ALG-055009

SOUTH SAN FRANCISCO, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today reported recent business progress and financial results for the first quarter 2024. “We have executed on a number of key deliverables to position Aligos for success,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President & CEO of Aligos Therapeutics. “Importantly, we began dosing in the Phase 2a HERALD study of our THR- drug candidate, ALG-055009, and we expect topline data in Q4 2024. In addition, we recently presented data from our three clinical programs at scientific conferences, showcasing our robust pipeline of potentially best-in-class small molecule drug candidates. In particular, we demonstrated positive safety, tolerability, and antiviral activity data after dosing for up to 64 weeks with our hepatitis B virus capsid assembly modulator, ALG-000184, and positive safety and PK data for our ritonavir-free, pan-coronavirus protease inhibitor, ALG-097558. We remain excited by the potential of these programs and look forward to continuing to deliver for our shareholders.” Recent Business Progress Aligos Portfolio of Drug Candidates ALG-055009: Potential best-in-class small molecule THR-β agonist for MASH Data presented at the Asian Pacific Association for the Study of the Liver (APASL) conference highlighted ALG-055009 Phase 1 data that showed multiple-ascending doses (MAD) over 14 days in hyperlipidemic subjects produced favorable, dose-dependent pharmacodynamic effects on atherogenic lipids and sex hormone binding globulin (SHBG), an indicator of target engagement in the liverThe Phase 2a HERALD study was initiated in Q1 2024 with the first subject dosed in April 2024Topline HERALD data are anticipated in Q4 2024 ALG-000184: Potential first-/best-in-class small molecule CAM-E for CHB Interim data from Parts 3 and 4 of Study ALG-000184-201 were presented at the APASL conference and showed consistent, potent antiviral activity across multiple cohorts of untreated chronic hepatitis B (CHB) patients receiving once daily doses of ALG-000184 as monotherapy or in combination with entecavir (ETV) x ≤ 64 weeksDosing continues in this ongoing Phase 1a/1b study, with subjects planning to dose for up to 96 weeks. Additional interim data readouts are planned to be presented this year at the following conferences: European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases (AASLD)Phase 2 enabling activities, including regulatory interactions and drug supply manufacturing, are underway ALG-097558: Potential best-in-class small molecule pan-coronavirus protease inhibitor Topline data presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Annual Meeting demonstrated single (up to 2000 mg) and multiple (up to 800 mg Q12 for 7 days) doses of ALG-097558 were well tolerated in healthy volunteers with a pharmacokinetic (PK) profile supporting twice daily, ritonavir-free dosing without a food effectReceived an additional $1.3M grant from the National Institutes of Health (NIH)Phase 2 enabling activities, including nonclinical and clinical studies, are underway with financial support from the NIH Financial Results for the First Quarter 2024 Cash, cash equivalents and investments totaled $112.7 million as of March 31, 2024, compared with $135.7 million as of December 31, 2023. Additionally, in October 2023, we raised $92.1 million in gross proceeds in private placement financing, before deducting placement agent’s fees and other expenses. Including the proceeds from the private placement financing, we continue to believe our cash balance provides sufficient cash to fund planned operations through the end of 2025. Net losses for the three months ended March 31, 2024 were $34.9 million or basic and diluted net loss per common share of $(0.22), compared to net losses of $23.0 million or basic and diluted net loss per common share of $(0.53) for the three months ended March 31, 2023. Research and development (R&D) expenses for the three months ended March 31, 2024 were $16.4 million, compared with $18.1 million for the same period of 2023. The decrease was primarily due to a decrease in employee related costs, partially offset by an increase in third party expenses. Total R&D stock-based compensation expense incurred for the three months ended March 31, 2024 was $1.4 million, compared with $2.2 million for the same period of 2023. General and administrative (G&A) expenses for the three months ended March 31, 2024 were $6.7 million, compared with $8.5 million for the same period of 2023. The decrease in G&A expenses for this comparative period is primarily due to a decrease in third party expenses including legal expenses. Total G&A stock-based compensation expense incurred for the three months ended March 31, 2024 was $1.2 million, compared with $1.5 million for the same period of 2023. Interest and other income (expense), net, for the three months ended March 31, 2024 was an expense of $12.8 million compared with income of $1.0 million for the same period of 2023. The change in interest and other income (expense), net, is primarily due to an increase in the fair value of the Common Warrants liability, which resulted in a non-cash charge, associated with the Securities Purchase Agreement entered into in October 2023 following the private investment in public equity (PIPE) offering. About Aligos Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements with respect to Aligos being positioned for success; the potential of the company’s three clinical programs and the company looking forward to continuing to deliver for its shareholders; the expectation of topline Phase 2a HERALD data for ALG-055009 in Q4 2024; the continuation of dosing in the ongoing Phase 1a/1b study for ALG-000184 with subjects planning to dose for up to 96 weeks and the planned presentation of additional interim data readouts at this year’s EASL and AASLD; and the company’s continued belief its cash balance provides sufficient cash to fund planned operations through the end of 2025. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the impact of global events and other macroeconomic conditions on the Aligos’ business. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2024 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. Aligos Therapeutics, Inc Condensed Consolidated Statements of Operations(In thousands, except share and per share amounts) Three Months Ended March 31, 2024 2023 (Unaudited) (Unaudited) Revenue from Collaborations$292 $2,583 Revenue from Customers 694 140 Operating Expenses: Research and development 16,366 18,135 General and administrative 6,666 8,506 Total operating expenses 23,032 26,641 Loss from operations (22,046) (23,918) Interest and other income (expense), net (12,793) 1,002 Loss before income tax expense (34,839) (22,916) Income tax expense (24) (39)Net loss (34,863) (22,955)Basic and diluted net loss per common share$(0.22)$(0.53)Weighted-average number of shares used in computing basic and diluted net loss per common share 156,154,156 42,910,065 Aligos Therapeutics, Inc. Condensed Consolidated Balance Sheets(In thousands) March 31, 2024 December 31, 2023 (Unaudited) (audited) (1)Assets Current assets: Cash and cash equivalents$24,151 $135,704Short-term investments 88,588 -Prepaid expenses and other current assets 5,325 5,380Total current assets 118,064 141,084Other assets 9,838 10,443Total assets$127,902 $151,527 Liabilities and Stockholders’ Equity Current liabilities$18,880 $23,906Other liabilities, noncurrent 49,226 35,541Total liabilities 68,106 59,447Total stockholders’ equity 59,796 92,080Total liabilities and stockholders’ equity$127,902 $151,527 _____________________________________________ (1) The balance sheet as of December 31, 2023 has been derived from the audited consolidated financial statements at that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. Investor ContactJordyn TaraziVice President, Investor Relations & Corporate Communications+1 (650) 910-0427jtarazi@aligos.com Media ContactMichael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com

▎药明康德内容团队编辑上个月，代谢功能障碍相关脂肪性肝炎（MASH）/非酒精性脂肪性肝炎（NASH）领域获得里程碑进展，美国FDA加速批准首款MASH疗法Rezdiffra（resmetirom）上市。然而这仅是MASH被攻克的开始，目前临床上还有多款处于临床中后期、有望在不久的将来获监管单位批准上市的MASH疗法。今日，药明康德内容团队将结合行业媒体BioSpace报道与公开资料，向读者介绍这些极具前景的MASH在研疗法。图片来源：123RF在研疗法：Pegozafermin开发公司：89bio临床阶段：3期临床试验规划中89bio公司在去年6月公布其评估pegozafermin治疗MASH患者的ENLIVEN临床2b期试验数据。在24周时，每两周给药44 mg治疗组和每周给药30 mg治疗组在两个主要组织学终点上均表现出具统计学意义的显著变化——在MASH状况不恶化的情况下至少有一个阶段的纤维化改善的受试者比例分别为27%和26%，与安慰剂组相比提高了3.5倍（7%）；MASH消退且纤维化状况没有恶化的受试者比例分别为26%和23%，大约是安慰剂组的12-14倍（2%）。▲Pegozafermin治疗MASH患者24周时的疗效结果（图片来源：参考资料[2]）Pegozafermin治疗也导致与基线时相比患者在肝脂肪和其他用以评估肝脏炎症和纤维化的关键非侵入性检测（NITs）结果出现了具临床意义的变化。糖化血红蛋白（HbA1c）、脂联素以及各种脂质标志物有所改善，这些标志物是MASH有效治疗的重要因素。ENLIVEN试验数据已发表于知名期刊《新英格兰医学杂志》（NEJM）上。89bio在去年11月公布，患者接受48周pegozafermin治疗的结果与24周一致，表明随着时间的推移患者可持续获益。▲第48周时肝脂肪与肝脏NIT标志物结果（图片来源：参考资料[3]）Pegozafermin是一款开发用以治疗MASH与严重性高甘油三酯血症（SHTG）的成纤维细胞生长因子21（FGF21）类似物。FGF21是一种内源性代谢激素，可调节能量消耗以及葡萄糖和脂质代谢。Pegozafermin利用该公司专有的糖基聚乙二醇化技术，可延长天然FGF21的半衰期和优化生物活性。在研疗法：ION224开发公司：Ionis Pharmaceuticals临床阶段：2期临床试验完成上个月所公布的2期试验结果显示，ION224在两种剂量（120 mg和90 mg）下均达到了主要终点，即通过非酒精性脂肪性肝病活动评分（NAS）至少降低2分来评估，接受120 mg（p<0.001）与90 mg（p=0.015）ION224患者显示具有统计学意义的肝脏组织学改善。此外，根据活检测量，ION224实现了统计学上显著的MASH缓解，且未出现纤维化恶化（p=0.039），试验达成关键次要终点。此外，根据磁共振成像-质子密度脂肪分数（MRI-PDFF）测量结果，接受120 mg治疗的患者中有44%的肝脏脂肪变性相对减少≥50%，而安慰剂组的这一比例为3%。而根据活检结果，有32%接受120 mg治疗的患者其纤维化得到≥1级的改善，且脂肪性肝炎没有恶化，而安慰剂组的这一比例为12.5%。ION224在试验中展现良好的安全性与耐受性。ION224是一种在研反义寡核苷酸（ASO）配体偶联（LICA）药物，旨在减少二酰基甘油O-酰基转移酶2（DGAT2）的产生。DGAT2是催化甘油三酯合成的两种同工酶之一。它与DGAT1一起几乎承担了所有甘油三酯的合成。由于MASH中甘油三酯的合成主要由DGAT2的催化活性驱动，因此抑制它的活性可能抑制甘油三酯的合成，延缓代谢相关脂肪肝病的疾病进展。根据新闻稿，该试验首次在临床上证明，DGAT2抑制所产生的肝脂肪减少与MASH组织学终点的改善相关。在研疗法：Pemvidutide开发公司：Altimmune临床阶段：2b期临床试验进行中在2022年12月所公布的随机1b期试验结果显示，接受pemvidutide治疗24周的代谢功能障碍相关脂肪性肝病（MASLD）患者，其肝脂肪显著减少。在1.8 mg剂量组中，约55%患者的肝脂肪量在12周内降至正常范围。此外，患者在肝脏炎症独立指标丙氨酸氨基转移酶（ALT）和校正T1（cT1）上皆显著降低，体重也有显著减轻。目前，pemvidutide用以治疗MASH的2b期临床试验IMPACT正在进行中，预计招募190位没有糖尿病的MASH患者，试验结果预计在2025年第一季度公布。▲Pemvidutide示意图（图片来源：参考资料[3]）Pemvidutide是一款基于多肽的GLP-1/胰高血糖素双重受体激动剂。胰高血糖素能够增加能量消耗，并且促进身体中储存能量的白色脂肪转化为消耗能量的褐色脂肪。它与GLP-1产生协同作用，有望促进比GLP-1受体激动剂单药更有效的体重减轻。胰高血糖素也被认为对肝脏脂肪代谢有直接影响，能够使肝脏脂肪水平迅速降低。在研疗法：VK2809开发公司：Viking Therapeutics临床阶段：2b期临床试验进行中Viking在去年5月公布VOYAGE临床2b试验的积极顶线结果，该试验共招募337位MASH患者。MRI-PDFF分析显示，试验12周时，接受每日2.5 mg VK2809治疗的MASH患者，其肝脏脂肪含量下降45.3%，而安慰剂对照组患者的肝脏脂肪仅下降3.7%，两组差异具统计学意义。接受每隔一天5 mg和10 mg VK2809的患者同样表现出比安慰剂更显著的优势，在12周时分别使肝脏脂肪量降低了36.8%和51.7%。Viking预计将于今年上半年获得该试验52周的活检数据。▲靶向不同亚型甲状腺受体的作用（图片来源：参考资料[6]）VK2809是一种口服甲状腺β受体（TRβ）的组织和受体亚型特异性激动剂，对肝组织和β受体亚型具有选择性，它在一系列脂质疾病中具有良好的治疗潜力。VK2809属于新型前药家族，它在体内被切割以释放强力的拟甲状腺素。在肝组织中对TRβ受体的选择性活化被认为能通过多种机制有力地影响胆固醇和脂蛋白水平，这些机制包括增加与脂质代谢和清除相关的基因表达。在研疗法：Denifanstat开发公司：Sagimet Biosciences临床阶段：2b期临床试验进行中今年1月，Sagimet公布FASCINATE-2临床2b期试验的积极顶线结果。FASCINATE-2是一项随机双盲、安慰剂为对照的试验，共有168位MASH患者入组。分析显示，在52周时，试验达到主要疗效终点与多项关键次要终点。主要终点方面，有36%的denifanstat组患者达成MASH症状消除且不伴纤维化恶化，NAS降低≥2分，与之相比，安慰剂组在此数值仅为13%（p=0.002）。此外，有52%的denifanstat组患者的NAS降低≥2分且无纤维化恶化，安慰剂组患者在此数值为20%（p=0.0001）。此外，接受denifanstatin治疗患者有41%纤维化改善≥1级且MASH未恶化，而安慰剂组的这一比例为18%（p=0.005）。▲Denifanstatin达试验主要终点（图片来源：参考资料[7]）▲Denifanstatin的MASH治疗机制（图片来源：参考资料[7]）Denifanstat（TVB-2640）为一款口服、选择性的FASN抑制剂，该疗法被设计为每日一次口服使用。在研疗法：ALG-055009开发公司：Aligos Therapeutics临床阶段：2a期临床试验进行中Aligos在去年4月公布ALG-055009的1期临床数据。结果显示，ALG-055009在健康受试者和高脂血症受试者中表现出良好的安全性和药代动力学特征。此外，研究人员在该研究中还观察到了预期的拟甲状腺素效应，包括致动脉粥样化脂质（atherogenic lipids）的剂量依赖性减少。目前Aligos已完成2a期HERALD试验的首位患者给药，该试验预计招募100位MASH患者，旨在评估ALG-055009的安全性、药代动力学特性和多种疗效生物标志物，包含MRI-PDFF。该研究的安全性和有效性顶线数据预计将于2024年第四季度公布。▲ALG-055009展现预期的拟甲状腺素效应（图片来源：参考资料[8]）ALG-055009是一款潜在“best-in-class”的甲状腺β受体小分子激动剂，设计为口服软胶囊形式使用。参考资料：[1] 5 Promising MASH Therapies That Could Follow Madrigal’s Rezdiffra. Retrieved April 15, 2024 from https://www.biospace.com/article/5-promising-mash-therapies-that-could-follow-madrigal-s-rezdiffra-/[2] Loomba R, Sanyal AJ, Kowdley KV, Bhatt DL, Alkhouri N, Frias JP, Bedossa P, Harrison SA, Lazas D, Barish R, Gottwald MD, Feng S, Agollah GD, Hartsfield CL, Mansbach H, Margalit M, Abdelmalek MF. Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH. N Engl J Med. 2023 Sep 14;389(11):998-1008. doi: 10.1056/NEJMoa2304286. Epub 2023 Jun 24. PMID: 37356033; PMCID: PMC10718287.[3] 89bio Announces New Positive Long-Term Data from the ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Nonalcoholic Steatohepatitis (NASH). Retrieved November 28, 2023, from https://www.globenewswire.com/news-release/2023/11/27/2786131/0/en/89bio-Announces-New-Positive-Long-Term-Data-from-the-ENLIVEN-Phase-2b-Trial-of-Pegozafermin-in-Patients-with-Nonalcoholic-Steatohepatitis-NASH.html[4] Ionis announces positive results from Phase 2 study of ION224, an investigational medicine demonstrating clinical efficacy in the treatment of NASH/MASH. Retrieved April 15, 2024 from https://www.prnewswire.com/news-releases/ionis-announces-positive-results-from-phase-2-study-of-ion224-an-investigational-medicine-demonstrating-clinical-efficacy-in-the-treatment-of-nashmash-302087276.html[5] Pemvidutide. Retrieved April 15, 2024 from https://altimmune.com/pemvidutide/[6] VK2809. Selective Thyroid Receptor-β Agonist. Retrieved April 15, 2024 from https://vikingtherapeutics.com/pipeline/metabolic-disease-program/vk2809/[7] Sagimet Biosciences Corporate Presentation January 2024. Retrieved January 22, 2024 from https://ir.sagimet.com/static-files/df000576-3450-4a62-9b8a-2ce2bea46f94[8] Corporate Presentation. Retrieved April 15, 2024 from https://aligos.com/wp-content/uploads/2024/04/Aligos-Corporate-Presentation-April-2024-v2.pdf本文来由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转发授权请在「药明康德」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。