investment as repayment is not planned or anticipated in the foreseeable future. It is the Company’s intent not to request payment of the intercompany loan for the foreseeable future. The foreign exchange gains or losses arising on the revaluation of intercompany loans of a long-term investment nature are reported within other comprehensive (loss) income, net of tax.

Our results of operations and cash flows will be subject to fluctuations due to changes in foreign currency exchange rates, which could harm our business in the future. We seek to minimize this exposure by maintaining currency cash balances at levels appropriate to meet forthcoming expenditure in U.S. dollars and pounds sterling. To date, we have not used hedging contracts to manage exchange rate exposure, although we may do so in the future.

In addition to currency fluctuations, adverse macroeconomic conditions, including inflation, slower growth or recession, new or increased tariffs, changes to fiscal and monetary policy, tighter credit, and higher interest rates, could materially adversely affect the Company by, for example, driving higher input costs and/or impacting the Company’s ability to raise future financing.

Taxation

We are subject to corporate taxation in the United Kingdom and the United States. We typically incur tax losses and tax credit carryforwards in the United Kingdom on an annual basis. No net deferred tax assets are recognized on our U.K. losses and tax credit carryforwards because there is currently no indication that we will make sufficient taxable profits to utilize these tax losses and tax credit carryforwards. The rate of U.K. corporation tax is 25% for the year ended December 31, 2024.

We benefit from reimbursable tax credits in the United Kingdom through the SME R&D Tax Credit Scheme as well as the RDEC Scheme which are presented as a deduction to research and development expenditure.

Our pre-existing subsidiary in the United States, Adaptimmune LLC, has generated taxable profits due to a Service Agreement between our U.S. and U.K. operating subsidiaries and is subject to U.S. federal corporate income tax of 21%. Due to its activity in the United States, and the sourcing of its revenue, the Adaptimmune LLC is not currently subject to any state or local income taxes. The Company also benefits from the U.S Research Tax Credit and Orphan Drug Credit.

TCR² has incurred net losses since acquisition and generates research and development tax credits. TCR²’s operating loss and tax credit carryforwards and other tax attributes are reduced by a valuation allowance to the amount supported by reversing taxable temporary differences because there is currently no indication that we will make sufficient taxable profits to utilize these deferred tax assets.

In the future, if we generate taxable income in the United Kingdom, we may benefit from the United Kingdom’s “patent box” regime, which would allow certain profits attributable to revenues from patented products to be taxed at a rate of 10%. As we have many different patents covering our products, future upfront fees, milestone fees, product revenues, and royalties may be taxed at this favorably low tax rate.

Table of Contents

U.K. Value Added Tax (“VAT”) is charged on all qualifying goods and services by VAT-registered businesses. An amount of 20% of the value of the goods or services is added to all relevant sales invoices and is payable to the U.K. tax authorities. Similarly, VAT paid on purchase invoices paid by Adaptimmune Limited and the Company is reclaimable from the U.K. tax authorities.

Critical Accounting Policies and Significant Judgments and Estimates

The preparation of our unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities, and the revenues and expenses incurred during the reported periods. We base our estimates on historical experience and on various other factors that we believe are relevant under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The accounting policies considered to be critical to the judgments and estimates used in the preparation of our financial statements are disclosed in the Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our 2023 Annual Report.

In addition, the following estimate was considered to be critical to the judgements and estimates used in the preparation of our financial statements for the nine months ending September 30, 2024.

Allocation of transaction price using the relative standalone selling price

Upfront and other payments included in the transaction price of a contract are allocated between performance obligations using the Company’s best estimate of the relative standalone selling price of the performance obligation. The relative standalone selling price is estimated by determining the market values of development and license obligations. As these inputs are not directly observable, the estimate is determined considering all reasonably available information including internal pricing objectives used in negotiating the contract, together with internal data regarding the cost and margin of providing services for each deliverable, taking into account the different stage of development of each development program and consideration of adjusted-market data from comparable arrangements, where applicable and available. This assessment involves significant judgment and could have a significant impact on the amount and timing of revenue recognition.

An assessment of the allocation of transaction price using the relative standalone selling price was required in the nine months ending September 30, 2024 and 2023 for the Galapagos Collaboration Agreement and the GSK Termination and Transfer Agreement, respectively, although the assessment for the GSK Termination and Transfer Agreement in 2023 was not considered to be a significant estimate.

Results of Operations

Comparison of three months ended September 30, 2024 and 2023

The following table summarizes the results of our operations for the three months ended September 30, 2024 and 2023, together with the changes to those items (in thousands):


	Three months ended
	September 30,
	2024		2023		Increase/decrease
Revenue	$	40,901	$	7,319	$	33,582	459	%
Research and development expenses		(34,304)		(37,788)		3,484	(9)	%
Selling, general and administrative expenses		(21,277)		(16,164)		(5,113)	32	%
Total operating expenses		(55,581)		(53,952)		(1,629)	3	%
Operating loss		(14,680)		(46,633)		31,953	(69)	%
Interest income		2,096		2,149		(53)	(2)	%
Interest expense		(1,109)		—		(1,109)	—	%
Gain on bargain purchase		—		(106)		106	(100)	%
Other (expense) income, net		(3,093)		(324)		(2,769)	855	%
Loss before income tax expense		(16,786)		(44,914)		28,128	(63)	%
Income tax expense		(831)		(687)		(144)	21	%
Loss for the period	$	(17,617)	$	(45,601)	$	27,984	(61)	%

Table of Contents

Revenue

Revenue increased by $33.6 million to $40.9 million for the three months ended September 30, 2024 compared to $7.3 million for the three months ended September 30, 2023. The increase is primarily due to the termination of the Genentech Collaboration Agreement in April 2024 and subsequent Mutual Release Agreement, resulting in the remaining deferred revenue of $25 million, representing deferred revenue at June 30, 2024, and $12.5 million payment, being recognized as revenue in the current quarter. The remaining revenue in the three months ended September 30, 2024 relates to the GSK and Galapagos agreements, whereas the revenue in the three months ended September 30, 2023 related to Genentech.

Research and Development Expenses

Research and development expenses decreased by 9% to $34.3 million for the three months ended September 30, 2024 from $37.8 million for the three months ended September 30, 2023.

Our research and development expenses comprise the following (in thousands):


	Three months ended
	September 30,
	2024		2023		Increase/decrease
Salaries, materials, equipment, depreciation of property, plant and equipment and other employee-related costs⁽¹⁾	$	23,245	$	22,405	$	840	4	%
Subcontracted expenditure		10,551		16,604		(6,053)	(36)	%
Manufacturing facility expenditure		2,025		2,049		(24)	(1)	%
Share-based compensation expense		1,070		789		281	36	%
In-process research and development costs		13		10		3	30	%
Reimbursements receivable for research and development tax and expenditure credits		(2,600)		(4,069)		1,469	(36)	%
	$	34,304	$	37,788	$	(3,484)	(9)	%

(1)

These costs are not analyzed by project since employees may be engaged in multiple projects simultaneously.

The net decrease in our research and development expenses of $3.5 million for the three months ended September 30, 2024 compared to the same period in 2023 was primarily due to the following:

●

a decrease of $6.1 million in subcontracted expenditure due primarily to a decrease in clinical trial expenses relating to TCR² as the TCR² programs wind down, offset by an increase in vector manufacturing; offset by

●

a decrease of $1.5 million in offsetting reimbursements receivable for research and development tax and expenditure credits due to decreases in the associated research and development costs for which the credits may be claimed.

Our subcontracted costs for the three months ended September 30, 2024 were $10.6 million, compared to $16.6 million in the same period in 2023. This includes $8.7 million of costs directly associated with our afami-cel, lete-cel and uza-cel T-cells and $1.9 million of other development costs.

Table of Contents

Selling, General and Administrative Expenses

Selling, general and administrative expenses increased by 32% to $21.3 million for the three months ended September 30, 2024 from $16.2 million in the same period in 2023. Our selling, general and administrative expenses consist of the following (in thousands):


	Three months ended
	September 30,
	2024		2023		Increase/decrease
Salaries, depreciation of property, plant and equipment and other employee-related costs	$	9,922	$	8,237	$	1,685	20	%
Other corporate costs		9,181		5,533		3,648	66	%
Share-based compensation expense		1,985		2,394		(409)	(17)	%
Commercial expenses		189		—		189	—	%
	$	21,277	$	16,164	$	5,113	32	%

The net increase in our selling, general and administrative expenses of $5.1 million for the three months ended September 30, 2024 compared to the same period in 2023 was largely due to an increase of:

●

$1.7 million in salaries, depreciation of property, plant and equipment and other employee-related costs, due primarily to increased travel and training costs, primarily due to commercialization-related activities; and

●

$3.6 million in other corporate costs due to an increase in accounting, legal and professional fees, due to a combination of fees relating to business development work and fees relating to preparation for commercialization.

Income Taxes

Income taxes arise in the United States due to Adaptimmune LLC generating taxable profits. We typically incur taxable losses in the United Kingdom on an annual basis and have incurred losses in TCR² since the acquisition.

Comparison of nine months ended September 30, 2024 and 2023

The following table summarizes the results of our operations for the nine months ended September 30, 2024 and 2023, together with the changes to those items (in thousands):


	Nine months ended
	September 30,
	2024		2023		Increase/decrease
Revenue	$	174,810	$	60,050	$	114,760	191	%
Research and development expenses		(109,959)		(93,301)		(16,658)	18	%
Selling, general and administrative expenses		(60,092)		(56,634)		(3,458)	6	%
Total operating expenses		(170,051)		(149,935)		(20,116)	13	%
Operating profit/(loss)		4,759		(89,885)		94,644	(105)	%
Interest income		4,817		4,368		449	10	%
Interest expense		(1,635)		—		(1,635)	—	%
Gain on bargain purchase		—		22,049		(22,049)	(100)	%
Other (expense) income, net		(2,657)		(494)		(2,163)	438	%
Profit/(loss) before income tax expense		5,284		(63,962)		69,246	(108)	%
Income tax expense		(1,883)		(1,992)		109	(5)	%
Profit/(loss) for the period	$	3,401	$	(65,954)	$	69,355	(105)	%

Table of Contents

Revenue

The revenue recognized in the nine months ended September 30, 2024 relates to development revenue under the Genentech Collaboration Agreement, the Galapagos Collaboration Agreement and the GSK Termination and Transfer Agreement whereas the revenue in the nine months ended September 30, 2024 relates to development revenue under the Genentech Collaboration Agreement and the Astellas Collaboration Agreement.

Revenue increased by $114.8 million to $174.8 million in the nine months ended September 30, 2024 compared to $60.1 million for the nine months ended September 30, 2023 primarily due to the termination of the Genentech Collaboration Agreement in April 2024, resulting in a cumulative catch-up adjustment of $101.3 million and the subsequent Mutual Release Agreement, resulting in the remaining deferred revenue and additional payment, being recognized as $37.8 million of revenue in the third quarter of 2024, compared to the termination of the Astellas Collaboration Agreement in the first quarter of 2023, which resulted in the remaining deferred revenue for the collaboration of $42.4 million being recognized as revenue in March 2023.

Total revenue from Genentech and GSK in the nine months ended September 30, 2024 was $163.9 million and $10.7 million respectively, compared to $16.1 million from Genentech and $44.0 million from Astellas in the nine months ended September 30, 2023. The revenue recognized in 2024 and 2023 for Genentech and Astellas, respectively, includes the impact of the events noted above, as well as revenue recognized as research and development work for the collaborations was performed.

Research and Development Expenses

Research and development expenses increased by 18% to $110.0 million for the nine months ended September 30, 2024 from $93.3 million for the nine months ended September 30, 2023.

Our research and development expenses comprise the following (in thousands):


	Nine months ended
	September 30,
	2024		2023		Increase/decrease
Salaries, materials, equipment, depreciation of property, plant and equipment and other employee-related costs⁽¹⁾	$	72,359		62,120	$	10,239	16	%
Subcontracted expenditure		35,970		37,249		(1,279)	(3)	%
Manufacturing facility expenditure		7,197		5,441		1,756	32	%
Share-based compensation expense		2,878		2,190		688	31	%
In-process research and development costs		34		(1,853)		1,887	(102)	%
Reimbursements receivable for research and development tax and expenditure credits		(8,479)		(11,846)		3,367	(28)	%
	$	109,959	$	93,301	$	16,658	18	%

(1)

These costs are not analyzed by project since employees may be engaged in multiple projects simultaneously.

The net increase in our research and development expenses of $16.7 million for the nine months ended September 30, 2024 compared to the same period in 2023 was primarily due to the following:

●

an increase of $10.2 million in salaries, materials, equipment, depreciation of property, plant and equipment and other employee-related costs, which is driven primarily by an increase in the average number of employees engaged in research

Table of Contents

and development following the acquisition of TCR² in June 2023 and annual salary increases, and increased costs relating to property due to additional lease properties acquired following the acquisition of TCR²;

●

an increase of $1.8 million in manufacturing facility expenditure due to the consumption of batches of clinical materials that had not previously been impaired, compared to 2023 where clinical materials consumed were primarily those that had been impaired to nil in previous years and therefore no corresponding expense was recognised;

●

an increase of $1.9 million in in-process research and development costs due to a credit of $1.9 million in 2023 that was not repeated in 2024; and

●

a decrease of $3.4 million in reimbursements receivable for research and development tax and expenditure credits due to decreases in the associated research and development costs for which the credits may be claimed and a reduction in the effective rate at which the tax credits can be claimed which was effective from April 1, 2023; offset by

●

a decrease of $1.3 million on subcontracted expenditure primarily due to a reduction in outsourced research costs.

Our subcontracted costs for the nine months ended September 30, 2024 were $36.0 million, compared to $37.2 million in the same period of 2023. This includes $26.7 million of costs directly associated with our afami-cel, lete-cel and uza-cel T-cells and $9.3 million of other development costs.

Selling, General and Administrative Expenses

Selling, general and administrative expenses increased by 6% to $60.1 million for the nine months ended September 30, 2024 from $56.6 million in the same period in 2023. Our selling, general and administrative expenses consist of the following (in thousands):


	Nine months ended
	September 30,
	2024		2023		Increase/decrease
Salaries, depreciation of property, plant and equipment and other employee-related costs	$	29,930	$	28,901	$	1,029	4	%
Restructuring charges		—		1,703		(1,703)	(100)	%
Other corporate costs		27,436		22,002		5,434	25	%
Share-based compensation expense		6,337		6,506		(169)	(3)	%
Commercial expenses		189		—		189	—	%
Reimbursements		(3,800)		(2,478)		(1,322)	53	%
	$	60,092	$	56,634	$	3,458	6	%

The net decrease in our selling, general and administrative expenses of $3.5 million for the nine months ended September 30, 2024 compared to the same period in 2023 was largely due to:

●

a reduction in restructuring charges of $1.7 million, which related to the restructuring programme completed in the first quarter of 2023; offset by

●

an increase of $5.4 million in other corporate costs due to an increase in accounting, legal and professional fees, due primarily to a combination of fees relating to business development work and fees relating to preparation for commercialization.

Gain on Bargain Purchase

The gain on bargain purchase arose in June 2023 from the strategic combination with TCR² on June 1, 2023.

Table of Contents

Liquidity and Capital Resources

Sources of Funds

Since our inception, we have incurred significant net losses and negative cash flows from operations. We financed our operations primarily through sales of equity securities, cash receipts under our collaboration arrangements and research and development tax and expenditure credits. From inception through to September 30, 2024, we have raised:

●

$900.2 million, net of issuance costs, through the issuance of shares;

●

$49.5 million, net of discount, drawn from the Hercules Capital loan facility;

●

$533.3 million through collaborative arrangements with Galapagos, Genentech, GSK and Astellas;

●

$141.3 million in the form of reimbursable U.K. research and development tax credits and receipts from the U.K. RDEC Scheme; and

●

$45.3 million in cash and cash equivalents and restricted cash and $39.5 million of marketable securities acquired as part of the strategic combination with TCR².

We use a non-GAAP measure, Total Liquidity, which is defined as the total of cash and cash equivalents and marketable securities, to evaluate the funds available to us in the near-term. A description of Total Liquidity and reconciliation to cash and cash equivalents, the most directly comparable U.S. GAAP measure, are provided below under “Non-GAAP measures”.

As of September 30, 2024, we had cash and cash equivalents of $116.7 million and Total Liquidity of $186.1 million.

Cash Flows

The following table summarizes the results of our cash flows for the nine months ended September 30, 2024 and 2023 (in thousands):


		Nine months ended
		September 30,
	2024		2023
Net cash used in operating activities	$	(39,002)	$	(126,204)
Net cash (used in)/provided by investing activities		(67,119)		108,341
Net cash provided by financing activities		78,748		806
Cash, cash equivalents and restricted cash		119,422		93,072

Operating Activities

Net cash used in operating activities was $39.0 million for the nine months ended September 30, 2024 compared to net cash used in operating activities of $126.2 million for the nine months ended September 30, 2023. Our activities typically result in net use of cash in operating activities. The net cash used in operating activities for the nine months ended September 30, 2024 decreased primarily due to the receipt of research and development credits of $30.8 million, an $85 million upfront payment from Galapagos and $9.7 million milestone payments from GSK which was offset by an increase in operating expenditures.

Net cash used in operating activities of $39.0 million for the nine months ended September 30, 2024 comprised a net profit of $3.4 million and a net cash outflow of $62.5 million from changes in operating assets and liabilities, offset by non-cash items of $20.1 million. The changes in operating assets and liabilities include the impact of a $21.5 million decrease in reimbursements receivable for research and development tax credits and the recognition of deferred revenue following the termination of the Genentech Collaboration

Table of Contents

Agreement. The non-cash items consisted primarily of depreciation expense on plant and equipment of $8.2 million, share-based compensation expense of $9.2 million, unrealized foreign exchange losses of $3.2 million and other items of $0.4 million.

Investing Activities

Net cash used in investing activities was $67.1 million for the nine months ended September 30, 2024 compared to $108.3 million provided investing activities for the nine months ended September 30, 2023. The net cash used in or provided by investing activities for the respective periods consisted primarily of:

●

purchases of property, plant and equipment of $0.7 million and $3.9 million for the nine months ended September 30, 2024 and 2023, respectively. Purchases of property, plant and equipment were higher in 2023 compared to 2024 due to the expansion of our manufacturing facilities, which was largely completed in 2022 and finalized in 2023;

●

purchases of intangible assets of $0.9 million and $0.2 million for the nine months ended September 30, 2024 and 2023, respectively;

●

investments in marketable securities of $65.7 million in the nine months ended September 30, 2024 compared to $73.0 million in the nine months ended September 30, 2023; and

●

there were no cash inflows from maturity or redemption of marketable securities in the nine months ended September 30, 2024 compared to $139.2 million for the nine months ended September 30, 2023.

The Company invests surplus cash and cash equivalents in marketable securities.

Financing Activities

Net cash provided by financing activities was $78.7 million and $0.8 million for the nine months ended September 30, 2024 and 2023, respectively. The net cash provided by financing activities in the nine months ended September 30, 2024 consisted of net proceeds of $29.2 million from shares issued in an ATM offering, net of commissions and issuance costs, and $49.5 million proceeds from the issuance of borrowings, net of discount. The net cash provided by financing activities in the nine months ended September 30, 2023 consisted primarily of net proceeds of $0.6 million from shares issued in an ATM offering, net of commissions and issuance costs.

Non-GAAP Measures

Total Liquidity

Total Liquidity (a non-GAAP financial measure) is the total of cash and cash equivalents and marketable securities. Each of these components appears in the condensed consolidated balance sheet. The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the condensed consolidated financial statements, which reconciles to Total Liquidity as follows (in thousands):


	September 30,		December 31,
	2024		2023
Cash and cash equivalents	$	116,741	$	143,991
Marketable securities - available-for-sale debt securities		69,349		2,947
Total Liquidity	$	186,090	$	146,938

We believe that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its management of overall solvency and liquidity, financial flexibility, capital position and leverage. The definition of Total Liquidity includes marketable securities, which are highly-liquid and available to use in our current operations.

Safe Harbor

See the section titled “Information Regarding Forward-Looking Statements” at the beginning of this Quarterly Report.

Table of Contents

Item 3. Quantitative and Qualitative Disclosures about Market Risk.

There have been no material changes to the Company’s market risk during the three and nine months ended September 30, 2024. For a discussion of the Company’s exposure to market risk, please refer to the Company’s market risk disclosures set forth in Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk” in our 2023 Annual Report.

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 Securities and Exchange Act of 1934, as amended (“Exchange Act”) as of September 30, 2024.

Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective at September 30, 2024.

Changes in Internal Control over Financial Reporting

No changes in our internal control over financial reporting (as defined in Rules 13a-15(e) and 15d – 15(e)) under the Exchange Act) occurred during the quarter ended September 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II - OTHER INFORMATION

Item 1. Legal Proceedings.

As of September 30, 2024 we were not a party to any material legal proceedings.

Item 1A. Risk Factors.

Our business has significant risks. You should carefully consider the risk factors set out in Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2023 and the disclosures and risk factors set out in this Quarterly Report, including our condensed consolidated financial statements and the related notes, before making an investment decision regarding our securities. The risks and uncertainties described are those material risk factors currently known and specific to us that we believe are relevant to our business, results of operations and financial condition. Additional risks and uncertainties not currently known to us or that we now deem immaterial may also impair our business, results of operations and financial condition.

As of and for the period ended September 30, 2024, save as provided below there have been no material changes from the risk factors previously disclosed by us in Part I, Item 1A. Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2023.

We may not be able to maintain compliance with the continued listing requirements of Nasdaq.

Our Americal Depository Shares (ADSs) are listed on Nasdaq. In order to maintain that listing, we must satisfy minimum financial and other requirements including, without limitation, a requirement that our closing bid price must not fall below $1.00 per ADS for 30 consecutive business days. On November 1, 2024, we received a notice from The Nasdaq Stock Market (“Nasdaq”) that the Company is not in compliance with Nasdaq’s Listing Rule 5450(a)(1), because the minimum bid price of the Company’s American Depositary Shares (“ADSs”) has been below $1.00 per share for 30 consecutive business days (the “Notice”). The Notice has no immediate effect on the listing or trading of the Company’s ADSs on The Nasdaq Global Select Market.

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 calendar days, or until April 30, 2025, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company’s ADSs must be at least

Table of Contents

$1.00 per ADS for a minimum of ten consecutive business days during this 180 calendar day grace period, unless Nasdaq exercises its discretion to extend this ten-day period. In the event the Company does not regain compliance with the minimum bid price requirement by April 30, 2025, the Company may be eligible for an additional 180 calendar day compliance period if it elects to ransfer to The Nasdaq Capital Market. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the minimum bid price requirement, and would need to provide written notice of its intention to cure the bid price deficiency during the second compliance period. However, if it appears to Nasdaq’s staff that the Company will not be able to cure the deficiency or if the Company is otherwise not eligible, Nasdaq would notify the Company that its securities would be subject to delisting. The Company may appeal any such determination to delist its securities, but there can be no assurance that any such appeal would be successful.

The Company intends to monitor the closing bid price of its ADSs and assess potential actions to regain compliance with Nasdaq’s Listing Rule 5450(a)(1). However, there can be no assurance that we will be able to regain compliance with the minimum bid price requirement or that we will otherwise maintain compliance with other Nasdaq listing requirements. If we fail to regain and maintain compliance with the minimum bid price requirement or to meet the other applicable continued listing requirements in the future and Nasdaq decides to delist our ADSs, the delisting could adversely affect the market price and liquidity of our ADSs, reduce our ability to raise additional capital and result in operational challenges and damage to investor relations and market reputation.

Although our financial statements have been prepared on a going concern basis, if we fail to obtain additional financing in the future, this may raise substantial doubt about our ability to continue as a going concern in future reporting periods

As of September 30, 2024, the Company had cash and cash equivalents of $116.7 million, marketable securities of $69.3 million, and stockholders’ equity of $80.0 million. During the nine months ended September 30, 2024, the Company incurred a net profit of $3.4 million, used cash of $39.0 million from its operating activities, and generated revenues of $174.8 million. The Company has incurred net losses in most periods since inception and it expects to incur operating losses in future periods.

We believe that our Total Liquidity will be sufficient to fund our operations for at least 12 months, based upon our currently anticipated research and development activities and planned restructuring of the company to reduce headcount and expenses. This belief is based on estimates that are subject to risks and uncertainties and may change if actual results, revenue from commercialisation of Tecelra or the currently anticipated costs and cost reductions (including those associated with the restructuring) differ from management’s estimates or do not occur within anticipated timeframes.

We must obtain additional capital to continue funding planned operations. There is no assurance that the Company will be able to obtain sufficient additional capital to continue funding its operations or, if we do, that it will be on terms that are favourable to our shareholders. Any future fundraising, if possible, is likely to be highly dilutive to our existing shareholders and may also divert our management from its day-to-day activities.

If the Company fails to obtain additional funding, it may be required to:

●

significantly reduce certain activities and operations of the business in order to reduce ongoing expenditure. Any such reduction could significantly delay the timelines under which we can bring new products to the market (including lete-cel) or our ability to commercialize Tecelra.

●

conduct a restructuring of the company to further reduce headcount and expenditure which will in turn reduce the activities and operations of the business.

●

repay all or part of the loan advances received under the Loan Agreement in accordance with the terms of the Loan Agreement (including any applicable repayment charges or costs).

●

seek further third party alliances for existing assets, including Tecelra, on terms that are less favorable than might otherwise be available;

●

seek an acquirer for all or part of the business on terms that are less favorable than might otherwise be available

●

relinquish or license on unfavorable terms or rights to technologies, intellectual property or product candidates we would otherwise seek to develop or commercialize ourselves.

Table of Contents

If we fail to obtain additional funding, or in the event that we significantly reduce our ongoing expenditures and operations (including the current restructuring), this may result in an inability to retain key individuals required for our ongoing business and may result in a need to delay or halt ongoing programs or change the nature and scope of such programs. As a result, our business financial condition and results of operations could be materially affected.

Our business is, in part, dependent on the successful commercialization of Tecelra in the United States.

Tecelra received FDA approval in August 2024. Tecelra is a genetically modified autologous T-cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic synovial sarcoma who have received prior systemic therapy, are positive for HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P, and negative for HLA-A*02:05P, and whose tumor expresses the MAGE-A4 antigen as detected by an FDA-approved test. The success of our business, including our ability to finance our company and generate any revenue in the future, will, at this point, depend on the successful commercialization of Tecelra in the U.S. Any failure to successfully commercialize Tecelra in the U.S. would have a material and adverse impact on our business.

The commercial success of Tecelra will depend on a number of factors, including the following:

●

our ability to obtain any additional required capital or equivalent sources of finance to support the commercialization on acceptable terms, or at all;

●

our ability to consistently manufacture Tecelra on a timely basis and sufficient to meet demand;

●

our ability to activate authorized treatment centres (ATC) capable of administering Tecelra and the timing of activation of those authorized treatment centres;

●

the ability of our authorized treatment centres to facilitate treatments with Tecelra given Tecelra is a novel T-cell therapy requiring patient specific administration;

●

the availability of the tests required to assess for the required HLA types and antigen presentation ahead of treatment with Tecelra and the ability of third party suppliers of such tests to make those tests available when required;

●

the prevalence, duration and severity of potential side effects or other safety issues that patients may experience with Tecelra;

●

achieving and maintaining, and, where applicable, ensuring that our third-party contractors (including those responsible for supply of Tecelra or any raw or intermediate materials required for such supply) achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to Tecelra;

●

the willingness of physicians, operators of hospitals and clinics and patients to adopt and administer Tecelra;

●

the availability of coverage and adequate reimbursement from managed care plans, private insurers, government payors (such as Medicare and Medicaid and similar foreign authorities) and other third-party payors for Tecelra;

●

patients’ ability and willingness to pay out-of-pocket for Tecelra in the absence of coverage and/or adequate reimbursement from third-party payors;

●

patient demand for Tecelra;

●

the identification of patients eligible for treatment by the authorized treatment centres (including by referral from other hospitals and treatment centres) and the ability of the authorized treatment centres to progress such patients through to treatment;

●

prevalence of the required HLA types and antigen within the synovial sarcoma population and the ability of the tests for HLA and antigen to function as expected;

●

our ability to avoid third-party patent interference, intellectual property challenges or intellectual property infringement claims; and

●

our ability to comply with any post marketing requirements and obligations including those imposed by the FDA as part of the authorization for Tecelra.

These factors, many of which are beyond our control, could cause us to experience significant delays or an inability to obtain regulatory approvals or commercialize Tecelra. While we have obtained regulatory approval of Tecelra in the United States, we may never be able to successfully commercialize Tecelra in the United States or receive regulatory approval of Tecelra outside the United States. Accordingly, we cannot provide assurances as to the revenue obtainable through the sale of Tecelra.

Tecelra is approved under accelerated approval in the United States, and additional confirmatory work is required in order to maintain that approval. Inability to maintain approval or to otherwise meet the requirements imposed by the FDA will have a significant impact on our ability to commercialize Tecelra.

Table of Contents

Tecelra is approved under accelerated approval in the U.S. based on overall response rate and duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. Our ability to obtain traditional approval for Tecelra may require the conduction of additional studies and will require ongoing discussions with the FDA. Any additional work required to satisfy the conditions of accelerated approval will require additional finances, and any ability to obtain any additional required capital or equivalent sources of finance may delay or prevent our ability to maintain approval for Tecelra.

As part of the approval of Tecelra, certain post approval requirements apply which, if not satisfied, could impact continued approval of Tecelra.

Tecelra is subject to continuing regulation by the FDA Failure to meet any of these requirements may result in negative consequences including adverse publicity, judicial or administrative enforcement, warning letters from the FDA, mandated corrective advertising or communications with doctors, and civil or criminal penalties.

These requirements include submissions of safety and other postmarketing information and reports, registration and listing, as well as continued compliance with cGMPs and cGCPs for any clinical trials that we conduct post-approval. In addition, the FDA and other regulatory authorities may impose additional restrictions or require amendments to our product label after marketing approval in the event of additional adverse events with our cell therapy or of other adverse events seen with similar cell therapy products.

As part of the approval of Teclera, the FDA has imposed certain Postmarketing Commitments (“PMCs”) and Postmarketing Requirements (“PMRs”), including certain requirements to conduct additional studies under proscribed timelines. Failure to conduct these PMCs and PMRs in a timely manner could result in enforcement action from the FDA.

We and our contract manufacturers will be subject to periodic unannounced inspections by the FDA to monitor and ensure compliance with cGMPs. We must also comply with requirements concerning advertising and promotion for any cell therapies for which we obtain marketing approval. Promotional communications with respect to prescription drugs, including biologics, are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved labeling. Thus, we will not be able to promote any cell therapies we develop for indications or uses for which they are not approved.

The approval of Tecelra is limited to adult patients with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P, and negative for HLA-A*02:05P, and whose tumor expresses the MAGE-A4 antigen.

As is common for initial approval of cancer therapies, Tecelra has been approved by the FDA for use in a limited patient population, who have unresectable or metastatic synovial sarcoma and who have already received prior systemic therapy. As a result, our ability to market Tecelra is generally limited to that patient population.

The use of prior therapies or treatment for synovial sarcoma may reduce the effectiveness of our cell therapies.

This is the first time we as an organization are marketing a product and we have limited experience as a commercial company and have never generated revenue from product sales.

Table of Contents

Tecelra is the first product for which we have obtained FDA approval. As a company we have not yet launched any approved products for commercial sale and have not previously generated any revenue from product sales. Accordingly, we will need to continue to transition from a company with a research and development focus to a company capable of supporting commercial activities. We may not be successful in such a transition. We have recruited experienced commercial and medical affairs teams and we will need to continue to develop those teams and the associated support network in order to supply Tecelra on a commercial basis.

We will have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train, and retain suitably skilled and experienced marketing and sales personnel. This process may result in additional delays in bringing our cell therapies to market or in certain cases require us to enter into alliances with third parties in order to do so. However, there can be no assurance that we will be able to establish or maintain such collaborative arrangements, or even if we are able to do so, that they will result in effective sales forces. Any revenue we receive will depend upon the efforts of such third parties, which may not be successful. We may have little or no control over the efforts of such third parties, and our revenue from cell therapy sales may be lower than if we had commercialized our cell therapies ourselves.

For Tecelra, we are using certain third parties to supplement the internal commercial facing teams. We are also using a third party distributor to supply Tecelra and third parties to provide some of the systems required to supply Tecelra and support patients prescribed with Tecelra. We are reliant on those third parties to provide the services we require in accordance with our planned timelines. If any critical third party supplier fails to provide the services as required that may result in a delay to the commercialization of Tecelra. Any inability on our part to develop inhouse sales and commercial distribution capabilities or to establish and maintain relationships with third-party collaborators that can successfully commercialize any cell therapy in the U.S. or elsewhere will have a materially adverse effect on our business and results of operations.

As a novel cell therapy, Tecelra may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community, including referral centers.

The use of engineered T-cells and cell therapies more generally as a potential cancer treatment is a recent development and may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers and others in the medical community. For example, the product labelling and prescribing information for Tecelra describe certain limitations of use, adverse events, and warnings and precautions, including a boxed warning related to Cytokine Release Syndrome (CRS), which may be severe or life threatening and which occurred in patients receiving Tecelra in clinical trials. Additional factors will influence whether Tecelra is accepted in the market, including:

●

physicians, hospitals, cancer treatment centers and patients considering Tecelra as a safe and effective treatment;

●

the potential and perceived advantages of Tecelra over alternative treatments;

●

the prevalence and severity of any side effects;

●

willingness of treating centers to test for the required HLA types and MAGE A4 antigen using the FDA approved tests;

●

our product labeling and prescribing information describe certain limitations of use, adverse events, and warnings and precautions;

●

the cost of Tecelra in relation to alternative treatments;

●

the willingness of referral centers and awareness of referral centers to refer patients to our authorized treatment centers;

●

the availability of coverage, adequate reimbursement and pricing by third-party payors and government authorities;

●

the willingness of patients to pay for Tecelra on an out-of-pocket basis in the absence of coverage by third-party payors and government authorities;

●

relative convenience and ease of administration as compared to alternative treatments and competitive therapies; and

●

the effectiveness of our sales and marketing efforts.

The product labelling and prescribing information for Tecelra includes a boxed warning for CRS as well as other warnings and precautions. As Tecelra is used commercially, the rate and nature of adverse reactions may increase and as afamitresgene autoleucel (afami-cel) is studied in additional indications and populations, toxicities may further limit its development and use.

Table of Contents

Coverage, price flexibility, and reimbursement may be limited or unavailable in certain market segments for Tecelra.

Successful sales of Tecelra may depend on the availability of coverage and adequate reimbursement from third-party payors. In addition, because Tecelra represents a new approach to the treatment of synovial sarcoma, we cannot accurately estimate the potential revenue from Tecelra.

Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Obtaining coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drugs and treatments they will cover and the amount of reimbursement. Reimbursement by a third-party payor may depend upon a number of factors, including, but not limited to, the third-party payor’s determination that use of a product is:

●

a covered benefit under its health plan;

●

safe, effective and medically necessary;

●

appropriate for the specific patient; and

●

cost-effective.

Obtaining coverage and reimbursement approval of Tecelra from a government or other third-party payor is a time consuming and costly process which could require us to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our products. Even if we obtain coverage for Tecelra, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Patients are unlikely to use Tecelra unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of Tecelra.

In the U.S., no uniform policy of coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our cell therapies to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained.

There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, national and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare, including the Affordable Care Act (“ACA”) or provisions of the Inflation Reduction Act (“IRA”). Such regulatory changes may bring prescription drug pricing reform or healthcare affordability programs that, for example, seek to lower prescription drug costs by allowing governmental healthcare programs to negotiate prices with drug companies, put an inflation cap on drug prices, and lower out-of-pocket expenses for recipients of governmental healthcare programs. We cannot predict the initiatives that may be adopted in the future.

Tecelra represents a novel approach to treatment of synovial sarcoma that could result in heightened regulatory scrutiny.

Use of Tecelra to treat a patient involves genetically engineering a patient’s T-cells. This is a relatively novel treatment approach that carries inherent development risks including the following, any of which can result in delays to our ability to provide confirmatory evidence of Tecelra’s effectiveness:

●

Further development, characterization and evaluation may be required if post-marketing or clinical data suggest any potential safety risk for patients. The need to develop further assays, or to modify in any way the protocols related to Tecelra to improve safety or effectiveness, may delay the commercialization and further clinical development;

●

End users and medical personnel require a substantial amount of education and training in their administration of Tecelra either to engage in confirmatory clinical trials and recruit patients or ultimately to provide Tecelra to patients.

●

Regulatory requirements governing gene and cell therapy products have changed frequently and may continue to change in the future.

●

There is the potential for delayed adverse events following exposure to gene therapy products due to persistent biological activity of the genetic material or other components of products used to carry the genetic material. In part for this reason, the FDA recommends a 15-year follow-up observation period for all surviving patients who receive treatment using gene therapies in clinical trials.

Table of Contents

●

Negative results seen in third party clinical trials utilizing gene therapy products may result in regulators halting development and commercialization of our cell therapies, including Tecelra, or in requiring additional data or requirements prior to our cell therapies progressing to the next stage of development.

Manufacturing and supply of cell therapies is complex, and if we encounter any difficulties in manufacture or supply of Tecelra or our ability to provide supply for confirmatory clinical trials commercial supply of Tecelra could be delayed or stopped.

The process of manufacturing and administering Tecelra is complex and highly regulated. Manufacture requires the harvesting of white blood cells from the patient, isolating certain T-cells from these white blood cells, combining patient T-cells with our lentiviral delivery vector through a process known as transduction, expanding the transduced T-cells to obtain the desired dose, and ultimately infusing the modified T-cells back into the patient. As a result of the complexities, our manufacturing and supply costs are likely to be higher than those at more traditional manufacturing processes and the manufacturing process is less reliable and more difficult to reproduce.

Delays or failures in the manufacture of Tecelra (whether by us, any collaborator or our third party contract manufacturers) may result in a patient being unable to receive Tecelra or a requirement to re-manufacture which itself then causes delays in manufacture for other patients. Any delay or failure or inability to manufacture on a timely basis can adversely affect a patient’s outcomes and delay the timelines for our confirmatory clinical trials and commercialization. With a commercial product delays or failure to manufacture could additionally lead to claims by patients for reimbursement or damages. Such delays or failure or inability to manufacture can result from:

●

a failure in the manufacturing process itself for example, by an error in manufacturing process (whether by us or our third party contract manufacturing organization), equipment or reagent failure, failure in any step of the manufacturing process, failure to maintain a GMP environment, failure in quality systems applicable to manufacture, sterility failures, contamination during process;

●

variations in patient starting material or apheresis product resulting in less product than expected or product which is not viable, or which cannot be used to successfully manufacture a cell therapy;

●

product loss or failure due to logistical issues including issues associated with the differences between patients’ white blood cells or characteristics, interruptions to process, contamination, failure to supply patient apheresis material within required timescales (for example, as a result of an import or export hold-up) or supplier error;

●

inability to have enough manufacturing slots to manufacture cell therapies for patients as and when those patients require manufacture;

●

inability to procure components, consumables, ingredients, or starting materials, or to manufacture starting materials (including at our U.K. vector facility), as a result of supply chain issues;

●

loss of or close-down of any manufacturing facility used in the manufacture of our cell therapies. For example, we will be manufacturing Tecelra at our Navy Yard manufacturing facility. Should there be a contamination event at the facility resulting in the close-down of that facility, it would not be possible to find alternative manufacturing capability for Tecelra within the timescales required for patient supply including for commercial supply.

●

loss or contamination of patient starting material, requiring the starting material to be obtained again from the patient or the manufacturing process to be re-started. In the context of commercial supply, this could result in cancellation of order for the commercial cell therapy or a claim from the patient;

●

a requirement to modify or make changes to any manufacturing process. Such changes may additionally require comparability testing which then may reduce the amount of manufacturing slots available for manufacture of Tecelra. Delays in our ability to make the required modifications or perform any required comparability testing within currently anticipated timeframes or that such modifications or comparability testing, when made, will obtain regulatory approval or that the new processes or modified processes will successfully be transferred to the third party contract suppliers within currently anticipated timeframes can also impact timelines for manufacture;

●

reduction or loss of the staff resources required to manufacture our cell therapies at our facilities or those of our CMOs;

●

allocation of the resources, materials, and services of any collaborator or our third party contract manufacturers away from our cell therapy programs;

●

reduction in available workforce to perform manufacturing processes, for example, as a result of a COVID-19 outbreak or workforce exhibiting potential COVID-19 symptoms, and pending receipt of test results for COVID-19 infection;

●

changes in the manufacturing and supply process. Any changes to the manufacturing process may require amendments to be made to regulatory applications or comparability tests to be conducted which can further delay timeframes. If Tecelra

Table of Contents

manufactured under the new process has a worse safety or efficacy profile than the prior product or the process is less reproducible than the previous process, we may need to re-evaluate the use of that manufacturing process, which could significantly delay or even result in the halting of our confirmatory clinical trials and commercialization.

We will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense as well as significant penalties if we fail to comply with regulatory requirements or experience unanticipated problems with Tecelra.

FDA approval is accompanied by requirements to conduct surveillance to monitor the safety and efficacy of Tecelra.

Later discovery of previously unknown problems with Tecelra, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

●

restrictions on our ability to conduct further clinical trials, including full or partial clinical holds on ongoing or planned trials;

●

restrictions on Tecelra’s manufacturing processes;

●

restrictions on the marketing of Tecelra;

●

restrictions on product distribution;

●

requirements to conduct additional post-marketing clinical trials;

●

untitled or warning letters;

●

withdrawal of Tecelra from the market;

●

refusal to approve pending supplements to the Tecelra that we submit;

●

recall of products;

●

fines, restitution or disgorgement of profits or revenue;

●

suspension or withdrawal of regulatory approvals;

●

refusal to permit the import or export of our products;

●

product seizure;

●

injunctions;

●

imposition of civil penalties; or

●

criminal prosecution

The FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could adversely impact the approval of Tecelra. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the U.S. or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose marketing approval and we may not achieve or sustain profitability.

In addition, FDA has required us to conduct a confirmatory trial to verify the clinical benefit of Tecelra. The results from the confirmatory trial or trials may not support the clinical benefit, which could result in the approval being withdrawn.

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.

項目 5. 其他信息。

於2024年9月30日結束的三個月內，我們的任何董事或高級管理人員採用, 修改了或終止都未訂立“第10b5-1條規交易安排”或“非第10b5-1條規交易安排”，如Regulation S-k的408(a)項所定義。

條款6. 附件。

本季度報告表10-Q已提供以下展品，或已納入參考：


附件數量	展覽說明
10.1**†		Adaptimmune Therapeutics有限公司、Genentech, Inc.和F. Hoffmann-La Roche Ltd.之間的機密保密協議及和解協議日期為2024年9月23日。

31.1**		根據1934年證券交易法第13a-14(a)條及第15d-14(a)條，信安金融主要執行官依據2002年沙賓斯-豪利法案第302條進行認證。.

31.2**		信安金融主管憑借第1934年證券交易法案第13a-14(a)條款和第15d-14(a)條款的要求進行證明，該法案根據2002年薩班斯-豪利法案第302條頒布.

32.1***		根據《Sarbanes-Oxley法案》第906條和18 USC 第1350條，負責執行官員的認證。.

32.2***		根據《2002年薩班斯-奧克斯利法案》第906條採納的《18 U.S.C.第1350條》的首席財務官認證。

101**		以下為adaptimmune therapeutics plc截至2024年9月30日季度結束的第10-Q表格中以iXBRL（內嵌可擴展商業報告語言）格式化的財務信息：(i) 2024年9月30日和2023年12月31日的未經審計簡明綜合賬簿；(ii) 截至2024年9月30日和2023年的三個月和九個月的未經審計簡明綜合損益表；(iii) 截至2024年9月30日和2023年的三個月和九個月的未經審計簡明綜合損益表； (iv) 截至2024年9月30日和2023年的三個月和九個月的未經審計簡明資本變動表；(v) 截至2024年9月30日和2023年九個月的未經審計簡明現金流量表；和(vi) 未經審計簡明綜合財務報表附註。

104**		互動日期檔案封面（採用內聯XBRL格式，包含於展示101中）。

** 連同本文件一併申報。

*** 一並提供。

†	根據S-k條例第601(b)(10)條，某些私人或機密資訊（如所示）已被刪除。

簽名

根據1934年證券交易所法案的要求，本公司已經授權下述人員代表本公司簽署此報告。


	adaptimmune therapeutics PLC


日期：2024年11月13日	/s/ 阿德里安·羅克利夫
	阿德里安·羅克利夫
	首席執行官


日期：2024年11月13日	/s/ 蓋文·伍德
	蓋文·伍德
	財務長