10-Q

請在複選框內指示註冊者是否： 1.在過去的12個月內（或註冊者需要提交此類報告的較短期間內）已經提交了根據證券交易所法案第13條或第15(d)條所需提交的全部報告；以及 2.在過去的90天內一直受到此類報告提交要求的規定。是 ☒ No ☐

請在勾選標誌處表示註冊人是否已經在過去12個月內（或者在註冊人要求提交這些文件的較短時期內）按照規則405 of協議S-T（本章節的§232.405）提交了每個交互式數據文件。 ☒ 沒有 ☐是 ☒ 沒有 ☐

請勾選圓圈以表示公司的註冊人是否爲大型加速報告公司、加速報告公司、非加速報告公司、小型報告公司或新興成長公司。有關「大型加速報告公司」、「加速報告公司」、「小型報告公司」和「新興成長公司」的定義，請參見《交易所法規》第120億.2條。

如果是新興成長型企業，請勾選複選標記，表明註冊者已選擇不使用延長過渡期來符合根據證券交易法第13(a)條規定提供的任何新財務會計準則。 ☐

請在檢查標記處說明申報人是否爲外殼公司 (見交易所法案 Rule 12b-2 定義)。是☐ No ☒

截至2020年6月30日和2019年6月30日三個月和六個月的營業額和綜合虧損

1. 組織和重要會計政策摘要

公司

viking therapeutics公司（以下簡稱「公司」）是一家專注於爲代謝和內分泌紊亂開發新型治療方案的臨床階段生物製藥公司。2021年6月，公司成立了澳洲子公司Viking Therapeutics PTY LTD，以便能夠利用澳大利亞本地研發公司可獲得的某些研發補助金，從而選擇在澳大利亞進行研究。

該公司根據Delaware州法律成立特拉華州提供2012年9月24日該公司的總部位於加利福尼亞州聖迭戈，旗下有一家位於澳大利亞阿德萊德的子公司。

報告範圍

附帶的未經審計的合併財務報表已按照美國通用會計準則（「GAAP」）編制。截至2024年9月30日的合併資產負債表，2024年9月30日及2023年同期的合併損益表和綜合損益表，2024年9月30日和2023年同期的股東權益變動表，以及2024年9月30日和2023年的現金流量表均爲未經審計。這些未經審計的合併財務報表已按照美國證券交易委員會（「SEC」）的規章制度爲中期財務信息編制。因此，這些報表不包括GAAP要求的完整財務報表中的所有信息和附註。應當閱讀這些合併財務報表與截至2023年12月31日年度報告中公司於2024年2月7日向SEC提交的10-k表格中包含的經審計的合併財務報表和附註一起。未經審計的中期合併財務報表已根據年度合併財務報表的基礎編制，並經管理層認爲，可以反映出截至2024年9月30日公司財務狀況，2024年9月30日及2023年同期經營業績，2024年9月30日和2023年同期的未經審計股東權益變動表以及2024年9月30日和2023年的未經審計現金流量表的所有調整（包括正常往來調整）。此處包括的2023年12月31日的合併資產負債表來源於經審計的合併財務報表，但並不包括GAAP要求的完整合並財務報表的所有披露或附註。

基本報表附註披露的財務數據和其他信息與截至2024年和2023年9月30日的三個月和九個月相關，在公司未經審計。中期業績未必代表整個年度的業績。

使用估計

按照美國通用會計準則編制財務報表要求管理層對陪同的合併財務報表中的數額進行估計和假設。在編制這些合併財務報表時所作的重大估計涉及經營租賃和某些承諾的會計處理。實際結果可能會與這些估計有所不同。

現金及現金等價物

公司視所有具有高度流動性且到期日在截至購買日期後不超過的投資爲現金及現金等價物。下表列出了公司截至2024年6月30日按公允價值計量的重複性財務資產和負債，按層次分類: 從購買日期起，投資可供出售

可供出售投資

可供出售證券按公允價值計量，未實現收益和損失計入其他綜合收益的累計。債務證券的攤銷成本根據溢價攤銷和貼現到期的折舊進行調整。溢價攤銷和貼現折舊包含在利息收入中。若有的話，可供出售證券的已實現收益和損失以及被判斷爲除暫時性以外的價值下降，包括在其他收入（費用）中。已出售證券的成本基於特定確認方法。將作爲可供出售分類的證券上的利息和分紅包括在利息收入中。

信貸風險集中

金融工具可能使公司面臨信用集中風險，主要包括現金及現金等價物和可市場買賣證券。公司在聯邦投保存款機構中保持的存款超過了聯邦投保限額。管理層認爲，由於這些存款所在的存款機構的財務狀況，公司暴露於較大的信用風險。此外，公司已建立了關於批准投資和投資到期的指導方針，旨在保持安全性和流動性。

預付的臨床試驗和臨床前研究費用

預付的臨床試驗和臨床前研究費用代表公司未來進行的臨床試驗和臨床前研究服務的預付款。隨着相關的臨床試驗和臨床前研究服務的進行，這些金額被確認爲研發費用。

租約

公司在初期確定安排是否爲租賃。經營租賃列入使用權資產，「ROU」資產，而租賃責任包括在公司的合併資產負債表中。ROU資產代表公司在租賃期內使用基礎資產的權利，而租賃責任代表公司根據租賃產生的租金支付的責任。ROU資產和負債在開始日根據租賃期內租金支付的現值確認。由於公司的租約通常不提供隱含利率，公司在確定租金支付的現值時會估算其增量借款利率，基於開始日期提供的信息。可估算隱含率時公司會使用隱含利率。ROU資產還包括任何支付的租金，但不含租金激勵和租金直接成本。公司的租約條款可能包括延長或終止租約的選擇權，當公司有充分把握會行使該選項時。租賃費用在租賃期內按直線法確認。更多信息請參閱附註4。

延期融資成本

遞延融資成本代表與公司通過公開或私下出售公司普通股籌集資金相關的法律、會計和其他直接成本。與公司公開出售的股票有關的成本將推遲到適當發行完成時，屆時此類成本將被再分類爲增加實收資本，以減少所得款項。與公司私下出售的股票有關的成本將推遲到適當發行完成時，屆時此類成本將按照適用購買協議的期限分期攤銷。

收入確認

公司自成立以來未記錄任何營業收入。然而，未來公司可能會參與合作研究和許可協議，根據這些協議，公司可能有資格獲得一次性許可費、研究資金、費用補償、有條件的基於事件的支付和/或版稅。

2018年1月1日，公司採用了財務會計準則委員會（「FASB」）2014-09號公告的會計準則更新《與客戶簽訂的合同的收入》及所有相關修訂（「ASC 606」或「營收準則」）。ASC 606是一種單一綜合模型，供實體用於處理與客戶簽訂的合同產生的收入，並取代了大部分當前的收入確認指南，包括行業特定指南。營收準則基於一個原則，即實體應當確認反映實體預計將在交換商品或服務的過程中有權收取的對價的數量來描繪向客戶轉移商品或服務的收入。爲實現這一核心原則，ASC 606規定了實體應當採取以下步驟：（1）識別與客戶簽訂的合同，（2）確定合同中的履約義務，（3）確定交易價格，（4）分配交易價格到合同中的履約義務，以及（5）在實體履行履約義務時（或隨着這一過程的進行）確認收入。營收準則還要求就客戶合同產生的收入及現金流的性質、金額、時間和不確定性以及獲取或履行合同的成本進行額外披露。公司將按照ASC 606前瞻性地應用於所有合同。

研發費用

所有研發成本均記入當期費用。研發成本主要包括支付給醫藥外包概念（"CROs"）和臨床試驗網站的費用，僱員和顧問相關費用，包括研發人員的工資、福利和以股票爲基礎的補償，根據與第三方製造機構的協議發生的外部研發費用、設施費用、差旅費、會費和訂閱費、折舊和用於臨床研究、臨床試驗和研發的材料。

公司根據與進行和管理公司預臨床研究和臨床試驗的研究機構和CRO簽訂的合同所接受的服務估計其預臨床研究和臨床試驗費用。與臨床試驗相關的合同在長度上存在顯著差異，可能是基於里程碑或可交付項目的固定金額，基於實際成本的變量金額，以某一限額為上限，或以上述元素的組合。公司根據完成的工作累計服務費用，這依賴於基於達成的里程碑、受試者招募和其他事件所導致的總成本估計。公司的大多數服務提供商向公司後期開具發票，就初始估計的支出差異而言，公司為額外費用予以累計。這些協議的財務條款因合同而異，可能導致支出和付款流程不均。預臨床研究和臨床試驗費用包括：

•

與預臨床研究有關的CRO、顧問和實驗室支付的費用；

•

與臨床試驗有關的CRO、臨床試驗地點、研究者和顧問支付的費用；和

•

與製備、測試和包裝用於預臨床研究和臨床試驗的活性藥物成分和藥品材料的代工廠商和服務提供商支付的費用。

根據一些協議的支付取決於里程碑的達成，包括招募特定數量的受試者、站點啟動和臨床試驗里程碑的完成。迄今為止，公司尚未遇到需要對其服務費用的累計進行重大調整的事件。如果公司未識別出已開始支出的成本，或者低估或高估所執行服務的程度或這些服務的費用，其實際支出可能與其估計不符，這可能對其營運成果產生重大影響。隨著協議累計的變化變得顯而易見，公司的累計調整將被記錄。此外，基於服務提供商向公司開出的金額，公司可能也將向這些服務提供商支付的款項記錄為預付費用，將來隨著服務的提供在未來期間確認為費用。

關於公司的澳洲子公司viking therapeutics PTY LTD，公司符合AusIndustry Research and Tax Development Tax Incentive Program的條件以獲得並已經獲得了來自澳洲稅務局（ATO）的現金支付。這項稅收激勵基於與在澳洲的研發支出相關的特定標準，公司必須遵守這些標準。由於沒有關於如何記錄這項研發稅收激勵的具體GAAP指引，公司借鑑國際會計準則（IAS）20並確定將在收到時將這些研發稅收激勵認定為抵消研發支出。這些金額根據成本核算基礎確定，該激勵與公司的研發支出相關，無論是否欠澳洲稅款均應支付。

專利費用

與提交和追蹤專利申請相關的成本按發生支出記入一般行政費用，因為此類支出的回收有所不確定。

基於股份的薪酬

公司通常使用直線法將補償成本分配到每個期權持有人的必要服務期間內的報告期，通常是授予期，並使用Black-Scholes option-valuation模型（“Black-Scholes模型”）估算員工和董事的股票獎勵或限制性股票單位的公允價值。 Black-Scholes模型需要輸入主觀假設，包括波動率、預期期限和授予日下的基礎普通股的公平價值等多個輸入。對於限制性股票和限制性股票單位獎勵，公司通常使用直線法將補償成本分配到持有人的必要服務期間內的報告期，通常是授予期，並使用授予日的公平值估價獎勵。對於在滿足特定績效條件時授予的限制性股票，當該績效條件可能達成時，公司會確認股票-based補償費用。在授予日，作為一家上市公司，公司使用內在價值或公司普通股的收盤價確定授予日公平值。當標準被認為可能達到時，公司會記錄股票-based補償，並在首次確認的期間內以累計補償費用記錄，然後以剩餘預期完成績效標準的期間的直線方式繼續記錄。

對於公司的2014年員工股票購買計劃（“2014 ESPP”）和2024年員工股票購買計劃（“2024 ESPP”），公司通常會就購買期權的公平價值，按授予日評估並使用分級發放方法將此報酬成本分配給相關兩年的發售期間內的每個購買期。正如2014 ESPP先前允許，並且2024 ESPP目前允許，在每個購買期內最多可增加一次捐款，如果員工選擇增加他或她的貢獻，公司將其視為一項會計處理。

修改。預修改和後修改的值是根據修改日期計算的，增量費用隨後按剩餘的購買期間攤銷。

所得稅

公司使用責任方法來核算其所得稅，根據財務報告和所得稅報告目的之間的暫時差異來確定這些差異。根據預期這些暫時差異將會逆轉的時間點，提供逆延所得稅根據在生效的稅率。如果更有可能公司無法透過未來營運實現這些稅收資產，那就提供逆延所得稅資產的估值准備金。

FASb會計準則解釋主題740-10，所得稅明確了識別公司合併財務報表中所認可的所得稅不確定性的會計處理，符合GAAP。所得稅項目必須符合比可能更高的認可門檻才能認可。先前未能達到比可能更高閾值的所得稅項目將在達到該閾值的首次後續財務報告期間被認可。反之，此前認可的稅收項目如果不再符合比可能更高的閾值，將在不再符合該閾值的首個後續財務報告期內被除名。

公司的政策是承認任何未認可稅收利益上計算的利息和懲罰，作為所得稅費用的一部分。

外幣

本公司外國附屬公司的基本货币為當地货币的基本報表轉換為美元以進行合併，方法如下：資產和負債按貸款餘額日期的匯率轉換，股東權益按歷史匯率轉換，收入和支出金額按期間平均匯率轉換。由於轉換子公司帳目而導致的轉換調整包含在「累計其他全面虧損」中，作為合併資產負債表中的權益。以非適用基本貨幣計價的交易將在交易日期按匯率轉換為基本貨幣。期末時，貨幣資產和負債將使用貸款餘額日期的匯率重新計量為基本貨幣。非貨幣資產和負債將按歷史匯率重新計量。由外幣交易產生的收益和損失將包含在合併綜合損益表中的「綜合虧損」中。截至九月三個月結束 2024年9月30日，外幣交易盈利為$2,0002023年9月30日，外幣交易虧損為$86,0002024年和2023年截至九月30日的九個月，外幣交易虧損為$58,000 15.1108,000，分別為。

綜合損益

公司的綜合損失包括因合并公司的外國子公司而產生的淨損失和外幣翻譯調整。

每普通股淨損失

每股基本淨損是通過將歸屬於普通股股東的淨損除以期間內流通普通股的加權平均數計算的，不考慮普通股等價物。每股稀釋淨損是通過將歸屬於普通股股東的淨損除以使用庫藏股法確定的期間內流通普通股等價物的加權平均數進行計算。在進行此計算時，公司當前沒有任何被視為普通股等價物；因此，其基本和稀釋每股淨損計算結果相同。

下表顯示基本和攤薄每股普通股淨虧損的計算（以千爲單位，除股票和每股數據外）：


	截至9月30日的三個月						截至9月30日的九個月
	2024			2023			2024			2023
分子：
歸屬於普通股股東的淨虧損	$	(24,940	)	$	(22,534	)	$	(74,546	)	$	(61,290	)

分母：
加權平均普通股股數		111,093,799			100,028,828			108,445,522			92,664,250
減去：受限股權平均權重數		(183,095	)		(183,095	)		(183,095	)		(183,095	)
基本和稀釋每股淨損失的分母		110,910,704			99,845,733			108,262,427			92,481,155

每股淨虧損:
基本和稀釋	$	(0.22	)	$	(0.23	)	$	(0.69	)	$	(0.66	)

由於發揮反稀釋作用未納入稀釋每股淨損失計算的可能稀釋證券如下（以普通等效股份計）：


	截至2022年9月30日，
	2024		2023
限制性股票單位		2,537,352		2,855,656
股票回購權下的普通股		183,095		183,095
普通股期權		4,864,642		5,243,807
		7,585,089		8,282,558

板塊

公司僅在業務中運營之一管理層使用現金流作爲管理業務的主要衡量標準，並不爲內部報告或決策目的劃分業務。

2024年9月30日，作爲可供出售的投資包括以下內容（以千爲單位）：


截至2024年9月30日	分期償還的成本		毛利未實現的收益 (1)		毛利未實現的虧損 (1)			總計預計公正價值
商業票據 (2)	$	14,550	$	—	$	—		$	14,550
企業債務證券 (2)		690,756		1,954		(138	)		692,572
政府債務證券 (2)		172,810		241		(80	)		172,971
	$	878,116	$	2,195	$	(218	)	$	880,093

(1)

可供出售證券的未實現收益和損失，計入綜合損失的組成部分。截至2024年9月30日，有 270 支持未實現盈利的證券，以及 58 支持未實現虧損的證券。未實現收益分別小於$100,000 ，合計小於$2.2 百萬。未實現虧損分別小於$42,000 ，合計小於$218,000 。公司並無意圖賣出這些投資，並且公司在這些投資的攤銷成本回收之前不太可能需要賣出這些投資，這種回收可能發生在到期時。公司審查其投資以確定和評估可能存在除非暫時性減值外影響的投資。確定減值是否爲非暫時性的因素包括市場價值長期低於成本基礎的時間和程度、投資方的財務狀況和近期前景以及公司持有該投資的意圖和能力以期允許市場價值的任何預期回升所需的充分時間。

(2)

2024年9月30日，無這些證券被列爲公司合併資產負債表上的現金及現金等價物，189.8 企業債券中有$百萬計劃在購買時超過一年到期。

截至2023年12月31日，以可供出售分類的投資包括以下金額（以千計）：


截至2023年12月31日	分期償還的成本		毛利未實現的收益 (1)		毛利未實現的虧損 (1)			總計預計公正價值
商業票據 (2)	$	24,226	$	—	$	—		$	24,226
企業債務證券 (2)		168,564		148		(128	)		168,584
政府債務證券 (2)		113,871		8		(126	)		113,753
	$	306,661	$	156	$	(254	)	$	306,563

(1)

可供出售證券的未實現收益和損失作爲綜合損失的組成部分。截至2023年12月31日，有 49 證券處於未實現盈利狀態，並且 115 證券處於未實現虧損狀態。未實現收益均低於$37,000 單獨小於$158,000 控件。未實現的損失小於$23,000 個別爲$258,000 控件。這些證券沒有連續的未實現損失或盈利超過12個月。公司不打算賣出這些投資，公司在收回攤銷成本基礎之前無需出售這些投資，並且公司更可能不會被要求在到期前出售這些投資。公司審查其投資，以確定並評估可能存在重大非暫時性損失跡象的投資。確定損失是否爲非暫時性的考慮因素包括公允價值低於成本基礎的時間長度和程度、投資者的財務狀況和短期前景，以及公司持有該投資的意圖和能力足以允許任何預期市值回升的時間。

(2)

截至2023年12月31日，無這些證券中有某些被分類爲公司資產負債表上的現金及現金等價物，無公司持有的企業債券中有計劃在購買時超過一年到期。

3. 金融工具的公允價值

公司的金融工具包括現金及現金等價物、投資和應付賬款。由於這些工具的短期到期性質，所以在附表中報告的現金及現金等價物和應付賬款的賬面價值接近公允價值。公允價值衡量按照以下三個類別進行分類和披露：

一級 —在活躍市場中報價的相同資產或負債。

二級 —除了可以直接或間接觀察到的 Level 1 之外的輸入，例如類似資產或負債的報價價格；市場不活躍的報價價格；或者可以由可觀察的市場數據支持或經可觀察市場數據證實的其他輸入，以及資產或負債的全部期限。

三級 —由較少或沒有市場活動支持的不可觀察輸入，這些輸入對資產或負債的公允價值具有重要意義。

截至2024年9月30日和2023年12月31日，公司所有受公允價值計量影響的金融資產均使用可觀察到的輸入值進行估值。公司根據一級輸入值進行估值的金融資產包括貨幣市場基金。根據二級輸入值進行估值的公司金融資產包括存單、商業票據、公司債券和政府債券，其中包括對評級較高的投資級公司的投資。

公司的投資策略側重於資本保值。公司投資於符合公司投資政策中規定的信用質量標準的工具。該政策還限制了對任何一種證券或工具的信用敞口金額。截至2024年9月30日，公司的投資包括政府貨幣市場基金、商業票據、公司債券和政府債券。

公司金融工具的公允價值如下所示（以千爲單位）：


			2024年9月30日的公允價值計量
	總費用		一級		二級		三級
按公允價值計量的金融資產：
現金等價物：	$	35,841	$	35,841	$	—	$	—
短期投資
商業票據，可供出售		14,550		—		14,550		—
公司債務證券，可供出售		692,572		—		692,572		—
政府債務證券，可供出售		172,971		—		172,971		—
總金融資產	$	915,934	$	35,841	$	880,093	$	—


			2023年12月31日的公平價值計量
	總費用		一級		二級		三級
按公允價值計量的金融資產：
現金等價物：	$	40,479	$	16,411	$	24,068	$	—
短期投資
商業票據，可供出售		24,226		—		24,226		—
公司債券，可供出售		168,584		—		168,584		—
政府債券，可供出售		113,753		—		113,753		—
總金融資產	$	347,042	$	16,411	$	330,631	$	—

4. 營業租賃 - ROU資產和租賃負債義務

公司擁有一份經營租賃（「辦公室租賃」），該租賃是租用辦公空間的合同，起租日期爲2022年3月1日，到期日期爲2027年7月31日（「期限」）。以下是公司截至2024年9月30日和2023年12月31日的ROU資產和租賃負債摘要（以千爲單位，除了年份和%）：


	2024年9月30日			2023年12月31日

租賃資產	$	1,113		$	1,126

租賃負債義務，流動	$	480		$	324
租賃負債義務，減去流動部分		755			936
總租賃負債義務	$	1,235		$	1,260

加權平均剩餘租賃期限	2.60年			3.58幾年

加權平均折扣率		3.70	%		3.00	%

截至2024年9月30日的三個月和九個月內，公司共認識 $97,000 和 $268,000 在營業租賃費用中分別爲，在公司的綜合損益表中列爲營業費用。

截至2023年9月30日的三個月和九個月內，公司認爲資產$84,000 和 $255,000 分別是租賃費用和營業費用中包括在公司綜合損益表中以及綜合損失。

截至2024年9月30日，公司資產的未來最低租賃付款如下（以千爲單位）：



2024年餘下的時間	$	127
2025		521
2026		418
2027		227
租賃支付的最低總額	$	1,293
扣除代表利息數額	$	(58	)
總租賃負債義務	$	1,235

辦公室租賃爲公司提供了，有初始期限辦公室租賃的期限爲月內。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。超出期限。如果選擇行使選項，續租期將按照辦公室租賃條款確定的市場價值確定基礎租金。延長期限的選擇並未被確認爲公司的租賃負債和使用權資產的一部分。

被渲染按照特定績效標準測量公司的股份。這些股份受到回購選項的約束，並在達到績效目標或觸發事件時獲得兩個一部分 500,000 股份，每個股份，根據績效目標的實現或定義時的觸發事件獲得。

公司判斷未承認費用的公允價值爲2014年2月20日的$168,000 授予日。2015年5月，公司以每股$的價格回購了這些股票中的 633,810 的一部分0.00001 每股。與回購相關，公司就股票購買協議進行了修訂，規定剩餘的 366,190 股份會在兩個一部分 183,095 股份，在達到績效目標或觸發事件發生後繼續分配。未確認費用的按比例授予日公允價值爲$62,000。2015年10月，觸發事件有可能發生，並於2016年10月被認爲已實現，屆時 183,095 股份已獲得；因此，公司記錄了$31,000 的股權報酬費用直至2016年12月31日。不在2024或2023年9月30日結束的九個月內確認了類似的費用。公司將在每個報告期繼續重新評估是否有可能實現業績目標，一旦被認定爲可能，公司將按照公平價值開始記錄補償費用，以判斷在公司估計的業績目標實際實現的期間，在其基本報表中確定基於股票的補償費用。

於2021年7月28日，公司與Stifel, Nicolaus & Company, Incorporated、Truist Securities, Inc.和H.C. Wainwright & Co. LLC（統稱爲「代理商」）簽署了《按市場價格發行股票協議》（「ATm協議」），根據該協議，公司可以不時通過代理商以銷售代理人或主體（「ATm發行」）的身份提供和出售公司普通股（「ATm股票」）。任何在ATm發行中提供和出售的ATm股票均應根據S-3表格（文件編號333-258231）的通用架構註冊聲明（「2021年架構註冊聲明」）和關於ATm發行的424（b）招股說明書進行發行，日期爲2021年8月11日。自成立以來，直至2023年7月到期的2021年架構註冊聲明到期，公司的普通股根據ATm發行以約合計約$XXX的淨收益出售。 1,587,404 公司普通股股票根據ATm發行出售，爲公司帶來約$XXX的淨收益13.6百萬美元。

於2022年3月10日，公司董事會授權了一項股票回購計劃，自2022年3月18日生效，公司可以在長達XXX的期間內回購高達XXX美元的普通股50.0 百萬美元的普通股，長達發生（「回購計劃」）。回購計劃應由公司董事會委員會自行決定，通過公開市場購買、一個或多個根據《1934年證券交易法》第10b5-1條規則的交易計劃、大宗交易及私下洽談中進行。通過 2024年3月18日。終止回購計劃的日期，公司根據回購計劃回購了公司普通股的總數 729,034 股份。公司在回購計劃下回購的股份由其持有，並作爲2024年3月發行（如下所定義）的一部分重新發行。

2023年4月3日，公司根據2021年備案註冊聲明完成了其普通股的承銷公開發行（「2023年4月發行」）。在2023年4月發行中，公司以每股 19,828,300 4414.50 的價格出售，其中包括承銷商完全行使其購買額外普通股選擇權的 2,586,300 股份。在2023年4月發行結束時，公司獲得淨收益$270.0 扣除承銷折扣、佣金和其他發行費用後，該公司從此次發行中獲得的淨收益爲$其他。

2023年7月26日，公司根據1933年修訂的證券法第405條規定中定義的優質常規發行人，在提交了S-3表格（文件號333-273460）後，提交了一份自動普通全球通用架構註冊聲明，該註冊聲明在提交後即生效（「2023 Shelf Registration Statement」）。2023架構註冊聲明允許公司隨時以2023架構註冊聲明中描述的方式提供不定量的證券，包括股權證券、債務證券、認股權證、權利、單位和存托股份。任何根據2023架構註冊聲明進行的發行的具體條款將在該發行時確定。2023架構註冊聲明將於到期 2026年7月26日.

2023年7月26日，公司與Stifel, Nicolaus & Company, Incorporated、Truist Securities, Inc.、H.C. Wainwright & Co. LLC和BTIG, LLC簽訂了《修正第1號關於市價股票發售協議（「ATm協議修正」）》。根據ATm協議修正，BTIG, LLC被添加爲ATm發售的銷售代理，ATm協議被修改爲允許ATm發售可根據公司隨後提交的S-3表格註冊聲明進行。ATm發售中提供和出售的任何ATm股票現在將根據2023架構註冊聲明和ATm發售的具體條款發行，該發行的招股說明書日期爲2023年7月26日，已包含在2023架構註冊聲明中（「ATm招股說明書」）。2023架構註冊聲明將於 2026年7月26日。從ATm招股說明書的日期到2024年9月30日， 1,426,303 公司的普通股在ATm發售中已售出，並且截至2024年9月30日，公司可根據ATm招股說明書隨時出售其普通股，以獲得最高總額達151.9 百萬美元的未售股淨收益。

2024年3月4日，公司根據2023年申請文件完成了其普通股的包銷公開發行（下稱「2024年3月發行」）。在2024年3月發行中，公司共賣出 7,441,650 4485.00 每股，其中包括承銷商完全行使其購買 970,650 額外普通股選擇權 2,193,251被預先批准了已發行的股份來自公司的庫存

6. 基於股份的報酬

公司通常使用直線法將補償成本分配到每位期權持有人的必要服務期間，通常是認股期，在估計員工和董事們的股票期權或受限股票單位的公允價值時，公司使用Black-Scholes期權定價模型。Black-Scholes模型需要輸入主觀假設，包括波動率、預期期限和授予日相關的基礎普通股公允價值，以及其他的輸入。對於受限股票和受限股票單位獎勵，公司通常使用直線法將補償成本分配到持有人的必要服務期間，通常是認股期，並使用授予日的公允價值來價值獎勵。對於根據特定業績條件實現解鎖的受限股票，公司在業績條件有望達成時確認股權補償費用。在授予日，公司以作爲上市公司的內在價值或授予日的普通股收盤價來確定授予日的公允價值。在標準滿足可能要求的時候，公司記錄股權補償費用，並在首次確認的期間以累積追溯費用的方式進行，然後在業績標準預計完成的剩餘期間內以直線方式進行。

對於2014 ESPP和2024 ESPP，公司通常確認購買期權的公允價值作爲補償費用，根據授予日測量，並使用分級授予方法將這種補償成本分配到相關兩年期內各購買期間。由於2014 ESPP過去允許，並且2024 ESPP當前允許，在每個購買期間最多增加一次捐款，當員工選擇增加捐款時，公司將此視爲會計修改。會計修改的前後價值是在修改日期計算的，然後遞增費用分攤在剩餘購買期間內。

2014計劃公司2014年的股權激勵計劃（「2014計劃」）規定公司董事會薪酬委員會（「薪酬委員會」）可以向2014計劃參與者授予或發行期權、股票增值權益、限制股、限制股單位、無限制股、延遲股份單位、業績和以現金結算的獎勵以及股利等同權益。最初，公司普通股的總數爲 1,527,770 股已經被保留用於根據2014計劃發行。2014計劃規定，除非公司董事會或薪酬委員會另有決定，否則2014計劃下可發行的股份數量將每年自2016年1月1日起，至2024年1月1日（含）終止，在這段時間內自動增加上一個日曆年度的12月31日尚未發行的公司普通股總數的%。 3.5公司根據2014計劃授予的普通股股票將以授權但未發行的公司普通股股票、公司持有的或信託中的公司普通股股票爲交付基礎。2014計劃規定，在股票交付前以現金結算或其他方式到期、或被沒收、終止或取消（包括根據薪酬委員會制定的交換計劃），以及公司的普通股股票股票計劃下的任何股票數再次可用於根據2014計劃發行。此外，爲支付行權價或與獎勵相關的稅款而扣留（或未發行）的公司的普通股股票、與支付任何行權價或代扣稅相關的普通股股票數一致的公司普通股股票，將再次可用於根據2014計劃發行。截至2023年12月31日，公司的可發行普通股爲股，並於2024年1月1日生效，另外新增 5,939,750 股。 3,503,981 根據2014計劃的條款，公司普通股股份增加到爲2014計劃發行而保留的股份數量。

2024計劃。 2024年5月21日，公司股東批准了Viking Therapeutics, Inc. 2024股權激勵計劃（「2024計劃」），該計劃取代了2014計劃。自2024年5月21日以來，不會再根據2014計劃進行任何獎勵。根據2024計劃最初授權發行的普通股股份數量等於（a） 12,000,000 普通股股份，加上（b）最多 7,674,614 在2014計劃之下授予的未行使期權或其他股權獎勵的普通股股份，這些股份將在未來根據2024計劃進行發行，前提是自2024年5月21日後，任何此類股權獎勵在行使或結算之前終止或到期後變得可用，因爲該獎勵以現金結算，因股份未獲授予而被取消，因未獲授予導致的終止或被回購或扣留（或未發行）以滿足稅款代扣義務或購買或行使價格。

2014 ESPP最初，公司普通股的總數爲 458,331 股根據2014年ESPP保留用於發行。2014年ESPP規定，除非公司董事會或薪酬委員會另行確定，否則每年1月1日自2016年1月1日起至2024年1月1日（含）自動增加公司普通股的發行股份數量相當於 1公司在前一年12月31日的出色普通股總數的百分比。根據2014年ESPP購買的普通股的份額已獲授權但未發行，公司其他持有的普通股，公司已購買或根據適用證券法以公平交易市場購買的普通股。根據補償委員會的判斷下，公司普通股的股份可獲購買，每期爲 24 個月，由四個個連續購買期組成六個月截至2023年12月31日，此公司的普通股份中有 4,251,444 股可供發行，截至2024年1月1日，根據2014年ESPP的條款，此公司的普通股份又增加了 1,001,137 股供發行的股份中又增加了按照2014 ESPP條款規定，公司的普通股份。 166,816 公司的普通股份中被2014 ESPP的參與者購買了

2024 ESPP。 2024年5月21日，公司的股東批准了Viking Therapeutics, Inc. 2024年員工股票購買計劃（「2024 ESPP」），取代2014 ESPP。自2024年5月21日起，不會再向2014 ESPP的參與者發行股份。公司的普通股份在2024 ESPP下可發行的最大數量不得超過 5,500,000 按照2024 ESPP的購買進行發行的股份將達到 24 通過一系列連續投放的方式決定進行購買的公司的普通股將在每期達到的期限爲四個連續購買期間六個月在2024 ESPP下的任何未來發行開始之前，薪酬委員會可能會判斷當前發行應終止，可在該終端購買期結束後第一天（或任何所需較晚日期）啓動新的發行，並決定未來發行將由一個或多個連續購買期間組成，每個期間的持續時間由薪酬委員會決定；但不會超過任何發行期超過 27 個月，購買期不會超過一年。公司員工中符合以下要求的每位員工（1）是2024 ESPP發行日之前的員工，（2）通常每週工作超過20小時且每年超過五個月，並（3）符合薪酬委員會確定的其他標準（與1986年修訂的《內部稅收法典》第423節一致）均有資格參與該發行中的每個購買期。公司普通股在2024 ESPP下的每股購買價格不得低於，並最初將等於，以下兩者中較低的一個：（1）公司普通股在發行日的每股公允市場價的 85%，或者 85公司普通股票的購買權行使日的每股公允市場價的百分比，這將是適用購買期的最後一天。

截至2024年和2023年9月30日的三個月和九個月期間，公司確認了以下股份補償費用（以千爲單位）：


	截至9月30日三個月結束時,				截至9月30日的九個月
	2024		2023		2024		2023
獎勵類型的股票補償費用：
期權	$	3,467	$	1,320	$	8,148	$	4,311
限制性股票和限制性股票單位		5,440		2,699		14,879		7,251
員工股票購買計劃		75		462		1,018		1,108
包括股票補償費用總額在費用中	$	8,982	$	4,481	$	24,045	$	12,670
按項目劃分的股票補償費用：
研發費用	$	3,016	$	1,145	$	7,062	$	3,571
一般及管理費用		5,966		3,336		16,983		9,099
包括股票補償費用總額在費用中	$	8,982	$	4,481	$	24,045	$	12,670

以下表格列出了公司按獎勵類型分類的未確認股票補償費用，以及預計承認該費用的加權平均期間（以千爲單位，年爲單位）：


	截至2024年9月30日
	無法識別費用，扣除後預計沒收		加權授予日期公允價值的平均數價格 Recognition 時期（年）

獎項類型：
期權	$	20,272		2.72
限制性股票和限制性股票單位	$	16,195		1.69

以下表格總結了2024年9月30日結束的九個月內受限股票交易情況：


	無		加權授予日期公允價值的平均數平均數授予日期公正價值
2023年12月31日的未歸屬股份		183,095	$	0.17
已行權		—	$	—
34,105		—	$	—
被取消		—	$	—
回購		—	$	—
截至2024年9月30日尚未獲得的股份		183,095	$	0.17

以下表格總結了2024年9月30日結束的九個月內受限制股票單位的活動：


	受限制股票單位的股數			加權授予日期公允價值的平均數平均數授予日期數值
2023年12月31日的未歸屬股份		2,855,656		$	7.32
已行權		1,310,533		$	17.40
34,105		(1,551,003	)	$	8.68
被取消		—		$	—
已取消		(77,834	)	$	7.77
2024年9月30日前尚未獲授的股份		2,537,352		$	11.68

公司發放基於績效的限制性股票單位（PRSU獎勵）。這些獎勵發放給公司的某些員工，PRSU獎勵的股份將在公司在四年內達到一定里程碑時獲得，任何未獲授的PRSU獎勵部分將在適用授予日期四週年時取消。在授予日期，公司以公開交易公司身份使用內在價值或公司普通股的收盤價確定授予日期的公允價值。在被認爲可能實現標準的時點，公司將在首次確認的期間記錄以累積形式計提的股份報酬，並且在預計完成績效標準的剩餘期間內以直線形式進行計提。

2020年1月，公司發行 244,000 PRSU授予給公司的多名員工，反映在上表總結的限制性股票單位活動中。這些PRSU獎勵的股份在公司實現特定里程碑時獲得， 100%的PRSU獎勵股份將在實現三個里程碑後的四年期。期間內解除限制，任何當時尚未解除的部分PRSU獎勵將在授予日期的四週年被取消。截至2024年1月4日，取消日期， 77,834 個PRSU獎勵被取消， 10,500 個PRSU獎勵被取消，兩個已達成里程碑，導致公司記錄了累計股票補償費用$1.2百萬美元。

2021年1月，公司發行了 205,500 PRSU獎勵給其多名員工，在上表總結的受限股單位活動中有所體現。這些PRSU獎勵股份將隨着公司實現特定里程碑而解鎖，其中 100%的PRSU獎勵股份將在實現三里程碑的四年期。期內解鎖，而 133.3%的PRSU獎勵股份將在實現所有四個在一段時間內的里程碑三年或四年任何未獲授予的PRSU獎勵在授予日期的四週年被取消。截至 9月份，已放棄了部分PRSU獎勵，其中四個里程碑中的兩個已達成，剩餘的兩個被認爲不可能實現，導致公司確認累計股權報酬費用達到$ 30, 2024, 10,000 截至 9月份，已放棄了部分PRSU獎勵，其中四個里程碑中的兩個已達成，剩餘的兩個被認爲不可能實現，導致公司確認累計股權報酬費用達到$800,000通過九月30, 2024年和股票補償費用$(191,000)在截至 2024年9月30日。

2022年1月，公司發行了 657,000 幾名員工的PRSU獎勵，這些獎勵反映在以上總結受限制的股票單位活動表中。這些PRSU獎勵的股份將在公司實現一定里程碑時解除限制，其中 100%的PRSU獎勵股份將在三個里程碑達到時解除限制四年期。期限爲 133.3在所有里程碑達成後，受限於PRSU獎勵的股票的百分比將解除鎖定四個期間內的各個里程碑四年期。期，而在授予日期的四週年之日起，則取消任何未解鎖的PRSU獎勵部分。截至2024年9月30日，否 PRSU awards had been forfeited, 三 of the four milestones had been met and the remaining 之一 was deemed improbable of achievement, resulting in the Company recording cumulative stock-based compensation expense of $3.2通過九月2024年30月，以及結束於（709,000在截至 2024年9月30日。

2023年1月，公司發行了 920,000 若干名員工獲得了PRSU獎勵，這些獎勵反映在上表概述的受限制股票單位活動中。這些PRSU獎勵股份在公司實現特定里程碑時才能解鎖，其中 100%的PRSU獎勵股份在實現三的里程碑後解鎖四年期。期間和 133.3股份的百分比受限於實現所有四個里程碑在一四年期。期內，任何此後未獲授予的PRSU獎勵部分將在授予日期四週年時取消。截至2024年9月30日，否 PRSU獎勵已被取消，兩個其中四個里程碑已經實現，剩下的兩個被視爲可能實現，導致公司記錄了累計股票報酬支出$7.9通過九月30, 2024年的股票報酬支出爲$2.9 未完成的九個月內總共籌得_X_百萬美元 2024年9月30日。

2024年1月，公司進行了定向增發 677,500 向幾位員工發放了_PRSU獎勵，這些獎勵反映在上表總結的受限制股票單位活動中。這些PRSU獎勵所涉及的股票將在公司實現某些里程碑時解鎖，其中_X_%的PRSU獎勵所涉及的股份將隨着達到_X_里程碑而解鎖 100實現_X_%的PRSU獎勵所涉及的股份解鎖三里程碑達成_X_的一部分四年期。期間和 133.3股票的一定百分比是基於所有 PRSU 獎勵的達成而解鎖的四個在一段時期內實現所有里程碑，之後任何尚未解鎖的部分的 PRSU 獎勵將在授予日期的四週年時取消。截至2024年9月30日，四年期。已經被取消否的 PRSU 獎勵之一四個里程碑中已經達成了三個，剩下的三被視爲可能實現的目標，導致公司在截至2024年9月30日的九個月內錄得了基於股票的補償費用$9.5 百萬美元 2024年9月30日。

下表總結了截至2024年9月30日的九個月內的期權交易活動:


	股份受期權制約			加權授予日期公允價值的平均數平均數行權價格		加權授予日期公允價值的平均數平均數剩餘加權合同期限（年）		總內在價值
2024年3月31日的未行使期權（未經審計）		5,248,682		$	6.79		7.10		62,210,000
已行權		1,197,200		$	22.39
行使		(1,568,990	)	$	6.00
被取消		(12,250	)	$	9.93
已取消		—		$	—
Options outstanding at September 30, 2024		4,864,642		$	10.87		7.51		255,374,000
Options exercisable at September 30, 2024		1,983,233		$	7.64		6.18		110,485,000

本公司參與了一個合資經營，擁有的經濟利益爲%。由於公司對該實體具有重大影響力但無控制能力，因此採用權益法對該合資經營進行會計處理。y received $9.8萬美元和6.6百萬 in cash proceeds from option exercises and ESPP common stock issuances during the nine months ended September 30, 2024 and 2023, respectively.

Compensation cost for stock options granted to employees is based on the estimated grant date fair value and is recognized ratably over the vesting period of the applicable option. The estimated per share weighted average fair value of stock options granted to employees during the nine months ended September 30, 2024爲$16.22.

本季度10-Q表格的這份季度報告包含根據1933年證券法修正案第27A條和1934年證券交易法修正案第21E條的定義進行的「前瞻性陳述」，涉及到1995年《私人證券訴訟改革法案》的風險和不確定性，以及假設，如果這些假設從未實現或被證明不正確，則可能導致我們的結果與這些前瞻性陳述所表達或暗示的結果存在實質和不利的差異。這樣的前瞻性陳述包括對我們的費用、未來營業收入、資本需求以及對額外融資的需求的估計；關於我們能夠將藥物候選推進、收購和成功完成臨床試驗和臨床前研究的能力的陳述；關於新產品候選藥物的聲明；與我們的研究和開發活動，包括我們的臨床試驗和臨床前研究相關的風險和不確定性；我們對潛在市場規模和藥物候選藥物使用後，患者人群規模的期望，以及我們能夠爲此類市場提供服務的能力的預期；關於我們能夠維持和建立合作關係或獲得額外資金的聲明；關於與我們的競爭對手和我們的行業有關的發展和預測的聲明以及與前述任何事項無關的歷史事實的嚴格相關或陳述的假設的聲明。這些聲明通常通過使用「預計」，「相信」，「繼續」，「可能」，「估計」，「期望」，「打算」，「可能」或「將要」，這些術語的負面版本和類似表達或變體來識別。這些聲明是基於我們管理層現有信息基礎上的信念和假設。這種前瞻性聲明受風險、不確定性和其他可能導致實際結果和某些事件的時間安排與這些前瞻性聲明所表達或暗示的未來結果存在實質和不利差異的因素的影響。可能導致或有助於產生這種差異的因素包括但不限於下文列出的那些因素，並在本季度10-Q表格和我們其他證券交易委員會或SEC提交的文件中的「風險因素」一節討論。此外，這樣的前瞻性聲明僅於本季度10-Q表格的日期。我們不承擔更新任何前瞻性聲明以反映此類聲明日期之後發生的事件或情況的責任。

在本10-Q季度報告中，除非上下文另有要求，「維京」、「我們」、「我們」和「我們」的術語在本10-Q季度報告中指的是維京治療公司及其子公司。

我們是一家臨床階段的生物製藥公司，專注於開發新型、一流或最佳療法，用於治療代謝和內分泌紊亂。

2022年1月，我們宣佈啓動了VK2735的第1期單劑量遞增（SAD）和多劑量遞增（MAD）臨床試驗，VK2735是一種新型的糖原樣肽1（GLP-1）和葡萄糖依賴性胰島素促多肽（GIP）雙激動劑，目前正在開發中，用於潛在治療各種代謝性疾病。

2023年3月28日，我們宣佈完成了第1階段試驗。該研究是一項隨機、雙盲、安慰劑對照的SAD和MAD研究，對象爲健康成年人。該研究的主要目標包括評估VK2735皮下單次和多次劑量的安全性和耐受性，以及確定適合進一步臨床開發的VK2735劑量。研究調查員還評估了VK2735單次和多次劑量的藥代動力學。根據這項第1階段研究的結果，我們於2023年9月啓動了創業公司研究，這是一項VK2735在肥胖患者中的第2階段臨床試驗。

第2階段的創業公司研究是一項隨機、雙盲安慰劑對照研究，旨在評估VK2735的安全性、耐受性、藥代動力學和減重療效，採用皮下注射，每週一次。爲期13周的研究將招募肥胖成年人（BMI ≥ 30 kg/m2）或超重成年人（BMI ≥ 27kg/m2），其至少患有一種與體重相關的共病控件。研究的主要終點是從基線到第13周的體重百分比變化，次要和探索性終點評估一系列額外的安全性和療效措施。2023年10月，我們宣佈了第2階段創業公司研究的患者入組工作已完成；2024年2月27日，我們宣佈，接受VK2735每週劑量的患者在13周後體重平均下降達到統計顯著水平，從基線下降達到高達14.7%。接受VK2735的患者相對安慰劑在體重平均下降也達到了統計顯著水平，降幅最高達到13.1%。根據美國食品藥品監督管理局（FDA）的書面反饋，我們計劃將VK2735的皮下製劑推進至第3階段發展。

2023年3月28日，我們宣佈啓動了評估VK2735新型口服制劑的I期臨床研究。該研究是我們最近完成的皮下注射VK2735I期評估的延伸，評估了爲期28天的每日口服劑量。2024年3月26日，我們宣佈28天MAD研究結果突顯口服VK2735治療後的臨床活性呈現出積極跡象。接受VK2735的隊列表現出基線體重的劑量依賴性減少，幅度高達約5.3%。根據這些I期結果，我們計劃在2024年晚些時候開始使用VK2735口服制劑進行肥胖症II期試驗。

我們最愛文思控股的臨床項目藥物候選VK2809是一種口服藥，組織和受體亞型選擇性激動劑，作用於甲狀腺激素受體β，或TRß。2019年11月，我們啓動了VOYAGE研究，進行了一項20億臨床試驗，VK2809在經組織活檢證實爲非酒精性脂肪肝炎的患者身上。

VOYAGE研究是一項隨機、雙盲、安慰劑對照、多中心試驗，旨在評估VK2809在經活檢證實爲MASH/NASH和纖維化範圍爲F1至F3階段患者中的療效、安全性和耐受性。該研究的主要終點將評估磁共振成像、質子密度脂肪分數或MRI-PDFF評估的肝脂含量相對變化，從基線到第12周，在接受VK2809治療的受試者中與安慰劑相比。二次目標包括評估在52周服藥後通過肝組織活檢評估的組織學變化。

2023年1月，我們宣佈完成了VOYAGE研究的患者招募，在2023年5月，我們報告稱VOYAGE研究成功達到了其主要終點，接受VK2809的患者在基線到第12周相比安慰劑，肝脂肪含量出現了統計學上顯著減少。

2024年6月，我們宣佈了VOYAGE研究52周組織學數據的積極結果，高達75%的接受VK2809治療的患者實現了MASH/NASH病變的緩解，其纖維化情況未惡化，而對照組僅爲29%（p=0.0001）。VK2809治療的患者中，達到纖維化≥1級改善，而MASH/NASH未惡化的患者高達57%，對照組僅爲34%（p<0.05）；達到MASH/NASH緩解以及纖維化≥1級改善的患者高達48%，對照組僅爲20%（p=0.01）。不良事件，包括胃腸相關的不良事件，在52周時VK2809治療患者與對照組相似，並與12週報道的先前數據吻合。

VK2809已在進行了8項完成的臨床研究中進行評估，共有400多名受試者參與。在這些完成的研究中，接受VK2809的受試者未觀察到嚴重不良事件（SAE），總體耐受性繼續令人鼓舞。此外，這種化合物還在爲期長達12個月的慢性毒性研究中進行了評估。

我們還在研製VK0214，它也是一種口服可用的、組織和受體次型選擇性TRß激動劑，用於X連鎖性腎上腺白質腦病，簡稱爲X-ALD，這是一種罕見的X連鎖遺傳性神經紊亂，特徵是大腦和神經細胞周圍保護屏障的破壞。該疾病尚無批准治療方法，由於ABCD1著名的長鏈脂肪酸過氧化物體運輸蛋白的突變導致。結果，轉運蛋白功能受損，患者無法有效代謝長鏈脂肪酸。已知TRß受體可以調節另一種長鏈脂肪酸運輸蛋白ABCD2的表達。各種臨床前模型表明，ABCD2表達增加可以導致長鏈脂肪酸代謝的正常化。初步數據表明，VK0214在體外模型中刺激ABCD2表達並在X-ALD的體內模型中降低了長鏈脂肪酸水平。

2021年6月，我們在X-ald患者中啓動了VK0214第十階段的10億臨床試驗。這項試驗是一項多中心、隨機、雙盲、安慰劑對照的研究，針對患有adrenomyeloneuropathy（AMN）型X-ald的成年男性患者。該研究招募了來自三個隊列的患者：安慰劑組、VK0214每日20毫克組和VK0214每日40毫克組。

該研究的主要目標是評估VK0214每日一次給藥在28天的給藥週期內的安全性和耐受性。次要目標包括評估該人群在28天給藥後VK0214的藥代動力學。探索性目標是評估VK0214對AMN患者血漿的長鏈脂肪酸或VLCFAs的影響。2024年10月，我們宣佈了第一，十億的臨床試驗結果，顯示VK0214在28天的研究期間每日一次給藥後是安全且耐受良好。此外，與安慰劑相比，血漿中VLCFAs和其他脂類的水平顯著降低。

其他臨床項目包括VK5211，一種口服的非甾體選擇性雄激素受體調節劑，或SARm。 2017年11月，我們宣佈了一項階段2的概念證明臨床試驗的積極頭號結果，該試驗涉及108名正在從非選擇性髖部骨折手術中恢復的患者。頂線數據顯示，與安慰劑相比，試驗達到了其主要終點，展示出在治療後，VK5211引起的瘦體重顯著、劑量依賴的增加。該研究還實現了某些次要終點，證明VK5211的所有劑量相對於安慰劑，均呈現出附肢瘦體重和總瘦體重的顯著增加。VK5211在這項研究中展現出令人鼓舞的安全性和耐受性，沒有報告與藥物相關的SAE。我們的意圖是在進行額外臨床研究之前，繼續尋求VK5211的合作伙伴關係或許可機會。

我們於2012年9月24日根據特拉華州的法律進行了公司註冊。自公司成立以來，我們將大部分精力投入於進行與VK2735、VK2809、VK0214、VK5211以及雙Amylin和鈣降鈣素受體激動劑項目相關的臨床試驗和臨床前研究，以及籌集資金和建設基礎設施。根據與ligand藥業公司簽訂的獨家許可協議，我們獲得了VK2809、VK0214和VK5211以及其他某些資產的全球獨家權利。此許可協議的條款詳見我們於2014年5月21日簽署並修訂的主許可協議。主許可協議的摘要。

許可協議可以在我們於2024年2月7日向證券交易委員會提交的10-k表格中「第I部分，第1項業務」，「與Ligand簽訂的協議-主許可協議」標題下找到。

截至目前，我們尚未產生任何營業收入。除非我們獲得監管批准並商業化我們的藥物候選品，或與第三方進入合作協議，否則我們不希望從我們開發的任何藥物候選品獲得任何收入。

在2023年12月31日結束的一年中，我們承擔了6380萬美元的研發費用，主要與進行VK2735第2期創業公司臨床試驗、VK2735第1期臨床試驗、VK2809第20億期 VOYAGE臨床試驗以及VK0214第10億期臨床試驗的努力相關。2024年9月30日結束的九個月中，我們承擔了7070萬美元的研發費用，主要與VK2735用於治療各種代謝紊亂的SAD和MAD臨床試驗的持續努力、爲皮下VK2735在肥胖症中進行第3期臨床試驗做準備的努力、結束VK2809第20億期VOYAGE臨床試驗的努力以及與結束VK0214在X-ald患者中的第10億臨床試驗相關的努力有關。我們預計我們持續的研發費用將包括用於開發我們藥物候選品的成本，包括但不限於：

進行必要的臨床研究以獲得監管批准的過程成本高昂且耗時且藥物候選品的成功開發高度不確定。我們未來的研發費用將取決於每個藥物候選品的臨床成功，以及對這些藥物候選品商業潛力的持續評估。此外，我們無法確定哪些藥物候選品可能會成爲未來合作的對象，這種安排何時將被確認（如果有的話），以及這種安排將如何影響我們的發展計劃和資本需求，我們無法準確預測。我們預計未來將增加研發費用，因爲我們繼續努力推進VK2735、VK2809和VK0214項目並尋求推進其他項目。

我們的一般及行政費用在過去一年中通常增加，因爲我們僱傭了額外的員工、發行了額外的股權獎勵，導致了增加的股權報酬支出，實施了某些系統以增加效率，併爲作爲上市公司運營相關的保險、法律和會計產生了額外費用。我們預計我們的一般及行政費用將繼續增加，以支持我們預期研發活動的增加，包括增加工資和其他相關費用、股權報酬以及執行、財務、會計和業務發展職能的諮詢費用。我們還預期一般及行政費用將因成爲上市公司而增加，包括與繼續遵守SEC和納斯達克交易所規則和法規相關的額外費用、額外的保險費用、投資者關係活動以及其他行政和專業服務。預計其他重要成本將包括與專利和公司事務相關的法律費用、未包括在研發費用中的設施費用，以及會計和其他諮詢服務的費用。

Other income (expense) includes interest income earned from our cash, cash equivalents and short-term investments.

Our management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments related to our preclinical, nonclinical and clinical development costs and drug manufacturing costs, which we consider to be critical accounting estimates. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Our significant accounting policies are more fully described in Note 1 and Note 3 to our consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

The following table summarizes our research and development expenses for the three months ended September 30, 2024 and 2023 (in thousands, except % change).

The increase in research and development expenses during the three months ended September 30, 2024 as compared to the same period in 2023 was primarily due to increased expenses related to manufacturing for our drug candidates, stock-based compensation, salaries and benefits and regulatory services, partially offset by decreased expenses related to preclinical studies and clinical studies.

The following table summarizes our general and administrative expenses for the three months ended September 30, 2024 and 2023 (in thousands, except % change).

The increase in general and administrative expenses during the three months ended September 30, 2024 as compared to the same period in 2023 was primarily due to increased expenses related to stock-based compensation, legal and patent services, services provided by third-party consultants and insurance.

The following table summarizes our other income (expense) for the three months ended September 30, 2024 and 2023 (in thousands, except % change).

2024年和2023年截至9月30日的其他收入（費用）主要包括利息收入，部分抵消了與某些融資成本攤銷相關的費用。

以下表格總結了截至2024年9月30日和2023年9月30日的九個月內我們的研發費用（以千爲單位，除%變動外）。

2024年9月30日結束的九個月內，與2023年同期相比，研發支出增加主要是由於與我們的藥物候選品、臨床研究、股票補償、臨床前研究和工資福利相關的製造業支出增加。

以下表格總結了截至2024年9月30日和2023年9月30日的九個月的一般和行政費用（以千計，除了%變動）。

2024年9月30日結束的九個月內，與2023年同期相比，一般和管理費用的增加主要是由於與股票補償、工資和福利、第三方顧問提供的服務以及保險相關的費用增加，部分抵消的是與法律和專利服務相關的費用減少。

以下表格總結了截至2024年9月30日和2023年9月30日之間的其他收入（費用）（以千爲單位，除%變動外）。

Other income (expense) recognized during the nine months ended September 30, 2024 and 2023 consisted primarily of interest income, partially offset by expense relating to the amortization of certain financing costs.

我們自成立以來虧損並現金流爲負，尚未實現任何收入。截至2024年9月30日，我們持有93040萬美元的現金、現金等價物和短期投資。因此，我們相信我們的現金、現金等價物和短期投資將足以資助我們的運營，至少到2025年12月31日，這是我們提交這份10-Q表格的日期後一年以上。

我們現金的主要用途是爲營業費用提供資金，這些費用到目前爲止主要包括從Ligand獲得知識產權許可的成本，與推動VK2735、VK2809、VK0214和VK5211進一步開發相關的某些研發費用，以及一般和行政費用。由於我們迄今爲止沒有產生任何收入，自公司成立以來我們一直出現營業虧損。用於支付營業費用的現金受這些費用支付時間的影響，在我們未付的應付賬款和應計費用的變化中反映。

2021年7月28日，我們與Stifel、Nicolaus及公司、Truist Securities公司和H.C. Wainwright及公司簽署了一份市場股權發行銷售協議，簡稱ATm協議，共同代理人，根據該協議，我們可以不時通過代理人或向代理人出售，作爲銷售代理或負責人，即ATm發行，發行總額爲12500萬美元的我們的普通股股票，簡稱ATm股份。在ATm發行中提供和出售的任何ATm股份均應根據2021年8月11日日期的424(b)招股說明書以及Form S-3（檔案編號爲333-258231）上的普適性Shelf註冊聲明，即2021年Shelf註冊聲明發行。自創立以來直到2021年7月到期的Shelf註冊聲明截止日期，我們的普通股股份中共計1,587,404股依照ATm發行進行出售，我方取得的淨收益約爲1360萬美元。

2023年4月3日，我們根據2021年備案註冊聲明完成了一項承銷的普通股公開發行，即2023年4月份的發行。在2023年4月份的發行中，我們以每股14.50美元的公開發行價出售了總計19,828,300股普通股，其中包括承銷商完全行使其購買額外2,586,300股普通股的選擇權。在2023年4月份發行結束時，我們獲得了總額爲2,8750萬美元的全部收益。

2022年3月10日，我們的董事會授權了一項股票回購計劃，即回購計劃，自2022年3月18日起生效，我們可以在長達兩年的時間內回購高達5000萬美元的普通股。回購計劃由我們的董事會委員會自行決定，通過公開市場購買、一個或多個根據第10b5-1條例制定的交易計劃、大宗交易以及私下協商的交易來執行。截至回購計劃的終止日期2024年3月18日，我們根據回購計劃回購了共計729,034股普通股。我們在回購計劃下回購的股票由我們持有並作爲2024年3月發行活動的一部分重新發行（如下文所定義）。

2023年7月26日，我們根據《證券法》修訂本的規定，作爲一家知名的成熟發行人，在S-3表格（文件編號333-273460）上提交了一份自動通用貨架註冊聲明，該聲明於提交時生效，即2023年貨架註冊聲明。2023年貨架註冊聲明允許我們隨時以2023年貨架註冊聲明中描述的方式提供不確定金額的證券，包括股票、債券、認股權證、權利、單位和存托股份。根據2023年貨架註冊聲明進行的任何發行的具體條款將在發行時確定。2023年貨架註冊聲明將於2026年7月26日到期。

2023年7月26日，我們與Stifel、Nicolaus ＆ Company, Incorporated、Truist Securities, Inc.、H.C. Wainwright ＆ Co. LLC 和 BTIG, LLC簽訂了《關於市場權益發行銷售協議的修正案1》，即ATm協議修正案。根據ATm協議修正案，將BTIG, LLC添加爲ATm發行的銷售代理，並對ATm協議進行修改，以便ATm發行可以在我們隨後提交的S-3表格註冊申報文件上進行。在ATm發行中提供和出售的任何ATm股票現在將根據2023年上市登記聲明和截至2023年7月26日的ATm發行相關的招售說明書發行，也就是被納入到2023年上市登記聲明中的ATm說明書中。2023年上市登記聲明將於2026年7月26日到期。自ATm說明書日期至2024年9月30日，我們的普通股已根據ATm發行出售了1,426,303股，截至2024年9月30日，我們可以根據ATm說明書不時出售我們的普通股，最高募集資金可達15190萬美元。

2024年3月4日，我們完成了一項根據2023年掛牌註冊聲明進行的常見股公開發行，即2024年3月發行。在2024年3月發行中，我們以每股85.00美元的公開發行價出售了共計7,441,650股普通股，其中包括承銷商全額行使其購買額外970,650股普通股的選擇權。在2024年3月發行結束時，我們收到了淨收益59710萬美元。

截至2024年9月30日的九個月內，資金運營活動中使用的5660萬美元主要反映了我們在該期間的淨損失，經調整後的非現金費用，如以股票爲基礎的薪酬、投資溢價攤銷、租賃資產攤銷、投資實現收益、融資成本攤銷以及與經營租賃負債相關的利息費用，以及有關工作資本帳戶的變動，主要包括應計費用和應計利息的增加，減去到期投資收到的利息淨額，部分抵消了應付賬款、預付費用和其他資產以及租賃負債的減少。

截至2023年9月30日的九個月內，運營活動中使用的現金爲5570萬美元，主要反映了我們在該期間的淨虧損，經調整後的非現金費用，如以股票爲基礎的補償、投資溢價攤銷、使用權資產攤銷、融資成本攤銷、以及與經營租賃負債相關的利息費用，以及工作資本帳戶的變動，這些主要包括應計利息的增加，減記投資到期收到的利息淨額，部分抵消了預付費用和其他資產的減少，以及應付賬款、應計費用和租賃負債的減少。

2024年9月30日結束的九個月內，投資活動中使用的現金爲56000萬美元，主要是由於購買投資97640萬美元，部分償付投資成熟收益41650萬美元。

During the nine months ended September 30, 2023, cash used in investing activities of $214.8 million resulted primarily from the purchase of investments of $380.8 million, partially offset by the proceeds of maturities of investments of $166.0 million.

During the nine months ended September 30, 2024, cash provided by financing activities was $611.5 million, which consisted primarily of proceeds from the issuance of common stock, net of discount, of $597.1 million in the March 2024 Offering, proceeds from certain option exercises and 2014 ESPP common stock issuance of $9.8 million and proceeds from the ATM Offering, net of fees, of $46.7 million, partially offset by value of shares withheld to cover taxes of $42.1 million.

During the nine months ended September 30, 2023, cash provided by financing activities was $271.2 million, which consisted primarily of proceeds from the issuance of common stock, net of discount, of $269.8 million in the April 2023 Offering, proceeds from certain option exercises and 2014 ESPP common stock issuance of $6.6 million and proceeds from the ATM Offering, net of fees of $2.0 million, partially offset by value of shares withheld to cover taxes of $7.1 million.

As of the date of this Quarterly Report on Form 10-Q and based upon our current operating plan, we believe that we have sufficient capital to fund our operating and capital requirements for at least the next 12 months. We anticipate, however, that we will continue to generate losses for the foreseeable future, and we expect the losses to increase materially as we continue the development of, and seek regulatory approvals for, our drug candidates, and seek to commercialize any drugs for which we receive regulatory approval. We will need to raise additional capital to fund our operations and complete our ongoing and planned clinical trials. We expect to finance future cash needs through public or private equity or debt offerings, however, funding may not be available to us on acceptable terms, or at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.

Our future capital requirements will depend on many factors, including, but not limited to:

As part of our investment portfolio, we own financial instruments that are sensitive to market risks. The investment portfolio is used to preserve our capital, provide adequate liquidity and earn returns commensurate with our risk appetite. We invest in instruments that meet the credit quality standards outlined in our investment policy, which also limits the amount of credit exposure to any one issue or type of instrument. These instruments principally include securities issued by the U.S. government and its agencies, investment-grade corporate bonds and commercial paper, and money market funds. These investments are denominated in U.S. Dollars and none are held for trading purposes.

All of our interest-bearing securities are subject to interest rate risk and could change in value if interest rates fluctuate. Substantially all of our investment portfolio consists of marketable securities with active secondary or resale markets to help ensure portfolio liquidity, and we have implemented guidelines limiting the term-to-maturity of our investment instruments. Since we account for these securities as available-for-sale, no gains or losses are realized due to changes in the fair value of our investments unless we sell our investments prior to maturity or incur a credit loss. Due to the conservative nature of these instruments, we do not believe that the fair value of our investments has a material exposure to interest rate risk.

While we are exposed to global interest rate fluctuations, our investment portfolio is most affected by fluctuations in U.S. interest rates, which affect the interest earned on our cash, cash equivalents and marketable securities. Interest income generated from the Company's cash, cash equivalents, and short-term investments – available-for-sale will vary with the general level of interest rates.

Based on the above balances at September 30, 2024, if short-term interest rates increased or decreased by 10%, or 46 basis points, for the remainder of the year, annual interest income, including interest earned on short-term investments – available-for-sale, would increase or decrease by approximately $1.4 million.

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in the reports we file or submit under the Securities Exchange Act of 1934, as amended, or the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Our disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports we file under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. As required by Rule 13a-15(b) or Rule 15d-15(b) promulgated by the SEC under the Exchange Act, we carried out an evaluation, under

the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on the foregoing, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Quarterly Report on Form 10-Q at the reasonable assurance level.

There has been no change in our internal control over financial reporting during the three months ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

From time to time, we may be party to lawsuits in the ordinary course of business. We are not presently a party to any legal proceedings, the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonably expected to have a material adverse effect on our business, operating results or financial condition.

In December 2022, we filed suit against Ascletis Bioscience Co., Ltd., Gannex Pharma Co., Ltd., Ascletis Pharmaceuticals Co., Ltd., Ascletis Pharma Inc., and Jinzi Jason Wu, or the Ascletis Defendants, in the Southern District of California, San Diego division, alleging, among other things: (1) violation of the Defend Trade Secrets Act; (2) violation of the California Uniform Trade Secrets Act; (3) breach of contract; (4) breach of the implied covenant of good faith and fair dealing; and (5) tortious interference with contract. In a related action, we also filed suit against the same Ascletis Defendants in the International Trade Commission, or the ITC, for unlawful and unfair methods of competition. These legal proceedings arise at least in part from the misappropriation of our trade secrets.

On October 3, 2024, the ITC’s Chief Administrative Law Judge issued a Notice of his determination in favor of Viking. The ruling states that Ascletis Defendants misappropriated our trade secrets while under a Confidential Disclosure Agreement (“CDA”) and engaged in discovery misconduct, warranting monetary and non-monetary sanctions. We plan to continue to vigorously pursue, as necessary, all of our legal remedies in these litigations, including through any appeals processes that the Ascletis Defendants may initiate.

Investing in our common stock involves a high degree of risk. You should consider carefully the risks and uncertainties described below, together with all of the other information in this Quarterly Report on Form 10-Q, before making a decision to invest in our common stock. The risks and uncertainties described below may not be the only ones we face. If any of the risks actually occur, our business, financial condition and results of operations could be materially and adversely affected. In that event, the trading price of our common stock could decline, and you could lose part or all of your investment.

Risk factors marked with an asterisk (*) below include a change from or an update to the risk factors included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 7, 2024.

Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Quarterly Report on Form 10-Q and our other filings with the SEC before making an investment decision regarding our common stock.

*We are a clinical-stage company, have a limited operating history and are expected to incur significant operating losses during the next stages of our corporate development.

We are a clinical-stage company. Since our incorporation in September 2012, our operations have been limited to raising capital, building infrastructure, obtaining the worldwide rights to certain technology from Ligand Pharmaceuticals Incorporated, or Ligand, and planning, preparing and conducting preclinical studies and clinical trials of our drug candidates, including VK2735 subcutaneous, VK2809, VK5211 and VK0612, which are currently in Phase 2 clinical development, VK2735, for which we continue to conduct an oral Phase 1 SAD/MAD clinical trial, and VK0214, for which we recently completed a Phase 1b clinical trial, as well as the diacylglycerol acyltransferase-1, or DGAT-1, erythropoietin receptor, or EPOR, and our dual amylin and calcitonin receptor agonist, or DACRA, programs, which are each currently in preclinical development. We have not yet demonstrated an ability to obtain marketing approval for any of our drug candidates or successfully overcome the risks and uncertainties frequently encountered by companies in the biopharmaceutical industry. We also have not generated any revenue to date, and we continue to incur significant research and development and other expenses. As of September 30, 2024, we had an accumulated deficit of $452.5 million. For the foreseeable future, we expect to continue to incur losses, which will increase significantly from historical levels as we expand our drug development activities, seek potential partnering opportunities and/or regulatory approvals for our drug candidates and begin to commercialize them if they are approved by the U.S. Food and Drug Administration, or the FDA, the European Medicines Agency, or EMA, or comparable foreign authorities. Even if we succeed in partnering or developing and commercializing one or more drug candidates, we may never become profitable. If we fail to achieve or maintain profitability, it would adversely affect the value of our common stock.

We are substantially dependent on technologies we licensed from Ligand Pharmaceuticals Incorporated, or Ligand, and if we lose the license to such technologies or our master license agreement with Ligand, or the Master License Agreement, is terminated for any reason, our ability to develop existing and new drug candidates would be harmed, and our business, financial condition and results of operations would be materially and adversely affected.

Our business is substantially dependent upon technology licensed from Ligand. Pursuant to the Master License Agreement, we have been granted exclusive worldwide rights to VK2809, VK0214, VK5211, VK0612 and preclinical programs for metabolic disorders and anemia. Selective androgen receptor modulators, such as the one used in our VK5211 program, are key compounds used by us in the development and commercialization of our drug candidates. Most of the intellectual property related to our drug candidates is currently owned by Ligand, and we have the rights to use such intellectual property pursuant to the Master License Agreement. Therefore, our ability to develop and commercialize our drug candidates depends entirely on the effectiveness and continuation of the Master License Agreement. If we lose the right to license any of these key compounds, our ability to develop existing and new drug candidates would be harmed.

Ligand has the right to terminate the Master License Agreement under certain circumstances, including, but not limited to: (1) in the event of our insolvency or bankruptcy, (2) if we do not pay an undisputed amount owing under the Master License Agreement when due and fail to cure such default within a specified period of time, or (3) if we default on certain of our material obligations and fail to cure the default within a specified period of time.

*We are dependent on the success of one or more of our current drug candidates and we cannot be certain that any of them will receive regulatory approval or be commercialized.

We have spent significant time, money and effort on the licensing and development of our core metabolic and endocrine disease assets, VK2735, VK2809, VK0214, VK5211, VK0612 and our earlier-stage assets, our DGAT-1, EPOR and DACRA programs. To date, no pivotal clinical trials designed to provide clinically and statistically significant proof of efficacy, or to provide sufficient

evidence of safety to justify approval, have been completed with any of our drug candidates. All of our drug candidates will require additional development, including clinical trials as well as further preclinical studies to evaluate their toxicology, carcinogenicity and pharmacokinetics and optimize their formulation, and regulatory clearances before they can be commercialized. Positive results obtained during early development do not necessarily mean later development will succeed or that regulatory clearances will be obtained. Our drug development efforts may not lead to commercial drugs, either because our drug candidates fail to be safe and effective or because we have inadequate financial or other resources to advance our drug candidates through the clinical development and approval processes. If any of our drug candidates fail to demonstrate safety or efficacy at any time or during any phase of development, we would experience potentially significant delays in, or be required to abandon, development of the drug candidate.

We do not anticipate that any of our current drug candidates will be eligible to receive regulatory approval from the FDA, EMA or comparable foreign authorities and begin commercialization for a number of years, if ever. Even if we ultimately receive regulatory approval for any of these drug candidates, we or our potential future partners, if any, may be unable to commercialize them successfully for a variety of reasons. These include, for example, the availability of alternative treatments, lack of cost-effectiveness, the cost of manufacturing the product on a commercial scale and competition with other drugs. The success of our drug candidates may also be limited by the prevalence and severity of any adverse side effects. If we fail to commercialize one or more of our current drug candidates, we may be unable to generate sufficient revenues to attain or maintain profitability, and our financial condition and stock price may decline.

*If development of our drug candidates does not produce favorable results, we and our collaborators, if any, may be unable to commercialize these products.

To receive regulatory approval for the commercialization of our core metabolic and endocrine disease assets, VK2735, VK2809, VK0214, VK5211, VK0612 and our earlier-stage assets, our DGAT-1. EPOR and DACRA programs, or any other drug candidates that we may develop, adequate and well-controlled clinical trials must be conducted to demonstrate safety and efficacy in humans to the satisfaction of the FDA, EMA and comparable foreign authorities. In order to support marketing approval, these agencies typically require successful results in one or more Phase 3 clinical trials, which our current drug candidates have not yet reached and may never reach. The development process is expensive, can take many years and has an uncertain outcome. Failure can occur at any stage of the process. We may experience numerous unforeseen events during, or as a result of, the development process that could delay or prevent commercialization of our current or future drug candidates, including the following:

Success in early development does not mean that later development will be successful because, for example, drug candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy despite having progressed through initial clinical trials.

In February 2024, we reported positive top-line results from the VENTURE Phase 2 clinical trial for VK2735 in patients with obesity. In May 2023, we reported positive top-line results from the VOYAGE Phase 2b clinical trial for VK2809 and in June 2024, we announced positive 52-week histologic data from the VOYAGE study. In late 2017, we reported positive top-line results from a Phase 2 clinical trial for VK5211. In October 2024, we reported positive data from our Phase 1b clinical trial of VK0214 in patients with X-ALD. However, there is no guarantee that the results of our Phase 2 clinical trials for VK2735 or VK2809 or our Phase 1b clinical trial for VK2014 will be repeated for our other drug candidates or lead to other positive outcomes. As a company, we have conducted only a limited number of clinical trials and preclinical studies for our drug candidates. Therefore, we have limited experience in conducting clinical trials for our drug candidates. Since our experience with our drug candidates is limited, we will need to train our existing personnel and hire additional personnel in order to successfully administer and manage our clinical trials and other studies as planned, which may result in delays in completing such planned clinical trials and preclinical studies. Moreover, to date, our drug candidates have been tested in less than the number of patients that will likely need to be studied to obtain regulatory approval. The data collected

from clinical trials with larger patient populations may not demonstrate sufficient safety and efficacy to support regulatory approval of these drug candidates.

We currently do not have strategic collaborations in place for clinical development of any of our current drug candidates. Therefore, in the future, we or any potential future collaborative partner will be responsible for establishing the targeted endpoints and goals for development of our drug candidates. These targeted endpoints and goals may be inadequate to demonstrate the safety and efficacy levels required for regulatory approvals. Even if we believe data collected during the development of our drug candidates are promising, such data may not be sufficient to support marketing approval by the FDA, EMA or comparable foreign authorities. Further, data generated during development can be interpreted in different ways, and the FDA, EMA or comparable foreign authorities may interpret such data in different ways than us or our collaborators. Our failure to adequately demonstrate the safety and efficacy of our drug candidates would prevent our receipt of regulatory approval, and ultimately the potential commercialization of these drug candidates.

Since we do not currently possess the resources necessary to independently develop and commercialize the majority of our drug candidates, we may seek to enter into collaborative agreements to assist in the development and potential future commercialization of some or all of these assets as a component of our strategic plan. However, our discussions with potential collaborators may not lead to the establishment of collaborations on acceptable terms, if at all, or it may take longer than expected to establish new collaborations, leading to development and potential commercialization delays, which would adversely affect our business, financial condition and results of operations.

We expect to continue to incur significant research and development expenses, which may make it difficult for us to attain profitability.

We expect to expend substantial funds in research and development, including preclinical studies and clinical trials of our drug candidates, and to manufacture and market any drug candidates in the event they are approved for commercial sale. We also may need additional funding to develop or acquire complementary companies, technologies and assets, as well as for working capital requirements and other operating and general corporate purposes. Moreover, our planned increases in staffing will dramatically increase our costs in the near and long-term.

However, our spending on current and future research and development programs and drug candidates for specific indications may not yield any commercially viable products. Due to our limited financial and managerial resources, we must focus on a limited number of research programs and drug candidates and on specific indications. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.

Because the successful development of our drug candidates is uncertain, we are unable to precisely estimate the actual funds we will require to develop and potentially commercialize them. In addition, we may not be able to generate sufficient revenue, even if we are able to commercialize any of our drug candidates, to become profitable.

*Given our lack of current cash inflows, it is expected that we may need to raise additional capital; however, it may be unavailable to us or, even if capital is obtained, may cause dilution or place significant restrictions on our ability to operate our business.

Since we will be unable to generate sufficient, if any, cash inflows to fund our operations for the foreseeable future, we may need to seek additional equity or debt financing to provide the capital required to maintain or expand our operations. As of September 30, 2024, we had cash, cash equivalents and investments totaling $930.4 million. There can be no assurance that we will be able to raise sufficient additional capital on acceptable terms or at all. If such additional financing is not available on satisfactory terms, or is not available in sufficient amounts, we may be required to delay, limit or eliminate the development of business opportunities and our ability to achieve our business objectives, our competitiveness, and our business, financial condition and results of operations may be materially adversely affected. In addition, we may be required to grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves. Our inability to fund our business could lead to the loss of your investment. Our future capital requirements will depend on many factors, including, but not limited to:

On July 26, 2023, we filed an automatic universal shelf registration statement on Form S-3 (File No. 333-273460) with the SEC as a well-known seasoned issuer as defined in Rule 405 under the Securities Act of 1933, as amended, which became effective upon filing, or the 2023 Shelf Registration Statement. The 2023 Shelf Registration Statement allows us to offer an indeterminate amount of securities, including equity securities, debt securities, warrants, rights, units and depositary shares, from time to time as described in the 2023 Shelf Registration Statement. The specific terms of any offering under the 2023 Shelf Registration Statement will be established at the time of such offering under a separate prospectus supplement, which will be filed with the SEC at the time of any offering. The 2023 Shelf Registration Statement will expire on July 26, 2026.

The 2023 Shelf Registration Statement includes a prospectus, or the ATM Prospectus, pursuant to which we may offer and sell, from time to time, through or to Stifel, Nicolaus & Company, Incorporated, Truist Securities, Inc., H.C. Wainwright & Co. LLC and BTIG, LLC, or, collectively, the ATM Agents, as sales agent(s) or principal(s), shares of our common stock having an aggregate offering price of up to $200.0 million, or the ATM Offering. Any shares offering and sold in ATM Offering will be issued pursuant to the ATM Prospectus and the At-The-Market Equity Offering Sales Agreement, dated July 28, 2021, as amended on July 26, 2023, among us and the ATM Agents. As of September 30, 2024, we may sell shares of our common stock for remaining gross proceeds of up to $151.9 million from time to time pursuant to the ATM Prospectus.

On March 4, 2024, we completed an underwritten public offering of our common stock, or the March 2024 Offering, pursuant to the 2023 Shelf Registration Statement. In the March 2024 Offering, we sold an aggregate of 7,441,650 shares of our common stock at a public offering price of $85.00 per share, which included the exercise in full by the underwriters of their option to purchase 970,650 additional shares of common stock. Upon the closing of the March 2024 Offering, we received net proceeds of $597.1 million, after deducting underwriting discounts, commissions and other offering expenses.

If we raise additional capital by issuing equity securities, the percentage ownership of our existing stockholders may be reduced, and accordingly these stockholders may experience substantial dilution. We may also issue equity securities that provide for rights, preferences and privileges senior to those of our common stock. Given our need for cash and that equity issuances are the most common type of fundraising for companies like ours, the risk of dilution is particularly significant for stockholders of our company.

Our drug candidates may cause undesirable side effects that could delay or prevent their regulatory approval or commercialization or have other significant adverse implications on our business, financial condition and results of operations.

Undesirable side effects observed in clinical trials or in supportive preclinical studies with our drug candidates could interrupt, delay or halt their development and could result in the denial of regulatory approval by the FDA, EMA or comparable foreign authorities for any or all targeted indications or adversely affect the marketability of any such drug candidates that receive regulatory approval. In turn, this could eliminate or limit our ability to commercialize our drug candidates.

Our drug candidates may exhibit adverse effects in preclinical toxicology studies and adverse interactions with other drugs. There are also risks associated with additional requirements the FDA, EMA or comparable foreign authorities may impose for marketing approval with regard to a particular disease.

Our drug candidates may require a risk management program that could include patient and healthcare provider education, usage guidelines, appropriate promotional activities, a post-marketing observational study, and ongoing safety and reporting mechanisms, among other requirements. Prescribing could be limited to physician specialists or physicians trained in the use of the drug, or could be limited to a more restricted patient population. Any risk management program required for approval of our drug candidates could potentially have an adverse effect on our business, financial condition and results of operations.

Undesirable side effects involving our drug candidates may have other significant adverse implications on our business, financial condition and results of operations. For example:

In addition, if any of our drug candidates receive marketing approval and we or others later identify undesirable side effects caused by the product:

Any of these events could prevent us from achieving or maintaining market acceptance of the affected product and could substantially increase the costs and expenses of commercializing the product, which in turn could delay or prevent us from generating significant revenues from the sale of the product.

Our efforts to discover drug candidates beyond our current drug candidates may not succeed, and any drug candidates we recommend for clinical development may not actually begin clinical trials.

We intend to continue to use our technology, including our licensed technology, knowledge and expertise to develop novel drugs to address some of the world’s most widespread and costly chronic diseases. We intend to expand our existing pipeline of core assets by advancing drug compounds from current ongoing discovery programs into clinical development. However, the process of researching and discovering drug compounds is expensive, time-consuming and unpredictable. Data from our current preclinical programs may not support the clinical development of our lead compounds or other compounds from these programs, and we may not identify any additional drug compounds suitable for recommendation for clinical development. Moreover, any drug compounds we recommend for clinical development may not demonstrate, through preclinical studies, indications of safety and potential efficacy that would support advancement into clinical trials. Such findings would potentially impede our ability to maintain or expand our clinical development pipeline. Our ability to identify new drug compounds and advance them into clinical development also depends upon our ability to fund our research and development operations, and we cannot be certain that additional funding will be available on acceptable terms, or at all.

We may expend our limited resources to pursue a specific product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Because we have limited financial and managerial resources, we must focus on a limited number of research programs and product candidates and on specific indications. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future discovery and preclinical development programs and product candidates for specific indications may not yield any commercially viable products. In addition, our projections of both the number of people who have the targeted indications, as well as the subset of people with these disorders who have the potential to benefit from treatment with our product candidates, are based on estimates. If any of our estimates are inaccurate, the market opportunities for any of our product candidates could be significantly diminished and have an adverse material impact on our business. Additionally, the potentially addressable patient population for our product candidates may be limited, or may not be amenable to treatment with our product candidates.

Delays in the commencement or completion of clinical trials could result in increased costs to us and delay our ability to establish strategic collaborations.

Delays in the commencement or completion of clinical trials could significantly impact our drug development costs. We do not know whether planned clinical trials will begin on time or be completed on schedule, if at all. The commencement of clinical trials can be delayed for a variety of reasons, including, but not limited to, delays related to:

In addition, once a clinical trial has begun, it may be suspended or terminated by us, our collaborators, the institutional review boards or data safety monitoring boards charged with overseeing our clinical trials, the FDA, EMA or comparable foreign authorities due to a number of factors, including:

If we experience delays in the completion or termination of any clinical trial of our product candidates, the commercial prospects of our product candidates will be harmed, and our ability to commence product sales and generate product revenues from any of our product candidates will be delayed. In addition, any delays in completing our clinical trials will increase our costs and slow down our product candidate development and approval process. Delays in completing our clinical trials could also allow our competitors to obtain marketing approval before we do or shorten the patent protection period during which we may have the exclusive right to commercialize our product candidates. Any of these occurrences may harm our business, financial condition and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

Results of earlier clinical trials may not be predictive of the results of later-stage clinical trials.

The results of preclinical studies and early clinical trials of product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy results despite having progressed through preclinical studies and initial clinical trials. Many companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to adverse safety profiles or lack of efficacy, notwithstanding promising results in earlier studies. Similarly, our future clinical trial results may not be successful for these or other reasons.

This drug candidate development risk is heightened by any changes in the planned clinical trials compared to the completed clinical trials. As product candidates are developed through preclinical to early to late stage clinical trials towards approval and commercialization, it is customary that various aspects of the development program, such as manufacturing and methods of administration, are altered along the way in an effort to optimize processes and results. While these types of changes are common and

are intended to optimize the product candidates for late stage clinical trials, approval and commercialization, such changes carry the risk that they will not achieve these intended objectives.

Any of these changes could make the results of our planned clinical trials or other future clinical trials we may initiate less predictable and could cause our product candidates to perform differently, including causing toxicities, which could delay completion of our clinical trials, delay approval of our product candidates and/or jeopardize our ability to commence product sales and generate revenues.

If we experience delays in the enrollment of patients in our clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.

We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or other regulatory authorities. Patient enrollment, a significant factor in the timing of clinical trials, is affected by many factors, including the size and nature of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the design of the clinical trial, competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating. For example, the COVID-19 pandemic previously negatively impacted our ability to recruit and enroll patients for our clinical trials, as they may have been reluctant or unable to visit clinical sites, or may have delayed seeking treatment for chronic conditions.

If we fail to enroll and maintain the number of patients for which the clinical trial was designed, the statistical power of that clinical trial may be reduced, which would make it harder to demonstrate that the product candidate being tested in such clinical trial is safe and effective. Additionally, enrollment delays in our clinical trials may result in increased development costs for our product candidates, which would cause the value of our company to decline and limit our ability to obtain additional financing. Our inability to enroll a sufficient number of patients for any of our current or future clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether.

We intend to rely on third parties to conduct our preclinical studies and clinical trials and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines, or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our drug candidates and our business, financial condition and results of operations could be substantially harmed.

We have relied upon and plan to continue to rely upon third-party CROs, medical institutions, clinical investigators and contract laboratories to monitor and manage data for our licensed ongoing preclinical and clinical programs. Nevertheless, we maintain responsibility for ensuring that each of our clinical trials and preclinical studies is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards and our reliance on these third parties does not relieve us of our regulatory responsibilities. We and our CROs and other vendors are required to comply with current requirements on good manufacturing practices, or cGMP, good clinical practices, or GCP, and good laboratory practice, or GLP, which are a collection of laws and regulations enforced by the FDA, EMA or comparable foreign authorities for all of our drug candidates in clinical development. Regulatory authorities enforce these regulations through periodic inspections of preclinical study and clinical trial sponsors, principal investigators, preclinical study and clinical trial sites, and other contractors. If we or any of our CROs or vendors fail to comply with applicable regulations, the data generated in our preclinical studies and clinical trials may be deemed unreliable and the FDA, EMA or comparable foreign authorities may require us to perform additional preclinical studies and clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP regulations. In addition, our clinical trials must be conducted with products produced consistent with cGMP regulations. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the development and regulatory approval processes.

If any of our relationships with these third-party CROs, medical institutions, clinical investigators or contract laboratories terminate, we may not be able to enter into arrangements with alternative CROs on commercially reasonable terms, or at all. In addition, our CROs are not our employees, and except for remedies available to us under our agreements with such CROs, we cannot control whether or not they devote sufficient time and resources to our ongoing preclinical and clinical programs. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our protocols, regulatory requirements, or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our drug candidates. CROs may also generate higher costs than anticipated. As a result, our business, financial condition, results of operations and the commercial prospects for our drug candidates could be materially and adversely affected, our costs could increase and our ability to generate revenue could be delayed.

Switching or adding additional CROs, medical institutions, clinical investigators or contract laboratories involves additional cost and requires management’s time and focus. In addition, there is a natural transition period when a new CRO commences work replacing a

previous CRO. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse effect on our business, financial condition or results of operations.

In addition, our CROs may need to make certain adjustments to the operation of our trials in an effort to ensure the monitoring and safety of patients and minimize risks to trial integrity during the pandemic in accordance with the guidance issued by the FDA on March 18, 2020 and generally, and may need to make further adjustments in the future. Many of these adjustments are new and untested, may not be effective, and may have unforeseen effects on the enrollment, progress and completion of these trials and the findings from these trials.

Our drug candidates are subject to extensive regulation under the FDA, EMA or comparable foreign authorities, which can be costly and time consuming, cause unanticipated delays or prevent the receipt of the required approvals to commercialize our drug candidates.

The clinical development, manufacturing, labeling, storage, record-keeping, advertising, promotion, export, marketing and distribution of our drug candidates are subject to extensive regulation by the FDA and other U.S. regulatory agencies, EMA or comparable authorities in foreign markets. In the U.S., neither we nor our collaborators are permitted to market our drug candidates until we or our collaborators receive approval of a new drug application, or an NDA, from the FDA or receive similar approvals abroad. The process of obtaining these approvals is expensive, often takes many years, and can vary substantially based upon the type, complexity and novelty of the drug candidates involved. Approval policies or regulations may change and may be influenced by the results of other similar or competitive products, making it more difficult for us to achieve such approval in a timely manner or at all. For example, the FDA has released draft guidance regarding clinical trials for drug candidates treating diabetes that may result in more stringent requirements for the clinical trials and regulatory approval of such drug candidates. This and any future guidance that may result from recent FDA advisory panel discussions on the topic of diabetes, non-alcoholic steatohepatitis, or MASH/NASH, and other metabolic indications, may make it more expensive to develop and commercialize such drug candidates for such indications. Such increased expense could make it more difficult to obtain favorable terms in the collaborative arrangements we require to maximize the value of our programs seeking to develop new drug candidates for diabetes. In addition, as a company, we have not previously filed NDAs with the FDA or filed similar applications with other foreign regulatory agencies. This lack of experience may impede our ability to obtain FDA or other foreign regulatory agency approval in a timely manner, if at all, for our drug candidates for which development and commercialization is our responsibility.

Despite the time and expense invested, regulatory approval is never guaranteed. The FDA, EMA or comparable foreign authorities can delay, limit or deny approval of a drug candidate for many reasons, including:

Our inability to obtain these approvals would prevent us from commercializing our drug candidates.

Even if our drug candidates receive regulatory approval in the U.S., we may never receive approval or commercialize our products outside of the U.S.

In order to market any products outside of the U.S., we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy. Approval procedures vary among countries and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries might differ from that required to obtain FDA approval. The regulatory approval process in other countries may include all of the risks detailed above regarding FDA approval in the U.S. as well as other risks. Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in others. Failure to obtain regulatory approval in other countries or any delay seeking or obtaining such approval would impair our ability to develop foreign markets for our drug candidates.

Even if any of our drug candidates receive regulatory approval, our drug candidates may still face future development and regulatory difficulties.

If any of our drug candidates receive regulatory approval, the FDA, EMA or comparable foreign authorities may still impose significant restrictions on the indicated uses or marketing of the drug candidates or impose ongoing requirements for potentially costly post-approval studies and trials. In addition, regulatory agencies subject a product, its manufacturer and the manufacturer’s facilities to continual review and periodic inspections. If a regulatory agency discovers previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, our collaborators or us, including requiring withdrawal of the product from the market. Our drug candidates will also be subject to ongoing FDA, EMA or comparable foreign authorities’ requirements for the labeling, packaging, storage, advertising, promotion, record-keeping and submission of safety and other post-market information on the drug. If our drug candidates fail to comply with applicable regulatory requirements, a regulatory agency may:

The FDA, EMA and comparable foreign authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses.

The FDA, EMA and comparable foreign authorities strictly regulate the promotional claims that may be made about prescription products, such as our drug candidates, if approved. In particular, a product may not be promoted for uses that are not approved by the FDA, EMA or comparable foreign authorities as reflected in the product’s approved labeling. If we receive marketing approval for our drug candidates for our proposed indications, physicians may nevertheless use our products for their patients in a manner that is inconsistent with the approved label, if the physicians personally believe in their professional medical judgment that our products could be used in such manner. However, if we are found to have promoted our products for any off-label uses, the federal government could levy civil, criminal or administrative penalties, and seek fines against us. Such enforcement has become more common in the industry. The FDA, EMA or comparable foreign authorities could also request that we enter into a consent decree or a corporate integrity agreement or seek a permanent injunction against us under which specified promotional conduct is monitored, changed or curtailed. If we cannot successfully manage the promotion of our drug candidates, if approved, we could become subject to significant liability, which would materially adversely affect our business, financial condition and results of operations.

*If our competitors have drug candidates that are approved faster, are marketed more effectively, are better tolerated, have a more favorable safety profile or are demonstrated to be more effective than ours, our commercial opportunity may be reduced or eliminated.

The biopharmaceutical industry is characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. While we believe that our technology, knowledge, experience and scientific resources provide us with competitive advantages, we face potential competition from many different sources, including commercial biopharmaceutical enterprises, academic institutions, government agencies and private and public research institutions. Any drug candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future.

Many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical studies, clinical trials, regulatory approvals and marketing approved products than we do. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. Our competitors may succeed in developing technologies and therapies that are more effective, better tolerated or less costly than any which we are developing, or that would render our drug candidates obsolete and noncompetitive. Even if we obtain regulatory approval for any of our drug candidates, our competitors may succeed in obtaining regulatory approvals for their products earlier than we do. We will also face competition from these third parties in recruiting and retaining qualified scientific and management

personnel, in establishing clinical trial sites and patient registration for clinical trials, and in acquiring and in-licensing technologies and products complementary to our programs or advantageous to our business.

The key competitive factors affecting the success of each of our drug candidates, if approved, are likely to be its efficacy, safety, tolerability, frequency and route of administration, convenience and price, the level of branded and generic competition and the availability of coverage and reimbursement from government and other third-party payors.

VK2735, if approved, will compete against therapies that are already approved and marketed for obesity, including Semaglutide (Wegovy®) and liraglutide (Saxenda®) from Novo Nordisk A/S, and tirzepatide (Zepbound™) from Eli Lilly and Company. We are also aware of several programs targeting obesity that are in the late development stage that will compete against VK2735, if approved, including CagriSema from Novo Nordisk A/S, orforglipron and retatrutide from Eli Lilly and Company, and survodutide (BI 456906) from Boehringer Ingelheim International GmbH. In addition, we are aware of active programs at Altimmune, Inc., Amgen Inc., AstraZeneca, BioAge Labs, Inc., Biophytis SA, D&D Pharmatech, Inc., ERX Pharmaceuticals Inc., F. Hoffmann-La Roche Ltd, Gubra, Hanmi Pharmaceutical Co., Ltd., Kailera Therapeutics Inc., Kallyope Inc., Metsera, Inc., Pfizer Inc., Regeneron Pharmaceuticals Inc., Rivus Pharmaceuticals Inc., Scholar Rock, Inc., Structure Therapeutics Inc., Terns Pharmaceuticals, Inc., Ventyx Biosciences, Inc., and Zealand Pharma A/S.

Resmetirom (Rezdiffra™), another agonist of the thyroid hormone receptor beta, or TRß, from Madrigal Pharmaceuticals, Inc., is the only therapy currently approved in the U.S. for the treatment of non-alcoholic steatohepatitis. In addition, we are aware of numerous development-stage programs targeting this disease, including arachidyl amido cholanoic acid from Galmed Pharmaceuticals Ltd., belapectin from Galectin Therapeutics Inc., lanifibranor from Inventiva S.A., semaglutide from Novo Nordisk A/S, efruxifermin (AKR-001) from Akero Therapeutics, Inc., firsocostat (GS-0976) and cilofexor (GS-9674) from Gilead Sciences, Inc., tirzepatide from Eli Lilly and Company, ervogastat (PF-06865571) and clesacostat (PF-05221304) from Pfizer Inc., pegozafermin (BIO89-100) from 89bio, Inc., denifanstat (TVB-2640) from Sagimet Biosciences Inc., efocipegtrutide (HM15211) from Hanmi Pharmaceutical Co., Ltd., survodutide (BI 456906) from Boehringer Ingelheim International GmbH, ION224 from Ionis Pharmaceuticals, Inc., rencofilstat (CRV431) from Hepion Pharmaceuticals, Inc., HTD1801 from HighTide Therapeutics Inc., GSK4532990 (ARO-HSD) from GlaxoSmithKline plc., ALN-HSD from Alnylam Pharmaceuticals, Inc./ Regeneron Pharmaceuticals Inc., efinopegdutide (MK-6024) from Merck & Co., Inc., and pemvidutide (ALT-801) from Altimmune, Inc. In addition, we are aware of active programs at Aligos Therapeutics, Inc., Arrowhead Pharmaceuticals, Inc., Ascletis Biopharmaceutical, AstraZeneca PLC, Boston Pharmaceuticals Inc.., ChemomAb Ltd., CohBar, Inc., Corcept Therapeutics Inc., CytoDyn Inc., D&D Pharmatech, Inc., Durect Corporation, Enyo Pharma SA, Inc., Future Medicine Co., Ltd., Galecto, Inc., Hepagene Therapeutics, Inc., Kowa Company, Ltd., MediciNova Inc., NorthSea Therapeutics BV, Poxel SA, Rivus Pharmaceuticals Inc., Seal Rock Therapeutics, Inc., Theratechnologies Inc., Yuhan Corporation, and Cadila Healthcare Limited (a.k.a. Zydus Cadila).

In the U.S., there are currently no marketed therapies for the treatment of X-ALD. Hematopoietic stem cell therapy has been used to treat the most severe form of X-ALD, cerebral adrenoleukodystrophy, or CALD. More recently, gene therapy has been shown to be effective in CALD, and elivaldogene autotemcel from bluebird bio, Inc., has received accelerated approval by the FDA (to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active CALD), and approval by the European Commission (for patients less than 18 years of age with early CALD without a matched sibling donor). However, both treatments are invasive, requiring surgical intervention, and these do not appear to have an effect on the most pervasive form of X-ALD, adrenomyeloneuropathy, or AMN. There are several experimental therapies that are in various stages of clinical development for X-ALD by companies, including Minoryx Therapeutics S.L., Neuraxpharm Group, Poxel SA, and Spur Therapeutics, Inc., which may be competitive with VK0214, if approved.

In the U.S., there are currently no marketed therapies for the maintenance or improvement of lean body mass, bone mineral density or physical function in patients recovering from non-elective hip fracture surgery. However, VK5211, if approved, will face competition from experimental therapies that are in various stages of clinical development for conditions characterized by muscle wasting by companies including Biophytis SA, MyMD Pharmaceuticals, Inc., and Pluri Inc. (formerly Pluristem Therapeutics Inc.). In addition, nutritional and growth hormone-based therapies are sometimes used in patients experiencing muscle wasting.

We, or any future collaborators, may not be able to obtain orphan drug designation or orphan drug exclusivity for our product candidates.

Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States. While we received orphan drug designation from the FDA for VK0214 for the treatment X-ALD in December 2016, we, or any future collaborators, may not be granted orphan drug designations for our product candidates in the U.S. or in other jurisdictions.

Even if we, or any future collaborators, obtain orphan drug designation for a product candidate, we, or they, may not be able to obtain orphan drug exclusivity for that product candidate. Generally, a product with orphan drug designation only becomes entitled to orphan drug exclusivity if it receives the first marketing approval for the indication for which it has such designation, in which case the FDA or the EMA will be precluded from approving another marketing application for the same drug for that indication for the applicable exclusivity period. The applicable exclusivity period is seven years in the United States and ten years in Europe. The European exclusivity period can be reduced to six years if a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified. Orphan drug exclusivity may be lost if the FDA or the EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.

Even if we, or any future collaborators, obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because FDA has taken the position that, under certain circumstances, another drug with the same active moiety can be approved for the same condition. Specifically, the FDA’s regulations provide that it can approve another drug with the same active moiety for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.

We are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our drug candidates.

The process of manufacturing our drug candidates is complex, highly regulated and subject to several risks. For example, the process of manufacturing our drug candidates is extremely susceptible to product loss due to contamination, equipment failure or improper installation or operation of equipment, or vendor or operator error. Even minor deviations from normal manufacturing processes for any of our drug candidates could result in reduced production yields, product defects and other supply disruptions. If microbial, viral, or other contaminations are discovered in our drug candidates or in the manufacturing facilities in which our drug candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. In addition, the manufacturing facilities in which our drug candidates are made could be adversely affected by equipment failures, labor shortages, natural disasters, epidemics, pandemics, power failures and numerous other factors.

In addition, any adverse developments affecting manufacturing operations of our drug candidates may result in shipment delays, inventory shortages, lot failures, withdrawals or recalls, or other interruptions in the supply of our drug candidates. We also may need to take inventory write-offs and incur other charges and expenses for drug candidates that fail to meet specifications, undertake costly remediation efforts, or seek costlier manufacturing alternatives.

We rely completely on third parties to manufacture our preclinical and clinical drug supplies, and our business, financial condition and results of operations could be harmed if those third parties fail to provide us with sufficient quantities of drug product, or fail to do so at acceptable quality levels or prices.

We do not currently have, nor do we plan to acquire, the infrastructure or capability internally to manufacture our preclinical and clinical drug supplies for use in our clinical trials, and we lack the resources and the capability to manufacture any of our drug candidates on a clinical or commercial scale. We rely on our manufacturers to purchase from third-party suppliers the materials necessary to produce our drug candidates for our clinical trials. There are a limited number of suppliers for raw materials that we use to manufacture our drugs, and there may be a need to identify alternate suppliers to prevent a possible disruption of the manufacture of the materials necessary to produce our drug candidates for our clinical trials, and, if approved, ultimately for commercial sale. We do not have any control over the process or timing of the acquisition of these raw materials by our manufacturers. Although we generally do not begin a clinical trial unless we believe we have a sufficient supply of a drug candidate to complete such clinical trial, any significant delay or discontinuity in the supply of a drug candidate, or the raw material components thereof, for an ongoing clinical trial due to the need to replace a third-party manufacturer could considerably delay completion of our clinical trials, product testing and potential regulatory approval of our drug candidates, which could harm our business, financial condition and results of operations.

We and our contract manufacturers are subject to significant regulation with respect to manufacturing our drug candidates. The manufacturing facilities on which we rely may not continue to meet regulatory requirements.

All entities involved in the preparation of therapeutics for clinical trials or commercial sale, including our existing contract manufacturers for our drug candidates, are subject to extensive regulation. Components of a finished therapeutic product approved for commercial sale or used in late-stage clinical trials must be manufactured in accordance with cGMP. These regulations govern manufacturing processes and procedures and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale. Poor control of production processes can lead to the introduction of contaminants or to inadvertent changes in the properties or stability of our drug candidates that may not be detectable in final product testing. We or our contract manufacturers must supply all necessary documentation in support of an NDA or marketing authorization application, or MAA, on a timely basis and must adhere to GLP and cGMP regulations enforced by the FDA, EMA or comparable foreign authorities through their facilities inspection program. Some of our contract manufacturers may not have produced a commercially approved pharmaceutical product and therefore may not have obtained the requisite regulatory authority approvals to do so. The facilities and quality systems of some or all of our third-party contractors must pass a pre-approval inspection for compliance with the applicable regulations as a condition of regulatory approval of our drug candidates or any of our other potential products. In addition, the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of our drug candidates or any of our other potential products or the associated quality systems for compliance with the regulations applicable to the activities being conducted. Although we oversee the contract manufacturers, we cannot control the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with the regulatory requirements. If these facilities do not pass a pre-approval plant inspection, regulatory approval of the products may not be granted or may be substantially delayed until any violations are corrected to the satisfaction of the regulatory authority, if ever.

The regulatory authorities also may, at any time following approval of a product for sale, audit the manufacturing facilities of our third-party contractors. If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of our product specifications or applicable regulations occurs independent of such an inspection or audit, we or the relevant regulatory authority may require remedial measures that may be costly or time consuming for us or a third party to implement, and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed upon us or third parties with whom we contract could materially harm our business, financial condition and results of operations.

If we or any of our third-party manufacturers fail to maintain regulatory compliance, the FDA, EMA or comparable foreign authorities can impose regulatory sanctions including, among other things, refusal to approve a pending application for a drug candidate, withdrawal of an approval, or suspension of production. As a result, our business, financial condition and results of operations may be materially and adversely affected.

Additionally, if supply from one manufacturer is interrupted, an alternative manufacturer would need to be qualified through an NDA supplement or MAA variation, or equivalent foreign regulatory filing, which could result in further delay. The regulatory agencies may also require additional studies or trials if a new manufacturer is relied upon for commercial production. Switching manufacturers may involve substantial costs and is likely to result in a delay in our desired clinical and commercial timelines.

These factors could cause us to incur higher costs and could cause the delay or termination of clinical trials, regulatory submissions, required approvals, or commercialization of our drug candidates. Furthermore, if our suppliers fail to meet contractual requirements and we are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, our clinical trials may be delayed, or we could lose potential revenue.

Any collaboration arrangement that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our current and potential future drug candidates.

We may seek collaboration arrangements with biopharmaceutical companies for the development or commercialization of our current and potential future drug candidates. To the extent that we decide to enter into collaboration agreements, we will face significant competition in seeking appropriate collaborators. Moreover, collaboration arrangements are complex and time-consuming to negotiate, execute and implement. 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, and the terms of the arrangements may not be favorable to us. If, and when, we collaborate with a third party for development and commercialization of a drug candidate, we can expect to relinquish some or all of the control over the future success of that drug candidate to the third party. The success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaborators generally have significant discretion in determining the efforts and resources that they will apply to these collaborations.

Disagreements between parties to a collaboration arrangement can lead to delays in developing or commercializing the applicable drug candidate and can be difficult to resolve in a mutually beneficial manner. In some cases, collaborations with biopharmaceutical

companies and other third parties are terminated or allowed to expire by the other party. Any such termination or expiration would adversely affect our business, financial condition and results of operations.

If we are unable to develop our own commercial organization or enter into agreements with third parties to sell and market our drug candidates, we may be unable to generate significant revenues.

We do not have a sales and marketing organization, and we have no experience as a company in the sales, marketing and distribution of pharmaceutical products. If any of our drug candidates are approved for commercialization, we may be required to develop our sales, marketing and distribution capabilities, or make arrangements with a third party to perform sales and marketing services. Developing a sales force for any resulting product or any product resulting from any of our other drug candidates is expensive and time-consuming and could delay any product launch. We may be unable to establish and manage an effective sales force in a timely or cost-effective manner, if at all, and any sales force we do establish may not be capable of generating sufficient demand for our drug candidates. To the extent that we enter into arrangements with collaborators or other third parties to perform sales and marketing services, our product revenues are likely to be lower than if we marketed and sold our drug candidates independently. If we are unable to establish adequate sales and marketing capabilities, independently or with others, we may not be able to generate significant revenues and may not become profitable.

The commercial success of our drug candidates depends upon their market acceptance among physicians, patients, healthcare payors and the medical community.

Even if our drug candidates obtain regulatory approval, our products, if any, may not gain market acceptance among physicians, patients, healthcare payors and the medical community. The degree of market acceptance of any of our approved drug candidates will depend on a number of factors, including:

In addition, the potential market opportunity for our drug candidates is difficult to precisely estimate. Our estimates of the potential market opportunity for our drug candidates include several key assumptions based on our industry knowledge, industry publications, third-party research reports and other surveys. Independent sources have not verified all of our assumptions. If any of these assumptions proves to be inaccurate, then the actual market for our drug candidates could be smaller than our estimates of our potential market opportunity. If the actual market for our drug candidates is smaller than we expect, our product revenue may be limited, it may be harder than expected to raise funds and it may be more difficult for us to achieve or maintain profitability. If we fail to achieve market acceptance of our drug candidates in the U.S. and abroad, our revenue will be limited and it will be more difficult to achieve profitability.

If we fail to obtain and sustain an adequate level of reimbursement for our potential products by third-party payors, potential future sales would be materially adversely affected.

There will be no viable commercial market for our drug candidates, if approved, without reimbursement from third-party payors. Reimbursement policies may be affected by future healthcare reform measures. We cannot be certain that reimbursement will be available for our current drug candidates or any other drug candidate we may develop. Additionally, even if there is a viable

commercial market, if the level of reimbursement is below our expectations, our anticipated revenue and gross margins will be adversely affected.

Third-party payors, such as government or private healthcare insurers, carefully review and increasingly question and challenge the coverage of and the prices charged for drugs. Reimbursement rates from private health insurance companies vary depending on the company, the insurance plan and other factors. Reimbursement rates may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services. There is a current trend in the U.S. healthcare industry toward cost containment.

Large public and private payors, managed care organizations, group purchasing organizations and similar organizations are exerting increasing influence on decisions regarding the use of, and reimbursement levels for, particular treatments. Such third-party payors, including Medicare, may question the coverage of, and challenge the prices charged for, medical products and services, and many third-party payors limit coverage of or reimbursement for newly approved healthcare products. In particular, third-party payors may limit the covered indications. Cost-control initiatives could decrease the price we might establish for products, which could result in product revenues being lower than anticipated. We believe our drugs will be priced significantly higher than existing generic drugs and consistent with current branded drugs. If we are unable to show a significant benefit relative to existing generic drugs, Medicare, Medicaid and private payors may not be willing to provide reimbursement for our drugs, which would significantly reduce the likelihood of our products gaining market acceptance.

We expect that private insurers will consider the efficacy, cost-effectiveness, safety and tolerability of our potential products in determining whether to approve reimbursement for such products and at what level. Obtaining these approvals can be a time consuming and expensive process. Our business, financial condition and results of operations would be materially adversely affected if we do not receive approval for reimbursement of our potential products from private insurers on a timely or satisfactory basis. Limitations on coverage could also be imposed at the local Medicare carrier level or by fiscal intermediaries. Medicare Part D, which provides a pharmacy benefit to Medicare patients as discussed below, does not require participating prescription drug plans to cover all drugs within a class of products. Our business, financial condition and results of operations could be materially adversely affected if Part D prescription drug plans were to limit access to, or deny or limit reimbursement of, our drug candidates or other potential products.

Reimbursement systems in international markets vary significantly by country and by region, and reimbursement approvals must be obtained on a country-by-country basis. In many countries, the product cannot be commercially launched until reimbursement is approved. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. The negotiation process in some countries can exceed 12 months. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our products to other available therapies. If the prices for our potential products are reduced or if governmental and other third-party payors do not provide adequate coverage and reimbursement of our drugs, our future revenue, cash flows and prospects for profitability will suffer.

Current and future legislation may increase the difficulty and cost of commercializing our drug candidates and may affect the prices we may obtain if our drug candidates are approved for commercialization.

In the U.S. and some foreign jurisdictions, there have been a number of adopted and proposed legislative and regulatory changes regarding the healthcare system that could prevent or delay regulatory approval of our drug candidates, restrict or regulate post-marketing activities and affect our ability to profitably sell any of our drug candidates for which we obtain regulatory approval.

In the U.S., the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, changed the way Medicare covers and pays for pharmaceutical products. Cost reduction initiatives and other provisions of this legislation could limit the coverage and reimbursement rate that we receive for any of our approved products. While the MMA only applies to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates. Therefore, any reduction in reimbursement that results from the MMA may result in a similar reduction in payments from private payors.

In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, collectively the PPACA, was enacted. The PPACA was intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms. The PPACA increased manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate amount for both branded and generic drugs and revised the definition of “average manufacturer price,” or AMP, which may also increase the amount of Medicaid drug rebates manufacturers are required to pay to states. The legislation also expanded Medicaid drug rebates and created an alternative rebate formula for certain new formulations of certain existing products that is intended to increase the rebates due on those drugs. The Centers for Medicare & Medicaid Services, or CMS, which administers the Medicaid Drug Rebate Program, also has proposed to expand Medicaid rebates to the utilization that occurs in the territories of the U.S., such as

Puerto Rico and the Virgin Islands. Further, beginning in 2011, the PPACA imposed a significant annual fee on companies that manufacture or import branded prescription drug products and required manufacturers to provide a discount, equal to 70% off, effective as of 2019, the negotiated price of prescriptions filled by beneficiaries in the Medicare Part D coverage gap, referred to as the “donut hole.” Legislative and regulatory proposals have been introduced at both the state and federal level to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.

Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, CMS may develop new payment and delivery models, such as bundled payment models. In addition, recently there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under government payor programs, and review the relationship between pricing and manufacturer patient programs. We also expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S. federal government will pay for healthcare products and services, which could result in reduced demand for our drug candidates, if approved for commercialization.

In Europe, the United Kingdom withdrew from the European Union on January 31, 2020, and entered into a transition period that expired on December 31, 2020. A significant portion of the previous regulatory framework in the United Kingdom was derived from the regulations of the European Union. In 2021, the United Kingdom’s Medicines and Healthcare products Regulatory Agency, or MHRA, and the European Medicines Agency, or EMA, released guidance explaining the new regulatory framework. We cannot predict the consequences or impact that the new regulatory framework will have on our future operations, if any, in these jurisdictions.

In addition, on August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022, which, among other things, includes policies that are designed to have a direct impact on drug prices and reduce drug spending by the federal government, which took effect in 2023. Under the Inflation Reduction Act, Congress authorized Medicare beginning in 2026 to negotiate lower prices for certain costly single-source drug and biologic products that do not have competing generics or biosimilars. This provision is limited in terms of the number of pharmaceuticals whose prices can be negotiated in any given year and it only applies to drug products that have been approved for at least 9 years and biologics that have been licensed for 13 years. Drugs and biologics that have been approved for a single rare disease or condition are categorically excluded from price negotiation. Further, the new legislation provides that if pharmaceutical companies raise prices in Medicare faster than the rate of inflation, they must pay rebates back to the government for the difference. The new law also caps Medicare out-of-pocket drug costs at an estimated $4,000 a year in 2024 and, thereafter beginning in 2025, at $2,000 a year.

Changes in government funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, properly administer drug innovation, or prevent our product candidates from being developed or commercialized, which could negatively impact our business, financial condition and results of operations.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including budget and funding levels, ability to hire and retain key personnel, and statutory, regulatory and policy changes. In addition, there may be delays in necessary interactions with regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government or contractor personnel. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of other agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

In December 2016, the 21st Century Cures Act was signed into law. This legislation is designed to advance medical innovation and empower the FDA with the authority to directly hire positions related to drug and device development and review. However, government proposals to reduce or eliminate budgetary deficits may include reduced allocations to the FDA and other related government agencies. These budgetary pressures may result in a reduced ability by the FDA to perform its roles, including the related impact to academic institutions and research laboratories whose funding is fully or partially dependent on both the level and timing of funding from government sources.

Disruptions at the FDA and other agencies may also slow the time necessary for our product candidates to be reviewed or approved by necessary government agencies, which could adversely affect our business, financial condition and results of operations.

We are subject to “fraud and abuse” and similar laws and regulations, and a failure to comply with such regulations or prevail in any litigation related to noncompliance could harm our business, financial condition and results of operations.

In the U.S., we are subject to various federal and state healthcare “fraud and abuse” laws, including anti-kickback laws, false claims laws and other laws intended, among other things, to reduce fraud and abuse in federal and state healthcare programs. The federal Anti-Kickback Statute makes it illegal for any person, including a prescription drug manufacturer, or a party acting on its behalf, to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce the referral of business, including the purchase, order or prescription of a particular drug, or other good or service for which payment in whole or in part may be made under

a federal healthcare program, such as Medicare or Medicaid. Although we seek to structure our business arrangements in compliance with all applicable requirements, these laws are broadly written, and it is often difficult to determine precisely how the law will be applied in specific circumstances. Accordingly, it is possible that our practices may be challenged under the federal Anti-Kickback Statute.

The federal False Claims Act prohibits anyone from, among other things, knowingly presenting or causing to be presented for payment to the government, including the federal healthcare programs, claims for reimbursed drugs or services that are false or fraudulent, claims for items or services that were not provided as claimed, or claims for medically unnecessary items or services. Under the Health Insurance Portability and Accountability Act of 1996, we are prohibited from knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private payors, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services to obtain money or property of any healthcare benefit program. Violations of fraud and abuse laws may be punishable by criminal or civil sanctions, including penalties, fines or exclusion or suspension from federal and state healthcare programs such as Medicare and Medicaid and debarment from contracting with the U.S. government. In addition, private individuals have the ability to bring actions on behalf of the government under the federal False Claims Act as well as under the false claims laws of several states.

Many states have adopted laws similar to the federal Anti-Kickback Statute, some of which apply to the referral of patients for healthcare services reimbursed by any source, not just governmental payors. In addition, some states have passed laws that require pharmaceutical companies to comply with the April 2003 Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers or the Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Professionals. Several states also impose other marketing restrictions or require pharmaceutical companies to make marketing or price disclosures to the state. There are ambiguities as to what is required to comply with these state requirements and if we fail to comply with an applicable state law requirement we could be subject to penalties.

Neither the government nor the courts have provided definitive guidance on the application of fraud and abuse laws to our business. Law enforcement authorities are increasingly focused on enforcing these laws, and it is possible that some of our practices may be challenged under these laws. Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. If we are found in violation of one of these laws, we could be subject to significant civil, criminal and administrative penalties, damages, fines, exclusion from governmental funded federal or state healthcare programs and the curtailment or restructuring of our operations. If this occurs, our business, financial condition and results of operations may be materially adversely affected.

If we face allegations of noncompliance with the law and encounter sanctions, our reputation, revenues and liquidity may suffer, and any of our drug candidates that are ultimately approved for commercialization could be subject to restrictions or withdrawal from the market.

Any government investigation of alleged violations of law could require us to expend significant time and resources in response, and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to generate revenues from any of our drug candidates that are ultimately approved for commercialization. If regulatory sanctions are applied or if regulatory approval is withdrawn, our business, financial condition and results of operations will be adversely affected. Additionally, if we are unable to generate revenues from product sales, our potential for achieving profitability will be diminished and our need to raise capital to fund our operations will increase.

*Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.

The regulatory framework for the collection, use, safeguarding, sharing, transfer and other processing of information worldwide is rapidly evolving and is likely to remain uncertain for the foreseeable future. Globally, virtually every jurisdiction in which we operate has established its own data security and privacy frameworks with which we must comply. For example, the collection, use, disclosure, transfer, or other processing of personal data regarding individuals in the European Union, the EU, including personal health data, is subject to the EU General Data Protection Regulation, or the GDPR, which took effect across all member states of the European Economic Area, or the EEA, in May 2018. The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive data, obtaining consent of the individuals to whom the personal data relates, providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors. In addition, the GDPR also imposes strict rules on the transfer of personal data to countries outside the EU, which includes the United States and, as a result, increases the scrutiny that clinical trial sites located in the EEA should apply to transfers of personal data from such sites to countries that are considered to lack an adequate level of data protection, such as the United States. The GDPR also permits data protection authorities to require destruction of

improperly gathered or used personal information and/or impose substantial fines for violations of the GDPR, which can be up to 4% of global revenues or €20 million, whichever is greater, and it also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR. In addition, the GDPR provides that EU member states may make their own additional laws and regulations limiting the processing of personal data, including genetic, biometric or health data.

The European Data Protection Board continues to release guidelines for industries and impose fines related to the GDPR, some of which have been very significant. To improve coordination among EU supervisory authorities, the European Commission has proposed a new regulation that would help to streamline enforcement of the GDPR in cross-border cases. Meanwhile, there continues to be persistent uncertainty relating to the transfer of personal data from Europe to the U.S., or other non-adequate countries, following the Schrems II decision. On July 10, 2023, the European Commission adopted its adequacy decision on the EU-U.S. Data Privacy Framework, or DPF. The decision, which took effect on the day of its adoption, concludes that the United States ensures an adequate level of protection for personal data transferred from the EEA to companies certified to the DPF. However, it remains too soon to tell how the future of Privacy Shield 2.0 will evolve and what impact it will have on our international activities. At least one challenge to the DPF is pending before the Court of Justice of the European Union.

Further, Brexit has led and could also lead to legislative and regulatory changes that may increase our compliance costs. As of January 1, 2021 and the expiry of transitional arrangements agreed to between the UK and the EU, data processing in the UK is governed by a UK version of the GDPR (combining the GDPR and the Data Protection Act 2018), exposing us to two parallel regimes, each of which authorizes similar fines and other potentially divergent enforcement actions for certain violations. On June 28, 2021, the European Commission adopted an Adequacy Decision for the UK, allowing for the relatively free exchange of personal information between the EU and the UK (as the UK correspondingly allows transfers back to the EU). However, the European Commission may suspend the Adequacy Decision if it considers that the UK no longer provides for an adequate level of data protection. A bill to amend the existing UK framework has been reintroduced (in a different form) by the new UK Government and was announced as a bill which will be introduced into Parliament at the King’s Speech on July 17, 2024. At this time, there is no specific clarity on the provisions of the bill, or the extent to which it will amend the UK framework, beyond general descriptions on its intended purpose.

Similar actions are either in place or under way in the United States. There are a broad variety of data protection laws that are applicable to our activities, and a wide range of enforcement agencies at both the state and federal levels that can review companies for privacy and data security concerns based on general consumer protection laws. The Federal Trade Commission and state Attorneys General all are aggressive in reviewing privacy and data security protections for consumers. New laws also are being considered at both the state and federal levels and several states have passed comprehensive privacy laws. For example, the California Consumer Privacy Act, or the CCPA, which went into effect on January 1, 2020, is creating similar risks and obligations as those created by the GDPR, though the CCPA does exempt certain clinical trial data. The California Privacy Rights Act, or the CPRA, which went into effect on January 1, 2023, amended and expanded the CCPA, and also created a new state agency that is vested with authority to implement and enforce the CCPA and the CRPA. The CCPA and the CRPA may increase our compliance costs and potential liability, and we cannot yet predict the impact of the CCPA or the CRPA on our business. Similar laws passed in Virginia, Colorado, Connecticut, and Utah took effect in 2023. Additionally, Delaware, Florida, Indiana, Iowa, Montana, Oregon, Tennessee, Texas and others have adopted privacy laws, which took or will take effect from July 1, 2024 through 2026. Some state laws also minimize what data can be collected from consumers and how businesses may use and disclose it. These state privacy laws also require businesses to make disclosures to consumers about data collection, use and sharing practices. In addition, some of these laws (including the CPRA), along with other standalone health privacy laws, subject health-related information to additional safeguards and disclosures and some specifically regulate consumer health data, such as the Washington My Health My Data Act, which became effective in 2023 and 2024. Additionally, a broad range of legislative measures also have been introduced at the federal level. Accordingly, failure to comply with federal and state laws (both those currently in effect and future legislation) regarding privacy and security of personal information could expose us to fines and penalties under such laws. There also is the threat of consumer class actions related to these laws and the overall protection of personal data.

Given the breadth and depth of changes in data protection obligations, preparing for and complying with these requirements is rigorous and time intensive and requires significant resources and a review of our technologies, systems and practices, as well as those of any third-party collaborators, service providers, CROs, contractors or consultants that process or transfer personal data collected in the EU. The GDPR and other changes in laws or regulations associated with the enhanced protection of certain types of sensitive data, such as healthcare data or other personal information from our clinical trials, could require us to change our business practices and put in place additional compliance mechanisms, may interrupt or delay our development, regulatory and commercialization activities and increase our cost of doing business, and could lead to government enforcement actions, private litigation and significant fines and penalties against us and could have a material adverse effect on our business, financial condition or results of operations. Similarly, failure to comply with federal and state laws regarding privacy and security of personal information could expose us to fines and penalties under such laws. Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could harm our reputation and our business.

We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. If we fail to comply with these laws, we could be subject to civil or criminal liabilities, other remedial measures and legal expenses, be precluded from developing, manufacturing and selling certain products outside the United States or be required to develop and implement costly compliance programs, which could adversely affect our business, results of operations and financial condition.

Our operations are subject to anti-corruption laws, including the U.S. Foreign Corrupt Practices Act, or the FCPA, the U.K. Bribery Act 2010, or the Bribery Act, and other anti-corruption laws that apply in countries where we do business and may do business in the future. The FCPA, the Bribery Act and these other laws generally prohibit us, our officers, and our employees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other persons to obtain or retain business or gain some other business advantage. Compliance with the FCPA, in particular, is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.

We may in the future operate in jurisdictions that pose a high risk of potential FCPA or Bribery Act violations, and we may participate in collaborations and relationships with third parties whose actions could potentially subject us to liability under the FCPA, the Bribery Act or local anti-corruption laws. In addition, we cannot predict the nature, scope or effect of future regulatory requirements to which our international operations might be subject or the manner in which existing laws might be administered or interpreted. If we expand our operations outside of the United States, we will need to dedicate additional resources to comply with numerous laws and regulations in each jurisdiction in which we plan to operate.

We are also subject to other laws and regulations governing our international operations, including regulations administered by the governments of the United States, the United Kingdom and authorities in the EU, including applicable export control regulations, economic sanctions on countries and persons, customs requirements and currency exchange regulations, collectively referred to as Trade Control Laws. In addition, various laws, regulations and executive orders also restrict the use and dissemination outside of the United States, or the sharing with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products. If we expand our presence outside of the United States, we will be required to dedicate additional resources to comply with these laws, and these laws may preclude us from developing, manufacturing, or selling certain products and product candidates outside of the United States, which could limit our growth potential and increase our development costs.

There is no assurance that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws, including the FCPA, the Bribery Act or other legal requirements, including Trade Control Laws. If we are not in compliance with the FCPA, the Bribery Act and other anti-corruption laws or Trade Control Laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations and liquidity. The SEC also may suspend or bar issuers from trading securities on U.S. exchanges for violations of the FCPA’s accounting provisions. Any investigation of any potential violations of the FCPA, the Bribery Act, other anti-corruption laws or Trade Control Laws by United States, United Kingdom or other authorities could also have an adverse impact on our reputation, our business, results of operations and financial condition.

Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.

In some countries, particularly member states of the EU, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the 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 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. 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 could be materially harmed.

*If we fail to retain current members of our senior management and scientific personnel, or to attract and keep additional key personnel, we may be unable to successfully develop or commercialize our drug candidates.

Our success depends on our continued ability to attract, retain and motivate highly qualified management and scientific personnel. As of September 30, 2024, we had thirty-three full-time employees, one part-time employee and a small number of consultants, which may make us more reliant on our individual employees than companies with a greater number of employees. The loss of any of our key personnel could delay or prevent the development of our drug candidates. These personnel are “at-will” employees and may terminate their employment with us at any time; however, our current executive officer has agreed to provide us with at least 60 days’ advance notice of resignation pursuant to his employment agreement with us. The replacement of key personnel likely would involve significant time and costs, and may significantly delay or prevent the achievement of our business objectives. We do not maintain “key person” insurance on any of our employees.

From time to time, our management seeks the advice and guidance of certain scientific advisors and consultants regarding clinical and regulatory development programs and other customary matters. These scientific advisors and consultants are not our employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us. In addition, our scientific advisors may have arrangements with other companies to assist those companies in developing products or technologies that may compete with ours.

Competition for qualified personnel is intense, especially in the greater San Diego, California area where we have a substantial presence and need for highly skilled personnel. We may not be successful in attracting qualified personnel to fulfill our current or future needs. Competitors and others have in the past attempted, and are likely in the future to attempt, to recruit our employees. While our employees are required to sign standard agreements concerning confidentiality and ownership of inventions, we generally do not have employment contracts or non-competition agreements with any of our personnel. In addition, we may experience employee turnover as a result of the ongoing “great resignation” occurring throughout the U.S. economy, which has impacted job market dynamics. New hires require training and take time before they achieve full productivity. New employees may not become as productive as we expect, and we may be unable to hire or retain sufficient numbers of qualified individuals. The loss of the services of any of our key personnel, the inability to attract or retain highly qualified personnel in the future or delays in hiring such personnel, particularly senior management and other technical personnel, could materially and adversely affect our business, financial condition and results of operations.

We will need to increase the size of our organization and may not successfully manage our growth.

We are a clinical-stage biopharmaceutical company with a small number of employees, and our management systems currently in place are not likely to be adequate to support our future growth plans. Our ability to grow and to manage our growth effectively will require us to hire, train, retain, manage and motivate additional employees and to implement and improve our operational, financial and management systems. These demands also may require the hiring of additional senior management personnel or the development of additional expertise by our senior management personnel. Hiring a significant number of additional employees, particularly those at the management level, would increase our expenses significantly. Moreover, if we fail to expand and enhance our operational, financial and management systems in conjunction with our potential future growth, it could have a material adverse effect on our business, financial condition and results of operations.

We are exposed to product liability, non-clinical and clinical liability risks which could place a substantial financial burden upon us, should lawsuits be filed against us.

Our business exposes us to potential product liability and other liability risks that are inherent in the testing, manufacturing and marketing of pharmaceutical formulations and products. In addition, the use in our clinical trials of pharmaceutical products and the subsequent sale of these products by us or our potential collaborators may cause us to bear a portion of or all product liability risks. A successful liability claim or series of claims brought against us could have a material adverse effect on our business, financial condition and results of operations.

We currently maintain product liability insurance; however, there can be no assurance that we will be able to continue to maintain such insurance, and we may be unable to obtain replacement product liability insurance on commercially reasonable terms or in adequate amounts. On occasion, large judgments have been awarded in class action lawsuits based on drugs that had unanticipated adverse effects. A successful product liability claim or series of claims brought against us could cause our stock price to decline and, if judgments exceed our insurance coverage, could adversely affect our results of operations and business.

Our research and development activities involve the use of hazardous materials, which subject us to regulation, related costs and delays and potential liabilities.

Our research and development activities involve the controlled use of hazardous materials, chemicals and various radioactive compounds, and we will need to develop additional safety procedures for the handling and disposing of hazardous materials. If an

accident occurs, we could be held liable for resulting damages, which could be substantial. We are also subject to numerous environmental, health and workplace safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and the handling of biohazardous materials. Additional federal, state and local laws and regulations affecting our operations may be adopted in the future. We may incur substantial costs to comply with, and substantial fines or penalties if we violate any of these laws or regulations.

We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively.

Despite the implementation of security measures, our internal computer systems and those of third parties with which we contract, including our CROs and other business partners, are vulnerable to damage from cyber-attacks, computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. System failures, accidents or security breaches could cause interruptions in our operations or the operations of our CROs and other business partners, and could result in a material disruption of our drug development and clinical activities and business operations, in addition to possibly requiring substantial expenditures of resources to remedy. The loss of drug development or clinical trial data could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. We have experienced cybersecurity incidents in the past and expect that we will experience cybersecurity incidents in the future. If we were to experience a significant cybersecurity breach of our information systems or data, the costs associated with the investigation, remediation and potential notification of the breach to counter-parties and data subjects could be material. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and our development programs and the development of our drug candidates could be delayed.

Our employees and consultants may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk of employee or consultant fraud or other misconduct. Misconduct by our employees or consultants could include intentional failures to comply with FDA regulations, provide accurate information to the FDA, comply with manufacturing standards, comply with federal and state healthcare fraud and abuse laws and regulations, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commissions, customer incentive programs and other business arrangements. Employee and consultant misconduct also could involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter such misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a material adverse effect on our business, financial condition and results of operations, and result in the imposition of significant fines or other sanctions against us.

Business disruptions such as natural disasters could seriously harm our future revenues and financial condition and increase our costs and expenses.

Our corporate headquarters are located in greater San Diego, California, a region known for seismic activity. In addition, one of our third-party manufacturers is located in the southeastern part of the United States, an area subject to hurricanes and related natural disasters. Our suppliers may also experience a disruption in their business as a result of natural or man-made disasters. A significant natural or man-made disaster, such as an earthquake, prolonged or repeated power outage, hurricane, flood, fire, drought or other extreme weather events and changing weather patterns, which are increasing in frequency due to the impacts of climate change, could severely damage or destroy our headquarters or facilities or the facilities of our manufacturers or suppliers, which could have a material and adverse effect on our business, financial condition and results of operations. In addition, terrorist acts or acts of war targeted at the U.S., and specifically the greater San Diego, California region, as well as the ongoing conflict between Ukraine and Russia and the global impact of restrictions and sanctions imposed on Russia and the Israel-Hamas war, could cause damage or disruption to us, our employees, facilities, partners and suppliers, which could have a material adverse effect on our business, financial condition and results of operations.

We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.

From time to time, we may consider strategic transactions, such as acquisitions of companies, asset purchases and out-licensing or in-licensing of products, drug candidates or technologies. Additional potential transactions that we may consider include a variety of different business arrangements, including spin-offs, strategic partnerships, joint ventures, restructurings, divestitures, business combinations and investments. Any such transaction may require us to incur non-recurring or other charges, may increase our near-

and long-term expenditures and may pose significant integration challenges or disrupt our management or business, which could adversely affect our business, financial condition and results of operations. For example, these transactions may entail numerous operational and financial risks, including:

Accordingly, although there can be no assurance that we will undertake or successfully complete any transactions of the nature described above, any transactions that we do complete may be subject to the foregoing or other risks, and could have a material adverse effect on our business, financial condition and results of operations.

Our employment agreements with our officers and certain other employees may require us to pay severance benefits to any of those persons who are terminated in connection with a change in control of our company, which could harm our financial condition or results.

Our officers and certain employees are parties to employment agreements that contain change in control and severance provisions in the event of a termination of employment in connection with a change in control of our company providing for cash payments for severance and other benefits and acceleration of vesting of stock options and shares of restricted stock. The accelerated vesting of options and shares of restricted stock could result in dilution to our existing stockholders and lower the market price of our common stock. The payment of these severance benefits could harm our financial condition and results. In addition, these potential severance payments may discourage or prevent third parties from seeking a business combination with us.

*Investors’ expectations of our performance relating to environmental, social and governance factors may impose additional costs and expose us to new risks.

There is an increasing focus from certain investors, employees, regulators and other stakeholders concerning corporate responsibility, specifically related to environmental, social and governance, or ESG, factors. Some investors and investor advocacy groups may use these factors to guide investment strategies and, in some cases, investors may choose not to invest in our company if they believe our policies relating to corporate responsibility are inadequate. Third-party providers of corporate responsibility ratings and reports on companies have increased to meet growing investor demand for measurement of corporate responsibility performance, and a variety of organizations currently measure the performance of companies on such ESG topics, and the results of these assessments are widely publicized. Investors, particularly institutional investors, use these ratings to benchmark companies against their peers and if we are perceived as lagging with respect to ESG initiatives, certain investors may engage with us to improve ESG disclosures or performance and may also make voting decisions, or take other actions, to hold us and our board of directors accountable. In addition, the criteria by which our corporate responsibility practices are assessed may change, which could result in greater expectations of us and cause us to undertake costly initiatives to satisfy such new criteria. If we elect not to or are unable to satisfy such new criteria, investors may conclude that our policies with respect to corporate responsibility are inadequate.

We may face reputational damage in the event our corporate responsibility initiatives or objectives do not meet the standards set by our investors, stockholders, lawmakers, listing exchanges or other constituencies, or if we are unable to achieve an acceptable ESG or sustainability rating from third-party rating services. A low ESG or sustainability rating by a third-party rating service could also result in the exclusion of our common stock from consideration by certain investors who may elect to invest with our competition instead. Ongoing focus on corporate responsibility matters by investors and other parties as described above may impose additional costs or

expose us to new risks. Any failure or perceived failure by us in this regard could have a material adverse effect on our reputation and on our business, share price, financial condition, or results of operations, including the sustainability of our business over time.

In addition, on March 6, 2024, the SEC finalized new rules for public companies that will require extensive climate-related disclosures and significant analysis of the impact of climate-related issues on our business strategy, results of operations, and financial condition, or the SEC Climate Disclosure Rules, and extensive attestation requirements. The new rules require disclosure of, among other things and to the extent material, our climate-related risks and opportunities, greenhouse gas emissions inventory, climate-related targets and goals, and financial impacts of physical and transition risks. Subsequently, in April 2024, the SEC issued an order staying implementation of the SEC Climate Disclosure Rules pending the resolution of certain challenges. Nonetheless, our legal, accounting, and other compliance expenses may increase significantly, and compliance efforts may divert management time and attention as we prepare for the potential implementation of the SEC Climate Disclosure Rules, and such expenses, efforts and diversions of management time and attention may be even greater if the SEC Climate Disclosure Rules ultimately go into effect. We may also be exposed to legal or regulatory action or claims as a result of these new regulations. Separately, the SEC has also announced that it is scrutinizing existing climate-change related disclosures in public filings, increasing the potential for enforcement if the SEC were to allege our existing climate disclosures are misleading or deficient. All of these risks could have a material adverse effect on our business, financial position, and/or stock price.

The impact of the Russian invasion of Ukraine and the Israel-Hamas war on the global economy, energy supplies and raw materials is uncertain, but may prove to negatively impact our business and operations.

The short and long-term implications of Russia’s invasion of Ukraine and the Israel-Hamas war are difficult to predict at this time. We continue to monitor any adverse impact that the outbreak of war in Ukraine, the subsequent institution of sanctions against Russia by the United States and several European and Asian countries, and the Israel-Hamas war may have on the global economy in general, on our business and operations and on the businesses and operations of our suppliers and other third parties with which we conduct business. For example, a prolonged conflict in Ukraine or Israel may result in increased inflation, escalating energy prices and constrained availability, and thus increasing costs, of raw materials. We will continue to monitor this fluid situation and develop contingency plans as necessary to address any disruptions to our business operations as they develop. To the extent the wars in Ukraine or Israel may adversely affect our business as discussed above, it may also have the effect of heightening many of the other risks described herein. Such risks include, but are not limited to, adverse effects on macroeconomic conditions, including inflation; disruptions to our global technology infrastructure, including through cyberattack, ransom attack, or cyber-intrusion; adverse changes in international trade policies and relations; disruptions in global supply chains; and constraints, volatility, or disruption in the capital markets, any of which could negatively affect our business and financial condition.

Unstable market and economic conditions may have serious adverse consequences on our business and financial condition.

Our business, financial condition and results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. A severe or prolonged economic downturn could result in a variety of risks to our business, including our ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy could also strain our suppliers, service providers, manufacturers or other partners and there is a risk that one or more would not survive or be able to meet their commitments to us under such circumstances. As widely reported, global credit and financial markets have experienced volatility and disruptions in the past several years and especially in 2020, 2021 and 2022 due to the impacts of the COVID-19 pandemic, and, more recently, the ongoing conflict between Ukraine and Russia and the global impact of restrictions and sanctions imposed on Russia, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability. Moreover, the global impacts of the Israel-Hamas war are still unknown. There can be no assurances that further deterioration in credit and financial markets and confidence in economic conditions will not occur. For example, U.S. debt ceiling and budget deficit concerns have increased the possibility of additional credit-rating downgrades and economic slowdowns, or a recession in the United States. Although U.S. lawmakers passed legislation to raise the federal debt ceiling on multiple occasions, including a suspension of the federal debt ceiling in June 2023, ratings agencies have lowered or threatened to lower the long-term sovereign credit rating on the United States. The impact of this or any further downgrades to the U.S. government’s sovereign credit rating or its perceived creditworthiness could adversely affect the U.S. and global financial markets and economic conditions. Absent further quantitative easing by the Federal Reserve, these developments could cause interest rates and borrowing costs to rise, which may negatively impact our results of operations or financial condition. Moreover, disagreement over the federal budget has caused the U.S. federal government to shut down for periods of time. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.

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

We currently have intellectual property rights to develop our drug candidates through a license from Ligand. As of September 30, 2024, we owned or co-owned 139 patent applications and 32 patents. Because our programs require the use of proprietary rights held by Ligand, the growth of our business will likely depend in part on our ability to maintain and exploit these proprietary rights. In addition, we may need to acquire or in-license additional intellectual property in the future. We may be unable to acquire or in-license any compositions, methods of use, processes or other intellectual property rights from third parties that we identify as necessary for our drug candidates. We face competition with regard to acquiring and in-licensing third-party intellectual property rights, including from a number of more established companies. These established companies may have a competitive advantage over us due to their size, cash 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 intellectual property rights to us. We also may be unable to acquire or in-license third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment.

We may enter into collaboration agreements with U.S. and foreign academic institutions to accelerate development of our current or future preclinical drug candidates. Typically, these agreements include an option for us to negotiate a license to the institution’s intellectual property rights resulting from the collaboration. Even with such an option, we may be unable to negotiate a license within the specified timeframe or under terms that are acceptable to us. If we are unable to license rights from a collaborating institution, the institution may offer the intellectual property rights to other parties, potentially blocking our ability to pursue our desired program.

If we are unable to successfully obtain required third-party intellectual property rights or maintain our existing intellectual property rights, including if our patent applications do not result in the issuance of patents, we may need to abandon development of the related program and our business, financial condition and results of operations could be materially and adversely affected.

If we fail to comply with our obligations in the agreements under which we in-license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business.

The Master License Agreement is important to our business and we expect to enter into additional license agreements in the future. The Master License Agreement imposes, and we expect that future license agreements will impose, various diligence, milestone payment, royalty and other obligations on us. If we fail to comply with our obligations under these agreements, or if we file for bankruptcy, we may be required to make certain payments to the licensor, we may lose the exclusivity of our license, or the licensor may have the right to terminate the license, in which event we would not be able to develop or market products covered by the license. Additionally, the milestone and other payments associated with these licenses could materially and adversely affect our business, financial condition and results of operations.

Pursuant to the terms of the Master License Agreement, Ligand may terminate the Master License Agreement under certain circumstances, including, but not limited to: (1) in the event of our insolvency or bankruptcy, (2) if we do not pay an undisputed amount owing under the Master License Agreement when due and fail to cure such default within a specified period of time, or (3) if we default on certain of our material obligations and fail to cure the default within a specified period of time. If the Master License Agreement is terminated in its entirety or with respect to a specific licensed program for any reason, among other consequences, all licenses granted to us under the Master License Agreement (or with respect to the specific licensed program) will terminate and we may be requested to assign and transfer to Ligand certain regulatory documentation and regulatory approvals related to the licensed programs (or those related to the specific licensed program), and we may be required to wind down any ongoing clinical trials with respect to the licensed programs (or those related to the specific licensed program). Additionally, Ligand may require us to assign to Ligand the trademarks owned by us relating to the licensed programs (or those related to the specific licensed program), and we would be obligated to grant to Ligand a license under any patent rights and know-how controlled by us to the extent necessary to make, have made, import, use, offer to sell and sell the licensed programs (or those related to the specific licensed program) anywhere in the world at a royalty rate in the low single digits.

In some cases, patent prosecution of our licensed technology may be controlled solely by the licensor. If our licensor fails to obtain and maintain patent or other protection for the proprietary intellectual property we in-license, then we could lose our rights to the intellectual property or our exclusivity with respect to those rights, and our competitors could market competing products using the intellectual property. In certain cases, we may control the prosecution of patents resulting from licensed technology. In the event we breach any of our obligations related to such prosecution, we may incur significant liability to our licensing partners. Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues. Disputes may arise regarding intellectual property subject to a licensing agreement, including, but not limited to:

If disputes over intellectual property and other rights that we have in-licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected drug candidates. If we fail to comply with any such obligations to our licensor, such licensor may terminate their licenses to us, in which case we would not be able to market products covered by these licenses. The loss of our license with Ligand, and potentially other licenses that we enter into in the future, would have a material adverse effect on our business.

We may be required to pay milestones and royalties to Ligand in connection with our use of the licensed technology under the Master License Agreement, which could adversely affect the overall profitability for us of any products that we may seek to commercialize.

Under the terms of the Master License Agreement, we may be obligated to pay Ligand up to an aggregate of approximately $1.54 billion in development, regulatory and sales milestones. We will also be required to pay Ligand single-digit royalties on future worldwide net product sales. These royalty payments could adversely affect the overall profitability for us of any products that we may seek to commercialize.

We may not be able to protect our proprietary or licensed technology in the marketplace.

We depend on our ability to protect our proprietary or licensed technology. We rely on trade secret, patent, copyright and trademark laws, and confidentiality, licensing and other agreements with employees and third parties, all of which offer only limited protection. Our success depends in large part on our ability, Ligand’s and any future licensor’s or licensee’s ability to obtain and maintain patent protection in the U.S. and other countries with respect to our proprietary or licensed technology and products. We currently in-license most of our intellectual property rights to develop our drug candidates and may in-license additional intellectual property rights in the future. Under the terms of the Master License Agreement, Ligand has the first right to file, prosecute and maintain the patents subject to the Master License Agreement in its name. We cannot be certain that patent enforcement activities by our current or future licensors have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents or other intellectual property rights. We also cannot be certain that our current or future licensors will allocate sufficient resources or prioritize their or our enforcement of such patents. Even if we are not a party to these legal actions, an adverse outcome could prevent us from continuing to license intellectual property that we may need to operate our business, which would have a material adverse effect on our business, financial condition and results of operations.

We believe we will be able to obtain, through prosecution of patent applications covering technology licensed from others, adequate patent protection for our proprietary drug technology, including those related to our in-licensed intellectual property. If we are compelled to spend significant time and money protecting or enforcing our licensed patents and future patents we may own, designing around patents held by others or licensing or acquiring, potentially for large fees, patents or other proprietary rights held by others, our business, financial condition and results of operations may be materially and adversely affected. If we are unable to effectively protect the intellectual property that we own or in-license, other companies may be able to offer the same or similar products for sale, which could materially adversely affect our business, financial condition and results of operations. The patents of others from whom we may license technology, and any future patents we may own, may be challenged, narrowed, invalidated or circumvented, which could limit our ability to stop competitors from marketing the same or similar products or limit the length of term of patent protection that we may have for our products.

*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 for licensed patents, pending patent applications and potential future patent applications and patents could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or patent applications will be due to be paid to the U.S. Patent and Trademark Office, or the USPTO, and various governmental patent agencies outside of the U.S. in several stages over the lifetime of the applicable patent and/or patent application. The USPTO and various non-U.S.

governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. 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 the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If this occurs with respect to our in-licensed patents or patent applications we may file in the future, our competitors might be able to use our technologies, which would have a material adverse effect on our business, financial condition and results of operations.

The patent positions of pharmaceutical products are often complex and uncertain. The breadth of claims allowed in pharmaceutical patents in the U.S. and many jurisdictions outside of the U.S. is not consistent. For example, in many jurisdictions, the support standards for pharmaceutical patents are becoming increasingly strict. Some countries prohibit method of treatment claims in patents. Changes in either the patent laws or interpretations of patent laws in the U.S. and other countries may diminish the value of our licensed or owned intellectual property or create uncertainty. In addition, publication of information related to our current drug candidates and potential products may prevent us from obtaining or enforcing patents relating to these drug candidates and potential products, including without limitation composition-of-matter patents, which are generally believed to offer the strongest patent protection.

Our intellectual property includes licenses covering issued patents and pending patent applications for composition of matter, method of use and method of manufacture. As of September 30, 2024, for each of VK2809 and VK0214, we in-licensed three patents in the U.S. and additional patents in certain foreign jurisdictions, and owned or co-owned and in-licensed three U.S. patents, four U.S. patent applications, and additional patents and patent applications in certain foreign jurisdictions. We also in-licensed one additional U.S. patent and one Japanese patent directed to VK0214, and owned two additional U.S. patents, one PCT application, and several patent applications in the U.S. and certain foreign jurisdictions directed to VK2809 as of September 30, 2024. For VK5211, as of September 30, 2024, we in-licensed ten patents and one patent application in the U.S. and several other patents and patent applications in certain foreign jurisdictions. As of September 30, 2024, for our GLP-1 program, we own one U.S. patent, additional patents in certain foreign jurisdictions, two PCT applications, and several patent applications in the U.S. and certain foreign jurisdictions. With respect to our other current drug candidates, we have a license covering several issued patents both in the U.S. and in certain foreign jurisdictions.

Patents that we currently license and patents that we may own or license in the future do not necessarily ensure the protection of our licensed or owned intellectual property for a number of reasons, including, without limitation, the following:

If we encounter delays in our development or clinical trials, the period of time during which we could market our potential products under patent protection would be reduced.

Our competitors may be able to circumvent our licensed patents or future patents we may own by developing similar or alternative technologies or products in a non-infringing manner. Our competitors may seek to market generic versions of any approved products by submitting abbreviated new drug applications to the FDA in which our competitors claim that our licensed patents or any future patents we may own are invalid, unenforceable or not infringed. Alternatively, our competitors may seek approval to market their own products similar to or otherwise competitive with our products. In these circumstances, we may need to defend or assert our licensed patents or any future patents we may own, including by filing lawsuits alleging patent infringement. In any of these types of proceedings, a court or other agency with jurisdiction may find our licensed patents or any future patents we may own invalid or unenforceable. We may also fail to identify patentable aspects of our research and development before it is too late to obtain patent protection. Even if we own or in-license valid and enforceable patents, these patents still may not provide protection against competing products or processes sufficient to achieve our business objectives.

The issuance of a patent is not conclusive as to its inventorship, scope, ownership, priority, validity or enforceability. In this regard, third parties may challenge our licensed patents or any future patents we may own in the courts or patent offices in the U.S. and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and potential products. In addition, given the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting such drug candidates might expire before or shortly after such drug candidates are commercialized.

We may infringe the intellectual property rights of others, which may prevent or delay our drug development efforts and prevent us from commercializing or increase the costs of commercializing our products.

Our commercial success depends significantly on our ability to operate without infringing the patents and other intellectual property rights of third parties. For example, there could be issued patents of which we are not aware that our current or potential future drug candidates infringe. There also could be patents that we believe we do not infringe, but that we may ultimately be found to infringe.

Moreover, patent applications are in some cases maintained in secrecy until patents are issued. The publication of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications were filed. Because patents can take many years to issue, there may be currently pending applications of which we are unaware that may later result in issued patents that our drug candidates or potential products infringe. For example, pending applications may exist that claim or can be amended to claim subject matter that our drug candidates or potential products infringe. Competitors may file continuing patent applications claiming priority to already issued patents in the form of continuation, divisional, or continuation-in-part applications, in order to maintain the pendency of a patent family and attempt to cover our drug candidates.

Third parties may assert that we are employing their proprietary technology without authorization and may sue us for patent or other intellectual property infringement. These lawsuits are costly and could adversely affect our business, financial condition and results of operations and divert the attention of managerial and scientific personnel. If we are sued for patent infringement, we would need to demonstrate that our drug candidates, potential products or methods either do not infringe the claims of the relevant patent or that the patent claims are invalid, and we may not be able to do this. Proving invalidity is difficult. For example, in the U.S., proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if we are successful in these proceedings, we may incur substantial costs and the time and attention of our management and scientific personnel could be diverted in pursuing these proceedings, which could have a material adverse effect on us. In addition, we may not have sufficient resources to bring these actions to a successful conclusion. If a court holds that any third-party patents are valid, enforceable and cover our products or their use, the holders of any of these patents may be able to block our ability to commercialize our products unless we acquire or obtain a license under the applicable patents or until the patents expire.

We may not be able to enter into licensing arrangements or make other arrangements at a reasonable cost or on reasonable terms. Any inability to secure licenses or alternative technology could result in delays in the introduction of our products or lead to prohibition of the manufacture or sale of products by us. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, in any such proceeding or litigation, we could be found liable for monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent. A finding of infringement could prevent us from commercializing our drug candidates or force us to cease some of our business operations, which could materially and adversely affect our business, financial condition and results of operations. Any claims by third parties that we have misappropriated their confidential information or trade secrets could have a similar material and adverse effect on our business, financial condition and

results of operations. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations.

*Any claims or lawsuits relating to infringement of intellectual property rights brought by or against us will be costly and time consuming and may adversely affect our business, financial condition and results of operations.

We may be required to initiate litigation to enforce or defend our licensed and owned intellectual property. For example, we were previously aware of at least two third-party companies that were selling products in the U.S. bearing the name “LGD-4033,” which is the name previously used by Ligand to refer to VK5211, without authority from either us or Ligand, and we may experience other potential intellectual property infringement in the future. In addition, in December 2022, we filed suit against Ascletis Bioscience Co., Ltd., Gannex Pharma Co., Ltd., Ascletis Pharmaceuticals Co., Ltd., Ascletis Pharma Inc., and Jinzi Jason Wu, or the Ascletics Defendants, in the Southern District of California, San Diego division, alleging, among other things: (1) violation of the Defend Trade Secrets Act; (2) violation of the California Uniform Trade Secrets Act; (3) breach of contract; (4) breach of the implied covenant of good faith and fair dealing; and (5) tortious interference with contract. In a related action, we also filed suit against the same Ascletis Defendants in the International Trade Commission, or the ITC, for unlawful and unfair methods of competition. On October 3, 2024, the ITC’s Chief Administrative Law Judge issued a Notice of his determination that the Ascletis Defendants misappropriated our trade secrets and engaged in discovery misconduct, warranting monetary and non-monetary sanctions. Lawsuits to protect our intellectual property rights can be time consuming and costly. There is a substantial amount of litigation involving patent and other intellectual property rights in the biopharmaceutical industry generally. Such litigation or proceedings could increase our operating expenses and reduce the resources available for development activities or any future sales, marketing or distribution activities.

In any infringement litigation, any award of monetary damages we receive may not be commercially valuable. 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 litigation. Moreover, there can be no assurance that we will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years before they are resolved. Further, any claims we assert against a perceived infringer could provoke these parties to assert counterclaims against us alleging that we have infringed their patents. 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. 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.

In addition, our licensed patents and patent applications, and patents and patent applications that we may apply for, own or license in the future, could face other challenges, such as interference proceedings, opposition proceedings, re-examination proceedings and other forms of post-grant review. Any of these challenges, if successful, could result in the invalidation of, or in a narrowing of the scope of, any of our licensed patents and patent applications and patents and patent applications that we may apply for, own or license in the future. Any of these challenges, regardless of their success, would likely be time-consuming and expensive to defend and resolve and would divert our management and scientific personnel’s time and attention.

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 material adverse effect on the market price of our common stock.

Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.

As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involves both technological and legal complexity and is costly, time-consuming and inherently uncertain. For example, on September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act included a number of significant changes to U.S. patent law, including provisions that affect the way patent applications will be prosecuted and that may also affect patent litigation. In particular, under the Leahy-Smith Act, the United States transitioned in March 2013 to a “first to file” system in which the first inventor to file a patent application is typically entitled to the patent. Third parties are allowed to submit prior art before the issuance of a patent by the USPTO, and may become involved in post-grant proceedings, including opposition, derivation, reexamination, inter partes review or interference proceedings challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope or enforceability of, or invalidate, our patent rights, which could adversely affect our competitive position.

In addition, the U.S. Supreme Court has ruled on several patent cases in recent years, either 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 federal courts and the USPTO, the laws and regulations

governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we might obtain in the future.

Similarly, changes in patent law and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we have licensed or that we may obtain in the future. For example, the complexity and uncertainty of European patent laws have also increased in recent years. In Europe, in June 2023, a new unitary patent system was introduced, which will significantly impact European patents, including those granted before the introduction of the system. Under the unitary patent system, after a European patent is granted, the patent proprietor can request unitary effect, thereby getting a European patent with unitary Effect, or a Unitary Patent. Each Unitary Patent is subject to the jurisdiction of the Unitary Patent Court, or the UPC. As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of any litigation. Patents granted before the implementation of the UPC will have the option of opting out of the jurisdiction of the UPC and remaining as national patents in the UPC countries. Patents that remain under the jurisdiction of the UPC may be potentially vulnerable to a single UPC-based revocation challenge that, if successful, could invalidate the patent in all countries who are signatories to the UPC. We cannot predict with certainty the long-term effects of the new unitary patent system.

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

Filing, prosecuting and defending patents on drug candidates throughout the world would be prohibitively expensive. Competitors may use our licensed and owned technologies in jurisdictions where we have not licensed or obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we may obtain or license patent protection, but where patent enforcement is not as strong as that in the U.S. These products may compete with our products in jurisdictions where we do not have any issued or licensed patents and any future patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biopharmaceuticals, which could make it difficult for us to stop the infringement of our licensed patents and future patents we may own, or marketing of competing products in violation of our proprietary rights generally. Further, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the U.S. As a result, we may encounter significant problems in protecting and defending our licensed and owned intellectual property both in the U.S. and abroad. For example, China, where we currently have a number of licensed patents and licensed and owned patent applications, currently affords less protection to a company’s intellectual property than some other jurisdictions. As such, the lack of strong patent and other intellectual property protection in China may significantly increase our vulnerability regarding unauthorized disclosure or use of our intellectual property and undermine our competitive position. Proceedings to enforce our future patent rights, if any, in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business.

Many countries, including European Union countries, India, Japan and China, have compulsory licensing laws under which a patent owner may be compelled under certain circumstances to grant licenses to third parties. In those countries, as of September 30, 2024, we had several licensed and owned patents and several licensed and owned patent applications and may have limited remedies if such patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of such patents. This could limit our potential revenue opportunities. Accordingly, our efforts to enforce intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we own or license.

We may be unable to adequately prevent unauthorized disclosure of trade secrets and other proprietary information.

In order to protect our proprietary and licensed technology and processes, we rely in part on confidentiality agreements with our corporate partners, employees, consultants, manufacturers, outside scientific collaborators and sponsored researchers and other advisors. These agreements may not effectively prevent unauthorized disclosure of our confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. For example, in our suit against the Ascletis Defendants that we filed in the Southern District of California, San Diego division, in December 2022, we brought claims related to breach of confidential disclosure agreements. There can be no assurance that we will be successful in this suit. In addition, others may independently discover our trade secrets and proprietary information. Failure to obtain or maintain trade secret protection could adversely affect our competitive business position.

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.

We employ individuals who were previously employed at other biopharmaceutical companies. Although we have no knowledge of any such claims against us, we may be subject to claims that we or our employees, consultants or independent contractors have

inadvertently or otherwise used or disclosed confidential information of our employees’ former employers or other third parties. Litigation may be necessary to defend against these claims. There is no guarantee of success in defending these claims, and even if we are successful, litigation could result in substantial cost and be a distraction to our management and other employees. To date, none of our employees have been subject to such claims.

We may be subject to claims challenging the inventorship of our licensed patents, any future patents we may own and other intellectual property.

Although we are not currently experiencing any claims challenging the inventorship of our licensed patents or our licensed or owned intellectual property, we may in the future be subject to claims that former employees, collaborators or other third parties have an interest in our licensed patents or other licensed or owned intellectual property as an inventor or co-inventor. For example, we may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing our drug candidates. Litigation may be necessary to defend against these and other claims challenging inventorship. 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, financial condition and results of operations. 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.

If we do not obtain additional protection under the Hatch-Waxman Amendments and similar foreign legislation extending the terms of our licensed patents and any future patents we may own, our business, financial condition and results of operations may be materially and adversely affected.

Depending upon the timing, duration and specifics of FDA regulatory approval for our drug candidates, one or more of our licensed U.S. patents or future U.S. patents that we may license or own may be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as 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 drug development and the FDA regulatory review process. This period is generally one-half the time between the effective date of an investigational new drug application (falling after issuance of the patent), and the submission date of an NDA, plus the time between the submission date of an NDA and the approval of that application. Patent term restorations, however, cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval by the FDA.

The application for patent term extension is subject to approval by the USPTO, in conjunction with the FDA. It takes at least six months to obtain approval of the application for patent term extension. 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. If we are unable to obtain patent term extension or restoration or the term of any such extension is less than we request, the period during which we will have the right to exclusively market our product will be shortened and our competitors may obtain earlier approval of competing products, and our ability to generate revenues could be materially adversely affected.

The trading price of our common stock is likely to be volatile. Our stock price could be subject to wide fluctuations in response to a variety of factors, including the following:

In addition, the stock market, in general, and small biopharmaceutical companies, in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. Further, a decline in the financial markets and related factors beyond our control may cause our stock price to decline rapidly and unexpectedly.

An active trading market for our common stock may not be sustained, and you may not be able to resell your common stock at a desired market price.

If no active trading market for our common stock is sustained, you may be unable to sell your shares when you wish to sell them or at a price that you consider attractive or satisfactory. The lack of an active market may also adversely affect our ability to raise capital by selling securities in the future, or impair our ability to acquire or in-license other drug candidates, businesses or technologies using our shares as consideration.

*Our management owns a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.

As of September 30, 2024, our executive officers, directors and 5% or greater stockholders beneficially owned 32.7% of our common stock. Therefore, our executive officers, directors and 5% or greater stockholders have the ability to influence us through this ownership position.

This concentration of stock ownership may adversely affect the trading price for our common stock because investors often perceive disadvantages in owning stock in companies with controlling stockholders. As a result, these stockholders, if they acted together, could materially influence all matters requiring approval by our stockholders, including the election of directors and the approval of mergers or other business combination transactions. These stockholders may be able to determine all matters requiring stockholder approval. The interests of these stockholders may not always coincide with our interests or the interests of other stockholders. This may also prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders and they may act in a manner that advances their best interests and not necessarily those of other stockholders, including seeking a premium value for their common stock, and might affect the prevailing market price for our common stock.

We are no longer a “smaller reporting company” within the meaning of the Securities Act of 1933, as amended, and as a result we are subject to certain enhanced disclosure requirements which will require us to incur significant expenses and expend time and resources.

We are no longer a “smaller reporting company,” as of January 1, 2024 and, as a result, we are or will be required to comply with various disclosure and compliance requirements that did not previously apply, such as the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act, the requirement that we hold a nonbinding advisory vote on executive compensation and obtain shareholder approval of any golden parachute payments not previously approved, the requirement to provide full and more detailed executive compensation disclosure and the reduction in the amount of time for filing our periodic and annual reports. Compliance with these additional requirements increases our legal and financial compliance costs and causes management and other personnel to divert attention from operational and other business matters to these additional public company reporting requirements. In addition, if we are not able to comply with changing requirements in a timely manner, the market price of our stock could decline and we could be subject to delisting proceedings by the stock exchange on which our common shares are listed, or sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources.

We became a large-accelerated filer effective January 1, 2024. We reassessed, as of June 30, 2024, and determined that we continue to qualify as a large accelerated filer for filings beyond the fiscal year ending December 31, 2024. We will need to reassess, as of June 30, 2025, whether we will continue to qualify as a large accelerated filer for filings beyond the fiscal year ending December 31, 2025.

Our internal control over financial reporting may not meet the standards required by Section 404 of the Sarbanes-Oxley Act, and failure to achieve and maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act, could have a material adverse effect on our business and share price.

During the fiscal year 2023, our management was required to report, on a quarterly basis, on the effectiveness of our internal control over financial reporting. Commencing with the fiscal year ended December 31, 2023, in addition to our management’s report on the effectiveness of our internal controls over financial reporting, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404. The rules governing the standards that must be met for our management and our independent registered public accounting firm to assess our internal control over financial reporting are complex and require significant documentation, testing and possible remediation.

In connection with the implementation of the necessary procedures and practices related to internal control over financial reporting, we may identify deficiencies or material weaknesses that we may not be able to remediate in time to meet the deadline imposed by the Sarbanes-Oxley Act for compliance with the requirements of Section 404. In addition, we may encounter problems or delays in completing the implementation of any requested improvements and receiving a favorable attestation in connection with the attestation provided by our independent registered public accounting firm. Failure to achieve and maintain an effective internal control environment could have a material adverse effect on our business, financial condition and results of operations and could limit our ability to report our financial results accurately and in a timely manner.

As a result of operating as a public company, we may incur significantly increased costs and our management and other personnel will be required to devote substantial time to new compliance initiatives.

As a public company and particularly after December 31, 2023, when we ceased to be a “smaller reporting company” and “non-accelerated filer,” and became a “large accelerated filer”, we expect to incur additional significant legal, accounting and other expenses. In addition, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, or the Dodd-Frank Act, as well as rules subsequently implemented by the SEC and The Nasdaq Stock Market LLC have imposed various requirements on public companies. There are significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that require the SEC to adopt additional rules and regulations in these areas. Stockholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact (in ways we cannot currently anticipate) the manner in which we operate our business. We have a small management team that, along with other personnel, will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. For example, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain our current levels of such insurance coverage.

As a publicly traded company, we have incurred and will incur legal, accounting and other expenses associated with the SEC reporting requirements applicable to a company whose securities are registered under the Exchange Act, as well as corporate governance requirements, including those under the Sarbanes-Oxley Act, the Dodd-Frank Act and other rules implemented by the SEC and The Nasdaq Stock Market LLC. In addition, we expect that we will need to hire additional personnel in our finance department to help us comply with the various requirements applicable to public companies. The expenses incurred by public companies generally to meet

SEC reporting, Sarbanes-Oxley Act compliance, finance and accounting and corporate governance requirements have been increasing in recent years as a result of changes in, and the adoption of, new rules and regulations applicable to public companies.

If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our stock price and trading volume could decline.

The trading market for our common stock depends, in part, on the research and reports that securities or industry analysts publish about us or our business. If one or more of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline. In addition, if our operating results fail to meet the forecast of analysts, our stock price would likely decline. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for our common stock could decrease, which might cause our stock price and trading volume to decline.

Sales of a substantial number of shares of our common stock in the public market by our existing stockholders or future issuances of our common stock or rights to purchase our common stock, could cause our stock price to fall.

Sales of a substantial number of shares of our common stock by our existing stockholders in the public market, or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that such sales may have on the prevailing market price of our common stock.

Our management will continue to have broad discretion over the use of the proceeds we received from our prior financings and available cash, and might not apply the proceeds in ways that increase the value of your investment.

Our management will continue to have broad discretion to use the net proceeds from our prior financings and available cash and you will be relying on the judgment of our management regarding the application of these proceeds. Our management might not apply the proceeds in ways that ultimately increase the value of your investment and the failure by our management to apply these proceeds effectively could harm our business. Because of the number and variability of factors that will determine our use of these remaining net proceeds, their ultimate use may vary substantially from their currently intended use. If we do not invest or apply these net proceeds in ways that enhance stockholder value, we may fail to achieve the expected financial results, which could cause our stock price to decline.

In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because biopharmaceutical companies have experienced significant stock price volatility in recent years. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business, financial condition and results of operations.

Our ability to use our net operating loss carryforwards may be subject to certain limitations.

As of December 31, 2023, we had approximately $98.7 million of federal net operating loss carryforwards, of which $17.8 million will begin to expire in 2032 and the remaining $80.9 million of which can be carried forward indefinitely. We have $79.9 million of state net operating loss carryforwards that will begin to expire in 2034.

Our ability to utilize our federal net operating loss carryforwards may be limited under Section 382 of the Internal Revenue Code of 1986, as amended, or the Code. In the event of an “ownership change,” Section 382 imposes an annual limitation on the amount of post-ownership change taxable income that may be offset with pre-ownership change net operating losses of the loss corporation experiencing the ownership change. An “ownership change” is defined by Section 382 as a cumulative change in ownership of our company of more than 50% within a three-year period. Additionally, we have determined that our underwritten public offering of common stock completed in February 2018 resulted in an “ownership change” of us. However, as of December 31, 2023, there is no limitation on the federal and state net operating losses. In addition, current or future changes in our stock ownership may trigger an “ownership change,” some of which may be outside our control. Accordingly, our ability to utilize our net operating loss carryforwards to offset federal taxable income, if any, will likely be limited by Section 382, which could potentially result in increased future tax liability to us.

We may never pay dividends on our common stock so any returns would be limited to the appreciation of our stock.

We have never declared or paid any cash dividend on our common stock. We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. Any return to stockholders will therefore be limited to the appreciation of their stock.

Provisions in our amended and restated certificate of incorporation and our amended and restated bylaws, as well as provisions of Delaware law, could make it more difficult or expensive for a third party to acquire us or change our board of directors or current management.

Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts by our stockholders to replace or remove our current management. These provisions include:

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, which is responsible for appointing the members of our management. In addition, we are subject to Section 203 of the General Corporation Law of the State of Delaware, or the DGCL, which generally prohibits a Delaware corporation from engaging in any of a broad range of business combinations with an interested stockholder for a period of three years following the date on which the stockholder became an interested stockholder, unless such transactions are approved in advance by our board of directors or ratified by our board of directors and certain of our stockholders. This provision could have the effect of delaying or preventing a change in control, whether or not it is desired by or beneficial to our stockholders. Further, other provisions of Delaware law may also discourage, delay or prevent someone from acquiring us or merging with us.

Our amended and restated bylaws designate the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.

Our amended and restated bylaws provide that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for (1) any derivative action or proceeding brought on our behalf, (2) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee to us or our stockholders, (3) any action asserting a claim against us or our directors, officers or employees arising pursuant to any provision of our amended and restated bylaws, our amended and restated certificate of incorporation or the DGCL, (4) any action asserting a claim against us or our directors, officers or employees that is governed by the internal affairs doctrine, or (5) any action to interpret, apply, enforce or determine the validity of our amended and restated bylaws or our amended and restated certificate of incorporation. Any person purchasing or otherwise acquiring any interest in any shares of our capital stock shall be deemed to have notice of and to have consented to this provision of our amended and restated bylaws. This choice-of-forum provision may limit our stockholders’ ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits. In addition, a stockholder that is unable to bring a claim in the judicial forum of its choosing may be required to incur additional costs in the pursuit of actions that are subject to these exclusive forum provisions, particularly if the stockholder does not reside in or near Delaware. Alternatively, if a court were to find this provision of our amended and restated bylaws inapplicable or unenforceable with respect to one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could materially and adversely affect our business, financial condition and results of operations.

本報告的附件101封面附上了以下內容的iXBRL（內嵌可擴展業務報告語言）格式：（i）截至2024年9月30日和2023年12月31日的綜合資產負債表，（ii）2024年9月30日和2023年三個月和九個月的綜合損益表，（iii）2024年9月30日和2023年三個月和九個月的股東權益（赤字）綜合表，（iv）2024年9月30日和2023年九個月的綜合現金流量表，及（v）綜合財務報表附註。

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


特拉華州		46-1073877
（國家或其他管轄區的公司成立或組織）		（IRS僱主（標識號碼）

9920 Pacific Heights Blvd, 第350號套房聖地亞哥, 加利福尼亞州		92121
(主要領導機構的地址)		(郵政編碼)


根據證券法第12(b)條註冊的證券

每種類別的證券	交易代碼	名稱爲每個註冊的交易所:
普通股，面值0.00001美元每股。	VKTX	納斯達克證券交易所 LLC




第一部分	財務信息	1

項目1。	基本報表	1

	2024年9月30日的合併資產負債表（未經審計）和2023年12月31日	1

	截至2024年9月30日和2023年的三個和九個月的合併損益表和綜合損益表（未經審計）	2

	截至2024年9月30日和2023年的三個和九個月的合併股東權益報表（未經審計）	3

	2024年9月30日止的未經審計的綜合現金流量表和2023年	5

	合併財務報表註釋（未經審計）	6

事項二	分銷計劃	20

第3項。	有關市場風險的定量和定性披露	27

事項4。	控制和程序	27

第二部分	其他信息	29

項目1。	法律訴訟	29

項目1A。	風險因素	29

事項二	未註冊的股票股權銷售和籌款用途	63

第3項。	對優先證券的違約	63

事項4。	礦山安全披露	63

項目5。	其他信息	63

項目6。	展示資料	64

簽名		65


	2020年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	$	50,347		$	55,516
可供出售的短期投資 - 可供出售		880,093			306,563
預付臨床試驗和臨床前研究費用		4,476			2,624
資產預付款和其他流動資產的變動		1,733			2,522
總流動資產		936,649			367,225
租賃資產		1,113			1,126
遞延融資成本		80			106
存款		46			33
總資產	$	937,888		$	368,490
負債和股東權益
流動負債:
應付賬款	$	254		$	7,512
其他應計負債		24,951			11,299
租賃負債，流動		480			324
流動負債合計		25,685			19,135
租賃負債，扣除流動部分後淨值		755			936
長期負債總額		755			936
負債合計		26,440			20,071
承諾和擔保（其他)注7)
股東權益:
優先股，$0.00010.00001面值：10,000,0002024年9月30日和2023年12月31日授權的股份數；否2024年9月30日和2023年12月31日已發行和流通的股份數。		—			—
普通股，每股面值爲 $0.0001；0.00001面值：300,000,0002024年9月30日和2023年12月31日授權的股份； 111,434,8212024年9月30日的已發行股份和流通股份； 100,113,770截至2023年12月31日發行並流通的股票爲		1			1
成本法下的庫藏股，否股份於2024年9月30日。 2,193,251　　股，截至2023年12月31日		—			(6,795	)
額外實收資本		1,362,305			733,546
累積赤字		(452,490	)		(377,944	)
累計其他綜合損失		1,632			(389	)
股東權益總額		911,448			348,419
負債和股東權益總額	$	937,888		$	368,490


	三個月結束 2020年9月30日						九個月結束 2020年9月30日
	2024			2023			2024			2023
收入	$	—		$	—		$	—		$	—
營業費用：
研發		22,785			18,379			70,657			43,304
ZSCALER, INC.		13,771			8,886			34,026			28,238
營業費用總計		36,556			27,265			104,683			71,542
經營虧損		(36,556	)		(27,265	)		(104,683	)		(71,542	)
其他收入（支出）：
融資成本攤銷		(24	)		(2	)		(70	)		(62	)
利息收入，淨額		11,531			4,733			30,096			10,314
投資實現收益，淨額		109			—			111			—
其他收入淨額		11,616			4,731			30,137			10,252
淨虧損		(24,940	)		(22,534	)		(74,546	)		(61,290	)
其他綜合損失，稅後淨額:
證券未實現收益		3,902			221			2,079			305
外匯翻譯收益（損失）		2			(86	)		(58	)		(108	)
綜合虧損	$	(21,036	)	$	(22,399	)	$	(72,525	)	$	(61,093	)
每股基本和稀釋淨損失	$	(0.22	)	$	(0.23	)	$	(0.69	)	$	(0.66	)
基本每股計算所使用的加權平均股份基本和稀釋每股淨損失		110,911			99,846			108,262			92,481


☒	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日結束的三個月期間
	普通股				額外的實繳		累積的			其他積累綜合			庫存股
	股份		數量		資本		$			收益（損失）			數量		總費用
2024年6月30日餘額		110,796,200	$	1	$	1,350,801	$	(427,550	)	$	(2,272	)	$	—	$	920,980
員工股票補償，淨額		—		—		8,982		—			—			—		8,982
與僱員稅額預扣相關的扣減股份		291,835		—		—		—			—			—		—
按員工股票計劃發行普通股		346,786		—		2,522		—			—			—		2,522
投資未實現收益		—		—		—		—			3,902			—		3,902
未實現的貨幣翻譯收益		—		—		—		—			2			—		2
淨虧損		—		—		—		(24,940	)		—			—		(24,940	)
2024年9月30日的餘額		111,434,821	$	1	$	1,362,305	$	(452,490	)	$	1,632		$	—	$	911,448


	2024年9月30日結束的九個月期間
	普通股					額外的實繳			累積的			其他積累綜合			庫存股
	股份			數量		資本			$			收益（損失）			數量			總費用
2023年12月31日結餘爲		100,113,770		$	1	$	733,546		$	(377,944	)	$	(389	)	$	(6,795	)	$	348,419
員工股權報酬，淨額		—			—		24,045			—			—			—			24,045
保留股份用於僱員稅款代扣		(541,876	)		—		(42,101	)		—			—			—			(42,101	)
按員工股票計劃發行普通股		2,994,974			—		9,813			—			—			—			9,813
普通股淨髮行額減去發行費用		8,867,953			—		637,002			—			—			6,795			643,797
投資未實現收益		—			—		—			—			2,079			—			2,079
未實現貨幣翻譯損失		—			—		—			—			(58	)		—			(58	)
淨虧損		—			—		—			(74,546	)		—			—			(74,546	)
2024年9月30日的餘額		111,434,821		$	1	$	1,362,305		$	(452,490	)	$	1,632		$	—		$	911,448


	截至2023年9月30日的三個月期間
	普通股				額外的實繳		累積的			其他積累綜合			庫存股
	股份		數量		資本		$			收益（損失）			數量			總費用
2023年6月30日的餘額		100,028,828	$	1	$	724,754	$	(330,805	)	$	(1,040	)	$	(6,795	)	$	386,115
員工股票補償淨額	—			—		4,481		—			—			—			4,481
普通股淨髮行額減去發行費用		—		—		43		—			—			—			43
投資未實現收益		—		—		—		—			221			—			221
未實現貨幣匯兌損失		—		—		—		—			(86	)		—			(86	)
淨虧損		—		—		—		(22,534	)		—			—			(22,534	)
2023年9月30日結餘		100,028,828	$	1	$	729,278	$	(353,339	)	$	(905	)	$	(6,795	)	$	368,240


	2023年9月30日結束的九個月期
	普通股					額外的實繳			累積的			其他積累綜合			庫存股
	股份			數量		資本			$			收益（損失）			數量			總費用
2022年12月31日結存餘額		78,257,258		$	1	$	445,267		$	(292,049	)	$	(1,102	)	$	(6,795	)	$	145,322
員工股權報酬，淨額		—			—		12,670			—			—			—			12,670
與僱員稅款代扣相關的扣減股份數		(509,686	)		—		(7,121	)		—			—			—			(7,121	)
按員工股票計劃發行普通股		2,274,752			—		6,580			—			—			—			6,580
普通股淨髮行額減去發行費用		20,006,504			—		271,882			—			—			—			271,882
投資未實現收益		—			—		—			—			305			—			305
未實現的貨幣翻譯損失		—			—		—			—			(108	)		—			(108	)
淨虧損		—			—		—			(61,290	)		—			—			(61,290	)
2023年9月30日結餘		100,028,828		$	1	$	729,278		$	(353,339	)	$	(905	)	$	(6,795	)	$	368,240


	2024年9月30日止九個月
預期波動率		82.86	%
預計期限（年）		6.10
無風險利率		3.86	%
預期股息率	0		%


	Three Months Ended September 30,				$ Change		% Change
	2024		2023
Research and development expenses	$	22,785	$	18,379	$	4,406		24.0	%


	截至9月30日的九個月				$ 改變		% 改變
	2024		2023
研究和開發費用	$	70,657	$	43,304	$	27,353		63.2	%


	截至9月30日的九個月
	2024			2023
經營活動現金流
淨虧損	$	(74,546	)	$	(61,290	)
用於調節淨虧損額與經營活動現金流量的淨額的調整：活動變動的現金流量:
投資溢價攤銷		(13,236	)		(5,500	)
融資成本攤銷		70			62
以股票爲基礎的報酬計劃		24,045			12,670
攤銷租賃權資產		236			218
投資的已實現收益		(111	)	—
與經營租賃責任相關的利息費用		27			33
經營性資產和負債變動:
資產預付款和其他流動資產的變動		(1,059	)		6,466
應計利息，減去投資到期應收利息淨額		1,845			422
應付賬款		(7,258	)		(2,819	)
應計費用		13,652			(5,738	)
租賃負債		(274	)		(260	)
經營活動使用的淨現金流量		(56,609	)		(55,736	)
投資活動現金流量
投資購買		(976,408	)		(380,770	)
投資到期收回款		416,458			165,951
投資活動產生的淨現金流出		(559,950	)		(214,819	)
籌資活動現金流量
發行公開股份淨額，扣除發行費用		597,094			269,760
與僱員稅款預扣相關的股票扣留價值		(42,101	)		(7,121	)
來自期權行權和員工股票購買計劃普通股發行的所得款項		9,813			6,580
ATM發行，扣除費用後淨額		46,658			1,969
籌資活動產生的現金淨額		611,464			271,188
現金及現金等價物淨增加額（減少額）		(5,095	)		633
現金及現金等價物期初餘額		55,516			36,632
匯率變動對現金的影響		(74	)		(80	)
期末現金及現金等價物餘額	$	50,347		$	37,185

非現金投資和融資的補充披露交易
未支付的遞延公開發行和其他融資成本	$	50		$	50
獲得的租賃義務換取的租賃資產	$	223		$	—


	截至9月30日的九個月
	2024			2023
用於經營活動的現金	$	(56,609	)	$	(55,736	)
用於投資活動的現金	$	(559,950	)	$	(214,819	)
融資活動提供的現金	$	611,464		$	271,188


姓名及職稱	採納日期	計畫類型	根據交易安排出售的普通股股數總計	期限
Greg Zante, 致富金融(臨時代碼)	2024年7月29日	10b5-1規則交易安排	131,687	2025年3月31日(1)


展覽數字	描述	申報人的表格	提交日期隨著這個美國證券交易委員會	展覽數字

3.1	公司修正和重立公司章程。	S-1	7/1/2014	3.3

3.2	2023年5月9日生效的維京生物製藥公司修訂後的章程。	8-K	5/11/2023	3.1

4.1	普通股證書形式。	S-1	7/1/2014	4.1

31.1	依照1934年證券交易法13a-14(a)或15d-14(a)規定，總執行長的證明。

31.2	依照1934年證券交易法13a-14(a)或15d-14(a)規定，財務主管的證明。

32.1	根據適用於Sarbanes-Oxley法案第906條的18 U.S.C.第1350條，首席執行官和信安金融主管的認證。

101.INS	內聯XBRL實例文檔-該實例文檔未出現在交互數據文件中，因為其XBRL標籤嵌入在內聯XBRL文檔中。

101.SCH	具有嵌入鏈接庫文件的內聯XBRL分類擴展架構。

104	封面頁交互式資料文件（格式為內嵌XBRL，包含在Exhibit 101中）。


	Nine Months Ended September 30,				$ Change		% Change
	2024		2023
Total other income, net	$	30,137	$	10,252	$	19,885		194.0	%


(in thousands)	September 30, 2024		December 31, 2023
Cash and cash equivalents	$	50,347	$	55,516
Short-term investments – available-for-sale	$	880,093	$	306,563
Total	$	930,440	$	362,079


	Viking Therapeutics, Inc.

日期：2024年10月23日	作者：	/s/ 廉建穎博士。
		Brian Lian博士。
		總裁、致富金融(臨時代碼)執行長兼董事（首席執行官）

日期：2024年10月23日	作者：	/s/ 格雷格·贊特
		格雷格·贊特
		致富金融(臨時代碼) （財務長兼會計主管）