Aligos Therapeutics Presents Positive Data at HEP-DART 2025

Rhea-AI Summary

Aligos Therapeutics (Nasdaq: ALGS) presented positive data at HEP-DART 2025 (Dec 7–11, 2025). Oral presentations covered 96-week and post-treatment follow-up data from a Phase 1 pevifoscorvir sodium monotherapy study in chronic HBV and new in vivo ALG-055009 data showing synergistic weight and fat-mass loss when combined with incretin receptor agonists.

In diet-induced obese mice, semaglutide (SEMA) produced a maximum 23.9% weight loss vs 33% for SEMA+ALG-055009 (additional 8.6%); tirzepatide (TIRZEP) monotherapy reached 27.1%–34.4% vs 39%–40% for TIRZEP+ALG-055009 (additional 5.8%–11.7%). Presentations also included early HBV and HDV ASO program posters.

Positive

• SEMA+ALG-055009 increased max weight loss to 33% (additional 8.6%)
• TIRZEP+ALG-055009 increased max weight loss to 39%–40% (additional 5.8%–11.7%)
• Additional weight loss driven by fat mass, not lean mass or reduced food intake
• Completed 96-week and post-treatment follow-up in pevifoscorvir Phase 1 cohorts

Negative

• ALG-055009 results are from preclinical DIO mice, not human clinical data
• Pevifoscorvir Phase 1 summary referenced but no quantitative antiviral endpoints were disclosed in this release

Key Figures

SEMA monotherapy weight loss 23.9 ±2.6% Maximum body weight loss in diet-induced obese mice

SEMA + ALG-055009 weight loss 33% Maximum body weight loss with additional 8.6% decrease vs SEMA alone

Low-dose TIRZEP weight loss 27.1 ±2.7% Maximum body weight loss with low-dose tirzepatide alone

High-dose TIRZEP weight loss 34.4 ±1.6% Maximum body weight loss with high-dose tirzepatide alone

Low-dose TIRZEP + ALG-055009 39% Maximum body weight loss; additional 11.7% vs low-dose tirzepatide alone

High-dose TIRZEP + ALG-055009 40% Maximum body weight loss; additional 5.8% vs high-dose tirzepatide alone

Treatment duration 28 days In vivo dosing period in diet-induced obese mice

Pevifoscorvir monotherapy duration 96 weeks Phase 1 HBV monotherapy treatment period with follow-up

Market Reality Check

$13.29 Last Close

Volume Volume 88,063 is 1.16x the 20-day average of 75,683, indicating modestly elevated trading interest ahead of the data. normal

Technical Shares at $11.33 are trading above the 200-day MA of $8.50, after a 2.26% gain over the prior day.

Peers on Argus

Biotech peers showed mixed moves, with BYSI and CVM up while IGMS, ACET and ENTX were down. ALGS’s 2.26% gain and positive HBV/obesity data point to a stock-specific driver rather than a broad sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 14	Inducement grants	Neutral	+9.7%	Equity awards to new hires under 2024 Inducement Plan.
Nov 10	Clinical data update	Positive	-2.6%	Strong Phase 1 HBV suppression and supportive preclinical data.
Nov 06	Earnings and pipeline	Negative	-3.1%	Q3 loss, ongoing cash burn and need for additional funding.
Nov 04	Investor conferences	Neutral	-4.3%	Announcements of upcoming Jefferies and Piper Sandler presentations.
Oct 30	Earnings notice	Neutral	-4.8%	Scheduling notice for upcoming Q3 2025 financial release.

Pattern Detected

News has often seen inconsistent follow-through: positive HBV data in November saw a price decline, while routine items like inducement grants produced a sharp gain, suggesting event reactions have been erratic.

Recent Company History

Over the last few months, Aligos reported Q3 2025 results on Nov 6, highlighting progress of pevifoscorvir sodium into Phase 2 and liquidity funded into Q3 2026. Subsequent positive HBV data at The Liver Meeting® 2025 on Nov 10 coincided with a share price decline, while routine inducement grants on Nov 14 saw a strong gain. The current HEP-DART 2025 data extend this HBV and metabolic pipeline narrative with additional long-term and combination-therapy findings.

Market Pulse Summary

This announcement highlights long-term pevifoscorvir data in chronic HBV and promising nonclinical synergy for ALG-055009 with incretin receptor agonists, achieving up to 40% body weight loss in diet-induced obese mice. In recent months, Aligos advanced HBV programs into Phase 2 while reporting substantial net losses and a funding runway into Q3 2026. Investors may monitor upcoming clinical readouts, additional cardiometabolic data, and future financing steps to assess how these results translate into longer-term value.

Key Terms

incretin receptor agonists medical

"demonstrating synergistic effects in combination with incretin receptor agonists (RAs)."

Incretin receptor agonists are medicines that imitate naturally occurring gut hormones to tell the body to release more insulin when blood sugar rises and to slow digestion, helping control diabetes and often reducing appetite. For investors, they matter because they can change prescription demand, treatment costs, and healthcare spending—like a new, more effective tool that reshapes which treatments doctors choose and how much patients and insurers pay.

thyroid hormone receptor beta medical

"ALG-055009 is a potent thyroid hormone receptor beta (THR-β) agonist under development"

Thyroid hormone receptor beta is a protein inside cells that acts like a lock for thyroid hormones, turning genes on or off when the right hormone key fits. It matters to investors because drugs or tests that target this receptor can change metabolism, growth, or disease processes; successful therapies or diagnostic tools tied to it can affect clinical outcomes, regulatory approvals, and a company’s commercial prospects in endocrine and metabolic markets.

monotherapy medical

"Phase 1 monotherapy study of pevifoscorvir sodium, a potent CAM-E"

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

antisense oligonucleotide medical

"An antisense oligonucleotide strategy targeting the Hepatitis Delta Virus"

An antisense oligonucleotide is a small piece of synthetic genetic material designed to attach to specific molecules in the body’s cells, effectively blocking or modifying how genes are expressed. This technology is important because it can be used to develop targeted treatments for certain diseases, which may influence the value of biotech companies and the broader healthcare sector. Its development reflects advances in personalized medicine and gene-based therapies.

AI-generated analysis. Not financial advice.

Oral presentation of ALG-055009 in vivo nonclinical data showcases synergistic fat mass loss in combination with incretin receptor agonists

SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 (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 positive data from four presentations, including two oral presentations, at the HEP-DART 2025 Meeting, being held December 7 – 11, 2025 in Honolulu, Hawaii.

The oral presentations highlight the Phase 1 monotherapy study of pevifoscorvir sodium, a potent CAM-E under development for the treatment of chronic hepatitis B virus (HBV) infection, and new ALG-055009 nonclinical data demonstrating synergistic effects in combination with incretin receptor agonists (RAs). ALG-055009 is a potent thyroid hormone receptor beta (THR-β) agonist under development for the treatment of obesity and metabolic dysfunction-associated steatohepatitis (MASH). Additionally, the poster presentations show the continued innovation and commitment to advancing next-generation therapies in the liver and viral spaces with presentations on both HBV and hepatitis delta virus (HDV).

Pevifoscorvir Sodium Data

The complete 96-week and post-treatment follow up data from the Phase 1 monotherapy (NCT04536337) cohorts in subjects with chronic HBV infection show the continued potential of pevifoscorvir sodium to become a first-line therapy for chronic suppression.

ALG-055009 Data

New in vivo data in diet induced obese (DIO) mice treated with semaglutide (SEMA), tirzepatide (TIRZEP), or a combination of ALG-055009 and SEMA or TIRZEP for 28 days demonstrated synergistic weight loss in the combination groups compared to monotherapy groups. SEMA monotherapy resulted in a maximum of 23.9 ±2.6% body weight loss, while the combination of SEMA and ALG-055009 had an additional 8.6% decrease for a maximum 33% body weight loss. The low and high doses of TIRZEP led to maximum of 27.1 ±2.7% and 34.4 ±1.6% body weight loss, respectively. Combination of TIRZEP (low) or TIRZEP (high) with ALG-055009 induced an additional 11.7% and 5.8% decrease for a maximum of 39% and 40% body weight loss respectively.

Furthermore, the additional weight loss in the combination therapy of either incretin receptor agonist and ALG-055009 was mainly due to additional loss of fat mass, with no significant effect on lean mass or food consumption as compared to incretin receptor agonist monotherapy. The data suggest a significant benefit of adding ALG-055009 to an incretin receptor agonist therapy for weight loss, especially in combination with a low-dose of a potent molecule, such as tirzepatide.

“We are pleased to present these data at the 30^th anniversary meeting of HEP-DART,” said Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and CEO of Aligos Therapeutics. “The results demonstrate our continued enthusiasm for the potential of pevifoscorvir sodium in patients with chronic HBV infection. Additionally, we are excited to present the nonclinical ALG-055009 data in combination with incretin receptor agonists, which showed an impressive synergistic effect. As the cardiometabolic space moves towards combination therapy, we believe ALG-055009 has the potential to play an important role in these future regimens. Lastly, data from our early-stage HBV and HDV ASO programs are promising, and we look forward to continuing to explore their potential.”

Details of the presentations are as follows:

Pevifoscorvir sodium: Potential first-/best-in-class small molecule CAM-E under investigation for chronic hepatitis B virus (HBV) infection 

Type: Invited Oral Presentation
Title: Rapid, profound and durable antiviral effects in treatment-naïve or currently-not-treated subjects with chronic hepatitis B virus infection that received 300 mg pevifoscorvir sodium monotherapy for 96 weeks
Presenter: Lawrence Blatt, PhD, MBA
Date/Time: Oral - December 9, 2025 at 5:45pm GMT-10
Session: Industry Session

ALG-055009: Potential best-in-class small molecule THR- under investigation for obesity and metabolic dysfunction-associated steatohepatitis (MASH)

Poster #: 6
Type: Accepted Oral & Poster Presentation
Title: Synergistic fat mass loss in diet-induced obese mice when thyroid hormone receptor-β agonist ALG-055009 was administered in combination with incretin receptor agonists
Presenter: Xuan (Susan) Luong, PhD
Date/Time: Oral - December 10, 2025 at 4:10pm GMT-10; Poster - December 9, 2025 at 2:00pm – 4:00pm GMT-10

Preclinical

Poster #: 1
Type: Poster Presentation
Title: Explorations Towards the Selection of a Potential Best-in-Class HBV ASO
Presenter: Lawrence Blatt, PhD, MBA & David B. Smith, PhD
Date/Time: December 9, 2025 at 2:00pm – 4:00pm GMT-10

Poster #: 2
Type: Poster Presentation
Title: An antisense oligonucleotide strategy targeting the Hepatitis Delta Virus
Presenter: Lawrence Blatt, PhD, MBA & David B. Smith, PhD
Date/Time: December 9, 2025 at 2:00pm – 4:00pm GMT-10

The presentations can be found on the Posters & Presentations section of the Aligos website (www.aligos.com) after the live event.

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’ research and development activities, including the potential success of nonclinical and clinical development of our investigational compounds and the potential for regulatory approval and commercial availability of those compounds. 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

What did Aligos announce about ALG-055009 at HEP-DART 2025 (ALGS)?

Aligos presented preclinical DIO mouse data showing ALG-055009 added to semaglutide or tirzepatide increased max weight loss to 33%–40% versus monotherapy.

How much additional weight loss did ALG-055009 provide with semaglutide in the ALGS presentation?

The combination of semaglutide and ALG-055009 produced an additional 8.6% weight loss versus semaglutide alone (max 33%).

Did the ALGS release report human efficacy numbers for pevifoscorvir sodium (ALGS)?

The company reported completion of 96-week and post-treatment follow-up in Phase 1 cohorts but did not provide detailed antiviral numeric endpoints in this release.

Were the ALG-055009 results at HEP-DART 2025 clinical or preclinical (ALGS)?

The ALG-055009 weight-loss data were preclinical, from diet-induced obese mice treated for 28 days.

What drove the additional weight loss when ALG-055009 was combined with incretin receptor agonists?

The release states the extra weight loss was mainly due to additional fat mass loss with no significant change in lean mass or food consumption.