SOUTH SAN FRANCISCO, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) --  Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”, the “Company”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced the appointment of Heather Preston, M.D. and Margarita Chavez, J.D. as Class II Independent Directors to the Board of Directors, effective August 7, 2024. Dr. Preston will join the Nominating and Corporate Governance Comm ...

研发管线和临床进展 - 公司主要专注于开发治疗代谢性脂肪肝炎(MASH)、慢性乙型肝炎(CHB)和冠状病毒感染的创新疗法[116] - 公司已完成ALG-055009(MASH治疗候选药物)的1期临床试验,并启动了2a期HERALD研究,预计2024年第四季度公布结果[117] - ALG-000184(CHB治疗候选药物)在1b期剂量范围研究中表现出潜在的最佳-首创类活性,包括多对数HBV DNA和RNA的降低,以及HBsAg的降低[118,119] - ALG-097558(冠状病毒感染治疗候选药物)在1期临床试验中表现出良好的安全性和药代动力学特征,并展现出对多种冠状病毒株的广谱抑制活性[120,121] - 公司正在寻求外部资金支持,以推进ALG-097558的后续临床开发[121] 财务状况 - 公司2023年全年净亏损为8770万美元,2024年6月30日累计亏损达5.166亿美元[122] - 公司目前无内部制造能力和销售团队,大部分临床试验工作外包给第三方[122] - 公司的研发费用未来可能会继续增加,以推进在研药物的临床开发[126] - 公司直接外部研发费用按项目分类，包括代谢紊乱相关脂肪肝、慢性乙型肝炎、冠状病毒和早期项目[127] - 研发费用中包括直接费用和间接费用，总研发费用有所增加[127] - 来自合作伙伴的收入和来自客户的收入均有所下降[136][137] - 研发费用增加主要由于临床试验成本上升[138] - 管理费用下降主要由于法律和知识产权费用减少[139][140] - 其他收益大幅增加主要由于普通认股权证公允价值变动[144] - 公司目前现金和投资总额为94.5亿美元，预计未来12个月内可维持运营[146][150] - 未来公司计划继续推进临床试验和研发新药品，预计费用将进一步增加[147][148][149] - 公司研发项目存在诸多风险和不确定性，无法估算研发费用和时间[151] - 公司未来资金需求取决于多方面因素，包括研发进度、获批时间、商业化成本、制造成本等[151] - 公司需要大量额外资金才能实现业务目标，但可能无法以可接受的条件获得[153] - 如果无法筹集到足够资金，可能需要延迟、限制或终止产品开发计划[154] - 公司在2024年上半年经营活动使用了4,223.9万美元现金，主要由于净亏损和营运资金变动[156] - 公司在2024年上半年投资活动使用了4,864.9万美元现金，主要用于购买短期投资[157] - 公司在2024年上半年筹资活动提供了26.2万美元现金，主要来自ESPP计划[158] - 公司没有重大的合同义务和承诺变化[159] - 公司没有重大的资产负债表外安排[160] - 公司提供了一般性知识产权赔付承诺[161]

临床试验进展 - 公司完成了ALG-055009 Phase 2a HERALD研究的提前入组,预计在2024年第四季度初公布临床试验数据[4] - 公司在EASL 2024大会上发布了ALG-000184的中期数据,显示在HBeAg阳性和阴性慢性乙型肝炎患者中均展现了持续的强效抗病毒活性,无病毒突破[5] - 公司获得FDA的积极反馈,支持后续以持续HBV DNA抑制作为主要可评价终点的慢性抑制疗法研究,有利于ALG-000184的潜在注册[5] - 公司的ALG-097558在健康受试者中表现出良好的耐受性和药代动力学特征,支持无需利托那韦增强剂的每日两次给药方案,正在进行II期临床前准备[6] 财务状况 - 公司于2024年6月30日的现金、现金等价物和投资总额为9.45亿美元,预计可为公司的计划运营提供足够的资金支持至2025年底[7] - 2024年第二季度公司实现净利润510.1万美元,主要由于公司认股权证公允价值减少导致的非现金收益3050万美元[8] - 2024年第二季度研发费用为2110.1万美元,较2023年同期增加,主要由于临床试验第三方费用增加[9] - 2024年第二季度管理费用为637.6万美元,较2023年同期下降,主要由于法律等第三方费用减少[10]

Amoytop to sponsor a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® (Mipeginterferon alfa-2b) in CHB patients SOUTH SAN FRANCISCO, Calif., July 22, 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 announced that it has entered into a clinical trial collaboration agr ...

Amoytop to sponsor a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® (Mipeginterferon alfa-2b) in CHB patients SOUTH SAN FRANCISCO, Calif., July 22, 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 announced that it has entered into a clinical trial collaboration agre ...

SOUTH SAN FRANCISCO, Calif., June 05, 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 announced positive data from six poster presentations at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy. The clinical poster presentations highlight the continued potent antiviral act ...

SOUTH SAN FRANCISCO, Calif., June 05, 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 announced positive data from six poster presentations at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy. The clinical poster presentations highlight the continued potent antiviral acti ...

Shares of Aligos Therapeutics, Inc. (ALGS) have been struggling lately and have lost 8.1% over the past two weeks. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road.While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts abou ...

SOUTH SAN FRANCISCO, Calif., May 22, 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 announced six abstracts have been accepted for poster presentations, including two Top abstracts, at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy. The abstracts released today can be ...

SOUTH SAN FRANCISCO, Calif., May 22, 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 announced six abstracts have been accepted for poster presentations, including two Top abstracts, at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy. The abstracts released today can be ...