Aligos Therapeutics Inc. (NASDAQ:ALGS) is a clinical-stage biopharmaceutical company based in South San Francisco, California, that is focused on developing best-in-class therapies to address liver and viral diseases with significant unmet medical needs. Founded by industry veterans with decades of experience in antiviral and liver disease research, the company has built a reputation as an innovator in the discovery and development of small molecules and oligonucleotide-based therapeutics. Aligos was established with the mission of improving patient outcomes worldwide, targeting conditions such as chronic hepatitis B virus (HBV) infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses—diseases that collectively represent some of the most pressing healthcare challenges of our time.
The company’s lead program, ALG-000184, is a potent oral capsid assembly modulator (CAM-E) being developed for the treatment of chronic HBV infection, a condition that affects over 254 million people globally and leads to more than a million deaths annually from cirrhosis, liver failure, and hepatocellular carcinoma. ALG-000184 was derived from initial intellectual property licensed from Emory University and further optimized by Aligos’ scientific team, demonstrating robust antiviral activity and favorable safety data across multiple Phase 1 studies. This compound has shown sustained reductions in key viral markers, including HBV DNA, RNA, and surface antigens, establishing itself as a potential first-in-class therapy with the ability to transform the treatment landscape for HBV patients.
Beyond HBV, Aligos has also advanced ALG-055009, a thyroid hormone receptor beta agonist (THR-β) in development for MASH, a disease that affects more than a billion people worldwide and is a leading cause of liver transplants. Early clinical results have demonstrated significant reductions in liver fat content as well as improvements in lipid profiles, underscoring its potential in one of the fastest-growing therapeutic markets. Additionally, the company is advancing ALG-097558, a first-in-class, ritonavir-free pan-coronavirus protease inhibitor designed to provide a new line of defense against current and future coronavirus threats. This candidate has entered human clinical studies and reflects the company’s versatility in addressing both chronic and emerging viral diseases.
Aligos has successfully built a diversified portfolio with a focus on precision, innovation, and scalability. Its leadership team, which includes scientists and executives with prior experience in developing transformative antivirals such as sofosbuvir for hepatitis C, brings a proven track record of success in drug development. With strategic collaborations, regulatory alignment across multiple regions, and a strong financial position providing runway into the second half of 2026, Aligos has established itself as a resilient and forward-looking player in the biotech sector. The company’s commitment to advancing science, addressing global health burdens, and delivering shareholder value makes it a compelling story in the next wave of liver and viral disease therapeutics.
Aligos Therapeutics: Advancing a Potential First-in-Class Therapy for Chronic Hepatitis B
Aligos Therapeutics, Inc., headquartered in South San Francisco, is a clinical-stage biopharmaceutical company dedicated to improving patient outcomes through best-in-class therapies for liver and viral diseases. The company has strategically positioned itself as a leader in the development of small molecule and oligonucleotide therapies designed to address diseases with high unmet medical needs. With a strong scientific foundation, highly experienced leadership, and deep expertise in hepatology and virology, Aligos is building a pipeline that could transform the treatment landscape for patients worldwide.
The company’s vision has always been to target areas of significant unmet need, particularly in chronic hepatitis B virus (HBV) infection—a disease that remains a global health crisis despite decades of research and available antivirals. HBV affects over 254 million individuals worldwide, with 1.2 million new infections reported annually. According to the European Association for the Study of the Liver, HBV-related complications such as cirrhosis, end-stage liver disease, and hepatocellular carcinoma account for more than 1.08 million deaths each year. The sheer scale of HBV’s impact underscores the urgent need for therapies that can provide better efficacy, durability, and safety compared to existing treatment regimens.
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The Launch of the B-SUPREME Study Marks a Pivotal Milestone
In August 2025, Aligos announced the initiation of its Phase 2 B-SUPREME study of ALG-000184, its lead investigational compound for chronic HBV infection. This randomized, double-blind, active-controlled multicenter trial will evaluate ALG-000184 monotherapy compared to tenofovir disoproxil fumarate in approximately 200 untreated HBeAg-positive and HBeAg-negative adults with chronic HBV. Patients will be treated for 48 weeks, with the primary endpoint focused on reductions in HBV DNA levels—a gold-standard biomarker of antiviral efficacy.
The trial builds on a foundation of compelling Phase 1 data that demonstrated ALG-000184’s strong antiviral activity across multiple HBV viral markers, including HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. The drug was shown to be well-tolerated at doses up to 300 mg daily for 96 weeks, with no concerning safety signals observed. Importantly, ALG-000184’s activity persisted even after long-term treatment, highlighting its potential as both a potent and durable therapeutic option. Interim results from B-SUPREME are expected in 2026, with topline results anticipated in 2027, providing investors and the scientific community with clear milestones to monitor.
ALG-000184: A Potential Best-in-Class Capsid Assembly Modulator
ALG-000184 is a novel capsid assembly modulator (CAM-E), a class of antiviral agents designed to interfere with the formation of the HBV viral capsid—a critical step in the viral life cycle. By disrupting this process, ALG-000184 reduces HBV replication and antigen production. What makes ALG-000184 unique is its breadth of activity across multiple viral markers, its strong pharmacokinetics, and its oral administration, which make it both practical and scalable.
Derived from intellectual property licensed from Dr. Raymond Schinazi’s laboratory at Emory University and subsequently optimized by Aligos, ALG-000184 represents the culmination of world-class science and drug development expertise. Regulatory agencies including the FDA, EMA, and China’s NMPA have all acknowledged ALG-000184’s potential and provided a clear regulatory path forward under the chronic suppressive pathway, reinforcing confidence in the compound’s approvability if pivotal trials succeed.
Chronic Hepatitis B: A Global Market Opportunity
The global burden of chronic HBV infection presents one of the largest untapped opportunities in infectious disease therapeutics. Current standard-of-care antivirals such as tenofovir and entecavir effectively suppress viral replication but rarely achieve a functional cure. Patients often require lifelong therapy, and breakthrough infections and progression to liver disease remain major concerns.
With 254 million individuals living with HBV worldwide, even a modestly more effective therapy could unlock billions of dollars in annual revenue. A treatment capable of achieving superior viral suppression, improving antigen clearance, and offering better long-term outcomes would represent a paradigm shift in HBV management. ALG-000184, with its demonstrated potency and tolerability, is well-positioned to capture significant share in this vast and underserved market.
Expert Validation and Clinical Confidence
Leading experts in hepatology and gastroenterology have voiced strong support for Aligos’ approach. Dr. Nezam Afdhal of Harvard Medical School emphasized the urgent need for better HBV therapies and highlighted the impressive antiviral activity seen to date with ALG-000184. Such endorsements from key opinion leaders lend credibility to Aligos’ strategy and reinforce the view that its lead compound could become a best-in-class treatment for HBV.
CEO Lawrence Blatt has also underscored the company’s confidence in ALG-000184, noting both the enthusiasm of clinicians and the recognition by regulators of its strong potential. His leadership, combined with Aligos’ ability to engage top-tier investigators and patients, reflects the company’s disciplined execution and clear vision of becoming a leader in HBV innovation.
Financial Strength and Pipeline Diversification
Aligos is not a one-trick pony. While ALG-000184 is its crown jewel, the company has also advanced promising candidates in metabolic dysfunction-associated steatohepatitis (MASH) and pan-coronavirus therapeutics. These programs diversify Aligos’ pipeline and provide additional opportunities for value creation. Financially, Aligos has strengthened its balance sheet, providing sufficient runway to advance its clinical programs through key data readouts without immediate dilution risk. This stability enables the company to focus on execution while keeping shareholders positioned for upside as trial milestones unfold.
A Bullish Investment Case for Aligos Therapeutics
The bullish case for Aligos is compelling. The company is leading the charge in developing therapies for chronic HBV, a disease that causes more than a million deaths annually. With ALG-000184 now in Phase 2, the company is entering a critical stage where strong interim data could substantially de-risk the program and attract potential partnership or acquisition interest. The breadth of ALG-000184’s activity across viral markers, combined with a favorable safety profile, positions it as a potential first-in-class or best-in-class therapy.
Moreover, the company’s diversified pipeline in MASH and coronavirus further enhances its long-term growth prospects. With global regulatory alignment, expert validation, and a clear timeline for clinical readouts, Aligos is building momentum at precisely the time when the biotech sector is seeing renewed investor interest. For investors seeking exposure to high-impact biotech innovation, Aligos Therapeutics offers a unique opportunity to participate in the next wave of liver and viral disease treatment breakthroughs.
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