SOUTH SAN FRANCISCO, Calif., Jan. 21, 2026 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (NASDAQ:ALGS), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced a progress update for the Phase 2 B-SUPREME study of pevifoscorvir sodium in subjects with chronic hepatitis B virus (HBV) infection.

"2026 is an important year for Aligos as we continue to make progress with the Phase 2 B-SUPREME study with 144 subjects currently enrolled across the world," stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and CEO. "We look forward to our interim analyses, which will contain directional insights on how the study is tracking. The study remains on track to complete enrollment, with topline data expected in 2027. We believe pevifoscorvir sodium is poised for success in this study and look forward to sharing more details later this year."

Planned Interim Analyses

The first protocol defined interim analysis includes approximately 60% (or 36) HBeAg- participants that complete 12 weeks of the treatment period. This enrollment milestone occurred in Q4 2025. In addition, the planned enrollment of this cohort of 60 HBeAg- participants completed in January 2026. The first interim analysis is expected to occur in the first half of 2026.

A second protocol defined interim analysis is planned when approximately 50% (or 55) HBeAg+ participants complete 24 weeks of the treatment period. This enrollment milestone occurred in January 2026. This interim analysis is expected to occur in the second half of 2026.

To preserve study integrity and comply with FDA regulatory requirements, the company will remain blinded to subject-level data and will receive insights from the Data Safety Monitoring Board on protocol-specified assessments, including the potential for sample size re-estimation at each interim analysis.

Leadership Change

Hardean Achneck, MD resigned from his position as Executive Vice President, Chief Medical Officer. The company thanks him for his contributions and wishes him success in his future endeavors. A formal search has commenced to identify his successor.

About B-SUPREME

The Phase 2 B-SUPREME study (NCT06963710) is a randomized, double-blind, active-controlled multicenter study evaluating the safety and efficacy of ALG-000184 monotherapy compared with tenofovir disoproxil fumarate in approximately 200 untreated HBeAg⁺ and HBeAg^- adult subjects with chronic HBV infection for 48 weeks. The primary endpoint in the HBeAg⁺ part is HBV DNA <LLOQ (10 IU/mL, target detected [TD] or target not detected [TND]) and the primary endpoint in the HBeAg^- part is HBV DNA <LLOQ (10 IU/mL, target not detected [TND]). The study will also evaluate the safety, pharmacokinetics, and other secondary and exploratory biomarkers, including reductions in HBV antigens and other markers of HBV infection.

About pevifoscorvir sodium

Pevifoscorvir sodium (formerly known as ALG-000184) was derived from initial IP licensed from the laboratory of Dr. Raymond Schinazi at Emory University, which was further optimized by Aligos. Pevifoscorvir sodium is a potent potential best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for chronic hepatitis B virus (HBV) infection. Phase 1 studies have demonstrated after single and multiple daily doses that pevifoscorvir sodium was well-tolerated by study participants, with no safety signals observed, and demonstrated linear PK and excellent antiviral activity. In longer term Phase 1 studies, pevifoscorvir sodium 300mg QD x ≤96 weeks monotherapy has demonstrated sustained reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. Pevifoscorvir sodium has a regulatory path, as acknowledged by the FDA, EMA, and NMPA (China), for subsequent studies utilizing the chronic suppressive pathway.

About Aligos

Aligos Therapeutics, Inc. (NASDAQ:ALGS) is a clinical stage biotechnology 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 high unmet medical needs such as chronic hepatitis B virus (HBV) infection, obesity, metabolic dysfunction-associated steatohepatitis (MASH), 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' potential success in meeting research and development milestones, the outcome of our clinical trials, the potential success in our regulatory path for pevifoscrovir sodium, and the timing of announcements and updates relating to our clinical trial progress and regulatory filings. 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 November 6, 2025 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

Aligos Therapeutics, Inc.

Jordyn Tarazi

Vice President, Investor Relations & Corporate Communications

+1 (650) 910-0427

jtarazi@aligos.com

Media Contact

Inizio Evoke

Jake Robison

Vice President

Jake.Robison@inizioevoke.com

Aligos Therapeutics Provides Phase 2 B-SUPREME Study Progress Updates