Aligos Therapeutics Provides Phase 2 B-SUPREME Study Progress Updates

Aligos Therapeutics (Nasdaq: ALGS) provided a Phase 2 B-SUPREME study update for pevifoscorvir sodium in chronic HBV.

Rhea-AI Summary

Aligos Therapeutics (Nasdaq: ALGS) provided a Phase 2 B-SUPREME study update for pevifoscorvir sodium in chronic HBV. The study has 144 subjects enrolled worldwide and remains on track to complete enrollment with topline data expected in 2027. The first protocol‑defined interim analysis (≈36 HBeAg‑ participants completing 12 weeks) is expected in 1H 2026; the second interim (≈55 HBeAg+ participants completing 24 weeks) is expected in 2H 2026. The company will remain blinded and rely on the Data Safety Monitoring Board for protocol assessments, including potential sample size re‑estimation. The company also announced the resignation of its EVP/CMO and has initiated a formal search for a successor.

Positive

• Study enrollment of 144 subjects worldwide
• First interim milestone met: 36 HBeAg- completed 12 weeks
• Topline data expected in 2027

Negative

• EVP/CMO resignation may disrupt clinical leadership
• Interim analyses allow for sample size re-estimation, adding uncertainty

Argus Jan 21 session

-0.12% close to close Open Argus

Details

News Market Reaction – ALGS

On Jan 21, the day this news came out, ALGS closed 0.12% below the previous close.

Data tracked by StockTitan Argus for the Jan 21 session.

Key Figures

Enrolled subjects: 144 subjects HBeAg- interim set: 36 HBeAg- participants HBeAg- cohort size: 60 HBeAg- participants +2 more

Enrolled subjects

144 subjects

Phase 2 B-SUPREME chronic HBV study enrollment to date

HBeAg- interim set

36 HBeAg- participants

Approx. 60% completing 12 weeks for first interim analysis

HBeAg- cohort size

60 HBeAg- participants

Planned enrollment for HBeAg- cohort completed in Jan 2026

HBeAg+ interim set

55 HBeAg+ participants

Approx. 50% completing 24 weeks for second interim analysis

Topline timing

2027

Topline Phase 2 B-SUPREME data expected year

Historical Context

5 past events · Latest: Jan 13

5 events

1. Jan 13

   Leadership appointment

   24h Move

   +6.1%

   New Chief Commercial Officer appointed to build global commercial capabilities.

2. Dec 12

   Equity inducement awards

   24h Move

   +15.5%

   Stock option inducement grants to new hires under 2024 Inducement Plan.

3. Dec 11

   Scientific data update

   24h Move

   +1.6%

   Positive HEP‑DART 2025 data for HBV program and obesity candidate ALG‑055009.

4. Nov 14

   Equity inducement awards

   24h Move

   +9.7%

   Additional stock option inducement awards to newly hired employees.

5. Nov 10

   Clinical data presentation

   24h Move

   -2.6%

   Positive Phase 1 and preclinical data for pevifoscorvir sodium and ALG‑001075.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

phase 2, chronic hepatitis b virus (hbv), hbeag-, hbeag+, +2 more

6 terms

phase 2 medical

"progress update for the Phase 2 B-SUPREME study of pevifoscorvir sodium"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

chronic hepatitis b virus (hbv) medical

"subjects with chronic hepatitis B virus (HBV) infection"

A long-term liver infection caused by the hepatitis B virus that persists in the body and can slowly damage the liver, sometimes progressing to cirrhosis or liver cancer. Investors care because chronic HBV defines markets for vaccines, treatments, diagnostics and long-term care, shapes regulatory review and trial risk, and affects potential revenue and public health spending much like a slow leak that gradually increases repair costs and demand for fixes.

hbeag- medical

"includes approximately 60% (or 36) HBeAg- participants that complete 12 weeks"

HBeAg is a small protein produced by the hepatitis B virus that appears in the blood when the virus is actively replicating. For investors, HBeAg status is a practical indicator used in clinical trials and regulatory reports to show whether a treatment is reducing viral activity — like a dashboard light signaling whether an engine is running — and changes in HBeAg rates can affect a drug’s commercial and regulatory prospects.

hbeag+ medical

"planned when approximately 50% (or 55) HBeAg+ participants complete 24 weeks"

HBeAg+ indicates the presence of the hepatitis B “e” antigen in a patient’s blood, a laboratory marker that signals the virus is actively replicating and the person is more likely to spread infection. Investors care because HBeAg status affects clinical trial goals, treatment choices, diagnostic and screening demand, and regulatory or public health priorities—similar to a dashboard light showing an engine is running and needs attention, which can drive market opportunities for drugs and tests.

data safety monitoring board medical

"insights from the Data Safety Monitoring Board on protocol-specified assessments"

A data safety monitoring board is a group of experts who regularly review information from a research or testing process to ensure it is safe and ethical. Think of them as watchdogs that watch over ongoing projects to protect participants and ensure everything is proceeding correctly. Their oversight helps maintain trust and safety, which is important for investors who want to see responsible management and reliable results.

fda regulatory

"comply with FDA regulatory requirements, the company will remain blinded"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Interim analyses on track for the first and second half of 2026

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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How many subjects are enrolled in Aligos B-SUPREME Phase 2 as of Jan 21, 2026 (ALGS)?

The study has 144 subjects enrolled worldwide.

When is the first interim analysis for ALGS B-SUPREME expected?

The first interim analysis is expected in 1H 2026 after ~36 HBeAg‑ participants complete 12 weeks.

When will Aligos report topline B-SUPREME results for ALGS?

Topline data are expected in 2027.

What triggers the second interim analysis in the ALGS B-SUPREME study?

The second interim occurs when ~55 HBeAg+ participants complete 24 weeks, expected in 2H 2026.

Will Aligos be unblinded for the B-SUPREME interim analyses (ALGS)?

No; the company will remain blinded and receive DSMB insights only.

What leadership change did Aligos announce on Jan 21, 2026 (ALGS)?

EVP/Chief Medical Officer Hardean Achneck, MD resigned and a formal search for a successor is underway.