10-Q

請在以下複選框中打勾，指示註冊人：(1)在前12個月(或註冊人被要求提交這些報告的更短期間內)已經提交了1934年證券交易法第13或15(d)條規定需要提交的所有報告；以及(2)在過去的90天內一直受到了此類文件提交要求的限制。Yes☒ 不是 ☐

請在以下複選框中打勾，指示註冊人是否已經電子提交了根據Regulation S-T規則405條(本章節的§232.405條)需要提交的所有互動數據文件在過去的12個月內(或註冊人被要求提交這些文件的更短期間內)。Yes☒ 不是 ☐

勾選以下選框，指示申報人是大型加速評估提交人、加速評估提交人、非加速評估提交人、小型報告公司或新興成長型公司。關於「大型加速評估提交人」、「加速評估提交人」、「小型報告公司」和「新興成長型公司」的定義，請參見《交易所法規》第12億.2條。

如果是新興成長型公司，在選中複選標記的同時，如果公司已選擇不使用根據證券交易法第13(a)條提供的任何新的或修訂後的財務會計準則的延長過渡期來符合新的或修訂後的財務會計準則，則表明該公司已選擇不使用根據證券交易法第13(a)條提供的任何新的或修訂後的財務會計準則的延長過渡期來符合新的或修訂後的財務會計準則。☐

請在以下空格內打勾，表示註冊人是不是外殼公司（按交易所法則120億.2條定義）。是 ☐ 否 ☒

A截至2024年11月4日，註冊人普通股的流通股數量爲 48,345,573和註冊人B類普通股的流通股數量爲 0.

1。重要會計政策的組織和摘要

組織

BioAtla, LLC成立於特拉華在 2007 年 3 月並於2020年7月改爲特拉華州的一家公司，並更名爲BioAtla, Inc.（「公司」）。該公司擁有用於製造生物製劑的專有平台，包括其條件活性生物製劑（「CAB」或「CAB」）。CAB被設計爲僅在患病組織中發現的某些條件下才有活性，而在正常組織中保持非活性。該公司目前正在臨床開發幾種CaB候選藥物，包括：其兩種主要CaB抗體藥物偶聯物（「CaB ADC」），mecbotamab vedotin（BA3011）、靶向AXL和ozuriftamab vedotin的CaB ADC（BA3021）、靶向ROR2的CaB ADC；evalstotug（BA3071），一種CaB的抗CaB-4抗體；以及BA3182（cab-epcam x cab-CD3）），一種靶向 epCam 的 CaB 雙特異性抗體。

演示基礎

截至2024年9月30日以及截至2024年9月30日和2023年9月30日的三個月和九個月的未經審計的簡明財務報表是根據美國證券交易委員會（「SEC」）的規章制度以及適用於中期財務報表的美國普遍接受的會計原則（「GAAP」）編制的。這些未經審計的簡明財務報表是在與經審計的財務報表相同的基礎上編制的，包括所有調整，僅包括正常的經常性應計費用，管理層認爲，這對於公允列報公司截至中期的財務狀況和所列中期的經營業績是必要的。中期業績不一定代表全年或未來時期的業績。這些未經審計的簡明財務報表應與公司截至2023年12月31日止年度的經審計的財務報表一起閱讀，包含在2024年3月26日向美國證券交易委員會提交的10-k表年度報告中。

流動性和持續經營

自成立以來，該公司已出現累計營業虧損和運營現金流負數，隨着其持續開發候選產品，預計在可預見的將來將繼續產生巨額支出和營業虧損。截至 2024 年 9 月 30 日，該公司累計赤字爲 $471.2 百萬。該公司計劃繼續通過公開或私募股權或債務融資或其他來源爲運營和資本融資需求的虧損提供資金。如果公司無法獲得足夠的額外資金，公司可能被迫削減支出，延長與供應商的付款期限，儘可能清算資產，或者暫停或削減計劃中的計劃。任何這些行爲都可能對公司的業務、經營業績和未來前景造成重大損害。

2023年1月，公司與傑富瑞集團簽訂了公開市場銷售協議（「銷售協議」），根據該協議，公司可以不時自行決定出售公司普通股，總銷售收益不超過美元100.0 百萬。截至目前，公司尚未根據銷售協議出售任何普通股 2024 年 9 月 30 日。

管理層必須對公司繼續作爲持續經營企業的能力進行兩步分析。管理層必須首先評估是否存在使人們對公司繼續作爲持續經營企業的能力產生重大懷疑的情況和事件（步驟1）。如果管理層得出結論認爲提出了重大疑問，則管理層還必須考慮其計劃是否緩解了這種疑慮（步驟2）。管理層的評估包括編制現金流預測，管理層得出的結論是，公司繼續經營的能力不容置疑，因爲其目前的現金和現金等價物足以爲公司自這些未經審計的簡明財務報表發佈之日起至少一年的運營提供資金。

估算值的使用

公司簡明財務報表的編制要求其做出估算和假設，以影響公司簡明財務報表和附註中報告的資產、負債、收入和支出金額以及或有資產和負債的披露。公司簡明財務報表中最重要的估計與收入確認、研發成本應計額和股權薪酬有關。這些估計和假設基於當前事實、歷史經驗和在當時情況下被認爲合理的各種其他因素，其結果構成了對資產和負債賬面價值做出判斷的基礎，並記錄了從其他來源看不出來的收入和支出。實際結果可能與這些估計值存在重大和不利的差異。如果估計值與實際業績之間存在實質性差異，則公司未來的經營業績將受到影響。

現金及現金等價物

公司認爲90天或更短期限的原始到期日當天購買的所有高流動性投資都屬於現金及現金等價物。現金及現金等價物包括高評級證券，包括美國政府和美國國債貨幣市場基金，這些基金沒有提取或使用限制。

可能使公司面臨重大信用風險集中的金融工具主要包括現金及現金等價物。公司在受聯邦保險覆蓋的金融機構中保有超過聯邦保險限額的存款，並且可能將不需要立即用於運營的現金投資於承擔極小風險的高流動性工具中。公司在此類帳戶中未經歷任何損失，並且管理層認爲由於存款所在的存款機構的財務狀況，公司不會面臨重大信用風險。

以股票爲基礎的補償

基於股票的補償費用代表權益獎勵的授予日公允價值，包括股票期權、受限股票單位（RSUs）和員工股票購買計劃權益，在獎勵的必要服務期（通常是獲得期）內按比例進行攤銷。公司使用Black-Scholes期權定價模型估計股票期權授予和員工股票購買計劃權益的公允價值。在公司IPO之前，RSU的公允價值基於授予日根據估計值計算的基礎普通股的公允價值，而在公司IPO之後，公允價值基於授予日公司普通股的收盤成交價格。權益獎勵的沒收在其發生時確認。

租約

公司在合同簽訂時確定是否爲租賃安排。如果租賃包括爲期一段時間的使用某一特定資產的權利並支付費用，則視爲租賃。如果確定存在租賃，分類將在租賃開始時確定。從租賃開始日起，將按照未來租賃付款的現值確認經營租賃負債。公司的租賃不提供隱含利率，因此公司估算其用於貼現租賃付款的增量借貸利率。增量借貸利率反映了公司在類似經濟環境中以類似期限抵押借款的利率。經營租賃使用權益（ROU）資產基於相應的租賃負債調整，包括在開始前或開始時進行的任何租賃付款、初始直接成本和租賃激勵。除非公司相當肯定會行使這些選擇權，否則不計入續訂或提前終止。經營租賃費用確認並且ROU資產按照租賃期限進行按比例攤銷。可變租賃費用按發生確認，不包括在ROU資產或相關租賃負債的計算中。

公司與租賃和非租賃元素簽訂單一租賃協議，將其視爲單一租賃元素進行覈算。對於租期不超過十二個月的短期租賃，按照直線法在租期內列支租金。目前公司沒有任何短期租賃。

經營租賃包括在公司資產負債表中列示的經營租賃權利使用資產、經營租賃負債以及經營租賃負債，歸屬於非流動資產。公司沒有任何融資租賃。

收入確認

公司根據展示產品或服務的控制權已轉移給客戶並反映公司有權換取此類產品或服務的對價的方式確認營業收入。爲此，公司遵循五步方法：(i) 確定與客戶的合同，(ii) 確定合同中的履約義務，(iii) 確定交易價格，(iv) 將交易價格分配到履約義務，以及 (v) 客戶獲得產品或服務的控制權時（或在此時），確認營業收入。公司在應用營業收入確認準則時考慮合同條款和所有相關事實和情況。

客戶是與公司簽訂合同的一方，合同的目的是換取公司在正常經營活動中的產出的產品或服務，以換取對價。要被視爲合同，（i）合同必須經過批准（書面、口頭或按照其他慣例商業實踐），（ii）關於待轉讓產品或服務的雙方權利可以確定，（iii）可確定待轉讓產品或服務的支付條款，（iv）合同必須具有商業實質（即預期未來現金流的風險、時間或金額預計會因合同而改變），以及（v）公司能夠收回幾乎所有應得的對價，作爲與產品或服務轉讓交換所應收到的對價實現可能性。

績效義務定義爲向客戶轉讓產品或服務的承諾。公司確定每個承諾以轉讓產品或服務（或一攬子產品或服務，或一系列實質相同且具有相同轉讓模式的產品和服務）爲獨立。如果（i）客戶可以單獨從產品或服務中受益，或者與客戶現有的其他資源一起受益，以及（ii）客戶可以立即使用產品或服務。

公司承諾將產品或服務轉移給客戶的行爲，必須能夠單獨確定，與合同中的其他承諾有所區分。轉移產品或服務的每個不同承諾都是確認營收的計量單位。如果轉移產品或服務的承諾無法與合同中的其他承諾單獨確定，這些承諾應合併爲單一履約義務。

交易價格是公司有權收取的對價金額，以換取將產品或服務的控制權轉移給客戶。爲了確定交易價格，公司考慮任何重大融資性要素的存在、任何可變要素的影響、非貨幣對價和支付給客戶的對價。如果存在重大融資性要素，交易價格將根據時間價值進行調整。如果存在可變要素，公司必須估計預期收到的對價，並將該金額作爲確認營收的依據，直至將產品或服務轉交給客戶。確定可變對價的金額有兩種方法：(i) 預期價值法，即在可能的考慮金額區間內的概率加權金額總和，以及(ii) 最有可能金額法，確定可能的考慮金額區間內單一最可能金額。

如果合同包括多項履約義務，公司將根據每項不同履約義務應收取的對價來分配交易價格。對於每項不同履約義務，當公司轉移與該履約義務相關的產品或服務的控制權時，將確認營收。

在公司首次先行收到對價而尚未履行履約義務的情況下，公司將該對價分類爲遞延營收，直至（或按照）公司完成該履約義務。在公司先行完成履約義務而尚未收到對價時，對價將記錄爲應收賬款。

公司在獲得和履約合同的增量成本發生時，如果預期攤銷期限一年或更短的資產微不足道，或者資產金額微小，則將費用資本化。否則，如果這些成本對合同具有增量作用且與基礎合同的營業收入成比例攤銷到費用，這些成本將被記爲合同資產。

綜合虧損

綜合損失定義爲期間內因非所有者來源的交易和其他事件和情況而導致的股東權益變動，包括淨損失和其他綜合收益（損失）。沒有符合其他綜合損失資格的項目，因此，在展示的所有期間內，公司的綜合損失與其報告的淨損失相同。

每股淨虧損

每股基本淨損失是通過將淨損失除以期間內未償還的普通股平均數量計算的，不考慮潛在稀釋證券。每股稀釋淨損失是通過將淨損失除以期間內根據庫存費用法確定的普通股和稀釋普通股等效份額的加權平均數量計算的。稀釋普通股等效份額包括受限股單位（RSUs）、公司股票期權以及BioAtla，Inc.員工股票購買計劃（「ESPP」）下有條件發行股票。

未包含在計算每股稀釋淨損失中的潛在稀釋證券因會產生抗稀釋效應而未計入，具體爲以下內容（以普通股等效計）：


	截至2022年9月30日，
	2024		2023
普通股期權		6,217,492		6,362,386
限制性股票單位		1,567,081		161,219
員工股票購買計劃		100,395		124,969
總計		7,884,968		6,648,574

最近的會計聲明

在2024年9月30日結束的九個月內，對公司基本報表產生重大影響的新會計準則沒有。

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」。 ASU 2023-09要求對報告實體的有效稅率和協調進行細分信息披露。

2. 資產負債表詳情

預付款項和其他流動資產包括以下內容（以千元計）：


	9月30日, 2024		12月31日, 2023
預付研究與開發	$	3,235	$	4,615
預付保險		356		—
其他預付費用和流動資產		460		320
總計	$	4,051	$	4,935

固定資產和設備包括以下項目(以千爲單位)：


	有用壽命 (年)	9月30日, 2024			12月31日, 2023
傢俱、裝置和辦公設備	3 - 7	$	1,721		$	1,721
實驗室設備	5		2,280			2,280
租賃改良	2 - 3		3,680			3,680
			7,681			7,681
減：累計折舊和攤銷			(6,775	)		(6,078	)
總計		$	906		$	1,603

應付賬款和應計費用如下（以千爲單位）：


	9月30日, 2024		12月31日, 2023
應付賬款	$	2,928	$	3,819
應計的薪資		3,056		3,790
已計提的研發費用（包括相關方金額$1,775和$0）		11,441		18,246
其他應計費用		786		865
總計	$	18,211	$	26,720

4. 租賃

公司在加利福尼亞州聖迭戈擁有一份用於公司總部和實驗室空間的營業租賃。租約於2025年7月到期，公司有權選擇延長租約的期限月內。2023年和2022年的三個和九個月期權授予均以授予日公司普通股的公允價值相等的行權價格授予，並且是非法定股票期權。此外，租約包括某些租金減免、租金遞增、承租人裝修津貼和公共區域維護等其他費用的額外收費。

包括在公司損益表中的租賃費用元件爲（以千元爲單位）：


	截至9月30日的三個月				截至9月30日的九個月
	2024		2023		2024		2023
營業租賃費用	$	261	$	261	$	782	$	782
變量租賃費用		159		147		530		401
總租賃費用淨額	$	420	$	408	$	1,312	$	1,183

變量租賃成本主要涉及支付給出租方的公共區維護、物業稅、保險和其他營業費用。公司在2024年和2023年9月30日結束的三個和九個月內沒有任何短期租賃或融資租賃。

經營租賃的加權平均剩餘租賃期限和加權平均貼現率如下：


	截至2022年9月30日，
	2024			2023
加權平均剩餘租賃期限（年）		0.75			1.75
加權平均貼現率百分比		3.50	%		3.50	%

公司作爲承租人與租憑相關的補充現金流信息如下（金額以千計）：


	截至9月30日的三個月				截至9月30日的九個月
	2024		2023		2024		2023
支付用於計量營業租賃的金額	$	425	$	411	$	1,260	$	1,226

截至2024年9月30日的營業租賃負債到期情況如下（以千計）： 2024年9月30日的營業租賃到期情況如下（金額以千計）：


	操作 lease
截至2024年12月31日的三個月		425
2025		845
此後		—
總租賃未來支付款項		1,270
減：隱含利息		(19	)
總營業租賃負債	$	1,251

Paltalk, Inc. 修訂和重列的2011年長期激勵計劃（"2011年計劃"）於2016年5月16日終止，將不再向未來授予獎勵。總共：

2020年股權激勵計劃

公司可以根據2020年股權激勵計劃（「2020計劃」）向公司的僱員、顧問和非僱員董事授予普通股獎勵，包括期權獎勵、股票增值權獎勵、限制性股票獎勵、限制性股票單位獎勵、業績股票獎勵、業績股票單位獎勵和其他以股票爲基礎的獎勵。截至2024年9月30日和2023年12月31日，2020計劃授權發行的普通股總數爲 10,735,431 和 9,196,970、分別。每年的1月1日，從2020計劃生效日期後的第一個1月1日開始，根據2020計劃授權發行的股份將增加一定數量的股份等於不超過 4董事會確定的在上一個12月31日的已發行總股份數量的百分比以及該公司董事會確定的較少數量的股份。根據2020年計劃授予的期權的最長期限不超過 $244,200，將在歸屬期內按比例確認。。2020年計劃下的獎勵通常於 25之後的第一年每月按比例分配，持續一段 36個月，須保持連續服務。

2023年2月26日，該公司的薪酬委員會批准了對公司的2020年計劃進行修改，以允許限制性股票單位（RSUs）或股票期權根據授予人繼續爲公司和/或其附屬公司提供服務作爲僱員、非僱員董事或獨立承包商的授予對象，未獲授予的RSUs總計 139,730持續經營活動中普通股股東的收益574,244 原定於2020年計劃的未投資期權，繼續獲得。公司對這些獎勵應用了修改會計處理，導致這些獎勵的公允價值減少。公司計算了經過修改的未投資獎勵的補償成本爲$416,000 與RSUs相關的爲$，與期權相關的爲$，並將於剩餘的必要服務期內確認這些金額。修改還導致了期權的期限延長962,000 完全歸屬的期權，根據修改的日期立即確認了額外的補償成本$。 130,699 已報告爲截至2024年和2023年9月30日的三個和九個月的損益綜合表中的金額（以千美元計）123,000 完全歸屬的期權，根據修改的日期立即確認了額外的補償成本$。

相應的股權報酬費用分別爲。下表中的金額爲千元人民幣：已報告爲截至2024年和2023年9月30日的三個和九個月的損益綜合表中的金額（以千美元計）


	三個月截止 9月30日,				九個月結束 9月30日,
	2024		2023		2024		2023
研發	$	1,071	$	1,321	$	3,314	$	4,322
一般行政		1,123		2,196		3,676		6,484
總計	$	2,194	$	3,517	$	6,990	$	10,806

受限股票單位

以下表格總結了2020年計劃下的RSU活動 2024年9月30日結束的九個月：


	數量股份			加權平均授予日期公正價值
2023年12月31日未行使的股票期權		99,104		$	18.00
已行權		1,598,000		$	2.48
34,105		(99,023	)	$	18.00
被取消		(31,000	)	$	2.65
截至2024年9月30日應收款項		1,567,081		$	2.48

截至2024年9月30日，認股期權單位尚未認可的股票補償支出總額美元3.3 年。 3.2年。

股票期權

以下表格總結了2020年計劃下的股票期權活動 2024年9月30日結束的九個月：


	數量 Options			加權平均行權每股價格分享		加權平均剩餘加權術語（以年爲單位）		總計截至2023年7月29日的餘額數值
2023年12月31日結餘爲		6,273,507		$	7.62		8.64	$	74,680
已行權		37,000		$	2.70
被取消		(61,488	)	$	5.40
到期的		(31,527	)	$	3.95
2024年9月30日的餘額		6,217,492		$	7.63		7.88	$	3,100
已投資並預計在2024年9月30日完全投資		6,217,492		$	7.63		7.88	$	3,100
2024年9月30日可行使		3,468,180		$	9.60		7.64	$	120

截至2024年9月30日未認可的未實現普通股期權的總成本爲$9.7 年。 2.21 年。權重平均授予日期公允價值爲該年度期權的授予公司已發行2019 ESPP下的股票，截至爲$2.04 每股。該年度已經行權的期權的總公允價值爲公司已發行2019 ESPP下的股票，截至爲$8.0 百萬美元。期權行使後，公司發行新股

用於判斷期權授予的公允價值的Black-Scholes期權定價模型所使用的假設如下：


	九個月結束 9月30日,
	2024	2023
預期波動率	88.7%	77.9%
無風險利率	4.25%	3.88%
預期股息收益	0.0%	0.0%
預期期限	5.95 年	6.05 年

預期波動率。由於公司的普通股沒有明顯的交易歷史，預期波動率假設是基於一組具有公開股價的類似公司的波動性。同行分組是基於生物技術行業公司。

無風險利率。公司基於美國國債零息債券利率，假設無風險利率。這些債券的到期期限與估值對象預期任期相似。

預期股息率。 The Company bases the expected dividend yield assumption on the fact that it has never paid cash dividends and has no present plans to pay cash dividends.

預期期限。 For employees, the expected term represents the period of time that options are expected to be outstanding. Because the Company has minimal historical exercise behavior, it determines the expected life assumption using the simplified method, which is an average of the contractual term of the option and its vesting period. For nonemployees, the expected term is generally the contractual term of the option.

員工股票購買計劃（「ESPP」）

The ESPP permits participants to purchase common stock through payroll deductions of up to 15% of their eligible compensation. As of September 30, 2024 and December 31, 2023, a total 的 2,281,600股票和 1,737,098 根據公司股票期權計劃，分別授權發行普通股股份。每個日曆年的1月1日，自2021年1月1日至2030年1月1日，授權發行的普通股股份數量將自動增加。分別爲（i） 1.0按照以下三者中的最小值：（i）前一年12月31日公司普通股股份總量的％（在全面攤薄基礎上計算），（ii） 929,658 普通股份或（iii）由公司董事會判斷的一個小於（i）和（ii）的數量。公司發行了 191,020 和 56,793普通股股份的回購在2024年和2023年截至9月30日的ESPP期間。截至2024年9月30日， 1,766,284 普通股股份普通股的剩餘可用數量爲

ESPP發行。截至2024年9月30日和2023年九個月的與ESPP相關的股票補償費用微不足道。

在2024年3月31日結束的三個月和2023年3月31日結束的三個月中，保留供將來發行的普通股的發行量如下:

未來發行的普通股儲備情況如下，以普通等效股份計算：


	9月30日, 2024		12月31日, 2023
已發行和未償還的普通股期權和受限股股票單位		7,784,573		6,372,611
2020計劃下可供未來發行的獎勵		1,018,889		991,413
ESPP下可供未來發行的獎勵		1,766,284		1,412,802
所有板塊未來發行的普通股總數		10,569,746		8,776,826

7. 合作、許可和選擇協議

與百濟神州簽訂全球共同開發和合作協議

2019年4月，公司與百濟神州、百濟神州瑞士有限公司（統稱「百濟神州」）簽訂了一項全球共同開發和合作協議（「百濟協議」），用於 evalstotug（BA3071）的開發、製造和商業化。百濟協議在某段時間內進行了多次修訂。 2019 和 2021 並且公司在那段時間內從百濟神州收到了總額爲$的不可退還款項。25.0 萬美元。

2021年11月，百濟協議被終止，但某些條款仍鬚生效，百濟神州歸還了根據修訂後百濟協議獲得的專有技術和材料的權利。因此，公司負責 evalstotug 的全球開發和商業化。作爲修訂的考慮，公司同意向百濟神州支付全球銷售額的中等一位數的提成，並在有限的範圍內分享通過 evalstotug 分許可證時獲得的一次性和里程碑款項。公司將其剩餘的$百萬的遞延收入重新分類爲長期負債，預計將根據結果修訂向百濟神州支付許可費。19.8 萬美元。許可終止時，責任將會解除，無需向百濟神州支付任何進一步的款項。

公司在2024年3月31日和2023年3月31日結束的三個月內都沒有記錄任何所得稅支出。公司已爲所有報表期的淨運營虧損記錄了完整的減值準備，並未在隨附的簡明財務報表中反映任何此類淨運營虧損的盈餘。no與百濟神州的合作協議相關的營業收入在此期間內未被確認。 2024年和2023年截至9月30日的九個月，分別。該公司截至日期和許可方仍有一$19.8 百萬責任。分別是2024年9月30日和2023年12月31日。

與施貴寶簽署的合作和供應協議

2022年1月，公司與施貴寶公司（「BMS」）簽訂了臨床試驗合作和供應協議（「BMS協議」）。根據BMS協議的條款，bioatla和bms合作開展不同組合療法的臨床試驗，使用bioatla的兩種CAb ADCs，分別是mecbotamab vedotin（BA3011）和ozuriftamab vedotin（BA3021），每種與Opdivo®（nivolumab），bms的專有的抗PD-1單克隆抗體產品結合。公司作爲計劃試驗的研究發起方，並負責與試驗執行相關的費用。bms免費爲組合試驗提供Opdivo®臨床藥物供應。在完成組合療法試驗後，公司有義務向bms提供試驗結果數據的最終報告。BMS協議於2022年10月進行修改，以增加我們mecbotamab vedotin和ozuriftamab vedotin組合試驗的附加領土。由於該協議，公司截至2023年和2024年9月30日的三個月和九個月的財務結果未受影響。

與Context Therapeutics Inc.簽訂的許可協議

2024年9月，公司與Context Therapeutics Inc.（「Context」）簽訂了許可協議（「Context許可協議」）。根據Context許可協議的條款，bioatla授予Context獨家全球許可，開發、生產和商業化兩種授權抗體，包括BA3362（由Context更名爲Ct-202），公司的Nectin-4 x CD3-萬億電芯結合（TCE）雙特異性抗體（「許可」）。公司還轉讓了知識產權，包括Context執行研究和開發所需的任何材料。作爲許可的交換，公司有資格獲得最多$百萬的總付款，包括預付現金付款和潛在的開發、監管和商業里程碑，以及未來產品淨銷售的分層中個位數到低兩位數的版稅。在簽署Context許可協議的同時，公司還與相關方Himalaya Therapeutics SECZ簽署了協議（請參閱注8）。133.5 百濟神州簽署的合作和供應協議中有以下條款：營業收入、全球貨幣、百濟神州、電芯、全球貨幣、交易所、BioAtla、施貴寶、一千萬。

8. 關聯方交易

Himalaya Therapeutics SEZC

臨床試驗服務協議

2024年1月，公司與Himalaya Therapeutics SEZC（「Himalaya」）簽訂了一份經修訂的臨床試驗服務協議（經修訂後稱爲「臨床試驗服務協議」）。根據臨床試驗服務協議，bioatla將支付給Himalaya以全職使用其兩名人員並提供與在中國評估evlastotug進行臨床試驗啓動有關的服務，爲期12個月。

全球交易協議

2024年9月，公司與Himalaya簽署了一項全球交易協議（「Himalaya協議」）。 BioAtla和Himalaya先前在2020年1月簽署了一份經修訂的獨家權利協議（「修訂的權利協議」）。根據修訂的權利協議，Himalaya擁有開發、製造和商業化特定資產的權利，包括已授權給Context（見附註7）的BA3362，在修訂的權利協議中進一步指定的某些領土中。根據Himalaya協議，Himalaya同意BioAtla執行和履行協議，並向BioAtla授予受影響產品和知識產權的全球獨家次許可證。此外，如修訂的權利協議中所載明並在Himalaya協議中進一步澄清，BioAtla同意支付給Himalaya（i）BioAtla從Context根據Context許可協議獲得的所有預付款和開發里程碑的中等百分比；（ii）根據Context許可協議中定義的淨銷售額（在中文許可協議中定義）在中華人民共和國以及香港，澳門和臺灣的任何和所有銷售里程碑和/或版稅的特定百分比。

公司是Context許可協議和Himalaya協議中的主體，並將根據以毛利基礎記錄收入和費用，因爲公司對在Context許可協議中設定的考慮定價具有全權，公司將主要負責提供許可，並且Himalaya無需參與任何履行活動的義務。

截至2024年9月30日，公司確認營業額$三億。1.8萬美元和2.0 分別爲$，與喜馬拉雅交易相關的研發費用，截至2024年9月30日，公司已確認了研發費用，相比之下，分別爲$，2013年9月30日結束的三個月和九個月，分別爲$。0 和 $0.1 分別爲$，2023年9月30日結束的三個月和九個月，數量分別爲$億。截至2024年9月30日，公司對喜馬拉雅欠款$三億。1.8 億美元。所欠喜馬拉雅的金額分別爲$三億。

您應當閱讀本季度報告形式10-Q中包含的「項目1.基本報表」中的未經審計的簡化財務報表及其附註，並與2023年12月31日止的年度報告形式10-K中包含的經審計的基本報表及相關附註一起閱讀，該報告已於2024年3月26日遞交給證券交易委員會，即SEC。除了歷史信息外，本季度報告還包含涉及風險、不確定性和假設的前瞻性聲明。由於特定因素，我們的實際結果可能與這些前瞻性聲明中預期的結果有實質性差異，這些因素包括但不限於年度報告10-K中「風險因素」標題下所列事項，以及本季度報告中「風險因素」標題下所列事項，在1934年修正版的證券交易法案或交易所法案項下經過更新的我們隨後的提交。此外，過去的運營結果未必能反映未來時期可能出現的結果。

我們是一家臨床階段生物製藥公司，正在開發我們自己的一類高度特異和選擇性抗體爲基礎的新型治療固體腫瘤癌的療法。我們的CABs利用我們在腫瘤生物學方面的專利發現，使我們能夠瞄準已知且廣泛驗證的腫瘤抗原，這些抗原以前很難或不可能被瞄準。我們的新型CAb治療候選藥物利用腫瘤微環境與健康組織之間的特徵性pH差異。與健康組織不同，腫瘤微環境呈酸性，並且我們設計我們的抗體在酸性pH條件下選擇性地結合到腫瘤細胞的靶標上，但不會結合到正常組織中的靶標上。我們的方法是確定對癌細胞破壞所需的必要靶向和效力，同時旨在消除或大大減少對靶標的作用，背離腫瘤毒性，這是現有癌症治療面臨的根本性挑戰之一。

我們是一家總部位於美國的公司，在聖地亞哥、加利福尼亞州設有研究設施，並通過與BioDuro-Sundia的合同關係，在中國北京設有前臨床發展服務提供商。自開展業務以來，我們幾乎所有資源都集中在進行研究開發活動上，包括藥物發現、前臨床研究以及產品候選物的臨床試驗，包括目前進行中的mecbotamab vedotin（BA3011）、ozuriftamab vedotin（BA3021）和evalstotug（BA3071）的2期臨床試驗，以及我們BA3182（CAb-EpCAm x CAb-CD3）的1期臨床試驗，建立和維護知識產權組合，通過第三方製造臨床和研究材料，招聘人員，與第三方建立產品開發和商業化合作關係，籌集資金併爲這些活動提供一般和行政支持。自2014年以來，這些研究和開發活動專門涉及基於CAb抗體的產品候選物的研究、開發、製造以及1期和2期臨床測試，以及加強我們專有的CAb技術平台和產品線。

我們迄今爲止已經遭受了重大損失。我們能否創造出足以實現盈利的產品收入將取決於我們當前和未來一項或多項產品候選品的成功開發和最終商業化。截至2024年9月30日三個月和九個月的淨虧損分別爲1060萬美元和5490萬美元，而截至2023年9月30日三個月和九個月的淨虧損分別爲3330萬美元和9650萬美元。截至2024年9月30日，我們累計虧損爲47120萬美元。這些虧損主要是由於與研究和開發活動以及與我們運營相關的一般管理費用所發生的成本。我們預計在可預見的未來不會從產品銷售中獲得有意義的收入，我們預計將因研究和開發成本繼續承擔重大營業費用以及進行臨床試驗和產品候選品的監管批准過程、以及確定和設計產品候選品以及進行臨床前研究而在可預見的未來繼續發生。隨着我們將開發工作重點放在選定的資產和適應症上，我們預計費用和潛在損失會存在一定變量。我們預計短期內研發費用將會下降，因爲我們完成了某些試驗中患者的招募和治療，但在未來隨着我們將主導產品候選品推進監管批准流程，研發費用可能會普遍增加。

我們預計，隨着我們正在進行的活動，我們的費用和資本需求可能會大幅增加，因爲我們：

因此，我們將需要大量額外資本來開發我們的產品候選者並資助未來的運營。在我們能夠從產品銷售中獲得重大營業收入之前（如果有的話），我們預計將通過公共或私人股權發行、債務融資、合作和其他類似安排來籌集資金。我們未來融資需求的金額和時間將取決於許多因素，包括我們開發工作的進展速度和結果。我們無法向您保證我們會盈利或從經營活動中產生正現金流量。

由於產品開發涉及衆多風險和不確定性，我們無法準確預測增加支出的時間或金額，以及是否能夠實現盈利。即使我們實現盈利，也可能無法在季度或年度基礎上維持或增加盈利。如果我們無法實現盈利或無法持續保持盈利，那麼我們可能無法籌集資金，維持研發工作，擴大業務或按計劃水平繼續運營，因此我們可能被迫大幅減少或終止運營。

截至2024年9月30日，我們的現金及現金等價物總額約爲5650萬美元。根據我們當前的運營計劃，我們的現金及現金等價物預計足以支持我們持續運營至少12個月，即從本報告中包含的財務報表發佈之日起算。我們目前的運營計劃側重於選定資產和適應症的臨床開發，幷包括完成某些臨床試驗。我們對現有現金及現金等價物足以支持我們運營的預期時間的估計基於可能被證明錯誤的假設，我們可能會比當前預期更早地利用我們可用的資本資源。

截至目前，我們尚未從產品銷售中產生任何營業收入，並且不指望在不久的將來產生實質性的營業收入。

公司已與多家第三方合作並許可協議，部分情況下可能向我們提供未來的里程碑和版稅支付（請參閱我們的基本報表注7）。 2024年9月，公司將Nectin-4 x CD3萬億級細胞結合雙特異性抗體BA3362授權給Context Therapeutics（「Context」）。我們分別在2024年9月30日結束的三個月和九個月內，與Context的許可協議相關的營業收入爲1100萬美元。

在開發我們自己的項目之前，我們從根據固定價格服務合同提供的服務中獲得營業收入，在某些情況下，這些合同還可能向我們支付里程碑和版稅。我們在截至2023年和2024年9月30日結束的三個和九個月內，未認可任何來自我們傳統服務合同的營業收入。

迄今爲止，我們的研究和開發費用與AV-101的開發有關。研究和開發費用按照發生的原則確認，並將在收到將用於研究和開發的貨物或服務之前支付的款項資本化，直至收到這些貨物或服務。

研發費用主要包括在發現和開發我們候選產品過程中發生的成本。

我們在發生的期間支出研發成本。未退款的預付款用於未來期間收到的貨物或服務，用於研發活動，被推遲並資本化。隨着相關貨物交付和服務執行，資本化金額隨後會被支出。

我們預計，在不久的將來，隨着我們完成某些臨床試驗的招募和治療工作，並將開發重點放在選擇的潛力很高的適應症上，我們的研發費用將有所減少。但是，新的臨床試驗啓動後，包括我們主力產品候選藥的註冊試驗在內，研發費用可能會增加。進行必要的臨床前和臨床研究以獲得監管批准的過程既昂貴又耗時。處於臨床開發後期的成功產品候選藥通常比處於早期的具有更高的開發成本，主要原因是後期臨床試驗的規模和持續時間增加。因此，若我們的產品候選藥繼續進展到臨床試驗階段，包括更大規模和後期階段的臨床試驗，我們的費用將大幅增加，並可能變得更爲變量。我們的產品候選藥的實際成功概率可能受到多種因素的影響，包括產品候選藥的安全性和有效性、其製造過程的質量和穩定性、對臨床項目的投資以及與其他產品的競爭。由於這些變量的存在，我們無法確定研發項目和計劃的持續時間和完成成本，以及我們將何時以何種程度從商業化和銷售我們的產品候選藥中獲得營業收入。我們可能永遠無法獲得我們產品候選藥的監管批准。

我們的一般和行政支出包括高管、財務、企業和其他行政職能人員的與人員相關的支出，知識產權和專利費用，設施和其他分攤費用，外部專業服務等其他費用，包括法律、人力資源、投資者關係、審計和會計服務以及保險費用。與人員相關的支出包括工資、福利和基於股權的補償。我們預計我們的一般和行政支出將在未來保持平穩或適度增加，以支持我們優先的CAb計劃的發展。

利息收入主要包括我們現金及現金等價物結存所賺取的利息。

2024年9月30日結束的三個月內，合作和其他營業收入爲1100萬美元，其中包括根據上下文許可協議確認的收入。2023年9月30日結束的三個月內未確認任何營業收入。有關合作和許可協議的進一步詳情，請參閱我們的基本報表第7條。

以下表格總結了我們根據指定時期對CAb項目進行的研發支出分配情況。

截至2024年9月30日的三個月，研發費用分別爲1640萬美元和2840萬美元，與2023年相比略有減少約1200萬美元，主要是因爲我們早期臨床項目BA3142，我們的CAb B7H3 x CD3雙特異性項目，以及BA3361，我們的CAb Nectin-4 ADC項目的研發成本減少了540萬美元，我們的臨床階段項目研發成本減少了480萬美元，主要是因爲完成了我們進行中ADC試驗的2期招募，用於mecbotamab vedotin和ozuriftamab vedotin的製造成本減少了300萬美元，根據我們2020年股權激勵計劃發放的股票獎勵減少了30萬美元，以及與設施相關的成本減少了20萬美元。這一減少部分被2024年9月與Context Therapeutics簽訂的許可協議產生的180萬美元相關方費用抵消，這在我們的基本報表的附註7和附註8中有進一步討論。

截至2024年9月30日的三個月，總務及管理費用分別爲590萬美元和660萬美元。大約70萬元的減少主要是由於根據我們2020年股權激勵計劃發行的獎勵相關的100萬元股權報酬減少，以及20萬元董事和高級管理人員責任保險費用減少，部分抵消了與2024年9月與Context Therapeutics達成許可協議有關的專業和顧問費用增加的50萬元。

截至2024年9月30日的三個月，利息收入分別爲70萬美元和170萬美元，較2023年同期減少了100萬美元，原因是現金及現金等價物較2023年同期更低。

2024年9月30日止九個月的合作及其他營業收入爲1100萬美元，包括在上下文許可協議下確認的營業收入。2023年9月30日止九個月未確認任何營業收入。有關合作和許可協議的進一步詳情，請參閱我們基本報表註釋7。

以下表格總結了我們根據指定時期對CAb項目進行的研發支出分配情況。

截至2024年9月30日，研發費用分別爲5140萬美元和8110萬美元，而2024年和2023年同期的情況。大約2960萬美元的減少主要是由1520萬美元的減少驅動，這主要是由我們的臨床前項目，主要是BA3142，我們的CAb B7H3 x CD3雙特異性項目，以及BA3361，我們的CAb Nectin-4 ADC項目的開發成本減少所致，製造成本減少780萬美元，評估斯托通的開發成本減少760萬美元，我們的臨床階段項目的開發成本減少760萬美元，主要是因爲我們已完成我們進行中ADC試驗的二期招募，包括mecbotamab vedotin和ozuriftamab vedotin，基於我們2020年股權激勵計劃發放的股權獎勵減少100萬美元，其次是旅行和其他開支減少30萬美元。然而在2024年9月與Context Therapeutics的許可協議有關的關聯方費用增加了180萬美元，這在我們的基本報表的第7和第8注中進一步討論，以及相關人員成本增加了60萬美元。

截至2024年9月30日的九個月，一般和管理費用分別爲1730萬美元和2010萬美元，較2023年同期減少約280萬美元，主要由於根據我們的2020年股權激勵計劃發放的獎勵引起的股權報酬減少280萬美元，董事與高級管理人員責任保險費用減少50萬美元。

由於2024年9月與Context Therapeutics達成許可協議，專業和顧問費用增加了50萬美元。

利息收入分別爲2024年和2023年截至9月30日的$280萬和$470萬。$190萬的減少是由於與2023年同期相比現金及現金等價物較低所致。

我們自成立以來已經累計淨虧損和經營性現金流量爲負，並預計在可預見的未來將繼續出現淨虧損。自2020年7月以來，我們主要通過發行股票以及與合作和許可證的方式資助運營。截至2024年9月30日，我們的現金及現金等價物爲5650萬美元。

2023年1月，公司與Jefferies LLC（「Jefferies」）簽署了一份公開市場銷售協議（「銷售協議」），Jefferies作爲銷售代理，根據該協議，公司可以自行決定在任何時候出售公司的普通股，總規模的銷售收益達到10000萬美元。公司將向Jefferies支付相當於公司從銷售協議項下銷售的所有公司普通股的全部售價的3.0%的佣金。截至2024年9月30日，我們尚未根據銷售協議出售任何公司普通股。

截至2024年3月31日，考慮到我們2024年4月從ATM計劃獲得的2360萬美元的淨收益之前，我們的現金及現金等價物和短期投資爲9930萬美元。我們預計根據我們當前的經營計劃，我們現有的現金、現金等價物和短期投資將足以支持我們的計劃運營，直到2026年。但是，我們對於我們財務資源支持我們的運營的期間的預測是一種前瞻性陳述，其中涉及風險和不確定性，實際結果可能有所不同。我們的估計是基於可能被證明是錯誤的假設，並且我們可能比預期更早地耗盡資本資源。此外，進行臨床試驗的過程是昂貴的，這些試驗的進展和開支時間是不確定的。

我們現金的主要用途是用於支持營業費用，主要包括與我們的項目相關的研發費用和相關人員成本。未來資金需求的時間和數額取決於許多因素，包括以下:

根據我們當前的營運計劃，我們目前的現金及現金等價物預計足以支持我們未來至少十二個月的運營。我們所做的估計是基於可能被證明是錯誤的假設，並且我們可能比當前預期更早地利用我們可用的資本資源。

爲完成產品候選品的開發並商業化我們的產品（如果獲批），我們將需要額外資金。我們可能會通過公開或私人股權發行、債務融資、合作、戰略聯盟、許可安排和其他營銷和分銷安排的組合籌集所需的額外資本。我們不能保證，如果我們需要額外融資，這樣的融資將以對我們而言可接受的條款可用，甚至是否會提供。失敗

爲了從業務運營中產生足夠的現金流，籌集額外資金，並在額外資金不可用時減少自由支出，這樣做可能會對我們實現既定業務目標產生重大不利影響。由於與我們產品候選品的開發和商業化相關的諸多風險和不確定性，我們無法估計與我們當前和預期的臨床前研究和臨床試驗相關的增加資本支出和運營支出金額。在通過與第三方合作、戰略聯盟或許可安排籌集額外資本的程度上，我們可能不得不放棄對我們產品候選品有價值的權利。我們可能還需要在產品研發早期階段或以不太有利的條款或以可能對我們不太有利的條款授予許可的情況下壯大研究項目的未來收入。我們籌集額外資金的能力將取決於財務、經濟和其他因素，其中許多因素超出我們的控制範圍。例如，由於各種原因引起的市場波動，包括供應鏈中斷，以及地緣政治動盪，包括俄羅斯和烏克蘭之間最近的衝突以及以色列與恐怖組織哈馬斯和真主黨之間的戰爭可能會對我們按需獲取資金的能力產生不利影響。即使我們認爲我們有足夠的資金用於當前或未來的運營計劃，根據市場條件或戰略考慮，我們也可能選擇通過發行股本或可轉換債務證券籌集額外資金。如果我們在未來發行其他普通股或其他股本或可轉換債務證券，將進一步稀釋我們的投資者，並且這些證券的條款可能包括影響股東權益的清算或其他優先權。如果我們通過債務融資籌集額外資金，我們可能會受限於限制或限制我們能夠採取的特定行動的契約，例如增加其他債務，進行資本支出，收購其他企業、產品或技術，或宣佈分紅派息。如果我們無法從這些或其他來源獲得額外資金，可能需要通過減少員工和延遲、減少或停止某些研發項目明顯減少我們的支出節奏。

2024年9月30日結束的九個月內，經營活動使用的淨現金爲5520萬美元，其中包括5490萬美元的淨虧損，運營資產和負債的淨變動爲790萬美元，以及770萬美元的非現金交易。我們運營資產和負債的淨變動主要是由於應付賬款和應計費用減少了850萬美元，運營租賃權益資產和租賃負債淨減少了50萬美元，部分抵消了預付費用和其他資產增加100萬美元。非現金交易主要包括700萬美元的股票補償和與折舊及攤銷相關的70萬美元的非現金費用。

2023年9月30日止九個月的經營活動中使用的淨現金爲7410萬美元，其中包括淨損失9650萬美元，我們的經營資產和負債的淨變動爲1080萬美元，以及1170萬美元的非現金交易。我們經營資產和負債的淨變動主要是由應付賬款和預提費用增加1250萬美元，部分抵消了預付費用和其他資產增加130萬美元，以及經營租賃權利資產和租賃負債減少40萬美元。非現金交易主要包括1080萬美元的股份報酬和90萬美元的與折舊和攤銷相關的非現金費用。

2024年9月30日止九個月的投資活動中使用的現金爲0美元。2023年9月30日止九個月的投資活動中使用的現金爲90,000美元，涉及購買房地產和設備。

截至2024年9月30日，融資活動產生的淨現金爲20萬美元，主要包括ESPP和2020計劃認股股票所得的收入，部分被與受限制股票單位淨結算相關的稅金支付所抵銷。

2023年9月30日結束的九個月中，籌資活動中使用的淨現金金額不大，主要包括ESPP和2020計劃下普通股發行所得款項，減去與限制性股票單位的淨結算有關的稅款支付。

我們對財務狀況和經營成果的管理討論與分析是基於我們的基本報表，這些報表是按照GAAP準則編制的。編制這些基本報表要求我們做出會影響資產和負債報告金額、以及財務報表日期確認的應收賬款和應付款項披露，以及報告期間產生的營業收入和報告的費用支出的估計和假設。我們的估計基於我們的歷史經驗和我們認爲在適當情況下是合理的各種其他因素，其結果構成了對於非直接來源清晰的資產和負債的賬面價值的判斷的基礎。實際結果可能會根據不同的假設和條件與這些估計有所不同。

我們的關鍵會計政策是美國普遍公認的會計準則，要求我們對不確定且可能對我們的財務控件和運營結果產生重大影響的事項做出主觀估計和判斷，以及我們應用這些準則的具體方式。有關我們的關鍵會計政策的描述，請參閱我們截至2023年12月31日的年度報告中包含的「管理層對財務狀況和運營結果的討論與分析-關鍵會計政策和估計」一節。在截至2024年9月30日的九個月內，這些關鍵會計政策未發生任何重大變化。

我們沒有參與任何資產負債表外安排，正如SEC的規定所定義的。

根據《交易所法》第13a-15(b)和15d-15(b)條的要求，我們的管理層，在我們的首席執行官和首席財務官的參與下，評估了截至2024年9月30日的我們的披露控制和程序的有效性。根據《交易所法》第13a-15(e)和15d-15(e)條定義，"披露控制和程序"指的是公司旨在確保公司在根據《交易所法》提交的報告中需要披露的信息被記錄、處理、彙總和報告的控制和其他程序，這些信息在SEC規則和表格規定的時間內記錄、處理、彙總和報告。披露控制和程序包括但不限於，旨在確保公司在根據《交易所法》提交的報告中需要披露的信息被累積並傳達給公司管理層，包括其首席執行官和首席財務官，以便及時作出有關所需披露的決定的控制和程序。管理層認識到，無論設計和運作如何出色的控制和程序，都只能提供實現其目標的合理保證，並且管理層在評估可能的控制和程序的成本效益關係時必須運用自己的判斷。根據截至2024年9月30日的我們的披露控制和程序的評估，我們的首席執行官和首席財務官得出結論，在該日期，我們的披露控制和程序在合理保證水平上是有效的。

在截至2024年9月30日的季度內，我們的財務報告內部控制沒有發生影響或有可能影響我們的財務報告內部控制的重大變化。

我們可能不時面臨各種在業務日常中產生的索賠和訴訟。目前我們並未參與任何法律訴訟程序，如果最終判定對我們不利，可能會對我們的業務、運營結果或財務狀況產生重大不利影響。

投資我們的普通股涉及高風險。在購買我們的普通股之前，您應仔細考慮這份第10-Q表格的季度報告中出現在其他部分和「管理層對財務狀況和經營業績的討論與分析」中的簡明財務報表和相關附註中的所有信息。這些風險在「風險因素」部分更全面地討論。這些風險和不確定性包括但不限於以下內容：

我們是一家處於臨床階段的生物製藥公司，經營歷史有限，並沒有任何產品獲得商業銷售批准。我們有着巨額虧損的歷史，未來預計將繼續承擔巨額虧損，在我們有限的經營歷史與此相結合的情況下，很難評估我們未來的生存能力。

我們是一家處於2期臨床階段的生物製藥公司，經營歷史有限，您可以評估我們的業務和前景。我們尚未獲得任何產品的商業銷售批准，並沒有從產品銷售中產生任何營業收入。自公司成立以來，我們幾乎所有資源都用於開展研發活動，包括藥物發現、臨床前研究和我們產品候選藥物的臨床試驗，包括進行中的mecbotamab vedotin（BA3011）、ozuriftamab vedotin（BA3021）、evalstotug（BA3071）的2期臨床試驗以及BA3182（CAb-EpCAm x CAb-CD3）的1期臨床試驗，建立和維護我們的知識產權組合，通過第三方製造臨床和研究材料，招聘人員，建立產品開發和商業合作關係，籌集資金併爲這些運營提供一般和行政支持。我們尚未證明成功獲得營銷批准、生產商業規模產品或安排第三方代表我們進行銷售和營銷活動以成功實現產品商業化的能力。因此，您可能會發現更難評估我們的未來可行性，而如果我們有更長的營運歷史，則可能更容易。

迄今爲止，我們已經遭受了重大損失。我們能夠產生足以實現盈利的產品收入，將取決於我們當前和未來一個或多個產品候選者的成功開發和最終商業化。我們的淨虧損分別爲2023年和2022年12月31日結束的年度分別爲12350萬美元和10650萬美元。2024年9月30日結束的九個月，我們的淨虧損分別爲5490萬美元和9650萬美元。截至2024年9月30日，我們已累計虧損47120萬美元。這些損失主要是由與研究和開發活動以及與我們運營相關的一般行政成本有關的支出造成的。我們預計在可預見的未來內不會從產品銷售中產生有意義的收入，由於研究和開發成本，包括識別和設計產品候選者並進行臨床前研究和臨床試驗，以及我們的產品候選者的監管批准過程，我們預計將繼續在可預見的未來內承擔重大的營業費用。在短期內，我們

預計隨着我們完成某些臨床試驗的招募，這些費用將開始減少，然而，這些費用以及可能出現的損失，在我們推進主導產品候選品通過監管批准過程時，可能會普遍增加。我們也預計，我們的費用會因宏觀經濟因素而波動，包括通貨膨脹。例如，最近，我們的幾家供應商已經由於通貨膨脹而經歷的價格上漲，將這些上漲成本轉嫁給了我們。

然而，我們未來支出和潛在損失的金額是不確定的。我們是否能實現盈利將取決於許多因素，包括成功開發產品候選藥物、獲得監管批准以營銷和商業化產品候選藥物、以合理的條件製造任何獲批產品，以及潛在地建立一個銷售和營銷組織或合適的第三方替代方案來商業化任何獲批產品。如果我們或我們現有或未來的合作伙伴無法開發和商業化我們的一個或多個產品候選藥物，或者任何獲得批准的產品候選藥物的銷售收入不足，我們將無法實現盈利，這可能對我們的業務、財務狀況、經營業績和前景產生重大不利影響。

我們將需要大量額外資本來支持我們的運營。如果我們無法按時融得到這樣的資本，或是不能接受其條件，我們可能會被迫推遲、減少或取消一個或多個研究和藥物開發項目，或是未來的商業推廣努力。

生物製藥產品的開發，包括進行臨床前研究和臨床試驗，是一個非常耗時、昂貴和不確定的過程，需要數年時間才能完成。自我們成立以來，我們的業務已消耗大量現金，並且在進行臨床試驗和尋求mecbotamab vedotin、ozuriftamab vedotin、evalstotug和BA3182的上市許可等持續活動方面，我們將繼續承擔重大費用。即使我們開發的一個或多個產品候選被批准商業銷售，我們預計在銷售、市場營銷、製造和分銷活動方面將產生重大成本。如果FDA、EMA或其他類似的外國監管機構要求我們進行額外的臨床試驗或臨床前研究，而不僅僅是我們目前預期的那些，我們的支出可能會超出預期。還可能會出現其他預期之外的費用。由於我們計劃和預期的臨床試驗的設計和結果高度不確定，我們無法合理估計成功完成我們開發的任何產品候選的開發和商業化所需的實際資源和資金。因此，我們需要獲得大量額外資金才能繼續開展業務。

截至2024年9月30日，我們的現金及現金等價物約爲5650萬美元。根據我們目前的營運計劃，我們當前的現金及現金等價物預計可以足以支持我們未來至少12個月的運營，從本報告中包含的財務報表的日期開始計算。我們目前的營運計劃優先考慮和專注於選定資產和適應症的臨床開發，幷包括完成某些臨床試驗。我們對現有的現金及現金等價物可以支持我們運營的預期時限的估計是基於可能證明不正確的假設，我們可能會比當前預期更早地使用可用資本資源。不可抗力造成的變化可能導致我們的資本消耗速度比當前預期快得多，我們可能需要提前尋求額外資金。

我們計劃利用現有的現金及現金等價物來資助我們的產品候選者和開發項目的研究和開發，並用於資助營運資本和其他一般公司用途。推動產品候選者的開發將需要大量資本。我們現有的現金及現金等價物可能不足以資助任何一個產品候選者通過監管批准。由於成功研究和開發任何個體產品候選者所需的時間和活動是高度不確定的，我們無法估計我們將需要用於開發、營銷批准和商業化活動的實際資金。我們的運營支出的時間和金額將在很大程度上取決於：

如果我們無法及時獲得資金，包括在我們當前或未來的合作中，或以可接受的條件獲得資金，我們可能不得不延遲、減少或終止我們的研發項目和臨床前研究或臨床試驗，限制戰略機會或進行人員裁減，或進行其他公司重組活動。我們可能會通過公開或私人股權發行、債務融資、合作、戰略聯盟、許可安排和其他營銷和分銷安排的組合來籌集任何必要的額外資本。我們不能保證此類融資對我們而言是否以可接受的條件可獲得，如果可能的話。如未能從業務運營中產生足夠現金流、籌集額外資本和減少自由支出，並且如沒有可獲得的額外資本，可能會對我們實現預期業務目標的能力產生重大不利影響。就我們通過與第三方合作、戰略聯盟或許可安排籌集額外資本的程度而言，我們可能不得不放棄我們產品候選者的寶貴權利。我們可能還不得不放棄早期開發階段研究項目的未來收入流，或以比我們否則選擇或不得不授予的更不利條款許可許可。我們籌集額外資金的能力將取決於金融、經濟和其他因素，其中很多是我們無法控制的。我們的財務狀況可能會受全球經濟和全球金融市場的總體狀況的不利影響。例如，全球金融危機已導致資本市場和信貸市場出現極端波動和混亂。如果銀行和金融機構因銀行體系和金融市場的金融狀況而進入接管或破產，導致我們無法獲得現有的現金、現金等價物和投資，可能會威脅我們的業務和財務狀況，對我們的業務和財務狀況產生重大不利影響。嚴重或持續的經濟衰退，比如全球金融危機，可能對我們的業務造成各種風險，包括在需要時以可接受的條件籌集額外資本的能力。無法保證信貸和金融市場惡化以及對經濟狀況的信心不會進一步發生。如果我們通過公開或私人股本或可轉債發行籌集額外資本，我們現有股東的所有權權益將被攤薄，這些證券的條款可能包括對我們股東權益產生不利影響的清算或其他優先權。如果我們通過債務融資籌集額外資本，可能會受到限制或約束我們採取特定行動的契約，比如增加債務、進行資本支出、許可產品權利、參與產品開發合作、收購其他企業、產品或技術或宣佈股息。如果我們無法從這些或其他來源獲得額外資金，可能需要通過裁減員工、推遲、縮減或終止某些研發項目來顯著降低我們的支出速度。

我們將部分現金投資於貨幣型基金，這會使我們的業務和財務狀況容易受到市場特定風險的影響。

我們將一部分現金投資在由美國政府證券支持的貨幣型基金中。所有證券都面臨風險，包括利率期貨波動風險、信用風險、市場風險和制度經濟風險。這些與投資相關的風險項中任何一項的變化或波動可能導致我們投資的現金損失或減值，並可能對我們的業務和財務狀況產生重大不利影響。

我們目前的產品候選品處於不同的開發階段。我們的產品候選品可能在開發過程中失敗或遭遇延遲，影響其商業可行性。如果我們或我們現有或未來的合作伙伴無法完成產品候選品的開發、獲得監管批准或商業化，或出現重大延遲，我們的業務將受到重大損害。

我們目前市場上沒有任何產品，我們的候選產品正處於不同階段的開發中。我們目前正在進行mecbotamab vedotin、ozuriftamab vedotin和evalstotug的2期臨床試驗；BA3182的1期試驗；其他各種產品候選品正處於較早的開發階段。我們實現和保持盈利能力的能力取決於獲得監管批准並且在獲得批准後成功地與第三方合作，商業化我們的產品候選品。在獲得產品候選品商業分銷的監管批准之前，我們或現有或未來的合作伙伴必須進行廣泛的臨床前試驗和臨床試驗，以證明我們的產品候選品的安全性、有效性、純度和效力。任何產品候選品都可能在臨床前或臨床開發的任何階段意外失敗，而產品候選品的歷史失敗率很高。產品候選品的臨床前測試結果可能無法預測將來在產品候選品的後續臨床試驗中獲得的結果。我們或我們現有或未來的合作伙伴可能遇到延誤或阻止臨床試驗和監管批准，或者我們商業化產品候選品的能力可能遇到問題，包括，但不限於：

由於CABs代表了一種新一代的抗體，任何CAb產品候選的開發延遲或失敗可能會給我們的專利技術平台和公司整體帶來重大挫折。

早期臨床試驗的結果可能無法預測晚期臨床試驗或其他臨床試驗的結果，且我們的臨床試驗結果可能無法滿足FDA、EMA或其他類似的外國監管機構的要求。

從臨床前研究和早期臨床試驗中得出的積極和有希望的結果可能無法預測來自臨床後期試驗或用於治療其他適應症的同一產品候選者的結果。儘管通過了臨床前研究和初期臨床試驗，並進入臨床後期試驗階段的產品候選者可能在安全性和有效性方面未能達到期望的特徵。臨床後期試驗可能在很多方面與早期臨床試驗不同，包括入選和排除標準、有效終點、用藥方案和統計設計的變化。此外，臨床試驗在特定適應症中取得成功並不代表該產品候選者在治療其他適應症時會取得成功。許多生物製藥行業的公司在早期開發取得令人鼓舞或積極結果後，在臨床後期試驗中遭受重大挫折。我們不能向您保證我們在正在進行或計劃中的臨床試驗，或在任何隨後的或後市場確證臨床試驗中不會面臨類似的挫折。

此外，臨床前和臨床數據往往容易產生不同的業績解讀和分析，許多公司認爲他們的產品候選在臨床前研究和臨床試驗中表現令人滿意，但最終未能獲得FDA、EMA或類似外國監管機構的批准。我們無法保證FDA將同意我們的臨床試驗計劃，也無法向您保證FDA會同意我們試驗結果是否足以支持任何產品候選的批准。例如，我們在主要終點的客觀反應率可能不足，我們可能無法展示足夠長的反應持續時間，或者我們的研究總樣本規模和劑量選擇策略可能存在侷限性。如果試驗結果未能令FDA或外國監管機構滿意，無法支持營銷申請，我們可能需要耗費大量資源（這些資源可能不可用）來開展額外的試驗，以支持我們的產品候選的潛在批准。即使我們的任何產品候選獲得了監管批准，批准的條款可能限制我們產品候選的範圍和用途，從而可能限制其商業潛力。此外，FDA、EMA或類似外國監管機構的批准政策或法規可能會發生重大變化，以致我們的臨床數據無法滿足批准要求，可能導致FDA、EMA或類似外國監管機構推遲、限制或拒絕對我們產品候選的批准。

而且，在過去，也許在將來，會有一些由調查人員發起的臨床試驗，使用我們的調查產品。我們無法控制這些或其他可能進行的由調查人員發起的試驗的設計或管理，也無法控制進行任何此類試驗所需的任何IND或外國等價物的提交或批准。任何由調查人員發起的試驗都可能，取決於這些第三方的行動，危及所產生臨床數據的有效性，發現與我們的產品候選者相關的重大問題，可能影響我們的發現或臨床試驗，並且可能對我們獲得FDA或其他適用的監管機構的營銷批准能力產生不利影響。如果這些或其他由調查人員發起的試驗的結果與我們正在進行的或計劃中的公司贊助試驗的結果不一致，或不同，或引起對我們的產品候選者的關注，FDA或外國監管機構可能會質疑公司贊助試驗的結果，或對這些結果進行比正常更嚴格的審查。在這些情況下，FDA或該等外國監管機構可能要求我們獲取並提交額外的臨床數據，這可能會延遲我們的產品候選者的臨床開發或上市批准。此外，雖然由調查人員發起的試驗可能有助於指導我們自己的臨床開發工作，但不能保證我們能夠利用這些試驗的數據作爲獲得我們產品候選者監管批准的依據。

我們在很大程度上依賴於我們專利的CAb技術平台的成功，並且我們未來的成功在很大程度上取決於該平台的成功開發。

我們使用我們的CAb技術平台來開發癌症治療的產品候選物。任何涉及我們的CAb技術平台的失敗或挫折，包括不良事件，都可能對我們所有的產品候選物和研究管道產生不利影響。例如，我們可能會發現與CABs相關的以前未知風險或其他問題，這些問題可能比我們目前認爲的更爲棘手，這可能會延長獲得所需觀察期的時間，需要額外的臨床測試或導致未能獲得監管批准。如果我們的CAb技術在某些產品候選物中不安全，我們可能會被要求放棄或重新設計我們所有當前的產品候選物，這可能會對我們的業務、財務狀況、經營業績和前景產生重大不利影響。

在利用和拓展我們的專利CAb技術平台以繼續構建產品候選管線並開發可銷售產品的努力中，我們可能並不會取得成功。

我們正在使用我們的專利技術平台，在腫瘤領域開發CAB產品，其中包括我們的主打產品候選藥mecbotamab vedotin，ozuriftamab vedotin，evalstotug和BA3182，同時繼續建立我們的產品候選藥管線。我們的業務不僅取決於我們成功開發、獲得監管批准並商業化目前在臨床和臨床前研發中的產品候選藥的能力，還取決於通過我們的平台繼續生成新的產品候選藥。即使我們成功地繼續建立我們的管線並進一步推進當前產品候選藥的臨床開發，任何額外的產品候選藥也可能不適合臨床開發，包括由於有害副作用、製造問題、有效性有限或其他特徵表明它們不太可能成爲在臨床開發中取得成功、獲得上市批准或取得市場認可的產品。如果我們無法通過成功商業化CAB產品候選藥來驗證我們的技術平台，我們可能無法在未來時期獲得產品、許可或合作收入，這將不利地影響我們的業務、財務狀況、經營業績和前景。

我們可能會耗盡資源來追求特定的產品候選者，而未能充分利用可能更具盈利性或更可能成功的產品候選者。

由於我們的財務和管理資源有限，我們必須就追求的目標和產品候選人作出戰略決策，可能會放棄或延遲追求其他具有更大商業潛力的機會的目標或產品候選人或其他適應症。例如，我們正在探索與第三方進行潛在的戰略合作，以加快特定資產的開發。此外，我們可能決定進一步優先發展某些項目和某些適應症。我們的資源配置決策可能導致我們未能充分利用可行的商業產品或有利可圖的市場機會。未能正確評估潛在的產品候選人可能導致我們專注於市場潛力較低的產品候選人，這將損害我們的業務、財務狀況、經營業績和前景。我們對現有和未來研究開發項目以及特定目標或適應症的產品候選人的支出可能不會產生任何具有商業價值的產品。我們對用於發現和開發新CAb產品候選人的生物靶點的理解和評估可能無法識別隨後在臨床前和臨床開發中遇到的挑戰。如果我們不能準確評估特定產品候選人的臨床試驗成功的可能性、商業潛力或目標市場，我們可能會通過合作、許可或其他版稅安排放棄那些產品候選人的有價值權利，在這些情況下，維持獨家開發和商業化權利對我們更有利。

如果我們開發的任何產品的市場機會小於我們預期的，我們的營業收入可能受到不利影響，我們的業務可能會受到影響。

我們將產品候選開發重點放在治療各種腫瘤適應症的治療性CAb抗體上，例如軟組織肉瘤、非小細胞肺癌、黑色素瘤和頭頸癌等。我們對可能從我們的產品候選治療中受益的患者人群的預測是基於我們的估計。這些估計是從各種來源獲取的，包括科學文獻、診所調查、醫師訪談、患者基金會和市場研究。這些估計可能被證明是不正確的。此外，新的研究可能會改變這些癌症的預計發病率或患病率。此外，我們產品候選的潛在治療人群最終可能與我們的產品候選不相宜。我們的市場機會也可能會受到未來競爭對手進入市場的限制。如果我們的任何估計被證明不準確，我們或我們的戰略合作伙伴開發的任何產品候選的市場機會可能會受到嚴重減少，並對我們的業務產生不利的重要影響。

市場可能不會接受我們的產品候選者，因爲它們基於我們的新穎治療方式，我們可能無法通過銷售或授權產品候選者獲得任何未來的營業收入。

我們正在開發的產品候選者主要基於我們擁有專利的CAb技術平台，該平台利用新技術來創造我們的新穎治療方法。具有重要影響力的市場參與者，如醫生和第三方支付方，可能不會採用基於我們專利技術平台的產品或治療方法，我們可能無法說服患者、醫療社區和第三方支付方接受和使用，或爲我們或我們現有或未來的合作伙伴開發的任何產品候選者提供有利的報銷。我們的產品候選者的市場接受將取決於其他因素之一：

如果我們商業化的任何產品候選者未能獲得市場認可，可能會對我們的業務、財務狀況、運營結果和前景產生重大不利影響。

我們不時公佈或發表的臨床試驗的初步、預先計劃的中期和總體數據可能會隨着更多患者數據的出現和/或經審核和驗證程序而發生變化，可能導致最終數據發生重大變化。

我們可能不時公開披露我們臨床試驗的初步、預先計劃的過渡性或概要數據。這些數據及相關發現和結論可能只反映某些終點而非所有終點，並且可能會發生變化。例如，我們可能報告某些患者的腫瘤反應，但這些反應在當時尚未經確認，在隨訪評估後也未最終導致治療的確認反應。我們在分析數據時也可能進行假設、估算、計算和得出結論，可能尚未收到或未有機會全面仔細評估所有數據。因此，我們報告的初步結果可能與相同研究的未來結果不同，或者可能需要在收到和全面評估額外數據後對這些結果進行不同的結論或考慮。概要數據仍需接受可能導致最終數據與先前公佈的初步數據存在重大差異的審計和驗證程序。因此，在最終數據出來之前，應謹慎看待概要數據。此外，我們可能報告我們可能完成的臨床試驗的預先計劃的過渡性分析，這可能存在這樣的風險，即其中一個或多個臨床結果可能會發生重大變化

患者招募持續進行，並且更多患者數據變得可用。中間數據和最終數據之間的不良變化可能會嚴重損害我們的業務和前景。此外，我們或我們的競爭對手將來進一步披露中間數據可能導致我們普通股價格的波動。

此外，我們選擇公開披露有關某項研究或臨床試驗的信息通常是從大量可用信息中精選而出的。您或其他人可能不同意我們判斷爲材料或其他適當的信息，而我們決定不披露的任何信息最終可能被認爲在未來決策、結論、觀點、活動或其他方面對某個產品候選人或我們的業務具有重要意義。如果我們報告的初步預先計劃的中期數據或最終數據與稍後的最終或實際結果不符，或者其他人，包括監管機構，對所得結論持不同意見，我們獲取批准並商業化產品候選人的能力可能會受損，這可能會損害我們的業務、財務狀況、經營業績和前景。

臨床試驗的開始和完成延遲可能會導致成本增加，並延遲或阻止我們產品候選物的監管批准和商業化。

我們不能保證我們的候選藥品的臨床試驗將按計劃進行或按時完成，甚至可能根本無法進行。一項或多項臨床試驗失敗可能發生在臨床試驗過程的任何階段，並且其他事件可能導致我們暫時或永久停止臨床試驗。可能阻礙臨床開發成功或及時開始和完成的事件包括：

如果我們中斷或終止臨床試驗，可能會遇到延誤，可能是由我們、執醫所機構的倫理審查委員會、數據安全監測委員會或DSMb制止，或由FDA或其他監管機構制止。這些機構可能會由於多種因素而實施這種暫停或終止，包括未按照監管要求或我們的臨床方案進行臨床試驗、FDA或其他監管機構檢查臨床試驗運營或試驗站點導致實施臨床掛起、意外的安全問題或不良反應、未能證明使用藥物的益處、政府法規或管理措施的變化或缺乏足夠資金繼續臨床試驗。如果我們在完成任何產品候選藥的臨床試驗方面遇到延誤或終止，將損害產品候選藥的商業前景，也將影響我們從這些

產品候選品將被延遲。此外，臨床試驗完成的任何延誤都將增加我們的成本，減緩我們的產品候選品開發和批准過程，危及我們開始產品銷售並創造收入的能力。這些情況中的任何一種都可能嚴重損害我們的業務、財務狀況、運營結果和前景。此外，導致臨床試驗開始或完成延遲的許多因素也可能最終導致我方的產品候選品被否定獲得監管批准。

另外，從試驗和研究獲得的數據容易被不同的解讀影響，監管機構可能不像我們一樣看待我們的數據，這可能會延遲、限制或阻止監管批准。我們的臨床試驗結果可能不成功，即使成功了，也可能不會導致獲得監管批准。

臨床試驗中患者的招募和留存是一個昂貴且耗時的過程，可能會因我們無法控制的多種因素而變得更加困難甚至變得不可能。

我們可能會在招募過程中遇到延遲或困難，或者無法在當前時間軸上招募足夠數量的患者，甚至一旦招募完成，我們可能無法保留足夠數量的患者來完成我們的任何臨床試驗。我們臨床試驗的招募可能比我們預期的要慢，導致開發時間表延遲。

患者在臨床試驗中的招募和留存取決於許多因素，包括患者群體的規模和特性，試驗方案的性質，我們招募具有適當背景和經驗的臨床試驗調查員的能力，由於旅行或隔離政策而導致的招募延遲，或者與健康流行病或大流行有關的其他因素，關於研究藥物的安全性和有效性數據的現有內容，競爭性治療措施的數量和性質以及用於相同適應症的競爭性藥物正在進行的臨床試驗，患者與臨床試驗點的接近程度，試驗的資格標準以及符合這些標準的患者篩選比例，包括與生物標誌物相關的標準，我們獲得和保持患者同意的能力，包括爲青少年患者招募所需的任何額外同意，以及我們成功完成招募某些患者群體之前的先決條件研究的能力。此外，我們可能在我們的產品候選藥物的臨床試驗中報告的任何負面結果或新的安全信號可能會使我們在進行的其他臨床試驗中難以或不可能招募和留存患者。同樣，我們競爭對手關於他們藥物候選者的結果可能會對我們臨床試驗中的患者招募產生不利影響。此外，同類藥物中競爭對手的上市許可可能會影響我們吸收患者參與臨床試驗的能力，延遲或可能阻止我們完成一個或多個試驗的招募。

計劃患者招募或保留的延遲或失敗可能導致成本增加、項目延遲或兩者並存，這可能對我們開發產品候選藥物的能力產生有害影響，甚至可能使進一步開發變得不可能。此外，我們依賴臨床試驗中心確保及時進行臨床試驗，儘管我們已簽訂規管其服務的協議，但在迫使其實際履行方面能力有限。

我們的產品候選可能會引起不良和意想不到的副作用，或者具有其他影響安全性的特性，可能會阻止其臨床開發，延遲或阻止其監管批准，限制其商業潛力或導致重大負面後果。

我們產品候選物可能導致不良副作用，這可能會導致我們或監管機構中斷、延遲或停止臨床試驗，進而可能導致更爲嚴格的標籤、或使FDA或其他監管機構延遲或拒絕批准，以及潛在的產品責任索賠。這些副作用也可能影響患者招募或已入組患者完成試驗的能力。生物製藥行業中開發的許多化合物最初表現出對治療癌症具有潛力的跡象，但後來發現會導致副作用，從而阻止了它們的進一步研發。這些事件中的任何一種可能對我們的業務、財務狀況、運營結果和前景造成重大不利影響。

在我們的抗體藥物複合物mecbotamab vedotin和ozuriftamab vedotin的臨床試驗中，我們觀察到可逆的骨髓抑制、短暫的肝酶升高、發熱、代謝紊亂和周圍神經病變等不良事件。在我們的evalstotug臨床試驗中，我們觀察到輸注相關反應、細胞因子釋放綜合徵和免疫相關的不良事件。在其他產品候選品的臨床試驗中，我們也可能觀察到不良的副作用。

對於我們當前和未來的臨床試驗，我們已經與有經驗的CRO公司簽訂合同，並預計將繼續與在臨床試驗期間評估和管理產生毒性的CRO公司簽訂合同。儘管如此，他們可能會在觀察患者和治療毒性方面遇到困難，可能由於人員變動、班次變動、住院醫師覆蓋或相關問題而更具挑戰性。這可能導致更嚴重或持續時間更長的毒性反應，甚至患者死亡，這可能導致我們或FDA延遲、暫停或終止一個或多個臨床試驗，可能危及監管批准。

此外，臨床試驗通常只在潛在患者群體的樣本中測試候選藥物。在這類試驗中，由於患者數量有限且暴露時間有限，我們產品候選的罕見和嚴重副作用可能不會被

在更多患者接受產品候選物之後才能揭示。例如，雖然我們認爲mecbotamab vedotin、ozuriftamab vedotin和evalstotug迄今已表現出可管理的耐受性，但我們不能向您保證這些以及其他產品候選物不會在更多患者中引起更嚴重的副作用。

此外，mecbotamab vedotin、ozuriftamab vedotin和evalstotug正在研究與其他療法結合使用，這可能加劇與療法相關的不良事件。接受這些或我們的其他產品候選者治療的患者可能最近接受了手術、放射或化療治療，這可能會引起與我們的產品候選者無關但仍可能影響我們臨床試驗成功的副作用或不良事件。

將危重病患納入我們的臨床試驗可能導致死亡或其他不良醫療事件，這可能是由於這些患者正在使用的其他療法或藥物，也可能是由於這些患者疾病的嚴重性。例如，在我們的臨床試驗中招募的一些晚期患者可能會因其疾病的嚴重性而在臨床試驗過程中或參加此類試驗後主要出現死亡或經歷重大臨床事件，這在過去曾發生過。

如果我們的任何產品候選獲得監管批准，並且我們或他人後來發現由該產品導致的不良和意想不到的副作用，可能會發生負面後果，包括以下任何一種：

任何這些事件可能阻止我們獲得或維持特定產品候選人的市場接受度，如果獲得批准，可能導致我們的重要收入流失，從而對我們的運營業務和業務產生實質和不利影響。此外，如果我們的一個或多個產品候選人被證明不安全，可能會對我們的業務，財務狀況，經營業績和前景產生實質和不利影響。

我們正在與其他療法結合開發我們的某些產品候選藥物，這些其他療法的監管批准、安全性或供應問題可能會延遲或阻礙我們產品候選藥物的研發和批准。

目前，我們正在評估mecbotamab vedotin、ozuriftamab vedotin和evalstotug與抗PD-1抗體聯合使用。未來，我們可能會探索這些或其他候選產品與其他療法的聯合使用。如果我們選擇開發用於與批准療法聯合使用的候選產品，我們面臨FDA、EMA或其他司法管轄區的類似外國監管機構可能會撤銷對所用聯合產品的批准，或者可能會出現安全性、有效性、製造業或供應問題。如果我們與候選產品結合使用的療法被取代爲標準護理，FDA、EMA或其他司法管轄區的類似外國監管機構可能要求我們進行額外的臨床試驗。任何這些風險的發生可能導致我們的產品候選品，一旦獲批，被撤出市場或在商業上取得的成功較少。

在我們開發一種產品候選藥物用於與尚未獲得FDA、EMA或其他司法管轄區類似外國監管機構批准的治療方案結合時，除非未批准的治療方案獲得監管批准，否則我們將無法將我們的產品候選藥物用於與此類未批准的治療方案結合營銷。此外，其他公司可能會開發他們的產品或產品候選藥物，以與未批准的治療方案結合。

are developing our product candidates for use in combination. Any setbacks in these companies’ clinical trials, including the emergence of serious adverse effects, may delay or prevent the development and approval of our product candidates.

If the FDA, EMA or comparable foreign regulatory authorities in other jurisdictions do not approve or revoke their approval of, or if safety, efficacy, manufacturing, or supply issues arise with, therapies we choose to evaluate in combination with any of our product candidates, we may be unable to obtain regulatory approval of or to commercialize such product candidates in combination with these therapies.

如果任何我們的產品候選品，如mecbotamab vedotin和ozuriftamab vedotin的安全有效使用依賴於一個伴隨診斷試驗，那麼FDA通常要求在FDA批准我們的產品候選品之前或同時批准或清除該伴隨診斷試驗，如果有必要。如果我們無法成功開發出產品候選品的伴隨診斷試驗，或在這方面遇到重大延遲，或依賴第三方開發此類伴隨診斷試驗，或未能獲得或面臨FDA批准伴隨診斷試驗的延遲，我們的產品候選品的全部商業潛力和生成營業收入的能力將受到重大損失。

If use of a companion diagnostic test is determined to be essential for the safe and effective use of any of our product candidates, such as mecbotamab vedotin and ozuriftamab vedotin, then the FDA generally will require approval or clearance of that companion diagnostic before or at the same time that the FDA approves our product candidates, if at all. The FDA has generally required in vitro companion diagnostics intended to select the patients who will respond to cancer treatment to obtain a PMA for that diagnostic simultaneously with approval of the therapeutic. The process of obtaining or creating such diagnostic and obtaining PMA approval is time-consuming and costly and a delay in diagnostic approval could delay drug approval. According to FDA guidance, if the FDA determines that a companion diagnostic device is essential to the safe and effective use of a novel therapeutic product or indication, the FDA generally will not approve the therapeutic product or new therapeutic product indication if the companion diagnostic is not also approved or cleared for that indication. If a satisfactory companion diagnostic is not commercially available, we may be required to create or obtain one that would be subject to regulatory approval requirements. For example, we have in the past explored predictive biomarkers, such as the Tumor Membrane Percent Score (“TmPS”), which measures AXL and ROR2 expression levels on the tumor membrane, to help inform which patients may be most suitable for treatment with mecbotamab vedotin and ozuriftamab vedotin. Currently, patients with negative or only 1% TmPS scores appear to have experienced clinical benefit in our ongoing clinical trials. However, if the AXL and/or ROR2 TmPS scores predict those most likely to experience clinical benefit, we may be required to pursue the further use of a companion diagnostic in our mecbotamab vedotin or ozuriftamab vedotin clinical trials, and the available market for mecbotamab vedotin or ozuriftamab vedotin, both in patient numbers and patient acceptance of the protocol, could be limited. In addition, we expect to rely on third parties for the design, development and manufacture of companion diagnostic tests for any of our product candidates that require such tests.

On April 13, 2020, the FDA issued new guidance on developing and labeling companion diagnostics for a specific group of oncology therapeutic products, including recommendations to support a broader labeling claim rather than individual therapeutic products. We will continue to evaluate the impact of this guidance on our companion diagnostic development and strategy. This guidance and future policies from the FDA and other regulatory authorities may impact our development of a companion diagnostic for our product candidates and result in delays in regulatory approval. We may be required to conduct additional studies to support a broader claim. Also, to the extent other approved diagnostics are able to broaden their labeling claims to include our approved drug products, we may be forced to abandon our companion diagnostic development plans or we may not be able to compete effectively upon approval, which could adversely impact our ability to generate revenue from the sale of our approved products and adversely affect our business, financial condition, results of operations and prospects.

If the FDA, EMA or a comparable foreign regulatory authority requires approval of a companion diagnostic for any of our product candidates, whether before or after it obtains marketing approval, we, and/or future collaborators, may encounter difficulties in developing and obtaining approval for such product candidate. If we or our third-party collaborators experience any delay in developing or obtaining regulatory approval of a companion diagnostic, we may be unable to enroll enough patients for our current and planned clinical trials, the development of our product candidates may be adversely affected or we may not obtain marketing approval, and we may not realize the full commercial potential of our product candidates, including mecbotamab vedotin and ozuriftamab vedotin.

We face competition from entities that have developed or may develop product candidates for cancer, including companies developing novel treatments and technology platforms. If these companies develop technologies or product candidates more rapidly than we do or their technologies are more effective, our ability to develop and successfully commercialize product candidates may be adversely affected.

The development and commercialization of drugs and therapeutic biologics is highly competitive. We compete with a variety of multinational biopharmaceutical companies and specialized biotechnology companies, as well as technology being developed at universities and other research institutions. Our competitors have developed, are developing and will develop product candidates and processes competitive with our product candidates. We believe that a significant number of products are currently under development,

and may become commercially available in the future, for the treatment of conditions for which we are developing product candidates. We believe that while our patented CAB technology platform, its associated intellectual property and our scientific and technical know-how give us a competitive advantage in this space, competition from many sources remains. Our success will partially depend on our ability to develop and protect therapeutics that are safer and more effective than competing products. Our commercial opportunity and success will be reduced or eliminated if competing products are safer, more effective or less expensive than the therapeutics we develop.

Although we do not believe competing companies have selective CAB technology, there is a wide array of activity in multiple areas of immune-based cellular therapies for oncology including CAR-T and T-cell receptor therapies. Certain companies are also pursuing antibody therapies in immuno-oncology, ADCs and various prodrug biologic products designed to be preferentially activated at tumor sites. There are several FDA approved ADC products and several companies in various stages of clinical development of ADCs mostly directed at oncology indications, a key feature of our product candidates mecbotamab vedotin and ozuriftamab vedotin. There are also companies developing technologies designed to deliver biologics and chemotherapeutic agents with some targeting capabilities. In addition, if any of our product candidates are approved in oncology indications, they may compete with existing biologics and small molecule therapies, or may be used in combination with existing therapies. There are also many other therapies under development that are intended to treat the same cancers that we are targeting or may target with our CAB platform, including through approaches that could prove to be more effective, have fewer side effects, be cheaper to manufacture, be more convenient to administer or have other advantages over any products resulting from our technologies.

Many of our competitors, either alone or with strategic partners, have significantly greater financial, technical, manufacturing, marketing, sales and supply resources or experience than we do. Accordingly, our competitors may be more successful than us in obtaining approval for treatments and achieving widespread market acceptance, rendering our treatments obsolete or non-competitive. Accelerated merger and acquisition activity in the biotechnology and biopharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors. These companies also compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials and acquiring technologies complementary to, or necessary for, our programs. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. The level of generic competition and the availability of reimbursement from government and other third-party payors will also significantly affect the pricing and competitiveness of our products. In addition, our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

There are also requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries. Sponsors of clinical trials of FDA-regulated products, including biologics, are required to register and disclose certain clinical trial information, which is publicly available at www.clinicaltrials.gov. Information related to the product, patient population, phase of investigation, study sites and investigators, and other aspects of the clinical trial is then made public as part of the registration. Sponsors are also obligated to discuss the results of their clinical trials after completion. Disclosure of the results of these trials can be delayed in certain circumstances for up to two years after the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding the progress of development of our programs.

Our commercial opportunity could be substantially limited in the event that our competitors develop and commercialize products that are more effective, safer, less toxic or more convenient than products we may develop. In geographies that are critical to our commercial success, competitors may also obtain regulatory approvals before us, resulting in our competitors building a strong market position in advance of our products’ entry. Such competitors could also recruit our employees, which could negatively impact our level of expertise and our ability to execute our business plan.

Our biologic product candidates for which we intend to seek approval may face competition through an abbreviated pathway.

The Biologics Price Competition and Innovation Act of 2009 (the “BPCIA”), enacted as part of the Affordable Care Act (the “ACA”), which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full Biologics License Application (“BLA”) for the competing product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty. While it is uncertain when such processes intended to implement BPCIA may be fully adopted by the FDA, any such processes could have an adverse effect on the future commercial prospects for our product candidates.

There is a risk that any product candidates we may develop that are approved as a biological product under a BLA would not qualify for the 12-year period of exclusivity or that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider any product candidates we may develop to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated.

Our business entails a significant risk of product liability, and if we are unable to obtain sufficient insurance coverage, such failure could have a material and adverse effect on our business, financial condition, results of operations and prospects.

We expect to be exposed to significant product liability risks inherent in the development, testing and manufacturing of our product candidates and products, if approved. Product liability claims could delay or prevent completion of our development programs. If we succeed in marketing products, such claims could result in an FDA investigation of the safety and effectiveness of our products, our third-party manufacturer’s manufacturing processes and facilities or our marketing programs and potentially a recall of our products or more serious enforcement action, including limitations on the approved indications for which our product candidates may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in decreased demand for our products, injury to our reputation, costs to defend the related litigation, a diversion of management’s time and our resources, substantial monetary awards to trial participants or patients and a decline in our stock price. We currently have product liability insurance that we believe is appropriate for our stage of development and may need to obtain higher levels prior to marketing any of our product candidates. Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities. In addition, we may be subject to liability based on the actions of our existing or future collaborators in connection with their development of products using our CAB technology. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be unable to maintain sufficient insurance at a reasonable cost to protect us against losses caused by product liability claims that could have a material and adverse effect on our business, financial condition, results of operations and prospects.

我們可能無法獲得美國或外國的監管批准，結果可能無法將我們的產品候選品商品化。

我們的產品候選者受到廣泛的政府監管，涉及研究、開發、測試、製造、質量控制、進出口、安全性、有效性、標籤、包裝、儲存、分銷、記錄保留、批准、廣告、推廣、營銷、批准後監測和批准後報告藥物和治療生物製品等諸多方面。在美國和許多外國司法管轄區完成新藥物或治療生物製品的市場營銷前，需要經過嚴格的臨床前測試和臨床試驗，以及複雜的監管批准流程。滿足這些以及其他監管要求是昂貴、費時、耗時、不確定的，並可能會出現意外延遲。我們之前從未向FDA提交過BLA，或者向其他國外監管機構提交過類似的藥物批准申請，用於任何產品候選者，而且我們開發的任何產品候選者可能都無法獲得必要的監管批准，以便我們或我們現有或未來合作伙伴開始銷售它們。

我們尚未完成任何大規模或具有關鍵意義的臨床試驗，也沒有與FDA或其他監管機構管理審批流程。獲得FDA和其他批准的時間是不確定的，但通常需要在臨床試驗開始後的多年內，具體取決於產品候選人的類型、複雜性和創新性，以及包括監管機構的重大自由裁量權在內的諸多其他因素。FDA及其外國同行，包括EMA，在我們及我們現有或未來的合作伙伴進行監管時使用的標準需要判斷，可能會發生變化，這使得難以準確預測它們將如何被應用。我們對來自臨床前和臨床活動的數據執行的任何分析都需要監管機構的確認和解釋，這可能會延誤、限制或阻止監管批准。我們可能還會因新的政府法規遇到意外的延遲或成本增加，例如，來自未來立法或行政行動，或來自產品開發、臨床試驗和FDA監管審查期間FDA政策的變化。無法預測是否會出台立法變更，或者FDA或外國法規、指導方針或解讀是否會發生變化，或者這種變更，如果有的話，可能會產生什麼影響。例如，FDA內的腫瘤中心推出了Project Optimus，這是一個旨在改革腫瘤藥物開發中劑量優化和劑量選擇範式的倡議，強調選擇最佳劑量，即最大化藥物療效以及安全性和耐受性的劑量或幾種劑量。這種從先前方法的轉變通常確定最大耐受劑量，可能需要贊助商花費額外的時間和資源來進一步探索產品候選人的劑量-反應關係，以促進在目標人群中選擇最佳劑量。其他腫瘤中心的倡議還包括Project FrontRunner，這是一個旨在開發識別初期先進環境中需要首次臨床開發的候選藥物框架的倡議，而不是用於治療接受過多次治療方案或已經耗盡現有治療選擇的患者的倡議，以及Project Equity，這是一個旨在確保提交給FDA用於批准腫瘤醫療產品的數據充分反映了這些醫療產品所針對的患者的人口統計代表性的倡議。最近，作爲食品和藥物全面改革法案（FDORA）的一部分，贊助商將被要求提交用於新藥第3期研究或其他關鍵研究的多樣性行動計劃（DAPs）。DAPs必須包括贊助商的

招生目標應按年齡組、性別和臨床相關研究人群的種族和民族特徵進行細分；贊助商制定這些目標的基本原理；以及贊助商打算如何實現這些目標的解釋。FDA計劃於2025年6月底發佈有關DAP的最終指導意見，這些要求計劃於2025年底實施。然而，對於這些要求的最終細節及其對開發項目的影響仍存在重大不確定性。在我們考慮與我們的項目相關的這些以及其他政策變化。

此外，我們的產品候選者可能由於許多原因未能獲得監管批准，包括以下原因：

獲取所需批准出現任何延遲或失敗可能會對我們從尋求批准的特定產品候選方面產生重大不利影響。此外，市場藥品獲得任何監管批准都可能受到對我們可以市場藥品的批准用途或適應症或藥品標籤或其他限制的重大限制。此外，FDA有權要求REMS作爲批准BLA的一部分，或在批准後要求，這可能對批准藥品的分銷或使用施加進一步要求或限制。這些要求或限制可能包括將處方限制在經過專門培訓的某些醫生或醫療中心，將治療限制在符合某些安全使用標準的患者，並要求接受治療的患者加入登記冊。這些限制和限制可能會顯著限制藥品的市場規模，並影響第三方支付者的報銷。

我們還受制於許多涉及臨床試驗、製造和營銷授權、定價以及第三方報銷等事項的外國監管要求。外國監管批准流程在各國之間存在差異，可能包括所有上述FDA批准相關風險，以及與滿足外國司法管轄區域的本地法規相關的風險。此外，獲取批准所需的時間可能不同於獲取FDA批准所需的時間。FDA的批准並不保證獲得美國以外監管機構的批准，反之亦然。

We intend to seek approval from the FDA or comparable foreign regulatory authorities through the use of accelerated approval pathways, if available. If we are unable to obtain such approval, we may be required to conduct additional preclinical studies or clinical trials beyond those that we contemplate, which could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals. Even if we receive accelerated approval from the FDA, if our confirmatory trials do not verify clinical benefit or if we do not comply with rigorous post-marketing requirements, the FDA may seek to withdraw accelerated approval.

We intend to seek accelerated approval for one or more of our product candidates. Under the accelerated approval program, the FDA may grant accelerated approval to a product candidate designed to treat a serious or life-threatening condition that provides meaningful advantage over available therapies upon a determination that the product candidate has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as irreversible morbidity or mortality. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is

reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage but is a clinically important improvement from a patient and public health perspective. We intend to seek accelerated approval for some of our product candidates on the basis of objective response rate, a surrogate endpoint that we believe is reasonably likely to predict clinical benefit. For products granted accelerated approval, sponsors are required to verify and describe the product’s clinical benefit generally in the form of confirmatory trials. These confirmatory trials must be completed with due diligence, and the FDA may require that the trial be designed, initiated, and/or fully enrolled prior to approval. If we were to pursue accelerated approval for a product candidate for a disease or condition, we would likely do so on the basis that there is no available therapy for that disease or condition. If any of our competitors were to receive full approval on the basis of a confirmatory trial for a drug for a disease or condition for which we are seeking accelerated approval before we receive accelerated approval, the disease or condition would no longer qualify as one for which there is no available therapy, and accelerated approval of our product candidate would not occur, unless we were able to demonstrate a meaningful advantage over the approved product. Many cancer therapies rely on accelerated approval, and the treatment landscape can change quickly as the FDA converts accelerated approvals to full approvals on the basis of successful confirmatory trials. Failure to conduct required post-approval studies, or to confirm a clinical benefit during post-marketing studies, would allow the FDA to withdraw the product from the market on an expedited basis. All promotional materials for product candidates approved under accelerated regulations are subject to prior review by the FDA.

Prior to seeking accelerated approval for any of our product candidates, we intend to seek feedback from the FDA and will otherwise evaluate our ability to seek and receive accelerated approval. We cannot assure you that after our evaluation of the feedback and other factors we will decide to pursue or submit a BLA for accelerated approval or any other form of expedited development, review or approval. Similarly, we cannot assure you that after subsequent FDA feedback we will continue to pursue accelerated approval or any other form of expedited development, review or approval, even if we initially decide to do so. Furthermore, if we decide to submit an application for accelerated approval or receive an expedited regulatory designation (e.g., breakthrough therapy designation) for our product candidates, we cannot assure you that such application will be accepted or that any expedited development, review or approval will be granted on a timely basis, or at all. The FDA or other comparable foreign regulatory authorities could also require us to conduct further studies prior to considering our application or granting approval of any type.

Recently, the accelerated approval pathway has come under scrutiny within the FDA and by Congress. The FDA has put increased focus on ensuring that confirmatory studies are conducted with diligence and, ultimately, that such studies confirm the benefit. For example, the FDA has convened its Oncologic Drugs Advisory Committee to review what the FDA has called dangling or delinquent accelerated approvals where confirmatory studies have not been completed or where results did not confirm benefit.

The enactment of FDORA included provisions related to the accelerated approval pathway. Pursuant to FDORA, the FDA is authorized to require a post-approval study to be underway prior to approval or within a specified time period following approval. FDORA also requires the FDA to specify conditions of any required post-approval study and requires sponsors to submit progress reports for required post-approval studies and any conditions required by the FDA. FDORA enables the FDA to initiate enforcement action for the failure to conduct with due diligence a required post-approval study, including a failure to meet any required conditions specified by the FDA or to submit timely reports. In addition, the Oncology Center of Excellence has announced Project Confirm, which is an initiative to promote the transparency of outcomes related to accelerated approvals for oncology indications and provide a framework to foster discussion, research and innovation in approval and post-marketing processes, with the goal to enhance the balance of access and verification of benefit for therapies available to patients with cancer and hematologic malignancies.

美國食品和藥物管理局（FDA）已授予ozuriftamab vedotin在頭頸部鱗狀細胞癌（SCCHN）復發或轉移性的快速通道指定，如果獲得，對於我們的其他任何產品候選可能不會促使更快的開發或監管審查或批准流程，並且不會增加我們的產品候選獲得監管批准的可能性。

2024年7月，FDA授予ozuriftamab vedotin在複發性或轉移性SCCHN中的快速通道指定，並且我們將來可能會爲其他產品候選者尋求快速通道指定。如果一種藥物用於治療嚴重或危及生命的疾病，並且這種藥物顯示出有望滿足這種疾病未滿足的醫療需求的潛力，該藥物可能有資格獲得快速通道指定。FDA在是否授予此指定方面擁有廣泛裁量權。即使我們認爲特定產品候選者有資格獲得此指定，我們也不能向您保證FDA會決定授予它。即使產品候選者確實獲得了快速通道指定，如ozuriftamab vedotin在複發性或轉移性SCCHN中已獲得的情況，我們也可能不會經歷比傳統FDA程序更快的開發、審查或批准過程。如果FDA認爲快速通道指定不再得到其臨床開發項目數據支持，FDA可能會撤回快速通道指定。許多獲得快速通道指定的藥物最終未能獲得批准。

即使我們的任何產品候選品獲得監管批准，我們仍需遵守持續的監管義務和持續的監管審查，可能會導致額外巨額支出。此外，如果獲准，我們的產品候選品可能會受到標籤和其他限制，並可能被撤離市場，如果我們未能遵守監管要求或我們的產品出現意外問題，我們可能會受到處罰。

我們或我們現有或未來的合作者獲得的任何監管批准，也可能受到對產品可營銷的批准適應症的限制，或者受到批准條件的限制，或者包含對潛在昂貴的後市場測試的要求，包括「第四階段」臨床試驗以及監測產品候選藥物的安全性和有效性。此外，市場營銷產品的任何監管批准可能受到產品標籤的限制，或可能要求提供安全警告或其他限制。此外，FDA有權要求在生物許可申請書（BLA）的一部分或批准後製定REMS（風險評估和緩解戰略）計劃，這可能對批准的生物製劑的分發或使用施加進一步的要求或限制，例如將處方限制在接受專門培訓的某些醫師或醫療中心，限制治療對象爲符合某些安全使用標準的患者，並要求接受治療的患者加入登記系統。這些限制和限制可能會限制產品的市場規模，並影響第三方支付者的報銷。

此外，如果FDA或類似的外國監管機構批准我們的任何產品候選藥物，製造過程、標籤、包裝、配送、不良事件報告、儲存、進口、出口、廣告、促銷和產品的記錄保存都將受到廣泛和持續的監管要求。這些要求包括提交安全性和其他發售後信息和報告、註冊，以及繼續遵守我們獲批准後進行的任何臨床試驗的cGMP和GCP標準。我們將用於製造未來產品（如果有的話）的製造商和製造設施也將定期接受FDA和其他監管機構的審查和檢查，包括持續遵守cGMP要求。任何產品的推廣和廣告也將受到監管要求和持續監管審查的約束。隨後發現產品中以前未知的問題，包括意外嚴重程度或頻率的不良事件，或與第三方製造商或製造過程不符合監管要求，可能導致，除其他事項外：

美國食品藥品管理局的政策可能會發生變化，並可能頒佈額外的政府監管措施，這可能會阻止、限制或延遲我們產品候選品的監管批准。我們也無法預測未來立法或行政行動可能產生的監管概率、性質或範圍，無論是在美國還是國外。如果這些規定對FDA進行監督和實施活動施加了限制，我們的業務可能會受到負面影響。如果我們在適應現有要求的變化或新要求或政策的採納方面緩慢或不能夠適應，或如果我們無法保持監管合規性，則我們可能會失去任何可能獲得的營銷批准，也可能無法實現或維持盈利能力，從而對我們的業務、財務狀況、經營業績和前景產生不利影響。

即使我們能夠使任何產品候選品商業化，這些產品候選品可能會受到不利的定價法規或第三方支付政策的約束，這將損害我們的業務。

各國對新藥和治療生物製品的監管批准、定價和報銷政策差異很大。一些國家要求在藥物或治療生物製品上市之前批准銷售價格。在許多國家，定價審查期開始於獲得上市批准之後。在一些國外市場，處方生物製藥產品的定價甚至在獲得初步批准後仍受持續政府控制。因此，我們可能會在特定國家獲得產品的監管批准，但隨後受到可能延遲我們產品的商業推出和可能長時間的定價限制，進而對我們能夠從該國產品銷售中獲得的收入產生負面影響。不利的定價限制可能妨礙我們收回對一個或多個產品候選者的投資，即使我們的產品候選者獲得監管批准。

我們成功推廣任何產品的能力部分取決於這些產品和相關治療措施從政府機構、私人健康保險提供者和其他組織那裏獲得的報銷程度。即使我們成功向市場推出一種或多種產品，這些產品可能不被視爲成本效益高，而且對任何產品的報銷金額可能不足以讓我們以競爭的方式賣出產品。在我們項目目前的發展階段，我們目前無法判斷其成本效益或報銷水平或方式。越來越多的第三方支付者（如政府和私人保險計劃）要求藥品公司向他們提供比定價給出的折扣，並尋求降低生物製藥產品的售價或報銷額。如果我們開發的任何產品能夠收取的價格或爲該等產品提供的報銷額鑑於我們的研發成本等情況不足，那麼我們的投資回報可能會受到不利影響。

針對新獲批准的藥物，與第三方支付者的支付範圍和報銷存在重大不確定性。例如，在美國，對於新產品的報銷，主要決定權通常由美國衛生與公衆服務部內的康哲藥業（CMS）負責。CMS決定新產品是否以及在何種程度上可以在醫保範圍內獲得報銷，並且私人第三方支付者通常會在很大程度上遵循CMS關於報銷範圍的決定。然而，一個第三方支付者決定爲一種產品提供報銷範圍並不意味着其他支付者也會提供報銷範圍給這種產品。因此，報銷範圍的決定過程通常既費時又昂貴。這一過程將需要我們爲每個第三方支付者提供我們產品使用的科學和臨床支持，但無法保證保險範圍和足夠的報銷將會得到一致的應用或在首次獲得。

此外，最近政府對藥品製造商定價方式進行了加強審查，導致了多次國會調查和提議以及通過的聯邦和州法律，旨在增加產品定價的透明度，審查定價與製造商患者項目之間的關係，並改革政府藥品項目的報銷方法。在州一級，立法機構日益通過旨在控制藥品製造商定價的法律，並實施相關法規，包括價格或患者報銷限制、折扣、限制某些產品的進入和營銷成本的披露和透明度措施，以及在某些情況下，鼓勵從其他國家進口和批量購買。

In some countries, particularly member states of the European Union (EU), the pricing of prescription drugs is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after receipt of marketing approval for a product. In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various EU member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. In some countries, we or our existing or future collaborators may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of our product candidates to other available therapies in order to obtain or maintain reimbursement or pricing approval. Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries.

There may be significant delays in obtaining reimbursement for newly-approved drugs or therapeutic biologics, and coverage may be more limited than the purposes for which the drug or therapeutic biologic is approved by the FDA or similar regulatory authorities outside of the United States. Moreover, eligibility for reimbursement does not imply that any drug or therapeutic biologic will be reimbursed in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim reimbursement levels for new drugs or therapeutic biologics, if applicable, may also be insufficient to cover our costs and may not be made permanent. Reimbursement rates may be based on payments allowed for lower-cost drugs or therapeutic biologics that are already reimbursed, may be incorporated into existing payments for other services and may reflect budgetary constraints or

imperfections in Medicare data. Net prices for drugs or therapeutic biologics may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs or therapeutic biologics from countries where they may be sold at lower prices than in the United States. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement rates. If reimbursement of any product candidate approved for marketing is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business, financial condition, results of operations or prospects could be materially and adversely affected, and our ability to commercialize such products, once approved, could be materially impaired.

The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

If any of our product candidates are approved and we are found to have improperly promoted off-label uses of those products, we may become subject to significant liability. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products, such as our product candidates, if approved. In particular, a product may not be promoted for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. For example, if we receive marketing approval for mecbotamab vedotin as a treatment for soft tissue sarcoma, and we are found to have promoted off-label uses, we may become subject to significant liability. Physicians may nevertheless use our product for their patients in a manner that is inconsistent with the approved labeling. Moreover, although we believe that our product candidates may be safer or more effective than other therapies, unless we conduct head-to-head comparative studies, we will not be able to make any claims of superiority. The U.S. federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If we cannot successfully manage the promotion of our product candidates, if approved, we could become subject to significant liability, which would materially adversely affect our business, financial condition, results of operations and prospects.

Disruptions at the FDA, the SEC and other government agencies caused by, among other factors, funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, statutory, regulatory and policy changes and other events that may otherwise affect the FDA’s ability to perform routine functions. In addition, government funding of the Securities and Exchange Commission, or the SEC, and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed or approved by necessary government agencies, which would adversely affect our business. For example, in recent years, notably in 2018 and 2019, the U.S. government shut down several times and certain regulatory agencies, such as the FDA and the SEC, had to furlough critical employees and stop critical activities. Separately, in response to the COVID-19 pandemic, on March 10, 2020, the FDA announced its intention to postpone most inspections of foreign manufacturing facilities and products through April 2020 and subsequently, on March 18, 2020, the FDA announced its intention to temporarily postpone routine surveillance inspections of domestic manufacturing facilities. Subsequently, on July 20, 2020, the FDA announced its intention to resume certain domestic on-site inspections, subject to a risk-based prioritization system. The FDA intends to use this risk-based assessment system to identify the categories of regulatory activity that can occur within a given geographic area, ranging from mission critical inspections to resumption of all regulatory activities. In addition, on October 26, 2023, the FDA issued a draft guidance document in which the FDA outlined plans to conduct voluntary remote interactive evaluations of certain drug manufacturing facilities and clinical research sites. According to the guidance, the FDA intends to request such remote interactive evaluations in situations where it determines it is appropriate based on mission needs and any travel limitations. Regulatory authorities outside the United States may adopt similar restrictions or other policy measures.

Furthermore, the application of newly developed artificial intelligence (“AI”) and other technologies may have the impact of reducing the development time to bring new products to market, which may materially increase the volume of applications for product approval to the FDA compared to historical application levels. If this increased application volume materializes and funding for additional staff and resources are not allocated to the FDA, the FDA may not be able to continue its current pace of application reviews and review timelines could be extended. Regulatory authorities outside the U.S. facing similar increases in application volume may also experience delays in their regulatory activities.

If a prolonged government shutdown occurs, if global health concerns continue to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, or if the volume of applications to the

新產品候選品的FDA許可增加，可能會顯著影響FDA及時審核和處理我們的監管申請，從而可能對我們的業務產生重大不利影響。此外，未來政府關閉或延遲可能會影響我們進入公開市場和獲得必要資金以適當資本化和繼續經營的能力。

美國食品藥品監督管理局（FDA）、歐洲藥品管理局（EMA）和其他類似的外國監管機構可能不接受在其管轄範圍之外的地點進行的試驗數據。

我們未來可能選擇在國際範圍內進行臨床試驗。美國食品藥品監督管理局（FDA）、歐洲藥品管理局（EMA）或其他類似國外監管機構接受在其各自司法範圍之外進行的臨床試驗數據可能受到一定條件的約束。在外國臨床試驗數據旨在作爲在美國獲得上市批准的依據時，FDA通常不會僅基於外國數據批准申請，除非（i）數據適用於美國人口和美國醫療實踐；（ii）試驗由公認的臨床調查人員進行，並符合當前的GCP要求；以及（iii）FDA能夠通過現場檢驗或其他適當手段驗證數據。此外，FDA的臨床試驗要求，包括研究的患者人口和統計學效能，必須得到滿足。此外，這些外國試驗將受到在進行試驗的外國司法管轄區中的適用當地法律的約束。我們無法保證FDA、EMA或任何適用的外國監管機構將接受在其適用司法管轄區之外進行的試驗數據。如果FDA、EMA或任何適用的外國監管機構不接受此類數據，將導致需要進行額外試驗，這將是昂貴和耗時的，並可能會延遲我們業務計劃的某些方面，也可能導致我們的產品候選藥物未獲得在適用司法管轄區的商業化批准。

醫療保險制度改革措施可能對我們的業務和運營產生重大不利影響。

現有的監管政策可能會發生變化，並可能頒佈額外的政府法規，這可能會阻止，限制或延遲我們的產品候選藥物的監管批准。我們無法預測未來立法或行政行動所引發的政府監管的可能性，性質或程度，無論是在美國還是國外。如果我們對現有要求的變化或新要求或政策的採納緩慢或無能，或者我們無法保持監管合規性，我們可能會失去任何可能獲得的營銷批准，也可能無法實現或維持盈利能力。

已經提出了立法和監管建議，旨在擴大藥品的核準後要求，並限制銷售和促銷活動。我們不能確定是否會頒佈額外的立法變化，或者FDA的規定、指導意見或解讀會發生變化，以及這些變化對我們的產品候選品的營銷批准（如有）可能會產生何種影響。此外，美國國會對FDA審批過程的加大監督可能會顯著延遲或阻止營銷批准，並使我們受到更嚴格的產品標籤和後市場測試等要求。

此外，在美國，一直有一系列立法舉措旨在控制醫療保健成本。2010年3月，ACA生效，旨在擴大醫療保險覆蓋範圍，削減或抑制醫療支出增長，加強打擊欺詐和濫用的手段，爲醫療保健和醫療保險行業增加新的透明度要求，對醫療行業徵收新的稅費，並實施額外的健康政策改革。

醫療保健改革舉措最終在2022年8月頒佈通脹削減法案，即IRA，該法案允許HHS直接談判CMS在Medicare B部分和D部分報銷的特定數量的藥物和生物製品的銷售價格，只有那些已獲批准至少11年（藥物爲7年）的高支出單一來源生物製品有資格由CMS選擇用於談判，談判價格將在選定年份後2年生效。Medicare D產品的談判將於2024年進行，談判價格將於2026年生效，而Medicare B產品的談判將於2026年開始，談判價格將於2028年生效。2023年8月，HHS宣佈了選定用於談判的十種Medicare D藥物和生物製品。HHS已宣佈了談判的最高公平價格，這些價格上限不得超過法定天花板價格，將於2026年1月1日生效。只有獲得恩賜藥物指定用於一種罕見疾病或控件的藥物或生物製品將被排除在IRA的價格談判要求之外，但如果獲得兩種或更多罕見疾病或控件指定，或者獲得的適應症不在該單一指定的罕見疾病或控件內，除非截止CMS評估該藥物用於談判選擇的時候，這種額外指定或不符合資格的批准被撤銷後，將失去這種排除。談判價格將代表對批發商和直接購買者平均價格的顯著折扣。該法律還對價格上漲速度超過通貨膨脹速度的Medicare B和D部分藥物施加回扣。IRA還將增加ACA市場通過2025年計劃年度購買保險的個人的補貼。未遵守IRA的製造商可能會面臨各種處罰，包括民事罰款。IRA允許HHS部長通過指導而不是規章制度來實施其中許多條款的初始年份。這些條款可能會面臨法律挑戰，例如，與高支出單一來源藥物銷售價格談判相關的條款。

藥品和生物製品在多起訴訟中受到挑戰。因此，雖然我們尚不清楚IRA的某些條款將如何實施，但IRA可能會對藥品行業產生重大影響。目前還不清楚其他法定、監管和行政舉措將會得到實施以及到什麼程度，以及當前政府或隨後的政府可能會對我們的業務產生何種影響，包括產品的市場接受度和銷售額，以及我們的產品及產品候選品。

此外，2018年5月30日，即2017年通過的特里克特·溫德勒、弗蘭克·蒙吉洛、喬丹·麥林和馬修·貝利納試行權利法案，或稱試行權利法案，已被簽署成法。該法案在其他方面規定了一個聯邦框架，使某些患者能夠獲得已完成第1期臨床試驗並正在接受FDA批准調查的某些新產品候選藥物。在某些情況下，符合條件的患者可以在不參加臨床試驗並且不在FDA擴大獲準計劃下獲得治療。根據試行權利法案，藥品生產者無義務向符合條件的患者提供其產品。

At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, the FDA released a final rule in September 2020 providing guidance for states to build and submit plans for importing drugs from Canada, and FDA authorized the first such plan in Florida in January 2024. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our drug products that we successfully commercialize or put pressure on our product pricing. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. These measures could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing.

We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our current product candidates and any future product candidates or additional pricing pressures.

Our relationships with healthcare professionals, clinical investigators, CROs and third-party payors in connection with our current and future business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, government price reporting and health information privacy and security laws, which could expose us to significant losses, including, among other things, criminal sanctions, civil penalties, contractual damages, exclusion from governmental healthcare programs, reputational harm, administrative burdens and diminished profits and future earnings.

Healthcare providers, physicians and third-party payors will play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval. Our current and future arrangements with healthcare professionals, clinical investigators, CROs, third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute our product candidates for which we obtain marketing approval. Restrictions under applicable federal and state healthcare laws and regulations, include the following:

Foreign and state laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. For instance, the collection and use of health data in the EU is governed by the General Data Protection Regulation, or the GDPR, which extends the geographical scope of EU data protection law to non-EU entities under certain conditions, tightens existing EU data protection principles and creates new obligations for companies and new rights for individuals. Failure to comply with the GDPR may result in substantial fines and other administrative penalties. The GDPR may increase our responsibility and liability in relation to personal data that we possess and we may be required to put in place additional mechanisms ensuring compliance with the GDPR. We comply with the GDPR and the UK GDPR, which, together with the amended UK Data Protection Act 2018, retains the GDPR in United Kingdom national law, the latter regime having the ability to separately fine and penalize violations. The relationship between the United Kingdom and the EU in relation to certain aspects of data protection law remains unclear, and it is unclear how United Kingdom data protection laws and regulations will develop in the medium to longer term, and how data transfers to and from the United Kingdom will be regulated in the long term. Ongoing developments in the United Kingdom have created additional uncertainty regarding personal data transfers from the European Economic Area (EEA) to the United Kingdom following the termination of the personal data transfer grace period set out in the EU and United Kingdom Trade and Cooperation Agreement, which ended on June 30, 2021. It is not clear whether (and when) an adequacy decision may be granted by the European Commission enabling data transfers from EU member states to the United Kingdom long term without additional measures. Moreover, in July 2020 the Court of Justice of the European Union (CJEU) invalidated the EU-US Privacy Shield Framework (Privacy Shield) under which personal data could be transferred from the EEA and the United Kingdom to entities in the United States who had self-certified under the Privacy Shield scheme. This has led to uncertainty about the adequate transfer mechanisms for other personal data transfers from the EEA and the United Kingdom to the United States or interruption of such transfers. In the event that any court of law orders the suspension of personal data transfers to or from a particular jurisdiction this could give rise to operational interruption in the performance of services for customers, greater costs to implement alternative data transfer mechanisms that are still permitted, regulatory liabilities or reputational harm.

In addition, state laws govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Certain state laws may be more stringent or broader in scope, or offer greater individual rights, with respect to personal information, and such laws may differ from each other, all of which may complicate compliance efforts. For example, the CCPA, as modified by the CPRA, creates individual privacy rights for California consumers and increases the privacy and security obligations of entities handling certain personal information. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. The CCPA and CPRA may increase our compliance costs and potential liability, and similar laws have been proposed at the federal level and in other states. In addition, Virginia’s Consumer Data Protection Act, which took effect on January 1, 2023, requires businesses subject to the legislation to conduct data protection assessments in certain circumstances and requires opt-in consent from consumers to acquire and process their sensitive personal information, which includes information revealing a consumer’s physical and mental health diagnosis and genetic and biometric information that can identify a consumer. Colorado enacted the Colorado Privacy Act, and Connecticut enacted the Connecticut Data Privacy Act, each of which

took effect on July 1, 2023, and Utah enacted the Consumer Privacy Act, which became effective on December 31, 2023, and each of these laws may increase the complexity, variation in requirements, restrictions, and potential legal risks, and could require increased compliance costs and changes in business practices and policies. Other states have also enacted, proposed, or are considering proposing, data privacy laws, which could further complicate compliance efforts, increase our potential liability and adversely affect our business.

Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare, privacy and securities laws and regulations worldwide will involve substantial costs. If our operations are found to be in violation of any of the laws described above or any other governmental laws and regulations that may apply to us, we may be subject to regulatory investigations and enforcement actions, as well as civil private plaintiff litigation, which could mean significant penalties, including civil, criminal and administrative penalties, damages, fines, exclusion from participation in government-funded healthcare programs such as Medicare and Medicaid or similar programs in other countries or jurisdictions, disgorgement, imprisonment, reputational harm and diminished profits. Responding to regulatory inquiries and defending against any such actions can be costly, time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.

If we fail to comply with U.S. and foreign regulatory requirements, regulatory authorities could limit or withdraw any marketing or commercialization approvals we may receive and subject us to other penalties that could materially harm our business.

Even if we receive marketing and commercialization approval of a product candidate, we will be subject to continuing regulatory requirements, including in relation to adverse patient experiences with the product and clinical results that are reported after a product is made commercially available, both in the United States and any foreign jurisdiction in which we seek regulatory approval. The FDA has significant post-market authority, including the authority to require labeling changes based on new safety information and to require post-market studies or clinical trials to evaluate safety risks related to the use of a product or to require withdrawal of the product from the market. The FDA also has the authority to require a REMS plan after approval, which may impose further requirements or restrictions on the distribution or use of an approved drug or therapeutic biologic. The manufacturer and manufacturing facilities we use to make a future product, if any, will also be subject to periodic review and inspection by the FDA and other regulatory agencies, including for continued compliance with cGMP requirements. The discovery of any new or previously unknown problems with our third-party manufacturers, manufacturing processes or facilities may result in restrictions on the product, manufacturer or facility, including withdrawal of the product from the market. We rely, and expect we will continue to rely, on third-party manufacturers, and we will not have control over compliance with applicable rules and regulations by such manufacturers. Any product promotion and advertising will also be subject to regulatory requirements and continuing regulatory review. If we or our existing or future collaborators, manufacturers or service providers fail to comply with applicable continuing regulatory requirements in the United States or foreign jurisdictions in which we seek to market our products, we or they may be subject to, among other things, fines, warning or untitled letters, holds on clinical trials, delay of approval or refusal by the FDA to approve pending applications or supplements to approved applications, suspension or withdrawal of regulatory approval, product recalls and seizures, administrative detention of products, refusal to permit the import or export of products, operating restrictions, injunctions, civil penalties and criminal prosecution.

Our research and development activities could be affected or delayed as a result of possible restrictions on animal testing.

Certain laws and regulations may require us to test our product candidates on animals before initiating clinical trials involving humans. Animal testing activities have been the subject of controversy and adverse publicity. Animal rights groups and other organizations and individuals have attempted to stop animal testing activities by pressing for legislation and regulation in these areas and by disrupting these activities through protests and other means. To the extent the activities of these groups are successful, our research and development activities may be interrupted, delayed or become more expensive.

We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.

We are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls, the U.S. Foreign Corrupt Practices Act of 1977, as amended, or FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors and other collaborators from authorizing, promising, offering or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector. We may engage third parties to sell our products outside the United States, to conduct clinical trials and/or to obtain necessary permits, licenses, patent registrations and other regulatory approvals. We have direct or indirect interactions with officials and employees of government agencies or

government-affiliated hospitals, universities and other organizations. We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors and other collaborators, even if we do not explicitly authorize or have actual knowledge of such activities. Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences.

We and our third-party contractors must comply with environmental, health and safety laws and regulations. A failure to comply with these laws and regulations could expose us to significant costs or liabilities.

We and our third-party contractors are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the use, generation, manufacture, distribution, storage, handling, treatment, remediation and disposal of hazardous materials and wastes. Hazardous chemicals, including flammable and biological materials, are involved in certain aspects of our business, and we cannot eliminate the risk of injury or contamination from the use, generation, manufacture, distribution, storage, handling, treatment or disposal of hazardous materials and wastes. In the event of contamination or injury, or failure to comply with environmental, health and safety laws and regulations, we could be held liable for any resulting damages, fines and penalties associated with such liability which could exceed our assets and resources.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of biological or hazardous materials or wastes arising out of and in the course of employment, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials.

Environmental, health and safety laws and regulations are becoming increasingly more stringent. We may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Changes in tax laws or in their implementation or interpretation may adversely affect us or our investors.

The rules dealing with the U.S. federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service, or IRS, and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely affect us or holders of our common stock. In recent years, many changes have been made and changes are likely to continue to occur in the future. For example, on January 1, 2022, a provision of the Tax Cuts and Jobs Act of 2017 went into effect that eliminates the option to deduct domestic research and development costs in the year incurred and instead requires taxpayers to amortize such costs over five years. 2022 also saw the enactment of the Inflation Reduction Act of 2022 (IRA), which imposes, among others, a 1% excise tax on certain repurchases of stock and a 15% alternative minimum income tax on “adjusted financial statement income” of certain corporations. It cannot be predicted whether, when, in what form, or with what effective dates, new tax laws may be enacted, or regulations and rulings may be enacted, promulgated or issued under existing or new tax laws, which could result in an increase in our or our stockholders’ tax liability or require changes in the manner in which we operate in order to minimize or mitigate any adverse effects of changes in tax law or in the interpretation thereof.

Risks related to employee matters, managing our growth and other risks related to our business

If we fail to attract and retain qualified senior management and key clinical and scientific personnel, our business may be materially and adversely affected.

Our success depends in part on our continued ability to attract, retain and motivate highly qualified management and clinical and scientific personnel. We are highly dependent upon members of our senior management, including Jay M. Short, Ph.D., our Chairman and Chief Executive Officer, as well as our clinical development leaders, senior scientists, and other members of our senior management team. The loss of services of any of these individuals could delay or prevent the successful development of our product pipeline, the initiation and completion of our planned clinical trials or the commercialization of product candidates or any future product candidates.

Competition for qualified personnel in the pharmaceutical, biopharmaceutical and biotechnology field is intense due to the limited number of individuals who possess the skills and experience required by our industry. We will need to hire additional personnel as we expand our clinical development and if we initiate commercial activities. We may not be able to attract and retain quality personnel on acceptable terms, or at all. In addition, to the extent we hire personnel from competitors, we may be subject to allegations that they have been improperly solicited or that they have divulged proprietary or other confidential information, or that their former employers own their research output.

We currently have no sales organization. If we are unable to establish sales, marketing and distribution capabilities on our own or through third parties, we may not be able to market and sell our product candidates, if approved, effectively in the United States and foreign jurisdictions or generate product revenue.

We currently do not have a marketing or sales organization. In order to commercialize our product candidates in the United States and foreign jurisdictions on our own, we must build our marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and we may not be successful in doing so. If any of our product candidates receives regulatory approval, we will need to develop internal sales, marketing and distribution capabilities to commercialize such products, which would be expensive and time-consuming, or make arrangements with third parties to perform these services. If we decide to market our products directly, we will need to commit significant financial and managerial resources to develop a marketing and sales force with technical expertise and supporting distribution, administration and compliance capabilities. If we rely on third parties with such capabilities to market our products or decide to co-promote products with existing or future collaborators, we will need to establish and maintain marketing and distribution arrangements with third parties, and we cannot assure you that we will be able to enter into such arrangements on acceptable terms, or at all. In entering into third-party marketing or distribution arrangements, any revenue we receive will depend upon the efforts of the third parties, and we cannot assure you that such third parties will establish adequate sales and distribution capabilities or be successful in gaining market acceptance of any approved product. If we are not successful in commercializing any product approved in the future, either on our own or through arrangements with one or more third parties, we may not be able to generate any future product revenue and we would incur significant additional losses.

In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.

In order to successfully implement our development and commercialization plans and strategies, and operate as a public company, we expect to need additional development, managerial, operational, financial, sales, marketing and other personnel. Future growth would impose significant added responsibilities on members of management, including, among others:

Our future financial performance and our ability to successfully develop and, if approved, commercialize mecbotamab vedotin, ozuriftamab vedotin, evalstotug, BA3182, and any future product candidates will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.

To date, we have used the services of outside vendors to augment our capabilities in performing certain tasks, including preclinical and clinical trial management, manufacturing, statistics and analysis and research and development functions. Our growth strategy may also entail expanding our group of such contractors or consultants to assist in implementing these tasks going forward. Because we rely on numerous consultants, we will need to be able to effectively manage these consultants to ensure that they successfully carry out their contractual obligations and meet expected deadlines. However, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided by consultants is compromised for any reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for mecbotamab vedotin, ozuriftamab vedotin, evalstotug, BA3182, and any future product candidates or otherwise advance our business. We may not be able to manage our existing outside contractors or find other competent outside contractors and consultants on economically reasonable terms, or at all. If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and commercialize mecbotamab vedotin, ozuriftamab vedotin, evalstotug, BA3182, and any future product candidates and, accordingly, may not achieve our research, development and commercialization goals.

Our employees and independent contractors, including principal investigators, CROs, consultants and vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk that our employees and independent contractors, including principal investigators, CROs, consultants and vendors may violate (intentionally or unintentionally) our internal processes and procedures, or engage in misconduct or other illegal activity. Such actions could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violate: (1) the laws and regulations of the FDA and other similar regulatory requirements, including those laws that require the reporting of true, complete and accurate information to such authorities, (2) manufacturing standards, including cGMP requirements,

（3）數據隱私、安防-半導體、欺詐和濫用以及美國和其他國家的其他醫療法律和法規或（4）需要對財務信息或數據進行真實、完整和準確報告的法律。受這些法律約束的活動還涉及在臨床試驗過程中獲取的信息的不當使用或失實陳述、我們的臨床前研究或臨床試驗中製造假數據，或非法盜用藥物，這可能導致監管制裁併對我們的聲譽造成嚴重損害。不總是可能識別、預防和阻止員工和其他第三方的這些行爲和/或不當行爲，我們採取的預防措施可能無法有效控制未知或未管理的風險或損失，或保護我們免受因未合規而導致的政府調查或其他行動或訴訟的影響。此外，我們面臨的風險是某人或政府可能宣稱發生了此類行爲，包括欺詐或其他不當行爲，即使沒有發生。如果任何此類行爲對我們提起訴訟，我們可能會承擔重大成本予以回應，如果我們未能成功辯護或主張我們的權利，這些行動可能會對我們的業務和財務業績產生重大影響，包括但不限於，徵收重大民事、刑事和行政處罰、損害賠償、罰款、返還、可能被 Medicare、 Medicaid和其他聯邦醫療保健計劃參與排除、個人監禁、合同損害賠償、聲譽受損、利潤和未來收益減少、如果我們成爲履行企業完整協議或類似協議以解決不遵守這些法規的指控的對象則需增加報告要求和監管，我們的業務可能受到限制，這些可能會對我們經營業務和運營結果產生不利影響。

我們依賴於我們的信息技術系統以及我們的CROs、製造商、承包商和顧問的系統。我們內部的計算機系統，例如我們的企業資源計劃（「ERP」）系統，或我們的任何CROs、製造商、其他承包商、顧問、現有或未來的合作伙伴的系統，可能會出現故障、遭受安全性或數據隱私問題，或者發生未經授權或不當訪問、使用或獲取，或摧毀我們的專有和機密數據、員工數據或個人數據，這可能導致額外成本、營業收入的損失、重大責任、損害我們的聲譽以及我們運營的重大中斷。

在我們業務的日常過程中，我們收集、存儲和傳輸大量的機密信息，包括知識產權、專有業務信息和個人信息。儘管我們實施了安全措施，我們的內部計算機系統和製造商、現有或未來的CRO、其他承包商、顧問、現有或未來的合作伙伴和第三方服務提供商的基礎設施容易受到未經授權的訪問、損害或破壞，可能來自各種方法，包括網絡安全攻擊、勒索軟件攻擊、違規行爲、故意或意外的錯誤或失誤，或其他技術故障，這些可能包括計算機病毒、惡意軟件、對未修補產品或服務漏洞的利用、未經授權的訪問嘗試（包括第三方使用竊取的或推斷的憑據訪問系統）、拒絕服務攻擊、釣魚嘗試、服務中斷、自然災害、火災、恐怖主義、戰爭、電信和電力故障，以及通過人工智能增強或促進的攻擊。隨着網絡威脅格局的演變，這些攻擊在頻率、持續程度、複雜程度和強度上都在增長，變得越來越難以檢測，並由世界各地的擁有廣泛動機和專業知識的複雜群體和個人進行，我們也許會面臨網絡安全風險的增加，因爲我們依賴互聯網技術，以及遠程工作的員工數量增加，這可能爲網絡犯罪分子利用漏洞創造了更多機會。此外，由於用於獲取未經授權訪問或破壞系統的技術經常變化，通常在針對目標發動之前是不被認可的，我們可能無法預測這些技術或實施足夠的預防措施。我們也可能經歷安全漏洞，可能長時間未被察覺。如果發生這樣的事件導致我們的運營中斷，對關鍵數據或系統造成影響，或導致個人可識別信息或個別可識別健康信息被未經授權獲得或訪問（違反某些隱私、網絡安全或數據保護法律，如HIPAA、HITECH、CCPA和GDPR），可能會導致我們的產品候選品開發項目受到嚴重干擾，對我們的業務運營造成重大責任。我們還可能需要在未經授權訪問、獲取、破壞、變更或濫用個人信息或健康信息的情況下通知個人和監管機構，這可能源於我們或我們的供應商、承包商或與之建立戰略關係的組織遇到的漏洞，通知和關於安全漏洞的後續行動可能會影響我們的聲譽，並導致我們產生重大成本，包括法律費用和補救成本，並導致合作伙伴、客戶和利益相關者對我們失去信心，從而對我們的業務運營和營業收入產生更長期的不利影響。例如，喪失涉及我們產品候選品的已完成、正在進行或將來進行的多個臨床試驗的臨床試驗數據可能會導致我們的監管批准工作受阻，並顯著增加我們恢復或重現丟失數據的成本。另外，由於我們同時展開多個臨床試驗的方法，我們的計算機系統的任何違規行爲可能會導致許多處於不同發展階段節目的數據丟失或數據完整性受損。

我們還依賴第三方來製造我們的候選產品，與其計算機系統相關的類似事件也可能對我們的業務產生重大不利影響。在任何破壞或安全漏洞導致我們的數據或應用程序丟失、損壞，或者機密或專有信息被不當披露的情況下，我們可能受到訴訟和政府調查的風險，我們的候選產品的進一步開發和商業化可能會延遲，並且我們可能會因未遵守某些州、聯邦或國際隱私和安全法而面臨重大罰款或處罰。

我們在SaaS平台上運營我們的ERP系統和其他關鍵業務系統。因此，我們依賴於這些系統以及這些服務的第三方提供商來實現我們業務的許多方面。如果這些服務提供商或這些系統出現故障，或者我們無法繼續以商業上合理的條款或完全訪問這些系統，業務操作可能會受到嚴重干擾，直到找到可以識別、許可或開發的等效系統，並將其整合到我們的運營中。這種干擾可能會對我們的業務產生重大不利影響。

我們的保險政策可能不足以賠償因任何這種中斷、故障或安全漏洞而造成的潛在損失。此外，這種保險可能在未來無法以經濟合理的條件提供給我們，甚至可能根本無法提供。此外，我們的保險可能無法涵蓋針對我們提出的所有索賠，並且在任何情況下免賠額可能很高，而無論其價值如何，進行辯護可能會昂貴並分散管理注意力。

除了經歷安防-半導體事故外，第三方可能會從公開來源、數據經紀人或其他途徑收集、蒐集或推斷出關於我們的敏感數據，這些數據可能揭示有關我們組織的競爭敏感細節，並可能被用於破壞我們的競爭優勢或市場地位。此外，作爲結果或與我公司員工、人員或供應商使用生成式人工智能技術有關，公司的敏感數據可能會泄露、披露或揭示。

A portion of our research and development activities take place in China. Uncertainties regarding the interpretation and enforcement of Chinese laws, rules and regulations, a trade war, deterioration of international relations, or political unrest in China could materially adversely affect our business, financial condition and results of operations.

We conduct preclinical research and development activities in China through BioDuro-Sundia, which is U.S. owned, but governed by Chinese laws, rules and regulations. Additionally, our agreement with Himalaya Therapeutics Limited Company is for the initiation of clinical trials of evalstotug in the People’s Republic of China. The Chinese legal system is a civil law system based on written statutes. Unlike the common law system, prior court decisions may be cited for reference but have limited precedential value. In addition, the Chinese legal system is based in part on government policies and internal rules, some of which are not published on a timely basis or not published at all, and which may have a retroactive effect. As a result, we may not be aware of our violation of these policies and rules until after the occurrence of the violation. Any administrative and court proceedings in China may be protracted, resulting in substantial costs and diversion of resources and management attention. Since Chinese administrative and court authorities have significant discretion in interpreting and implementing statutory and contractual terms, it may be more difficult to evaluate the outcome of administrative and court proceedings and the level of legal protection we enjoy than in U.S. or EU legal systems.

We do some business with companies in China and it is possible some of our contractual counterparties could be impacted by the legislation targeting China. One particular executive order titled Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy signed on September 12, 2022 will likely impact the pharmaceutical industry to encourage U.S. domestic manufacturing of pharmaceutical products. Moreover, there have been Congressional legislative proposals, such as the bill titled the BIOSECURE Act, which was passed by the House of Representatives on September 9, 2024 and is now subject to the full Senate vote along with the Senate’s own version of the BIOSECURE Act. If passed by the Senate and signed into law, this legislation would, among other things, prohibit U.S. federal procurement of biotechnology equipment or services produced or provided by certain named Chinese “biotechnology companies of concern” and loans and grants to, and federal contracts with any entity that uses biotechnology equipment or services from one of these entities in performance of the government contract, grant, or loan. On May 10, 2024, the House of Representatives released an updated version of the BIOSECURE Act bill which would delay the application of the BIOSECURE Act’s provisions (1) until January 1, 2032, with respect to biotechnology equipment and services provided or produced by a named biotechnology company of concern under a contract or agreement entered before the effective date of the legislation and (2) for a period of 5 years after the identification of new biotechnology companies of concern, with respect to biotechnology equipment and services provided or produced under a contract or agreement entered before the effective date of the legislation by an entity that the government identifies in the future as a biotechnology company of concern.

Furthermore, we are exposed to the possibility of disruption of our research and development activities in the event of changes in the policies of the United States or Chinese governments, political unrest or unstable economic conditions in China, including the escalation of tensions between China and Taiwan, such as recent step up of military exercises around Taiwan by China. In addition, disagreements between the United States and China with respect to their political, military or economic policies toward Taiwan may contribute to further controversies. For example, a trade war could lead to increased costs for clinical materials that are manufactured in China. These interruptions or failures and any restrictive measures resulting from a deterioration of U.S.- China relations could also result in impeding the commercialization of our product candidates and impair our competitive position. Further, we may be exposed to fluctuations in the value of the local currency in China. Future appreciation of the local currency could increase our costs. These uncertainties may impede our ability to enforce the contracts we have entered into and our ability to continue our research and development activities and could materially and adversely affect our business, financial condition and results of operations.

Our current operations are concentrated in two locations. We or the third parties upon whom we depend may be adversely affected by earthquakes, wildfires or other natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

A portion of our current operations are located in our facilities in San Diego, California, and we conduct a portion of our research and development activities in China through our arrangement with BioDuro-Sundia. Any unplanned event, such as flood, fire, explosion, earthquake, extreme weather condition, medical epidemics or pandemics, power shortage, telecommunication failure or other natural or manmade accidents or incidents that result in us being unable to fully utilize our facilities, or the manufacturing facilities of our third-party contract manufacturers, may have a material and adverse effect on our ability to operate our business, particularly on a daily basis, and have significant negative consequences on our financial and operating conditions. Loss of access to these facilities may result in increased costs, delays in the development of our product candidates or interruption of our business operations. Earthquakes, wildfires or other natural disasters could further disrupt our operations, and have a material and adverse effect on our business, financial condition, results of operations and prospects. If a natural disaster, power outage or other event prevented us from using all or a significant portion of our headquarters, damaged critical infrastructure, such as our research facilities or the manufacturing facilities of our third-party contract manufacturers, or otherwise disrupted operations, it may be difficult or, in certain cases, impossible, for us to continue our business for a substantial period of time. The disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which could have a material adverse effect on our business. As part of our risk management policy, we maintain insurance coverage at levels that we believe are appropriate for our business. However, in the event of an accident or incident at these facilities, we cannot assure you that the amounts of insurance will be sufficient to satisfy any damages and losses. If our facilities, or the manufacturing facilities of our third-party contract manufacturers, are unable to operate because of an accident or incident or for any other reason, even for a short period of time, any or all of our research and development programs may be harmed. Any business interruption may have a material and adverse effect on our business, financial condition, results of operations and prospects. In addition, all of our therapeutic antibodies are manufactured by starting with cells from a master cell bank which are stored in multiple locations to reduce the risk of loss. While we believe we will have adequate backup should any cell bank be lost in a catastrophic event, and we take precautions when transporting our cell banks, it is possible that we could lose multiple cell banks and have our manufacturing severely impacted by the need to replace the cell banks.

Our business is subject to economic, political, regulatory and other risks associated with conducting business internationally.

We, our collaborators or licensees may seek regulatory approval of our product candidates outside of the United States including in China, the EU, Australia, New Zealand, and Japan. Additionally, pursuant to our agreement with Himalaya Therapeutics Limited Company, we conduct clinical trials in the People’s Republic of China. Accordingly, we expect that we will be subject to additional risks related to operating in foreign countries if we obtain the necessary approvals, including, among others:

Additionally, in February 2022, armed conflict escalated between Russia and Ukraine, and in October 2023, armed conflict escalated between Israel and Hamas, including in the Gaza Strip. It is not possible to predict the broader consequences of these conflicts, which could include further sanctions, embargoes, greater regional instability, geopolitical shifts and other adverse effects on

macroeconomic conditions, currency exchange rates, supply chains and financial markets. These and other risks associated with our international operations may materially adversely affect our ability to attain or maintain profitable operations.

We face risks related to health epidemics and outbreaks, including the COVID-19 pandemic, which could significantly disrupt our preclinical studies, affect enrollment of patients in our clinical trials or delay or prevent our receipt of necessary regulatory approvals.

We face risks related to health epidemics or outbreaks of communicable diseases. The outbreak of communicable diseases could result in a widespread health crisis that could adversely affect general commercial activity and the economies and financial markets of many countries, which in the case of COVID-19 has occurred. Although the U.S. federal government has declared an end to the public health emergency related to the COVID-19 pandemic and many activities worldwide have returned to normal, the COVID-19 pandemic in the past has resulted in, and in the future may result in, governments implementing numerous containment measures, such as travel bans and restrictions, particularly quarantines, shelter-in-place or total lock-down orders and business limitations and shutdowns.

We are following, and plan to continue to follow, recommendations from federal, state and local governments regarding workplace policies, practices and procedures. We are complying with all applicable guidelines for our clinical trials, including remote clinical monitoring. We are continuing to monitor the potential impact of the pandemic, but even though many restrictions aimed at minimizing the spread of COVID-19 have been eased or lifted in the U.S. and other countries, we cannot be certain what the overall impact will be on our business, financial condition, results of operations and prospects.

In addition, the COVID-19 pandemic in the past has had, and in the future may have, a severe effect on the clinical trials of many drug candidates of several sponsors. The extent to which the COVID-19 pandemic may impact our preclinical and clinical trial operations is uncertain and will depend on future developments, including the severity and duration of any resurgence of COVID-19 and its variants. To date, we have experienced modest business disruptions, including with respect to the clinical trials we are conducting, and non-material impairments as a result of the pandemic. A resurgence of COVID-19 or any of its variants could adversely impact our clinical trial operations, including our ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19 if an outbreak occurs in their geography. Disruptions or restrictions on our ability to travel to monitor data from our clinical trials, or to conduct clinical trials, or the ability of patients enrolled in our studies to travel, or the ability of staff at study sites to travel, as well as temporary closures of our facilities or the facilities of our clinical trial partners and their contract manufacturers, would negatively impact our clinical trial activities. In addition, we rely on independent clinical investigators, CROs and other third-party service providers to assist us in managing, monitoring and otherwise carrying out our preclinical studies and clinical trials, including the collection of data from our clinical trials, and an outbreak may affect their ability to devote sufficient time and resources to our programs or to travel to sites to perform work for us. Similarly, our preclinical trials could be delayed and/or disrupted by the COVID-19 pandemic. As a result, the expected timeline for data readouts of our preclinical studies and clinical trials and certain regulatory filings may be negatively impacted, which would adversely affect our ability to obtain regulatory approval for and to commercialize our product candidates, increase our operating expenses and have a material adverse effect on our business, financial condition, results of operations and prospects.

We have entered, and may in the future seek to enter, into collaborations with third parties for the development and commercialization of certain of our product candidates. If we fail to enter into such collaborations, or such collaborations are not successful, we may not be able to capitalize on the market potential of our patented technology platform and resulting product candidates.

We have entered, and may in the future seek to enter, into collaborations with third parties for the development and commercialization of certain of our product candidates. For example, in September 2024 we entered into an agreement to license BA3361, a Nectin-4 x CD3 T cell engaging (TCE) bispecific CAB antibody to Context Therapeutics. In addition, we are currently exploring potential third-party collaborators for development and commercialization of select CAB product candidates. With respect to our collaborations, and what we expect will be the case with any future license or collaboration agreements, we have, and would expect to have, limited control over the amount and timing of resources that our existing or future collaborators dedicate to the development or commercialization of our product candidates. Our ability to generate revenues from these arrangements will depend on our existing or future collaborators’ willingness to select additional product candidates to license and their abilities and willingness to fulfill their payment obligations and successfully perform the functions assigned to them in these arrangements.

Our existing collaboration arrangements currently pose, and future collaborations involving our product candidates will pose, the following risks to us:

Collaboration agreements may not lead to development or commercialization of our product candidates in the most efficient manner or at all. If a collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program could be delayed, diminished or terminated.

If our existing or future collaborators cease development efforts under our existing or future collaboration agreements, or if any of those agreements are terminated, we may lose committed funding under those agreements and these collaborations may fail to lead to commercial products and the reputation of our patented CAB technology platform may suffer.

Revenue from research and development collaborations depend upon continuation of the collaborations, initiation and expansion of the number of programs subject to the collaborations, the achievement of milestones and royalties, if any, derived from future products developed from our research. If we are unable to successfully advance the development of our product candidates or achieve milestones, revenue and cash resources from milestone payments under our existing or future collaboration agreements will be substantially less than expected.

Our ability to advance our product candidates may be limited by third parties on which we rely for certain technologies which we use in certain of our programs. If any third party developing our product candidates or other candidates based on our patented CAB technology platform experiences a delay or failure in development, regulatory approval or commercialization, even if such failure is not due to our CAB technology, it could reflect negatively on us, our other product candidates and our patented CAB technology platform. In addition, if one of our current or future collaborators terminates its agreement with us, we may find it more difficult to attract new collaborators and our perception in the business and financial communities and our stock price could be adversely affected.

We may not be successful in establishing commercialization collaborations, which could adversely affect our ability to commercialize our product candidates, if approved.

From time to time, we may evaluate and, if strategically attractive, seek to enter into additional collaborations, including with major biotechnology or biopharmaceutical companies. The competition for collaborators is intense, and such arrangements are complex and time-consuming to negotiate, document, and implement and they may require substantial resources to maintain. Any new collaboration may be on terms that are not optimal for us, and we may not be able to maintain any new collaboration if, for example, development or approval of a product candidate is delayed, sales of an approved product candidate do not meet expectations or the collaborator terminates the collaboration.

In addition, it is possible that a collaborator may not devote sufficient resources to the commercialization of our product candidates or may otherwise fail in its commercialization efforts, in which event the commercialization of such product candidates could be delayed or terminated and our business could be substantially harmed. In addition, the terms of any collaboration or other arrangement that we establish may not be favorable to us or may not be perceived as favorable, which may negatively impact our business, financial condition, results of operations and prospects.

If third parties on which we rely to conduct our preclinical and clinical trials, do not perform as contractually required, fail to satisfy regulatory or legal requirements or miss expected deadlines, our development programs could be delayed with material and adverse effects on our business, financial condition, results of operations and prospects.

We rely, and expect we will continue to rely, on third-party investigators, CROs, data management organizations and consultants to conduct, supervise and monitor our ongoing clinical trials and preclinical studies. Because we rely on these third parties and do not have the ability to conduct preclinical studies or clinical trials independently, we have less control over the timing, quality and other aspects of preclinical studies and clinical trials than we would have had we conducted them on our own. These investigators, CROs and consultants are not our employees and we will have limited control over the amount of time and resources that they dedicate to our development programs. These third parties may have contractual relationships with other entities, some of which may be our competitors, which may draw time and resources from our development programs. The third parties with whom we contract might not be diligent, careful or timely in conducting our preclinical studies or clinical trials, resulting in the preclinical studies or clinical trials being delayed or unsuccessful.

If we do not contract with acceptable third parties on commercially reasonable terms, or at all, or if these third parties do not carry out their contractual duties, satisfy legal and regulatory requirements for the conduct of preclinical studies or clinical trials or meet expected deadlines, our development programs could be delayed and otherwise adversely affected. Furthermore, we depend on the availability of various animals to conduct certain preclinical studies that we are required to complete prior to submitting an IND and initiating clinical development or to continue clinical development, including pharmacological and toxicology evaluations. There is currently a shortage of animals available for drug development due to an increase in demand from companies conducting research in the U.S., EU, and China. This has caused the cost of obtaining animals for our preclinical studies to increase dramatically, and if the shortage continues, could also result in delays to our development timelines. In all events, we are responsible for ensuring that each of our preclinical studies and clinical trials are conducted in accordance with the general investigational plan, protocols for the trial and regulatory requirements. The FDA requires preclinical studies to be conducted in accordance with GLPs and clinical trials to be conducted in accordance with GCPs, including for designing, conducting, recording and reporting the results of preclinical studies and clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of clinical trial participants are protected. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. Any adverse development or delay in our preclinical studies and clinical trials could have a material and adverse effect on our business, financial condition, results of operations and prospects.

We rely on third parties for the manufacture of our product candidates for preclinical studies and our ongoing clinical trials, and we expect to continue to do so for additional clinical trials and ultimately commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products, if approved, or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

We rely, and expect we will continue to rely, on third-party contract manufacturers to manufacture our preclinical and clinical trial product supplies and the raw materials used to create our product candidates. We do not own manufacturing facilities for producing such supplies, and we do not have long-term manufacturing agreements. Furthermore, the raw materials for our product candidates may be sourced, in some cases, from a single-source supplier. If we were to experience an unexpected loss of supply of any of our product candidates or any of our future product candidates for any reason, whether as a result of manufacturing, supply or storage issues or otherwise, we could experience delays, disruptions, suspensions or terminations of, or be required to restart or repeat, any pending or ongoing clinical trials. We cannot assure you that our preclinical and clinical development product supplies or raw materials will not be limited, interrupted, or be of satisfactory quality or continue to be available at acceptable prices. In particular, any replacement of a manufacturer could require significant effort and expertise because there are a limited number of qualified replacements. The technical skills or technology required to manufacture our product candidates may be unique or proprietary to the

original manufacturer and we may have difficulty transferring such skills or technology to another third party and a feasible alternative may not exist. These factors would increase our reliance on such manufacturer or require us to obtain a license from such manufacturer in order to have another third-party manufacture our product candidates.

If we submit an application for regulatory approval of any of our product candidates, the facilities used by our contract manufacturers to manufacture our product candidates will be subject to inspection by the FDA or other regulatory authorities. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others or if they are unable to maintain a compliance status acceptable to the FDA or other regulatory authorities, approval of our product candidates may be delayed or we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved.

We expect to continue to rely on third-party manufacturers if we receive regulatory approval for any product candidate. If we are unable to obtain or maintain third-party manufacturing for product candidates, or to do so on commercially reasonable terms, we may not be able to develop and commercialize our product candidates successfully. Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

In addition, we have no material long-term contracts with our suppliers, and we compete with other companies for raw materials and production. We may experience a significant disruption in the supply of raw materials from current sources or, in the event of a disruption, we may be unable to locate alternative materials suppliers of comparable quality at an acceptable price, or at all. In addition, if we experience significant increased demand, or if we need to replace an existing supplier, we may be unable to locate additional supplies of raw materials on terms that are acceptable to us, or at all, or we may be unable to locate any supplier with sufficient capacity to meet our requirements or to fill our orders in a timely manner. Identifying a suitable supplier is an involved process that requires us to become satisfied with their quality control, responsiveness and service, financial stability and labor and other ethical practices. Even if we are able to expand existing sources, we may encounter delays in production and added costs as a result of the time it takes to train suppliers in our methods, products and quality control standards.

The manufacture of biotechnology products is complex, and manufacturers often encounter difficulties in production. If we or any of our third-party manufacturers encounter any loss of materials or if any of our third-party manufacturers encounter other difficulties, or otherwise fail to comply with their contractual or regulatory obligations, our ability to provide product candidates for clinical trials or our products to patients, once approved, the development or commercialization of our product candidates could be delayed or stopped.

The manufacture of biotechnology products is complex and requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. We and our contract manufacturers must comply with cGMPs, regulations and guidelines for the manufacturing of biologics used in clinical trials and, if approved, marketed products. In order to conduct clinical trials of our product candidates, we and existing and future collaborators will need to manufacture them in large quantities and in accordance with cGMPs. Manufacturers of biotechnology products often encounter difficulties in production, particularly in scaling up and validating initial production. In addition, if microbial, viral or other contaminations are discovered in our products or in the manufacturing facilities in which our products are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. Delays in raw materials availability and supply may also extend

the period of time required to develop our products. Furthermore, changes in our manufacturing methods may require comparability studies, including clinical bridging studies, which may result in delays to the approval process for our product candidates.

All of our therapeutic antibodies are manufactured by starting with cells from a cell bank. In accordance with cGMPs, we produce one master cell bank for each antibody manufactured, which is then stored in multiple locations to reduce the risk of loss. We have also created a working cell bank for certain manufactured antibodies. While we believe we will have adequate backup should any cell bank be lost in a catastrophic event, and we take precautions when transporting our cell banks, it is possible that we could lose multiple cell banks and have our manufacturing severely impacted by the need to replace the cell banks.

We cannot assure you that any stability or other issues relating to the manufacture of any of our product candidates or products will not occur in the future. Additionally, our manufacturers may experience manufacturing difficulties due to resource constraints or as a result of labor disputes or unstable political environments. For example, the extent to which the COVID-19 pandemic impacts the ability to procure sufficient supplies for the development of our product candidates will depend on future developments, including the severity and duration of any resurgence of COVID-19 and its variants. If our manufacturers were to encounter any of these difficulties, or otherwise fail to comply with their contractual obligations, our ability to provide any product candidates to patients in planned clinical trials and products to patients, once approved, would be jeopardized. Any delay or interruption in the supply of clinical trial supplies could delay the completion of planned clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require us to commence new clinical trials at additional expense or terminate clinical trials completely. Any adverse developments affecting clinical or commercial manufacturing of our product candidates or products may result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls, or other interruptions in the supply of our product candidates or products or enforcement actions by regulatory authorities. We may also have to take inventory write-offs and incur other charges and expenses for product candidates or products that fail to meet specifications, undertake costly remediation efforts or seek more costly manufacturing alternatives. Accordingly, failures or difficulties faced at any level of our supply chain could adversely affect our business and delay or impede the development and commercialization of any of our product candidates or products and could have an adverse effect on our business, financial condition, results of operations and prospects.

If we are not able to obtain, maintain and protect our intellectual property rights in any product candidates or technologies we develop, or if the scope of the intellectual property protection obtained is not sufficiently broad, third parties could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our market.

Our success depends in part on our ability to obtain and maintain patents and other forms of intellectual property rights, including in-licenses of intellectual property rights of others, for our product candidates, methods used to develop and manufacture our product candidates and methods for treating patients using our product candidates, as well as our ability to preserve our trade secrets, to prevent third parties from infringing upon our proprietary rights and to operate without infringing upon the proprietary rights of others. The patent process is expensive and time-consuming, and we may not be able to apply for patents on certain aspects of our product candidates in a timely fashion, at a reasonable cost, in all jurisdictions, or at all. Our existing issued and granted patents and any future patents we obtain may not be sufficiently broad to prevent others from using our technology or from developing competing products and technology. There is no guarantee that any of our pending patent applications will result in issued or granted patents, that any of our issued or granted patents will not later be found to be invalid or unenforceable or that any issued or granted patents will include claims that are sufficiently broad to cover our product candidates or to provide meaningful protection from our competitors.

Moreover, the patent position of biotechnology and biopharmaceutical companies can be highly uncertain because it involves complex legal and factual issues. We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our current and future proprietary technology and product candidates are covered by valid and enforceable patents or are effectively maintained as trade secrets. If third parties disclose or misappropriate our proprietary rights, it may materially and adversely affect our position in the market. Furthermore, even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property, provide exclusivity for our product candidates, or prevent others from designing around our patent claims.

Once granted, patents may remain open to opposition, interference, re-examination, post-grant review, inter partes review, nullification or derivation action in court or before patent offices or similar proceedings for a given period after allowance or grant, during which time third parties can raise objections against granted patents. In the course of such proceedings, which may continue for a protracted period of time, the patent owner may be compelled to limit the scope of the allowed or granted patent claims thus attacked, or may lose the allowed or granted claims altogether. In the past, we have been party to a patent opposition proceeding at the European Patent Office, or EPO, and we may in the future become party to patent opposition proceedings in the EPO or similar proceedings in other foreign patent offices. In addition, we cannot assure you that:

If the breadth or strength of protection provided by the patents and patent applications we hold, obtain or pursue with respect to our product candidates is challenged, or if they fail to provide meaningful exclusivity for our product candidates, it could threaten our ability to practice our technologies or commercialize our product candidates. We cannot offer any assurances about which, if any, patents will issue, the breadth of any such patent, or whether any issued patents will be found invalid and unenforceable or will be threatened by third parties. Furthermore, an interference or derivation proceeding can be provoked by a third party or instituted by a patent office or in a court proceeding, to determine who was the first to invent any of the subject matter covered by the patent claims of our applications.

Where we obtain licenses from third parties, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that we license from third parties. We may also require the cooperation of our licensors to enforce any licensed patent rights, and such cooperation may not be provided. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. Moreover, if we do obtain necessary licenses, we will likely have obligations under those licenses, and any failure to satisfy those obligations could give our licensor the right to terminate the license. Termination of a necessary license could have a material adverse impact on our business.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to seeking patent protection for certain aspects of our product candidates, we also consider trade secrets, including confidential and unpatented know-how, important to the maintenance of our competitive position. We seek to protect trade secrets and confidential and unpatented know-how, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to such knowledge, such as our employees, corporate collaborators, outside scientific collaborators, CROs, contract manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants that obligate them to maintain confidentiality and assign their inventions to us. We also seek to preserve the integrity and confidentiality of our data, trade secrets and know-how by maintaining physical security of our premises and physical and electronic security of our information technology systems. Monitoring unauthorized uses and disclosures is difficult, and we do not know whether the steps we have taken to protect our proprietary technologies will be effective. We cannot guarantee that our trade secrets and other proprietary and confidential information will not be disclosed or that competitors will not otherwise gain access to our trade secrets. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts in the United States and certain foreign jurisdictions are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position could be harmed.

Trade secrets and know-how can be difficult to protect as trade secrets and know-how will over time be disseminated within the industry through independent development, the publication of journal articles, and the movement of personnel skilled in the art from company to company or academic to industry scientific positions. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position. If we are unable to prevent material disclosure of the intellectual property related to our technologies to third parties, we will not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, results of operations and financial condition. Even if we are able to adequately protect our trade secrets and proprietary information, our trade secrets could otherwise become known or could be independently discovered by our competitors. Competitors could willfully infringe our intellectual property rights, design around our protected technology or develop their own competitive technologies that fall outside of our intellectual property rights. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, in the absence of patent protection, we would have no right to prevent them, or those to whom they communicate, from using that technology or information to compete with us. If our trade secrets are not adequately protected so as to protect our market against competitors’ products, others may be able to exploit our product candidates and discovery technologies to identify and develop competing product candidates, and thus our competitive position could be adversely affected, as could our business.

The terms of our patents may not protect our competitive position on our product candidates for an adequate amount of time.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years after its earliest U.S. non-provisional effective filing date. Although various extensions may be available, the life of a patent, and the protection it affords, is limited. Even if patents covering our technologies or product candidates are obtained, once the patent life has expired, we may be open to competition. Our issued patents will expire on dates ranging from 2030 to 2040, subject to any additional patent extensions that may be available for such patents. If patents are issued on our pending patent applications, the resulting patents are projected to expire on dates ranging from 2030 to 2044 plus any potential patent extensions that may be available for such patents. Due to the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

If we do not obtain patent term extension for our product candidates, our business may be materially harmed.

Depending upon the timing, duration and specifics of FDA marketing approval of our product candidates, one or more of our U.S. patents may be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. A maximum of one patent may be extended per FDA-approved product as compensation for the patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only those claims covering such approved drug product, a method for using it or a method for manufacturing it may be extended. Patent term extension may also be available in certain foreign countries upon regulatory approval of our product candidates. However, we may not be granted an extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request or require. If we are unable to obtain patent term extension or restoration or the term of any such extension is less than we request or require, our competitors may obtain approval of competing products following our patent expiration, and our revenue could be reduced, possibly materially. Further, if this occurs, our competitors may take advantage of our investment in development and trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case.

Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.

In September 2011, the Leahy-Smith America Invents Act, or Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications will be prosecuted and may also affect patent litigation. In particular, under the Leahy-Smith Act, the United States transitioned in March 2013 to a “first inventor to file” system in which, assuming that other requirements of patentability are met, the first inventor to file a patent application will be entitled to the patent regardless of whether another party was first to invent the claimed invention. A third party that filed or files a patent application in the USPTO after March 2013 but before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party. This will require us to be cognizant going forward of the time from invention to filing of a patent application. Furthermore, our ability to obtain and maintain valid and enforceable patents depends on whether the differences between our technology and the prior art render our technology to be patentable over the prior art. Since patent applications in the United States and most other countries are confidential for a period of

在提交專利申請後或直到頒發之前，我們無法確定我們是否是第一家提交與我們產品候選人相關的專利申請或發明我們專利或專利申請中索賠的任何發明的公司。

Leahy-Smith法案還包括一系列重大變化，影響專利申請的處理方式，並可能影響專利訴訟。這些變化包括允許第三方在專利申請期間向USPTO提交先前的技術，並提供額外程序來對專利的有效性進行攻擊，包括PGR、IPR和導出程序等由USPTO管理的事後程序。在任何此類提交或程序中的不利決定可能會降低我們專利權的範圍或可執行性，甚至使其無效，從而可能對我們的競爭地位產生不利影響。

由於在美國專利商標局（USPTO）的訴訟中採用了比在美國聯邦法院適用的證據標準低的標準，第三方有可能在USPTO的程序中提供足以使USPTO判定某項專利索賠無效的證據，即使同樣的證據在首次在地方法院訴訟中呈現時不足以使該索賠無效。因此，第三方可能會嘗試使用USPTO流程來使專利索賠無效，儘管如果該第三方首次作爲被告在地方法院訴訟中挑戰，這些索賠可能不會被無效化。因此，利亞-史密斯法案及其實施可能增加我們或我們許可人的專利申請的審查和辯護，以及我們已授權專利的執行或辯護所面臨的不確定性和成本，所有這些可能對我們的業務、財務狀況、經營業績和前景產生重大不利影響。

美國專利法的變化或其他國家的法律可能會降低專利的價值，從而損害我們保護產品候選者的能力。

與其他生物製藥公司一樣，我們的成功在很大程度上取決於知識產權，特別是專利。在生物製藥行業獲得和執行專利涉及高度的技術和法律複雜性。因此，獲得和執行生物製藥專利是昂貴、耗時且固有不確定的。美國和其他國家專利法律的變化或對專利法律的解讀變化可能會降低我們知識產權的價值，並可能增加圍繞專利申請的審理、專利實施或保護的不確定性和成本。我們無法預測我們的專利或第三方專利中可能被允許或執行的權利要求的廣度。此外，國會或其他外國立法機構可能通過對我們不利的專利改革立法。

For example, the U.S. Supreme Court has ruled on several patent cases in recent years, sometimes narrowing the scope of patent protection available in certain circumstances, or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the U.S. federal courts, the USPTO or similar authorities in foreign jurisdictions, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and the patents we might obtain or license in the future.

Other companies or organizations may challenge our or our licensors’ patent rights or may assert patent rights that prevent us from developing and commercializing our products.

CAB therapeutics are a new scientific field. We have obtained grants and issuances of CAB therapeutic patents and the various technologies used in discovering and producing CAB therapeutic proteins. The issued patents and pending patent applications in the United States and in key markets around the world that we own or license claim many different methods, compositions and processes relating to the discovery, development, manufacture and commercialization of antibody and immunoregulatory therapeutics. Specifically, we own a portfolio of patents, patent applications and other intellectual property covering CAB compositions of matter as well as their development and methods of use.

As the field of antibody and immunoregulatory therapeutics matures, patent applications are being processed by national patent offices around the world. There is uncertainty about which patents will issue, and, if they do, as to when, to whom, and with what claims. In addition, third parties may attempt to invalidate our intellectual property rights. Even if our rights are not directly challenged, disputes could lead to the weakening of our intellectual property rights. Our defense against any attempt by third parties to circumvent or invalidate our intellectual property rights could be costly to us, could require significant time and attention of our management and could have a material and adverse effect on our business, financial condition, results of operations and prospects or our ability to successfully compete.

There are many issued and pending patents that claim aspects of our product candidates and modifications that we may need to apply to our product candidates. There are also many issued patents that claim antibodies or portions of antibodies that may be relevant for CAB products we wish to develop. Thus, it is possible that one or more organizations will hold patent rights to which we will need a license. If those organizations refuse to grant us a license to such patent rights on reasonable terms, we may not be able to market products or perform research and development or other activities covered by these patents.

Intellectual property rights of third parties could prevent or delay our drug discovery and development efforts and could adversely affect our ability to commercialize our product candidates, and we might be required to litigate or obtain licenses from third parties in order to discover, develop or market our product candidates. Such litigation or licenses could be costly or not available on commercially reasonable terms.

Our commercial success depends in part on our ability to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing or otherwise violating the patents and proprietary rights of third parties. There is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, derivation proceedings, post grant reviews, inter partes reviews, and reexamination proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions. Given the vast number of patents in our field of technology, we cannot assure you that marketing of our product candidates or practice of our technologies will not infringe existing patents or patents that may be granted in the future. Because the antibody landscape is still evolving and the CAB antibody landscape is a new field, it is difficult to conclusively assess our freedom to operate without infringing on third-party rights. There are numerous companies that have pending patent applications and issued patents broadly covering many aspects of antibodies generally or covering antibodies directed against the same targets as, or targets similar to, those we are pursuing. Our competitive position may suffer if patents issued to third parties or other third-party intellectual property rights cover our products or product candidates or elements thereof, or our manufacture or uses relevant to our development plans. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of any of our product candidates, any molecules formed during the manufacturing process or any final product or formulation itself, the holders of any such patents may be able to block our ability to commercialize such product candidate. In such cases, we may not be in a position to develop or commercialize products or product candidates unless we successfully pursue litigation to nullify or invalidate the third-party intellectual property right concerned, or enter into a license agreement with the intellectual property right holder, if available on commercially reasonable terms. Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further practice our technologies or develop and commercialize one or more of our product candidates. There may be issued patents of which we are not aware, held by third parties that, if found to be valid and enforceable, could be alleged to be infringed by our CAB technologies. There also may be pending patent applications of which we are not aware that may result in issued patents, which could be alleged to be infringed by our CAB technologies. If such an infringement claim should be brought and be successful, we may be required to pay substantial damages, be forced to abandon our product candidates or seek a license from any patent holders, and would most likely be required to pay license fees or royalties or both, each of which could be substantial. No assurances can be given that a license will be available on commercially reasonable terms, if at all. Even if we were able to obtain a license, the rights we obtain may be nonexclusive, which would provide our competitors access to the same intellectual property rights upon which we are forced to rely. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our product candidates or technologies may give rise to claims of infringement of the patent rights of others.

We or our collaboration partner, or any future strategic partners may be subject to third-party claims for infringement or misappropriation of patent or other proprietary rights. If we or our licensors, or any future strategic partners are found to infringe a third-party patent or other intellectual property rights, we could be required to pay damages, potentially including treble damages, if we are found to have willfully infringed. In addition, we or our licensors, or any future strategic partners may choose to seek, or be required to seek, a license from a third party, which may not be available on acceptable terms, if at all. Even if a license can be obtained on acceptable terms, the rights may be non-exclusive, which could give our competitors access to the same technology or intellectual property rights licensed to us. If we fail to obtain a required license, we or our existing or future collaborators may be unable to effectively market product candidates based on our technology, which could limit our ability to generate revenue or achieve profitability and possibly prevent us from generating revenue sufficient to sustain our operations. In addition, we may find it necessary to pursue claims or initiate lawsuits to protect or enforce our patent or other intellectual property rights. The cost to us in defending or initiating any litigation or other proceeding relating to patent or other proprietary rights, even if resolved in our favor, could be substantial, and litigation would divert our management’s attention. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could delay our research and development efforts and limit our ability to continue our operations.

We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect our ability to develop and market our products.

We cannot guarantee that any of our patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending application in the United States and abroad that is relevant to or necessary for the commercialization of our product candidates in any jurisdiction. For example, U.S. applications filed before November 29, 2000, and certain U.S. applications filed after that date that will not be filed outside the United States, remain confidential until patents issue. Patent applications in the United States and elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications

covering our product candidates or technologies could have been filed by others without our knowledge. Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our platform technologies, our products or the use of our products. Third-party intellectual property right holders may also actively bring infringement claims against us, even if we have received patent protection for our technologies and product candidates. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively impact our ability to market our products. We may incorrectly determine that our products are not covered by a third-party patent or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which may negatively impact our ability to develop and market our product candidates.

If we fail to identify and correctly interpret relevant patents, we may be subject to infringement claims. We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement claims. If we are unable to successfully settle future claims on terms acceptable to us, we may be required to engage in or continue costly, unpredictable and time-consuming litigation and may be prevented from or experience substantial delays in marketing our products. If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently prohibited from commercializing any of our product candidates that are held to be infringing. We might, if possible, also be forced to redesign product candidates or our technologies so that we no longer infringe the third-party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.

We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.

We may also be subject to claims that former employees, collaborators or other third parties have an ownership interest in our patents or other intellectual property. We may have ownership disputes in the future arising, for example, from conflicting obligations of consultants or others who are involved in developing our product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship or ownership. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful, and issued patents covering our product candidates could be found invalid or unenforceable if challenged in court in the United States or abroad.

Competitors may infringe our patents or the patents of our licensors. If we were to initiate legal proceedings against a third party to enforce a patent covering one of our products or our technology, the defendant could counterclaim that our patent is invalid or unenforceable, or the court may refuse to stop the defendant in such infringement proceeding from using the technology at issue on the grounds that our patents do not cover the technology in question. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, for example, lack of novelty, obviousness or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. The outcome following legal assertions of invalidity and unenforceability during patent litigation is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on one or more of our products or certain aspects of our platform technology. Such a loss of patent protection could have a material and adverse effect on our business, financial condition, results of operations and prospects. Patents and other intellectual property rights also will not protect our technology if competitors design around our protected technology without legally infringing our patents or other intellectual property rights.

Interference or derivation proceedings provoked by third parties or brought by us, the USPTO or any foreign patent authority may be necessary to determine the priority and/or ownership of inventions with respect to our patents or patent applications or those of our licensors. An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms, if any license is offered at all. Our defense of litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees.

We may not be able to prevent, alone or with our licensors, misappropriation of our intellectual property, trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as in the United States. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk

that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.

We may not be able to protect our intellectual property rights throughout the world.

Obtaining a valid and enforceable issued or granted patent covering our technology in the United States and worldwide can be extremely costly. In jurisdictions where we have not obtained patent protection, competitors may use our technology to develop their own products and further, may export otherwise infringing products to territories where we have patent protection, but where it is more difficult to enforce a patent as compared to the United States. Competitor products may compete with our future products in jurisdictions where we do not have issued or granted patents or where our issued or granted patent claims or other intellectual property rights are not sufficient to prevent competitor activities in these jurisdictions. The legal systems of certain countries, particularly certain developing countries, make it difficult to enforce patents and such countries may not recognize other types of intellectual property protection, particularly that relating to biopharmaceuticals. This could make it difficult for us to prevent the infringement of our patents or marketing of competing products in violation of our proprietary rights in certain jurisdictions. Proceedings to enforce our patent rights in foreign jurisdictions, regardless of whether they are successful, could result in substantial cost and divert our efforts and attention from other aspects of our business. Similarly, if our trade secrets are disclosed in a foreign jurisdiction, competitors worldwide could have access to our proprietary information and we may be without satisfactory recourse. Such disclosure could have a material adverse effect on our business. Moreover, our ability to protect and enforce our intellectual property rights may be adversely affected by unforeseen changes in foreign intellectual property laws.

We generally file a provisional patent application first (a priority filing) at the USPTO. An international application under the Patent Cooperation Treaty, or PCT, is usually filed within 12 months after the priority filing. Based on the PCT filing, national and regional patent applications may be filed in the United States, Europe, Japan, Australia and Canada and, depending on the individual case, also in any or all of, inter alia, Brazil, China, Hong Kong, India, Israel, Mexico, New Zealand, Russia, South Africa, South Korea and other jurisdictions. We have so far not filed for patent protection in all national and regional jurisdictions where such protection may be available. In addition, we may decide to abandon national and regional patent applications before grant. Finally, the grant proceeding of each national or regional patent is an independent proceeding which may lead to situations in which applications might in some jurisdictions be refused by the relevant registration authorities, while granted in other jurisdictions. It is also quite common that depending on the country, various scopes of patent protection may be granted on the same product candidate or technology. Furthermore, while we intend to protect our intellectual property rights in our expected significant markets, we cannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market our product candidates. Accordingly, our efforts to protect our intellectual property rights in such countries may be inadequate, which may have an adverse effect on our ability to successfully commercialize our product candidates in all of our expected significant foreign markets.

The laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws in the United States, and many companies have encountered significant difficulties in protecting and defending such rights in such jurisdictions. The requirements for patentability differ, in varying degrees, from country to country, and the laws of some foreign countries do not protect intellectual property rights, including trade secrets, to the same extent as federal and state laws of the United States. If we or our licensors encounter difficulties in protecting, or are otherwise precluded from effectively protecting, the intellectual property rights important for our business in such jurisdictions, the value of these rights may be diminished and we may face additional competition from others in those jurisdictions. Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we or any of our licensors are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position in the relevant jurisdiction may be impaired and our business and results of operations may be adversely affected.

Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.

Litigation or other legal proceedings relating to intellectual property claims, with or without merit, is unpredictable and generally expensive and time-consuming and is likely to divert significant resources from our core business, including distracting our technical and management personnel from their normal responsibilities. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities.

We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing upon or misappropriating or from successfully challenging our intellectual property rights. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product candidates or we could lose certain rights to grant sublicenses.

Our current and any future collaboration agreements or license agreements we enter into are likely to impose various development, commercialization, funding, milestone, royalty, diligence, sublicensing, insurance, patent prosecution and enforcement and/or other obligations on us. If we breach any of these obligations, or use the intellectual property licensed to us in an unauthorized manner, we may be required to pay damages and the licensor may have the right to terminate the license, which could result in us being unable to develop, manufacture and sell products that are covered by the licensed technology or enable a competitor to gain access to the licensed technology. Moreover, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing or otherwise violating the licensor’s rights. In addition, while we cannot currently determine the amount of the royalty obligations we would be required to pay on sales of future products, if any, the amounts may be significant. The amount of our future royalty obligations will depend on the technology and intellectual property we use in products that we successfully develop and commercialize, if any. Therefore, even if we successfully develop and commercialize products, we may be unable to achieve or maintain profitability.

We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.

We may find that our programs require the use of proprietary rights held by third parties, and the growth of our business may depend in part on our ability to acquire, in-license or use these proprietary rights. We may be unable to acquire or in-license compositions, methods of use, processes or other third-party intellectual property rights from third parties that we identify as necessary for our product candidates. The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies are also pursuing strategies to license or acquire third-party intellectual property rights that we may consider attractive. These established companies may have a competitive advantage over us due to their size, financial resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. Moreover, collaboration arrangements are complex and time-consuming to negotiate, document, implement and maintain. We may not be successful in our efforts to establish and implement collaborations or other alternative arrangements should we choose to enter into such arrangements. We also may be unable to license or acquire third-party intellectual property rights on terms that that would be favorable to us or would allow us to make an appropriate return on our investment. Even if we are able to obtain a license to intellectual property of interest, we may not be able to secure exclusive rights, in which case others could use the same rights and compete with us.

Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process. Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications. We employ reputable law firms and other professionals and rely on such third parties to help us comply with these requirements and effect payment of these fees with respect to the patents and patent applications that we own, and if we in-license intellectual property we may have to rely upon our licensors to comply with these requirements and effect payment of these fees with respect to any patents and patent applications that we license. In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case. The standards applied by the USPTO and foreign patent offices in granting patents are not always applied uniformly or predictably. For example, there is no uniform worldwide policy regarding patentable subject matter or the scope of claims allowable in biotechnology and biopharmaceutical patents. As such, we do not know the degree of future protection that we will have on our technologies and product candidates. While we will endeavor to try to protect our technologies and product candidates with intellectual property rights such as patents, as appropriate, the process of obtaining patents is time-consuming, expensive and sometimes unpredictable.

We may be subject to claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets of our employees’ or consultants’ former employers or their clients. These claims may be costly to defend and if we do not successfully do so, we may be required to pay monetary damages and may lose valuable intellectual property rights or personnel.

Many of our employees were previously employed at universities or biotechnology or biopharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. A loss of key research personnel or their work product could hamper our ability to commercialize, or prevent us from commercializing, our product candidates, which could severely harm our business. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

Our trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be infringing on other marks. We only have one currently registered trademark, and rely on common law protection for the rest of our trademarks. We may not be able to protect our rights to these trademarks and trade names or may be forced to stop using these names, which we need for name recognition by potential partners or customers in our markets of interest. During trademark registration proceedings, we may receive rejections. Although we would be given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings. If we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively and our business may be adversely affected.

Our operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.

We expect our operating results to be subject to annual and quarterly fluctuations. Our net loss and other operating results will be affected by numerous factors, including, among others:

If our operating results fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially. Furthermore, any fluctuations in our operating results may, in turn, cause the price of our stock to fluctuate substantially.

Our stock price may be volatile, and you could lose all or part of your investment.

The trading price of our common stock has been and is likely to continue to be highly volatile. The market price for our common stock may be influenced by many factors, including the other risks described in this section and the following:

In addition, the stock markets in general, and the markets for pharmaceutical, biopharmaceutical and biotechnology stocks in particular, have experienced extreme volatility that has been often unrelated to the operating performance of the issuer. These broad market and industry factors may seriously harm the market price of our common stock, regardless of our operating performance.

The future issuance of equity or of debt securities that are convertible into equity will dilute our share capital.

We will need to raise additional capital in the future. To the extent we raise additional capital through the issuance of equity or convertible debt securities in the future, there will be further dilution to investors and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. Future issuances of our common stock or other equity securities, or the perception that such sales may occur, could adversely affect the trading price of our common stock and impair our ability to raise capital through future offerings of shares or equity securities. We may choose to raise additional capital through the issuance of equity or convertible debt securities due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. No prediction can be made as to the effect, if any, that future sales of common stock or the availability of common stock for future sales will have on the trading price of our common stock.

If securities or industry analysts do not publish research or reports about our business, or if they issue adverse or misleading research or reports regarding us, our business or our market, our stock price and trading volume could decline.

The trading market for our common stock is influenced by the research and reports that industry or securities analysts publish about us, our business or our market. If no or few securities or industry analysts commence or maintain coverage of us, the trading price for our stock would be negatively impacted. If any of the analysts who cover us issue adverse or misleading research or reports regarding us, our business model, our intellectual property, our stock performance or our market, or if our operating results fail to meet the expectations of analysts, our stock price would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.

Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval and their interests may conflict with your interests as an owner of our common stock.

As of September 30, 2024, executive officers and directors, together with holders of 5% or more of our outstanding common stock and their respective affiliates, beneficially own approximately 38.8% of our outstanding common stock. More specifically, Jay M. Short, Ph.D, our Chairman and Chief Executive Officer, together with his spouse, beneficially own approximately 7.6%, of our outstanding common stock, as of September 30, 2024.

As a result, Dr. Short and our other principal stockholders will continue to have significant influence over the outcome of corporate actions requiring stockholder approval, including the election of directors, any merger, consolidation or sale of all or substantially all of our assets and any other significant corporate transaction. The interests of these stockholders may not be the same as or may even conflict with your interests. For example, these stockholders could delay or prevent a change of control of our company, even if such a change of control would benefit our other stockholders, which could deprive our stockholders of an opportunity to receive a premium for their common stock as part of a sale of our company or our assets and might affect the prevailing market price of our common stock. The significant concentration of stock ownership may adversely affect the trading price of our common stock due to investors’ perception that conflicts of interest may exist or arise.

In addition, we have entered into certain related party transactions with Himalaya Therapeutics SEZC, Inversagen, LLC and BioAtla Holdings, LLC, including various licensing arrangements with respect to certain CAB antibodies. Dr. Short and his spouse are each a manager of Inversagen, LLC and BioAtla Holdings, LLC and a director of Himalaya Therapeutics SEZC. In addition, Dr. Short’s spouse is also an officer of Himalaya Therapeutics SEZC. These related party transactions, and any future related party transactions, create the possibility of actual conflicts of interest with regard to Dr. Short.

Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.

Our common stock price could decline as a result of sales of a large number of shares of common stock or the perception that these sales could occur. These sales, or the possibility that these sales may occur, might also make it more difficult for us to sell equity securities in the future at a time and price that we deem appropriate.

All of our outstanding shares of common stock are freely tradable without restriction or further registration under the Securities Act unless held by our “affiliates” as defined in Rule 144 under the Securities Act, or Rule 144. Shares issued upon the exercise of stock options and warrants outstanding under our equity incentive plans or pursuant to future awards granted under those plans will become available for sale in the public market to the extent permitted by Rules 144 and 701 under the Securities Act.

We registered the offer and sale of all shares of common stock that we may issue under our equity compensation plans, which shares will be able to be sold in the public market upon issuance, subject to applicable securities laws.

Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.

Provisions in the amended and restated certificate of incorporation and our amended and restated bylaws may delay or prevent an acquisition of us or a change in our management. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Because our board of directors is responsible for appointing the members of our management team, these provisions could in turn affect any attempt by our stockholders to replace current members of our management team. These provisions include:

Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, as amended, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner. These provisions would apply even if the proposed merger or acquisition could be considered beneficial by some stockholders.

The Company’s ability to attract and retain qualified members of our board of directors may be impacted due to new laws, including recently enacted diversity quotas.

In September 2018, California enacted SB 826 (“SB 826”) requiring public companies headquartered in California with a board of directors having five members to have at least two female directors, and public company boards with six or more members to have at least three female directors. SB 826 has been challenged in legal proceedings and on May 13, 2022, the Superior Court of California for the County of Los Angeles entered an order striking down SB 826, holding that the statute violates the Equal Protection Clause of the California Constitution. The California Secretary of State has appealed the order and such appeal is currently pending. On September 16, 2022, the appellate court ruled to temporarily stay enforcement of the trial court’s order, which prevented the California Secretary of State from collecting diversity data on corporate disclosure forms pursuant to SB 826, pending a further order of the appellate court. On December 1, 2022, the appellate court vacated the temporary stay order and on February 3, 2023, a record on appeal was filed and such appeal is currently pending. To the extent that this ruling of the appellate court permits the Secretary of State of California to collect and report diversity data, we may be required to comply with additional disclosure requirements. However, ultimate enforceability of SB 826 remains uncertain.

In September 2020, California enacted AB 979 (“AB 979”), which requires that by the end of 2021 California-headquartered public companies have at least one director on their boards who is from an underrepresented community, defined as “an individual who self-identifies as Black, African American, Hispanic, Latino, Asian, Pacific Islander, Native American, Native Hawaiian, or Alaska Native, or who self-identifies as gay, lesbian, bisexual, or transgender.” On April 1, 2022, the Superior Court of California for the County of Los Angeles entered an order striking down AB 979, holding that the statute violates the Equal Protection Clause of the California Constitution. On June 6, 2022, a notice of appeal was filed. On September 16, 2022, the appellate court ruled to temporarily stay enforcement of the trial court’s order, which prevented the California Secretary of State from collecting diversity data on corporate disclosure forms pursuant to AB 979, pending a further order of the appellate court. On December 1, 2022, the appellate court vacated the temporary stay order and on February 3, 2023, a record on appeal was filed and such appeal is currently pending. To the extent that this ruling of the appellate court permits the Secretary of State of California to collect and report diversity data, we may be required to comply with additional disclosure requirements. In June 2023, the federal district court for the Eastern District of California granted the plaintiffs a summary judgment and determined that AB 979 was unconstitutional on its face. The Eastern District of California’s decision is currently on appeal. Litigation regarding AB 979 will continue.

In addition, the Company is subject to the listing rules from Nasdaq related to board diversity and disclosure, which require all companies listed on Nasdaq’s U.S. exchanges to publicly disclose consistent, transparent diversity statistics regarding their board of directors. Additionally, the rules require most Nasdaq-listed companies to have, or explain why they do not have, at least two diverse directors, including one who self-identifies as female and one who self-identifies as either an underrepresented minority or LGBTQ+.

Failure to achieve designated minimum gender and diversity levels in a timely manner exposes such companies to financial penalties and reputational harm. While we are currently in compliance with these regulations, we cannot assure that we can recruit, attract and/or retain qualified members of the board and meet gender and diversity quotas as a result of evolving state laws or Nasdaq rules, which may expose us to penalties and/or reputational harm.

We have incurred, and will continue to incur, significant costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives and corporate governance practices. Additionally, if we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.

As a public company, we have incurred and will continue to incur significant legal, accounting and other expenses that we did not incur as a private company. The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of The Nasdaq Global Market and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Also, the Exchange Act requires, among other things, that we file annual, quarterly and current reports with respect to our business and operating results. Our management and other personnel need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations increase our legal and financial compliance costs and make some activities, including obtaining director and officer liability insurance and maintaining such coverage, more time-consuming and costly. These rules and regulations could also make it more difficult for us to attract and retain qualified members of our board of directors or our board committees or as executive officers. However, these rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

In addition, as a public company, we are required to incur costs and obligations in order to comply with SEC rules that implement Section 404 of the Sarbanes-Oxley Act. Under these rules, we are required to make a formal assessment of the effectiveness of our internal control over financial reporting, and if we cease to be a smaller reporting company, we will be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. We engaged outside consultants to assist in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we have dedicated, and will continue to dedicate, internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of our internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are designed and operating effectively, and implement a continuous reporting and improvement process for internal control over financial reporting. As a result of the complexity involved in complying with the rules and regulations applicable to public companies, our management’s attention may be diverted from other business concerns, which could harm our business, operating results, and financial condition. Since becoming a public company, we increased, and may in the future further increase, the number of employees dedicated to finance and reporting, and the services of outside consultants to meet requirements, which has increased our operating expenses.

管理評估我們對財務報告的內部控制所必須滿足的標準的規定是複雜的，需要大量的文件、測試和可能的整改措施以符合規則下的詳細標準。在進行測試期間，我們的管理層可能會發現重大弱點或缺陷，這些弱點或缺陷可能無法及時修復，以滿足薩班斯-豪利法案規定的最後期限。我們的財務報告內部控制可能不能預防或檢測到所有錯誤和欺詐。

如果我們無法及時遵守《薩班斯 - 求利法》第404條的要求，或者我們無法保持適當和有效的內部控制，那麼我們可能無法及時和準確地製作財務報表。如果發生這種情況，我們的股票市場價格可能會下跌，我們可能會受到上市的股票交易所、美國證券交易委員會或其他監管機構的制裁或調查。此外，如果我們無法繼續滿足這些要求，我們可能無法繼續在納斯達克全球市場上市。

我們的披露控制和流程可能無法防止或發現所有錯誤或欺詐行爲。

我們受《交易所法》定期報告要求的約束。我們設計了披露控制和程序，以合理確保我們必須在根據《交易所法》提交的報告中披露的信息被累積並傳達給管理層，並在規則規定的時間段內記錄、處理、彙總和報告。

我們相信，無論控制系統的披露控制和程序或內部控制和程序多麼合理和正常運作，都只能提供合理的保證，而不是絕對保證，以確保控制系統的目標得以實現。

這些固有的侷限性包括這樣的事實：在決策中做出的判斷可能是錯誤的，並且由於簡單的錯誤或失誤可能會發生故障。此外，個人的行爲、兩個或更多人的串謀，或者對控制進行未經授權的覆蓋，都可能繞過控制。因此，由於我們控制系統中的固有侷限性，錯誤或欺詐可能發生而未被發現。

由於我們預計在可預見的將來不會支付任何現金股息，您投資的回報將取決於我們普通股價值的增值。

我們從未宣佈或支付現金股息。我們目前打算保留所有未來的收益，如果有的話，用於資助我們業務的增長和發展，並且在可預見的未來不打算宣佈或支付任何現金股息。因此，股東的任何回報將僅限於我們普通股價值的任何增值，這並不確定。

我們可能會受到證券訴訟的影響，這將耗費大量資金，並可能分散我們管理層的注意力。

過去，市場證券價格波動較大的公司可能會面臨證券集體訴訟。在未來，我們也可能成爲這類訴訟的目標。無論這類訴訟的事實依據或最終結果如何，針對我們提起的證券訴訟可能會帶來巨額成本，並分散我們管理層對其他業務問題的關注。

我們的公司登記證書和公司章程將特定類型的訴訟和程序的唯一和專屬法定論壇確定爲特拉華州州立法院，這可能限制我們的股東獲取有利於與我們或我們的董事、執行董事或僱員有爭議的司法論壇的能力。

我們修訂和重新規定的公司章程規定，除非我們書面同意選擇另一個論壇，否則特拉華州的法院（或者特拉華州法院沒有管轄權的情況下，特拉華州地區的聯邦地區法院）將是以下類型的訴訟的唯一和專屬論壇：（i）代表我們公司提起的任何衍生訴訟或程序，（ii）主張我們的董事、高管、僱員或股東對我們公司或我們股東承擔的受託責任違約的任何訴訟，（iii）主張根據特拉華州《公司總法》的任何規定而產生的任何訴訟或特拉華州《公司總法》授予特拉華州法院管轄權的任何訴訟，或（iv）主張根據我們修訂和重新規定的公司章程或修訂和重新規定的公司章程（在任何情況下，這些條款可能會不時修訂）或受公司內務條例管轄的任何訴訟。本條款不適用於提起以交易法案爲根據或美國聯邦法院具有專屬管轄權的任何其他索賠。此外，《證券法》第22條爲聯邦和州法院設立了對所有此類《證券法》訴訟的並行管轄權。因此，州和聯邦法院都有權審理此類索賠。我們修訂和重新規定的公司章程進一步規定，美國聯邦地區法院將是根據法律允許的最大範圍下，解決根據《證券法》產生的任何訴因行動的專屬論壇。此論壇選擇規定可能會限制股東在司法論壇提起自認爲有利於與我們或我們的董事、高管或其他僱員發生糾紛的索賠的能力，可能會阻止對我們及我們的董事、高管和僱員發起此類訴訟。或者，如果法院發現我們修訂和重新規定的公司章程和修訂和重新規定的公司章程中的這些規定在適用於一項或多項指定類型的訴訟或程序上無效或不可執行，我們可能會因在其他司法轄區解決此類事務而產生額外費用，可能會對我們的業務和財務狀況產生負面影響。購買或以其他方式取得我們股份的任何個人或實體將被視爲已注意並已同意我們上述修訂和重新規定的公司章程和修訂和重新規定的公司章程規定。

截至2024年9月30日的三個月內公司沒有任何董事或高管採納或者終止規則10b5-1交易安排或非規則10b5-1交易安排(如Regulation S-k第408(a)條的定義)

* 本展覽的部分內容已根據《規章S-k的601(b)(10)(iv)項》進行了編輯。

根據1934年的證券交易法的要求，註冊人已經指定代表簽署本報告。


特拉華州	85-1922320
(該州或其他司法管轄區公司成立或組織）	（IRS僱主唯一識別號碼）
11085 Torreyana Road, 聖地亞哥, 加利福尼亞州	92121
，（主要行政辦公地址）	(郵政編碼)



第I部分	財務信息
項目1。	基本報表:	1
	2024年9月30日（未經審計）和2023年12月31日的簡明資產負債表	1
	2024年9月30日和2023年結束的三個和九個月（未經審計）收入及綜合損失簡明利潤表	2
	2024年9月30日和2023年結束的三個和九個月（未經審計）股東權益簡明報表	3
	未經審計的2024年9月30日至2023年間的現金流量基本報表總結	5
	基本報表附註（未經審計）	6
事項二	分銷計劃	15
第3項。	有關市場風險的定量和定性披露	22
事項4。	控制和程序	22
第二部分	其他信息	23
項目1。	法律訴訟	23
項目1A。	風險因素	23
事項二	未註冊的股票股權銷售和籌款用途	67
第3項。	對優先證券的違約	67
事項4。	礦山安全披露	68
項目5。	其他信息	68
項目6。	展示資料	68
簽名		69


	9月30日, 2024			12月31日, 2023
	(未經審計)
資產
流動資產：
現金及現金等價物	$	56,516		$	111,471
預付費用和其他流動資產		4,051			4,935
總流動資產		60,567			116,406
資產和設備，淨值		906			1,603
經營租賃權益資產，淨值		763			1,495
其他		—			154
資產總額	$	62,236		$	119,658
負債和股東權益
流動負債:
應付賬款和應計費用（包括相關方金額$1,775和$0）	$	18,211		$	26,720
經營租賃負債		1,251			1,624
流動負債合計		19,462			28,344
租賃負債，除去當前部分		—			836
對許可方的負債		19,806			19,806
負債合計		39,268			48,986
承諾和 contingencies（附註5)
股東權益:
優先股，$0.00010.0001面值;200,000,000截至2024年9月30日，共有股份授權截至2023年12月31日； 02024年9月30日發行和流通的股份和2023年12月31日		—			—
普通股，每股面值爲 $0.0001；0.0001面值;350,000,000在2024年9月30日和2023年12月31日獲得了授權的股份 2024年9月30日和2023年12月31日已發行和流通的股份； 48,345,533 和 48,077,599 2024年9月30日和2023年12月31日授權的股份數量		5			5
B類普通股，$0.000030.0001面值;15,368,569在2024年9月30日和2023年12月31日獲得了授權的股份 2024年9月30日和2023年12月31日已發行和流通的股份； 0截至2024年6月30日和2023年12月31日，發行和待發行的股份 2024年9月30日和2023年12月31日，分別		—			—
額外實收資本		494,118			486,930
累積赤字		(471,155	)		(416,263	)
股東權益總額		22,968			70,672
負債和股東權益總額	$	62,236		$	119,658


	截至9月30日的三個月						截至9月30日的九個月
	2024			2023			2024			2023
合作及其他收入	$	11,000		$	—		$	11,000		$	—
營業費用：
研究與開發費用（包括關聯方金額 $1,775和$2,025三個月和九個月結束於截至2024年9月30日和$0和$125分別爲截至2023年9月30日的三個月和九個月分別是截至2023年9月30日結束的	$	16,395		$	28,400		$	51,445		$	81,057
總務費用		5,875			6,620			17,254			20,094
營業費用總計		22,270			35,020			68,699			101,151
經營虧損		(11,270	)		(35,020	)		(57,699	)		(101,151	)
其他收入：
利息收入		692			1,734			2,815			4,674
其他支出		(8	)		(39	)		(8	)		(60	)
總其他收入		684			1,695			2,807			4,614
淨虧損和綜合虧損	$	(10,586	)	$	(33,325	)	$	(54,892	)	$	(96,537	)
普通股每股淨虧損，基本和稀釋	$	(0.22	)	$	(0.70	)	$	(1.14	)	$	(2.02	)
普通股基本和稀釋的加權平均股份		48,335,847			47,834,122			48,213,183			47,707,259


	截至9月30日的九個月
	2024			2023
經營活動現金流
淨損失	$	(54,892	)	$	(96,537	)
調整爲淨損失到經營活動現金流量淨使用：
折舊與攤銷		697			853
基於股票的報酬		6,990			10,806
經營性資產和負債變動:
預付款項和其他資產		1,038			(1,305	)
應付賬款和應計費用		(10,284	)		12,533
		1,775			—
使用權資產和租賃負債，淨額		(477	)		(443	)
經營活動使用的淨現金流量		(55,153	)		(74,093	)
投資活動現金流量
購買固定資產		—			(90	)
投資活動產生的淨現金流出		—			(90	)
籌資活動現金流量
員工股票購買計劃下發行普通股所得款項		244			187
支付與淨清算權益獎勵相關的稅款		(46	)		(229	)
籌集資金的淨現金流量		198			(42	)
現金及現金等價物淨減少		(54,955	)		(74,225	)
現金及現金等價物期初餘額		111,471			215,507
現金及現金等價物期末餘額	$	56,516		$	141,282
補充披露的非現金投融資活動
股權獎勵淨結算相關的稅費已包括在應付賬款中應計費用	$	—		$	11


☒	根據1934年證券交易法第13或15(d)節的季度報告


☐	根據1934年證券交易法第13或15(d)節的轉型報告書


大型加速報告人	☐	加速文件提交人	☐

非加速文件提交人	☒	較小的報告公司	☒

新興成長公司	☐


	2024年9月30日止三個月
	普通股				B類普通股				額外的實收資本			累積的			總計股東的
	股份		數量		股份		數量		資本			$			股權
2024年6月30日餘額		48,326,138	$	5		—	$	—	$	491,934		$	(460,569	)	$	31,370
股票補償費用		—		—		—		—		2,194			—			2,194
在股權激勵計劃下發行普通股，扣除支付稅款的股數		19,395		—		—		—		—			—			—
與淨利潤結算股權獎勵相關的稅費		—		—		—		—		(10	)		—			(10	)
淨損失		—		—		—		—		—			(10,586	)		(10,586	)
2024年9月30日的餘額		48,345,533	$	5		—	$	—	$	494,118		$	(471,155	)	$	22,968


	2023年9月30日止三個月
	普通股				B類普通股				額外的實收資本			累積的			總計股東的
	股份		數量		股份		數量		資本			$			股權
2023年6月30日的餘額		47,803,306	$	5		—	$	—	$	480,524		$	(356,013	)	$	124,516
股票補償費用		—		—		—		—		3,517			—			3,517
在股權激勵計劃下發行普通股，扣除支付稅款的股數		88,428		—		—		—		—			—			—
爲員工股票購買計劃發行普通股		—		—		—		—		14			—			14
發行普通股以支付董事報酬		15,661		—		—		—		27			—			27
與淨利潤結算股權獎勵相關的稅費		—		—		—		—		(46	)		—			(46	)
淨損失		—		—		—		—		—			(33,325	)		(33,325	)
2023年9月30日結餘		47,907,395	$	5		—	$	—	$	484,036		$	(389,338	)	$	94,703


	截至2024年9月30日的九個月
	普通股				B 級普通股				額外付費			累積			總計股東
	股票		金額		股票		金額		資本			赤字			股權
截至2023年12月31日的餘額		48,077,599	$	5		—	$	—	$	486,930		$	(416,263	)	$	70,672
股票薪酬支出		—		—		—		—		6,990			—			6,990
根據股權激勵計劃發行普通股，扣除預扣稅款的股份		76,914		—		—		—		—			—			—
爲員工股票購買計劃發行普通股		191,020		—		—		—		244			—			244
與股權獎勵淨股結算相關的稅款		—		—		—		—		(46	)		—			(46	)
淨虧損		—		—		—		—		—			(54,892	)		(54,892	)
截至 2024 年 9 月 30 日的餘額		48,345,533	$	5		—	$	—	$	494,118		$	(471,155	)	$	22,968


	2023年9月30日止九個月
	普通股				B類普通股					額外的實收資本			累積的			總計股東的
	股份		數量		股份			數量		資本			$			股權
2022年12月31日結存餘額		46,336,166	$	5		1,211,959		$	—	$	473,135		$	(292,801	)	$	180,339
股票補償費用		—		—		—			—		10,806			—			10,806
在股權激勵計劃下發行普通股，扣除支付稅款的股數		268,009		—		—			—		—			—			—
爲員工股票購買計劃發行普通股		56,793		—		—			—		187			—			187
發行普通股以支付董事報酬		34,468		—		—			—		81			—			81
與淨利潤結算股權獎勵相關的稅費		—		—		—			—		(173	)		—			(173	)
B類普通股轉換		1,211,959		—		(1,211,959	)		—		—			—			—
淨損失		—		—		—			—		—			(96,537	)		(96,537	)
2023年9月30日結餘		47,907,395	$	5		—		$	—	$	484,036		$	(389,338	)	$	94,703


	三個月已結束九月三十日
	2024			2023			改變
（以千計）
協作和其他收入	$	11,000		$	—		$	11,000
運營費用：
研究和開發	$	16,395		$	28,400		$	(12,005	)
一般和行政		5,875			6,620			(745	)
運營費用總額		22,270			35,020			(12,750	)
運營損失		(11,270	)		(35,020	)		23,750
其他收入：
利息收入		692			1,734			(1,042	)
其他費用		(8	)		(39	)		31
其他收入總額		684			1,695			(1,011	)
淨虧損和綜合虧損	$	(10,586	)	$	(33,325	)	$	22,739


	九個月已結束九月三十日
	2024			2023			改變
（以千計）
協作和其他收入	$	11,000		$	—		$	11,000
運營費用：
研究和開發		51,445		$	81,057		$	(29,612	)
一般和行政		17,254			20,094			(2,840	)
運營費用總額		68,699			101,151			(32,452	)
運營損失		(57,699	)		(101,151	)		43,452
其他收入：
利息收入		2,815			4,674			(1,859	)
其他費用		(8	)		(60	)		52
其他收入總額		2,807			4,614			(1,807	)
淨虧損和綜合虧損	$	(54,892	)	$	(96,537	)	$	41,645


展示文件數量	Description	形式	文件編號	展示文件	陳述文件提交日期	隨附的文件/陳述如下

10.1*	bioatla與Context Therapeutics公司之間的許可協議，日期爲2024年9月23日	8-K	001-39787	10.1	9/23/2024
10.2*	bioatla與Himalaya Therapeutics SEZC公司之間的全球交易協議，日期爲2024年9月23日	8-K	001-39787	10.2	9/23/2024
31.1	根據Sarbanes-Oxley Act of 2002第302條規定，首席執行官依照第13a-14(a)和第15d-14(a)條規定的認證					X
31.2†	根據Sarbanes-Oxley Act of 2002第302條規定，首席財務官依照第13a-14(a)和第15d-14(a)條規定的認證					X
32.1†	根據Sarbanes-Oxley Act of 2002第906條規定，首席執行官和致富金融(臨時代碼)依照第1350條規定的認證					X
101.INS	Inline XBRL實例文檔 - 該實例文檔未出現在交互式數據文件中，因爲XBRL標籤嵌入在Inline XBRL文檔中。					X
101	BioAtla截至2024年9月30日的季度報告中的材料，採用iXBRL（內聯可擴展商業報告語言）格式：(i) 簡明資產負債表，(ii) 簡明經營業績和全面損失報表，(iii) 簡明股東權益報表，(iv) 簡明現金流量表，以及(v) 簡明財務報表附註，作爲文本塊進行標記，幷包括詳細標籤					X
104	封面頁面互動數據文件(格式爲內聯XBRL文檔，幷包含在展示文檔101中)。					X


	三個月截止 9月30日,
	2024		2023		Change
（以千爲單位）
其他外部費用：
美克波單抗維多替尼，BA3011（CAb AXL-ADC）	$	2,770	$	6,506	$	(3,736	)
奧祖利單抗維多替尼，BA3021（CAb ROR2-ADC）		2,593		4,065		(1,472	)
依伐司託格，BA3071（CAb CTLA-4）		2,095		4,916		(2,821	)
BA3182 (CAb EpCAm x CAb CD3)		1,352		1,086		266
其他 CAb 項目		2,615		6,341		(3,726	)
總外部開支		11,425		22,914		(11,489	)
人員和相關		2,970		3,033		(63	)
以股票爲基礎的補償		1,071		1,322		(251	)
設施和其他		929		1,131		(202	)
所有研發費用	$	16,395	$	28,400	$	(12,005	)


	九個月已結束九月三十日
	2024		2023		改變
（以千計）
外部開支：
Mecbotamab vedotin，BA3011（caB AXL-ADC）	$	11,603	$	17,759	$	(6,156	)
Ozuriftamab vedotin，BA3021（CaB ROR2-ADC）		7,157		10,713		(3,556	)
Evalstotug，BA3071（CaB CTLA-4）		7,150		13,302		(6,152	)
BA3182（CaB epCam x CaB CD3）		3,728		3,221		507
其他 CaB 項目		5,873		19,396		(13,523	)
外部支出總額		35,511		64,391		(28,880	)
人事及相關人員		9,740		9,183		557
基於股權的薪酬		3,314		4,323		(1,009	)
設施和其他		2,880		3,160		(280	)
研發費用總額	$	51,445	$	81,057	$	(29,612	)


	公司名

日期：2024 年 11 月 7 日	作者：	/s/ Jay m. Short，博士
		Jay m. Short，博士
		首席執行官（首席執行官）

日期：2024 年 11 月 7 日	作者：	/s/ 理查德·沃爾德隆
		理查德·A·沃爾德隆
		首席財務官（首席財務和會計官）