10-K

如果註冊人是《證券法》第405條所定義的知名經驗豐富的發行人，則通過複選標記進行驗證。是的☐沒有☒

如果註冊人無需根據該法案第13或15（d）條提交報告，則通過勾選標記進行驗證。是的☐沒有☒

通過複選標記確定登記人是否：（1）在過去12個月內（或在登記人被要求提交此類報告的較短期限內）提交了1934年證券交易法第13或15（d）條要求提交的所有報告，以及（2）在過去90天內是否遵守此類提交要求。是的 ☒ 沒有 ☐

通過勾選來驗證註冊人是否已在過去12個月內（或在註冊人被要求提交此類文件的較短期限內）以電子方式提交了根據S-T法規第405條（本章第232.405條）要求提交的所有交互數據文件。是的 ☒ 沒有 ☐

通過勾選標記來確定註冊人是大型加速歸檔者、加速歸檔者、非加速歸檔者、小型報告公司還是新興成長型公司。請參閱《交易法》第120億.2條規則中「大型加速備案人」、「加速備案人」、「小型報告公司」和「新興成長型公司」的定義。

如果是新興成長型公司，請通過勾選標記表明註冊人是否選擇不利用延長的過渡期來遵守根據《交易法》第13（a）條規定的任何新的或修訂的財務會計準則。 ☐

通過勾選標記檢查註冊人是否已提交報告並證明其管理層根據《薩班斯-奧克斯利法案》（15 U.S.C.）第404（b）條對其財務報告內部控制有效性的評估7262（b））由編制或發行其會計師事務所

如果證券是根據該法案第12（b）條登記的，請通過勾選標記表明文件中包含的登記人的財務報表是否反映了對先前發佈的財務報表錯誤的更正。 ☐

通過勾選標記來驗證這些錯誤更正是否是需要根據第240.10D-1（b）條對註冊人的任何高管在相關收回期內收到的激勵性補償進行收回分析的重述。 ☐

通過勾選標記檢查註冊人是否是空殼公司（定義見該法案第120億.2條規則）。是的☐沒有 ☒

註冊人非附屬公司持有的有投票權和無投票權普通股的總市值約爲美元38.7 截至2024年6月28日（註冊人最近完成的第二財年的最後一個工作日），百萬美元，基於（i）3，191，425股普通股，每股面值0.0001美元，已發行，包括3，067，732股有投票權普通股，每股面值0.0001美元和123，693股無投票權普通股，每股面值0.0001美元，和（ii）註冊人普通股於該日期在納斯達克資本市場的收盤銷售價格。

截至2025年3月6日，註冊人有 6,114,311 普通股，每股面值0.0001美元，已發行，包括 5,314,311 有投票權普通股，每股面值0.0001美元， 800,000 無投票權普通股，每股面值0.0001美元。該數字不包括截至2025年3月6日尚未發行的預先融資認購權行使後可發行的4，363，916股普通股（可立即以每股普通股0.0025美元和0.0001美元的行使價格行使，但須遵守受益所有權限制）於10月23日在註冊人的私募中出售，2023年和2025年2月13日。參見注釋8- 註冊人已審計財務報表的普通證和預融資證。

這份Form 10-K年度報告包含有關我們的業務、運營和財務業績和狀況的前瞻性陳述，以及我們對業務、運營和財務業績和狀況的計劃、目標和預期。本文中包含的任何非歷史事實的陳述均可被視爲前瞻性陳述。這些表述涉及已知和未知的風險、不確定性和其他重要因素，這些因素在某些情況下是我們無法控制的，可能導致我們的實際結果、業績或成就與前瞻性表述中明示或暗示的任何未來結果、業績或成就大不相同。

在某些情況下，您可以通過諸如「目標」、「預期」、「假設」、「相信」、「考慮」、「繼續」、「可能」、「到期」、「估計」、「預期」、「目標」、「打算」、「可能」、「目標」、「計劃」、「預測」、「潛在」、「定位」、「尋求」、「應該」等術語來識別前瞻性陳述，「Target」、「Will」、「Will」和其他類似的表達，是對未來事件和未來趨勢的預測或指示，或這些術語或其他類似術語的否定。這些前瞻性陳述包括但不限於關於以下方面的陳述：

這些前瞻性陳述主要基於管理層對我們經營的業務和行業的當前預期、估計、預測和預測，以及管理層的信念和假設，並不是對未來業績或發展的保證，涉及已知和未知的風險、不確定性和其他在某些情況下超出我們控制範圍的因素。這些前瞻性陳述僅在本Form 10-K年度報告發佈之日發表，可能會受到題爲「風險因素」一節以及本Form 10-K年度報告其他部分所述的一系列風險、不確定性和假設的影響。由於前瞻性陳述固有地受到風險和不確定性的影響，其中一些風險和不確定性是無法預測或量化的，因此您不應依賴這些前瞻性陳述作爲對未來事件的預測。我們的前瞻性陳述中反映的事件和情況可能無法實現或發生，實際結果可能與前瞻性陳述中預測的結果大不相同。除適用法律另有要求外，在我們以Form 10-K形式分發本年度報告之前，無論是否有任何新信息、未來事件或其他原因，我們都不打算公開更新或修改本文中包含的任何前瞻性陳述。

此外，「我們相信」的聲明和類似聲明反映了我們對相關主題的信念和觀點。這些聲明基於截至本報告日期我們可用的信息，雖然我們相信此類信息構成了此類聲明的合理基礎，但此類信息可能是有限的或不完整的，並且我們的聲明不應被解讀爲表明我們已經對所有潛在可用的相關信息進行了詳盡的調查或審查。這些陳述本質上是不確定的，我們警告您不要過度依賴這些陳述。

投資者和其他人應該注意，我們可能會使用我們的投資者關係網站、證券交易委員會或SEC、文件、網絡廣播、新聞稿和電話會議向投資者宣佈重大業務和財務信息。我們使用這些媒體（包括我們的網站）與股東和公衆就我們的公司、我們的產品和其他問題進行溝通。我們提供的信息可能被視爲重要信息。因此，我們鼓勵投資者和對我們公司感興趣的其他人審查我們在我們網站上提供的信息。

上述風險因素摘要應與下文題爲「風險因素」的部分中完整風險因素的文本以及本年度報告10-K表格中列出的其他信息（包括我們的綜合財務報表和相關注釋）以及我們向SEC提交的其他文件中列出的其他信息一起閱讀。上面總結或下面完整描述的風險並不是我們面臨的唯一風險。我們尚未確切了解或我們目前認爲不重大的額外風險和不確定性也可能對我們的業務、財務狀況、運營業績和未來增長前景產生重大不利影響。

我們是一家臨牀階段的生物技術公司，專注於開發新型療法，以解決肝臟疾病和病毒感染中未滿足的醫療需求，包括慢性乙型肝炎病毒（HB）感染、代謝功能障礙相關脂肪肝炎（MASH）和冠狀病毒感染（例如，SARS-CoV-2、SARS-CoV、MERS-CoV和其他相關感染）。Aligos團隊在肝臟和病毒疾病的藥物開發和藥物化學方面擁有良好的成功記錄，併產生了三種潛在的一流候選藥物。

我們的候選藥物包括用於慢性乙肝感染的ALG-000184，用於甲型肝炎的ALG-055009，用於冠狀病毒感染的ALG-097558，以及一系列臨牀前計劃。ALG-000184是我們潛在的最好/一流的衣殼組裝調節劑(cAM-E)，與競爭對手的cAM-E藥物相比，具有更強的藥理特性，並顯示出比標準護理、核苷酸(T)類似物(Nas)以及多對數更強的對乙肝病毒脫氧核糖核酸(HBVdna)的抑制作用10在一項正在進行的、多部分的1期臨牀試驗中，病毒抗原的減少持續了96周。ALG-055009是我們潛在的同類中最好的甲狀腺激素受體β(Thr-β)激動劑，與競爭對手Thr-β激動劑相比，具有增強的藥理特性。2a期TOPLINE數據顯示，ALG-055009劑量組達到了主要終點，根據磁共振成像質子密度脂肪分數(mri-pdff)的測量，第12周時肝臟脂肪顯著減少。ALG-097558是我們潛在的同類最佳小分子冠狀病毒3CL蛋白酶抑制劑(PI)，在基於細胞的冠狀病毒感染檢測中的效力至少是其他獲批冠狀病毒PI的3倍，並且根據迄今進行的第一階段臨牀研究，可以每天服用兩次，而不需要同時服用利托那韋。

我們專注於肝臟和病毒疾病，我們的員工在這些領域擁有專業知識和數十年的經驗。在慢性乙型肝炎感染領域，我們最先進的候選藥物ALG-000184在擾亂乙型肝炎生命週期方面發揮着重要作用，具有更強的病毒抑制作用以及減少病毒抗原，並有可能取代標準護理NA併成爲下一代治療的支柱。我們已通過2a期研究推進了MASH的THR-β激動劑，並正在評估各種選擇來資助持續開發，包括潛在的對外許可。我們用於治療COVID-19的不含利托那韋的泛冠狀病毒蛋白酶抑制劑（PI）在一項1期研究中似乎也得到了有利的區分，目前正在對高危COVID-19患者進行臨牀研究。

慢性乙型肝炎病毒感染是世界上最常見的病毒感染，也是一個巨大的醫療需求未得到滿足的領域。儘管有有效的預防性疫苗，但全球仍有超過29600萬慢性攜帶者，每年仍有約150萬人新感染。2019年，僅中國就有超過9000萬例慢性乙型肝炎感染病例，而歐盟、美國和日本就有近800萬例。根據世界衛生組織（WHO）的數據，慢性乙型肝炎感染的併發症包括肝硬化、終末期肝臟疾病和肝細胞癌（HepG），這些併發症在2022年總共導致約110萬人死亡。慢性乙型肝炎病毒感染是全球範圍內肝癌的主要原因，與乙型肝炎相關的死亡率持續增加。

主要治療目標是將HBVDNA降低至無法檢測的水平，使肝酶正常化，預防肝損傷並降低發生肝癌的風險。世界衛生組織2024年指南目前建議在存在嚴重纖維化、或乙型肝炎病毒DNA > 2，000 IU/mL且ALT>ULN、或存在特殊風險因素的情況下進行治療。目前針對慢性乙型肝炎感染的治療可能需要終生治療，並且無法消除大量患者中的病毒。就NAs而言，長期治療可以降低體循環中的HBVDNA量，從而改善長期疾病結局，但治療停止後病毒學復發很常見。此外，某些患者在接受NA治療期間繼續發展爲肝臟疾病。

我們對ALG-000184的目標是實現更高的病毒抑制率（通過HBVDNA和HBV標誌物組合測量），有可能取代標準護理NA治療併成爲下一代治療的支柱。這包括有可能有意義地提高功能性治癒率，功能性治癒率被定義爲在有限療程後，有或沒有乙型肝炎表面抗體血清轉化的情況下，乙型肝炎病毒DNA持續喪失。此外，ALG-000184有可能治療所有慢性乙型肝炎患者，並有可能降低乙型肝炎病毒表面抗原，這可能使更多患者有資格接受治療。

我們開發了一系列治療慢性乙型肝炎的差異化候選藥物組合，包括一種已進入臨牀開發的小分子CAM-E，旨在干擾乙型肝炎病毒的生命週期。我們還在尋求一種策略，通過靶向PD-1 / PD-L1途徑來恢復慢性乙型肝炎患者的免疫功能，並最近選擇了一種開發候選藥物ALG-093940。

ALG‑000184：潛在的一流小分子CAM‑E代表慢性乙型肝炎病毒感染

2018年，我們從埃默裏大學Raymond S****教授的實驗室獲得了一種主要候選藥物（GLP-26）和CAM-E的相關IP的許可。我們的科學家優化了這一候選先導藥物，以發現高效的CAM-E ALG-001075，並進一步優化爲前藥ALG-000184。與其他已知CAM相比，ALG-000184具有優異的DMPK性質，吸收增強和肝臟吸收高，體外效力提高約2-300倍。

CAM-E 是一類小分子抗病毒藥物，可加速乙型肝炎病毒殼組裝並抑制pgRNA再聚化（第一MOA），導致病毒殼空並降低循環中的乙型肝炎病毒DNA和RNA水平。CAM-Es還被認爲可以調節ccDNA（第二MOA）的建立，ccDNA是導致乙肝病毒感染持續存在的主要因素，可以通過循環的乙肝抗原水平（乙型肝炎表面抗原、HBcr抗原和乙型肝炎e抗原）進行評估。在臨牀試驗中，競爭對手CAM-E顯示出HBVDNA和RNA減少（第一MOA），但很少或不一致地顯示出HBVDNA和RNA減少（第二MOA）。還觀察到病毒CAM-E耐藥性的出現。

一項多部分的I期研究正在進行中，已完成對ALG-000184在健康志願者（HVs）中的安全性、耐受性和藥代動力學特徵的評估。此外，還完成了一項劑量範圍探索的1期研究，該研究評估了在未經治療的慢性乙型肝炎病毒感染受試者中在28天內給予10-300毫克劑量的ALG-000184的安全性、藥代動力學和抗病毒活性。研究發現ALG-000184耐受性良好，PK特徵良好，並在所有測試劑量下均顯示出HBVDNA和RNA大幅降低，並且在接受300毫克ALG-000184的一個BEP陽性受試者亞組中也顯示出HBVDNA和RNA大幅降低（Hou等人，AASLD 2022）。

基於給藥高達300毫克ALG-000184 x 28天后的有利特徵，其他正在進行的隊列正在評估每天給藥高達300毫克ALG-000184（聯用或不聯用恩替卡韋（ETV））的安全性和有效性，在BEP +/-受試者中持續時間不超過96周。來自其中幾個隊列的初步數據（Agarwal等人，EASC 2024; Yuen等人，AASLD 2024）的研究表明，ALG-000184（± ETV）在給藥長達92周後耐受良好，表現出良好的PK特徵，並表現出潛在的一流抗病毒活性。具體來說，抗病毒活性數據表明300毫克ALG-000184單藥治療導致

HBVDNA的顯著減少，這比單獨使用ETV實現的效果更大(圖3)。此外，無論單獨使用ALG-000184還是與ETV聯合使用，對HBVDNA的抑制程度都是相似的，這可能表明ETV對觀察到的HBVDNA降低效果沒有顯著貢獻。同樣值得注意的是，根據HBVdna水平評估，alg-000184單一治療與病毒突破無關。 (圖3)。這些數據表明，通過CAM-E第一個MOA產生了強大的抗病毒效果。抗病毒活性數據也表明，ALG-000184可能抑制cccDNA的建立(第二個MOA)，第二個MOA是維持乙肝病毒生命週期的重要組成部分，破壞它可能會提高功能治癒率。圖4中可以找到抑制cccDNA建立/補充的證據，其中多種重要的cccDNA衍生病毒抗原(乙肝表面抗原、HBcrAg和HBeAg)的比率隨着時間的推移和劑量反應的方式而降低(袁等人，AASLD 2024)。

圖4 - 300毫克ALG的抗病毒作用‑000184慢性乙型肝炎感染受試者（e抗原+）的單藥治療

對乙型肝炎e抗原+/-受試者的給藥將持續到2025年，96周的安全性、PK和抗病毒活性數據將在即將舉行的科學會議上公佈。預計將於2025年開始與mipeg干擾素阿爾法-20億進行的探索性聯合研究。此外，一項隨機、雙盲、活性對照II期研究正在進行中，該研究旨在在乙型肝炎e抗原+和乙型肝炎e抗原-受試者中進行ALG-000184與富馬酸替諾福韋二索普利單藥治療，II期研究預計將於2025年中期開始。

飲食不當和運動不足的影響之一是肝臟中脂肪堆積，被稱爲代謝功能障礙相關性脂肪變性肝病(MASLD)，據估計，截至2019年，全球約30%的人口會發生這種疾病。據估計，全球1.5%至6.5%的人口對這些多餘的脂肪沉積有持續的炎症反應，以前被稱爲NASH(非酒精性脂肪性肝炎)，現在被稱爲MASH。在過去的幾年裏，MASH的患病率持續上升。僅在美國，甲型肝炎的患病率預計將從2015年的約1650萬增加到2030年的2700萬。在不改變飲食和運動的情況下，MASH固有的炎症會持續存在，並可能導致進行性肝纖維化，從而可能導致肝硬化。這些纖維化改變與許多疾病相關，包括因肝硬變、肝細胞癌併發症而反覆住院、需要肝移植和死亡。

ALG‑055009：潛力最佳‑在……裏面‑類小分子THR‑b MASH激動劑

甲狀腺激素三碘甲狀腺原寧（T3）對全身具有許多生理作用，從增加新陳代謝（包括脂肪代謝）到刺激生長和發育。T3通過結合甲狀腺激素受體（THR）發揮作用，該受體有兩種亞型：阿爾法（THR-a）和貝塔（THR-b).兩種THR亞型的分佈因器官而異，THR-b 主要在肝臟中表達，THR-a主要在其他組織中表達（例如，心臟、骨骼肌和骨骼）。瑞美替隆等藥物優先結合THR-b 臨牀試驗表明，亞型可以降低血清和肝臟中的脂質水平，同時避免與THR-a刺激相關的不必要影響。除了降低MASH患者肝臟脂質水平的預期效果外，還通過THR-降低血清脂質水平b 激動症還可能對該人群產生有利的心血管後果，該人群患有潛在心血管疾病的比例很高。

最先進的THR-b 激動劑是瑞美替隆，根據有利的3期數據，於2024年3月獲得FDA批准（Harrison等人，EASC 2023）。該藥物已被證明可顯着降低肝臟和血清中的脂質水平，並且迄今爲止，具有可接受的風險效益。此外，瑞美替隆在3期中證明了MASH消退和纖維化改善的組織學證據，這都是FDA批准的MASH終點。我們的THR-b 候選藥物ALG-055009可能比該化合物具有重要優勢。在HEK 293萬億細胞中進行的基於細胞的並行實驗表明，ALG-055009的效力高出50倍，選擇性高出2倍 b 受體與瑞美替隆相比。

ALG-055009在HIV（口服單次給藥）和高脂血症受試者（每日口服14劑）中的首次人體研究已經完成。此前，EASC 2022和AASLD 2023分別報告了單次給藥高達4毫克和每日多次給藥高達1毫克的數據。在這些會議上，提供的數據表明ALG-055009耐受性良好，具有劑量成比例的PK和低變異性，並表現出預期的擬甲狀腺效應（即，性激素結合球蛋白通常與劑量成比例增加，各種致動脈粥樣硬化脂質和甲狀腺激素減少，而沒有任何甲狀腺功能障礙的臨牀證據）。

第二項1期研究也已完成，該研究評估了ALG-055009和阿託伐他汀之間是否存在藥物間相互作用（DID）的可能性，數據表明阿託伐他汀之間沒有臨牀意義的安全性問題或DID的證據。

我們於2024年根據開放研究性新藥申請（IND）的修正案完成了2a期概念驗證研究（HERALD）。該研究設計爲一項爲期12周的隨機、雙盲、安慰劑對照試驗，在102名疑似肝纖維化1-3期（F1-F3）MASH的受試者中評估4劑ALG-055009與安慰劑的治療。本研究的主要終點是第12周通過MRI-PDFF測量的肝臟脂肪含量的相對變化百分比。本研究還評估了ALG-055009治療的安全性和PK及其對多種其他療效生物標誌物的影響。

每日口服一次ALG-055009治療12周的患者達到了主要終點，第12周時肝臟脂肪含量顯著減少。劑量爲0.5毫克至0.9毫克的ALG-055009在第12周顯示肝臟脂肪顯著減少，經安慰劑調整的中位數相對減少達46.2%，根據磁共振成像-PDFF值(圖5)。與基線相比，多達70%的受試者的肝臟脂肪相對減少了30%，這是≥消退和減少纖維化方面的組織學改善的積極預後指標。18名接受穩定的GLP-1激動劑治療的受試者有資格參加這項研究，根據磁共振成像-PDFF值，肝臟脂肪含量符合基線時≥10%的納入標準。值得注意的是，服用ALG-055009的14名服用穩定的GLP-1激動劑的受試者中有11名肝臟脂肪減少，而服用安慰劑的服用穩定的GLP-1激動劑的4名受試者中有4名在12周的服藥期內肝臟脂肪增加(圖6)。

注：0.9毫克劑量組僅入組體重> 85公斤的受試者，其他劑量組不實施體重限制。來自MRI-PDFF分析數據集的數據，定義爲在基線和第12周均獲得MRI-PDFF測量結果的所有隨機受試者;安慰劑組的中位數變化%爲+7.2%; *p<0.05 *p<0.001。

致動脈粥樣硬化脂質（包括LDL-C、脂蛋白（a）和載脂蛋白B）和劑量顯着減少‑觀察到性激素結合球蛋白的依賴性增加。特別是ALG‑055009證明，第12周脂蛋白（a）較基線呈劑量依賴性下降高達26.8%，脂蛋白（a）是對他汀類藥物治療耐藥性的心血管疾病的既定風險因素。ALG-055009治療耐受良好，接受ALG的受試者未發生嚴重不良事件‑055009. 1例既往失眠受試者因失眠惡化的治療後出現的不良事件（AAA）而停藥。大多數TEAEs爲輕度或中度，沒有臨牀甲狀腺功能減退/功能減退。未觀察到具有臨牀意義的實驗室、心電圖、體檢或生命體徵趨勢/結果。與安慰劑相比，活性劑量組的腹瀉率相似，沒有劑量反應。

基於其良好的效力/選擇性和PK，我們相信ALG-055009有潛力成爲同類最佳的THR-b 激動劑，並可能在未來的MASH聯合方案中發揮不可或缺的作用。20億期賦能活動正在進行中，預計將於2025年中期完成。我們還在與關鍵意見領袖一起評估潛在的200億期臨牀試驗研究設計。最後，我們正在評估各種爲持續開發提供資金的選擇，包括潛在的對外許可。

新冠肺炎大流行已經感染了76000多名萬患者，並導致全球700多名萬患者死亡(世衛組織-2025年1月14日)，其中包括美國的約120名萬患者。SARS-CoV-2是繼中東呼吸綜合徵(MERS)和SARS冠狀病毒(SARS-CoV-1)之後，在過去20年中已知的第三種由動物傳播到人類的冠狀病毒，並導致顯著的發病率和死亡率。由於新冠肺炎大流行和未來出現更多新型冠狀病毒的風險，需要開發具有泛冠狀病毒活性的新療法，這些療法具有很高的抗藥性屏障。雖然現在有多種疫苗可用，但疫苗接種不太可能對所有新出現的變種和/或廣泛採用完全有效，這表明仍然需要有效的治療方法。兩種口服療法已被批准用於門診治療新冠肺炎，但兩種療法都有重要限制，涉及次佳療效(核苷類似物Molnupiravir；默克；默克)或需要利托那韋(PF-07321332/nirmatrelvir，一種病毒蛋白酶抑制劑；輝瑞)。我們的候選藥物alg-097558的效力是它的3倍。在基於細胞的分析中，尼馬瑞韋與一組SARS-CoV-2變種(包括奧密克戎)相比，具有廣泛的泛冠狀病毒活性，並且不需要利托那韋增強。

ALG‑097558：潛力最佳‑在……裏面‑類小分子利托那韋‑自由盤‑冠狀病毒蛋白酶抑制劑

2024年，我們完成了對ALG-097558單次和多次（每日兩次給藥x 7天）在HIV中的安全性和藥代動力學的評估。在這項首次人體1期臨牀研究中，單次給藥高達2000毫克和多次給藥高達800毫克Q12 H，持續7天耐受良好，PK特徵可接受，表明不需要利托那韋加強治療，並且與咪達唑侖不存在臨牀相關的DID，這表明ALG-097558可以與CYP 3A 4代謝物聯合給藥。根據這些1期數據（Wilkes et al，RespiDart，2024），治療SARS-CoV-2的預計有效劑量範圍爲200 - 600毫克ALG-097558 Q12 H x 5天。

ALG-097558於2024年開始了另外三項臨牀試驗。AGILE利物浦大學是一項英國政府支持的平台試驗（MRC和Wellcome Trust資助），正在贊助並開展一項針對高危COVID-19患者的研究，評估ALG-097558作爲單藥治療或與瑞德西韋聯合治療。此外，兩項評估特殊人群（腎/肝損傷受試者）PK的臨牀研究正在進行中，資金來自NIAID合同。NIAID還贊助了一項藥物相互作用和相對生物利用度研究

預計將於2025年第二季度開始給藥的健康志願者。我們預計ALG-097558的未來開發，包括正在進行的第二階段支持活動，將由外部來源資助，包括下文所述的公共資金來源。

我們冠狀病毒計劃的臨牀前活動部分資金來自美國國立衛生研究院(NIH)和國家過敏和傳染病研究所(NIAID)抗病毒藥物研發中心(AViDD)通過大都會抗病毒藥物加速器(MAVDA)財團開展的大流行關注病原體計劃。根據第75N93023C00052號合同，ALG-097558計劃和後續化合物的特定臨牀和非臨牀研究現在也由美國國家衛生研究院衛生與公衆服務部的聯邦資金資助。我們在2024年第三季度提交了IND，作爲NIAID合同的一部分，在2024年下半年啓動了對特殊人群的臨牀研究。我們預計將在這兩項獎勵和合同中獲得約1380美元的萬資金，以支持這些活動。我們還在尋求額外的外部資金(例如，來自政府機構)，以支持未來的研究(例如，第二階段)，因爲我們推進了ALG-097558，用於治療新冠肺炎和未來的冠狀病毒大流行。

除了我們的開發階段候選藥物外，我們還通過我們的藥物發現平台瞄準其他新型肝臟和病毒靶點。我們還在尋找備用候選人，以創建強大的資產組合，我們可以利用這些資產來爲我們所有感興趣的疾病領域創建優化的治療方案。

我們的管理團隊由一群高度協作、文化多元化的高管組成，擁有數十年的藥物發現和開發經驗，以及在病毒感染和肝臟疾病領域的成功記錄。我們管理團隊的大多數成員都曾在多家公司合作過，其中許多已經工作了十多年，並共同參與了許多已成功商業化的藥物的發現和/或開發，包括Ganova、Sovaldi、Infergen、Neupogen、Andexxa、Esbriet和Pegasys等。爲了支持我們的管理團隊，我們還組建了一個行業領先的董事會和一群世界一流的科學顧問，他們在肝臟疾病和病毒感染的藥物開發方面擁有豐富經驗。

我們的團隊在發現和開發針對肝臟和病毒疾病的藥物方面的集體經驗和成功，加上我們在藥物發現方面的內部專業知識，爲我們提供了一套差異化的能力，使我們能夠快速建立多種新藥候選產品的強大渠道。

我們的策略是開發NPS優化的候選藥物，旨在實現更好的治療結果。我們的重點領域是肝臟和病毒疾病，我們的團隊正在利用他們深入的知識和專業知識來開發潛在的治療方案，以解決大部分未滿足的醫療需求。我們業務戰略的核心要素包括：

我們的小分子和寡聚核酸平台旨在使我們能夠發現可用於開發潛在一流治療方案的候選藥物。我們相信，我們擁有一套差異化的內部能力，可用於在我們當前所有重點領域開發新穎、優化的聯合治療方案。

我們的團隊在多個治療領域和學科擁有豐富的端到端藥物發現和開發經驗。我們的臨牀開發策略利用過去的經驗，快速推進候選藥物的優化方案。我們通過對選定的知識產權進行內部許可來加強我們的平台，這與我們的內部專業知識一起使我們能夠開發新穎和專有候選藥物。

我們的團隊擁有快速識別和優化小分子的能力和經驗，包括傳統小分子、肽模擬物和前藥。我們的團隊在開發和商業化小分子候選藥物方面擁有良好的記錄。我們使用最先進的計算化學和晶體學來實現結構引導的藥物設計。我們已將這種方法應用於多個治療領域（包括肝臟疾病和病毒感染）的潛在候選藥物的多維優化。

迄今爲止，傳統小分子代表了絕大多數已批准的藥物，並且是用於藥物發現的主要化學方法。

CAM-Es是一種小分子，已被證明可以顯着降低慢性乙型肝炎感染受試者的乙型肝炎DNA和RNA水平。我們已經確定了ALG-001075，它已表現出潛在的同類最佳體外效力。 ALG-001075的前藥ALG-000184已在HIV和慢性乙型肝炎感染受試者中進行了單次和多次給藥的評估，發現耐受性良好，具有良好的PK和可觀的抗病毒活性。ALG-000184目前正在有或不有ETV的較長持續時間（<96周）隊列中進行評估，在各種乙型肝炎標誌物中，它繼續表現出一流的抗病毒特性。 ALG-000184目前正在推進第二階段研究。

THR-β激動劑是一種小分子，已被證明可以顯着降低MASH患者的循環脂質水平並改善肝臟組織學。根據目前處於臨牀開發中的THR-β激動劑公開和/或內部收集的體外數據，我們的候選藥物ALG-055009已證明對THR-具有最大的β選擇性和最高的效力b 受體的在一項評估長達14天給藥的已完成的I期研究中，ALG-055009還證明了劑量成比例的藥代動力學，具有低變異性和預期的甲狀腺效應。ALG-055009於2024年完成了一項2a期研究，該研究達到了主要終點，通過MRI-PDFF測量，第12周肝臟脂肪出現了統計學顯着下降。

PD-1/PD-L1抑制劑是通過程序性死亡1（配體）PD-1/PD-L1相互作用增強免疫反應的一種方法。我們合理地設計了這些T細胞激活候選藥物，以在肝臟中分配，從而可能減輕全身毒性，以努力爲慢性乙型肝炎感染患者開發耐受性更好的PD-1/PD-L1抑制劑。我們最近選擇了一種先導分子ALG-093940，並正在完成體內劑量範圍探索研究以進一步推進臨牀開發。ALG-093940在小鼠腫瘤模型中表現出與已批准的PD-1/PD-L1抗體相似的體內功效。與競爭對手小分子PD-L1抑制劑相比，我們的小分子先導化合物還證明，在人源化PD-L1皮下腫瘤模型中，在較低劑量下具有更高的PD-L1靶點佔有率。

前藥是一種化合物，給藥後代謝爲藥理活性的母藥。我們使用小分子前藥化學來優化候選藥物的類藥物性質，以提高其溶解度和藥代動力學。我們已成功將這種方法應用於ALG-001075，創建了ALG-000184，這是我們的領先CAM-E候選藥物，目前正在臨牀評估該藥物用於治療慢性乙型肝炎感染。

我們正在參與其他多項小分子發現工作，以確定用於治療肝臟和病毒疾病的其他潛在同類最佳候選藥物。

多肽模擬物是由短肽衍生的小分子，可用作針對多個靶點的候選藥物。模擬多肽方法已成功地應用於抗病毒領域，開發出針對丙型肝炎病毒(HCV)和人類免疫缺陷病毒(HIV)的蛋白酶抑制劑藥物。我們的團隊與KU魯汶、CISTIM和CD3合作，發現了多個針對冠狀病毒3C樣蛋白酶的潛在候選藥物，這些藥物已顯示出泛冠狀病毒活性，不需要基於非臨牀研究的利托那韋增強。ALG-097558是我們的主要蛋白酶抑制劑(PI)，其效力是我們的3倍在針對一組SARS-CoV-2變種(包括奧密克戎)的基於細胞的分析中，Nirmatrelvir和其他PI在臨牀開發中的應用優於Nirmatrelvir和其他PI。它還顯示了廣泛的泛冠狀病毒活性，根據臨牀數據，不需要利托那韋加強治療。ALG-097558的安全性和PK特性在HV的第一階段研究中進行了評估。單劑劑量達2,000毫克和多次劑量達800毫克的Q12H連續7天耐受性良好，PK曲線可接受，表明利托那韋不需要強化，也沒有與咪達唑侖臨牀相關的DDI，這表明ALG-097558可以與細胞色素P3A4底物聯合給藥。ALG-097558目前正在一項針對高危新冠肺炎患者的臨牀研究中進行評估。

我們的寡核酸平台內有不同的模式，包括siRNA。我們擁有先進用於治療慢性乙型肝炎感染的多種寡核苷酸候選藥物，包括ALG-125755，一種siRNA候選藥物。

我們擁有獨家許可的專有技術，可以增強我們的寡核武器平台。這些技術包括第三代橋連核酸（BNA）和N-乙基半乳糖胺（GalNAc）化學物質，它們可以改善肝臟靶向、提高效力並增強藥代動力學性質。

siRNA是一類雙鏈非編碼RNA，可以通過沉默基因表達來干擾病毒複製。在臨牀試驗中，多種siRNA已證明可以顯着降低乙型肝炎病毒表面抗原水平。我們新穎且專有的RNA技術識別出了包括ALG-125755在內的分子，這些分子在非臨牀慢性乙型肝炎感染模型中表現出高效和持久持久的持久性。對於ALG-125755，我們進行了一項I期研究，評估了分別對HIV和病毒學抑制的BeAg-慢性乙型肝炎受試者進行20-200毫克和50-320毫克的單次劑量。在這項研究中，我們發現這些單次給藥耐受性良好，併產生了有利的PK數據。就抗病毒活性而言，現有數據表明，在評估的所有3個劑量水平下，有證據表明表面抗原都有所降低。

我們的所有資產目前都處於商業化前，因此我們尚未建立銷售和營銷組織或分銷能力。我們打算在選定的適應症和市場上追求獨立開發和商業化，並計劃建立商業基礎設施來支持專業銷售和營銷組織以及分銷能力。與我們的研究、臨牀和製造業務類似，我們希望通過專職員工以及第三方承包商和顧問管理銷售、營銷和分銷。我們可能會趁機探索與一家或多家制藥公司達成許可協議、合作或合作伙伴關係，以增強我們的商業能力。

我們目前正在開發兩種主要形式的候選藥物：小分子和寡聚酸。我們擁有內部的小分子和寡聚酸化學團隊，能夠以足夠大的規模生產候選藥物來支持發現活動。此外，我們還擁有一支專門的內部化學、製造和控制（SMC）團隊，該團隊與合同開發和製造組織合作，大批量生產候選藥物，包括支持非臨牀和臨牀研究。我們已經建立了進行和管理流程開發、分析開發、質量、製造和供應鏈活動所需的團隊和基礎設施。

小分子製造是一個成熟的行業，並得到了廣泛的合同製造商網絡的大力支持。與我們的寡聚酸方法一樣，我們的內部MCC團隊進行工藝開發和優化，並通過技術轉讓支持我們的合同製造商。

過去幾十年來，寡核酸生產技術已經顯着成熟，先進的寡核酸合成器已上市，可支持小規模合成，而寡核酸合同製造商網絡則可支持大規模合成。我們的內部MCC團隊爲我們的合同製造商提供工藝開發和優化的支持，或者在需要時，我們可能會與外部顧問和承包商合作以優化合成和放大。

生命科學行業競爭激烈，並受到快速而重大的技術變革的影響。我們的競爭對手包括跨國製藥公司、老牌生物技術公司、大學和其他研究機構。與我們相比，我們的許多競爭對手擁有更多的財力、技術、人力和其他資源，而且可能更有能力開發、製造和營銷技術領先的產品。此外，這些競爭對手中的許多人在對候選新藥進行非臨牀研究和人體臨牀試驗以及獲得人類治療候選藥物的監管批准方面可能比我們擁有更多的經驗。因此，我們的競爭對手可能會開發出更好的候選藥物，並可能成功地獲得FDA對這些候選藥物的批准。我們的許多競爭對手已經建立了產品商業化的分銷渠道，而我們沒有這樣的渠道或能力。此外，許多競爭對手擁有更高的知名度和更廣泛的合作關係。

我們成功開發和商業化的任何候選藥物都可能與現有療法和/或未來可能出現的新療法競爭。我們的競爭對手可能比我們更快地獲得其候選藥物的監管批准，或者可能獲得專利保護或其他知識產權，這些限制了我們開發或商業化我們的候選藥物或任何未來候選藥物的能力。我們的競爭對手也可能開發比我們的藥物更有效、更方便、更廣泛使用和更便宜的藥物，或者比我們的藥物(如果有的話)具有更好的安全性，這些競爭對手在製造和營銷他們的產品方面也可能比我們更成功。如果我們不能有效地與我們的競爭對手競爭，我們可能無法將我們的候選藥物或任何未來的候選藥物商業化，也無法在市場上獲得競爭地位。這將對我們創造收入的能力造成不利影響。我們的競爭對手，無論是單獨工作還是與他人合作，都可能比我們擁有更多的財務資源，在目標市場站穩腳跟，擁有研發、製造、非臨牀和臨牀測試方面的專業知識，以及獲得監管批准以及報銷和營銷批准的產品的經驗。我們還在爭奪有限的合格科學、銷售、營銷和管理人員，臨牀試驗場地的空間，臨牀試驗的患者註冊以及與我們的計劃互補或必要的技術。可能會出現新的競爭對手，規模較小或處於初創階段的公司可能會自行成長，或通過與大型和成熟公司的合作安排成長，而競爭對手可能會通過合併和收購集中起來。

目前美國食品和藥物管理局批准的治療慢性乙肝病毒感染的藥物包括羅氏控股公司(羅氏)銷售的聚乙二醇干擾素α，以及由吉利德科學公司(吉利德)和百時美施貴寶公司銷售的口服抗病毒藥物，如NITOS(T)ide類似物。這些治療在絕大多數患者中既不是功能性的，也不是完全的治癒，對於核素(T)類似物，可能需要終生治療。幾家大小製藥公司正在開發具有不同作用機制的計劃，單獨使用或聯合使用，目標是在慢性乙肝感染患者中實現更高的病毒抑制率或功能性治癒。擁有臨牀開發中的寡核苷酸藥物的公司包括Arbutus Biophma公司、Ionis製藥公司(連同葛蘭素史克(葛蘭素史克))、箭頭製藥公司(連同揚森製藥公司(Janssen))和Vir生物技術公司(連同Alnylam製藥公司)。一些公司正在開發CAM-ES，包括Assembly Biosciences Inc.和Enanta PharmPharmticals。包括葛蘭素史克和揚森在內的幾家公司正在開發乙肝治療性疫苗，其他幾家公司已經批准了乙肝疫苗，包括Dyavax Technologies，Inc.，GSK，強生和默克。Replicor公司正在開發用於慢性乙肝病毒感染患者的核酸聚合物(NAP)。

目前有一種FDA批准的MASH治療方法：Madrigal Pharmaceuticals，Inc.，THR-b 激動劑。包括艾伯維公司在內的多家制藥公司，阿斯利康PLC/MedImmune LLC、百時美施貴寶公司、禮來公司、默克公司、輝瑞公司、諾和諾德以及89 bio，Inc.等大大小小的生物技術公司，Akero Therapeutics，Inc. Gilead、Inventiva Pharma SA、MediciNova，Inc.、和維京治療公司正在尋求針對MASH的藥物的開發或營銷。尋求開發治療MASH等嚴重代謝疾病的產品和療法的公司數量也可能會增加。

除了FDA批准的瑞美昔韋外，輝瑞公司還於2021年12月22日獲得FDA的批准，用於與利托那韋共同服用的口服SARS-CoV-2蛋白酶抑制劑帕昔洛韋。同樣，默克(與Ridgeback Bio)正在開發藥物Molnupiravir，這是一種口服抗病毒藥物，已於2021年12月23日獲得FDA的緊急使用授權。有幾種藥物可能在標籤外用於治療，如地塞米松。幾種被批准的藥物正在研究它們在降低SARS-CoV-2感染嚴重程度方面的效用，包括Alexion製藥公司的Soliris和Incell公司的Jakafi。全球正在努力開發治療和預防候選藥物，包括Enanta製藥公司和Shionogi公司。有幾家公司專注於抗體治療，包括Regeneron製藥公司和Vir生物技術公司(連同葛蘭素史克、生物遺傳公司和藥明生物有限公司)。

2020年12月，我們與默克公司簽訂了獨家許可和研究合作協議，根據該協議，默克公司和Aligos將應用我們的寡核寡聚酸平台技術來發現、研究、優化和開發針對MASH靶點和最多一種額外的肝臟靶向心髒代謝和/或纖維化靶點的寡聚酸。

2022年1月，我們對該許可和研究合作協議達成了一項修正案，該修正案擴大了我們的合作範圍，包括向默克公司授予一項針對第二個未公開的MASH目標的早期計劃的許可，我們之前一直在獨立地與默克公司分開開展工作。此外，根據這一擴大的安排，默克有權在合作中添加第三個感興趣的目標。如果添加第三個目標，將是基於肝臟的心臟代謝/纖維化目標。在合作中添加第三個目標的權利已於2023年1月到期。

根據原始協議的條款，我們收到了默克公司的預付款。根據該修正案，我們收到了默克公司的付款，用於開展第二個未公開的MASH目標的研究計劃。對於每個合作目標，我們將有資格獲得高達約46000萬美元的開發和商業化里程碑以及淨銷售的分層特許權使用費。

默克有權隨時提前90天書面通知我們，全面或逐個目標終止《許可和研究合作協議》。從默克承擔後續研究責任起，直到達成某項監管事件爲止，如果默克在指定期限內停止所有開發活動，並且未能在我們向默克提供恢復通知後的合理時間內恢復此類活動，我們可以終止許可和研究合作協議。如果另一方未解決的重大違約或無力償債，任何一方都可以終止許可和研究合作協議。在因重大違約以外的任何原因終止後，我們將有權從默克收購默克根據許可和研究合作協議正在開發或商業化的產品和化合物。我們與默克公司之間將進行真誠談判，以制定過渡計劃。

2023年2月和2024年5月，默克向我們提供了合作中兩個目標的終止書面通知。

2018年6月，我們與埃默裏大學簽訂了許可協議（《埃默裏許可協議》），根據該協議，埃默里根據其某些知識產權授予我們全球範圍內的可再許可，可以製造、製造、開發、使用、出售要約、銷售、進口和出口含有與埃默裏乙型肝炎病毒外殼組裝調節劑技術相關的某些化合物的產品，用於所有治療和預防用途。等

許可最初對於Emory擁有的特定許可專利是獨家的，對於Emory的某些特定專有技術是非獨家的。2022年6月，這些專利的許可證在除治療和預防乙肝病毒外的所有領域都成爲非排他性的；然而，我們可以選擇最多六種化合物，這些化合物將保持對所有治療和預防用途的排他性。對於許可專利允許的所有其他化合物，由我們和Emory或S****實驗室的發明人共同發明的或在特定許可專利中披露的那些化合物，包括Emory在內，僅授權給我們；而所有其他此類化合物非獨家授權給我們。根據埃默裏許可協議的條款，我們有義務根據雙方商定的發展計劃，採取商業上合理的努力，將許可產品推向市場。除非任何一方按照協議的規定提前終止，否則《埃默裏許可協議》應繼續有效，直至根據該協議向我們授予的專利的最後一期到期。

埃默裏保留自己執業的權利，其他實體僅出於與埃默裏合作研究的目的，根據用於教育目的、埃默裏內部目的以及非商業研究、患者護理和治療的許可專利進行執業。埃默裏大學還可以向非營利機構和政府機構授予內部非商業研究和學術用途的許可。

根據《埃默裏許可協議》，因我們的活動而產生的任何新發明的所有權均遵循美國發明法。對於Emory擁有的許可專利，我們需要爲起訴和維護此類許可專利準備文件和備案文件，而Emory保留提供此類文件的最終編輯和批准的選擇權，並負責此類文件的實際歸檔。我們負責起訴和維護被許可的專利的費用，我們有第一權，但沒有義務強制執行這些專利。我們單獨負責我們選擇發起的任何訴訟的費用，以強制執行許可的專利，並且在未經Emory事先書面同意的情況下，不能就此類訴訟達成和解。在此類訴訟中追回的任何款項，在償還我們的訴訟費用後，將在我們和Emory之間平分，但對於任何基於損失的利潤的裁決，Emory將追回賠償金或Emory在侵權銷售由我們進行的情況下收到的特許權使用費中較大的50%。

埃默裏許可協議下的許可專利所聲稱的技術可能是使用美國政府資金開發的，因此許可可能受到美國政府持有的非排他性許可的約束，許可產品大部分在美國製造的某些要求和美國政府的進軍權。有關使用政府資金開發的技術相關風險的更多信息，請參閱標題爲「風險因素-與知識產權相關的風險」的部分。

根據《埃默裏許可協議》的條款，我們有義務根據雙方商定的開發計劃，採取商業上合理的努力將許可產品推向市場。

2020年6月，我們修改了與埃默裏大學的許可協議。根據修訂後的許可協議，埃默裏向我們授予了某些針對治療或預防乙型肝炎病毒的化合物的額外專利權。作爲額外權利的對價，我們向埃默裏一次性支付了20萬美元，不可退還，並有額外義務支付最多35，000美元。同一天，我們與埃默裏大學達成了一項合作協議，初步研究計劃涉及化合物的合成和評估，該計劃通過修訂後的許可協議中授予的額外專利權獲得許可。該研究計劃原定於2020年6月生效之日起終止一年，但我們行使了將其延長第二年的選擇權。2022年6月，研究計劃終止。結合研究計劃，我們將每年爲埃默裏大學提供高達30萬美元的資金。

我們同意在實現指定的開發、監管和商業里程碑以及所有持續的專利成本後向埃默裏支付總計高達12500萬美元的費用。我們還同意按季度並逐產品計算，就全球授權產品的年度淨銷售額向埃默裏分層的個位數特許權使用費。對於包含任何指定特許化合物子集的特許產品，此類特許使用費的範圍從中個位數到高個位數百分比不等。對於不含此類化合物的許可產品，如果在埃默裏許可協議生效之日起三年內對產品啓動第一階段臨牀試驗，則特許權使用費的範圍爲中間個位數以內的百分比;如果在生效日期後三年多開始第一階段臨牀試驗，則特許權使用費的範圍爲低個位數到中間個位數。

埃默裏許可協議將在根據該協議授權給我們的最後一個到期專利到期時到期。爲了方便起見，我們可以隨時終止《Emory許可協議》的全部內容或特定專利，方法是向Emory發出90天的書面通知，如果我們最終決定停止任何許可產品的研究、開發或商業化，則必須終止《Emory許可協議》。如果任何一方嚴重違反埃默裏許可協議並未能及時糾正，則任何一方均可終止埃默裏許可協議。如果我們未能在商定的日期達到里程碑，並且未能及時爲此類失敗提供合理、誠信的商業或技術理由的合理證據，Emory可能會終止Emory許可協議。在因我們的重大違規行爲而終止《Emory許可協議》時，應Emory的要求，我們將向Emory授予非排他性、免版稅的許可，授予Emory我們在我們擁有、許可或控制的專利中的所有權利，只要這些專利與我們行使Emory許可協議下的許可權利有關，幷包括涉及製造、使用或銷售任何含有許可化合物的許可產品的索賠。如果我們破產或資不抵債，或者如果我們對根據埃默裏許可協議向我們授權的任何專利的有效性或可執行性提出質疑，埃默裏許可協議將自動終止。

我們已同意賠償埃默裏和埃默裏許可協議項下的某些其他人因該協議項下許可的權利或含有許可化合物的任何產品的製造、測試、設計、使用、銷售或貼上標籤而可能遭受的損失，除非是由該潛在的受償人的疏忽造成的。

2018年12月19日，我們與Luxna簽訂了一份許可協議，根據該協議，Luxna授予我們一項獨家的、全球範圍內的、可再許可的許可，以研究、開發、製造和商業化用於所有治療和預防用途，（i）含有靶向乙型肝炎病毒基因組的寡聚體的產品，（ii）含有某些針對最多三個導致MASH的基因的寡聚核寡核酸的產品，我們可以在任期的前八年內隨時選擇，但不得向第三方授權，和（iii）含有靶向多達三種導致肝細胞癌的基因的寡聚酸的產品，我們可以在本學期前三年的任何時候選擇，該協議於2021年12月到期。作爲本協議的對價，我們支付了60萬美元的預付許可費。

2020年4月，我們修改了與Luxna的許可協議。根據修訂後的許可協議，Luxna根據許可專利授予我們全球獨家許可，以研究、開發、製造、製造和商業化含有針對三個病毒家族的寡聚酸的產品：正粘病毒科、副粘病毒科和冠狀病毒科（包括SARS-CoV-2）。作爲修訂後許可協議的對價，我們於2020年4月向Luxna支付了一次性不可退還費用20萬美元。

在實現指定的開發、監管和商業里程碑後，我們有義務向Luxna支付總計不超過5550萬美元的款項。我們還需要就適用產品的淨銷售額向Luxna支付低個位數的版稅百分比（如果有的話）。

Luxna對Luxna協議規定的知識產權的權利源於大坂大學（大坂）對與許可專利涵蓋的XNA和其他間隔器技術的修改相關的某些權利的獨家許可（Luxna-大坂協議）。另外，大坂還向某些第三方授予了與許可專利相關的權利，例如用於MASH等特定適應症的氨橋核酸（AmNA）的權利、生產含有AmNA修飾的試劑的權利以及使用特定基因的權利。此類權利不包括在Luxna協議下授予我們的權利範圍內，Luxna協議並不阻止大坂將Luxna協議下的任何許可權利用於與XNA修改相關的非商業研究目的。

Ownership of any new inventions arising out of our activities under the Luxna Agreement will follow the inventorship laws of the United States. Luxna retains the responsibility for the prosecution and maintenance of the licensed patents, provided that Luxna consider our comments and suggestions in connection therewith. We retain step-in rights should Luxna decide to no longer prosecute or maintain any licensed patents under the Luxna Agreement. We have the first right, but not the obligation, at our sole expense to enforce the licensed patents. In connection with any infringement suit, neither party can enter into a settlement without the prior written consent of the other.

The Luxna Agreement will expire upon expiration of the last-to-expire patent licensed to us under the agreement. We may terminate the Luxna Agreement at any time for convenience by providing Luxna with 90 days’ written notice. In addition, we have agreed to terminate the Luxna Agreement if we make a final decision to cease research, development or commercialization of the licensed products. Either party may terminate the Luxna Agreement if the other party materially breaches the Luxna Agreement and fails to timely cure such breach. The Luxna Agreement will automatically terminate if we become bankrupt or insolvent.

We have agreed to indemnify Luxna and certain others under the Luxna Agreement for losses they may suffer arising out of the rights licensed thereunder or the manufacturing, testing, design, use, sale or labeling of any product containing a licensed product, unless caused by such potential indemnitee’s negligence.

2020年6月25日，我們與魯汶大學簽訂了研究、許可和商業化協議(KU魯汶協議)，根據協議，我們正在與魯汶大學的Rega醫學研究所及其CD3合作，研究和開發潛在的用於治療、診斷或預防冠狀病毒(包括SARS-CoV-2)的蛋白酶抑制劑。除非任何一方根據協議的規定提前終止，否則合作期限將在所有合作活動較早完成時終止，或在兩年半內終止。關於KU魯汶協議，吾等與KU魯汶相互授予獨家交叉許可，以便在合作期間使用對方的某些專有技術和現有專利以及某些聯合專有技術和聯合專利開展研發合作活動。截至2022年12月，原協作期已到期。該協議的一項修正案於2023年7月達成，其中包括一項新的合作計劃。KU魯汶根據KU魯汶的某些專有技術和現有專利，以及某些聯合專利和聯合技術，向我們授予獨家(包括KU魯汶)全球許可，以製造和商業化用於治療、診斷或檢測人類病毒感染的許可產品。顧魯汶保留將魯汶大學的所有專有技術、現有的魯汶專利、聯合專利和聯合技術用於學術和非商業研究及教學的權利。作爲本許可證的對價，我們有義務在實現某些商業銷售里程碑後向KU魯汶支付總計不超過3,000美元的萬。對於通過KU魯汶和我們的合作努力開發的每個許可產品，我們有義務在實現某些開發和法規里程碑時向KU魯汶支付總計高達3,200美元的萬。我們還被要求根據適用產品的淨銷售額(如果有)向KU魯汶支付低至中個位數的特許權使用費百分比，但需進行某些調整。如果計劃與外部合作，我們還需要向KU魯汶支付預付交易對價的一部分。除非任何一方提前終止，否則本協議應持續到最後一個到期的專利權使用費期限屆滿爲止，該期限是涉及許可產品在特定國家的製造、使用、銷售或進口的最後一項有效專利權利要求期滿或終止的較晚者，或許可產品首次商業銷售後10年。

我們成功的一個關鍵是我們有能力建立和維護對我們的候選藥物、平台技術和專有技術的保護，以執行和保護我們的知識產權。爲了保護我們的候選藥物和技術，我們提交了與我們的發明、改進、製造和分析過程和技術相關的美國專利合作條約(PCT)和外國專利申請。除了商標、版權和商業祕密法律，以及員工披露和發明轉讓協議外，我們還依靠我們的技術訣竅、保密方法和流程、持續的技術創新以及我們活躍的第三方知識產權內部許可計劃來發展和維護我們的專有地位。儘管我們採取措施保護我們的專有信息和商業祕密，包括通過與我們的員工、顧問和顧問簽訂合同的方式，但這些協議可能會被違反，我們可能沒有足夠的補救措施來應對任何違反。此外，第三方可以獨立開發基本相同的專有信息和技術，或以其他方式獲取我們的商業祕密或披露我們的技術。因此，我們可能無法有意義地保護我們的商業祕密。我們的政策是要求我們的員工、顧問、外部科學合作者、贊助研究人員和其他顧問在與我們開始僱傭或諮詢關係時執行保密協議。這些協議規定，在與我方的關係過程中，向有關個人或實體披露的所有與我方業務或財務有關的機密信息均應保密，除非在特定情況下，否則不得向第三方披露。就僱員而言，協議規定，個人在受僱期間構思的所有發明，如涉及或合理地有能力或正在使用於

我們當前或計劃中的業務或研發是我們的獨家財產。此外，我們還採取其他適當的預防措施，例如物理和技術安全措施，以防止第三方挪用我們的專有技術。然而，此類協議和政策可能會被違反，並且我們可能沒有足夠的補救措施來應對此類違規行爲。有關與我們知識產權相關的風險的更多信息，請參閱標題爲「風險因素-與知識產權相關的風險」的部分。

我們擁有各種實體的專利許可和專利申請，包括埃默裏、盧克斯納和AM化學公司，下文將對其進行進一步描述。就我們擁有的專利組合而言，截至2024年12月31日，我們擁有30項美國專利，17項美國非臨時專利申請，8項美國臨時專利申請(不包括任何已優先申請的未到期的美國臨時申請)，13項PCT申請，14項外國專利授權和243項外國專利申請，包括在阿拉伯聯合酋長國、ARIPO、阿根廷、澳大利亞、巴西、加拿大、智利、中國、哥倫比亞、歐亞大陸、埃及、歐盟、格魯吉亞、印度尼西亞、以色列、印度、日本、韓國、馬來西亞、墨西哥、新西蘭、OAPI、秘魯、菲律賓、俄羅斯聯邦、新加坡、泰國、臺灣、烏克蘭、烏茲別克斯坦和南非。我們已頒發的專利的預期到期日爲2040年至2042年，我們的非臨時美國和外國專利申請頒發的任何專利預計將在2040年至2044年之間到期，但不包括任何潛在的專利期限延長和/或專利期限調整。

對於我們的候選藥物，我們已提交併許可了某些專利申請，我們通常打算尋求涵蓋此類候選藥物的組成、製備方法、形式和配方以及使用方法的專利保護。截至2024年12月31日，我們擁有7項美國專利，其權利要求涉及ALG-000184、ALG-055009、ALG-125755和ALG-097558。

我們在CAM-E化學領域獲得了埃默裏大學專利權的獨家許可，其中包括2項已發佈的美國專利、1項正在審批的非臨時美國專利申請以及16項已發佈的外國專利和22項外國專利申請。已發佈的美國專利預計有效期爲2037年3月，我們非臨時美國和外國專利申請中發佈的任何專利預計將在2037年至2041年間到期，不包括任何可能可用的專利期限延長或調整。

我們擁有Luxna在寡聚酸化學領域的專利權，其中包括7項已發佈的美國專利、15項已發佈的外國專利和3項外國專利申請。我們擁有使用該技術開發治療慢性乙型肝炎感染的候選藥物的獨家權利，以及MASH和呼吸道疾病（包括冠狀病毒）中某些指定目標的權利。已發佈的美國專利預計將在2030年10月至2038年2月之間到期，不包括任何可能可用的專利期限延長或調整。

我們已獲得AM Chemical專利權所涵蓋的特定寡核寡核酸構建體使用的獨家權利，包括兩項已發佈的美國專利和三項外國專利申請。已頒發的美國專利預計有效期爲2037年7月，外國專利申請頒發的任何專利預計將於2037年到期，不包括任何可能可用的專利期限延長或專利期限調整。

我們擁有一個專利系列，其中包括2項已發佈的美國專利、1項非臨時美國專利申請以及31項在多個司法管轄區未決的申請，這些申請的權利涉及物質組成，包括ALG-000184（我們的主要CAM-E分子）、藥物組合物和使用方法的權利。該專利系列還包括針對我們的主導分子與針對慢性乙型肝炎感染的其他作用模式藥物和候選藥物的聯合治療的權利要求。我們已發佈的美國專利11，191，747和11，771，680預計將於2040年4月到期，我們非臨時美國和外國專利申請中發佈的任何專利預計將於2040年到期，不包括任何可能可用的專利期限延長或調整。

我們擁有一個專利系列，其中包括2項已發佈的美國專利、1項美國非臨時申請、2項美國臨時申請、1項PCT申請、4項已發佈的外國申請和28項外國申請，這些申請涉及ALG-055009（我們用於治療MASH的主要候選藥物）的物質組成、製造、配方和使用方法。這些專利家族還公開了與我們的主導分子的聯合療法。我們已發佈的美國專利1，1091，467和12，180，192預計將於2040年5月到期，我們的非臨時美國申請發佈的任何專利預計將在2040年至2044年間到期，不包括任何可能可用的專利期限延長或專利期限調整。

我們擁有一個專利系列，其中包括一項已發佈的美國專利、一項非臨時美國申請和26項外國專利申請，所有這些申請均針對物質組合物和使用方法，包括ALG-097558，這是我們治療冠狀病毒的主要候選藥物。該專利家族還公開了與我們的主導分子的聯合療法。我們發佈的美國專利11，851，422將於2042年到期，我們的非臨時專利申請發佈的任何專利預計將於2042年到期，不包括任何可能可用的專利期限延長或調整。

我們擁有一個專利系列，其中包括2項已發佈的美國專利、3項非臨時美國專利和30項在多個司法管轄區未決的外國專利申請，這些申請涉及ALG-125755（我們的主要候選人）的物質組成和使用方法。該專利家族還公開了與我們的主導分子的聯合療法。我們已發佈的美國專利11，549，110和12，129，469預計將於2041年3月到期，不包括潛在專利期限延長或調整的任何額外期限。

我們擁有多個額外的專利申請系列，其中包括針對使用我們的額外候選藥物治療慢性乙型肝炎感染的物質組合物、藥物組合物和使用方法的權利要求。這些系列包括14項已頒發的美國專利、8項美國非臨時專利申請、7項美國臨時專利申請、5項PCT專利申請、4項已頒發的外國專利和84項小分子和寡聚酸領域的外國專利申請。這些專利家族還公開了與我們的候選藥物和其他化合物一起治療慢性乙型肝炎感染的聯合療法。我們已發佈的專利以及這些專利系列中從我們的美國非臨時或外國專利申請中發佈的任何專利預計將在2040年至2044年間到期，不包括任何可能可用的專利期限延長或專利期限調整。

我們擁有4項已頒發的美國專利和4項外國專利申請，其中包括針對物質組合物和與我們治療MASH的額外候選藥物一起使用方法的權利要求。這些申請還公開了與我們的候選藥物和其他化合物治療MASH的聯合療法。我們已發佈的專利預計將於2041年到期，而我們在美國和外國非臨時申請中發佈的任何專利預計將於2041年到期，不包括任何可能可用的專利期限延長或專利期限調整。

我們有2項允許的美國專利申請、4項美國非臨時專利申請、2項美國臨時專利申請、4項PCT申請和25項外國申請，其中包括針對物質組合物、藥物組合物和治療冠狀病毒的方法的權利要求。其中一些應用程序由Aligos和合作者共同擁有。這些專利家族還包括與治療冠狀病毒的聯合治療策略相關的披露。我們的美國非臨時專利和外國專利申請頒發的任何專利預計將在2041年至2044年期間到期，不包括任何可能可用的專利期限延長或專利期限調整。

就我們許可的知識產權和我們擁有的知識產權而言，我們不能確保我們的任何未決專利申請或我們未來提交的任何專利申請都將獲得專利，我們也不能確保任何當前的專利或未來可能授予我們的任何專利在保護我們的平台和候選藥物以及用於製造它們的方法方面將具有商業用途。此外，我們候選藥物的開發、測試和監管審查所需的時間可能會縮短商業化後有效專利保護的時間。如果我們確實爲我們的候選藥物獲得了任何專利，這些專利的期限取決於獲得專利的國家的法律條款。在我們提交申請的大多數國家，專利期爲自非臨時專利申請最早提交之日起20年。在美國，涵蓋FDA批准的藥物或生物的專利期限也有資格延長，這允許專利期限恢復，作爲對FDA監管審查過程中丟失的專利期限的補償。哈奇-瓦克斯曼法案允許專利期限在專利到期後最多延長五年。專利期延長的長度與藥物或生物受到監管審查的時間長度有關。專利期限的延長不能超過自產品批准之日起的14年，並且只能延長一項適用於經批准的藥物或生物的專利。歐盟和其他外國司法管轄區也有類似的規定，以延長涵蓋經批准的藥物或生物的專利的期限。未來，如果我們的候選藥物獲得FDA的批准，如果我們與這些候選藥物相關的專利申請作爲專利發佈，我們預計將在適用於這些藥物的專利的情況下申請延長專利期限。我們計劃在任何可以獲得專利的司法管轄區爲我們未來頒發的任何專利尋求專利期限延長，但不能保證適用當局，包括美國的FDA，會同意我們對是否應該批准這些延長，以及如果批准，這些延長的長度的評估。有關我們的專有技術、發明、改進、平台和候選產品的這一風險和其他風險，請參閱標題爲「風險因素--與知識產權相關的風險」一節。

截至2024年12月31日，我們的商標組合包含多項商標申請和註冊，包括美國和外國的。商標組合包括在美國、澳大利亞、歐盟、英國、日本和中國註冊的ALIGOS商標。

FDA和聯邦、州、地方各級以及外國的其他監管機構廣泛監管藥品的研究、開發、測試、製造、儲存、記錄保存、批准、標籤、營銷和促銷、分銷、批准後監測和報告、抽樣以及進出口等藥品，例如我們正在開發的藥品。獲得監管批准以及隨後遵守適當的聯邦、州、地方和外國法規和法規的過程需要花費大量時間和財政資源。

在美國，FDA根據《聯邦食品、藥物和化妝品法案》（FDCA）及其實施法規對藥物進行監管。任何未經批准的新藥都需要獲得FDA的批准才能在美國上市。藥物還受其他聯邦、州和地方法規和法規的約束。不遵守適用的FDA或其他要求可能會使公司受到各種行政或司法制裁，例如FDA臨牀擱置、拒絕批准待決申請、撤回批准、警告或無標題信件、產品召回、產品扣押、完全或部分暫停生產或分銷、禁令、罰款、民事處罰和刑事起訴。

候選藥物在美國上市之前，FDA要求的流程通常包括以下內容：

非臨牀和臨牀測試過程可能需要多年時間，獲得批准所需的實際時間（如果有的話）可能會根據所治療藥物或病症的類型、複雜性和新穎性而存在很大差異。

非臨牀測試包括對藥物化學、配方和毒性的實驗室（體外）評估，以及評估候選藥物的特徵以及潛在安全性和有效性的動物（體內）研究。提供安全性和毒理學信息的非臨牀研究的進行必須遵守聯邦法規和要求，包括GL。非臨牀研究的結果與其他信息一起作爲IND的一部分提交給FDA，包括有關藥物CMS的信息以及支持在人體中使用該藥物的任何可用人體數據或文獻。提交IND後，可以繼續進行長期非臨牀試驗，例如生殖毒性和致癌性的動物試驗。

IND提交的中心重點是一般研究計劃和人體研究方案。IND必須在人體臨牀試驗開始之前生效。IND將在FDA收到後30天自動生效，除非在此之前FDA提出與擬議臨牀試驗相關的擔憂或問題。在這種情況下，IND可能會被暫停臨牀，IND申辦者和FDA必須在開始臨牀試驗之前解決任何懸而未決的擔憂或問題。

對於使用研究藥物進行的每項連續臨牀試驗，必須向現有IND單獨提交新的方案，以及對研究計劃的任何後續變更。申辦者還必須遵守持續的報告要求，包括提交與使用研究藥物相關的任何嚴重不良經歷的IND安全性報告或表明人類受試者存在重大風險的非臨牀研究結果，以及IND下進行的研究進展的年度報告。

臨牀試驗涉及根據GCP在合格研究人員的監督下給人類受試者服用研究藥物，其中包括要求所有研究受試者提供參與每項臨牀試驗的知情同意。臨牀試驗是在詳細說明試驗目標、用於監測安全性的參數和將要評估的療效標準的方案下進行的。作爲IND的一部分，必須向FDA提交每項臨牀試驗的方案和任何後續的方案修正案。此外，還必須獲得每個臨牀試驗站點的IRB的批准，然後才能在該站點啓動試驗，並且IRB必須監督試驗直到完成。臨牀試驗的贊助商通常必須向公共註冊機構註冊並報告正在進行的臨牀試驗和臨牀試驗結果，包括由美國國立衛生研究院，ClinicalTrials.gov維護的網站。

爲了獲得NDA批准，人體臨牀試驗通常分爲三個或四個階段。儘管這些階段通常是順序進行的，但它們可能會重疊或合併。

FDA、倫理委員會或臨牀試驗申辦者可以隨時以各種理由暫停或終止臨牀試驗，包括髮現研究受試者面臨不可接受的健康風險。申辦者還可以根據不斷變化的業務目標和/或競爭環境暫停或終止臨牀試驗。

在臨牀試驗的同時，公司可能會完成額外的體內研究並開發有關候選藥物特徵的額外信息。公司還必須根據GMP要求最終確定生產商業適用數量藥物的流程。生產工藝必須能夠一致生產高質量的藥物批次，並且除其他外，必須使用經過驗證的方法根據質量標準測試藥物，以確認其身份、強度、質量和純度。此外，必須選擇和測試適當的包裝，並進行穩定性研究，以證明藥物在保質期內不會發生不可接受的變質。

假設根據所有適用的監管要求成功完成所有所需的測試，產品開發和測試的結果將以NDA的形式提交給FDA，請求批准該藥物用於一種或多種適應症的上市。提交NDA需要向FDA支付大量申請用戶費用，除非適用豁免或豁免。

NDA必須包括相關非臨牀研究和臨牀試驗中可用的所有相關數據，包括陰性或模糊結果以及陽性結果，以及與藥物化學、製造、控制和擬議標籤等相關的詳細信息。數據可以來自公司贊助的旨在測試藥物特定用途的安全性和有效性的臨牀試驗，也可以來自許多替代來源，包括研究人員發起的研究。爲了支持上市批准，提交的數據必須在質量和數量上足夠，以確定藥物的安全性和有效性，並達到FDA滿意的程度。

FDA在收到NDA後有60天的時間來根據該機構的門檻確定申請是否被接受提交，即申請足夠完整，可以進行實質性審查。FDA可能會要求提供更多信息，而不是接受提交申請。在這種情況下，必須重新提交申請並附上附加信息，並需要支付額外的用戶費用。重新提交的申請在FDA接受提交之前還需要接受審查。一旦提交材料被接受提交，FDA將開始進行深入的實質性審查。根據適用的《處方藥用戶收費法案》（PDUFA）績效目標，FDA努力在標準審查下的60天提交日起十個月內或在優先審查下的60天提交日起六個月內審查含有新分子實體的藥物的NDA。

FDA可以將新藥品或存在安全性或有效性難題的藥品的申請提交給諮詢委員會，以審查、評估和建議是否應批准該申請以及在什麼條件下批准。

在批准NDA之前，FDA通常會檢查生產藥物的一個或多個設施。FDA不會批准申請，除非它確定生產工藝和設施符合GMP要求並且足以確保藥物在所需規格內一致生產。此外，FDA通常會檢查一個或多個臨牀中心，以確保獲得相關試驗數據符合GCP要求。

FDA評估NDA並對生產設施進行檢查後，可能會發出批准函或完整的回覆函。完整的回覆信表明申請的審查週期已完成，申請尚未準備好審批。完整的回覆信通常會概述提交材料中的缺陷，並可能需要大量額外的測試或信息才能讓FDA重新考慮申請。即使提交了這些額外信息，FDA最終也可能決定申請不符合監管批准標準。如果或當缺陷已在重新提交申請時得到令FDA滿意的解決，FDA將發出批准函。批准函授權該藥物的商業營銷，並附有特定適應症的特定處方信息。

作爲NDA批准的條件，FDA可能要求風險評估和緩解策略（REMS）計劃，以幫助確保藥物的益處超過其風險。如果FDA確定需要REMS計劃，則藥物申辦者必須在批准之前開發並提交REMS，作爲其NDA的一部分。REMS計劃可能需要包括各種元素，例如藥物指南或患者包裝說明書、教育醫療保健提供者了解藥物風險的溝通計劃，或確保安全使用的其他元素，例如對誰可以開處方或分發藥物的限制、僅在某些情況下分發、特殊監控和患者登記處的使用。此外，所有REMS計劃都必須包括實施後定期評估戰略的時間表。

此外，FDA可能要求進行大量的批准後檢測和監測，作爲NDA批准的條件，以監測藥物的安全性和有效性，並且FDA有權根據這些上市後計劃的結果防止或限制產品的進一步營銷。一旦獲得批准，如果未能保持對監管要求的合規性或在初始營銷後發現問題，產品批准可能會被撤回。此外，對已批准申請中規定的條件的變更，包括適應症、標籤或製造工藝或設施的變更，可能需要提交新的NDA或NDA補充材料並獲得FDA批准，然後才能實施這些變更。針對新適應症的NDA補充劑通常需要與支持原始批准的臨牀數據類似的臨牀數據，FDA在審查補充劑時使用與審查原始申請類似的程序。

FDA爲合格藥物提供了許多快速開發和審查計劃，其中一個或多個可能可用於我們當前或未來的候選藥物。

如果新藥候選藥物旨在治療嚴重或危及生命的疾病或病症，並顯示出解決該疾病或病症未得到滿足的醫療需求的潛力，則有資格獲得快速通道指定。快速通道指定適用於藥物與正在研究的特定適應症的組合。快速通道候選藥物的贊助商在藥物開發期間有機會與審查小組頻繁互動，一旦提交了保密協議，候選藥物可能有資格接受優先審查。快速通道候選藥物也可能有資格進行滾動審查，在這種情況下，FDA可以在提交完整申請之前滾動考慮NDA的審查部分，如果贊助商提供了提交NDA部分的時間表，FDA同意接受NDA的部分並確定該時間表是可接受的，並且贊助商在提交NDA的第一部分時支付任何所需的使用費。

旨在治療嚴重或危及生命的疾病或病症的候選藥物也可能有資格獲得突破性治療指定，以加快其開發和審查。如果初步臨牀證據表明候選藥物可能在一個或多個具有臨牀意義的終點（例如在臨牀開發早期觀察到的實質性治療效果）上表現出比現有療法的實質性改善，則候選藥物可以獲得突破性治療指定。該指定包括所有快速通道計劃

功能，以及早在第一階段就開始的更密集的FDA互動和指導，以及加快候選藥物開發和審查的組織承諾，包括高級管理人員的參與。

候選藥物（包括具有快速通道指定和/或突破性治療指定的候選藥物）提交保密協議後，保密協議可能有資格獲得優先審查。與已上市的產品相比，如果NDA有可能在嚴重疾病或病症的治療、診斷或預防方面提供顯着改進，則有資格獲得優先審查。根據候選藥物是否包含新的分子實體，優先審查指定意味着FDA的目標是在60天提交日期後的6至8個月內對上市申請採取行動，而標準審查下需要10至12個月。

此外，根據在治療嚴重或危及生命的疾病或狀況方面的安全性和有效性而研究的候選藥物，在確定候選藥物對合理地可能預測臨牀益處的替代終點、或在可比不可逆轉的發病率或死亡率更早地測量的臨牀終點、合理地可能預測不可逆轉的發病率或死亡率或其他臨牀益處的臨牀終點上，考慮到病情的嚴重性、稀有性或流行率以及可用或缺乏替代治療的情況下，可獲得加速批准。作爲加速批准的條件，FDA通常會要求贊助商進行充分和良好控制的上市後臨牀試驗，以驗證和描述對不可逆轉的發病率或死亡率或其他臨牀益處的預期影響。此外，FDA目前要求作爲加速批准的條件，預先批准宣傳材料，這可能會對藥物商業推出的時間產生不利影響。

我們可能會酌情爲一種或多種當前或未來的候選藥物尋求孤兒藥物指定，如果獲得批准，我們的產品有可能獲得孤兒藥物獨家經營權。

根據《孤兒藥法》，FDA可以授予用於治療罕見疾病或病症的藥物孤兒稱號，該疾病或病症是指在美國影響少於20萬人或超過200人的疾病或病症。美國有000名個人，沒有合理預期在美國開發和提供用於此的藥物的成本該藥物在美國的銷售將恢復疾病或病症類型。在提交NDA之前必須請求孤兒藥物認定。FDA授予孤兒藥稱號後，該治療劑的通用名稱及其潛在的孤兒用途將由FDA公開披露。孤兒藥指定不會在監管審查或批准流程中帶來任何優勢，也不會縮短監管審查或批准流程的持續時間。

如果獲得孤兒藥指定的藥物隨後獲得FDA對其具有孤兒藥指定的疾病的首次批准，則該藥物有權獲得孤兒藥獨家批准（或排他性），這意味着FDA在七年內不得批准任何其他申請，包括完整的NDA，以上市用於相同適應症的相同藥物，除非在有限的情況下，例如表現出相對於具有孤兒藥排他性的藥物的臨牀優越性。孤兒藥獨佔權並不阻止FDA批准不同的藥物用於同一疾病或病症，或相同的藥物用於不同的疾病或病症。孤兒藥指定的其他好處包括某些研究的稅收抵免和免除應用用戶費用。

A designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation. In addition, exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the drug to meet the needs of patients with the rare disease or condition.

根據《兒科研究公平法》，某些NDA和NDA的某些補充劑必須包含數據，以評估該藥物在所有相關兒科亞群中針對聲稱的適應症的安全性和有效性，並支持該產品安全有效的每個兒科亞群的劑量和給藥。FDA可以批准推遲提交兒科數據或全部或部分豁免。美國食品藥品監督管理局安全與創新法案修訂了FDCA，要求計劃提交包含新活性成分、新適應症、新劑量、新給藥方案或新給藥途徑的藥物的NDA的申辦者在第2階段會議結束後60天內提交初始兒科研究計劃（iPSP），或者，如果沒有此類會議，在開始3期或2/3期研究之前儘早進行。

iPSP必須包括申辦者計劃進行的兒科研究的大綱，包括研究目標和設計、年齡組、相關終點和統計方法，或不包括此類詳細信息的理由，以及任何推遲兒科評估的請求或完全或部分豁免提供兒科研究數據以及支持信息的要求。FDA和申辦者必須就iSP達成協議。如果需要根據從非臨牀研究、早期臨牀試驗和/或其他臨牀開發計劃收集的數據考慮兒科計劃的變更，申辦者可以隨時提交對商定的iPSP的修訂案。

藥品還可以在美國獲得兒科市場獨佔權。如果獲得兒科排他性，將使現有的排他性期限和專利期限增加六個月。這種爲期六個月的排他性從其他排他性保護或專利期結束起，可以根據FDA針對此類研究發佈的「書面請求」自願完成兒科研究而授予。

一旦NDA獲得批准，藥物將受到FDA普遍且持續的監管，其中包括與藥物上市和註冊、記錄保存、定期報告、產品抽樣和分銷、不良事件報告和廣告、營銷和推廣相關的要求。藥物只能針對批准的適應症並按照批准的標籤的規定銷售。雖然醫生可以開出標籤外用途的處方，但製造商只能根據批准的標籤規定針對批准的適應症進行宣傳。然而，公司可能會分享與產品FDA批准的標籤一致的真實而非誤導性的信息。FDA和其他機構積極執行禁止推廣標籤外使用的法律法規，被發現不當推廣標籤外使用的公司可能會承擔重大責任。

在批准後，對批准的藥物的大多數更改，如增加新的適應症或其他標籤聲明，都要經過FDA的事先審查和批准。還有持續的使用費要求，根據這一要求，FDA評估批准的NDA中確定的每種藥物的年度計劃費用。此外，質量控制、藥品製造、包裝和標籤程序在獲得批准後必須繼續符合cGMP。藥品製造商和他們的某些分包商被要求向FDA和某些州機構登記他們的工廠。在FDA的註冊要求實體接受FDA和這些州機構的定期未經宣佈和宣佈的檢查，在此期間，該機構檢查製造設施，以評估對cGMP的遵守情況。FDA法規還要求調查和糾正任何偏離cGMP的情況，並對製造商及其分包商提出報告要求(如果適用)。因此，製造商必須繼續在生產和質量控制領域花費時間、金錢和精力，以保持遵守cGMP和其他方面的法規遵從性。

如果藥物未能保持對監管要求的合規性或藥物上市後出現問題，FDA可能會撤回對藥物的批准。後來發現藥物以前未知的問題，包括意外嚴重程度或頻率的不良事件，或製造工藝的不良事件，或未能遵守監管要求，可能會導致對已批准的標籤進行修改以添加新的安全信息;實施上市後研究或臨牀試驗以評估新的安全風險;或實施分銷限制或REMS計劃下的其他限制。其他潛在後果包括：

如果FDA發現科學數據（包括有關相關藥物的信息）認爲適當，FDA還可能要求進行批准後研究和臨牀試驗。此類研究的目的是評估與藥物相關的已知嚴重風險或嚴重風險信號，或者在可用數據表明可能存在嚴重風險時識別意外嚴重風險。如果FDA意識到其認爲應包含在藥物標籤中的新安全信息，則可能會要求更改標籤。

除了美國的法規外，如果我們尋求在其他司法管轄區銷售我們的藥品(如果獲得批准)，我們還必須遵守某些法規，如果我們尋求在其他司法管轄區銷售我們的藥品，還可能受到有關我們藥品的開發、批准、商業銷售和分銷的各種額外外國法規的約束。無論我們是否獲得FDA對候選藥物的批准，我們都必須獲得外國可比監管機構的必要批准，才能在這些國家開始臨牀試驗或銷售該藥物。審批過程因國家而異，可能涉及額外的藥物測試和額外的審查期，時間可能比獲得FDA批准所需的時間長或短。除其他事項外，管理臨牀試驗、藥品許可、定價和報銷等方面的要求因國家而異。一個國家的監管批准不能確保另一個國家的監管批准，但在一個國家未能獲得監管批准或拖延可能會對其他國家的監管過程產生負面影響。如果我們不遵守適用的外國監管要求，我們可能會被罰款、暫停或撤回監管批准、藥品召回、扣押藥品、運營限制和刑事起訴。

製藥公司須接受聯邦政府及其開展業務的州和外國司法管轄區當局的額外醫療保健監管和執法。在美國，此類法律包括但不限於州和聯邦反回扣、欺詐和濫用、虛假索賠、價格報告以及有關藥品定價和支付以及向醫生和其他醫療保健提供者進行的其他價值轉移的透明度法律和法規。違反任何此類法律或適用的任何其他政府法規可能會導致重大處罰，包括但不限於行政民事和刑事處罰、損害賠償、沒收罰款、額外報告要求和監督義務、合同損害賠償、業務縮減或重組、被排除參與政府醫療保健計劃和監禁。

我們或我們的合作者獲得監管批准的任何候選藥物的覆蓋範圍和報銷狀態都存在重大不確定性。在美國和其他國家的市場，我們或我們的合作者獲得監管機構批准商業銷售的任何藥物的銷售將在一定程度上取決於第三方付款人提供保險的程度，併爲此類藥品制定足夠的報銷水平。

在美國，第三方付款人包括聯邦和州醫療保健計劃、政府當局、私人管理的醫療保健提供者、私人健康保險公司和其他組織。第三方付款人正在越來越多地挑戰價格，審查醫療必要性，審查醫療藥品和醫療服務的成本效益，同時質疑其安全性和有效性。這樣的付款人可能會將覆蓋範圍限制在批准的清單上的特定藥物產品，也被稱爲處方集，其中可能不包括FDA批准的特定適應症的所有藥物。我們或我們的合作者可能需要進行昂貴的藥物經濟學研究，以證明我們的藥物的醫療必要性和成本效益，以及獲得FDA批准所需的成本。儘管如此，我們的候選藥物可能不被認爲是醫學上必要的或具有成本效益的。付款人決定爲藥品提供保險並不意味着將批准適當的報銷率。此外，一個付款人決定爲一種藥品提供保險並不能保證其他付款人也會爲該藥品提供保險。

此外，確定第三方付款人是否將爲藥品提供承保的過程可以與設定藥品價格或確定此類付款人將爲藥品支付的報銷費率的過程分開。對於在醫生監督下服用的藥物來說，獲得保險和充分的報銷可能特別困難，因爲此類藥物通常價格較高。此外，藥物本身或使用藥物的治療可能無法單獨報銷，這可能會影響醫生的利用。可能無法獲得足夠的第三方報銷，使我們能夠維持足以實現藥物開發投資的適當回報的價格水平。

其他國家也有不同的定價和報銷方案。在歐洲，政府通過定價和報銷規則以及對國家醫療保健系統的控制來影響藥品的價格，這些系統爲消費者支付的大部分藥品成本提供資金。一些司法管轄區實行正面清單和負面清單制度，只有在商定了補償價格後，才能銷售藥品。爲了獲得報銷或定價批准，其中一些國家可能要求完成臨牀試驗，將特定候選藥物的成本效益與目前可用的療法進行比較。其他成員國允許公司固定自己的藥品價格，但監控公司的利潤。醫療成本，特別是處方藥的下行壓力變得非常大。其結果是，對新藥進入市場的壁壘越來越高。此外，在一些國家，來自低價市場的跨境進口對一國國內的定價施加了商業壓力。

如果政府和第三方支付者未能提供足夠的保險和報銷，我們或我們的合作者獲得監管機構批准進行商業銷售的任何候選藥物的市場性都可能受到影響。此外，美國對管理式醫療的重視程度有所提高，我們預計藥品定價的壓力將繼續加大。承保政策和第三方報銷標準可能隨時更改。即使我們或我們的合作者獲得監管機構批准的一種或多種候選藥物獲得了有利的覆蓋範圍和報銷狀態，未來可能會實施不太有利的覆蓋政策和報銷率。

美國醫療保健行業和其他地區的主要趨勢是控制成本。政府當局和其他第三方支付者試圖通過限制特定醫療產品和服務的覆蓋範圍和報銷金額、減少醫療保險和其他醫療保健資金以及採用新的支付方法來控制成本。例如，2010年3月，《平價醫療法案》（ACA）頒佈了，影響了現有的政府醫療保健計劃，並導致了新計劃的開發。

除了上述規定外，ACA對製藥行業具有重要意義的條款包括以下內容：

自頒佈以來，ACA的某些方面受到了司法、行政和國會的挑戰。2021年6月17日，美國最高法院駁回了幾個州對ACA提出的最新司法挑戰，但沒有對ACA的合憲性做出具體裁決。

自ACA頒佈以來，美國還提出並通過了其他立法修改。2011年8月2日，除其他事項外，2011年預算控制法案包括對醫療保險提供者支付的聯邦醫療保險付款的總體削減，該法案於2013年4月1日生效，並將一直有效到2032年，除非國會採取額外行動，否則從2020年5月1日到2022年3月31日暫停支付除外。此外，2013年1月，2012年的《美國納稅人救濟法》被簽署爲法律，其中包括進一步減少了向包括醫院、成像中心和癌症治療中心在內的幾家醫療服務提供者支付的醫療保險，並將政府追回向醫療服務提供者多付款項的訴訟時效從三年延長到五年。此外，2021年美國救援計劃法案被簽署爲法律，從2024年1月1日起取消了法定的醫療補助藥品退稅上限。之前的回扣上限是藥品製造商平均價格的100%

最近，政府對製藥公司爲其上市產品定價的方式也加強了審查，這導致了幾次國會調查和擬議的聯邦立法，以及州政府的努力，這些努力的目的之一是提高藥品定價的透明度，降低聯邦醫療保險下處方藥的成本，審查定價與製造商患者計劃之間的關係，以及改革政府計劃對藥品的報銷方法。最近的一次是在2022年8月16日，《2022年通脹削減法案》(IRA)簽署成爲法律。除其他事項外，愛爾蘭共和軍要求某些藥品的製造商與聯邦醫療保險進行價格談判(從2026年開始)，價格可以談判，但有上限；根據聯邦醫療保險B部分和聯邦醫療保險D部分實施回扣，以懲罰超過通脹的價格上漲(首次於2023年到期)；並用新的折扣計劃取代D部分覆蓋缺口折扣計劃(開始於2025年)。醫療保險和醫療補助服務中心(CMS)已經公佈了最初10種藥物的談判價格，這些藥物將於2026年首次生效，並公佈了隨後將接受談判的15種藥物的清單。愛爾蘭共和軍允許衛生與公衆服務部(HHS)秘書在最初幾年通過指導而不是監管來實施其中許多規定。隨着這些計劃的實施，HHS已經並將繼續發佈和更新指導意見，儘管藥品價格談判計劃目前受到法律挑戰。由於這一原因和其他原因，目前尚不清楚愛爾蘭共和軍將如何實施。

我們預計這些新法律將給我們獲得的任何批准藥物的覆蓋範圍和價格帶來額外的下行壓力，並可能嚴重損害我們的業務。醫療保險和其他政府計劃報銷的任何減少都可能導致私人支付者付款的類似減少。實施成本控制措施或其他醫療保健改革可能會阻止我們產生收入、實現盈利或將我們的藥物商業化（如果獲得批准）。此外，可能還會有進一步的立法或監管，可能損害我們的業務、財務狀況和運營結果。

我們還可能遵守聯邦、州和外國數據隱私和安全法律法規。在美國，衆多聯邦和州法律法規，包括州數據泄露通知法、州健康信息隱私法以及聯邦和州消費者保護法律法規（例如，《聯邦貿易委員會法案》第5條）規範健康相關信息和其他個人信息的收集、使用、披露和保護，並可能適用於我們或我們合作伙伴的運營。此外，某些外國法律規範個人數據（包括與健康相關的數據）的隱私和安全。隱私和安全法律、法規和其他義務不斷變化，可能會相互衝突，使合規工作複雜化，並可能導致調查、訴訟或行動，從而導致重大民事和/或刑事處罰以及對數據處理的限制。

截至2024年12月31日，我們擁有全職員工70名，其中從事研發的員工54名。我們的員工沒有工會代表或集體談判協議的涵蓋範圍。我們認爲我們與員工的關係很好。

我們的人力資本資源目標包括（如適用）識別、招聘、保留、激勵和整合我們的現有和額外員工。我們股權激勵計劃的主要目的是

通過授予股票薪酬獎勵和現金績效獎金獎勵來吸引、保留和激勵選定的員工、顧問和董事。

我們成立於2018年2月，是一家特拉華州公司。我們的主要行政辦公室位於One Corporate Dr.，加利福尼亞州南舊金山2樓94080，我們的電話號碼是（800）466-6059。

我們的網站地址是Www.aligos.com。我們在我們的網站上或通過我們的網站提供我們根據1934年證券交易法(修訂後的證券交易法)或交易法向美國證券交易委員會提交或提交的某些報告和對這些報告的修正。這些報告包括我們關於Form 10-K的年度報告、我們關於Form 10-Q的季度報告以及我們目前關於Form 8-K的報告，以及對根據交易法第13(A)或15(D)節提交或提交的報告的修正。在我們以電子方式將信息存檔或提供給美國證券交易委員會後，我們在合理可行的範圍內儘快在我們的網站上免費提供這些信息。對我們網站地址的引用並不構成通過引用併入網站上的信息，網站上包含的信息也不是本文件或我們向美國證券交易委員會備案或提供的任何其他文件的一部分。美國證券交易委員會在全球網站上設有一個網站，其中包含有關我們在www.sec.gov提交的文件的報告、委託書和信息聲明以及其他信息。

投資我們的普通股涉及很高的風險。在決定是否投資我們的普通股之前，您應仔細考慮下文描述的風險以及本10-K表格年度報告中的其他信息，包括我們的合併財務報表和相關注釋以及題爲「管理層對財務狀況和經營結果的討論和分析」的部分。下文描述的任何事件或事態發展的發生可能會損害我們的業務、財務狀況、運營業績和增長前景。在這種情況下，我們普通股的市場價格可能會下跌，您可能會失去全部或部分投資。我們目前不知道或我們目前認爲不重要的額外風險和不確定性也可能損害我們的業務運營和我們普通股的市值。

與我們有限的運營歷史、財務狀況和額外資本需求相關的風險

我們是一家臨牀階段的生物技術公司，運營歷史有限，沒有獲准商業銷售的產品。自成立以來，我們已經遭受了重大損失。我們預計至少在未來幾年內會出現虧損，並且可能永遠無法在整個財年實現或維持盈利能力，再加上我們有限的運營歷史，使得很難評估我們未來的生存能力。

生物製藥產品開發是一項高度投機的事業，涉及很大程度的風險。我們是一家臨牀階段的生物技術公司，我們的運營歷史有限，您可以據此評估我們的業務和前景。我們目前沒有獲准商業銷售的產品，也沒有從產品銷售中產生任何收入，並且自2018年2月成立以來每年都出現虧損。此外，我們作爲一家公司的經驗有限，尚未證明有能力成功克服公司在新的和快速發展的領域（特別是生物製藥行業）經常遇到的許多風險和不確定性。

自成立以來，我們發生了重大的淨虧損。截至2024年12月31日的年度，我們的淨虧損爲13120美元萬，截至2023年12月31日的年度，淨虧損爲8,770美元萬。截至2024年12月31日，我們的股東赤字總額爲2,900美元萬。到目前爲止，我們的運營資金主要來自出售普通股、優先股和可轉換票據的收益。到目前爲止，我們已將幾乎所有的資源用於組織和配備我們的公司、業務規劃、籌集資金、收購和發現開發計劃、保護知識產權以及爲我們的計劃開展發現、研究和開發活動。我們還沒有證明我們有能力成功完成任何臨牀試驗，包括關鍵的臨牀試驗、獲得市場批准、製造商業規模的產品或安排第三方代表我們這樣做，或進行成功的產品商業化所需的銷售和營銷活動。我們的候選藥物將需要大量額外的開發時間和資源，然後我們才能申請或獲得監管部門的批准，如果獲得批准，我們將開始從產品銷售中獲得收入。在可預見的未來，我們可能會繼續招致巨額費用和運營虧損。

我們從未從產品銷售中產生過收入，並且可能永遠不會在整個財年實現盈利。

我們從產品銷售中產生收入並實現盈利的能力取決於我們單獨或與合作伙伴一起成功完成候選藥物的開發並獲得商業化所需的監管批准的能力。我們預計未來幾年不會從產品銷售中產生收入（如果有的話）。我們從產品銷售中產生收入的能力在很大程度上取決於我們以及我們當前和潛在的未來合作者在以下方面的成功：

即使我們開發的一種或多種候選藥物被批准商業銷售，我們預計將產生與任何已批准的候選藥物商業化相關的巨額成本。如果美國食品和藥物管理局（FDA）、歐洲藥品管理局（EMA）或其他監管機構要求我們在我們目前預期的範圍內進行臨牀試驗或研究，那麼我們的費用可能會超出預期。即使我們能夠從銷售任何批准的產品中產生收入，我們也可能無法在整個財年實現盈利，並且可能需要獲得額外資金才能繼續運營。

We will require substantial additional financing to achieve our goals, which may not be available on acceptable terms, or at all. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts.

Our operations have consumed substantial amounts of cash since our inception. Since our inception, we have invested a significant portion of our efforts and financial resources in research and development activities for our initial nonclinical and clinical drug candidates. Nonclinical studies and clinical trials and additional research and development activities will require substantial funds to complete. In October 2023 and February 2025, we closed private investments of our securities that generated approximately $92.1 million and $105.0 million in gross proceeds, respectively, before deducting placement agent fees and other offering expenses. As of December 31, 2024, we had cash, cash equivalents and investments of $56.9 million. We expect to continue to spend substantial amounts to continue the nonclinical and clinical development of our current and future programs. If we are able to gain marketing approval for drug candidates that we develop, we will require significant additional amounts of cash in order to launch and commercialize such drug candidates. In addition, other unanticipated costs may arise. Because the design and outcome of our planned and anticipated clinical trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of any drug candidate we develop.

To date, we have primarily financed our operations through the sale of common stock, preferred stock, convertible notes and warrants. For example, in November 2024, we filed a Registration Statement on Form S-3 covering the offering of up to $400.0 million of common stock, preferred stock, debt securities, warrants, units and rights, which was declared effective by the SEC in November 2024 (November 2024 Shelf Registration Statement). In October 2023, we completed a private placement of common stock, warrants and pre-funded warrants.

We expect to finance our cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements. In addition, we may seek additional capital to take advantage of favorable market conditions or strategic opportunities even if we believe we have sufficient funds for our current or future operating plans. Based on our research and development plans, we expect that our existing cash, cash equivalents and investments will enable us to fund our operations for at least 12 months following the date of this report. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned. Moreover, it is particularly difficult to estimate with certainty our future expenses given the dynamic nature of our business, and the macro-economic environment generally.

Our ability to raise additional funds depends on financial, economic and other factors, many of which are beyond our control. For example, if there is a disruption of global financial markets, we could be unable to access additional capital, which could negatively affect our ability to consummate certain corporate development transactions or other important, beneficial or opportunistic investments. If additional funds are not available to us when we need them, on terms that are acceptable to us, or at all, we may be required to:

We currently have a shelf registration statement effective, however, our ability to raise capital under this registration statement may be limited by, among other things, SEC rules and regulations impacting the eligibility of smaller companies to use Form S-3 for primary offerings of securities. Although alternative public and private transaction structures may be available, these may require additional time and cost, may impose operational restrictions on us, and may not be available on attractive terms.

Our operating results may fluctuate significantly, which will make our future results difficult to predict and could cause our results to fall below expectations.

Our quarterly and annual operating results may fluctuate significantly, which will make it difficult for us to predict our future results. These fluctuations may occur due to a variety of factors, many of which are outside of our control and may be difficult to predict, including:

The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past results as an indication of our future performance.

This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially. Such a stock price decline could occur even if we have met any previously publicly stated revenue or earnings guidance we may provide.

Our business could be materially adversely affected by the effects of health pandemics or epidemics and in particular in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations, including the San Francisco Bay Area where our headquarters are located.

Our business could be materially adversely affected by the effects of health pandemics or epidemics. For instance, the outbreak of COVID-19, which the World Health Organization had declared a global pandemic, prompted severe lifestyle and commercial restrictions aimed at reducing the spread of the disease. In March 2020, the San Francisco Bay Area counties issued a joint shelter-in-place order, which was subsequently followed by a California state-wide shelter order, and other state and local governments implemented similar orders which, among other things, directed individuals to shelter at their places of residence, directed businesses and governmental agencies to cease non-essential operations at physical locations, prohibited certain non-essential gatherings, and ordered cessation of non-essential travel. As a result of these developments, we had implemented work-from-home policies for most of our employees until March 2022 when we allowed our employees to return to work at our U.S. facility. Government-imposed quarantines and any future work-from-home policies may negatively impact productivity, disrupt our business and delay our clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions, the potential impact of changing government orders in response to health pandemics or epidemics and other limitations on our ability to conduct our business in the

ordinary course. These and similar, and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial condition in the future.

Quarantines, shutdowns and shelter-in-place and similar government orders related to infectious diseases, or the perception that such events, orders or other restrictions on the conduct of business operations could occur, could impact personnel at third-party manufacturing facilities in the United States and other countries, or the availability or cost of materials, which would disrupt our supply chain. Restrictions resulting from health pandemics or epidemics may at any time disrupt our supply chain and delay or limit our ability to obtain sufficient materials for our drug candidates.

In addition, our current clinical trial and planned clinical trials may be affected by any future public health pandemics or epidemics. Site initiation and patient enrollment may be delayed due to prioritization of hospital resources toward the disease, and potential patients may not be able or willing to comply with clinical trial protocols, whether due to quarantines impeding patient movement or interrupting healthcare services, or due to potential patient concerns regarding interactions with medical facilities or staff. Similarly, our ability to recruit and retain principal investigators and site staff who, as healthcare providers, may have heightened exposure to the disease, may be delayed or disrupted, which may adversely impact our clinical trial operations.

In addition, any future significant outbreak of contagious diseases in the human population could similarly adversely affect the economies and financial markets of many countries, including the United States, resulting in an economic downturn that could suppress demand for our future products. Any of these events could have a material adverse effect on our business, financial condition, results of operations or cash flows.

In addition, a continuing widespread pandemic could result in significant disruption of global financial markets, reducing our ability to access capital, which could negatively affect our liquidity and ability to progress our operations. In addition, a recession, down-turn, market correction or supply chain disruption resulting from health pandemics or epidemics could materially adversely affect the value of our common stock.

We are early in our development efforts, and our business is dependent on the successful development of our current and future drug candidates. If we are unable to advance our current or future drug candidates through clinical trials, obtain marketing approval and ultimately commercialize any drug candidates we develop, or experience significant delays in doing so, our business will be materially harmed.

Our clinical development efforts across our drug candidates are in an early stage. We have initiated clinical trials for our most advanced drug candidates in many countries (e.g., New Zealand, Hong Kong, the United Kingdom). Our other programs are in the discovery or nonclinical development stage. We have invested substantially all of our efforts and financial resources in the identification of targets and nonclinical development of therapeutics to address hepatological indications and viral diseases. However, the biology of these indications and diseases is complex and not completely understood, and our current and future drug candidates may never achieve expected or functional levels of efficacy or achieve an acceptable safety profile. For example, our chronic HBV infection portfolio previously included our STOPSTM drug candidate, ALG-010133, one of our proprietary s-antigen transport-inhibiting oligonucleotide polymers that was in a Phase 1b dose range finding trial (NCT04485663) evaluating subjects with CHB as well as our proprietary antisense oligonucleotide, ALG-020572, that was in a Phase 1a/1b umbrella study (NCT05001022) and for which dosing in chronic HBV infection patients were initiated as part of the multiple ascending dose portion of such study. However, in January 2022, we announced we halted further development of ALG-010133 based on data from such trial indicating insufficient antiviral activity to warrant further development of such drug candidate. And, in March 2022, we announced our discontinuation of further development of ALG-020572 due to an unanticipated serious adverse event involving significant increase in alanine aminotransferase (ALT) in one subject and several additional subjects experiencing ALT flares. Finally, for our siRNA drug candidate targeting HBsAg production, ALG‑125755, we conducted a Phase 1 study evaluating single doses ranging from 20-200 mg and 50-320 mg in HVs and virologically suppressed HBeAg- subjects with chronic HBV infection, respectively. In this study, we found that these single doses were well tolerated with a favorable PK profile. With respect to antiviral activity, while available data indicate evidence of HBsAg lowering at all 3 dose levels evaluated, the comparative efficacy of ALG-125755 vs. competitor siRNAs is inconclusive. Because further clinical evaluation of ALG-125755 is not prioritized with current funding, any further advancement of ALG-125755 will require additional external funding which we may not be able to obtain.

Our use of clinically validated targets to pursue treatments of these indications and diseases does not guarantee efficacy or safety or necessarily reduce the risk that our current or future drug candidates will not achieve expected or functional levels of efficacy or achieve an acceptable safety profile.

The success of our business, including our ability to finance our company and generate revenue from products in the future, which we do not expect will occur for several years, if ever, will depend heavily on the successful development and eventual commercialization of the drug candidates we develop, which may never occur. Our current drug candidates, and any future drug candidates we develop, will require additional nonclinical and clinical development, management of clinical, nonclinical and manufacturing activities, marketing approval in the United States and other markets, demonstrating effectiveness to pricing and reimbursement authorities, obtaining sufficient manufacturing supply for both clinical development and commercial production, building of a commercial organization, and substantial investment and significant marketing efforts before we generate any revenues from product sales.

We are evaluating drug candidates in clinical trials in many countries (e.g., New Zealand, Hong Kong, the United Kingdom). As a company, we have limited experience in preparing, submitting and prosecuting regulatory filings. Specifically, we have not previously submitted a new drug application (NDA) to the FDA or similar approval filings to a comparable foreign regulatory authority for any drug candidate. An NDA or other relevant regulatory filing must include extensive nonclinical and clinical data and supporting information to establish that the drug candidate is safe and effective for each desired indication. The NDA or other comparable regulatory filing must also include significant information regarding the chemistry, manufacturing and controls for the product. We have had limited interactions with the FDA and cannot be certain how many clinical trials of any of our drug candidates will be required or whether the FDA will agree with the design or implementation of our clinical trials. In addition, we cannot be certain that our current or future drug candidates will be successful in clinical trials such that the information contained in an NDA or comparable regulatory filing would support approval, and thus we cannot guarantee that any of our drug candidates will receive regulatory approval. Further, even if our current or future drug candidates are successful in clinical trials, such candidates may not receive regulatory approval. If we do not receive regulatory approvals for current or future drug candidates, we may not be able to continue our operations. Even if we successfully obtain regulatory approval to market a drug candidate, our revenue will depend, in part, upon the size of the markets in the territories for which we gain regulatory approval and have commercial rights, as well as the availability of competitive products, third-party reimbursement and adoption by physicians.

We plan to seek regulatory approval to commercialize our drug candidates both in the United States and in select foreign countries. While the scope of regulatory approval in other countries is generally similar to that in the United States, in order to obtain separate regulatory approval in other countries we must comply with numerous and varying regulatory requirements of such countries regarding safety and efficacy. Other countries also have their own regulations governing, among other things, clinical trials and commercial sales, as well as pricing and distribution of drugs, and we may be required to expend significant resources to obtain regulatory approval and to comply with ongoing regulations in these jurisdictions.

The success of our current and future drug candidates depends on many factors, which may include the following:

If we are not successful with respect to one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully obtain approval of or commercialize the drug candidates we develop, which would materially harm our business. If we do not receive marketing approvals for our current or future drug candidates, we may not be able to continue our operations. Even if regulatory approvals are obtained, we may never be able to successfully commercialize any products. Accordingly, we cannot provide assurances that we will be able to generate sufficient revenue through the sale of products to continue our business.

Nonclinical development is uncertain. Our nonclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize our drug candidates on a timely basis or at all, which would have an adverse effect on our business.

In order to obtain approval from the FDA and other major regulatory agencies in non-U.S. countries to market a new drug candidate, we must demonstrate proof of safety and efficacy in humans. To meet these requirements, we will have to conduct adequate and well-controlled clinical trials. Before we can commence clinical trials for a drug candidate, we must complete extensive nonclinical studies that support our planned INDs or CTAs in the United States and other countries. At this time, we are evaluating drug candidates in clinical trials in many countries (e.g., New Zealand, Hong Kong, the United Kingdom). The rest of our programs are in nonclinical research or earlier stages of development, including our other chronic hepatitis B (CHB) drug candidates and our coronavirus drug candidates. We cannot be certain of the timely completion or outcome of our nonclinical studies and cannot predict if the FDA or other regulatory authorities will accept our proposed clinical programs or if the outcome of our nonclinical studies will ultimately support further development of our programs. In addition, the FDA may decline to accept the data we obtain from foreign clinical studies in support of an IND or NDA in the United States, which may require us to repeat or conduct additional nonclinical studies or clinical trials that we did not anticipate in the United States. As a result, we cannot be sure that we will be able to submit INDs in the United States, or CTAs or similar applications in other jurisdictions, on the timelines we expect, if at all, and we cannot be sure that submission

of INDs, CTAs or similar applications will result in the FDA or other regulatory authorities allowing additional clinical trials to begin.

Conducting nonclinical testing is a complex, lengthy, time-consuming and expensive process. The length of time may vary substantially according to the type, complexity and novelty of the program, and often can take several years or more per program. Delays associated with programs for which we are directly conducting nonclinical studies may cause us to incur additional operating expenses. Moreover, we may be affected by delays associated with the studies of certain programs that are the responsibility of potential future partners, if any, over which we have no control. The commencement and rate of completion of nonclinical studies and clinical trials for a drug candidate may be delayed by many factors, including:

Moreover, even if candidates from our drug programs advance into clinical trials, our development efforts may not be successful, and clinical trials that we conduct or that third parties conduct on our behalf may not demonstrate sufficient safety or efficacy to obtain the requisite regulatory approvals for any drug candidates we develop. Even if we obtain positive results from nonclinical studies or initial clinical trials, we may not achieve the same success in future trials.

The regulatory approval processes of the FDA, the EMA and comparable foreign authorities are lengthy, time-consuming, complex and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our drug candidates, our business will be substantially harmed.

The time required to obtain approval by the FDA, the EMA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a drug candidate’s clinical development and may vary across jurisdictions. We have not obtained regulatory approval for any drug candidate and it is possible that none of our current or future drug candidates will ever obtain regulatory approval.

Our current and future drug candidates could fail to receive regulatory approval for many reasons, including the following:

This lengthy approval process as well as the unpredictability of clinical trial results may result in our failing to obtain regulatory approval to market any drug candidate we develop, which would significantly harm our business, results of operations and prospects. The FDA, the EMA and other comparable foreign authorities have substantial discretion in the approval process, and in determining when or whether regulatory approval will be obtained for any drug candidate that we develop. Even if we believe the data collected from future clinical trials of our drug candidates are promising, such data may not be sufficient to support approval by the FDA, the EMA or any other regulatory authority.

In addition, even if we were to obtain approval, regulatory authorities may approve any of our drug candidates for fewer or more limited indications than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a drug candidate with a label that does not include the labeling claims that we believe are necessary or desirable for the successful commercialization of that drug candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our drug candidates.

We cannot be certain that any of our programs will be successful in clinical trials or receive regulatory approval. Further, drug candidates we develop may not receive regulatory approval even if they are successful in clinical trials. If we do not receive regulatory approvals for our drug candidates, we may not be able to continue our operations.

Clinical product development involves a lengthy and expensive process, with uncertain outcomes. We may experience delays in completing, or ultimately be unable to complete, the development and commercialization of our current and future drug candidates, which could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our business, financial condition, results of operations and prospects.

To obtain the requisite regulatory approvals to commercialize any of our drug candidates, we must demonstrate through extensive nonclinical studies and clinical trials that our products are safe and effective in humans. Clinical trials are expensive and can take many years to complete, and their outcomes are inherently uncertain. Failure can occur at any time during the clinical trial process and our future clinical trial results may not be successful. For example, in January 2022, we halted further development of ALG‑010133. This decision was based on emerging data from the Phase 1 Study ALG-010133-101, that indicated that at the projected efficacious dose (400 mg, estimated to achieve liver exposures >3 x EC90 for HBsAg inhibition) there was no meaningful HBsAg reduction. Furthermore, higher doses levels (maximum feasible dose is 600 mg) that were planned to be evaluated in a subsequent cohort were very unlikely to reach the 1 log10 IU/mL HBsAg reduction level that we had previously defined as necessary to advance the program. As another example, in March 2022, we discontinued further development of our ASO drug candidate for CHB, ALG‑020572, due to an unanticipated serious adverse event involving significant increase in ALT in one CHB subject and several other subjects experiencing ALT flares in the same study. Finally, for our siRNA drug candidate targeting HBsAg production, ALG‑125755, we conducted a Phase 1 study evaluating single doses ranging from 20-200 mg and 50-320 mg in HVs and virologically suppressed HBeAg negative subjects with chronic HBV infection, respectively. In this study, we found that these single doses were well tolerated with a favorable PK profile. With respect to antiviral activity, while available data indicate evidence of HBsAg lowering at all 3 dose levels evaluated, the comparative efficacy of ALG-125755 vs. competitor siRNAs is inconclusive. Because further clinical evaluation of ALG-125755 is not prioritized with current funding, any further advancement of ALG-125755 will require additional external funding which we may not be able to obtain.

We may experience delays in completing our clinical trials and initiating or completing additional clinical trials. We may also experience numerous unforeseen events prior to, during, or as a result of our nonclinical studies

or clinical trials that could delay or prevent our ability to receive marketing approval or commercialize the drug candidates we develop, including:

We could encounter delays if a clinical trial is suspended or terminated by us, by the IRBs or ethics committees of the institutions in which such trials are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA or other regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. 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 marketing approval of our drug candidates.

Further, we are currently conducting clinical trials in many countries (e.g., New Zealand, Hong Kong, the United Kingdom). We may also in the future conduct clinical trials for these and other drug candidates in other countries and territories which presents additional risks that may delay completion of our clinical trials. These risks include the possibility that we could be required to conduct additional nonclinical studies before initiating any clinical trials, may be unable to enroll and retain patients as a result of differences in healthcare services, research guidelines or cultural customs, or may face additional administrative burdens associated with comparable foreign regulatory schemes, as well as political and economic risks relevant to such foreign countries.

If we experience termination or delays in the completion of any clinical trial of our drug candidates, the commercial prospects of our drug candidates will be harmed, and our ability to generate product revenues from any of these drug candidates will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow down our drug candidate development and approval process and jeopardize our ability to commence product sales and generate revenues. Significant clinical trial delays could also allow our competitors to bring products to market before we do, shorten any periods during which we may have the exclusive right to commercialize our drug candidates, impair our ability to commercialize our drug candidates and harm our business and results of operations.

Specifically, should we experience another pandemic or epidemic outbreak on a similar if not greater scale as the COVID-19 outbreak, the clinical trial sites for our current drug trials, and future planned trials may be affected due to prioritization of hospital resources toward the outbreak efforts, travel or quarantine restrictions imposed by national, federal, state or local governments, and the inability to access sites for initiation and patient monitoring and enrollment. As a result, patient screening, new patient enrollment, monitoring and data collection may be affected or delayed. Some of our third-party manufacturers we use for the supply of materials for drug candidates or other materials necessary to manufacture product to conduct clinical trials may be located in countries affected by the

outbreak, and, should they experience disruptions such as temporary closures or suspension of services, we would likely experience delays in advancing these trials.

In addition, the U.S. House of Representatives has passed the BIOSECURE Act and the Senate has advanced a substantially similar bill, which legislation, if passed and enacted into law, would have the potential to restrict the ability of U.S. biopharmaceutical companies like us to purchase services or products from, or otherwise collaborate with, certain Chinese biotechnology companies “of concern” without losing the ability to contract with, or otherwise receive funding from, the U.S. government. We do business with companies in China and it is possible some of our contractual counterparties could be impacted by this legislation.

Separately, principal investigators for our clinical trials serve as scientific advisors or consultants to us from time to time and may receive cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, or a regulatory authority concludes that the financial relationship may have affected the interpretation of the clinical trial, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection of any applications we submit. Any such delay or rejection could prevent or delay us from commercializing our current or future drug candidates.

There is also uncertainty as to how measures being implemented by the new administration will impact the operations of various agencies. Any of these occurrences may harm our business, financial condition and prospects significantly. In addition, many of the factors that cause, or could lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our drug candidates or result in the development of our drug candidates being terminated.

Our pursuit of potential treatments for CHB is at an early stage and we may be unable to produce a therapy that successfully treats CHB. Even if successful, we may be unable to obtain regulatory approval for and successfully commercialize our drug candidates.

We have invested a significant portion of our time and financial resources in the pursuit of a treatment for CHB, including ALG‑000184, a CAM-E that is currently in a multipart Phase 1 trial. If we cannot successfully develop, obtain regulatory approval for and commercialize our drug candidates for the treatment of CHB, our business may be harmed. The mechanism of action of our CHB drug candidates is complex, and we do not know the degree to which it will translate into a therapeutic benefit, if any, in CHB or any other indication, and we do not know the degree to which the complex mechanism of action may contribute to long-term safety issues or adverse events when our drug candidates are taken for prolonged periods, as is inherent in the treatment of CHB.

In addition, the standards implemented by clinical or regulatory agencies may change at any time and we cannot be certain what efficacy endpoints the FDA or foreign clinical or regulatory agencies may require at the time we plan to conduct clinical trials with respect to CHB or any other applicable indication. Also, if we are able to obtain accelerated approval of our drug candidates, we may be required to conduct one or more post-approval clinical outcome trials to confirm the clinical benefit of the drug candidate; if any such post-approval trial is not successful, we would not be able to continue marketing the product.

If we are successful and any of our drug candidates are approved for the treatment of CHB, our drug candidates will likely compete with products that have already been approved or may in the future be approved for the treatment of CHB prior to our drug candidates and/or that have greater efficacy than our drug candidates, either alone or in combination.

Our pursuit of potential treatments for MASH is at an early stage and we may be unable to produce a therapy that successfully treats MASH. Even if successful, we may be unable to obtain regulatory approval for and successfully commercialize our drug candidates.

We have invested a significant portion of our time and financial resources in the pursuit of a treatment for MASH, including ALG-055009, our THR‑ß agonist which is currently in a Phase 2a trial. If we cannot successfully develop, obtain regulatory approval for and commercialize our drug candidates for the treatment of MASH, our business may be harmed. The mechanism of action of our MASH drug candidates is complex, and we do not know the degree to which it will translate into a therapeutic benefit, if any, in MASH or any other indication, and we do not know the degree to which the complex mechanism of action may contribute to long-term safety issues or adverse events when our drug candidates are taken for prolonged periods, as is inherent in the treatment of MASH.

In addition, the standards implemented by clinical or regulatory agencies may change at any time and we cannot be certain what efficacy endpoints the FDA or foreign clinical or regulatory agencies may require at the time we plan to conduct clinical trials with respect to MASH or any other applicable indication. Also, if we are able to obtain accelerated approval of our drug candidates, we may be required to conduct one or more post-approval clinical outcome trials to confirm the clinical benefit of the drug candidate; if any such post-approval trial is not successful, we would not be able to continue marketing the product.

If we are successful and any of our drug candidates are approved for the treatment of MASH, our drug candidates will likely compete with products that have already been approved or may in the future be approved for the treatment of MASH prior to our drug candidates and/or that have greater efficacy than our drug candidates, either alone or in combination. Behavioral modifications, such as diet and exercise, can also decrease or eliminate the demand for our potential MASH treatments.

In response to the outbreak of COVID-19, the disease caused by the virus SARS-CoV-2, we are pursuing various potential therapies to address the disease, including our drug candidate ALG-097558, an oral protease inhibitor which is currently in a Phase 1 trial. Our development of this potential therapy is at an early stage, and we may be unable to produce in a timely manner a therapy that successfully treats the virus or that has broad clinical applicability, if at all.

For example, in June 2020, we entered into a Research, Licensing and Commercialization Agreement with KU Leuven under which we were collaborating with KU Leuven’s Rega Institute for Medical Research, as well as its CD3, to research, develop, manufacture and commercialize potential protease inhibitors for the treatment of coronaviruses, including SARS-CoV-2. In July 2023, we amended our license agreement with KU Leuven (as amended, KU Leuven Agreement) to further our collaboration. While ALG-097558 has been selected as our drug candidate to move forward into development, the KU Leuven Agreement may ultimately not result in a therapy that successfully treats SARS-CoV-2. Further, if the KU Leuven Agreement does result in such a therapy, the therapy may not be developed and commercialized in a timely manner, or at all.

We are also committing significant personnel to the development of ALG-097558 for COVID-19, which may cause delays in or otherwise negatively impact our other development programs, despite uncertainties surrounding the longevity and extent of COVID-19 as a global health concern. COVID-19 may be substantially eradicated prior to our development of a successful therapy or a vaccine may be developed that is highly efficacious and widely adopted, reducing or eliminating the need for therapies to treat the disease. For instance, the Pfizer/BioNTech BNT162b2, the adenovirus type 26 (Ad26) vaccine by Janssen Pharmaceutical Companies of Johnson & Johnson, Moderna mRNA-1273 and Novavax NVX-CoV2373 COVID-19 vaccines have been approved and/or authorized for emergency use and are in the process of being widely being administered in various countries throughout the world which could adversely impact the need for our potential COVID-19 therapies. Further, while we hope to develop potential therapies that are effective against other or future coronaviruses, in addition to SARS-CoV-2, we cannot be certain this will be the case. If our potential therapies are not effective against other or future coronaviruses, the value and/or sales potential of our therapies will be reduced or eliminated. Our business could be negatively impacted by our allocation of significant resources to a global health threat that is unpredictable and could rapidly dissipate or against which our potential therapies, if developed, may not be partially or fully effective, and may ultimately prove unsuccessful or unprofitable. Furthermore, there are no assurances that our therapy will be approved for inclusion in government stockpile programs, which may be material to the commercial success of any approved coronavirus-related drug candidate, either in the United States or abroad.

We will also need to enter into manufacturing arrangements in the future in order to create a supply chain for our COVID-19 drug candidates that can adequately support demand. Even if we are successful in developing and manufacturing an effective treatment for COVID-19, the SARS-CoV-2 virus could develop resistance to our treatment, which could affect any long-term demand or sales potential for our potential therapies.

In addition, another party may be successful in producing a more efficacious therapy for COVID-19 or a therapy with a more convenient or preferred route of administration or in producing a therapy in a more timely manner, which may lead to the diversion of funding away from us and toward other companies or lead to decreased demand for our potential therapies. For instance, on May 25, 2023, Pfizer, Inc. received an approval from the FDA for Paxlovid, an orally administered SARS-CoV-2 protease inhibitor co-administered with ritonavir. Similarly, Merck (together with Ridgeback Bio), is developing the drug molnupiravir, an oral antiviral drug which has been

issued an emergency use authorization by the FDA on December 23, 2021. Several drugs are likely being used off-label for treatment, such as dexamethasone. Several approved drugs are being studied for their utility in reducing the severity of SARS-CoV-2 infections, including Soliris by Alexion Pharmaceuticals Inc., Atea Pharmaceuticals, Inc., Jakafi by Incyte Corporation, and Kevzara by Sanofi S.A./Regeneron Pharmaceuticals, Inc. There are significant efforts by other companies globally to develop both therapeutic and prophylactic drug candidates. These other entities may be more successful at developing, manufacturing or commercializing a therapy for COVID-19, especially given that several of these other organizations are much larger than we are and have access to larger pools of capital, including U.S. government funding, and broader manufacturing infrastructure. The success or failure of other entities, or perceived success or failure, may adversely impact our ability to obtain any future funding for our development and manufacturing efforts or to ultimately commercialize a therapy for COVID-19, if approved.

The results of nonclinical studies and early-stage clinical trials may not be predictive of future results.

The results of nonclinical studies may not be predictive of the results of clinical trials, and the results of any early-stage clinical trials we commence may not be predictive of the results of the later-stage clinical trials. Drug candidates in later stages of clinical trials may fail to show the desired safety and efficacy despite having progressed through nonclinical studies and initial clinical trials. There is a high failure rate for drugs proceeding through clinical trials, and a number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even after achieving promising results in earlier studies. There can be no assurance that any of our current or future clinical trials will ultimately be successful or support further clinical development of any of our drug candidates. Even if our clinical trials are completed, the results may not be sufficient to obtain regulatory approval of any products. Any such setbacks in our clinical development could have a material adverse effect on our business and operating results.

Interim, “topline” and preliminary data from our clinical trials may differ materially from the final data.

From time to time, we may disclose interim data from our clinical trials. Interim data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more data on existing patients become available. Adverse differences between interim data and final data could significantly harm our business, financial condition, results of operations and prospects. From time to time, we may also publicly disclose preliminary or “topline” data from our clinical trials, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the topline results that we report may differ from future results of the same clinical trials, or different conclusions or considerations may qualify such topline results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are available.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular drug candidate or product and the value of our company in general.

In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is typically a summary of extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product, drug candidate or our business. If the topline data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our drug candidates may be harmed, which could harm our business, financial condition, operating results and prospects.

If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The enrollment of patients depends on many factors, including:

In addition, our clinical trials will compete with other clinical trials for drug candidates that are in the same therapeutic areas as our current and potential future drug candidates. This competition will reduce the number and types of patients available to us, because some patients who might have enrolled in our trials may instead opt to enroll in a trial conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we may conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which would reduce the number of patients who are available for our clinical trials at such sites. Moreover, because our current and potential future drug candidates may represent a departure from more commonly used methods for treatment, potential patients and their doctors may be inclined to use conventional therapies rather than enroll patients in our clinical trials.

Delays in patient enrollment may result in increased costs or may affect the timing or outcome of clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our drug candidates.

Changes in methods of drug candidate manufacturing or formulation may result in additional costs or delay.

As drug candidates proceed from nonclinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered to optimize results. However, any change could entail additional cost and risks potential delay if the reformulated or otherwise altered drug candidate performs differently than expected or intended, which could require modification to the nonclinical or clinical program. Such changes may also require additional testing, including bridging or comparability testing to demonstrate the validity of clinical data obtained in clinical trials following manufacturing changes, FDA notification or FDA approval.

Moreover, we have not yet manufactured or processed on a commercial scale any of our drug candidates. We may make changes as we work to optimize our manufacturing processes, but we cannot be sure that even minor changes in our processes will result in therapies that are safe and effective or that will be approved for commercial sale.

Our current or future drug candidates may cause undesirable side effects or have other properties when used alone or in combination with other approved products or investigational new drugs that could delay or halt their clinical development, prevent their marketing approval, limit their commercial potential or result in significant negative consequences.

Undesirable or clinically unmanageable side effects from one or more of our drug candidates or potential future products could occur and cause us or regulatory authorities to interrupt, delay or terminate clinical trials, could result in a more restrictive label or could cause the delay or denial of marketing approval by the FDA or comparable foreign regulatory authorities. Further, results of our planned clinical trials could reveal unacceptably severe and prevalent side effects or unexpected characteristics.

If unacceptable toxicities or other undesirable side effects arise in the development of any of our current or future drug candidates, we could suspend or terminate our trials, or the FDA or comparable foreign regulatory authorities could order us to cease clinical trials or deny approval of the drug candidate for any or all targeted indications. Treatment-related side effects could also affect patient recruitment or the ability of enrolled subjects to complete the trial, or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. Inadequately recognizing or managing the potential side effects of our drug candidates could result in patient injury or death. Any of these occurrences may prevent us from achieving or maintaining market acceptance of the affected drug candidate and may harm our business, financial condition and prospects significantly.

Although our current and future drug candidates will undergo safety testing to the extent possible and, where applicable, under such conditions discussed with regulatory authorities, not all adverse effects of drugs can be predicted or anticipated. Unforeseen side effects could arise either during clinical development or, if such side effects are more rare, after our products have been approved by regulatory authorities and the approved product has been marketed, resulting in the exposure of additional patients. To date, we have not demonstrated that any of our drug candidates are safe in humans, and we cannot predict if ongoing or future clinical trials will do so.

Furthermore, we plan to evaluate our drug candidates in combination with approved and/or experimental therapies. These combinations may have additional or more severe side effects than caused by our drug candidates as monotherapies or may cause side effects at lower doses. The uncertainty resulting from the use of our drug candidates in combination with other therapies may make it difficult to accurately predict side effects in potential future clinical trials.

If any of our drug candidates receives marketing approval and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could occur, including:

Any of the foregoing events could prevent us from achieving or maintaining market acceptance of the particular drug candidate, if approved, and result in the loss of significant revenue to us, which would adversely affect our business, financial condition, results of operations and prospects. In addition, if one or more of our drug candidates prove to be unsafe, our entire technology platform and pipeline could be affected, which would have a material adverse effect on our business, financial condition, results of operations and prospects.

Even if we complete the necessary nonclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us or any of our future collaboration partners from obtaining approvals for the commercialization of our current drug candidates and any other drug candidate we develop.

Any current or future drug candidates we may develop and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, and distribution, are subject to comprehensive regulation by the FDA and other regulatory authorities in the United States and by comparable authorities in other countries. Failure to obtain marketing approval for a drug candidate will prevent us from commercializing the drug candidate in a given jurisdiction. We have not received approval to market any drug candidates from regulatory authorities in any jurisdiction and it is possible that none of our current or future drug candidates will ever obtain regulatory approval. As an organization, we have no experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely on third-party CROs or regulatory consultants to assist us in this process. Securing regulatory approval requires the submission of extensive nonclinical and clinical data and supporting information to the various regulatory authorities for each therapeutic indication to establish the drug candidate’s safety and efficacy. Securing regulatory approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority. Any drug candidates we develop may not be effective, may be only moderately effective, or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use.

The process of obtaining marketing approvals, both in the United States and abroad, is expensive, may take many years if additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity, and novelty of the drug candidates involved. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. There is also uncertainty as to how measures being implemented by the new administration will impact the operations of various agencies. For example, the potential loss of personnel at various agencies could lead to disruptions and delays in review of our product candidates.

The FDA and comparable authorities in other countries have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional nonclinical, clinical or other studies. In addition, varying interpretations of the data obtained from nonclinical and clinical testing could delay, limit, or prevent marketing approval of a drug candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

If we experience delays in obtaining marketing approval or if we fail to obtain marketing approval of any current or future drug candidates we may develop, the commercial prospects for those drug candidates may be harmed, and our ability to generate revenues will be materially impaired.

Even if a current or future drug candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

If any current or future drug candidate we develop receives marketing approval, whether as a single agent or in combination with other therapies, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, and others in the medical community, or such participants may prefer existing treatment options such as nucleos(t)ide analogs including tenofovir and entecavir. If the drug candidates we develop do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable for a full fiscal year. The degree of market acceptance of any drug candidate, if approved for commercial sale, will depend on a number of factors, including:

Adverse events in our therapeutic areas of focus, including hepatological indications and viral diseases, could damage public perception of our current or future drug candidates and negatively affect our business.

The commercial success of our products will depend in part on public acceptance of our therapeutic areas of focus. Adverse events in clinical trials of our drug candidates, or post-marketing activities, or in clinical trials of others developing similar products or targeting similar indications and the resulting publicity, as well as any other adverse events in our therapeutic areas of focus, including hepatological indications and viral diseases, could result in decreased demand for any product that we may develop. If public perception is influenced by claims that the use of therapies in our therapeutic areas of focus are unsafe, whether related to our therapies or those of our competitors, our products may not be accepted by the general public or the medical community.

Future adverse events in our therapeutic areas of focus or the biopharmaceutical industry could also result in greater governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approvals of our products. Any increased scrutiny could delay or increase the costs of obtaining marketing approval for the drug candidates we have developed, are developing and may in the future develop.

Negative developments and negative public opinion of technologies on which we rely may damage public perception of our drug candidates or adversely affect our ability to conduct our business or obtain regulatory approvals for our drug candidates.

The clinical and commercial success of our drug candidates will depend in part on public acceptance of the use of technologies for the prevention or treatment of human diseases. Adverse public attitudes may adversely impact our ability to enroll clinical trials. Moreover, our success will depend upon physicians specializing in our targeted diseases prescribing, and their patients being willing to receive, our drug candidates as treatments in lieu of, or in addition to, existing, more familiar, treatments for which greater clinical data may be available. Any increase in negative perceptions of the technologies that we rely on may result in fewer physicians prescribing our products (if approved) or may reduce the willingness of patients to utilize our products or participate in clinical trials for our drug candidates.

Increased negative public opinion or more restrictive government regulations in response thereto, would have a negative effect on our business, financial condition, results of operations or prospects and may delay or impair the development and commercialization of our drug candidates or demand for such drug candidates. Adverse events in our nonclinical studies or clinical trials or those of our competitors or of academic researchers utilizing similar technologies, even if not ultimately attributable to drug candidates we may discover and develop, and the resulting publicity could result in increased governmental regulation, unfavorable public perception, potential regulatory delays in the testing or approval of potential drug candidates we may identify and develop, stricter labeling requirements for those drug candidates that are approved, a decrease in demand for any such drug candidates and a suspension or withdrawal of approval by regulatory authorities of our drug candidates.

Even if we receive marketing approval of a drug candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products, if approved.

Any marketing approvals that we receive for any current or future drug candidate may be subject to limitations on the approved indicated uses for which the product may be marketed or contain requirements for potentially costly post-market testing and surveillance to monitor the safety and efficacy of the drug candidate. The FDA may also require a REMS as a condition of approval of any drug candidate, which could include requirements for a

Medication Guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk-minimization tools. In addition, if the FDA or a comparable foreign regulatory authority approves a drug candidate, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import and export and record keeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, establishment registration, as well as continued compliance with cGMP, and GCP, for any clinical trials that we conduct post-approval. Later discovery of previously unknown problems with any approved candidate, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay marketing approval of a product. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, and we may not achieve profitability for a full fiscal year.

Even if we obtain and maintain approval for our drug candidates from the FDA, we may never obtain approval outside the United States, which would limit our market opportunities.

Approval of a drug candidate in the United States by the FDA does not ensure approval of such drug candidate by regulatory authorities in other countries or jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries. Sales of our drug candidates outside the United States will be subject to foreign regulatory requirements governing clinical trials and marketing approval. Even if the FDA grants marketing approval for a drug candidate, comparable foreign regulatory authorities also must approve the manufacturing and marketing of the drug candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and more onerous than, those in the United States, including additional nonclinical studies or clinical trials. In many countries outside the United States, a drug candidate must be approved for reimbursement before it can be approved for sale in that country. In some cases, the price that we intend to charge for any drug candidates, if approved, is also subject to approval. Obtaining approval for our drug candidates in the European Union from the European Commission following the opinion of the EMA, if we choose to submit a marketing authorization application there, would be a lengthy and expensive process. Even if a drug candidate is approved, the EMA may limit the indications for which the product may be marketed, require extensive warnings on the product labeling or require expensive and time-consuming additional clinical trials or reporting as conditions of approval. Approval of certain drug candidates outside of the United States, particularly those that target diseases that are more prevalent outside of the United States, will be particularly important to the commercial success of such drug candidates. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our drug candidates in certain countries.

Further, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries. For example, we have or are currently conducting initial clinical trials for ALG-000184, ALG-055009 and ALG-097558 in many countries (e.g., New Zealand, Hong Kong, the United Kingdom), and plan to conduct additional clinical trials in several other countries and territories within the Asia Pacific and/or Europe and our conduct of the trials must satisfy specific requirements in order for the FDA to accept the data in support of an IND or NDA in the United States. Further, any regulatory approval for our drug candidates may be withdrawn. If we fail

to comply with the applicable regulatory requirements, our target market will be reduced and our ability to realize the full market potential of our drug candidates will be harmed and our business, financial condition, results of operations and prospects could be harmed.

Risks associated with our international operations, including seeking and obtaining approval to commercialize our drug candidates in foreign jurisdictions, could harm our business.

We engage in international operations with offices in the United States, Belgium and China and intend to seek approval to market our drug candidates outside of the United States. We may also do so for future drug candidates. We expect that we are or will be subject to additional risks related to these international business markets and relationships, including:

In addition, there are complex regulatory, tax, labor and other legal requirements imposed by many of the individual countries in which we may operate, with which we will need to comply.

Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or could otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s hiring and retention of key personnel and receipt of user fees, changes in senior leadership at FDA and HHS, and other events that may otherwise affect the FDA’s performance of routine functions. Average review times at the agency have fluctuated in recent years as a result. Disruptions at the FDA and other agencies may also slow the time necessary for new products to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, including for 35 days beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

Relatedly, in response to the COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points. Even though the FDA has since resumed standard inspection

operations, any resurgence of the virus or emergence of new variants may lead to further inspectional or administrative delays.

If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impair the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

If the market opportunities for our drug candidates are smaller than we believe or any approval we obtain is based on a narrower definition of the patient population, our business may suffer.

We currently focus our product development on novel therapeutics to address unmet needs in hepatological indications and viral diseases. Our eligible patient population, pricing estimates and available coverage and reimbursement may differ significantly from the actual market addressable by our drug candidates. Our estimates of both the number of people who have these diseases, as well as the subset of people with these diseases who have the potential to benefit from treatment with our drug candidates, are based on our beliefs and analyses based on a variety of sources, including scientific literature, patient foundations or market research, and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of the diseases we are targeting. The number of patients may turn out to be lower than expected, and the potentially addressable patient population for each of our drug candidates may be limited or may not be receptive to treatment with our drug candidates, and new patients may become increasingly difficult to identify or access. Certain potential patients may have or develop a resistance to our potential therapies or otherwise be unable to be treated with our potential therapies for HBV, COVID-19 or other viral diseases as a result of their genetic makeup. In addition, the route of administration for our potential therapies could be inconvenient and/or not commercially viable, which could also limit the potential market for our therapies.

If the market opportunities for our drug candidates are smaller than we estimate, it could have an adverse effect on our business, financial condition, results of operations and prospects.

For example, we believe MASH to be one of the most prevalent chronic liver diseases worldwide, however, our projections of the number of people who have MASH, as well as the subset of people with the disease who have the potential to benefit from treatment with our drug candidates, are based on our beliefs and estimates. The effort to identify patients with MASH is in early stages, and we cannot accurately predict the number of patients for whom treatment might be possible. MASH is often undiagnosed and may be left undiagnosed for a long time, partly because a definitive diagnosis of MASH is currently based on a histological assessment of a liver biopsy, which impairs the ability to easily identify patients. If improved diagnostic techniques for identifying MASH patients who will benefit from treatment are not developed, our market opportunity may be smaller than we currently anticipate. Further, if government authorities and third-party payors choose to limit coverage and reimbursement of our MASH drug candidate, such as limiting the number of patients’ treatment that would be covered and reimbursable, this could result in a smaller market opportunity for our MASH drug candidate than we anticipate.

In addition, the number of people who have HBV, as well as the subset of people with the disease who have the potential to benefit from treatment with our drug candidates, may be reduced due to factors including the genotype or variant of HBV, more widespread use of vaccines or alternative therapies, political roadblocks to approval and/or treatment in certain countries and the virus’s development of resistance to our potential treatments after long-term and persistent exposure to antiviral therapy.

We intend to develop our current drug candidates, and expect to develop other future drug candidates, in combination with other therapies, which exposes us to additional risks.

We intend to develop our current drug candidates, and expect to develop other future drug candidates, in combination with one or more therapies, including therapies that we develop and those developed externally. Even if a drug candidate we develop were to receive marketing approval or be commercialized for use in combination with other therapies, we would face the risk that the FDA or similar regulatory authority outside of the United States could revoke approval of the therapy used in combination with our drug candidate or that safety, efficacy, manufacturing or supply issues could arise with these other therapies. Combination therapies are commonly used for the treatment of viral diseases and it is generally believed they will be required for MASH, and we would be subject to similar risks if we develop any of our drug candidates for use in combination with other drugs. This could result in our own products, if approved, being removed from the market or suffering commercially. In addition, we may

evaluate our current drug candidates and other future drug candidates in combination with one or more other therapies that may have not yet been approved for marketing by the FDA or similar regulatory authorities outside of the United States. We will not be able to market and sell any drug candidate we develop in combination with any such unapproved therapies that do not ultimately obtain marketing approval.

If the FDA or similar regulatory authorities outside of the United States do not approve these other drugs or revoke their approval of, or if safety, efficacy, manufacturing, or supply issues arise with, the drugs we choose to evaluate in combination with or any of our drug candidate, we may be unable to obtain approval of or market any of our combination treatments.

We face significant competition, and if our competitors develop and market products that are more effective, safer or less expensive than the drug candidates we develop, our commercial opportunities will be negatively impacted.

The life sciences industry is highly competitive. We are currently developing therapies that will compete, if approved, with other products and therapies that currently exist or are being developed. Products we may develop in the future are also likely to face competition from other products and therapies, some of which we may not currently be aware of. We have competitors both in the United States and internationally, including major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, universities and other research institutions. Many of our competitors have significantly greater financial, manufacturing, marketing, product development, technical and human resources than we do. Large pharmaceutical companies, in particular, have extensive experience in clinical testing, obtaining marketing approvals, recruiting patients and manufacturing pharmaceutical products. These companies also have significantly greater research and marketing capabilities than we do and may also have products that have been approved or are in late stages of development, and collaborative arrangements in our target markets with leading companies and research institutions. Established pharmaceutical companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the drug candidates that we develop obsolete. Further, mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. As a result of all of these factors, our competitors may succeed in obtaining patent protection and/or marketing approval or discovering, developing and commercializing products in our field before we do.

Current FDA-approved treatments for chronic HBV infection include peg-IFNα, marketed by Roche Holding AG (Roche), and oral antiviral agents such as nucleoside analogs, marketed by Gilead Sciences, Inc. (Gilead) and Bristol-Myers Squibb Company. These treatments do not lead to either a functional or a complete cure in the vast majority of patients, and in the case of nucleoside analogs, may require life-long treatment. Several large and small pharmaceutical companies are developing programs with various mechanisms of action, to be used alone or in combination, with the goal of achieving higher rates of viral suppression or functional cure in patients with CHB. Companies with oligonucleotide agents in clinical development include Arbutus Biopharma Corporation, Ionis Pharmaceuticals, Inc. (together with GlaxoSmithKline plc (GSK)), Arrowhead Pharmaceuticals, Inc. (together with Janssen Pharmaceuticals, Inc. (Janssen)), and Vir Biotechnology, Inc. (together with Alnylam Pharmaceuticals, Inc.). Several companies are developing CAM-Es, including Assembly Biosciences Inc. and Enanta Pharmaceuticals. Several companies, including GSK and Janssen, are developing therapeutic vaccines for HBV, and several others have approved HBV vaccines, including Dynavax Technologies, Inc., GSK, Johnson & Johnson, and Merck. Replicor, Inc. is developing nucleic acid polymers (NAPs) for use in CHB patients.

There is one currently FDA-approved THR-b agonist treatment for MASH by Madrigal Pharmaceuticals, Inc. A number of pharmaceutical companies, including AbbVie, Inc., AstraZeneca PLC/MedImmune LLC, Bristol‑Myers Squibb Company, Eli Lilly and Company, Merck, Pfizer, Inc., Novo Nordisk, as well as large and small biotechnology companies such as 89bio, Inc., Akero Therapeutics, Inc., Gilead, Inventiva Pharma SA, MediciNova, Inc., and Viking Therapeutics, Inc. are pursuing the development or marketing of pharmaceuticals that target MASH.

In addition to remdesivir, which is FDA-approved, on December 22, 2021, Pfizer, Inc. received approval from the FDA for Paxlovid, an orally administered SARS-CoV-2 protease inhibitor co‑administered with ritonavir. Similarly, Merck (together with Ridgeback Bio), is developing the drug molnupiravir, an oral antiviral drug which has been issued an emergency use authorization by the FDA on December 23, 2021. Several drugs are likely being used off-label for treatment, such as dexamethasone. Several approved drugs are being studied for their utility in

reducing the severity of SARS-CoV-2 infections, including Soliris by Alexion Pharmaceuticals Inc. and Jakafi by Incyte Corporation. There are significant efforts globally to develop both therapeutic and prophylactic drug candidates including by Enanta Pharmaceuticals and Shionogi. Several companies are focused on antibody treatments, including Regeneron Pharmaceuticals, Inc. and Vir Biotechnology, Inc. (together with GSK, Biogen Inc. and WuXi Biologics Ltd.). The availability of such COVID-19 vaccines and each of Pfizer’s and Merck’s oral COVID-19 drug may reduce or eliminate the need for our potential COVID-19 therapies to treat the disease and therefore negatively impact the commercial opportunity.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe effects, are more convenient, have a broader label, are marketed more effectively, including gaining exclusivity for their competing products on formularies thereby excluding our products from such formularies, are reimbursed or are less expensive than any products that we may develop. Our competitors also may obtain FDA, EMA or other marketing approval for their products more rapidly than we may obtain approval for ours (if at all), which could result in our competitors establishing a strong market position before we are able to enter the market (if ever). Even if the drug candidates we develop achieve marketing approval, they may be priced at a significant premium over competitive products, resulting in reduced competitiveness of our products.

Smaller and other early stage companies may also prove to be significant competitors. In addition, academic research departments and public and private research institutions may be conducting research on compounds that could prove to be competitive.

These third parties compete with us not only in drug candidate development, but also in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring and/or licensing technologies complementary to, or necessary for, our programs.

In addition, the biopharmaceutical industry is characterized by rapid technological change. If we fail to keep pace with technological change, we may be unable to compete effectively. Technological advances or products developed by our competitors may render our drug candidates obsolete, less competitive or not economical, thereby adversely affecting our business, financial condition and results of operations.

If any of our current or future drug candidates obtain regulatory approval, additional competitors could enter the market with generic versions of such products, which may result in a material decline in sales of our competing products.

Under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Amendments to the FDCA, a pharmaceutical manufacturer may file an abbreviated new drug application (an ANDA) seeking approval of a generic version of an approved innovator product. Under the Hatch-Waxman Amendments, a manufacturer may also submit an NDA under section 505(b)(2) of the FDCA that references the FDA’s prior approval of the innovator product. A 505(b)(2) NDA product may be for a new or improved version of the original innovator product. The Hatch-Waxman Amendments also provide for certain periods of regulatory exclusivity, which preclude FDA approval (or in some circumstances, FDA filing and review) of an ANDA or 505(b)(2) NDA. In addition to the benefits of regulatory exclusivity, an innovator NDA holder may have patents claiming the active ingredient, product formulation or an approved use of the drug, which would be listed with the product in the FDA publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” known as the Orange Book. If there are patents listed in the Orange Book for a product, a generic or 505(b)(2) applicant that seeks to market its product before expiration of the patents must include in their applications what is known as a “Paragraph IV” certification, challenging the validity or enforceability, or claiming non-infringement, of the listed patent or patents. Notice of the certification must be given to the patent owner and NDA holder and if, within 45 days of receiving notice, either the patent owner or NDA holder sues for patent infringement, approval of the ANDA or 505(b)(2) NDA is stayed for up to 30 months.

Accordingly, if any of our future drug candidates are approved, competitors could file ANDAs for generic versions of these products or 505(b)(2) NDAs that reference our products. If there are patents listed for such drug products in the Orange Book, those ANDAs and 505(b)(2) NDAs would be required to include a certification as to each listed patent indicating whether the ANDA applicant does or does not intend to challenge the patent. We cannot predict which, if any, patents in our current portfolio or patents we may obtain in the future will be eligible for

listing in the Orange Book, how any generic competitor would address such patents, whether we would sue on any such patents or the outcome of any such suit.

We may not be successful in securing or maintaining proprietary patent protection for products and technologies we develop or license, despite expending a significant amount of resources that could have been focused on other areas of our business. Moreover, if any of our owned or in-licensed patents that are listed in the Orange Book are successfully challenged by way of a Paragraph IV certification and subsequent litigation, the affected product could immediately face generic competition and its sales would likely decline rapidly and materially.

Even if we are able to commercialize any drug candidates, such products may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business.

The regulations that govern marketing approvals, pricing and reimbursement for new products vary widely from country to country. Some countries require approval of the sale price of a product before it can be marketed. In many countries, the pricing review period begins after marketing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval for a drug candidate in a particular country, but then be subject to price regulations that delay our commercial launch of the drug candidate, possibly for lengthy time periods, and negatively impact the revenues we are able to generate from the sale of the drug candidate in that country, potentially to the point of unviability. Adverse pricing limitations may hinder our ability to recoup our investment in one or more drug candidates, even if our drug candidates obtain marketing approval.

Our ability to successfully commercialize any drug candidates, whether as a single agent or in combination, will also depend in part on the extent to which coverage and reimbursement for these drug candidates and related treatments is available from government authorities, private health insurers and other organizations. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels. It is difficult to predict at this time what government authorities and third-party payors may decide with respect to coverage and reimbursement for our programs (if approved).

A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities, particularly in the European Union, and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular products and requiring substitutions of generic products and/or biosimilars. Increasingly, third-party payors are scrutinizing the prices charged for drugs. We cannot be sure that coverage will be available for any drug candidate that we commercialize and, if coverage is available, the level of reimbursement. These government authorities and third-party payors are also examining the cost-effectiveness of drugs, in addition to their safety and efficacy. For example, in some countries, we, or any future collaborators, may be required to conduct a clinical trial that compares the cost-effectiveness of our drug to other therapies to obtain reimbursement or pricing approval. Reimbursement may impact the demand for, or the price of, any drug candidate for which we obtain marketing approval. If reimbursement is not available or is available only to limited levels, we may not be able to successfully commercialize any drug candidate for which we obtain marketing approval.

Further, there may be significant delays in obtaining coverage and reimbursement for newly approved drugs, as the process is time-consuming and costly, and coverage may be more limited than the purposes for which the drug is approved by the FDA or comparable foreign regulatory authorities. Additionally, no uniform policy requirement for coverage and reimbursement for drug products exists among third-party payors in the United States, which may result in coverage and reimbursement for drug products that differ significantly from payor to payor. Moreover, eligibility for reimbursement does not imply that any drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim reimbursement levels for new drugs, if applicable, may not be sufficient to cover our costs and may not be permanent. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower-cost drugs and may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Our inability to promptly obtain coverage and profitable payment rates from both government-funded and private payors for any approved drugs that

we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize drugs and our overall financial condition.

We may not be successful in our efforts to identify or discover other drug candidates and may fail to capitalize on programs or drug candidates that may present a greater commercial opportunity or for which there is a greater likelihood of success.

The success of our business depends upon our ability to identify, develop and commercialize drug candidates. If we do not successfully develop and eventually commercialize products, we will face difficulty in obtaining product revenue in future periods, resulting in significant harm to our financial position and adversely affecting our share price. Research programs to identify new drug candidates require substantial technical, financial and human resources, and we may fail to identify potential drug candidates for numerous reasons.

Additionally, because we have limited resources, we may forego or delay pursuit of opportunities with certain programs or drug candidates or for indications that later prove to have greater commercial potential. For example, we are currently focused on the development of our current drug candidates for hepatological indications. In addition, we are pursuing other drug candidates for viral diseases. However, the advancement of these drug candidates may ultimately prove to be unsuccessful or less successful than another program in our pipeline that we might have chosen to pursue on a less aggressive basis. However, due to the significant resources required for the development of our drug candidates, we must focus on specific diseases and disease pathways and decide which drug candidates to pursue and the amount of resources to allocate to each. Our near-term objective is to demonstrate favorable profiles through Phase 1 clinical trials of our drug candidates ALG-000184, ALG‑055009 and ALG-097558. Our estimates regarding the potential market for our drug candidates could be inaccurate and our decisions concerning the allocation of research, development, collaboration, management and financial resources toward particular drug candidates or therapeutic areas may not lead to the development of any viable commercial product and may divert resources away from better opportunities. Similarly, any potential decision to delay or terminate development of a drug candidate or program may subsequently also prove to be suboptimal and could cause us to miss valuable opportunities. Further, if we do not accurately evaluate the commercial potential for a particular drug candidate, we may relinquish valuable rights to that drug candidate through collaboration, licensing or other arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such drug candidate. Alternatively, we may allocate internal resources to a drug candidate in a therapeutic area in which it would have been more advantageous to enter into a partnering arrangement.

If any of these events occur, we may be forced to abandon or delay our development efforts with respect to a particular drug candidate or we may fail to develop a potentially successful drug candidate or capitalize on profitable market opportunities, all of which could have a material adverse effect on our business, financial condition, results of operations and prospects.

We may seek and fail to obtain fast track or breakthrough therapy designations from the FDA for our current or future drug candidates or priority review designation for any NDA we may submit to the FDA. Even if we are successful, these programs may not lead to a faster development or regulatory review process, and they do not guarantee we will receive approval for any drug candidate. We may also seek to obtain accelerated approval for one or more of our drug candidates but the FDA may disagree that we have met the requirements for such approval.

If a product is intended for the treatment of a serious or life-threatening condition and nonclinical or clinical data demonstrate the potential to address an unmet medical need for this condition, the product sponsor may apply for fast track designation. The FDA has broad discretion whether or not to grant this designation, so even if we believe a particular drug candidate is eligible for this designation, we cannot assure you that the FDA would decide to grant it. Even if we do receive fast track designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may rescind the fast track designation if it believes that the designation is no longer supported by data from our clinical development program.

We may also seek breakthrough therapy designation for any drug candidate that we develop. A breakthrough therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over currently approved therapies on one or more clinically significant endpoints, such as

substantial treatment effects observed early in clinical development. Like fast track designation, breakthrough therapy designation is within the discretion of the FDA. Accordingly, even if we believe a drug candidate we develop meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of breakthrough therapy designation for a drug candidate may not result in a faster development process, review or approval compared to drugs considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if a drug candidate we develop qualifies as a breakthrough therapy, the FDA may later decide that the drug no longer meets the conditions for qualification and rescind the designation.

Drugs designated as fast track products or breakthrough therapies by the FDA are also eligible for priority review of any NDA submitted for such drug candidates, which could result in FDA action on the NDA in a shorter timeframe than under standard review. In order to grant priority review designation, the FDA must find that the product, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious disease or condition. However, priority review does not guarantee approval of the NDA and may not result in a shorter overall review timeline if the FDA has significant questions or additional requests as part of the NDA review.

In addition, the FDA may grant accelerated approval to a product if the FDA determines that it has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. For example, this is currently the case with drugs for the treatment of MASH. As a condition of accelerated approval, the FDA will generally require the sponsor to perform adequate and well-controlled post-marketing clinical studies to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. If such confirmatory studies fail to confirm the drug’s clinical benefit or are not completed in a timely manner, the FDA may withdraw its approval of the drug on an expedited basis. In addition, in December 2022, President Biden signed an omnibus appropriations bill to fund the US government through fiscal year 2023. Included in the omnibus bill is the Food and Drug Omnibus Reform Act of 2022, which among other things, provided the FDA with new statutory authority to mitigate potential risks to patients from continued marketing of ineffective drugs previously granted accelerated approval and additional oversight over confirmatory trials. Under these provisions, the FDA may, among other things, require a sponsor of a product seeking accelerated approval to have a confirmatory trial underway prior to such approval being granted.

In addition, the FDA requires pre-approval of promotional materials for accelerated approval products, once approved. We cannot guarantee that the FDA will conclude that any of our drug candidates has met the criteria to receive accelerated approval, which would require us to conduct additional clinical testing prior to seeking FDA approval. Even if any of our drug candidates received approval through this pathway, the product may fail required post-approval confirmatory clinical trials, and we may be required to remove the product from the market or amend the product label in a way that adversely impacts its marketing.

We may be required to make significant payments under our license agreements with Emory University, KU Leuven, and Luxna Biotech Co., Ltd.

We entered into a License Agreement with Emory in June 2018, a Research, Licensing and Commercialization Agreement with KU Leuven in June 2020 and an amendment in July 2023 and a License Agreement with Luxna in December 2018 and an amendment in April 2020 (as amended, the Luxna Agreement). Under the Emory License Agreement, KU Leuven Agreement and Luxna Agreement, we are subject to significant obligations, including milestone payments, royalty payments, and certain other agreed-to costs. For more information regarding our license agreements, please see the section titled “Business—License agreements and collaborations” of this report. If these payments become due under the terms of the Emory University License Agreement, the KU Leuven Agreement or the Luxna Agreement, we may not have sufficient funds available to meet our obligations and our development efforts may be materially harmed. Furthermore, if we are forced to raise additional funds, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts, or grant rights to develop and market drug candidates that we would otherwise develop and market ourselves.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of any approved products.

We face an inherent risk of product liability as a result of the clinical testing of drug candidates and will face an even greater risk if we commercialize any products. For example, we may be sued if any drug candidate we develop causes or is perceived to cause illness or is found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of any approved products. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

Our inability to obtain sufficient product liability insurance at an acceptable cost or at all to protect against potential product liability claims could prevent or inhibit the commercialization of products we develop, alone or with collaboration partners.

Insurance coverage is increasingly expensive. We may not be able to maintain insurance, including product liability insurance at a reasonable cost or in an amount adequate to satisfy any liability that may arise, if at all. Our product liability insurance policy contains various exclusions, and we may be subject to a product liability claim for which we have no coverage. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Even if our agreements with current or future collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise.

Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.

In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs. For example, in March 2010, the Affordable Care Act (the ACA) was passed, which substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacted the U.S. pharmaceutical industry. The ACA, among other things, increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations, and established annual fees and taxes on manufacturers of certain branded prescription drugs.

Since its enactment, there have been judicial, executive and Congressional challenges to certain aspects of the ACA. On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA.

Other legislative changes have been proposed and adopted in the United States since the ACA was enacted. On August 2, 2011, the Budget Control Act of 2011, among other things, included aggregate reductions of Medicare payments to providers. These reductions went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2032, with the exception of a temporary suspension from May 1, 2020 through March 31, 2022, unless additional Congressional action is taken. In addition, on January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers. The American Rescue Plan Act of 2021 was also signed into law, which eliminated the statutory Medicaid drug rebate cap, beginning January 1, 2024. The rebate was previously capped at 100% of a drug's average manufacturer price.

Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives.

There has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation and regulation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. Most recently, on August 16, 2022, the Inflation Reduction Act of 2022 (the IRA), was signed into law. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount program with a new discounting program (which began in 2025). CMS has published the negotiated prices for the initial ten drugs, which will first be effective in 2026, and has published the list of the subsequent 15 drugs that will be subject to negotiation. The IRA permits the Secretary of the Department of Health and Human Services (HHS) to implement many of these provisions through guidance, as opposed to regulation, for the initial years. HHS has and will continue to issue and update guidance as these programs are implemented, although the drug price negotiation program is currently subject to legal challenges. For that and other reasons, it is currently unclear how the IRA will be effectuated.

We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in additional pricing pressure or reduced demand for any drug candidate we develop or complementary or companion diagnostics.

Our actual or perceived failure to comply with current or future federal, state and foreign laws and regulations and industry standards relating to data privacy and protection laws could lead to government investigations and enforcement actions, which could result in civil or criminal penalties, private litigation, and/or adverse publicity and could negatively affect our operating results, financial condition and business.

The global data protection landscape is rapidly evolving, and we and our partners may be subject to federal, state and foreign data privacy and security laws and regulations governing the collection, use, disclosure, retention, and security of personal information, such as information that we may collect in connection with clinical trials in the United States and abroad. Any actual or alleged failure by us or our third-party vendors, collaborators, contractors and consultants to comply with any of these laws and regulations could result in, among other things, notification obligations, government investigations or enforcement actions against us, which could result in fines and penalties, claims for damages by affected individuals and third parties, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations or prospects. These laws, rules and regulations evolve frequently and their scope may continually change, through new legislation, amendments to existing legislation and changes in enforcement practices, and may be inconsistent from one jurisdiction to another. The interpretation and application of health information-related and data protection laws in the United States, the EU and elsewhere, are often uncertain, contradictory and in flux. As a result, implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future. As our

operations and business grow, we may become subject to or affected by new or additional data protection laws and regulations and face increased scrutiny or attention from regulatory authorities.

In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), which govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators. In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under the Health Insurance Portability and Accountability Act of 1996 as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and regulations implemented (collectively, HIPAA). Depending on the facts and circumstances, we could be subject to criminal penalties if we knowingly obtain, use, or disclose individually identifiable health information provided to us by a HIPAA covered entity in a manner that is not authorized or permitted by HIPAA.

Many states have also adopted comparable privacy and security laws and regulations, some of which may be more stringent than HIPAA. Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners. Further, we may also be subject to other state laws governing the privacy, processing and protection of personal information. For example, the California Consumer Privacy Act as amended by the California Privacy Rights Act (collectively, CCPA) requires certain businesses that process personal information of California residents to, among other things: provide certain disclosures to California residents regarding the business’s collection, use, and disclosure of their personal information; receive and respond to requests from California residents to access, delete, and correct their personal information, or to opt-out of certain disclosures of their personal information; and enter into specific contractual provisions with service providers that process California resident personal information on the business’s behalf. It has also created a new California data protection agency authorized to issue substantive regulations and could result in increased privacy and information security enforcement, and additional compliance investment and potential business process changes may be required. Similar laws have passed in other states, and are continuing to be proposed at the state and federal level, reflecting a trend toward more stringent privacy legislation in the United States. The enactment of such laws could have potentially conflicting requirements that would make compliance challenging. In the event that we are subject to or affected by HIPAA, the CCPA, the CPRA or other domestic privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition.

We currently operate in countries outside of the United States, including Belgium, Australia and China, where laws may in some cases be more stringent than the requirements in the United States. For example, in Europe, the EU General Data Protection Regulation (GDPR) went into effect in May 2018 and imposes strict requirements for the processing of the personal data of individuals within the European Economic Area (EEA) or in the context of our activities within the EEA. The GDPR applies enhanced protections to health or sensitive personal data and other special categories of personal data, including some of the personal data we process in respect of clinical trial participants which may be subject to additional compliance obligations and to local law derogations. The GDPR also imposes additional obligations when we contract with third-party processors in connection with the processing of any personal data. Failure to comply with the requirements of the GDPR could result in fines of up to €20 million or 4% of the total worldwide annual turnover of our preceding fiscal year, whichever is higher. In addition to fines, a breach of the GDPR may result in regulatory investigations, reputational damage, orders to cease/ change our data processing activities, enforcement notices, assessment notices (for a compulsory audit), civil claims (including class actions) and/or other administrative penalties.

Further, from January 1, 2021, we have to comply with the United Kingdom GDPR (UK GDPR), which, together, with the amended Data Protection Act 2018, retains the GDPR in UK national law (collectively, the UK GDPR), and imposes separate but similar obligations to those under the GDPR and comparable penalties, including fines up to the greater of £17.5 million or 4% of global turnover of the annual global revenues of the noncompliant undertaking.

Among other requirements, the GDPR regulates the transfer of personal data to third countries outside of the EEA, such as the United States, which are not considered by the European Commission to provide an adequate level of personal data protection, and the efficacy and longevity of current transfer mechanisms between the EEA, and the United States remains uncertain. We currently rely on approved data transfer mechanisms such as the EU standard

contractual clauses (SCCs), the UK Addendum to the SCCs, the UK International Data Transfer Agreement and the new EU-U.S. Data Privacy Framework (DPF) to transfer personal data outside the EEA and the UK, including to the United States, with respect to both intragroup and third party transfers. We expect the existing legal complexity and uncertainty regarding international personal data transfers to continue. In particular, we expect the adequacy of the DPF as an approved GDPR transfer mechanism to be challenged and international transfers to the United States and to other jurisdictions more generally to continue to be subject to enhanced scrutiny by regulators. As supervisory authorities issue further guidance on personal data export mechanisms, including circumstances where the SCCs cannot be used, and/or start taking enforcement action, we could suffer additional costs, complaints and/or regulatory investigations or fines, and/or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results.

In addition, we use artificial intelligence, including machine learning, and automated decision-making, technologies (collectively, “AI Technologies”) in our business. The regulatory framework for AI Technologies is rapidly evolving as many federal, state, and foreign government bodies and agencies have introduced or are currently considering additional laws and regulations. Additionally, existing laws and regulations may be interpreted in ways that would affect the operation of AI Technologies. As a result, implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, and we cannot yet determine the impact future laws, regulations, standards, or market perception of their requirements may have on our business and may not always be able to anticipate how to respond to these laws or regulations.

It is possible that new laws and regulations will be adopted in the United States and in other non-U.S. jurisdictions, or that existing laws and regulations, including competition and antitrust laws, may be interpreted in ways that would limit our ability to use AI Technologies for our business, or require us to change the way we use AI Technologies in a manner that negatively affects the performance of our products, services, and business and the way in which we use AI Technologies. We may need to expend resources to adjust our products or services in certain jurisdictions if the laws, regulations, or decisions are not consistent across jurisdictions. Further, the cost to comply with such laws, regulations, or decisions and/or guidance interpreting existing laws, could be significant and would increase our operating expenses (such as by imposing additional reporting obligations regarding our use of AI Technologies). Such an increase in operating expenses, as well as any actual or perceived failure to comply with such laws and regulations, could adversely affect our business, financial condition and results of operations.

Compliance with U.S. and foreign privacy and security laws, rules and regulations could require us to take on more onerous obligations in our contracts, require us to engage in costly compliance exercises, restrict our ability to collect, use and disclose data, or in some cases, impact our or our partners’ ability to operate in certain jurisdictions. Each of these evolving laws can be subject to varying interpretations. Our actual or alleged failure by us or our employees, representatives, contractors, consultants, collaborators, or other third parties to comply with U.S. and foreign data protection laws and regulations could result in government investigations and enforcement actions (which could include civil or criminal penalties), fines and penalties, private litigation, and/or adverse publicity and could negatively affect our financial condition, operating results and business.

Our business and operations may suffer in the event that our information technology systems, or those used by our CROs or other contractors or consultants, fail or suffer security breaches.

We collect and maintain information in digital form that is necessary to conduct our business, and we are increasingly dependent on information technology systems and infrastructure to operate our business. In the ordinary course of our business, we collect, store and transmit large amounts of confidential information, including intellectual property, proprietary business information and the personal information of our employees and contractors. Despite the implementation of security measures, our information technology systems and those of our CROs and other contractors and consultants are vulnerable to attack, damage and interruption from natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks, computer hacks, employee theft or misuse, fraud, viruses and malware (e.g., ransomware), malicious software, phishing and other social engineering schemes, human error, denial or degradation-of-service attacks, sophisticated nation-state and nation-state-supported actors, and other unauthorized access and security breaches that could jeopardize the confidentiality, integrity, and/or performance of our software, information technology systems, and data, and could expose us to legal, financial and reputational harm. There can be no assurance that our cybersecurity risk management program and processes,

including our policies, controls or procedures, will be fully implemented, complied with or effective in protecting our systems and information.

Attacks upon information technology systems are increasing in their frequency, levels of persistence, sophistication and intensity, and are being conducted by sophisticated and organized groups and individuals with a wide range of motives and expertise. As a result of the COVID-19 pandemic, we may also face increased cybersecurity risks due to our reliance on internet technology and the number of our employees who continue to work remotely, which may create additional opportunities for cybercriminals to exploit vulnerabilities. Furthermore, because the techniques used to obtain unauthorized access to, or to sabotage, systems change frequently and often are not recognized until launched against a target, we may be unable to anticipate these techniques or implement adequate preventative measures. We may also experience security breaches that may remain undetected for an extended period. Even if identified, we may be unable to adequately investigate or remediate incidents or breaches due to attackers increasingly using tools and techniques that are designed to circumvent controls, to avoid detection, and to remove or obfuscate forensic evidence.

We and certain of our service providers are from time to time subject to cyberattacks and security incidents. While we have not to our knowledge experienced any significant system failure or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations, whether due to a loss, corruption or unauthorized disclosure of our trade secrets, personal information or other proprietary or sensitive information or other similar disruptions. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our marketing approval efforts and significantly increase our costs to recover or reproduce the data. Likewise, we rely on third parties for the manufacture of our drug candidates and to conduct clinical trials, and similar events relating to their information technology systems could also have a material adverse effect on our business. 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 be subject to enforcement actions and investigations by regulatory authorities, and potentially result in regulatory penalties, fines and significant liability and the development and commercialization of our future drug candidates could be delayed. Further, if we or our third-party vendors were to experience a significant cybersecurity breach of our or their 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. In addition, our remediation efforts may not be successful. Further, our insurance coverage may not be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of our systems.

We depend on collaborations with third parties for the development of certain of our potential drug candidates, and we may depend on additional collaborations in the future for the development and commercialization of these or other potential candidates. If our collaborations are not successful, we may not be able to capitalize on the market potential of these drug candidates.

We are currently collaborating with third parties to develop certain of our potential drug candidates. In the future, we may form or seek strategic alliances, joint ventures, or collaborations, or enter into additional licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to drug candidates we develop.

Collaborations involving our current and future drug candidates may pose the following risks to us:

As a result, if we enter into additional collaboration agreements and strategic partnerships or license our intellectual property, products or businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations, which could delay our timelines or otherwise adversely affect our business. We also cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that justifies such transaction. Any delays in entering into new collaborations or strategic partnership agreements related to any drug candidate we develop could delay the development and commercialization of our drug candidates, which would harm our business prospects, financial condition, and results of operations.

We may seek to establish additional collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.

The advancement of our drug candidates and development programs and the potential commercialization of our current and future drug candidates will require substantial additional cash to fund expenses. For some of our programs, we may decide to collaborate with other pharmaceutical and biotechnology companies with respect to development and potential commercialization. Any of these relationships may require us to incur non-recurring and other charges, increase our near- and long-term expenditures, issue securities that dilute our existing stockholders, divert our management’s attention and disrupt our business.

We face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Whether we reach a definitive agreement for any other collaborations will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include the design or results of clinical trials, the progress of our clinical trials, the likelihood of approval by the FDA or similar regulatory authorities outside the United States, the potential market for the subject drug candidate, the costs and complexities of manufacturing and delivering such drug candidate to patients, the potential of competing products, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge and industry and market conditions generally. The collaborator may also consider alternative drug candidates or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for our drug candidate. Further, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for future drug candidates because they may be deemed to be at too early of a stage of development for collaborative efforts and third parties may not view them as having the requisite potential to demonstrate safety and efficacy.

We may also be restricted under future collaboration agreements from entering into additional agreements on certain terms with potential collaborators.

In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators.

We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have to curtail the development of the drug candidate for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all. If we do not have sufficient funds, we may not be able to further develop our drug candidates or bring them to market and generate product revenue.

If conflicts arise between us and our collaborators or strategic partners, these parties may act in a manner adverse to us and could limit our ability to implement our strategies.

If conflicts arise between our academic collaborators or strategic partners and us, the other party may act in a manner adverse to us and could limit our ability to implement our strategies. Current or future collaborators or strategic partners may develop, either alone or with others, products in related fields that are competitive with the products or potential products that are the subject of these collaborations.

Our current or future collaborators or strategic partners may preclude us from entering into collaborations with their competitors, fail to obtain timely regulatory approvals, terminate their agreements with us prematurely, or fail to devote sufficient resources to the development and commercialization of products. Furthermore, competing products, either developed by our current or future collaborators or strategic partners or to which our collaborators or strategic partners may have rights, may result in the withdrawal of partner support for our drug candidates. Any of these developments could harm our product development efforts.

We rely on third parties to conduct our ongoing and planned clinical trials and certain of our nonclinical studies for drug candidates we develop. If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize the drug candidates we are developing and our business could be substantially harmed.

We do not have the ability to independently conduct certain nonclinical studies and clinical trials. We rely on medical institutions, clinical investigators, contract laboratories, and other third parties, such as CROs, to conduct or otherwise support certain nonclinical studies and clinical trials for our drug candidates, including ALG‑000184, ALG‑055009, and ALG-097558, and we control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our nonclinical studies and clinical trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards, and our reliance on CROs will not relieve us of our regulatory responsibilities. For any violations of laws and regulations during the conduct of our nonclinical studies or clinical trials, we could be subject to untitled and warning letters or enforcement action that may include civil penalties up to and including criminal prosecution.

We and our CROs are required to comply with regulations and requirements, including GLP and GCP, for conducting, monitoring, recording and reporting the results of nonclinical studies and clinical trials, respectively, to ensure that the data and results are scientifically credible and accurate, and that the trial patients are adequately informed of the potential risks of participating in clinical trials and their rights are protected. These regulations are enforced by the FDA, the Competent Authorities of the Member States of the EEA and comparable foreign regulatory authorities for any drugs in clinical development. The FDA enforces GLP and GCP requirements through periodic inspections of laboratories conducting studies, clinical trial sponsors, principal investigators and trial sites. If we or our CROs fail to comply with applicable GLP or GCP, the data generated in our nonclinical studies or clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional nonclinical studies before allowing us to proceed with clinical trials or additional clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, the FDA will determine that any of our future nonclinical studies or clinical trials will comply with GLP or GCP, as applicable. In addition, our nonclinical studies and clinical trials must be conducted with drug candidates produced under cGMP

regulations. Our failure or the failure of our CROs to comply with these regulations may require us to delay or repeat nonclinical studies or clinical trials, which would delay the marketing approval process and could also subject us to enforcement action. We also are required to register certain ongoing clinical trials and provide certain information, including information relating to the trial’s protocol, on a government-sponsored database, ClinicalTrials.gov, within specific timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

Although we intend to design the nonclinical studies and clinical trials for our drug candidates, CROs conduct all of the clinical trials and certain nonclinical studies. As a result, many important aspects of our nonclinical and clinical development, including their conduct and timing, will be outside of our direct control. Our reliance on third parties to conduct future nonclinical studies and clinical trials will also result in less direct control over the management of data developed through nonclinical studies or clinical trials than would be the case if we were relying entirely upon our own staff. Communicating with outside parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. Outside parties may:

These factors may materially adversely affect the willingness or ability of third parties to conduct our nonclinical studies or clinical trials and may subject us to unexpected cost increases and/or delays that are beyond our control. If the CROs do not perform nonclinical studies or clinical trials in a satisfactory manner, breach their obligations to us or fail to comply with regulatory requirements, the development, marketing approval and commercialization of our drug candidates may be delayed, we may not be able to obtain marketing approval and commercialize our drug candidates, or our development program may be materially and irreversibly harmed. If we are unable to rely on nonclinical or clinical data collected by our CROs, we could be required to repeat, extend the duration of, or increase the size of any nonclinical studies or clinical trials we conduct and this could significantly delay commercialization and require significantly greater expenditures.

If any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs on commercially reasonable terms, or at all. 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 nonclinical or clinical data they obtain are compromised due to the failure to adhere to our protocols, regulatory requirements or for other reasons, any nonclinical studies or clinical trials such CROs are associated with may be extended, delayed or terminated, and we may not be able to obtain marketing approval for or successfully commercialize our drug candidates. As a result, we believe that our financial results and the commercial prospects for our drug candidates in the subject indication would be harmed, our costs would increase and our ability to generate revenue would be delayed.

We rely on third parties to manufacture nonclinical and clinical drug supplies, and we intend to rely on third parties to produce commercial supplies of any approved product which increases the risk that we will not have sufficient quantities of such drug candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

We do not own or operate manufacturing facilities for the production of nonclinical, clinical or commercial supplies of the drug candidates that we are developing or evaluating in our development programs. We have limited personnel with experience in drug manufacturing and lack the resources and the capabilities to manufacture any of our drug candidates on a nonclinical, clinical or commercial scale. We rely on third parties for supply of our nonclinical and clinical drug supplies (including key starting and intermediate materials), and our strategy is to outsource all manufacturing of our drug candidates and products to third parties. A disruption or termination in the supply of nonclinical or clinical drug supplies due to our reliance on third parties and/or a disruption in the supply chain generally could delay, prevent or impair our development or commercialization efforts.

In order to conduct clinical trials of drug candidates, we will need to have them manufactured in potentially large quantities. Our third-party manufacturers may be unable to successfully increase the manufacturing capacity for any of our clinical drug supplies (including key starting and intermediate materials) in a timely or cost-effective manner, or at all. In addition, quality issues may arise during scale-up activities and at any other time. For example, ongoing data on the stability of our drug candidates may shorten the expiry of our drug candidates and lead to clinical trial material supply shortages, and potentially clinical trial delays. If these third-party manufacturers are unable to successfully scale up the manufacture of our drug candidates in sufficient quality and quantity, the development, testing and clinical trials of that drug candidate may be delayed or infeasible, and regulatory approval or commercial launch of that drug candidate may be delayed or not obtained, which could significantly harm our business.

Our use of new third-party manufacturers increases the risk of delays in production or insufficient supplies of our drug candidates (and the key starting and intermediate materials for such drug candidates) as we transfer our manufacturing technology to these manufacturers and as they gain experience manufacturing our drug candidates (and the key starting and intermediate materials for such drug candidates).

Even after a third-party manufacturer has gained significant experience in manufacturing our drug candidates (or the key starting and intermediate materials for such drug candidates) or even if we believe we have succeeded in optimizing the manufacturing process, there can be no assurance that such manufacturer will produce sufficient quantities of our drug candidates (or the key starting and intermediate materials for such drug candidates) in a timely manner or continuously over time, or at all.

We may be delayed if we need to change the manufacturing process used by a third party. Further, if we change an approved manufacturing process, then we may be delayed if the FDA or a comparable foreign authority needs to review the new manufacturing process before it may be used.

We do not currently have any agreements with third-party manufacturers for long-term commercial supply. In the future, we may be unable to enter into agreements with third-party manufacturers for commercial supplies of any drug candidate that we develop, or may be unable to do so on acceptable terms. Even if we are able to establish and maintain arrangements with third-party manufacturers, reliance on third-party manufacturers entails risks, including:

Third-party manufacturers may not be able to comply with cGMP requirements or similar regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable requirements could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of drug candidates or products, operating restrictions and/or criminal prosecutions, any of which could significantly and adversely affect supplies of our drug candidates.

Our future drug candidates and any products that we may develop may compete with other drug candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP requirements and that might be capable of manufacturing for us.

If the third parties that we engage to supply any materials or manufacture product for our nonclinical studies and clinical trials should cease to continue to do so for any reason, we likely would experience delays in advancing

these studies and trials while we identify and qualify replacement suppliers or manufacturers and we may be unable to obtain replacement supplies on terms that are favorable to us or at all. In addition, if we are not able to obtain adequate supplies of our drug candidates or the substances used to manufacture them, it will be more difficult for us to develop our drug candidates and compete effectively.

Some of our third-party manufacturers which we use for the supply of materials for drug candidates or other materials necessary to manufacture product to conduct clinical trials could experience unexpected disruptions from man-made or natural disasters or public health pandemics or epidemics or other business interruptions which, if they occurred, might result in delays in advancing our clinical development.

Our current and anticipated future dependence upon others for the manufacture of our drug candidates (or the key starting and intermediate materials for such drug candidates) may adversely affect our future profit margins and our ability to develop drug candidates and commercialize any products that receive marketing approval on a timely and competitive basis.

Our future relationships with customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.

Healthcare providers, physicians and third-party payors in the United States and elsewhere will play a primary role in the recommendation and prescription of any drug candidates for which we obtain marketing approval. Our future arrangements with third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act (the FCA), which may constrain the business or financial arrangements and relationships through which we sell, market and distribute any products for which we obtain marketing approval. In addition, we may be subject to transparency laws by the U.S. federal and state governments and by governments in foreign jurisdictions in which we conduct our business. The applicable federal, state and foreign healthcare laws and regulations that may affect our ability to operate include:

Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available under such laws, it is possible that some of our business activities could be subject to challenge under one or more of such laws. The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Ensuring that our business arrangements with third parties comply with applicable healthcare laws, as well as responding to investigations by government authorities, can be time- and resource-consuming and can divert management’s attention from the business.

If our operations are found to be in violation of any of the laws described above or any other government regulations that apply to us, we may be subject to penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, possible exclusion from participation in federal- and state-funded healthcare programs, contractual damages and the curtailment or restricting of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, any of which could harm our ability to operate our business and our financial results. Further, if the physicians or other providers or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs. In addition, the approval and commercialization of any drug candidate we develop outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.

If we and our collaborators are unable to obtain, maintain, protect and enforce sufficient patent and other intellectual property protection for our drug candidates and technology, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our market or successfully commercialize any drug candidates we may develop.

Our success depends in significant part on our ability and the ability of our current or future collaborators and licensors to obtain, maintain, enforce and defend patents and other intellectual property rights with respect to our drug candidates and technology and to operate our business without infringing, misappropriating, or otherwise violating the intellectual property rights of others. If we and our current or future collaborators and licensors are unable to obtain and maintain sufficient intellectual property protection for our drug candidates or other drug candidates that we may identify, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors and other third parties could develop and commercialize drug candidates similar or identical

to ours, and our ability to successfully commercialize our drug candidates and other drug candidates that we may pursue may be impaired. While we own some issued or allowed patents with respect to our programs, including our CHB and MASH programs, we do not own or in-license any issued patents with claims that specifically recite our ALG-097558 or ALG-125755 drug candidates. We can provide no assurance that any of our other current or future patent applications will result in issued patents or that any issued patents will provide us with any competitive advantage. We cannot be certain that there is no invalidating prior art of which we and the patent examiner are unaware or that our interpretation of the relevance of prior art is correct. If a patent or patent application is determined to have an earlier priority date, it may prevent our patent applications from issuing at all or issuing in a form that provides any competitive advantage for our drug candidates. Failure to obtain additional issued patents could have a material adverse effect on our ability to develop and commercialize our drug candidates. Even if our patent applications do issue as patents, third parties may be able to challenge the validity and enforceability of our patents on a variety of grounds, including that such third party’s patents and patent applications have an earlier priority date, and if such challenges are successful, we may be required to obtain one or more licenses from such third parties, or be prohibited from commercializing our drug candidates.

We seek to protect our proprietary positions by, among other things, filing patent applications in the United States and abroad related to our current drug candidates and other drug candidates that we may identify. Obtaining, maintaining, defending and enforcing pharmaceutical patents is costly, time consuming and complex, and we may not be able to file and prosecute all necessary or desirable patent applications, or maintain, enforce and license any patents that may issue from such patent applications, at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Moreover, under certain of our license or collaboration agreements, we may not have the right to control the preparation, filing, prosecution and maintenance of patent applications, or to maintain the rights to patents licensed to or from third parties.

We currently are the assignee of a number of U.S. provisional patent applications. U.S. provisional patent applications are not eligible to become issued patents until, among other things, we file a non-provisional patent application within 12 months of filing one or more of our related provisional patent applications. With regard to such U.S. provisional patent applications, if we do not timely file any non-provisional patent applications, we may lose our priority dates with respect to our provisional patent applications and any patent protection on the inventions disclosed in our provisional patent applications. Further, in the event that we do timely file non-provisional patent applications relating to our provisional patent applications, we cannot predict whether any such patent applications will result in the issuance of patents or if such issued patents will provide us with any competitive advantage.

Although we enter into confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development output, such as our employees, collaborators, CROs, contract manufacturers, consultants, advisors and other third parties, any of these parties may breach these agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. Further, we may not be aware of all third-party intellectual property rights potentially relating to our drug candidates. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing or, in some cases, not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our patents or pending patent applications, or that we were the first to file for patent protection of such inventions.

The patent position of pharmaceutical companies generally is highly uncertain, involves complex legal, technological and factual questions and has, in recent years, been the subject of much debate and litigation throughout the world. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States, or vice versa. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. The subject matter claimed in a patent application can be significantly reduced or eliminated before the patent issues, if at all, and its scope can be reinterpreted or narrowed after issuance. Therefore, our pending and future patent applications may not result in patents being issued in relevant jurisdictions that protect our drug candidates, in whole or in part, or that effectively prevent others from commercializing competitive drug candidates, and even if our patent applications issue as patents in relevant jurisdictions, they may not issue in a form that will provide us with any meaningful protection for our drug candidates or technology, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Additionally, our competitors may be able to circumvent our patents by challenging their validity or by developing similar or alternative drug candidates or technologies in a non-infringing manner.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad. We may be subject to a third-party preissuance submission of prior art to the United States Patent and Trademark Office (the USPTO), or become involved in opposition, derivation, revocation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or the patent rights of others, or other proceedings in the USPTO or applicable foreign offices that challenge priority of invention or other features of patentability. An adverse determination in any such submission, proceeding or litigation could result in loss of exclusivity or ability to sell our products free from infringing the patents of third parties, patent claims being narrowed, invalidated or held unenforceable, in whole or in part, and limitation of the scope or duration of the patents directed to our drug candidates, all of which could limit our ability to stop others from using or commercializing similar or identical drug candidates or technology to compete directly with us, without payment to us, or result in our inability to manufacture or commercialize drug candidates or approved products (if any) without infringing third-party patent rights. In addition, if the breadth or strength of the claims of our patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop or commercialize current or future drug candidates, or could have a material adverse effect on our ability to raise funds necessary to continue our research programs or clinical trials. Such proceedings also may result in substantial cost and require significant time from our scientists and management, even if the eventual outcome is favorable to us.

In addition, given the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products or technology similar or identical to ours for a meaningful amount of time, or at all. Moreover, some of our licensed patents and owned or licensed patent applications may in the future be co-owned with third parties. If we are unable to obtain exclusive licenses to any such co-owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In addition, we may need the cooperation of any such co-owners in order to enforce such patents against third parties, and such cooperation may not be provided to us. Any of the foregoing could harm our competitive position, business, financial condition, results of operations and prospects.

We have entered into licensing and collaboration agreements with third parties. If we fail to comply with our obligations in the agreements under which we license intellectual property rights to or from third parties, or these agreements are terminated, or we otherwise experience disruptions to our business relationships with our licensors or licensees, our competitive position, business, financial condition, results of operations and prospects could be harmed.

In addition to patent and other intellectual property rights we own or co-own, we have licensed, and may in the future license, patent and other intellectual property rights to and from other parties. In particular, we have in-licensed significant intellectual property rights from Emory and Luxna. Licenses may not provide us with exclusive rights to use the applicable intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize our drug candidates, products (if approved) and technology in the future. As a result, we may not be able to prevent competitors from developing and commercializing competitive products or technologies.

In addition, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications or to maintain, defend and enforce the patents that we license to or from third parties, and we may have to rely on our partners to fulfill these responsibilities. For example, under the Luxna Agreement, we obtained a license from Luxna under patents relevant to certain aspects of our HBV programs as well as to various potential therapies, which we are pursuing to address SARS-CoV-2. Although we have review and comment rights regarding prosecution of patents that we license under the Luxna Agreement, Luxna retains ultimate decision-making control with respect to the prosecution of these patents. Additionally, under the Emory License Agreement, we obtained a license from Emory University under patents relevant to certain aspects of our small molecule CHB program. Although we direct prosecution of patents licensed under the Emory License Agreement, we are obligated to consult with Emory University with respect to prosecution of these patents and Emory and its counsel are responsible for making all filings related to such prosecution. Similarly, although we will control the prosecution of jointly developed patents resulting from our collaboration with the Rega Institute for Medical Research and the CD3 under the KU Leuven Agreement, we are obligated to consult with such parties with respect

to prosecution of these patents. Consequently, any such licensed patents and applications may not be prepared, filed, prosecuted, maintained, enforced, and defended in a manner consistent with the best interests of our business. If our current or future licensors, licensees or collaborators fail to prepare, file, prosecute, maintain, enforce, and defend licensed patents and other intellectual property rights, such rights may be reduced or eliminated, and our right to develop and commercialize any of our drug candidates or technology that are the subject of such licensed rights could be adversely affected. In addition, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing or otherwise violating the licensor’s rights.

If we fail to comply with our obligations, including the obligation to make various milestone payments and royalty payments, under any of the agreements under which we license intellectual property rights from third parties, such as the Emory License Agreement or Luxna Agreement, the licensor may have the right to terminate the license. Under some of our in-license agreements, as a sublicensee, we may be obligated to comply with applicable requirements, limitations or obligations of our sublicensors to other third parties. For example, the Luxna Agreement includes rights that Luxna in-licensed from Osaka University (Osaka), which are in turn sublicensed to us. Prior to granting such rights to Luxna, Osaka granted certain rights to third parties and therefore the rights we in-license from Luxna are subject to such third-party rights. Although we understand that these rights granted to such third parties are for uses outside the scope of our business, license agreements are complex, subject to multiple interpretations and disputes may arise regarding scope of such licensed rights. Further, under the Luxna Agreement and other in-licenses under which we sublicense certain rights, we rely on Luxna and our other sublicensors to comply with their obligations under their upstream license agreements, where we may have no relationship with the original licensor of such rights. If our sublicensors fail to comply with their obligations under their upstream license agreements, and the upstream license agreements are consequently terminated, such termination may result in the termination of our sublicenses.

If any of our license agreements are terminated, the underlying licensed patents fail to provide the intended exclusivity or we otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business or be prevented from developing and commercializing our drug candidates, and competitors could have the freedom to seek regulatory approval of, and to market, products identical to ours. Termination of these agreements or reduction or elimination of our rights under these agreements may also result in our having to negotiate new or reinstated agreements with less favorable terms, cause us to lose our rights under these agreements, including our rights to important intellectual property or technology, or impede, delay or prohibit the further development or commercialization of one or more drug candidates that rely on such agreements. It is possible that we may be unable to obtain any additional licenses at a reasonable cost or on reasonable terms, if at all. In that event, we may be required to expend significant time and resources to redesign our drug candidates or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis.

In addition, the research resulting in certain of our owned and in-licensed patent rights and technology may have been funded in part by the U.S. federal or state governments. As a result, the government may have certain rights, including march-in rights, to such patent rights and technology. When new technologies are developed with government funding, the government generally obtains certain rights in any resulting patents, including a non-exclusive license authorizing the government to use the invention for noncommercial purposes. These rights may permit the government to disclose our confidential information to third parties or allow third parties to use our licensed technology. The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the government-funded technology, or because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give preference to U.S. industry. In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the United States. Any of the foregoing could harm our competitive position, business, financial condition, results of operations and prospects.

Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues and certain provisions in intellectual property license agreements may be susceptible to multiple interpretations. Disputes may arise between us and our licensing partners regarding intellectual property subject to a license agreement, including:

The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could harm our business, financial condition, results of operations and prospects. If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms or at all, we may be unable to successfully develop and commercialize the affected drug candidates. Moreover, any dispute or disagreement with our licensing partners may result in the delay or termination of the research, development or commercialization of our drug candidates or any future drug candidates, and may result in costly litigation or arbitration that diverts management attention and resources away from our day-to-day activities, which may adversely affect our business, financial conditions, results of operations and prospects.

Furthermore, current and future collaborators or strategic partners may develop, either alone or with others, products in related fields that are competitive with the products or potential products that are the subject of these collaborations. Competing products, either developed by our collaborators or strategic partners or to which the collaborators or strategic partners have rights, may result in the withdrawal of partner support for our drug candidates. Any of these developments could harm our product development efforts.

In addition, if our licensors fail to abide by the terms of the license, if the licensors fail to prevent infringement by third parties or if the licensed patents or other rights are found to be invalid or unenforceable, our business, competitive position, financial condition, results of operations and prospects could be materially harmed. For more information regarding our license agreements, see the section titled “Business—License agreements and collaborations” of this report.

If we are unable to obtain licenses from third parties on commercially reasonable terms or at all, our business could be harmed.

It may be necessary for us to use the patented or proprietary technology of third parties to commercialize our products (if approved), in which case we would be required to obtain a license from these third parties. The licensing of third-party intellectual property rights is a competitive area, and more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. More established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. If we are unable to license such technology, or if we are forced to license such technology on unfavorable terms, our business could be materially harmed. If we are unable to obtain a necessary license, we may be unable to develop or commercialize the affected drug candidates, which could materially harm our business, and the third parties owning such intellectual property rights could seek either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of compensation. Even if we are able to obtain a license, it may be or become non-exclusive, thereby giving our competitors access to the same technologies licensed to us. For example, under the Emory License Agreement we currently have an exclusive license with respect to certain patents and a non-exclusive license with respect to certain of Emory’s specified know-how. In June 2022, the license to such patents became non-exclusive with respect to all fields except for the treatment and prevention of HBV. For more information regarding our license agreements, see the section titled “Business—License agreements and

collaborations” of this report. Any of the foregoing could harm our competitive position, business, financial condition, results of operations and prospects.

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

We cannot guarantee that any of our or our licensors’ patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending patent application in the United States and abroad that is relevant to or necessary for the commercialization of our drug candidates in any jurisdiction. For example, U.S. patent applications filed before November 29, 2000 and certain U.S. patent applications filed after that date that will not be filed outside the United States remain confidential until patents issue. As mentioned above, patent applications in the United States and elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications covering our drug candidates could have been filed by third parties without our knowledge. Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our drug candidates or the use of our drug candidates. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively impact our ability to market our drug candidates. We may incorrectly determine that our drug candidates are not covered by a third-party patent or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which may negatively impact our ability to develop and market our drug candidates. Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our drug candidates.

We are aware of certain third-party issued patents and pending patent applications, including those of our competitors, that, if issued with their current claim scope, may be construed to cover our drug candidates, including ALG‑055009 and ALG-125755. In the event that any of these patents were asserted against us, we believe that we would have defenses against any such action, including that such patents are not valid. However, if any such patents were to be asserted against us and our defenses to such assertion were unsuccessful and alternative technology was not available or technologically or commercially practical, unless we obtain a license to such patents, we could be liable for damages, which could be significant and include treble damages and attorneys’ fees if we are found to willfully infringe such patents, and we could be precluded from commercializing any drug candidates that were ultimately held to infringe such patents.

In addition, if we fail to identify and correctly interpret relevant patents, we may be subject to infringement claims. We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement claims. If we fail in any such dispute, in addition to being forced to pay damages, which may be significant, we may be temporarily or permanently prohibited from commercializing any of our drug candidates that are held to be infringing. We might, if possible, also be forced to redesign drug candidates so that they no longer infringe the third-party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business and could adversely affect our business, financial condition, results of operations and prospects.

Patent terms may be inadequate to establish our competitive position on our drug candidates for an adequate amount of time.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our drug candidates are obtained, once the patent life has expired for a drug candidate, we may be open to competition from competitive medications, including generic versions. Given the amount of time required for the development, testing and regulatory review of new drug candidates, patents directed towards such drug candidates might expire before or shortly after such drug candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing drug candidates similar or identical to ours for a meaningful amount of time, or at all.

Depending upon the timing, duration and conditions of any FDA marketing approval of our drug candidates, one or more of our owned or licensed U.S. patents may be eligible for limited patent term extension under the Hatch-Waxman Act, and similar legislation in the EU and certain other countries. The Hatch-Waxman Act permits a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process. However, we may not receive an extension if we fail to exercise due diligence during the testing phase or regulatory review process, fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request. Only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years from approval and only those claims for the approved drug, a method for using it or a method for manufacturing it may be extended. If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for the applicable drug candidate will be shortened and our competitors may obtain approval to market competing products sooner. As a result, our revenue from applicable products could be reduced. Further, if this occurs, our competitors may take advantage of our investment in development and trials by referencing our clinical and nonclinical data and launch their product earlier than might otherwise be the case, and our competitive position, business, financial condition, results of operations and prospects could be materially harmed.

Further, there are detailed rules and requirements regarding the patents that may be submitted to the FDA for listing in the Orange Book. We may be unable to obtain patents covering our drug candidates that contain one or more claims that satisfy the requirements for listing in the Orange Book. Even if we submit a patent for listing in the Orange Book, the FDA may decline to list the patent, or a manufacturer of generic drugs may challenge the listing. If one of our drug candidates is approved and a patent covering that drug candidate is not listed in the Orange Book, a manufacturer of generic drugs would not have to provide advance notice to us of any abbreviated new drug application filed with the FDA to obtain permission to sell a generic version of such drug candidate. Any of the foregoing could harm our competitive position, business, financial condition, results of operations and prospects.

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

Filing, prosecuting, maintaining, defending and enforcing patents on our drug candidates in all countries throughout the world would be prohibitively expensive, and consequently our intellectual property rights in some countries outside the United States may be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patents to develop their own products and may export otherwise infringing products to territories where we have patents, but enforcement rights are not as strong as those in the United States. These products may compete with our drug candidates and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of some countries do not favor the enforcement or protection of patents, trade secrets and other intellectual property, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our intellectual property and proprietary rights generally. Proceedings to enforce our intellectual property rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

Many foreign countries, including some EU countries, India, Japan and China, have compulsory licensing laws under which a patent owner may be compelled under specified circumstances to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of the applicable patents and limit our potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be

inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license, which could adversely affect our business, financial condition, results of operations and prospects.

In addition, on June 1, 2023, the European Patent Package, or EU Patent Package, regulations were implemented with the goal of providing a single pan-European Unitary Patent and a new European Unified Patent Court, or UPC, for litigation involving European patents. Under the UPC, all European patents, including those issued prior to ratification of the European Patent Package, will by default automatically fall under the jurisdiction of the UPC. The UPC will provide our competitors with a new forum to centrally revoke our European patents, and allow for the possibility of a competitor to obtain pan-European injunctions. It will be several years before we will understand the scope of patent rights that will be recognized and the strength of patent remedies that will be provided by the UPC. Under the EU Patent Package as currently proposed, we have the right to opt our patents out of the UPC over the first seven years of the court’s existence, but doing so may preclude us from realizing the benefits of the new unified court.

Moreover, geo-political actions in the U.S. and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of our patent applications or those of any current or future licensors and the maintenance, enforcement or defense of our issued patents or those of any current or future licensors. For example, the U.S. and foreign government actions related to Russia’s conflict in Ukraine may limit or prevent filing, prosecution, and maintenance of patent applications in Russia. Government actions may also prevent maintenance of issued patents in Russia. These actions could result in abandonment or lapse of our patents or patent applications, resulting in partial or complete loss of patent rights in Russia. In addition, a decree was adopted by the Russian government in March 2022, allowing Russian companies and individuals to exploit inventions owned by patentees from the U.S. without consent or compensation. Consequently, we would not be able to prevent third parties from practicing our inventions in Russia or from selling or importing products made using our inventions in and into Russia. Accordingly, our competitive position may be impaired, and our business, financial condition, results of operations and prospects may be adversely affected.

Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our drug candidates.

Obtaining and enforcing patents in the pharmaceutical industry is inherently uncertain, due in part to ongoing changes in the patent laws. For example, in the United States, depending on decisions by Congress, the federal courts, and the USPTO, the laws and regulations governing patents, and interpretation thereof, could change in unpredictable ways that could weaken our and our collaborators’ or licensors’ ability to obtain new patents or to enforce existing or future patents. For example, 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. Therefore, there is increased uncertainty with regard to our and our collaborators’ or licensors’ ability to obtain patents in the future, as well as uncertainty with respect to the value of patents once obtained.

Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our and our collaborators’ or licensors’ patent applications and the enforcement or defense of our or our collaborators’ or licensors’ issued patents. For example, assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith America Invents Act (the Leahy-Smith Act), enacted in September 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. The Leahy-Smith Act also includes a number of significant changes that affect the way patent applications filed after March 2013 are prosecuted and may also affect patent litigation. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to challenge the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. The USPTO has developed new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, particularly the first inventor-to-file provisions. Similarly, statutory or judicial changes to the patent laws of other countries may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. All of the foregoing could harm our business, financial condition, results of operations and prospects.

We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and issued patents directed towards our technology and drug candidates could be found invalid or unenforceable if challenged.

Competitors and other third parties may infringe or otherwise violate our issued patents or other intellectual property or the patents or other intellectual property of our licensors and collaborators. In addition, our patents or the patents of our licensors and collaborators may become involved in inventorship or priority disputes. To counter infringement or other unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. Significantly, our pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from such applications. Our ability to enforce patent rights also depends on our ability to detect infringement. It may be difficult to detect infringers who do not advertise the components or methods that are used in connection with their products and services. Moreover, it may be difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s product or service. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents or that our patents are invalid or unenforceable. In a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology. An adverse result in any litigation proceeding could put one or more of our owned or licensed patents at risk of being invalidated, held unenforceable or interpreted narrowly. We may find it impractical or undesirable to enforce our intellectual property against some third parties.

If we were to initiate legal proceedings against a third party to enforce a patent directed to our drug candidates, or one of our future drug candidates, the defendant could counterclaim that our patent is invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement or insufficient written description. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO or made a misleading statement during prosecution. Third parties may also raise similar claims before the USPTO or an equivalent foreign body, even outside the context of litigation. Potential proceedings include reexamination, post-grant review, inter partes review, interference proceedings, derivation proceedings and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in the revocation of, cancellation of, or amendment to our patents in such a way that they no longer cover our technology or any drug candidates that we may develop. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art of which we and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent rights directed towards the applicable drug candidates or technology related to the patent rendered invalid or unenforceable. Such a loss of patent rights would materially harm our business, financial condition, results of operations and prospects.

Interference proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority of inventions with respect to our patents or patent applications. An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be materially harmed if the prevailing party does not offer us a license on commercially reasonable terms.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.

Some of our competitors are larger than we are and have substantially greater resources. They are, therefore, likely to be able to sustain the costs of complex patent litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing, misappropriating or otherwise violating our intellectual property. Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims could result in substantial costs and diversion of management resources, which could harm our business. In addition, the uncertainties associated with litigation could compromise our ability to raise the funds necessary to continue our clinical trials, continue our internal research programs, or in-license

needed technology or other drug candidates. There could also be public announcements of the results of the hearing, motions, or other interim proceedings or developments. If securities analysts or investors perceive those results to be negative, it could cause the price of shares of our common stock to decline. Any of the foregoing events could harm our business, financial condition, results of operation and prospects.

Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could negatively impact the success of our business.

Our commercial success depends upon our ability to develop, manufacture, market and sell our drug candidates and use our proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property and other proprietary rights of third parties. There is considerable intellectual property litigation in the pharmaceutical industry. We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our drug candidates and their manufacture and our other technology, including reexamination, interference, post-grant review, inter partes review or derivation proceedings before the USPTO or an equivalent foreign body. Numerous U.S.- and foreign-issued patents and pending patent applications owned by third parties exist in the fields in which we are developing our drug candidates. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future, regardless of their merit.

Even if we believe third-party intellectual property claims are without merit, there is no assurance that a court would find in our favor on questions of claim scope, infringement, validity, enforceability or priority. A court of competent jurisdiction could hold that third-party patents asserted against us are valid, enforceable and infringed, which could materially and adversely affect our ability to commercialize any drug candidates we may develop and any other drug candidates or technologies covered by the asserted third-party patents. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. If we are found to infringe, misappropriate or otherwise violate a third party’s intellectual property rights, and we are unsuccessful in demonstrating that such rights are invalid or unenforceable, we could be required to obtain a license from such a third party in order to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be or may become 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. A finding of infringement could prevent us from commercializing our drug candidates or force us to cease some of our business operations. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties and other fees, redesign our infringing drug candidate or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business. Any of the foregoing events would harm our business, financial condition, results of operations and prospects.

We may be subject to claims by third parties asserting that we or our employees have infringed, misappropriated or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property.

Many of our employees were previously employed at other biotechnology or pharmaceutical companies. Although we try to ensure that our employees, consultants and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these individuals have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s former employer. We may also be subject to claims that patents and applications we have filed to protect inventions made on our behalf by our employees, consultants and advisors, even those related to one or more of our drug candidates, are rightfully owned by their former or concurrent employer. Litigation may be necessary to defend against these claims.

If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in prosecuting or defending against such

claims, litigation could result in substantial costs, delay development of our drug candidates and be a distraction to management. Any of the foregoing events would harm our business, financial condition, results of operations and prospects.

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

We or our licensors may be subject to claims that former employees, collaborators or other third parties have an interest in our owned or in-licensed patents, trade secrets, or other intellectual property as an inventor or co-inventor. For example, we or our licensors or collaborators may have inventorship disputes arising from conflicting obligations of employees, consultants or others who are involved in developing our drug candidates. While it is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own. Our and their assignment agreements may not be self-executing or may be breached, and litigation may be necessary to defend against these and other claims challenging inventorship or our or our licensors’ or collaborators’ ownership of our owned or in-licensed patents, trade secrets or other intellectual property. If we or our licensors or collaborators 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, intellectual property that is important to our drug candidates. 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. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

The degree of future protection, if any, afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

Should any of these events occur, they could harm our business, financial condition, results of operations and prospects.

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

We are highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.

We are highly dependent on our management, scientific and medical personnel. The loss of the services of any of them may adversely impact the achievement of our objectives. Any of our executive officers could leave our employment at any time, as all of our employees are “at-will” employees. We currently do not have “key person” insurance on any of our employees.

Recruiting and retaining qualified employees, consultants and advisors for our business, including scientific and technical personnel, also will be critical to our success. Competition for skilled personnel is intense and the turnover rate can be high. We may not be able to attract and retain personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies and academic institutions for skilled individuals. In addition, failure to succeed in nonclinical studies, clinical trials or applications for marketing approval may make it more challenging to recruit and retain qualified personnel. The inability to recruit, or the loss of services of certain executives, significant employees, consultants or advisors, may impede the progress of our research, development and commercialization objectives and have a material adverse effect on our business, financial condition, results of operations and prospects.

We currently have no sales organization. If we are unable to establish sales capabilities on our own or through third parties, we may not be able to market and sell any products effectively, if approved, or generate product revenue.

We currently do not have a marketing or sales organization. In order to commercialize any product, if approved, in the United States and foreign jurisdictions, we must build our marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and we may not be successful in doing so. In advance of any of our drug candidates receiving regulatory approval, we expect to establish a sales organization with technical expertise and supporting distribution capabilities to commercialize each such drug candidate, which will be expensive and time-consuming. We have no prior experience in the marketing, sale and distribution of pharmaceutical products, and there are significant risks involved in building and managing a sales organization, including our ability to hire, retain, and incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely impact the commercialization of our drug candidates. We may choose to collaborate with third parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of our own sales force and distribution systems. If we are unable to enter into such arrangements on acceptable terms or at all, we may not be able to successfully commercialize our drug candidates. If we are not successful in commercializing products, either on our own or through arrangements with one or more third parties, we may not be able to generate any future product revenue and we would incur significant additional losses.

We will need to grow the size of our organization, and we may experience difficulties in managing this growth.

As of December 31, 2024, we had 70 full-time employees, including 54 employees engaged in research and development. As our development and commercialization plans and strategies develop, and as we transition into operating as a public company, we expect to need additional managerial, operational, sales, marketing, financial and other personnel. Future growth would impose significant added responsibilities on members of management, including:

Our future financial performance and our ability to advance development of and, if approved, commercialize our current drug candidates and any other drug candidate we develop will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.

We currently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants to provide certain services, including substantially all aspects of marketing, clinical management, and manufacturing. We cannot assure you that the services of independent organizations, advisors and consultants will continue to be available to us on a timely basis when needed or at a reasonable cost, or that we can find qualified replacements. In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided by consultants is compromised for any reason, our nonclinical studies and clinical trials may be extended, delayed or terminated, and we may not be able to obtain marketing approval of any current or future drug candidates or otherwise advance our business. We cannot assure you that we will be able to manage our existing consultants or find other competent outside contractors and consultants on economically reasonable terms, or at all.

If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may experience delays or may not be able to successfully implement the tasks necessary to further develop and commercialize our current drug candidates and any future drug candidates we develop and, accordingly, may not achieve our research, development and commercialization goals.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including chemicals and biological and radioactive materials. Our operations also produce hazardous waste products. We cannot eliminate the risk of contamination or injury from these materials, and we generally contract with third parties for the disposal of these materials and wastes. In the event of contamination or injury resulting from our use or third-party disposal of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials, and as such we would have to pay the full amount of any resultant liability out of pocket, which could significantly impair our financial condition.

We, or the third parties upon whom we depend, may be adversely affected by earthquakes or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

Our corporate headquarters and other facilities are located in the San Francisco Bay Area, which in the past has experienced both severe earthquakes and wildfires. We are also conducting clinical trials in New Zealand, an area also known for earthquakes. We do not carry earthquake insurance, and as such we would have to pay the full amount of any resultant liability out of pocket, which could significantly impair our financial condition. In addition, earthquakes, wildfires or other natural disasters could severely disrupt our operations. If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as our enterprise financial systems or manufacturing resource planning and enterprise quality systems, that delayed our clinical trials, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible, for us to continue our business for a substantial period of time. The disaster recovery and business continuity plans we have in place currently are limited and are unlikely to prove adequate in the event of a serious disaster or similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which, particularly when taken together with our lack of earthquake insurance, could have a material adverse effect on our business, results of operations, financial condition and

prospects. Furthermore, integral parties in our supply chain are similarly vulnerable to natural disasters or other sudden, unforeseen and severe adverse events. If such an event were to affect our supply chain, it could have a material adverse effect on our business.

Our employees, independent contractors, vendors, principal investigators, CROs, consultants and collaborators may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.

We are exposed to the risk that our employees, independent contractors, vendors, principal investigators, CROs, consultants and collaborators may engage in fraudulent conduct or other illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violate the regulations of the FDA and comparable foreign regulatory authorities, including those laws requiring the reporting of true, complete and accurate information to such authorities; healthcare fraud and abuse laws and regulations in the United States and abroad; or laws that require the reporting of financial information or data accurately. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, 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 commission, customer incentive programs and other business arrangements. Activities subject to these laws also involve the improper use of information obtained in the course of clinical trials or creating fraudulent data in our nonclinical studies or clinical trials, which could result in regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify and deter misconduct by employees and other third parties, 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 comply with these laws or regulations. Additionally, we are subject to the risk that a person could allege such fraud or other misconduct, even if none occurred. 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 significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for investors.

Our stock price is likely to be volatile. The stock market in general and the market for biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. The market price for our common stock may be influenced by many factors, including:

These and other market and industry factors may cause the market price and demand for our common stock to fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from selling their shares at or above the price paid for the shares and may otherwise negatively affect the liquidity of our common stock.

Some companies that have experienced volatility in the trading price of their shares have been the subject of securities class action litigation. Any lawsuit to which we are a party, with or without merit, may result in an unfavorable judgment. We also may decide to settle lawsuits on unfavorable terms. Any such negative outcome could result in payments of substantial damages or fines, damage to our reputation or adverse changes to our business practices. Defending against litigation is costly and time-consuming, and could divert our management’s attention and our resources. Furthermore, during the course of litigation, there could be negative public announcements of the results of hearings, motions or other interim proceedings or developments, which could have a further negative effect on the market price of our common stock.

An active trading market for our shares may not be sustained. In the absence of an active trading market common stock, investors may not be able to sell their common stock at a price or at the time that they would like to sell.

An inactive market may also impair our ability to raise capital by selling shares and may impair our ability to acquire other drug candidates, businesses, or technologies using our shares as consideration.

We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.

We do not currently intend to pay any cash dividends on our common stock for the foreseeable future. We currently intend to invest our future earnings, if any, to fund our growth. Therefore, investors are not likely to receive any dividends on common stock owned by them for the foreseeable future. Since we do not intend to pay dividends, an investor’s ability to receive a return on its investment will depend on any future appreciation in the market value of our common stock. There is no guarantee that our common stock will appreciate or even maintain the price at which our holders purchased it.

We are an emerging growth company and a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies will make our common stock less attractive to investors.

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the JOBS Act). For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, certain disclosure obligations regarding executive compensation and the requirements of holding nonbinding advisory votes on executive compensation and stockholder approval of any golden parachute payments not previously approved. We could be an emerging growth company for up to five years following the year of our IPO, although circumstances could cause us to lose that status earlier. We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of our IPO, i.e., December 31, 2025, (b) in which we have total annual gross revenue of at least $1.235 billion or (c) in which we are deemed to be a large accelerated filer, which requires the market value of our common stock that is held by non-affiliates to exceed $700.0 million as of the prior June 30th, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

Under the JOBS Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have elected to use the extended transition period for any other new or revised accounting standards during the period in which we remain an emerging growth company; however, we may adopt certain new or revised accounting standards early. As a result, changes in rules of U.S. generally accepted accounting principles or their interpretation, the adoption of new guidance or the application of existing guidance to changes in our business could significantly affect our financial position and results of operations.

Even after we no longer qualify as an emerging growth company, we may continue to qualify as a smaller reporting company, which would allow us to rely on certain reduced disclosure requirements, such as an exemption from providing selected financial data and executive compensation information. We are also exempt from the requirement to obtain an external audit on the effectiveness of internal control over financial reporting provided in Section 404(b) of the Sarbanes-Oxley Act. These exemptions and reduced disclosures due to our status as a smaller reporting company mean that our auditors do not review our internal controls over financial reporting and may make it harder for investors to analyze our results of operations and financial prospects.

We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions as an emerging growth company and a smaller reporting company. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

Our executive officers, directors and their affiliates have significant influence over our company, which will limit an investor’s ability to influence corporate matters and could delay or prevent a change in corporate control.

As of December 31, 2024, our executive officers, directors and their affiliates beneficially own, in the aggregate, approximately 57% of our outstanding common stock (assuming all shares of non-voting common stock are converted into voting common stock in accordance with the terms of our amended and restated certificate of incorporation), and 26% of our outstanding common stock (assuming all shares of non-voting common stock are converted to voting common stock and all pre-funded warrants are exercised in full on a cash exercise basis). In addition, in our October 2023 and February 2025 private placements, certain of the holders of 5% or more of our capital stock acquired pre-funded warrants to purchase shares of our common stock (which are immediately exercisable and have an exercise price of $0.0025 and $0.0001 per share, respectively) and common warrants to purchase shares of our common stock (which are immediately exercisable and have an exercise price of $18.92 and $26.02 per share, respectively). Until exercised, the shares issuable upon the exercise of the pre-funded warrants and the common warrants are not included in the number of our outstanding shares of common stock. If such holders exercise their warrants, then the shares of our capital stock beneficially owned by our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates would increase significantly. As a result, these stockholders, if they act together, will be able to influence our management and affairs and the outcome of matters submitted to our stockholders for approval, including the election of directors and any sale, merger, consolidation or sale of all or substantially all of our assets. In addition, this concentration of ownership might adversely affect the market price of our common stock by:

The dual class structure of our common stock may limit the ability to influence corporate matters and may limit the visibility with respect to certain transactions.

The dual class structure of our common stock may limit an investor’s ability to influence corporate matters. Holders of our common stock are entitled to one vote per share, while holders of our non-voting common stock are not entitled to any votes. Nonetheless, each share of our non-voting common stock may be converted at any time into one share of our common stock at the option of its holder by providing written notice to us, subject to the limitations provided for in our amended and restated certificate of incorporation. Consequently, the exercise by holders of our non-voting common stock of their option to make this conversion will have the effect of increasing the relative voting power of such holders, and correspondingly decreasing the voting power of the holders of our

common stock, which may limit an investor’s ability to influence corporate matters. As of December 31, 2024, we had 123,693 shares of non-voting common stock outstanding. Additionally, stockholders who hold, in the aggregate, more than 10% of our common stock and non-voting common stock, but 10% or less of our common stock, and are not otherwise a company insider, may not be required to report changes in their ownership due to transactions in our non-voting common stock pursuant to Section 16(a) of the Securities Exchange Act of 1934, as amended (the Securities Exchange Act), and may not be subject to the short-swing profit provisions of Section 16(b) of the Exchange Act.

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

If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, the market price of our common stock could decline.

As of December 31, 2024, approximately 0.7 million shares of common stock that are either subject to outstanding options or RSUs or reserved for future issuance under our equity incentive plans, and excluding all outstanding pre-funded warrants, are eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules and Rule 144 and Rule 701 under the Securities Act. If these additional shares of common stock are sold, or if it is perceived that they will be sold, in the public market, the market price of our common stock could decline.

In addition, the holders of approximately 3.9 million of our total common stock and non-voting common stock are entitled to rights with respect to the registration of their shares under the Securities Act described above. Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares purchased by affiliates. Any sales of securities by these stockholders could have a material adverse effect on the market price of our common stock.

Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.

Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the Code), and corresponding provisions of state law, if a corporation undergoes an “ownership change” (generally defined as a greater than 50 percentage point change (by value) in its equity ownership over a rolling three-year period), the corporation’s ability to use its pre-change net operating loss (NOL) carryforwards and other pre-change tax attributes to offset its post-change income may be limited. We performed a Code Section 382 analysis in 2023 and determined there was an ownership change that resulted in Section 382 limitations. The ownership change limited our ability to utilize NOLs against future taxable income but will not result in the expiration of any NOLs. We may have experienced additional ownership changes in the past and may in the future experience ownership changes as a result of changes in our stock ownership (some of which are not in our control). In addition, under current tax law, federal NOL carryforwards generated in periods after December 31, 2017, may be carried forward indefinitely but may only be used to offset 80% of our taxable income. For these reasons, our ability to utilize our NOL carryforwards and other tax attributes to reduce future tax liabilities may be limited.

If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline.

The trading market for our common stock relies, in part, on the research and reports that industry or financial analysts publish about us or our business. If no or few analysts commence coverage of us, the trading price of our stock would likely decrease. If one or more of the analysts covering our business downgrade their evaluations of our stock, the price of our stock could decline. If one or more of these analysts cease to cover our stock, we could lose visibility in the market for our stock, which, in turn, could cause our stock price to decline.

If we fail to implement and maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our common stock may decline.

Pursuant to Section 404 of Sarbanes-Oxley, our management is required to report upon the effectiveness of our internal control over financial reporting for our fiscal year ended December 31, 2024. When we lose our status as an “emerging growth company,” our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting. The rules governing the standards that must be met

for management to assess our internal control over financial reporting are complex and require significant documentation, testing and possible remediation. To comply with the requirements of being a reporting company under the Exchange Act, we will need to implement additional financial and management controls, reporting systems and procedures and hire additional accounting and finance staff, all of which will entail additional expense.

We cannot assure you that there will not be material weaknesses in our internal control over financial reporting in the future. Any failure to implement and maintain internal control over financial reporting could severely inhibit our ability to accurately report our financial condition, results of operations or cash flows. If we are unable to conclude that our internal control over financial reporting is effective, or if our independent registered public accounting firm determines we have a material weakness in our internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities. Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.

Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.

Our amended and restated certificate of incorporation and amended and restated bylaws contain provisions that could delay or prevent changes in control or changes in our management without the consent of our board of directors. These provisions include the following:

We are also subject to the anti-takeover provisions contained in Section 203 of the Delaware General Corporation Law. Under Section 203, a corporation may not, in general, engage in a business combination with any holder of 15% or more of its capital stock unless the holder has held the stock for three years or, among other exceptions, the board of directors has approved the transaction.

Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.

Our amended and restated certificate of incorporation and amended and restated bylaws provide that we will indemnify our directors and officers, in each case to the fullest extent permitted by Delaware law.

In addition, as permitted by Section 145 of the Delaware General Corporation Law, our amended and restated bylaws and our indemnification agreements that we have entered into with our directors and officers provide that:

Our amended and restated certificate of incorporation provides for an exclusive forum in the Court of Chancery of the State of Delaware for certain disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our amended and restated certificate of incorporation specifies that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware is the sole and exclusive forum for any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, our amended and restated certificate of incorporation, our amended and restated bylaws or any action as to which the Delaware General Corporation Law confers jurisdiction to the Court of Chancery of the State of Delaware; or any action asserting a claim against us that is governed by the internal affairs doctrine. Our amended and restated certificate of incorporation also provides that the federal district courts of the United States of America is the exclusive forum for the resolution of any complaint asserting a cause of action against us or any of our directors, officers, employees or agents and arising under the Securities Act. We believe these provisions may benefit us by providing increased consistency in the application of Delaware law and federal securities laws by chancellors and judges, as applicable, particularly experienced in resolving corporate disputes, efficient administration of cases on a more expedited schedule relative to other forums and protection against the burdens of multi-forum litigation. However, these provisions may have the effect of discouraging lawsuits against our directors and officers. The choice of forum provision requiring that the Court of Chancery of the State of Delaware or the federal district courts of the United States of America be the exclusive forum for certain actions does not apply to suits brought to enforce any liability or duty created by the Exchange Act. Our exclusive forum provision does not relieve us of our duties to comply with the federal securities laws and the rules and regulations thereunder, and our stockholders will not be deemed to have waived our compliance with these laws, rules and regulations. Although our amended and restated certificate of incorporation contains the choice of forum provisions described above, it is possible that a court could find that such a provision is inapplicable for a particular claim or action or that such provision is unenforceable.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies.

To date, we have primarily financed our operations through the sale of common stock, preferred stock, convertible notes, revenue from customer and collaboration agreements, and warrants. We will be required to seek additional funding in the future and may to do so through public or private equity offerings or debt financings, credit or loan facilities, collaborations or a combination of one or more of these funding sources. If we raise additional funds by issuing equity securities, our stockholders may suffer dilution and the terms of any equity financing may adversely affect the rights of our stockholders. In addition, as a condition to providing additional funds to us, future investors may demand, and may be granted, rights superior to those of existing stockholders. Debt financing, if available, is likely to involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency, debt holders would be repaid before holders of our equity securities received any distribution of our corporate assets. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our drug candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us. Attempting to secure additional financing may also divert our management’s attention from our day-to-day activities, which may adversely affect our ability to develop our drug candidates.

Unfavorable global economic conditions could adversely affect our business, financial condition, stock price and results of operations.

Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. Adverse developments that affect financial institutions, transactional counterparties, or other third parties, or concerns or rumors about these events, have in the past and may in the future lead to market-wide liquidity problems. For example, on March 10, 2023, Silicon Valley Bank (SVB) was closed by the California Department of Financial Protection and Innovation, which appointed the U.S. Federal Deposit Insurance Corporation (FDIC) as receiver. Similarly, other institutions have been and may continue to be swept into receivership. We have no borrowing or deposit exposure to directly impacted institutions and have not experienced an adverse impact to our liquidity or to our business operations, financial condition, or results of operations as a result of these recent events. However, uncertainty may remain over liquidity concerns in the broader financial services industry, and there may be unpredictable impacts to our business and our industry.

Further, Russia began a full-scale invasion of Ukraine in February 2022 which is the largest conventional military attack in Europe since World II and has triggered unprecedented sanctions against Russia. While the situation remains highly fluid and the outlook of such war in Ukraine is subject to extraordinary uncertainty, the ongoing war and associated sanctions will likely have a severe impact on the global economy. A severe or prolonged economic downturn, such as the 2008 global financial crisis, and one that could be caused by the war in Ukraine, could result in a variety of risks to our business, including, weakened demand for any drug candidates we may develop and our ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy or disruptions in the supply chain generally could also strain our suppliers, possibly resulting in supply disruption. If the current equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly, and more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and stock price and could require us to delay or abandon clinical development plans. In addition, there is a risk that one or more of our current service providers, manufacturers or other partners may not survive such difficult economic times, which could directly affect our ability to attain our operating goals on schedule and on budget. 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. Furthermore, our stock price may decline due in part to the volatility of the stock market and any general economic downturn.

Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.

We do not carry insurance for all categories of risk that our business may encounter. Some of the policies we currently maintain include general liability, property, umbrella, clinical trials and directors’ and officers’ insurance. Any additional insurance coverage we acquire in the future may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive and in the future we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. Any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our cash position and results of operations.

We also expect that operating as a public company will make it more difficult and more expensive for us to obtain directors’ and officers’ liability insurance, and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for us to attract and retain qualified people to serve on our board of directors, our board committees or as executive officers.

We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations, violations of which can have serious negative consequences for our business.

U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations (collectively, Trade Laws), prohibit, among other matters, companies and their employees, agents, clinical research organizations, legal counsel, accountants, consultants, contractors, and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, and reputational harm, among other consequences. We routinely have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations, and we expect our non-U.S. activities to increase in time. We plan to engage third parties for clinical trials and/or obtain necessary permits, licenses, patent registrations, and other regulatory approvals from such officials, employees and government agencies and affiliates and we may be held liable for any corrupt or other illegal activities of our personnel, agents, or partners, even if we do not explicitly authorize or have prior knowledge of such activities.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent rights, if any, could be reduced or eliminated if we fail to comply with these requirements.

Periodic maintenance fees, renewal fees, annuity fees, and various other fees are required to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of a patent. In certain circumstances, we rely on our collaborators or licensors to pay these fees. The USPTO and various foreign patent agencies also require compliance with a number of procedural, documentary, fee payment and other similar requirements during the patent application and prosecution process. Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official communications within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. While an inadvertent lapse can in some cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which non-compliance can result in irrevocable abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If we or our licensors fail to maintain the patents and patent applications covering our drug candidates, our competitors might be able to enter the market with similar or identical products or technology, which would harm our business, financial condition, results of operations and prospects.

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

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim

proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. As noted above, 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 compromise our ability to compete in the marketplace, including compromising our ability to raise the funds necessary to continue our clinical trials, continue our research programs, license necessary technology from third parties, or enter into development collaborations that would help us commercialize our drug candidates, if approved. Any of the foregoing events would harm our business, financial condition, results of operations and prospects.

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

We rely on confidential methodologies and processes and confidentiality agreements to protect our unpatented know-how, technology and other proprietary information and to maintain our competitive position. Trade secrets and know-how can be difficult to protect. We seek to protect these trade secrets and other proprietary technology, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, licensors, collaborators, CROs, contract manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. We cannot guarantee that we have entered into such agreements with each party that may have or has had access to our trade secrets or proprietary technology and processes. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Unauthorized parties may also attempt to copy or reverse engineer certain aspects of our drug candidates that we consider proprietary. Monitoring unauthorized uses and disclosures is difficult, and we do not know whether the steps we have taken to protect our proprietary information will be effective.

We also seek to preserve the integrity and confidentiality of our confidential proprietary information by maintaining physical security of our premises and physical and electronic security of our information technology systems, but it is possible that these security measures could be breached. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets, and we may need to share our trade secrets and proprietary know-how with current or future partners, collaborators, contractors and others located in countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or foreign actors, and those affiliated with or controlled by state actors. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent them from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor or other third party, our competitive position would be materially and adversely harmed.

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

Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential collaborators or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected. Further, we may license our trademarks and trade names to third parties, such as distributors. Though these license agreements may provide guidelines for how our trademarks and trade names may be used, a breach of these agreements or misuse of our trademarks and tradenames by our licensees may jeopardize our rights in or diminish the goodwill associated with our trademarks and trade names. Our

efforts to enforce or protect our proprietary rights related to trademarks, trade names, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our business, financial condition, results of operations and prospects.

We may in the future engage in strategic transactions; such transactions could affect our liquidity, dilute our existing stockholders, increase our expenses and present significant challenges in focus and energy to our management or prove not to be successful.

From time to time, we may consider strategic transactions, such as acquisitions of companies, asset purchases and out-licensing or in-licensing of intellectual property, products or technologies.

Such potential transactions that we may consider in the future include a variety of business arrangements, including spin-offs, strategic partnerships, joint ventures, restructurings, divestitures, business combinations, investments and licensings. Any future transactions could result in potentially dilutive issuances of our equity securities, including our common stock, or the incurrence of debt, contingent liabilities, amortization expenses or acquired in-process research and development expenses, any of which could affect our financial condition, liquidity and results of operations. Future acquisitions may also require us to obtain additional financing, which may not be available on favorable terms or at all. These transactions may never be successful and may require significant time and attention of management. In addition, the integration of any business that we may acquire in the future may disrupt our existing business and may be a complex, risky and costly endeavor for which we may never realize the full benefits of the acquisition.

Public health pandemics or epidemics, political instability, terrorist attacks, other acts of violence or war, or other unexpected events could materially and adversely impact us.

Public health pandemics or epidemics, political instability, terrorist attacks, other acts of violence or war or other unexpected events could materially interrupt our business operations (or those of the third parties upon whom we depend), cause consumer confidence and spending to decrease or result in increased volatility in the United States and worldwide financial markets and economy. They also could result in or prolong an economic recession in the United States. Any of these occurrences could materially and adversely affect us.

Current or future litigation or administrative proceedings could have a material adverse effect on our business, our financial condition and our results of operations.

We may be involved in legal proceedings, administrative proceedings, claims, and other litigation that arise in the ordinary course of business. Unfavorable outcomes or developments relating to proceedings to which we are a party or transactions involving our current or future drug candidates, such as judgments for monetary damages, injunctions, or denial or revocation of permits, could have a material adverse effect on our business, our financial condition, and our results of operations. In addition, settlement of claims could adversely affect our financial condition and our results of operations.

We incur significantly increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives and corporate governance practices.

As a public company, we incur significant legal, accounting and other expenses that we did not previously incur as a private company. We are subject to the reporting requirements of the Exchange Act, which requires, among other things, that we file with the SEC, annual, quarterly and current reports with respect to our business and financial condition. In addition, the Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC and Nasdaq to implement provisions of the Sarbanes-Oxley Act, impose significant requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls and changes in corporate governance practices. Further, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act (the Dodd-Frank Act) was enacted. 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, such as “say on pay” and proxy access. Recent legislation permits emerging growth companies to implement many of these requirements over a longer period and up to five years from the pricing of the IPO. We intend to take advantage of this legislation, but cannot guarantee that we will not be required to implement these requirements sooner than budgeted or planned and thereby incur unexpected expenses. 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 the manner in which we operate our business in ways we cannot currently anticipate.

We expect the rules and regulations applicable to public companies to substantially increase our legal and financial compliance costs and to make some activities more time-consuming and costly. If these requirements divert the attention of our management and personnel from other business concerns, they could have a material adverse effect on our business, financial condition, results of operations and prospects. The increased costs will decrease our net income or increase our net loss, and may require us to reduce costs in other areas of our business or increase the prices of our products or services (if approved). 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 the same or similar coverage. We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers.

We may experience fluctuations in our tax obligations and effective tax rate, which could materially and adversely affect our results of operations.

We are subject to U.S. federal and state income taxes and taxes in certain other non-U.S. jurisdictions. Tax laws, regulations and administrative practices in various jurisdictions may be subject to significant change, with or without advance notice, due to economic, political and other conditions, and significant judgment is required in evaluating and estimating our provision and accruals for these taxes. There are many transactions that occur during the ordinary course of business for which the ultimate tax determination is uncertain. Our effective tax rates could be affected by numerous factors, such as changes in tax, accounting and other laws, regulations, administrative practices, principles and interpretations, the outcome of current and future tax audits, examinations, or administrative appeals, changes in the mix and level of earnings in a given taxing jurisdiction or changes in our ownership or capital structures.

Our current shares outstanding and resulting market valuation do not reflect shares of our common stock issuable upon the exercise of pre-funded warrants and common warrants that are exercisable at the discretion of the holders of such warrants. If we sell shares of our common stock in future financings, stockholders may experience immediate dilution and, as a result, our stock price may decline.

We may from time to time issue additional shares of common stock at a discount from the current trading price of our common stock. As a result, our stockholders would experience immediate dilution upon the purchase of any shares of our common stock sold at such discount. In addition, as opportunities present themselves, we may enter into financing or similar arrangements in the future, including the issuance of debt securities, preferred stock or common stock. For example, in October 2023 and February 2025, we closed private placements which included the sale of pre-funded warrants and common warrants to purchase shares of our common stock. If we issue common stock or securities convertible into common stock, our common stockholders would experience additional dilution, such dilutive impact may be difficult to compute, and our stock price may decline.

If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our operating results could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity, revenue and expenses that are not readily apparent from other sources. If our assumptions change or if actual circumstances differ from our assumptions, our operating results may be adversely affected and could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.

Item 1C. Cybersecurity.

Cybersecurity Risk Management and Strategy

We have developed and implemented a cybersecurity risk management program intended to protect the confidentiality, integrity, and availability of our critical systems and information.

Our cybersecurity risk management program is integrated into our overall enterprise risk management program, and shares common methodologies, reporting channels and governance processes that apply across the enterprise risk management program to other legal, compliance, strategic, operational, and financial risk areas.

Key elements of our cybersecurity risk management program include but are not limited to the following:

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risk assessments designed to help identify material risks from cybersecurity threats to our critical systems and information;

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a security team principally responsible for managing (1) our cybersecurity risk assessment processes, (2) our security controls, and (3) our response to cybersecurity incidents;

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the use of external service providers, where appropriate, to assess, test or otherwise assist with aspects of our security processes;

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cybersecurity awareness training of our employees, including incident response personnel, and senior management; and

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a cybersecurity incident response plan that includes procedures for responding to cybersecurity incidents; and

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a third-party risk management process for key service providers, suppliers, and vendors based on our assessment of their criticality to our operations and respective risk profile.

We have not identified risks from known cybersecurity threats, including as a result of any prior cybersecurity incidents, that have materially affected us, including our operations, business strategy, results of operations, or financial condition. We face risks from cybersecurity threats that, if realized are reasonably likely to materially affect us, including our operations, business strategy, results of operations, or financial condition. For more information , see the section titled “Risk Factor— Risks related to product development and regulatory process—Our business and operations may suffer in the event that our information technology systems, or those used by our CROs or other contractors or consultants, fail or suffer security breaches.”

Cybersecurity Governance

Our Board considers cybersecurity risk as part of its risk oversight function and has delegated to the Audit Committee (Committee) oversight of cybersecurity risks, including oversight of management’s implementation of our cybersecurity risk management program. The Committee receives reports from management on our cybersecurity risks, at a minimum annually and as needed. In addition, management updates the Committee, where it deems appropriate, regarding any cybersecurity incidents it considers to be significant or potentially significant. The Committee reports to the full Board regarding its activities, including those related to cybersecurity.

Our management team, lead by our Executive Director, Information Technology, is responsible for assessing and managing our material risks from cybersecurity threats. The team has primary responsibility for our overall cybersecurity risk management program and supervises our retained external cybersecurity consultants. Our Executive Director, Information Technology's experience includes 25 years of experience in managing IT environments including assessing the overall risk management program and material risks, as well as building our cybersecurity framework over the past six years.

Our management team takes steps to stay informed about and monitor efforts to prevent, detect, mitigate, and remediate cybersecurity risks and incidents through various means, which may include threat intelligence and other information obtained from governmental, public or private sources, including external consultants engaged by us; and alerts and reports produced by security tools deployed in the IT environment.

Our corporate headquarters are located in South San Francisco, California, where we lease and occupy space in two separate buildings. The total amount of space leased across both buildings equals approximately 51,000 square feet of office and laboratory space. The current term of each of our two South San Francisco leases expires in March 2027 and July 2027, with options to extend the terms through March 2035 and July 2032, respectively.

We also have an office in Leuven, Belgium, where we lease and occupy approximately 8,100 square feet of office and laboratory space. The current term of our Leuven, Belgium lease expires in August 2028.

We lease all of our facilities and do not own any real property. We believe our existing facilities are sufficient for our needs for the foreseeable future. To meet the future needs of our business, we may lease additional or alternate space, and we believe suitable additional or alternative space will be available in the future on commercially reasonable terms.

From time to time, we may become involved in litigation or other legal proceedings. While the outcome of any such proceedings cannot be predicted with certainty, we are not currently involved in any legal proceedings that we believe are, individually or in the aggregate, material to our business, results of operations or financial condition. However, regardless of the outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of associated costs and diversion of management time.

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Our common stock was listed on The Nasdaq Global Select Market under the symbol “ALGS” from October 20, 2020 to March 5, 2024 and has been listed on The Nasdaq Capital Market since March 6, 2024. Prior to October 20, 2020, there was no public trading market for our common stock.

As of March 6, 2025, there were 33 holders of record of our common stock, which consist of 31 holders of record of our voting common stock and 2 holders of record of our non-voting common stock. The actual number of stockholders is greater than this number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street name by brokers and other nominees.

We have never declared or paid any cash dividend on our common stock. We do not expect to declare or pay any cash dividends in the foreseeable future. Any future determination related to dividend policy will be made at the discretion of our board of directors and will depend upon, among other factors, our results of operations, financial condition, capital requirements, contractual restrictions, business prospects and other factors our board of directors might deem relevant.

The information required by this item is incorporated by reference to the definitive Proxy Statement for our 2025 Annual Meeting of Stockholders, which will be filed with the SEC no later than 120 days after December 31, 2024.

In October 2024, an investor exercised a Pre-Funded Warrant to purchase an aggregate of 263,000 shares of Common stock for an aggregate purchase price of $657.50 and was issued 263,000 shares of Common Stock.

In November 2024, an investor exercised a Pre-Funded Warrant to purchase an aggregate of 244,000 shares of Common stock for an aggregate purchase price of $610.00 and was issued 244,000 shares of Common Stock.

In December 2024, an investor net exercised a Common Warrant to purchase an aggregate of 48,822 shares of Common stock and was issued 22,024 shares of Common Stock.

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10-K. In addition to historical financial information, this discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Special Note Regarding Forward-Looking Statements” and “Risk Factors” and elsewhere in this Annual Report on Form 10-K. Our fiscal year ends on December 31 each year.

We are a clinical-stage biotechnology company focused on developing novel therapeutics to address unmet medical needs in liver diseases and viral infections, including in the areas of chronic HBV infection, MASH, and coronavirus infections (e.g., SARS‑CoV‑2, SARS‑CoV, MERS‑CoV, and other related infections). The Aligos team has a demonstrated track record of success in drug development and medicinal chemistry in liver and viral diseases, resulting in three potential best‑in‑class drug candidates.

Our pipeline of drug candidates includes ALG‑000184 for CHB, ALG‑055009 for MASH, ALG‑097558 for coronavirus infections, and a portfolio of preclinical programs. ALG‑000184 is our potential best‑/first‑in‑class Capsid Assembly Modulator (CAM‑E) for chronic HBV infection with enhanced pharmacologic properties vs. competitor CAM‑E drugs and has demonstrated greater HBV DNA suppression compared to the standard of care, NAs, as well as multi-log10 reductions in viral antigens in Phase 1 clinical studies conducted to date. ALG‑055009 is our potential best‑in‑class THR‑β agonist for MASH with enhanced pharmacologic properties vs. competitor THR-β agonists. Phase 2a topline data demonstrated that ALG‑055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at Week 12 as measured by MRI-PDFF. ALG‑097558 is our potential best‑in‑class small molecule coronavirus 3CL PI which is at least 3-fold more potent in cell-based assays of coronavirus infection than other approved CoV PIs and can be dosed twice daily without the requirement for ritonavir co-dosing based on Phase 1 clinical studies conducted to date.

ALG‑000184: Potential best‑in‑class small molecule CAM‑E for chronic HBV infection

Our primary area of focus seeks to enhance the viral suppression and rate of functional cure for chronic HBV infection, which often results in life-threatening conditions such as cirrhosis, end-stage liver disease, and the most common form of liver cancer, HCC. To achieve this, we are developing a portfolio of differentiated chronic HBV infection drug candidates, including a small molecule CAM that results in the production of empty viral capsids and small molecule inhibitors of the Programmed Cell Death Ligand 1 (PD‑1/PD-L1) interaction.

A multi-part Phase 1 study is ongoing, with the completed evaluation of the safety, tolerability, and pharmacokinetic profile of ALG-000184 in HVs. Additionally, a dose-ranging phase assessing the safety, pharmacokinetics, and antiviral activity of 10-300 mg doses of ALG-000184 administered over 28 days in untreated HBeAg+/- subjects with chronic HBV infection has also been completed. In these study phases, ALG‑000184 was found to be well tolerated with a favorable PK profile and demonstrated potentially best-in-class multi-log10 HBV DNA and RNA reductions at all doses tested, as well as HBV surface antigen (HBsAg) reductions in a subset of HBeAg+ subjects receiving 300 mg ALG000184 (Hou et. al, AASLD 2022). Based on the favorable profile observed with dosing up to 300 mg of ALG-000184 for 28 days, additional Phase 1 cohorts are currently underway to evaluate the risk-benefit profile of ALG-000184 at doses of 300 mg, with or without entecavir (ETV) therapy, for up to 96 weeks in HBeAg+ and HBeAg- subjects with chronic HBV infection. Preliminary data from several of these cohorts (Agarwal et al., EASL 2024; Yuen et al., AASLD 2024) have been presented, showing that ALG‑000184, administered for up to 92 weeks, was well tolerated, exhibited a favorable PK profile, and demonstrated potentially best-in-class antiviral activity.

Data from the 300 mg ALG‑000184 monotherapy cohort with up to 92 weeks in HBeAg+ and up to 84 weeks in HBeAg- subjects demonstrated sustained HBV DNA suppression (<LLOQ <10 IU/mL) in 7/7 (100%) HBeAg+ subjects with chronic HBV infection at week 84 and sustained HBV DNA suppression in all (11/11) HBeAg- subjects by Week 24. Importantly, no viral breakthrough was observed in any subject, and no known CAM resistant mutations were identified. At week 48, data from the 300 mg ALG-000184 monotherapy cohort demonstrated sustained HBV DNA suppression (<LLOQ <10 IU/mL) in 6/10 (60%) HBeAg+ subjects with chronic HBV infection and sustained HBV DNA suppression in all (11/11) HBeAg- subjects by Week 24. In addition, 91% (10/11) HBeAg- subjects achieved HBV DNA below the lower limit of detection (LLOD <4.29 IU/mL).

Compared to Phase 3 studies with the current standard of care NAs, tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) (Buti et al., Lancet Gastro, 2016; Chen et al., Lancet Gastro 2016), these Phase 1 data to date indicate that ALG‑000184 treatment may be superior to NAs in HBeAg+/- subjects in achieving HBV DNA levels < LLOQ (10 IU/mL) after 48 weeks on treatment, which is the approvable endpoint for chronic suppressive therapy in CHB (Food and Drug Administration (FDA) Guidance, Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment Guidance for Industry, April 2022 – Section III.B.1.a). We have received supportive feedback from the FDA regarding chronic suppressive therapy with ALG-000184, along with the Committee for Medicinal Products for Human Use (CHMP; EU) and the National Medical Products Administration (NMPA; China). Subsequent clinical studies of ALG‑000184 will be conducted to show superiority to standard of care NA treatment (HBV DNA levels < LLOQ ) after 48 weeks of treatment. Furthermore, when combined with other mechanisms of action, such as Amoytop’s mipeginterferon alfa-2b, a well-established immunomodulator, and other candidates in our chronic HBV infection portfolio (as described below), ALG-000184 dosing regimens have the potential to contribute to achieving higher rates of functional cure than with currently approved agents. Dosing of HBeAg+ and HBeAg- subjects with ALG‑000184 ± ETV in Phase 1 will continue through 2025 and 96-week safety, PK, and antiviral activity data will be presented at upcoming scientific conferences. In October 2024, Aligos announced that the FDA cleared the Company’s investigational new drug application (IND) for a Phase 1 drug-drug interaction study, and Phase 2 enabling activities are ongoing with the study expected to begin in mid-2025.

We are also exploring additional ways to boost immune responses via small molecule inhibitors of the Programmed Cell Death Ligand 1 (PD-L1) transmembrane protein and its interaction with Programmed Cell Death Protein 1 (PD-1). We have rationally designed these T cell activating drug candidates to partition preferentially to the liver and thereby potentially mitigate systemic toxicity with the goal to develop better tolerated PD-1/PD-L1 inhibitors for CHB patients. Lead molecules developed to date show in vivo efficacy in tumor models similar to approved PD-1/PD-L1 antibodies. Our small molecule lead compounds also demonstrate greater PD-L1 target occupancy at a lower dose in a humanized PD-L1 subcutaneous tumor model compared to competitor small molecule PD-L1 inhibitors. We have recently selected a lead molecule, ALG‑093940, and are completing in vivo studies to enable further advancement towards clinical development.

MASH is a complex, chronic liver disease which is a leading cause of liver-related morbidity including cirrhosis, hepatocellular carcinoma, liver transplant, and end-stage liver disease. In 2024, the FDA approved resmetirom, a THR-β agonist, as the first drug for the treatment of MASH. However, additional therapies may address unmet needs, including the potential for improved efficacy and a more favorable risk-benefit profile. To achieve this, ALG-055009 has been purposefully designed to exhibit significantly greater potency (approximately 50-fold higher compared to resmetirom in head-to-head in vitro studies) and enhanced β selectivity, along with optimized pharmacologic properties to deliver an improved PK profile. We believe these advantages position ALG‑055009 as a strong candidate to become a best-in-class THR-β agonist.

A first-in-human Phase 1 study of ALG‑055009 in HVs (oral single ascending doses (SAD)) and in subjects with hyperlipidemia (14 oral daily multiple ascending doses (MAD)) has been completed. Clinical data after single doses up to 4 mg and multiple doses up to 1 mg showed that ALG‑055009 was well tolerated, had dose proportional PK with low intersubject variability, and demonstrated expected thyromimetic effects (i.e., generally dose proportional increases in sex hormone binding globulin and decreases in various atherogenic lipids and thyroid hormones without any clinical evidence of thyroid dysfunction). In this same study, we also evaluated relative bioavailability where we showed the soft gelatin capsules used in the Phase 2a study described below delivered similar exposures compared to the solution formulation used in the SAD/MAD parts of the Phase 1 study; we observed low intersubject PK variability and there was no evidence of a meaningful food effect.

Based on these promising Phase 1 data, we initiated the Phase 2a HERALD study (NCT06342947) at sites across the United States. The study was a 12-week randomized, double-blind, placebo-controlled trial evaluating 4 doses (0.3 mg, 0.5 mg, 0.7 mg, and 0.9 mg) of ALG-055009 vs. placebo in 102 subjects with presumed MASH and liver fibrosis at stages 1-3 (F1-F3). The primary endpoint of this study was percent relative change in liver fat content by MRI-PDFF at Week 12. This study also evaluated the safety and PK of ALG-055009 treatment and its effect on multiple other efficacy biomarkers, including other non-invasive tests previously shown to be impacted by treatment with THR‑β agonists. We announced positive topline data from this study in 2024, demonstrating that ALG-055009 dose groups were well-tolerated and met the primary endpoint. Specifically, doses of 0.5 mg to 0.9 mg ALG-055009 demonstrated statistically significant reductions in liver fat at Week 12, with placebo-adjusted median

relative reductions up to 46.2% as measured by MRI-PDFF. Up to 70% of subjects achieved ≥30% relative reduction in liver fat compared to baseline. Eighteen subjects who were on stable GLP-1 agonist therapy qualified for enrollment in the study, with liver fat content meeting the inclusion criteria of ≥10% at baseline as measured by MRI-PDFF. Notably, 11 of 14 subjects on stable GLP-1 agonists treated with ALG-055009 had liver fat decreases, whereas 4 of 4 subjects on stable GLP-1 agonists treated with placebo had increases in liver fat over the 12-week dosing period.

In the Phase 2a study, ALG‑055009 demonstrated a favorable tolerability profile with no evidence of clinical hyper/hypothyroidism. Incidence of gastrointestinal-related treatment emergent adverse events were similar in ALG‑055009 dose groups compared to placebo. Specifically, similar rates of diarrhea were observed in ALG‑055009 dose groups compared to placebo, with no dose-response. Significant reductions in atherogenic lipids, including LDL-C, lipoprotein (a), and apolipoprotein B, were also observed. Phase 2b enabling activities are underway, with expected completion in the middle of 2025. We are also assessing potential Phase 2b clinical trial study designs with key opinion leaders. We are evaluating a variety of options to fund continued development, including potential out-licensing.

ALG‑097558: Potential best-in-class small molecule ritonavir-free pan-coronavirus protease inhibitor

Another area of focus is to develop drug candidates with pan-coronavirus antiviral activity, including against Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for COVID-19. In this area of focus, we are exploring small molecule coronavirus 3CL protease inhibitors (PIs) in collaboration with the Rega Institute at Katholieke Universiteit Leuven (KU Leuven), the Center for Innovation and Stimulation of Drug Discovery (CISTIM) and the Centre for Drug Design and Discovery (CD3). This collaboration led to the discovery of ALG‑097558 which has completed Phase 1 first-in-human evaluation in healthy volunteers and advanced into a clinical trial evaluating high-risk COVID-19 patients.

ALG‑097558 has been shown to be at least 3-fold more potent than nirmatrelvir and other PIs in clinical development against a panel of SARS-CoV-2 variants (including Omicron). It also has demonstrated broad pan‑coronavirus activity, including against SARS-CoV-1 and MERS-CoV. In the first-in-human Phase 1 clinical study, single doses up to 2000 mg and multiple doses up to 800 mg Q12H for 7 days were well tolerated with an acceptable PK profile that indicates ritonavir boosting is not required and absence of a clinically relevant DDI with midazolam, suggesting ALG‑097558 can be co-administered with CYP3A4 substrates. Based on these Phase 1 data (Wilkes et al, RespiDart, 2024), the projected efficacious dose range to treat SARS-CoV-2 is 200-600 mg ALG‑097558 Q12 x 5 days, without the need for ritonavir coadministration.

ALG‑097558 began three additional clinical trials in 2024. AGILE University of Liverpool, a UK government supported platform trial (MRC and Wellcome Trust funding), is sponsoring and performing a study in high‑risk COVID‑19 patients evaluating ALG‑097558 as monotherapy or in combination with remdesivir. Additionally, clinical studies evaluating PK in special populations (renal and hepatic impairment subjects; NIAID contract) are on-going. NIAID is also sponsoring a drug‑drug interaction and relative bioavailability study in healthy volunteers expected to start dosing in the second quarter of 2025. We expect that future development of ALG‑097558, including ongoing Phase 2 enabling activities, will be funded by external sources, including public funding sources as described below.

Preclinical activities for our coronavirus program were partially funded through a grant from the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID) Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern program through the Metropolitan AntiViral Drug Accelerator (MAVDA) consortium. Specific clinical and nonclinical studies for the ALG-097558 program and the follow up compound, are now also being funded with federal funds from the NIAID, NIH, Department of Health and Human Services, under Contract No. 75N93023C00052. We filed an IND in the third quarter of 2024 and clinical studies in special populations were initiated in the second half of 2024 as part of this NIAID contract. We expect to receive approximately $13.8 million in funds across these two NIH awards and contracts to support these activities. We are also seeking additional external funding (e.g., from governmental agencies) to support future studies (e.g., Phase 2) as we advance ALG‑097558 for the treatment of COVID‑19 and future coronavirus pandemics.

Collaboration revenue includes recognition of our upfront payments pursuant to the Merck Original Agreement and First Amendment. In order to record collaboration revenue, we utilize an input method to recognize revenue over time as costs are incurred.

Contract revenue includes recognition of revenue generated from research and development services under third-party contracts with customers. In order to record contract revenue, we utilize an input method to recognize revenue over time as costs are incurred.

Our operating expenses since inception have consisted solely of research and development costs and general and administrative costs.

We rely substantially on third parties to conduct our discovery activities, nonclinical studies, clinical trials and manufacturing. We primarily estimate research and development expenses based on estimates of services performed and rely on third party contractors and vendors to provide us with timely and accurate estimates of expenses of services performed to assist us in these estimates. A portion of our research and development expenses are based on contractual milestones. Research and development costs consist primarily of costs incurred for the identification and development of our drug candidates through our technology platforms, which include:

We expense research and development costs as the services are performed or the goods are received. Non-refundable payments for goods or services that will be used for future research and development activities are deferred and capitalized. Such amounts are recognized as an expense as the goods are delivered or the related services are performed until it is no longer expected that the goods will be delivered, or the services will be rendered.

Our research and development costs may increase in future periods as we continue to invest in research and development activities and advance our nonclinical and clinical programs through clinical development. The process of conducting nonclinical studies and, eventually, clinical trials necessary to obtain regulatory approval is costly and time consuming, and the successful development of our drug candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects or clinical trials or if and to what extent we will generate revenue from the commercialization and sale of any of our drug candidates.

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive, finance, corporate and business development and administrative functions. General and administrative expenses also include legal fees relating to patent and corporate matters; professional fees for accounting, auditing, tax and consulting services; insurance costs; travel expenses; and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs not otherwise classified as research and development costs.

Interest and other income, net comprises interest income, and other income, net. Interest income, net primarily

consists of interest earned on our cash, cash equivalents, and investments. Other income, net consists primarily of accretion/amortization of investments and foreign currency exchange gains/losses.

The change in fair value of Common Warrants includes the remeasurement of the Common Warrants using the Black Scholes option pricing model at each reporting period, and the change in fair value is recorded in earnings.

Since our inception in 2018, we have not recorded any U.S. federal or state income tax benefits for the net losses we have incurred in any year or for our earned research and development tax credits, due to our uncertainty of realizing a benefit from those items. As of December 31, 2024, we had federal net operating loss (NOL) carryforwards of $41.8 million available to reduce taxable income and these NOLs can be carried forward indefinitely. We have state NOL carryforwards of $90.7 million as of December 31, 2024, available to reduce future state taxable income, which expire at various dates beginning in 2043. As of December 31, 2024, we also had federal and state research and development tax credit carryforwards of $1.9 million and $1.2 million, respectively. The federal research and development tax credit carryforwards begin to expire in 2043, while the state research and development tax credit carryforwards can be carried forward indefinitely. As of December 31, 2024, the Company had $8.4 million of Australian NOL carryforwards and $0.6 million of Australian research and development tax credit carryforwards available. The Australian NOL carryforwards and research and development tax credits have no expiration date.

Under Sections 382 and 383 of the Code, and corresponding provisions of state law, if a corporation undergoes an “ownership change” (generally defined as a greater than 50 percentage point change (by value) in its equity ownership over a rolling three-year period), our ability to use our pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income may be limited. We performed a Code Section 382 analysis in 2023 and determined there was an ownership change that resulted in Section 382 limitations, the impact of which is reflected in the financial statements. We performed a Code Section 382 analysis in 2024 and determined no further ownership change.

We may experience additional ownership changes as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. In the future, if we earn net taxable income, our ability to use our pre-change net operating loss carryforwards or other tax attributes to offset U.S. federal taxable income may be subject to limitations, which could potentially result in increased future tax liability to us and could adversely affect our business, results of operations, and cash flows. In addition, under current tax law, federal NOL carryforwards generated in periods after December 31, 2017, may be carried forward indefinitely but, may only be used to offset 80% of our taxable income.

The following table summarizes our operating expenses for the years ended December 31, 2024 and 2023:

Revenue from collaborations was $0.3 million for the year ended December 31, 2024, compared to $9.3 million for the year ended December 31, 2023, a decrease of $9.0 million. This is due to the completion of the Original Agreement with Merck in the first quarter of 2023, leaving the Amended collaboration agreement with Merck to continue in the year ended December 2023. The Amended collaboration agreement with Merck ended in May 2024.

Revenue from customers was $3.6 million for the year ended December 31, 2024, compared to $6.2 million for the year ended December 31, 2023, a decrease of $2.6 million, primarily due to the agreement with Amoytop, which was signed in 2023. Refer to footnote 12, Revenue from Contracts with Customers for further information.

We track direct external research and development expenses on a program-specific basis (CHB, coronaviruses, MASH and early-stage programs). The following table summarizes these research and development costs, in thousands:

Research and development expenses were $70.3 million for the year ended December 31, 2024, compared to $73.0 million for the year ended December 31, 2023, a decrease of $2.8 million. This is primarily due to a decrease of $4.2 million in employee-related costs, of which $1.8 million related to stock-based compensation. There was also a decrease of $0.3 million in depreciation and a decrease of $0.7 million in facility expenses. Offsetting this was an increase of $2.4 million in third-party expenses mainly related to increases in our ongoing CAM and MASH clinical study activities and related expenditures.

General and administrative expenses were $22.8 million for the year ended December 31, 2024, compared to $30.6 million for the year ended December 31, 2023, a decrease of $7.8 million. This is due to a decrease of $4.2 million of third-party expenses primarily due to reduced legal and IP spend, a decrease of $3.0 million of employee-related costs, of which $2.0 million related to stock-based compensation, and a decrease of $1.3 million in facility and depreciation expenses. This was partially offset by an increase of $0.7 million in travel and recruiting costs.

Interest income, net was $1.7 million for the year ended December 31, 2024 compared to $4.3 million for the year ended December 31, 2023, a decrease of approximately $2.6 million, primarily due to an decrease in market interest rates and a lower average investment balance.

Other income, net was an income of $2.7 million for the year ended December 31, 2024 compared to expense of $0.9 million for the year ended December 31, 2023, a difference of $3.6 million. The difference was due to an increase in the accretion of short-term investments.

The change in fair value of Common Warrants was an expense of $46.1 million for the year ended December 31, 2024 compared to an expense of $2.2 million for the year ended December 31, 2023, an increase of $44.0 million. The increase was due to a change in the fair value of the Common Warrants measured using the Black Scholes option pricing model remeasured at each reporting period.

We have incurred net losses and negative cash flows from operations in each year since our formation in February 2018. Our net losses were $131.2 million and $87.7 million for the years ended December 31, 2024 and 2023, respectively. We have had no revenue from product sales. We have not yet commercialized any products and we do not expect to generate revenue from sales of any drug candidates for at least several years, if ever.

Our operations have been financed primarily by net proceeds from the sale and issuance of our convertible preferred stock, net proceeds from our IPO, and the issuance of convertible debt.

In October 2023, we completed a PIPE offering and entered into a securities purchase agreement (the "2023 Securities Purchase Agreement") pursuant to which we issued 1,257,168 shares of our common stock, par value $0.001 per share, pre-funded warrants to purchase an aggregate of 3,242,018 shares of our common stock (the “2023 Pre-Funded Warrants”), and common warrants to purchase an aggregate of 2,249,680 shares of our common stock (the “2023 Common Warrants,” and together with the 2023 Pre-Funded Warrants, the "2023 Warrants"). Each 2023 Warrant is exercisable for one share of common stock. The Company received gross proceeds of $92.1 million, and after deducting the placement agent fees and expenses and offering costs, net proceeds were $86.2 million.

As of December 31, 2024, we had cash, cash equivalents and investments of $56.9 million. As of December 31, 2024, we had an accumulated deficit of $618.0 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We expect to continue to incur significant expenses and increasing operating losses over at least the next several years. Our net operating losses may fluctuate from quarter to quarter and year to year depending primarily on the timing of our clinical trials and nonclinical studies and our other research and development expenses. We have no internal manufacturing capabilities or sales force and outsource a substantial portion of our clinical trial work to third parties.

In February 2025, we entered into a securities purchase agreement (the Securities Purchase Agreement) with certain investors names therein (the Purchasers) pursuant to which we issued (i) 2,103,307 shares of Common Stock, consisting of 1,427,000 shares of voting Common Stock and 676,307 shares of non-voting Common Stock, (ii) pre‑funded warrants (the Pre-Funded Warrants) to purchase up to an aggregate of 1,922,511 shares of voting Common Stock, and (iii) accompanying common warrants (the Common Warrants and, together with the Pre-Funded Warrants, the Warrants) to purchase up to an aggregate of 2,012,909 shares of voting Common Stock. Each Warrant is exercisable for one share of common stock (the 2025 Private Placement). We received gross proceeds of approximately $105.0 million. In connection to the 2025 Private Placement, we also entered into a registration rights agreement with the Purchasers, pursuant to which we agreed to register for resale the shares of common stock sold to the Purchasers, as well as the shares of common stock underlying the warrants sold to the Purchasers, on the terms set forth therein. We also entered into a registration rights agreement with Baker Brothers Life Sciences, L.P. (together with its affiliates, the Lead Investor), pursuant to which we agreed to file a resale registration statement with the Securities and Exchange Commission following demand by the Lead Investor to register the resale of shares of Common Stock and any Common Stock issued or issuable upon the exercise or conversion of non-voting Common Stock and any of our other securities held by the Lead Investor.

Our primary use of cash is to fund operating expenses, which consist primarily of research and development costs related to our drug candidates and our discovery programs, and to a lesser extent, general and administrative expenditures. We expect our expenses to increase substantially in connection with our ongoing clinical development activities related to our CHB drug candidate ALG-000184, which we have initiated clinical trials, as well as our research and development of our other drug candidates within our MASH and coronavirus programs.

In addition, we continue to incur additional costs associated with operating as a public company following our IPO in October 2020. We expect that our expenses will increase substantially to the extent we:

We believe that our existing cash, cash equivalents and investments will enable us to fund our planned operating expenses and capital expenditure requirements through at least the twelve months from the date of issuing our financial statements. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. Furthermore, we may elect to raise additional capital on an opportunistic basis to fund operations.

Because of the numerous risks and uncertainties associated with our research and development programs and because the extent to which we may enter into collaborations with third parties for development of our drug candidates is unknown, we are unable to estimate the timing and amounts of increased capital outlays and operating expenses associated with completing the research and development of our drug candidates. Our future capital requirements will depend on many factors, including:

Developing pharmaceutical products, including conducting nonclinical studies and clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval for any drug candidates or generate revenue from the sale of any drug candidate for which we may obtain marketing approval. In addition, our drug candidates, if approved, may not achieve commercial success. Our commercial product revenues, if any, will be derived from sales of drugs that we do not expect to be commercially available for many years, if ever. Accordingly, we will need to obtain substantial additional funds to achieve our business objectives.

Adequate additional funds may not be available to us on acceptable terms, or at all. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interest may be diluted, and the terms of these securities may include liquidation or other preferences and anti-dilution protections that could adversely affect the rights of a common stockholder. Additional debt or preferred equity financing, if available, may involve agreements that include restrictive covenants that may limit our ability to take specific actions, such as incurring debt, making capital expenditures or declaring dividends, which could adversely constrain our ability to conduct our business, and may require the issuance of warrants, which could potentially dilute ownership interest.

If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technology, future revenue streams, research programs, or drug candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or collaborations, strategic alliances or licensing arrangements with third parties when needed, we may be required to delay, limit, reduce and/or terminate our product development programs or any future commercialization efforts or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.

The following table summarizes our sources and uses of cash for each of the periods presented:

During Fiscal 2024, operating activities used $80.7 million of cash, primarily resulting from our net loss of $131.2 million and cash used as a result of changes in our operating assets and liabilities of $5.0 million, partially offset by non-cash charges of $55.4 million. Net cash used as a result of changes in our operating assets and liabilities of $5.0 million consisted of a decrease of $2.7 million in operating lease liabilities, a decrease of $1.2 million in deferred revenue, and an increase in other current assets of $0.2 million, partially offset by an increase in accrued liabilities of $1.4 million, and an increase of $0.1 million in accounts payable.

During Fiscal 2023, operating activities used $79.0 million of cash, primarily resulting from our net loss of $87.7 million and cash used as a result of changes in our operating assets and liabilities of $9.5 million, partially offset by non-cash charges of $18.2 million. Net cash used as a result of changes in our operating assets and liabilities of $9.5 million consisted of an increase in accrued liabilities of $0.9 million, and a decrease in other current assets of $2.3 million, offset by a decrease of $2.4 million in operating lease liabilities, a decrease of $2.2 million in accounts payable, and a decrease of $8.1 million in deferred revenue.

During Fiscal 2024, investing activities used $18.3 million of cash, consisting primarily of investment purchases of $108.1 million partially offset by investment maturities of $90.0 million.

During Fiscal 2023, investing activities provided $45.0 million of cash, consisting primarily of investment maturities.

During Fiscal 2024, net cash provided by financing activities was $0.4 million, primarily from share purchases through our employee stock purchase plan.

During Fiscal 2023, net cash provided by financing activities was $88.3 million, consisting primarily of $87.9 million from the issuance of common stock, common warrants and pre-funded warrants in the PIPE, the issuance of shares through our employee stock purchase plan, partially offset by payments of our finance leases.

Our principal commitments consist of obligations under our operating leases for office space in South San Francisco, California, and Belgium, and finance lease commitments representing obligations related to vehicle leases for employees and a lease for lab equipment. All of our finance leases are for assets in Belgium. We do not have any material purchase commitments for contracts with fixed or minimum service requirements. We also enter into contracts in the normal course of business with various vendors that generally provide for contract termination following a certain notice period. The Company enters into contracts in the normal course of business that includes arrangements with clinical research organizations, vendors for preclinical research and vendors for manufacturing. These agreements generally allow for cancellation with notice. As of December 31, 2024, the Company had no material non-cancellable purchase commitments.

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

We enter into standard indemnification arrangements in the ordinary course of business. Pursuant to these arrangements, we indemnify, hold harmless and agree to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, in connection with any trade secret, copyright, patent or other intellectual property infringement claim by any third party with respect to its technology. The term of these indemnification agreements is generally perpetual any time after the execution of the agreement. The maximum potential amount of future payments we could be required to make under these arrangements is not determinable. We have never incurred costs to defend lawsuits or settle claims related to these indemnification agreements. As a result, we believe the fair value of these agreements is minimal.

Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (GAAP). The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts and the disclosure of assets and liabilities at the date of the consolidated financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on relevant assumptions 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.

While our significant accounting policies are described in the notes to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K, we believe that the following critical accounting policies are most important to understanding and evaluating our reported financial results and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

We record accrued expenses for estimated costs of our research and development activities conducted by third-party service providers, which include the conduct of clinical trials and nonclinical studies. We record the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and include these costs in accrued liabilities in the Consolidated Balance Sheets and within research and development expense in the Consolidated Statements of Operations and Comprehensive Loss. These expenses are a significant component of our research and development costs. We record accrued expenses for these costs based on factors such as estimates of the work completed and in accordance with agreements established with these third-party service providers. Any payments made in advance of services provided are recorded as prepaid expenses and other assets, which are expensed as the contracted services are performed.

We estimate the amount of work completed through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. We make significant judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, we adjust our accrued estimates. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed could vary from actuals and result in us reporting amounts that are too high or too low in any particular period. Our accrued expenses are dependent, in part, upon the receipt of timely and accurate reporting from clinical research organizations and other third-party service providers. For the periods presented, we have experienced no material differences between our accrued expenses and actual expenses.

In April 2012, the Jumpstart Our Business Startups Act of 2012 (the JOBS Act), was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” (an EGC) can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Thus, an EGC can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to use the extended transition period for any new or revised accounting standards during the period in which we remain an EGC; however, we may adopt certain new or revised accounting standards early.

We will remain an EGC until the earliest to occur of: (1) the last day of the fiscal year in which we have more than $1.235 billion in annual revenue; (2) the date we qualify as a “large accelerated filer,” with at least $700.0 million of equity securities held by non-affiliates; (3) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period; and (4) the last day of the fiscal year ending after the fifth anniversary of our initial public offering, i.e., December 31, 2025.

In addition, we intend to rely on the other exemptions and reduced reporting requirements provided to EGCs by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, as an EGC, we are not required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis) or (iv) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the Chief Executive Officer’s compensation to median employee compensation.

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our consolidated financial statements.

Our cash, cash equivalents and investments of $56.9 million as of December 31, 2024, consist of bank deposits, money market funds, and US Treasury available-for-sale securities. We are exposed to market risk related to changes in interest rates applicable to our investment portfolio of cash equivalents and short-term investments. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates. Should U.S. interest rates decline, interest income would be reduced in future periods for short-term investments which mature and the proceeds of which are reinvested in similar instruments at lower interest rates. Additionally, the fair value of our short-term investments is subject to change as a result of potential changes in market interest rates. As of December 31, 2024, we estimate that a hypothetical 100 basis point adverse movement would not result in a material impact on our financial position or results of operations or cash flows.

We have employees and operations, including contracts with third-party vendors, in Europe through our subsidiary Aligos Belgium BVBA. We have similar, but more limited, operations in Australia and China. Though the functional currency in these locations is the U.S. dollar, we remeasure transactions initially recorded in local currencies in these locations, the Euro, Australian dollar and Chinese Yuan, respectively, to the U.S. dollars periodically. As such, we are exposed to foreign currency exchange risk as the underlying contracts to pay employees or vendors in these locations are generally denominated in the local currencies. A decline in the value of the U.S. dollar relative to these currencies would increase our cost of doing business in these locations. We are subject to foreign currency transaction gains or losses on our contracts denominated in foreign currencies. To date, foreign currency transaction gains and losses have not been material to our financial statements, and we have not had a formal hedging program with respect to foreign currency. A 10% increase or decrease in current exchange rates would not have a material effect on our financial position or results of operations or cash flows.

These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

The accompanying notes are an integral part of these consolidated financial statements.

Unless otherwise indicated, financial information except share and per share data, including dollar values stated in the text of the notes to financial statements, is expressed in thousands of dollars.

1. Organization

Description of business

Aligos Therapeutics, Inc. (Aligos-US) was incorporated in the state of Delaware on February 5, 2018 (inception). On September 10, 2018, the Company formed Aligos Belgium BVBA (the Subsidiary or Aligos-Belgium). On March 30, 2020, the Company formed as a wholly owned subsidiary, Aligos Australia Pty LTD (Aligos-Australia), a proprietary limited company. On May 18, 2021, the Company formed as a wholly owned subsidiary, Aligos Therapeutics (Shanghai) Co. Ltd. (Aligos-Shanghai) and together with Aligos-US, Aligos-Belgium, and Aligos-Australia being the Company or Aligos.

Aligos is a clinical-stage biotechnology company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, including in the areas of chronic hepatitis B (CHB), metabolic dysfunction associated steatohepatitis (MASH), and coronavirus (e.g., SARS-CoV-2 and related infections).

The Company is devoting substantially all of its efforts to the research and development of its drug candidates. The Company has not generated any product revenue to date. The Company is also subject to a number of risks similar to other companies in the biotechnology industry, including the uncertainty of success of its preclinical studies and clinical trials, regulatory approval of drug candidates, uncertainty of market acceptance of products, competition from substitute products and larger companies, the need to obtain additional financing, compliance with government regulations, protection of proprietary technology, dependence on third-parties, product liability, and dependence on key individuals.

Liquidity

The Company has incurred losses and negative cash flows from operations since its inception. As of December 31, 2024 and 2023, the Company had an accumulated deficit of approximately $618.0 million and $486.8 million, respectively. Management expects to continue to incur additional substantial losses in the foreseeable future as a result of expanded research and development activities.

As of December 31, 2024, the Company has cash, cash equivalent and investments of approximately $56.9 million, which is available to fund future operations. The Company expects to continue to spend substantial amounts to continue the nonclinical and clinical development of its current and future programs. If the Company is able to gain marketing approval for drug candidates that are being developed, it will require significant additional amounts of cash in order to launch and commercialize such drug candidates. In addition, other unanticipated costs may arise. Because the design and outcome of the Company’s planned and anticipated clinical trials is highly uncertain, the Company cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of any drug candidate the Company may develop.

The Company expects to finance its cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements. Based on the Company’s research and development plans, it is expected that the Company’s existing cash, cash equivalents and investments, inclusive of the cash received from the PIPE financing in February 2025, will enable the Company to fund its operations for at least 12 months following the date the consolidated financial statements are issued. However, the Company’s operating plan may change as a result of many factors currently unknown, and the Company may need to seek additional funds sooner than planned. Moreover, it is particularly difficult to estimate with certainty the Company’s future expenses given the dynamic nature of its business, and the macro-economic environment generally.

The Company’s ability to raise additional funds will depend on financial, economic and other factors, many of which are beyond its control. If additional funds are not available to the Company when needed, on terms that are acceptable to the Company, or at all, the Company may be required to: delay, limit, reduce or terminate nonclinical studies, clinical trials or other research and development activities or eliminate one or more of its development

programs altogether; or delay, limit, reduce or terminate its efforts to establish manufacturing and sales and marketing capabilities or other activities that may be necessary to commercialize any future approved products, or reduce the Company’s flexibility in developing or maintaining its sales and marketing strategy.

2. Summary of significant accounting policies

The accompanying consolidated financial statements have been prepared on a basis that contemplates the continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business.

Risks and uncertainties

The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing. As a result, the Company is unable to predict the timing or amount of increased expenses or when or if the Company will be able to achieve or maintain profitability. Drug candidates currently under development will require significant additional research and development efforts, including extensive nonclinical and clinical testing and regulatory approval.

Moreover, it is particularly difficult to estimate with certainty the Company’s future expenses given the dynamic nature of its business, and the macro-economic environment generally.

Basis of presentation

The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. Any reference in these notes to applicable accounting guidance is meant to refer to the authoritative U.S. GAAP included in the Accounting Standards Codification (ASC), and Accounting Standards Update (ASU) issued by the Financial Accounting Standards Board (the FASB).

Certain amount previously reported in 2023 Consolidated Statements of Operations and Comprehensive Loss has been reclassified to conform the 2024 presentation, with respect to the separate presentation of changes in fair value of common warrants in the amount of $2.2 million, previously included in interest and other income, net. The reclassification had no impact on our net loss.

Principles of consolidation

The accompanying consolidated financial statements include Aligos-US and its wholly owned subsidiaries Aligos-Belgium, Aligos-Australia and Aligos-Shanghai. All intercompany balances and transactions have been eliminated.

Use of estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Accounting estimates and judgments are inherently uncertain, and the actual results could differ from these estimates.

Foreign currency

The Company’s foreign subsidiaries use the U.S. dollar as their functional currency, and they initially measure the foreign currency denominated assets and liabilities at the transaction date. Monetary assets and liabilities are then re-measured at exchange rates in effect at the end of each period, and non-monetary assets and liabilities are converted at historical rates. A re-measurement loss was recognized during the year ended December 31, 2024 of $3.4 thousand, and a re-measurement loss was recognized during the year ended December 31, 2023 of $45.7 thousand, and are reflected within interest and other income, net on the Consolidated Statements of Operations and Comprehensive Loss.

Segment information

The Company has one reportable segment which is focused on discovering and developing drug candidates in both liver and viral diseases. The Company’s Chairman, President and Chief Executive Officer, who is the chief operating decision maker (CODM), assesses segment performance and decides how to allocate resources based on net loss that is also reported on the Consolidated Statements of Operations and Comprehensive Loss. See Note 17, Segment disclosure, for additional information.

Cash equivalents

The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents.

Restricted cash

As of December 31, 2024 and 2023, the restricted cash balance was $0.1 million and $0.1 million, respectively, and was used primarily to secure letters of credit in relation to the Company’s operating leases and deposits on rental assets (Note 6), as well as employee withholdings for the employee stock purchase plan.

Short-term investments

The Company generally invests its excess cash in money market funds and investment grade short-to-intermediate-term fixed income securities. Such investments are included in cash, cash equivalents and investments on the Consolidated Balance Sheets.

The Company determines the appropriate classification of securities at the time of purchase and re-evaluates such designation as of each balance sheet date. Available-for-sale debt securities are measured and reported at fair value using quoted prices in active markets for similar securities. Unrealized gains and losses on available-for-sale securities are reported as a separate component of stockholders’ (deficit) equity. Premiums or discounts from par value are amortized to investment income over the life of the underlying investment. The cost of securities sold is determined on a specific identification basis, and realized gains and losses are included in interest and other income, net within the Consolidated Statements of Operations and Comprehensive Loss.

The Company assesses available-for-sale debt securities on a quarterly basis to see whether any unrealized loss is due to credit-related factors. Factors considered in determining whether an impairment is credit-related include the extent to which the investment’s fair value is less than its cost basis, declines in published credit ratings, changes in interest rates, and any other adverse factors related to the security. If it is determined that a credit-related impairment exists, the Company will measure the credit loss based on a discounted cash flow model. Credit-related impairments on available-for-sale debt securities are recognized as an allowance for credit losses with a corresponding adjustment to other income, net in the Company’s consolidated statement of operations. The unrealized loss position that is not credit-related is recorded, net of any related tax effects, in other comprehensive income until realized. There were no credit-related losses recognized for the periods presented

Accrued Interest Receivable

Accrued interest receivable related to the Company’s available-for-sale debt securities is presented within prepaid expenses and other current assets on the Company’s consolidated balance sheets. The Company has elected to exclude accrued interest receivable from both the fair value and the amortized cost basis of available-for-sale debt securities for the purposes of identifying and measuring any impairment. The Company writes off accrued interest receivable once it has determined that the asset is not realizable. Any write offs of accrued interest receivable are recorded by reversing interest income, recognizing credit loss expense, or a combination of both. To date, the Company has not written off any accrued interest receivables associated with its available-for-sale debt securities.

Concentrations of credit risk and significant suppliers

The Company has no significant off-balance sheet risk, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, restricted cash and investments. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with

commercial banking relationships. The Company generally invests its excess capital in money market funds, U.S. treasury bonds, U.S. treasury bills and certificates of deposit that are subject to minimal credit and market risks.

The Company is dependent on various third parties to manufacture compounds for the Company to conduct research and studies for its programs. These programs would be adversely delayed by a significant interruption in the supply of active pharmaceutical ingredients.

Accounting for Government Grants

In 2022, the Company was awarded a grant of $1.1 million by the National Institutes of Health (NIH) for research to target coronaviruses. The grant is for multiple years with the amount updated after each year of progress through 2025, subject to the annual reapplication and approval by the NIH. In 2023, the approved grant awarded was an additional $1.4 million. In 2024, the approved grant awarded was an additional $1.5 million.

In 2023, the Company was awarded a contract of $8.5 million by the National Institute of Allergies and Infectious Diseases (NIAID) for research to target coronaviruses. In March 2024, the Company entered into an amendment to the above contract and was awarded an additional $1.3 million, making the total contract value $9.8 million. The contract will end in early 2026.

U.S. GAAP does not contain authoritative accounting standards for grants or contracts provided by governmental entities to a for-profit entity. Absent authoritative accounting standards, interpretative guidance issued and commonly applied by financial statement preparers allows for the selection of accounting policies amongst acceptable alternatives. The Company determined it most appropriate to account for grants by analogy to International Accounting Standards 20 (“IAS 20”), Accounting for Government Grants and Disclosure of Government Assistance. Under this model, reimbursements the Company receives from the U.S. government for qualifying expenditures under the NIH grant will be recognized in earnings as a reduction to research and development expense when there is reasonable assurance that the Company will receive the grant. IAS 20 does not define “reasonable assurance”; however, the Company analogized this to “probable” as defined in FASB ASC 450-20-20 under U.S. GAAP, which is the definition the Company has applied. The grants and contracts will be recognized in earnings as a reduction of the related research and development (R&D) expenses.

During the year ended December 31, 2024, $2.8 million was recognized as a reduction to R&D expenses. During the year ended December 31, 2023, $1.6 million was recognized as a reduction to R&D expenses.

Common Warrants liability

The Company accounts for certain warrants as liabilities at fair value and adjusts the instruments to fair value at each reporting period. The Company determined that its outstanding warrants are freestanding derivative instruments. The warrants are subject to remeasurement at each balance sheet date until exercised, and any change in fair value is recognized in the Consolidated Statements of Operations and Comprehensive Loss. The fair value of the warrants issued by the Company has been estimated and is remeasured at the end of each reporting period using a Black-Scholes option pricing model.

Leases

The Company determines at the inception of the lease if an arrangement is a lease. Operating leases are included in operating lease right-of-use (ROU) assets and operating lease liabilities in the Consolidated Balance Sheets. Finance leases are included in property and equipment and finance lease liabilities in the Consolidated Balance Sheets.

ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. When the Company’s leases do not provide an implicit rate, an incremental borrowing rate is used based on the information available at the commencement dates in determining the present value of lease payments. The Company uses the implicit rate when readily determinable. The operating lease ROU assets also include any lease payments made and excludes lease incentives when paid by the Company or on the Company’s behalf. The Company’s lease terms may include the period covered by options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for operating leases is recognized on a straight-line basis over the lease term.

The Company has lease agreements with lease and non-lease components. The Company elected to not separate lease and non-lease components for all of its building leases. For vehicle leases, lease and non-lease components are accounted for separately. The Company also made an accounting policy election to recognize lease expense for leases with a term of 12 months or less on a straight-line basis over the lease term and not recognize ROU assets or lease liabilities for such leases.

Property and equipment

Property and equipment is stated at cost less accumulated depreciation, and is depreciated using the straight-line method over the estimated useful life of the asset, which are as follows:


Lab equipment		3 years
Computer equipment		3 years
Furniture and office equipment		3-8 years
Vehicles		4 years
Leasehold improvements		Shorter of the useful life or remaining lease term

Expenditures for repairs and maintenance of assets are charged to expense as incurred. Upon retirement or sale, the cost and related accumulated depreciation of assets disposed of are removed from the accounts and any resulting gain or loss is included in loss from operations.

Impairment of long-lived assets

The Company regularly reviews the carrying amount of its property, equipment, other long-lived assets and intangible assets to determine whether indicators of impairment may exist which warrant adjustments to carrying values or estimated useful lives. If indications of impairment exist, projected future undiscounted cash flows associated with the asset are compared to the carrying amount to determine whether the asset’s value is recoverable. If the carrying value of the asset exceeds such projected undiscounted cash flows, the asset will be written down to its estimated fair value. During the year ended December 31, 2023, the Company vacated certain leased office space and, as a result, the Company recorded an impairment charge against right of use assets of $0.7 million, recorded in the Consolidated Statements of Operations and Comprehensive Loss as general and administrative (G&A) expenses. No other impairment charges were recorded during the years ended December 31, 2024 or 2023.

Research and development expenses

Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries, stock-based compensation and benefits, facilities costs, depreciation, and third-party license fees. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized.

In-process research and development (IPR&D) expense represents the costs to acquire technologies to be used in research and development that have not reached technological feasibility or have no alternative future uses and thus are expensed as incurred. IPR&D expense also includes upfront license fees and milestones paid to collaborators for technologies with no alternative use.

Collaborative arrangements

The Company enters into collaboration arrangements with pharmaceutical and other partners, under which the Company may grant licenses to its collaboration partners to research and develop potential drug candidates. Consideration under these contracts may include an upfront payment, development, regulatory, sales and other milestone payments. Contractual payments received for research and development activities performed are recognized on a gross basis in revenue from collaboration arrangements.

The Company may also perform research and development activities under the collaboration agreements where the Company may be granted licenses from its collaboration partners. Contractual payments to the other party in collaboration agreements and costs incurred by the Company are recognized on a gross basis in research and development expenses. Development and regulatory milestones payments to collaboration partners are recorded as

research and development costs when such payments become probable. Royalties and sales-based milestone payments are recorded when the related sales occur.

When the Company enters into collaboration arrangements, the Company assesses whether the arrangement falls within the scope of ASC 808, Collaborative Arrangements (ASC 808) based on whether the arrangement involves joint operating activities and whether both parties would be active participants and would be exposed to significant risks and rewards of the arrangement. To the extent that the arrangement falls within the scope of ASC 808, the Company assesses whether the payments between the parties fall within the scope of other accounting literature such as ASC 606, Revenue from Contracts with Customers (ASC 606).

Revenue from contracts with customers

The Company enters into revenue arrangements with certain partners. Consideration under these contracts may include an upfront payment, development, regulatory, sales and other milestone payments. Contractual payments received for research and development activities performed are recognized on a gross basis in Revenue from Customers.

The Company may also perform research and development activities under the revenue agreements where the Company may be granted licenses from its partners. Contractual payments to the other party in revenue agreements and costs incurred by the Company are recognized on a gross basis in research and development expenses. For arrangements that include royalties and sales-based milestone payments, the license is deemed to be the predominant item to which such payments relate and the Company recognizes revenue at the later of when the related sales occur or when the performance obligation to which the royalty has been allocated has been satisfied.

When the Company enters into revenue arrangements, the Company assesses whether the arrangement first falls within the scope of ASC 808, Collaborative Arrangements (ASC 808) based on whether the arrangement involves joint operating activities and whether both parties would be active participants and would be exposed to significant risks and rewards of the arrangement. If the arrangement does not fall into this literature, the Company then looks to ASC 606, Revenue from Contracts with Customers (ASC 606) to see whether the partner is considered a customer.

Fair value measurements

Certain assets and liabilities of the Company are carried at fair value under U.S. GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

Level 1—Quoted prices in active markets for identical assets or liabilities.

Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

Level 3—Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

Stock-based compensation

The Company’s stock-based awards consist of restricted stock awards and stock options. For stock-based awards issued to employees and nonemployees, the Company measures the estimated fair value of the stock-based awards on the date of grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective awards. The Company records expense for awards with service-based vesting using the straight-line method. The Company accounts for forfeitures as they occur.

The Company classifies stock-based compensation expense in its Consolidated Statements of Operations and Comprehensive Loss in the same manner in which the award recipient’s cash compensation costs are classified.

The fair value of each restricted stock award is the closing price of the Company’s common stock on the date of grant. The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. The Black-Scholes option-pricing model requires the use of a number of assumptions including the fair value of the common stock, expected volatility, risk-free interest rate, expected dividends, and expected term of the option.

The Company determined the expected stock volatility using a weighted-average of the historical volatility of a group of guideline companies that issued options with substantially similar terms, and expects to continue to do so until such time as the Company has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the simplified method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The Company has not paid, and does not anticipate paying, cash dividends on its common stock; therefore, the expected dividend yield is assumed to be zero.

The fair value of the Company’s 2020 Employee Stock Purchase Plan (the ESPP) is determined on the date the offering period begins using a Black-Scholes option-pricing model and similar assumptions for stock options as described above.

Income taxes

Deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established.

The Company accounts for uncertain tax positions recognized in the consolidated financial statements by prescribing a more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related interest and penalties.

Comprehensive Loss

Comprehensive loss comprises net loss and other comprehensive loss. Other comprehensive (loss) income consists of foreign currency translation adjustments, unrealized gain on marketable securities and unrealized (loss) gain on pension plans.

Net loss per share

Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. The weighted-average number of shares of common stock outstanding includes the shares subject to the pre-funded warrants as per ASC 260, shares issuable for little or no cash consideration upon the satisfaction of certain conditions, shall be considered outstanding common shares.

Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, stock options, common stock subject to repurchase related to early exercise of stock options, unvested restricted stock subject to repurchase, common stock warrants and convertible notes are considered to be potentially dilutive securities.

Accordingly, in periods in which the Company reports a net loss, diluted net loss per share is the same as basic net loss per share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.

Benefit plans

The Company has established a defined contribution savings plan for its employees in Aligos-US under Section 401(k) of the Internal Revenue Code, and a defined benefits plan for its employees in Aligos-Belgium.

The Company uses the standard method for the recognition of the actuarial results as described in ASC 715. This means application of a 10% corridor and amortization over the expected average remaining working lives of

3. Property and equipment

The components of property and equipment were as follows as of December 31, 2024 and 2023:


	December 31, 2024			December 31, 2023
Leasehold improvements	$	6,101		$	6,101
Lab equipment		5,975			5,830
Computer equipment		1,051			1,051
Furniture and office equipment		732			732
Vehicles and equipment		281			296
Asset under construction		4			4
Total, at cost		14,144			14,014
Accumulated depreciation		(11,782	)		(10,755	)
Total, net	$	2,362		$	3,259

During the years ended December 31, 2024 and 2023, depreciation expense was $1.0 million and $1.6 million, respectively. Finance leases for vehicles and lab equipment are also included in property and equipment on the Consolidated Balance Sheets (Note 6).

4. Short-term investments

As of December 31, 2024, amortized cost, gross unrealized gains and losses, and estimated fair values of total fixed-maturity securities were as follows:

         
        December 31, 2024

         
        Gross

        Gross

         
        Amortized

        Unrealized

        Unrealized

        Estimated

         
        Cost

        Gain

        Loss

        Fair Value

        Available-for-sale securities:

U.S. Treasury bonds

19,933

9

-

19,942

No short-term investments are in an unrealized loss position. The Company had no available-for-sale securities as of December 31, 2023.

Changes in fair value are related to changes in market interest rates. The Company expects to collect all contractual principal and interest payments and does not intend to sell the investments before recovery of their amortized cost bases. As of December 31, 2024, all investments had a remaining maturity of less than one year.

The Company recorded interest income of $1.7 million and $4.3 million, respectively, during the years ended December 31, 2024 and 2023, as a component of interest and other income, net on the Company’s Consolidated Statement of Operations and Comprehensive Loss.

5. Accrued liabilities

Accrued liabilities consisted of the following as of December 31:


	December 31,		December 31,
	2024		2023
Accrued R&D expenses	$	5,029	$	6,633
Accrued compensation		6,387		6,673
Other		2,670		3,025
Accrued payables		1,471		511
Total	$	15,557	$	16,842

Maturities of lease liabilities as of December 31, 2024, were as follows:


	Operating Lease			Finance Lease
Year ending December 31:
2025	$	3,671		$	63
2026		3,792			42
2027		1,434			-
2028		155			-
2029		-			-
Thereafter		-			-
		9,052			105
Less: imputed interest		(835	)		53
Present value of lease liabilities		8,217			158
Less: current portion		(3,422	)		(36	)
Lease liabilities, net of current portion	$	4,795		$	122

The components of lease expense were as follows for the years ended December 31, 2024 and 2023:


	2024		2023
Operating lease cost	$	1,931	$	2,321
Finance lease cost:
Amortization of right-of-use assets	$	56	$	84
Interest on lease liabilities		7		11
Total finance lease cost	$	63	$	95

The Company made payments of $3.6 million and $3.4 million during the years ended December 31, 2024 and 2023, respectively, which are included as cash flow from operations on the Consolidated Statements of Cash Flows.

As of December 31, 2024 and 2023, $0.6 million and $0.7 million of finance lease ROU assets, respectively, were presented as part of property and equipment on the Consolidated Balance Sheets with accumulated amortization of $0.5 million and $0.4 million, respectively.

Additional information related to the Company’s leases was as follows as of December 31:


	December 31,			December 31,
	2024			2023
Operating Lease:
Weighted-average remaining lease term (years)		1.78			3.38
Weighted-average discount rate		8.90	%		7.94	%
Finance Lease:
Weighted-average remaining lease term (years)		1.67			2.67
Weighted-average discount rate		3.59	%		5.57	%

8. Common Warrants and Pre-Funded Warrants

In October 2023, the Company completed a private investment in public equity offering and entered into a securities purchase agreement (the Securities Purchase Agreement) with certain institutional and accredited investors, pursuant to which the Company agreed to offer, issue and sell to these investors 1,257,168 shares of common stock, par value $0.0001 per share (the Common Stock), pre-funded warrants to purchase an aggregate of 3,242,018 shares of Common Stock (the Pre-Funded Warrants), and warrants to purchase an aggregate of 2,249,680 shares of Common Stock (the Common Warrants, and together with the Pre-Funded Warrants, the Warrants). Each Pre-Funded Warrant has an exercise price of $0.0025 per share of common stock, was immediately exercisable and is exercisable until exercised in full. Each accompanying Common Warrant has an exercise price of $18.92 per share of common stock, is immediately exercisable and will expire on October 25, 2030. The closing of the offering occurred on October 25, 2023. The Company received gross proceeds of $92.1 million, and after deducting the placement agent fees and expenses and offering costs, net proceeds were $86.2 million.

The Company measured the fair value of the Common Stock and the Pre-Funded Warrants based on the $18.92 per share purchase price stated in the Securities Purchase Agreement. The Company measured the fair value of the Common Warrants using the Black-Scholes option pricing model.

The Company used the with-and-without method to allocate the net proceeds received from the sale of the Common Stock, the Pre-Funded Warrants, and the Common Warrants on the Consolidated Balance Sheets as follows:


	As of October 25, 2023
Common Stock	$	18,641
Pre-Funded Warrants		48,079
Common Warrants		25,427
Total net proceeds	$	92,147

The following table summarizes information about shares issuable under the Pre-Funded Warrants outstanding at December 31, 2024 and 2023:


Pre-funded warrant shares outstanding	2024			2023
Outstanding at January 1		3,242,018			-
Issued		-			3,242,018
Exercised		(800,613	)		-
Outstanding at December 31		2,441,405			3,242,018
Exercisable at December 31		2,441,405			3,242,018

The following table sets forth a summary of the activities of the Company’s warrant liability, which represents a recurring measurement that is classified with Level 3 of the fair value hierarchy:


	2024			2023
Beginning liability as of January 1	$	27,596		$	-
Common warrants issued		-			25,427
Common warrants exercised		(1,361	)		-
Change in fair value of liability		46,132			2,169
Ending liability as of December 31	$	72,367		$	27,596

The fair value of the Common Warrants was measured using the Black Scholes option pricing model and will be remeasured each reporting period, and the change in fair value will be recorded in earnings. The assumptions that the Company used to determine the fair value at issuance and the reporting date of the Common Warrants granted to participants were as follows:


	December 31, 2024			December 31, 2023
Expected term (in years)		5.83			6.83
Risk-free interest rate		4.43	%		3.88	%
Dividend yield		-			-
Volatility		84.62	%		82.80	%

The following table summarizes information about shares issuable under the Common Warrants outstanding at December 31, 2024 and 2023:


Common warrant shares outstanding	2024			2023
Outstanding at January 1		2,249,680			-
Issued		-			2,249,680
Exercised		(48,822	)		-
Outstanding at December 31		2,200,858			2,249,680
Exercisable at December 31		2,200,858			2,249,680

equivalents, or other stock or cash-based awards. The Company has granted 778,025 shares subject to awards as of December 31, 2024 with 116,859 remaining available for future grant.

Following the effectiveness of the 2020 Plan, the Company will not make any further grants under the 2018 Plan. However, the 2018 Plan will continue to govern the terms and conditions of the outstanding awards granted under this plan. Shares of common stock subject to awards granted under the 2018 Plan that are forfeited or lapse unexercised and which following the effective date of the 2020 Plan are not issued under the 2018 Plan will be available for issuance under the 2020 Plan.

2024 Employment inducement award plan

The Company adopted the 2024 Employment Inducement Award Plan (the 2024 Plan) in September 2024 as an inducement material to entering employment in accordance with Nasdaq Listing Rule 5635(c)(4). The 2024 Plan is used exclusively for the grant of equity awards to individuals who were not previously employed by the Company. The 2024 Plan provides for issuance of non-qualified stock options only. The Company has granted 104,000 shares subject to awards as of December 31, 2024 with 496,000 remaining available for future grant.

2020 Employee stock purchase plan

The Company adopted the 2020 Employee Stock Purchase Plan (the 2020 ESPP) effective on October 15, 2020. The 2020 ESPP enables eligible employees of the Company to purchase shares of common stock at a discount to fair market value. The Company has initially reserved for issuance 14,756 shares of common stock pursuant to the 2020 ESPP. As of December 31, 2024, 72,561 grants of awards under this plan have been made.

During the year ended December 31, 2024 and 2023, the Company's 2020 ESPP compensation expense was $0.5 million and $0.9 million, respectively. The assumptions that the Company used to determine the grant-date fair value of shares granted to participants were as follows, disclosed on a grant date basis:


	2024		2023

Expected term (in years)	0.5 - 2.0 years		0.5 - 2.0 years
Risk-free interest rate	2.58% - 5.38%		2.07% - 5.38%
Dividend yield		-		-
Volatility	50.36% - 73.67%		50.36% - 64.26%
Weighted-average estimated fair value of purchase rights	$4.00 - $15.14		$4.00 - $60.68

Stock options

The exercise price for incentive stock options is at least 100% of the fair market value on the date of grant for stockholders owning less than 10% of the voting power of all classes of stock, or at least 110% of the fair market value for stockholders owning more than 10% of the voting power of all classes of stock. Options generally expire in 10 years and vest over periods determined by the Board, generally 48 months. Certain stock options referred to as “early exercise stock options” permit the holders to exercise the option in whole or in part prior to the full vesting of the option in exchange for unvested shares of Restricted Stock with respect to any unvested portion of the option so exercised.

During the years ended December 31, 2024 and December 31, 2023, the Company’s stock option compensation expense was approximately $7.9 million and $11.8 million, respectively, and there was no recognized tax benefit in either year. As of December 31, 2024, unrecognized stock-based compensation expense related to stock options was $5.9 million, to be recognized over a weighted-average period of 2.63 years.

The assumptions that the Company used to determine the grant-date fair value of stock options granted to Participants were as follows, presented on a weighted-average basis:


	2024			2023

Expected term (in years)		5.94			6.00
Risk-free interest rate		3.98	%		3.83	%
Dividend yield		-			-
Volatility		87.35	%		76.65	%

Stock option activity during the year ended December 31, 2024 and 2023 was as follows:


	Shares subject to options			Weighted- average exercise price		Weighted- average remaining contractual term (years)		Aggregate Intrinsic Value (in thousands)

Outstanding as of December 31, 2023		414,898		$	159.46		6.90	$	-
Granted		359,135		$	15.92
Replacement options from Exchange		76,147		$	24.00
Exercised		—		$	—			$	—
Forfeited or Expired		(67,340	)	$	159.09
Cancelled options from Exchange		(155,155	)	$	260.63
Outstanding as of December 31, 2024		627,685		$	35.93		8.50	$	10,611
Options vested and expected to vest as of December 31, 2024		627,685		$	35.93		8.50	$	10,611
Options vested and exercisable as of December 31, 2024		172,072		$	80.39		6.37	$	944

The weighted-average grant date fair value of stock options granted was $12.88 per share during the year ended December 31, 2024. The weighted-average grant date fair value of stock options granted was $20.67 per share during the year ended December 31, 2023. The total intrinsic value of stock options exercised during the years ended December 31, 2024 and 2023 were not material.

During the years ended December 31, 2024 and 2023 the Company did not issue shares for unvested stock options. As of December 31, 2024 and 2023, there were no shares of Common Stock held by employees subject to repurchase.

Restricted stock awards

The Company may grant restricted stock purchase awards to the Participants to purchase restricted stock under the Company’s Plan, which are subject to vesting conditions. The purchase prices of the restricted stock are determined by the Board. The Company has a right to repurchase the shares if the Participant’s service period is not fulfilled or upon termination of service at the original per share issuance price. The right of repurchase lapses over a service period which is typically four years with 25% vesting on the first anniversary of the vesting commencement date and 1/48 each month thereafter.

Before the adoption of the Company’s Plan, the Company granted 20,118 restricted stock awards to employees and founders. These restricted stock awards have similar characteristics to the restricted stock awards granted under the Company’s Plan, other than the right of repurchase, which typically lapses over three years with 33% vesting on the first anniversary of the vesting commencement date and 1/36 each month thereafter.

During the years ended December 31, 2024 and 2023, the Company recorded a total stock-based compensation expense of $73.0 thousand and $31.0 thousand, respectively, related to the restricted stock awards. During the years ended December 31, 2024 and 2023, total fair value of restricted stock awards vested was $0.1 million and zero, respectively. The number of restricted stock awards vested includes shares of common stock that the Company withheld on behalf of employees or sold to cover to satisfy the minimum statutory tax withholding requirements. As of December 31, 2024, there was $0.1 million unrecognized stock-based compensation costs related to outstanding unvested restricted stock awards that are expected to vest over 3.27 years.

The following table summarizes the Company’s restricted common stock activity for years ended December 31, 2024 and 2023:


	Number of Awards			Weighted- Average Grant Date Fair Value		Aggregate Fair Value (in thousands)

Issued and unvested as of December 31, 2023		5,362			21.00		113
Granted		4,241			14.99		64
Vested and released		(4,874	)		21.17		(103	)
Issued and unvested as of December 31, 2024		4,729		$	15.44	$	74

Stock-based compensation expense was allocated as follows for the years ended December 31, 2024 and December 31, 2023:


	Year Ended
	December 31,
	2024		2023
Research and development	$	4,842	$	6,843
General and administrative		3,610		5,809
Total	$	8,452	$	12,652

10. Fair value measurements

The following tables present the fair value of the Company’s financial instruments that are measured or disclosed at fair value on a recurring basis:


	Fair Value Measurements as of December 31, 2024
	Level 1		Level 2		Level 3
Assets:
Cash equivalents	$	36,997	$	-	$	-
Available for sale securities		19,942		-		-
Liabilities:
Warrant liability		-		-		(72,367	)
	$	56,939	$	-	$	(72,367	)

	Fair Value Measurements as of December 31, 2023
	Level 1		Level 2		Level 3
Assets:
Cash equivalents	$	135,704	$	-	$	-
Liabilities:
Warrant liability		-		-		(27,596	)
	$	135,704	$	-	$	(27,596	)

optimize and develop oligonucleotides directed against a MASH target and up to one additional liver-targeted cardiometabolic and/or fibrosis target. Under the terms of the Original Agreement, the Company received an upfront payment of $12 million from Merck. With respect to the collaboration target, the Company is eligible to receive up to $458.0 million in development and commercialization milestones as well as tiered royalties on net sales of licensed products.

In January 2022, the Company and Merck entered into an amendment to the exclusive License and Research Collaboration Agreement (the First Amendment, together with the Original Agreement, the Expanded Arrangement). As a result of the First Amendment, our collaboration with Merck was expanded to include our grant of rights to Merck of an early-stage program with respect to a second undisclosed MASH target, on which the Company had previously been working independently. In addition, under this Expanded Arrangement, Merck has the ability to add an additional third target of interest in the cardiometabolic/fibrosis space to the collaboration. This right to add an additional third target expired in January 2023. Under the Expanded Arrangement, the Company received an upfront payment of $15 million from Merck for our grant of rights to the program directed at a second undisclosed MASH target. Moreover, the Company may receive an additional payment of $15 million from Merck if Merck elects to designate a third target for collaboration. With respect to the second target in the collaboration, the Company is eligible to receive up to approximately $460.0 million in development and commercialization milestones as well as tiered royalties on net sales.

In February 2023 and May 2024, Merck provided us written notice of termination for both of the targets in the collaboration. There was no effect on the income statements as a result as all deferred revenue had been fully recognized prior to the termination notice provided.

The Company determined that the Original Agreement and First Amendment fall within the scope of ASC 808, Collaborative Arrangements (ASC 808), due to Merck and the Company being joint active participants, as well as both parties having significant risks and rewards. The Company analogized to ASC 606, Revenue from Contracts with Customers (ASC 606), for the accounting of payments including upfront payments and other milestones. Management of the Company determined that there was one performance obligation for each of the agreements given the deliverables are not distinct. The Company evaluated the performance obligation within each agreement and determined the performance obligations are satisfied over time as Merck jointly owns any collaboration intellectual property that is developed during the research term. Given the nature of the arrangements, the Company believes that the satisfaction of its performance obligations is best measured by the progress of its efforts. As such, the Company has used an input method based on costs incurred to recognize revenue associated with the upfront payments. This assessment is performed separately for each of the Original Agreement and the First Amendment, and the Company recognizes revenue over time based on the costs incurred. The effect of any updates to the estimated overall costs are recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) were evaluated based on the Company’s analysis that the probability of achieving any of the milestones is remote, and therefore determined to be constrained and excluded from the transaction price.

During the twelve months ended December 31, 2024 and 2023, the Company recognized $0.3 million and $9.3 million in revenue from collaborative arrangements related to upfront payments. During the twelve months ended December 31, 2024 and 2023, the Company recognized no revenue from collaborative arrangements related to milestone payments. The unrecognized portion of the upfront payments received during the twelve months ended December 31, 2024 and 2023 is recorded on the Consolidated Balance Sheets as “Deferred revenue, current”.

Changes in deferred revenue balances arose as a result of the Company recognizing the following revenue from collaborative arrangements during the periods below (in thousands):


	As of December 31,
	2024			2023

Deferred revenue from collaborations as of January 1	$	84		$	8,743
Consideration received in the period		250			679
Revenue from collaborations recognized in the period		(334	)		(9,338	)
Deferred revenue from collaborations as of December 31	$	—		$	84

Agreement with Emory University (Emory)

In June 2018, the Company entered into a license agreement with Emory (the Emory License Agreement), pursuant to which Emory granted the Company a worldwide, sublicensable license under certain of its intellectual property rights to make, have made, develop, use, offer to sell, sell, import and export products containing certain compounds relating to Emory’s hepatitis B virus capsid assembly modulator technology, for all therapeutic and prophylactic uses. Such license is initially exclusive with respect to specified licensed patents owned by Emory and non-exclusive with respect to certain of Emory’s specified know-how. In June 2022, the license to such patents became non-exclusive with respect to all fields except for the treatment and prevention of HBV; however, the Company may select up to six compounds which will maintain exclusivity with respect to all therapeutic and prophylactic uses. With respect to all other compounds that are enabled by the licensed patents, those which are jointly invented by the Company and Emory or inventors in the Schinazi laboratory, or which are disclosed in a specified licensed patent, are licensed to the Company exclusively including as to Emory; whereas all other such compounds are licensed to the Company non-exclusively. Under the terms of the Emory License Agreement, the Company is obligated to use commercially reasonable efforts to bring licensed products to market in accordance with a mutually agreed upon development plan. Unless terminated earlier by either party in accordance with the provisions thereof, the Emory License Agreement shall continue until the expiration of the last–to-expire of the patents licensed to the Company thereunder.

In June 2020, the Company amended the license agreement with Emory. Pursuant to the amended license agreement, Emory granted the Company additional patent rights to certain compounds targeting the treatment or prevention of HBV. As consideration for the additional rights, the Company made a one-time, non-refundable payment to Emory in the amount of $0.2 million, with an additional obligation to pay up to a maximum of $35,000. On the same date, the Company entered into a collaboration agreement with Emory, with the initial research plan pertaining to the synthesis and evaluation of the compounds licensed through the additional patent rights granted in the amended license agreement. The research plan was set to terminate one year from the effective date of June 2020 but the Company exercised its option to extend it for a second year. In June 2022, the research plan terminated. In connection with the research plan, the Company will provide Emory funding up to $0.3 million per year.

The Company has agreed to pay Emory up to an aggregate of $125.0 million upon the achievement of specified development, regulatory, and commercial milestones, and all ongoing patent costs. The Company also agreed to pay Emory tiered single-digit royalties on worldwide annual net sales of licensed products, on a quarterly basis and calculated on a product-by-product basis. With respect to licensed products containing any of a specified subset of the licensed compounds, such royalties range from a mid-single digit to a high-single digit percentage rate. With respect to licensed products which do not contain such compounds, the royalties span a range of percentage rates within the mid-single digits if a Phase 1 clinical trial is initiated for the product within three years of the effective date of the Emory License Agreement, and range from a low-single digit to a mid-single digit rate if a Phase 1 clinical trial is initiated more than three years after the effective date.

During the twelve months ended December 31, 2024 and 2023, the Company had no expenses related to milestone payments. During the twelve months ended December 31, 2024 and 2023, the Company made no payments associated with royalties but did recognize general expenses of $0.1 million and $0.4 million, respectively.

Agreement with Luxna Biotech Co., Ltd. (Luxna)

On December 19, 2018, the Company entered into a license agreement with Luxna, pursuant to which Luxna granted the Company an exclusive, worldwide, sublicensable license under certain of Luxna’s intellectual property rights to research, develop make, have made and commercialize for all therapeutic and prophylactic uses, (i) products containing oligonucleotides targeting the hepatitis B virus genome, (ii) products containing certain oligonucleotides targeting up to three genes which contribute to MASH, which the Company may select at any time during the first eight years of the term, to the extent not licensed to a third party, and (iii) products containing oligonucleotides targeting up to three genes which contribute to hepatocellular carcinoma, which the Company may select at any time during the first three years of the term, which expired in December 2021. As consideration for this agreement, the Company paid an upfront license fee of $0.6 million.

In April 2020, the Company amended the license agreement with Luxna. Pursuant to the amended license agreement, Luxna granted the Company an exclusive, worldwide license under the licensed patents to research, develop, make, have made and commercialize products containing oligonucleotides targeting three families of

viruses: Orthomyxoviridae, Paramyxoviridae, and Coronaviridae (a family which includes SARS-CoV-2). As consideration for the amended license agreement, the Company paid Luxna a one-time non-refundable fee of $0.2 million in April 2020. The Company is obligated to make payments to Luxna, in aggregate, totaling up to but no more than $55.5 million upon the achievement of specified development, regulatory, and commercial milestones.

During the year ended December 31, 2024 and 2023, the Company recognized no expenses related to milestone payments. The Company is also required to pay Luxna a low-single digit royalty percentage on net sale of applicable products, if any. During the twelve months ended December 31, 2024 and 2023, the Company made no payments associated with royalties.

Agreement with Katholieke Universiteit Leuven (KU Leuven)

On June 25, 2020, the Company entered into a Research, Licensing and Commercialization Agreement (KU Leuven Agreement) with KU Leuven, under which the Company is collaborating with KU Leuven’s Rega Institute for Medical Research, as well as its CD3, to research and develop potential protease inhibitors for the treatment, diagnosis or prevention of coronaviruses, including of SARS-CoV-2. Unless terminated earlier by either party in accordance with provisions in the agreement, the collaboration period will terminate at the earlier of completion of all collaboration activities or 2.5 years. In connection with the KU Leuven Agreement, KU Leuven and the Company granted each other exclusive cross-licenses to use certain know-how and existing patents of the other party as well as certain joint know-how and joint patents to carry out research and development collaboration activities during the collaboration period. As of December 2022, the original collaboration period has expired. An amendment to the agreement was agreed in July 2023 to include a new collaboration plan. KU Leuven granted to the Company an exclusive (including as to KU Leuven), worldwide license under certain of KU Leuven’s know-how and existing patents, and certain joint patents and joint know-how, to manufacture and commercialize the licensed products for the treatment, diagnosis or detection of viral infections in humans. KU Leuven reserved the right to use all KU Leuven knowhow, existing KU Leuven patents, joint patents and joint know-how for academic and non-commercial research and teaching purposes. As consideration for this license, the Company is obligated to make payments to KU Leuven, in aggregate, totaling up to but no more than $30.0 million upon the achievement of certain commercial sales milestones. For each licensed product developed through KU Leuven and the Company’s collaborative effort, the Company is obligated to make payments to KU Leuven, in aggregate, totaling up to $32.0 million upon the achievement of certain development and regulatory milestones. The Company is also required to pay KU Leuven a low-to-mid-single digit royalty percentage, subject to certain adjustments, on net sales of applicable products, if any. The Company is also required to pay a share of upfront transaction consideration received to KU Leuven should the program be partnered with an external party. Unless terminated earlier by either party, the agreement shall continue until the expiration of the last to expire royalty term, which is the later of the expiration or termination of the last valid patent claim covering the manufacture, use, sale or importation of the licensed product in a particular country or 10 years after the first commercial sale of a licensed product.

During the year ended December 31, 2023, we recognized and paid $2.0 million related to milestone payments due to the first dosing of the first patient in a Phase 1 clinical trial. No milestone payments were made in the year ended December 31, 2024.

The Company determined that the Amoytop agreement falls within the scope of ASC 606. The agreement did not fall under the ASC 808 guidance due to Amoytop and the Company not being joint active participants, and both parties not having significant risks and rewards. Management of the Company determined that there were three performance obligations for the agreement given the deliverables are distinct. The Company evaluated the standalone selling price for each obligation based on available data for similar arrangements. The Company evaluated the performance obligations and determined the provision of R&D services for the collaboration compound performance obligation will be satisfied over time, the research license including data and know-how has been satisfied, and the provision of materials will be satisfied upon delivery. Given the nature of the arrangement, the Company believes that the satisfaction of its performance obligations is best measured by the progress of its efforts as it relates to the performance of the R&D services. As such, the Company has used an input method based on costs incurred to recognize revenue associated with the upfront payments, and the Company recognizes revenue over time based on the costs incurred. The effect of any updates to the estimated overall costs are recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) were evaluated based on the Company’s analysis that the probability of achieving any of the milestone payments is remote, and therefore determined to be constrained and excluded from the transaction price.

Agreement with ADCT

The Company determined that the ADC Therapeutics (ADCT) agreement falls within the scope of ASC 606. The agreement did not fall under the ASC 808 guidance due to ADCT and the Company not being joint active participants, nor both parties having significant risks and rewards. Management of the Company determined that there was one performance obligation for the agreements given the deliverables are not distinct. The Company evaluated the performance obligation and determined the performance obligations are satisfied over time. Given the nature of the arrangement, the Company believes that the satisfaction of its performance obligations is best measured by the progress of its efforts. As such, the Company has used an input method based on costs incurred to recognize revenue associated with the upfront payments, and the Company recognizes revenue over time based on the costs incurred. The effect of any updates to the estimated overall costs are recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) were evaluated based on the Company’s analysis that the probability of achieving any of the milestones is remote, and therefore determined to be constrained and excluded from the transaction price.

During the twelve months ended December 31, 2024 and 2023, the Company recognized $3.6 million and $6.2 million, respectively, in revenue from customers related to upfront payments. During the twelve months ended December 31, 2024 and 2023, the Company recognized no revenue from customers related to milestone payments. The unrecognized portion of the upfront payments received during the twelve months ended December 31, 2024 and 2023 is recorded on the Consolidated Balance Sheets as “Deferred revenue from customers”.

Changes in deferred revenue balances arose as a result of the Company recognizing the following revenue from customers during the periods below (in thousands):


	As of December 31,
	2024			2023

Deferred revenue from customers as of January 1	$	1,224		$	700
Consideration received in the period		2,538			6,715
Revenue from customers recognized in the period		(3,611	)		(6,191	)
Deferred revenue from customers as of December 31	$	151		$	1,224

13. Income taxes

The components of the current provision for income taxes were as follows for the years ended December 31, 2024 and 2023:


	2024		2023

Current:
State	$	-	$	-
Federal		-		-
Foreign		331		795
Total current provision for income taxes	$	331	$	795

Deferred:
State	$	-	$	-
Federal		-		-
Foreign		-		-
Total deferred provision for income taxes	$	-	$	-

The Company did not have any deferred provision for income taxes for the years ended December 31, 2024 and 2023.

A reconciliation of the expected income tax computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows for the years ended December 31, 2024 and 2023:


	2024	2023

Income tax computed at federal statutory rate	21.00%	21.00%
State taxes, net of federal benefit	4.49%	6.71%
Research tax credits	0.79%	6.35%
Change in valuation allowance	-17.04%	86.68%
Stock based compensation	-1.92%	-2.30%
Permanent differences	0.10%	-0.63%
Section 382 limitation	0.00%	-117.98%
Foreign tax	-0.27%	-0.76%
Warrant marked to market	-7.41%	0.00%
Effective income tax rate	-0.26%	-0.93%

The components of the deferred tax assets and liabilities were as follows at December 31:


	2024			2023

Deferred tax assets:
Net operating loss carryforward	$	17,625		$	3,491
Operating lease liabilities		2,418			3,280
Tax credits		2,745			941
Other accruals and reserves		1,457			1,622
Stock-based compensation		1,555			2,714
Deferred revenue		-			24
Capitalized Sec 174 costs		31,848			23,962
Other		626			577
		58,274			36,611
Valuation allowance		(56,517	)		(34,235	)
Net deferred tax assets	$	1,757		$	2,376

Deferred tax liabilities:
Right of use assets		(1,520	)		(2,078	)
Stock-based compensation		-			-
Property and equipment		(237	)		(298	)
Total deferred tax liabilities	$	(1,757	)	$	(2,376	)

Total deferred income taxes	$	-		$	-

Management believes that, based on a number of factors, including the Company’s historical operating performance and accumulated deficit, it is more likely than not that the deferred tax assets will not be utilized, such that a full valuation allowance has been recorded against the Company’s deferred tax assets. In assessing the reliability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized on a jurisdiction-by-jurisdiction basis. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. The valuation allowance increased by $22.3 million during the year ended December 31, 2024, and decreased by $75.3 million during the year ended December 31, 2023.

As of December 31, 2024, the Company had $41.8 million of federal and $90.7 million of state net operating loss (NOL) carryforwards available to offset future taxable income. The Company’s federal NOL carryforwards can be carried forward indefinitely while state NOL carryforwards, if not utilized, will begin expiring in 2043. As of December 31, 2024, the Company had research and development credit carryforwards of $1.9 million and $1.2 million available to reduce future taxable income, if any, for federal and state income tax purposes, respectively. If not utilized, the federal credit carryforwards will begin expiring in 2043. The California credit carryforwards have no expiration date. The Company had $8.4 million of Australian NOL carryforwards and $0.6 million of Australian research and development tax credit carryforwards.

Under Sections 382 and 383 of the Code, and corresponding provisions of state law, if a corporation undergoes an “ownership change” (generally defined as a greater than 50 percentage point change (by value) in its equity ownership over a rolling three-year period), the Company’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income may be limited. The Company performed a Code Section 382 analysis in 2023 and determined there was an ownership change that resulted in Section 382 limitations, the impact of which is reflected in the financial statements. The Company performed a Code Section 382 analysis in 2024, which resulted in no further ownership changes.

generated in periods after December 31, 2017, may be carried forward indefinitely but, may only be used to offset 80% of our taxable income.

ASC 740-10 prescribes a comprehensive model for the recognition, measurement, presentation and disclosure in financial statements of any uncertain tax positions that have been taken or expected to be taken on a tax return. It is the Company’s policy to include penalties and interest expense related to income taxes as a component of other expense and interest expense, respectively, as necessary. During the years ended December 31, 2024 and 2023, the Company had not recognized any tax-related penalties or interest. No liability related to uncertain tax positions is recorded on the financial statements related to uncertain tax positions.


	2024		2023

Balance, beginning of the period	$	99	$	3,100
Increase (Decrease) related to prior year positions		17		(3,100	)
Increase related to current year positions		655		99
Balance, end of the period	$	771	$	99

The Company does not expect that its uncertain tax positions will materially change in the next twelve months. The reversal of the uncertain tax benefits would not impact the Company's effective tax rate as the Company continues to maintain a full valuation allowance against its deferred tax assets.

The Company files income tax returns in the United States, including California and Texas, Australia, Belgium, and China. The Company is not currently under examination by income tax authorities in federal, state or other jurisdictions. All income tax returns will remain open for examination by the federal, state and foreign authorities for three or four years, from the date of utilization of any NOLs or credits.

In October 2021, the Organization for Economic Co-operation and Development (OECD)/G20 finalized the significant components of a two-pillar global tax reform plan, which has now been agreed to by the majority of OECD members. Pillar Two requires multinational enterprises with annual global revenue exceeding €750 million to pay a global minimum tax of 15%. The Company does not currently expect to meet the €750 million revenue threshold. The Company will continue to evaluate the potential impact on future periods of the Pillar Two framework and the implementation of the Pillar Two rules in the jurisdictions in which it operates.

Defined benefit plans—regular pension plan

ASC Topic 715, Compensation—Retirement Benefits, requires an employer to: (a) recognize in its statement of financial position an asset for a plan’s overfunded status or a liability for a plan’s under-funded status; (b) measure a plan’s assets and its obligations that determine its funded status as of the end of the employer’s fiscal year; and (c) recognize changes in the funded status of a defined benefit post retirement plan in the year in which the changes occur. Accordingly, the Company is required to report changes in its funded status on its Consolidated Statement of Changes in Stockholders’ (Deficit) Equity and Consolidated Statement of Operations and Comprehensive Loss.

Aligos-Belgium offers its employees a regular pension plan in the form of a defined contribution plan (the Regular Pension Plan), which contains a 2.50% legally required minimum rate of return for the participants. The Regular Pension Plan does not meet all the requirements that are needed for recognition of the plans as a defined contribution plan. The Company therefore recognizes the Regular Pension Plan as a defined benefit plan.

The Company measures the fair value of the Regular Plan assets by using Level 3 inputs, unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of assets, including pricing models, discounted cash flow methodologies and similar techniques.

The net periodic benefit cost of the Pension Plan was $0.1 million and $0.2 million, and is recognized in accrued liabilities on the Consolidated Balance Sheets as of December 31, 2024 and 2023, respectively. As of December 31, 2024, the projected benefit obligation was $1.3 million, the plan assets were $1.3 million and the net pension liability was $0.1 million. As of December 31, 2023, the projected benefit obligation was $1.2 million, the plan assets were $1.2 million, and the net pension liability was $0.1 million. The Company has recorded the unfunded amount as a liability in its Consolidated Balance Sheets at December 31, 2024 and 2023, under the accrued liabilities caption. The unrealized actuarial gain and loss on pension benefits, net of tax, at December 31, 2024 and 2023 was $62.0 thousand and $40.0 thousand, respectively. These amounts were reflected in other comprehensive loss under the caption gain (loss) on pension plans. The Company expects to make contributions to the Pension Plan of approximately $0.2 million during 2024. The Company estimates future benefit payments from 2025 to 2028 to be $0.3 million, and from 2029 thereafter to be $0.9 million.

Defined benefit plans—Top Hat Plan

In Aligos-Belgium, the Company established a pension bonus complementary plan (the Top Hat Plan), where the bonus payments to each participant are added to the Top Hat Plan. The annual contributions to this plan are based on performance and determined on a discretionary basis by the Company. The Top Hat Plan contains a legal yield guarantee of 1.75%. The Top Hat Plan became effective as of January 1, 2019.

In 2019, the Company accounted for the Top Hat Plan in accordance with ASC 715, Compensation—Retirement Benefits, once it became effective. The Top Hat Plan does not meet all the requirements that are needed for recognition as a defined contribution plan. The Company therefore recognizes the Top Hat Plan as a defined benefit plan.

The net periodic benefit cost of the Top Hat Plan was $0.2 million and $0.2 million, and is recognized in accrued liabilities on the Consolidated Balance Sheets as of December 31, 2024 and 2023, respectively. As of December 31, 2024, the projected benefit obligation was $2.1 million, the plan assets were $1.9 million and the net pension liability was $0.2 million. As of December 31, 2023, the projected benefit obligation was $2.0 million, the plan assets were $1.8 million, and the net pension liability was $0.2 million. The Company has recorded the unfunded amount as a liability in its Consolidated Balance Sheets at December 31, 2024 and 2023, under the accrued liabilities caption. The unrealized actuarial gain and loss on pension benefits, net of tax, at December 31, 2024 and 2023 was $14.0 thousand and $3.0 thousand, respectively. These amounts were reflected in other comprehensive loss under the caption gain (loss) on pension plans. The Company expects to make contributions to the Pension Plan of approximately $0.2 million during 2024. The Company estimates future benefit payments from 2025 to 2028 to be $0.4 million, and from 2029 thereafter to be $1.2 million.

16. Net loss per share

The following table summarizes the computation of basic and diluted net loss per share of the Company:


	Year Ended
	December 31,
	2024			2023
Net loss	$	(131,211	)	$	(87,679	)
Weighted average common stock outstanding		6,264,612			2,563,470
Net loss per share - basic and diluted	$	(20.94	)	$	(34.20	)

The Company’s potentially dilutive securities, which include options to purchase common stock, unvested restricted stock and warrants to purchase common stock, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of shares of Common Stock outstanding used to calculate both basic and diluted net loss per share is the same. The Company excluded the following potential shares of Common Stock, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:


	Year Ended
	December 31,
	2024		2023
Options to purchase common stock		441,113		415,073
Unvested restricted stock		1,379		5,361
Warrants to purchase common stock		2,200,858		2,249,680
		2,643,350		2,670,114

The following table provides segment revenues, significant segment expenses and reported segment net income for the years ended December 31, 2024 and 2023:


	Year ended December 31,
	2024			2023
Revenue from collaborations	$	334		$	9,338
Revenue from Customers		3,611			6,191
Less:
Early-stage research and development(1)		(3,506	)		(9,213	)
Late-stage research and development(2)		(66,763	)		(63,827	)
General & Administrative		(22,830	)		(30,616	)
Total operating expenses		(93,099	)		(103,656	)
Interest and other income, net		4,406			3,412
Change in fair value of common warrants		(46,132	)		(2,169	)
Loss before income tax		(130,880	)		(86,884	)
Income tax provision		(331	)		(795	)
Segment and consolidated net loss	$	(131,211	)	$	(87,679	)

(1) Early-stage research and development includes costs incurred from Discovery programs.

(2) Late-stage research and development includes costs incurred from Phase 1 clinical trial programs.

The Company’s reportable segment primarily generates revenue through its license and collaboration agreements (see Notes 11 and 12). The Company has $2.1 million and $0.2 million of fixed assets in Aligos-US and Aligos-Belgium, respectively, as of December 31, 2024, and $2.9 million and $0.3 million of fixed assets in Aligos‑US and Aligos-Belgium, respectively as of December 31, 2023.

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.

Our management has evaluated, with the participation of our Chief Executive Officer and Chief Financial Officer, our principal executive officer and principal financial officer, respectively, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this Annual Report on Form 10‑K. 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 necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures have been designed to provide reasonable assurance of achieving their objectives. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of December 31, 2024, our disclosure controls and procedures were effective at the reasonable assurance level.

Management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Management has assessed the effectiveness of our internal control over financial reporting based on the framework set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework (2013 framework). Based on our evaluation, management has concluded that our internal control over financial reporting was effective as of December 31, 2024.

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended December 31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

The effectiveness of any system of internal control over financial reporting, including ours, is subject to inherent limitations, including the exercise of judgment in designing, implementing, operating, and evaluating the controls and procedures, and the inability to eliminate misconduct completely. Accordingly, any system of internal control over financial reporting, including ours, no matter how well designed and operated, can only provide reasonable, not absolute assurances. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. We intend to continue to monitor and upgrade our internal controls as necessary or appropriate for our business but cannot assure you that such improvements will be sufficient to provide us with effective internal control over financial reporting.

During the three months ended December 31, 2024, none of our directors or officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended) adopted, terminated or modified a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

We have adopted a code of ethics for directors, officers (including our principal executive officer, principal financial officer and principal accounting officer) and employees, known as the Code of Business Conduct and Ethics. This code is publicly available on our website at investor.aligos.com under the Governance section. If we make any amendments to this code other than technical, administrative or other non-substantive amendments, or grant any waivers, including implicit waivers, from a provision of this code we will disclose the nature of the amendment or waiver, its effective date and to whom it applies on our website at aligos.com or in a Current Report on Form 8-K filed with the SEC.

We have an insider trading policy (the Trading Policy), governing the purchase, sale and other dispositions of our securities that applies to all of our personnel, including directors, officers, employees and other covered persons. We believe that our Trading Policy is reasonably designed to promote compliance with insider trading laws, rules and regulations, and listing standards applicable to us. A copy of our Trading Policy is filed as Exhibit 19.1 to this Form 10-K.

The remaining information required by this item, including information about our Directors, Executive Officers and Audit Committee, is incorporated by reference to the definitive Proxy Statement for our 2025 Annual Meeting of Stockholders, which will be filed with the SEC no later than 120 days after December 31, 2024.

The information required by this Item will be set forth in the section headed “Executive Compensation” in our Proxy Statement and is incorporated in this Annual Report by reference.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

The information required by this Item will be set forth in the section headed “Security Ownership of Certain Beneficial Owners and Management” in our Proxy Statement and is incorporated in this Annual Report by reference.

Information regarding our equity compensation plans will be set forth in the section headed “Executive Compensation” in our Proxy Statement and is incorporated in this Annual Report by reference.

Item 13. Certain Relationships and Related Transactions, and Director Independence.

The information required by this Item will be set forth in the section headed “Transactions with Related Persons” in our Proxy Statement and is incorporated in this Annual Report by reference.

The information required by this Item will be set forth in the section headed “—Ratification of Selection of Independent Registered Public Accounting Firm” in our Proxy Statement and is incorporated in this Annual Report by reference.

The following financial statements are included in Part II, Item 8 of this Annual Report on Form 10-K.

† Portions of the exhibit, marked by brackets, have been omitted because the omitted information (i) is not material and (ii) is the type of information that the registrant both customarily and actually treats as private and confidential.

* The certifications attached as Exhibits 32.1 and 32.2 that accompany this Annual Report on Form 10-K, are deemed furnished and not filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Aligos Therapeutics, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, irrespective of any general incorporation language contained in such filing.

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Lawrence M. Blatt, Ph.D. and Lesley Ann Calhoun, and each of them acting individually, as his or her true and lawful attorneys-in-fact and agents, each with full power of substitution, for him in any and all capacities, to sign any and all amendments to this annual report on Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or his substitutes or substitute, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated.


特拉華	82-4724808
（州或其他司法管轄區成立或組織）	（國稅局僱主識別號）
一個企業驅動力, 2發送地板南舊金山, 加州	94080
（主要行政辦公室地址）	(Zip代碼）


		頁面
第一部分
項目1.	業務	1
項目1A.	危險因素	28
項目10億。	未解決的員工評論	87
項目1C.	網絡安全	87
項目2.	性能	88
項目3.	法律訴訟	88
項目4.	礦山安全披露	88

第二部分
項目5.	註冊人普通股市場、相關股東事項和發行人購買股票證券	89
項目6.	[保留]	89
項目7.	管理層對財務狀況和經營成果的討論和分析	90
項目7A.	關於市場風險的定量和定性披露	101
項目8.	財務報表和補充數據	102
項目9.	會計和財務披露方面的變化和與會計師的分歧	134
項目9A.	控制和程序	134
項目90億。	其他信息	134
項目9 C.	有關阻止檢查的外國司法管轄區的披露	134

第三部分
項目10.	董事、執行官和公司治理	135
項目11.	高管薪酬	135
項目12.	某些受益所有人和管理層的證券所有權以及相關股東事宜	135
項目13.	某些關係和關聯交易以及董事獨立性	135
項目14.	主要會計費用和服務	135

第四部分
項目15.	展品、財務報表附表	136
項目16.	表格10-k摘要	136


	Year ended December 31,
	2024		2023
Direct research and development expenses by development program:
Chronic Hepatitis B program	$	8,270	$	7,345
Metabolic dysfunction-associated steatohepatitis program		19,171		7,899
Coronaviruses program		4,511		8,421
Other early-stage programs		3,507		9,213
Total direct research and development expenses		35,459		32,878
Total indirect research and development expenses		34,810		40,162
Total research and development expense	$	70,269	$	73,040


	Year Ended
	December 31,
	2024			2023
Net cash and cash equivalents used in operating activities	$	(80,743	)	$	(78,997	)
Net cash and cash equivalents (used in) provided by investing activities		(18,279	)		44,981
Net cash and cash equivalents provided by financing activities		355			88,328
Net (decrease) increase in cash, cash equivalents, and restricted cash	$	(98,667	)	$	54,312


	December 31, 2024			December 31, 2023

ASSETS
Current assets:
Cash and cash equivalents	$	36,997		$	135,704
Restricted cash		110			70
Short-term investments		19,942			-
Other current assets		5,092			5,310
Total current assets		62,141			141,084
Operating lease right-of-use assets		4,964			6,559
Property and equipment, net		2,362			3,259
Other assets		627			625
Total assets	$	70,094		$	151,527

LIABILITIES AND
STOCKHOLDERS’ (DEFICIT) EQUITY
Current liabilities:
Accounts payable	$	2,571		$	2,517
Accrued liabilities		15,557			16,842
Operating lease liabilities, current		3,422			3,229
Finance lease liabilities, current		36			10
Deferred revenue, current		151			1,308
Total current liabilities		21,737			23,906
Operating lease liabilities, net of current portion		4,795			7,668
Finance lease liabilities, net of current portion		122			231
Common warrant liability		72,367			27,596
Long term liability		46			46
Total liabilities		99,067			59,447
Commitments and contingencies (Note 14)
Stockholders’ (deficit) equity:
Preferred Stock, $0.0001 par value; 10,000,000 shares authorized as of December 31, 2024 and December 31, 2023, respectively; no shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively.		-			-
Common stock, $0.0001 par value; 20,800,000 shares and 12,800,000 shares authorized as of December 31, 2024 and December 31, 2023, respectively; 3,864,436 and 3,003,855 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively.		8			7
Additional paid-in capital		588,576			578,325
Accumulated deficit		(618,008	)		(486,797	)
Accumulated other comprehensive income		451			545
Total stockholders’ (deficit) equity		(28,973	)		92,080
Total liabilities and stockholders’ (deficit) equity	$	70,094		$	151,527


☒	根據1934年《證券交易所法》第13或15（d）條提交的年度報告


☐	根據1934年證券交易法第13或15（d）條提交的過渡期過渡報告到


大型加速文件夾	☐	加速編報公司	☐

非加速歸檔	☒	小型上市公司	☒

		新興成長型公司	☒


	Twelve Months Ended
	December 31,						Change
	2024			2023			($)			%

Revenue from collaborations	$	334		$	9,338		$	(9,004	)		-96	%
Revenue from customers		3,611			6,191			(2,580	)		-42	%
Operating expenses:
Research and development		70,269			73,040			(2,771	)		-4	%
General and administrative		22,830			30,616			(7,786	)		-25	%
Total operating expenses		93,099			103,656			(10,557	)		-10	%
Loss from operations		(89,154	)		(88,127	)		(1,027	)		1	%
Interest and other income, net:
Interest income, net		1,670			4,297			(2,627	)		-61	%
Other income (expense), net		2,736			(885	)		3,621			-409	%
Change in fair value of common warrants		(46,132	)		(2,169	)		(43,963	)		2027	%
Loss before income tax		(130,880	)		(86,884	)		(43,996	)		51	%
Income tax provision		(331	)		(795	)		464			-58	%
Net loss		(131,211	)		(87,679	)		(43,532	)		50	%


Report of Independent Registered Public Accounting Firm (PCAOB ID 42)	103
Consolidated Balance Sheets	104
Consolidated Statements of Operations and Comprehensive Loss	105
Consolidated Statements of Changes in Stockholders’ (Deficit) Equity	106
Consolidated Statements of Cash Flows	107
Notes to Consolidated Financial Statements	109


	Year Ended December 31,
	2024			2023
Revenue from collaborations	$	334		$	9,338
Revenue from customers		3,611			6,191
Operating expenses:
Research and development		70,269			73,040
General and administrative		22,830			30,616
Total operating expenses		93,099			103,656
Loss from operations		(89,154	)		(88,127	)
Interest and other income, net		4,406			3,412
Change in fair value of common warrants		(46,132	)		(2,169	)
Loss before income tax		(130,880	)		(86,884	)
Income tax provision		(331	)		(795	)
Net loss		(131,211	)		(87,679	)
Other comprehensive (loss) income:
Unrealized gain on available-for-sale securities		9			96
Unrealized (loss) gain on pension plans		(103	)		48
Other comprehensive (loss) income		(94	)		144
Comprehensive loss	$	(131,305	)	$	(87,535	)
Net loss per share, basic and diluted	$	(20.94	)	$	(34.20	)
Weighted average shares of common stock, basic and diluted		6,264,612			2,563,470


	Year Ended December 31, 2024
	Common Stock				Additional Paid-in			Accumulated			Accumulated Other Comprehensive			Total Stockholders’
	Shares		Amount		Capital			Deficit			Income			(Deficit) Equity

Balance as of December 31, 2022		1,716,923	$	4	$	502,613		$	(399,118	)	$	401		$	103,900
Issuance of common stock upon exercise of stock options		680		-		23			-			-			23
Issuance of common stock related to ESPP purchase		29,084		-		551			-			-			551
Issuance of common stock in connection with PIPE offering, net of offering costs		1,257,168		3		18,641			-			-			18,644
Issuance of pre-funded warrants in connection with PIPE offering, net of offering costs		-		-		48,079			-			-			48,079
Costs related to the PIPE offering		-		-		(4,300	)		-			-			(4,300	)
Stock-based compensation expense related to employee stock awards		-		-		11,799			-			-			11,799
Stock-based compensation expense related to employee stock purchases		-		-		853			-			-			853
Vesting of early exercised common stock options		-		-		66			-			-			66
Other comprehensive income		-		-		-			-			144			144
Net loss		-		-		-			(87,679	)		-			(87,679	)
Balance as of December 31, 2023		3,003,855	$	7	$	578,325		$	(486,797	)	$	545		$	92,080

Issuance of common stock related to ESPP purchase		32,958		-		436			-			-			436
Issuance of common stock upon exercise of pre-funded warrants		800,613		1		2			-			-			3
Issuance of common stock upon exercise of common warrants		22,024		-		1,361			-			-			1,361
Issuance of common stock from RSU vesting		4,986		-		-			-			-			-
Stock-based compensation expense related to employee stock awards		-		-		7,948			-			-			7,948
Stock-based compensation expense related to employee stock purchases		-		-		504			-			-			504
Other comprehensive loss		-		-		-			-			(94	)		(94	)
Net loss		-		-		-			(131,211	)		-			(131,211	)
Balance as of December 31, 2024		3,864,436		8		588,576			(618,008	)		451			(28,973	)


	Twelve Months Ended December 31,
	2024			2023
Reconciliation to amounts on the Consolidated Balance Sheets:
Cash and cash equivalents	$	36,997		$	135,704
Restricted cash		110			70
Total cash, cash equivalents, and restricted cash	$	37,107		$	135,774


Supplemental disclosures of noncash financing and investing activities:
Mark to market adjustment for available-for-sale investments	$	9		$	96
Acquisition of right of use asset through operating lease obligation		-			1,094
Vesting of early exercised options		-			66
Change in pension obligation	$	(103	)	$	48
Net exercise of common warrants	$	1,361		$	-


		Incorporated by Reference			Filed Herewith
Exhibit Number	Exhibit Description	Form	Date	Number	Filed Herewith
3.1(a)	Amended and Restated Certificate of Incorporation.	8-K	10/20/2020	3.1
3.1(b)	Certificate of Amendment, dated June 27, 2024, to Amended and Restated Certificate of Incorporation.	8-K	6/28/2024	3.1
3.1(c)	Certificate of Amendment, dated August 14, 2024, to Amended and Restated Certificate of Incorporation.	8-K	8/19/2024	3.1
3.2	Amended and Restated Bylaws.	8-K	10/20/2020	3.2
4.1	Reference is made to Exhibits 3.1 and 3.2.
4.2	Form of Common Stock Certificate.	10-Q	11/6/2024	4.2
4.3	Description of Securities.				X
4.4	Form of 2023 Pre-Funded Warrant	8-K	10/25/2023	4.1
4.5	Form of 2023 Common Warrant	8-K	10/25/2023	4.2
4.6	Form of 2025 Pre-Funded Warrant	8-K	2/12/2025	4.1
4.7	Form of 2025 Common Warrant	8-K	2/12/2025	4.2
10.1(a)†	Aligos Therapeutics/Emory University License Agreement by and between Aligos Therapeutics, Inc. and Emory University, dated June 26, 2018.	S-1	9/25/2020	10.1(a)
10.1(b)†	First Amendment to License Agreement by and between Aligos Therapeutics, Inc. and Emory University, dated June 18, 2020.	S-1	9/25/2020	10.1(b)
10.2(a)†	License Agreement by and between Aligos Therapeutics, Inc. and Luxna Biotech Co., Ltd., dated December 19, 2018.	S-1	9/25/2020	10.2(a)
10.2(b)†	Amendment to License Agreement by and between Aligos Therapeutics, Inc. and Luxna Biotech Co., Ltd., dated April 8, 2020.	S-1	9/25/2020	10.2(b)
10.3	Lease between Aligos Therapeutics, Inc. and Britannia Biotech Gateway Limited Partnership, dated June 21, 2018.	S-1	9/25/2020	10.3
10.4(a)#	2018 Equity Incentive Plan, as amended.	S-1	9/25/2020	10.5(a)
10.4(b)#	Form of Stock Option Grant Notice and Stock Option Agreement under 2018 Equity Incentive Plan, as amended.	S-1	9/25/2020	10.5(b)
10.4(c)#	Form of Early Exercise Stock Option Grant Notice and Stock Option Agreement under 2018 Equity Incentive Plan, as amended.	S-1	9/25/2020	10.5(c)
10.4(d)#	Form of International Stock Option Grant Notice and Stock Option Agreement under 2018 Equity Incentive Plan, as amended.	S-1	9/25/2020	10.5(d)
10.5(a)#	2020 Incentive Award Plan.	S-1/A	10/9/2020	10.6(a)
10.5(b)#	Amendment to the Aligos Therapeutics, Inc. 2020 Incentive Award Plan.	8-K	6/28/2024	10.1
10.5(c)#	Form of Stock Option Grant Notice and Stock Option Agreement under the 2020 Incentive Award Plan.	S-1/A	10/9/2020	10.6(b)
10.5(d)#	Form of Restricted Stock Award Agreement under the 2020 Incentive Award Plan.	S-1/A	10/9/2020	10.6(c)
10.5(e)#	Form of Restricted Stock Unit Award Grant Notice under the 2020 Incentive Award Plan.	S-1/A	10/9/2020	10.6(d)
10.6#	2020 Employee Stock Purchase Plan.	S-1/A	10/9/2020	10.7


10.7(a)#	2024 Employment Inducement Award Plan	10-Q	11/6/2024	10.1(a)
10.7(b)#	Form of Stock Option Grant Notice and Stock Option Agreement	10-Q	11/6/2024	10.1(b)
10.7(c)#	Form of Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Award Agreement.	10-Q	11/6/2024	10.1(c)
10.8#	Form of Indemnification Agreement for Directors and Officers.	S-1/A	10/9/2020	10.12
10.9#	Amended and Restated Employment Agreement, effective as of February 10, 2021, by and between the Company and Lawrence M. Blatt, Ph.D.	10-Q	5/10/2021	10.2
10.10#	Employment Agreement by and between Aligos Therapeutics, Inc. and Julian Symons, D.Phil., effective as of May 14, 2019.	10-Q	5/10/2021	10.3
10.11#	Form of Change in Control and Severance Agreement.	10-Q	5/10/2021	10.4
10.12#	Lease Agreement between 601 & 651 Gateway Center LP and Aligos Therapeutics, Inc., dated December 9, 2021	10-K	3/10/2022	10.16
10.13#	Non-Employee Director Compensation Policy	10-Q	11/6/2024	10.3
10.14#	Form of Securities Purchase Agreement, dated October 23, 2023, by and among the Company and the Purchasers.	8-K	10/25/2023	10.1
10.15#	Amended and Restated Employment Agreement, effective as of December 1, 2020, by and between the Company and Lesley Calhoun	10-K	3/12/2024	10.17
10.16#	Employment Agreement by and between Aligos Therapeutics, Inc. and Hardean Achneck, M.D., effective as of September 4, 2024.	10-Q	11/6/2024	10.2
10.17	Securities Purchase Agreement, dated February 11, 2025, by and among the Company and the investors party thereto.	8-K	2/12/2025	10.1
10.18	Registration Rights Agreement, dated February 13, 2025, by and among the Company and the investors party thereto.				X
10.19	Lead Investor Registration Rights Agreement, by and among the Company and the investors party thereto.				X
10.20	Letter Agreement, by and among the Company and the investors party thereto.				X
19.1	Insider Trading Policy				X
21.1	Subsidiaries of Registrant.	10-K	3/9/2023	21.1
23.1	Consent of Independent Registered Public Accounting Firm.				X
24.1	Power of Attorney (included on signature page to this Form 10-K).				X
31.1	Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.				X
31.2	Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.				X
32.1*	Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.				X


32.2*	Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.				X
97.1	Policy relating to Recovery of Erroneously Awarded Compensation	10-K	3/12/2024	97.1
101.INS	Inline XBRL Instance Document.				X
101.SCH	Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents				X
104	The cover page from the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 has been formatted in Inline XBRL.				X


	Aligos Therapeutics, Inc.

Date: March 10, 2025	By:	/s/ Lawrence M. Blatt
		Lawrence M. Blatt, Ph.D.
		President, Chairman, and Chief Executive Officer


Name	Title	Date

/s/ Lawrence M. Blatt	Chairman, President, and Chief Executive Officer (Principal Executive Officer)	March 10, 2025
Lawrence M. Blatt, Ph.D.		March 10, 2025

/s/ Lesley Ann Calhoun	Executive Vice President, Chief Operating Officer & Chief Financial Officer (Principal Financial and Accounting Officer)	March 10, 2025
Lesley Ann Calhoun		March 10, 2025

/s/ K. Peter Hirth	Director	March 10, 2025
K. Peter Hirth, Ph.D.	Director	March 10, 2025

/s/ Carole Nuechterlein	Director	March 10, 2025
Carole Nuechterlein	Director	March 10, 2025

/s/ James Scopa	Director	March 10, 2025
James Scopa	Director	March 10, 2025

/s/ Bridget Martell	Director	March 10, 2025
Bridget Martell, M.D.	Director	March 10, 2025

/s/ Margarita Chavez	Director	March 10, 2025
Margarita Chavez	Director	March 10, 2025

/s/ Heather Preston	Director	March 10, 2025
Heather Preston, M.D	Director	March 10, 2025