HBcrAg

Company to conduct a Phase 1 Drug-Drug Interaction StudyPhase 2 filing on track for Q1 2025 SOUTH SAN FRANCISCO, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) for a Phase 1 Drug-Drug Interaction (DDI) study of ALG-000184, a capsid assembly modulator (CAM-E) for the treatment of Chronic Hepatitis B (CHB). “The acceptance of our third U.S. IND is an important milestone for Aligos,” said Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “This IND clearance allows us to begin the next stages of our clinical development for ALG-000184, including the advancement of the compound into Phase 2 clinical trials. ALG-000184 is the first novel, oral drug candidate for the treatment of HBV infection that can inhibit multiple components of the viral lifecycle, leading to more complete suppression of the virus compared to other therapeutic modalities.” The DDI study is designed to evaluate the effect of a cytochrome P450 inhibitor and inducer on ALG-000184 pharmacokinetics. In addition, Phase 2 enabling activities are ongoing, with a planned filing in Q1 2025 for the Phase 2 study. This clinical trial will be a randomized, double-blind, active controlled study of ALG-000184 vs. standard of care in HBeAg-positive and HBeAg-negative CHB subjects. “ALG-000184 has demonstrated impressive data to date with broad antiviral activity,” stated Hardean Achneck, MD, Chief Medical Officer at Aligos Therapeutics. “ALG-000184 has the potential to improve outcomes compared to the current standard of care. We look forward to finalizing the Phase 2 study design in conjunction with KOLs and the FDA and anticipate enrolling patients next year.” Data from ≤72 weeks following an oral daily dose of 300 mg ALG-000184 has demonstrated the ability to disrupt the entire HBV lifecycle through best-in-class reductions of the relevant viral markers: HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. Dosing through 96 weeks is ongoing, with interim data readouts expected at upcoming scientific conferences. ALG-000184 has a clear regulatory path endorsed by the FDA and CDE (China) for chronic suppressive therapy with a potential superiority label compared to standard of care. About ALG-000184 ALG-000184 was derived from initial IP licensed from the laboratory of Dr. Raymond Schinazi at Emory University, which was further optimized by Aligos. ALG-000184 is a potent potential best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for chronic hepatitis B (CHB). Phase 1a studies have demonstrated after single and multiple daily doses that ALG-000184 was well-tolerated, with no safety signals observed, and demonstrated linear PK and excellent antiviral activity. In longer term Phase 1b studies of ALG-000184 300mg QD x ≤96 weeks ± Entecavir (ETV) and ALG-000184 monotherapy have demonstrated best-in-class sustained reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. Dosing is ongoing through 2025 with interim data readouts expected at upcoming scientific conferences. Phase 2 enabling activities are ongoing, with a planned Phase 2 IND filing in Q1 2025. ALG-000184 has a clear regulatory path endorsed by the FDA and CDE (China) for chronic suppressive therapy with a potential superiority label compared to standard of care. About Chronic Hepatitis B There were more than 290 million chronic carriers of Chronic Hepatitis B (CHB) worldwide as of July 2020 and approximately 30 million individuals become newly infected every year despite the availability of a prophylactic vaccine. In 2015, there were more than 90 million cases of CHB in China alone, while the European Union, United States and Japan accounted for nearly 8 million cases. Complications from CHB include cirrhosis, end-stage liver disease, and hepatocellular carcinoma, which collectively resulted in approximately 900,000 deaths in 2015, according to the World Health Organization. CHB is the primary cause of liver cancer worldwide, and the mortality associated with HBV-related liver cancer continues to increase. About Aligos Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biopharmaceutical company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses. For more information, please visit www.aligos.com or follow us on LinkedIn or X. Forward-Looking Statements 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 regarding Aligos’ financial results and performance as well as research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials. 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, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. 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 August 6, 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. Investor ContactAligos Therapeutics, Inc.Jordyn TaraziVice President, Investor Relations & Corporate Communications+1 (650) 910-0427jtarazi@aligos.com Media ContactInizio EvokeJake RobisonVice PresidentJake.Robison@inizioevoke.com

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 agreement with Xiamen Amoytop Biotech Co., Ltd. (“Amoytop”). Under the terms of the agreement, Amoytop will sponsor and perform a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® (Mipeginterferon alfa-2b) in chronic hepatitis B (CHB) patients in China. The clinical study is expected to begin after approval by the National Medical Products Administration in China. “We are pleased to build on our existing relationship with Amoytop, as they have proven to be a valuable partner,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “We look forward to initiating this exploratory study to evaluate the combination of ALG-000184 with PEGBING®, one of the approved drugs for CHB patients in China, to assess the potential benefits of a combinatory approach.” ALG-000184 is a potent best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for CHB. It is designed to exploit the dual role of CAMs by disrupting hepatitis B cccDNA levels and its derived transcripts by reducing expression of viral markers such as DNA, RNA, and the relevant antigens (HBsAg, HBeAg, HBcrAg). Phase 1a studies have demonstrated after single and multiple daily doses that ALG-000184 was well-tolerated, with no safety signals observed, and demonstrated linear pharmacokinetics (PK) and excellent antiviral activity. In longer term Phase 1b studies of ALG-000184 300mg x ≤96 weeks ± entecavir (ETV), ALG-000184 monotherapy has demonstrated best-in-class reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg without viral breakthrough to date. PEGBING®, independently developed by Amoytop, is the world's first 40kD pegylated interferon α-2b injection. With dual effects of inhibiting viral replication and enhancing immunity, PEGBING® is mainly used in the clinical treatment of viral hepatitis and is the first-line drug for the antiviral treatment of chronic hepatitis B, which plays an important role in improving the clinical cure rate of hepatitis B and reducing the risk of liver cancer. “We are pleased to deepen our cooperation in the field of liver disease treatment and look forward to working together to provide a new treatment solution for patients in need,” said Sun Li, Chairman and Chief Executive Officer at Amoytop. “Amoytop is committed to further optimizing the chronic hepatitis B combination treatment pathway and hopes that the cooperation will lead to better clinical value drugs and drug combinations.” The Phase 1b study will be a randomized, double blinded, active controlled study to evaluate the safety, pharmacokinetics, and antiviral activity of oral once daily doses of 300 mg ALG-000184 + PEGBING® + entecavir (ETV) compared with 300 mg ALG-000184 + ETV or PEGBING® + ETV in treatment naïve or currently-not-treated HBeAg-positive and nucleos(t)ide analog (NA) suppressed HBeAg-negative subjects with CHB for 48 weeks. 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. For more information, please visit www.aligos.com or follow us on LinkedIn or X. About Xiamen Amoytop Biotech Co., Ltd. Xiamen Amoytop Biotech Co., Ltd. is an innovative biopharmaceutical company and a listed company on the Science and Technology Innovation Board (SSE STAR Market) in China, specializing in R&D, manufacturing and marketing of regular and long-acting recombinant protein drugs. Focusing on the R&D of immune-related cytokine medicines, Amoytop is committed to becoming a leader in solving cytokine medicine-based systemic immune problems, providing better solutions for major diseases (such as viral hepatitis, malignant tumors) and immunotherapy. Forward-Looking Statements 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 regarding Aligos’ financial results and performance as well as research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials. 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, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. 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 Investor Contact Jordyn TaraziVice President, Investor Relations & Corporate Communications+1 (650) 910-0427jtarazi@aligos.com Media Contact Michael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com Xiamen Amoytop Biotech Co., Ltd. Investor Contact Liu Peiyu联系电话：86592-6889118邮箱：ir@amoytop.com Media Contact Wu Xueyan联系电话：86592-6889127邮箱：wxy@amoytop.com

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 activity of ALG-000184 for chronic hepatitis B (CHB) in both HBeAg-positive and HBeAg-negative subjects. Data from ≤72 weeks following an oral daily dose of 300 mg ALG-000184 monotherapy demonstrated sustained HBV DNA suppression (<LLOQ <10 IU/mL) in 9/10 (90%) HBeAg-positive CHB subjects with no viral breakthrough. New data also showed that as HBeAg declined to near negativity in this patient population, anti-HBe antibody (HBeAb) levels exhibited a positive trend. Reported for the first time were antiviral and safety data in HBeAg-negative CHB subjects who received a daily single dose of 300 mg ALG-000184 monotherapy for ≤60 weeks. In all 11 subjects (100%), complete suppression of HBV DNA (<LLOQ 10 IU/mL) and RNA (<LLOQ 10 copies/mL) were noted, with reduction in HBcrAg levels indicating inhibition of HBV replication, as well as inhibition of cccDNA establishment/replenishment. In both patient populations, ALG-000184 continues to be well tolerated with no viral breakthrough. “We designed ALG-000184 as a highly potent agent that could deliver broad antiviral efficacy in hepatitis B patients, regardless of their HBeAg status,” stated Lawrence Blatt, PhD, MBA, Chairman, President & CEO of Aligos Therapeutics. “These new data in HBeAg-negative CHB patients complement the broad antiviral activity we have already reported in HBeAg-positive CHB patients, with data now up to 72 weeks showing 90% of subjects achieved HBV DNA suppression. The extent of HBV DNA suppression observed to date in both CHB patient populations appear to exceed those reported by the current standard of care nucleos(t)ides, leading us to believe this is a best/first-in-class molecule.” Additionally, other preclinical poster presentations demonstrate the potential of next generation siRNAs for treating metabolic dysfunction-associated steatohepatitis (MASH) and CHB as well as a novel CAM-A molecule for the treatment of CHB. Details of the presentations are as follows: ALG-000184: Potential best-in-class small molecule CAM-E for chronic hepatitis B (CHB) Title: Extended Treatment of HBeAg+ CHB Subjects with the Capsid Assembly Modulator ALG-000184 with or without Entecavir is Associated with Reductions in Viral Markers and Favorable Anti-HBeAb trends Presenter: Professor Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair and Chief of the Division of Gastroenterology and Hepatology, University of Hong Kong Date/Time: June 5, 2024 at 8:30am CEST Title: Dosing with the Capsid Assembly Modulator ALG-000184 in Untreated HBeAg Negative CHB Subjects Results in Potent Antiviral Effects Including Suppression of HBV DNA/RNA and Declines in HBcrAg Levels Presenter: Kosh Agarwal, MBBS, MRCP (UK), MD, FRCP (Ed), FRCP (London), Consultant Hepatologist and Transplant Physician, Institute of Liver Studies, King’s College Hospital NHS Foundation Trust Time: June 5, 2024 at 8:30am CEST Title: Association of baseline characteristics and plasma ALG-001075 to HBsAg responses in HBeAg+ CHB subjects following ALG-000184±ETV treatment Presenter: Kha Le, PhD Time: June 5, 2024 at 8:30am CEST Preclinical Title: In vitro and in vivo pharmacological characterization of human PNPLA3-targeting short interfering RNA molecules for the treatment of metabolic dysfunction-associated steatohepatitis Presenter: Jieun Song, PhD Time: June 6, 2024 at 8:30am CEST Title: Second generation HBV siRNAs with novel chemistries demonstrate improved profiles compared with ALG-125755 and other clinical stage siRNAs Presenter: Jin Hong, PhD Date/Time: June 8, 2024 at 8:30am CEST Title: Non-HAP CAM-A ALG-006746 and ALG-006780 induce rapid HBsAg reductions in AAV-HBV mice and have favorable pharmacokinetic profiles Presenter: Yannick Debing, PhD Date/Time: June 8, 2024 at 8:30am CEST The presentations can be found on the Scientific Presentations & Conferences section of the Aligos website ( ) after the live event. 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 Statements 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 regarding Aligos’ financial results and performance as well as research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials. 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, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. 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. Investor Contact Jordyn Tarazi Vice President, Investor Relations & Corporate Communications +1 (650) 910-0427 jtarazi@aligos.com Media Contact Michael Fitzhugh LifeSci Communications mfitzhugh@lifescicomms.com