Aligos gains FDA Fast Track for HBV drug

Aligos Therapeutics filed an update highlighting interim Phase 2 data and a key regulatory milestone for its hepatitis B drug candidate pevifoscorvir sodium.

Rhea-AI Filing Summary

Aligos Therapeutics filed an update highlighting interim Phase 2 data and a key regulatory milestone for its hepatitis B drug candidate pevifoscorvir sodium. An independent safety board reviewed early results from the B-SUPREME study and recommended continuing the trial while increasing the sample size in the HBeAg- cohort to strengthen statistical power, noting that futility criteria were not met. The company remains blinded to individual patient data. Enrollment has reached 74 participants in the HBeAg- cohort and 103 in the HBeAg+ cohort, with about 200 patients planned overall, and topline data targeted for 2027. The FDA has granted Fast Track Designation to pevifoscorvir sodium, based on Phase 1 data showing it was well tolerated with promising reductions in multiple viral markers, potentially supporting a faster and more interactive regulatory review path for this chronic hepatitis B program.

Positive

• FDA Fast Track Designation granted for pevifoscorvir sodium in chronic hepatitis B, potentially enabling more frequent FDA interactions and access to expedited review pathways.
• Phase 2 B-SUPREME trial continues after interim review, with the DSMB recommending increasing the HBeAg- cohort sample size rather than stopping the study for futility.

Negative

• None.

Insights

Biotech and regulatory analyst

Fast Track status and a positive DSMB review modestly de-risk Aligos’s HBV program.

The update shows pevifoscorvir sodium is progressing through the Phase 2 B-SUPREME trial, with a safety board recommending continuation and a larger HBeAg- cohort. This suggests the data did not trigger a futility stop, while still aiming for stronger statistical power.

The FDA Fast Track Designation, supported by 96-week Phase 1 data, can allow more frequent FDA interactions and eligibility for tools like Rolling Review or Accelerated Approval if criteria are met. This often helps streamline late-stage planning for serious diseases with unmet needs.

Operationally, Aligos expects to complete HBeAg- enrollment and run a second interim analysis in the second half of 2026, with topline data anticipated in 2027. Future outcomes will depend on whether Phase 2 confirms the sustained reductions in HBV DNA and other viral markers seen in earlier studies.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Interim analysis coverage: 60% of HBeAg- participants Participants at interim: N=174 Cohort enrollment: 74 HBeAg-, 103 HBeAg+ +5 more

8 metrics

Interim analysis coverage 60% of HBeAg- participants First interim analysis after about 60% (N=34) reached Week 12 or later

Participants at interim N=174 Safety data reviewed for all 174 participants enrolled at interim

Cohort enrollment 74 HBeAg-, 103 HBeAg+ Enrollment at interim in B-SUPREME Phase 2 study cohorts

Planned sample size ≈200 subjects Approximate total number of untreated HBeAg+ and HBeAg- adults in B-SUPREME

Treatment duration 48 weeks Pevifoscorvir sodium monotherapy versus tenofovir assessed over 48 weeks

Phase 1 dosing 300 mg QD ≤96 weeks Longer term Phase 1 monotherapy regimen for pevifoscorvir sodium

Global HBV burden 254 million patients Estimated worldwide chronic hepatitis B patient population

Annual new HBV infections 1.2 million individuals Estimated yearly new chronic HBV infections despite vaccination

Key Terms

Fast Track Designation, capsid assembly modulator (CAM-E), Data Safety Monitoring Review Board, HBeAg+, +2 more

6 terms

Fast Track Designation regulatory

"the United States Food and Drug Administration (FDA) has granted Fast Track Designation to pevifoscorvir sodium"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

capsid assembly modulator (CAM-E) medical

"a potential best/first-in-class capsid assembly modulator (CAM-E) under investigation for the treatment"

Data Safety Monitoring Review Board technical

"the independent Data Safety Monitoring Review Board (DSMB) has recommended continuation of the study"

An independent group of experts that watches over clinical trials or other studies to check participant safety and the reliability of results, like a safety inspector who can pause or change a project if risks or clear benefits emerge. For investors, their findings can affect a drug or device’s development timeline, regulatory approval prospects and company value, because a stoppage or positive endorsement often leads to major market moves.

HBeAg+ medical

"with 103 participants enrolled in the HBeAg+ cohort (Part 1a)"

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.

HBeAg- medical

"for the Part 2a (HBeAg- cohort) where the independent Data Safety Monitoring Review Board"

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.

Rolling Review regulatory

"clinical programs with Fast Track Designation may be eligible for Rolling Review, Accelerated Approval and Priority Review"

A rolling review is a regulatory process where health authorities examine data on a drug or vaccine as it becomes available instead of waiting for a complete file at the end. For investors, this can speed up the timeline to approval and reduce uncertainty because regulators assess progress in real time—think of reading and approving chapters of a book as they’re finished rather than waiting for the whole manuscript, which can bring forward potential market access and revenue.

FAQ

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

What did Aligos Therapeutics (ALGS) report about its B-SUPREME Phase 2 trial?

Aligos reported first interim analysis results from the Phase 2 B-SUPREME study of pevifoscorvir sodium in chronic hepatitis B. An independent safety board recommended continuing the trial and increasing the HBeAg- cohort size to improve statistical power, with topline data expected in 2027.

What is FDA Fast Track Designation granted to Aligos Therapeutics’ pevifoscorvir sodium?

Fast Track Designation is an FDA process that facilitates development and review of drugs for serious conditions with unmet needs. It allows more frequent FDA communication and potential eligibility for Rolling Review, Accelerated Approval, and Priority Review if standard criteria are satisfied.

How far along is enrollment in Aligos Therapeutics’ B-SUPREME study for chronic HBV?

At the interim analysis, 74 participants were enrolled in the HBeAg- cohort and 103 in the HBeAg+ cohort, toward a target of approximately 200 subjects. Completion of enrollment in the HBeAg- cohort and a second interim analysis are expected in the second half of 2026.

What prior data supported Fast Track for pevifoscorvir sodium at Aligos Therapeutics (ALGS)?

Fast Track was supported by a 96-week Phase 1 study of pevifoscorvir sodium monotherapy in chronic hepatitis B. That study showed the drug was well tolerated and demonstrated sustained, potentially best-in-class reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg viral markers.

What is pevifoscorvir sodium and how is Aligos Therapeutics developing it?

Pevifoscorvir sodium is an oral capsid assembly modulator (CAM-E) being developed for chronic hepatitis B infection. Phase 1 trials showed linear pharmacokinetics, good tolerability, and strong antiviral activity, and it is now being tested against tenofovir disoproxil fumarate in the Phase 2 B-SUPREME study.

Why is chronic hepatitis B infection a key focus area for Aligos Therapeutics (ALGS)?

Chronic hepatitis B affects about 254 million people worldwide and causes complications like cirrhosis and liver cancer, leading to roughly 1.08 million deaths in 2022. Despite vaccines, around 1.2 million new infections occur annually, leaving a large unmet need for better therapies.

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

Understanding 8-K Material Events →

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Accepted by SEC EDGAR 04/14/2026 - 04:17 PM EDT Learn about SEC filing dates

false 0001799448 0001799448 2026-04-14 2026-04-14

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 14, 2026

Aligos Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-39617		82-4724808
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification Number)

One Corporate Dr., 2nd Floor South San Francisco, CA		94080
(Address of principal executive offices)		(Zip Code)

(800) 466-6059

(Registrant’s telephone number, including area code)

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		ALGS		The Nasdaq Stock Market LLC
				(Nasdaq Capital Market)

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01. Other Events.

On April 14, 2026, Aligos Therapeutics, Inc. (the “Company”) issued a press release announcing the first interim analysis results of the Phase 2 B-SUPREME study of pevifoscorvir sodium in participants with chronic hepatitis B virus (“HBV”) infection for the Part 2a (HBeAg- cohort) where the independent Data Safety Monitoring Review Board has recommended continuation of the study with an increase in sample size for this cohort in order to optimize statistical powering; futility criteria for the cohort was not met. Additionally, the Company announced that the United States Food and Drug Administration has granted Fast Track Designation to pevifoscorvir sodium, a potential best/first-in-class capsid assembly modulator (CAM-E) under investigation for the treatment of HBV infection.

Item 9.01. Financial Statements and Exhibits.

Exhibit No.		Description
99.1		Press release of Aligos Therapeutics, Inc. dated April 14, 2026.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

				ALIGOS THERAPEUTICS, INC.
Date: April 14, 2026				By:		/s/ Lesley Ann Calhoun
						Lesley Ann Calhoun
						Executive Vice President, Chief Operating Officer & Chief Financial Officer

Exhibit 99.1

Aligos Therapeutics Announces First Interim Analysis Results from the Phase 2 B-SUPREME Study of Pevifoscorvir Sodium in Participants with Chronic Hepatitis B Virus Infection and Grant of FDA Fast Track Designation

• Received FDA Fast Track Designation for pevifoscorvir sodium for the treatment of chronic hepatitis B virus infection

• HBeAg- cohort sample size increased to optimize powering; futility criteria not met

• Study drugs were well-tolerated by participants

• Topline data expected in 2027, guidance remains unchanged

SOUTH SAN FRANCISCO, CA., April 14, 2026 (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 the first interim analysis results of the Phase 2 B-SUPREME study of pevifoscorvir sodium in participants with chronic hepatitis B virus (HBV) infection for the Part 2a (HBeAg- cohort) where the independent Data Safety Monitoring Review Board (DSMB) has recommended continuation of the study with an increase in sample size for this cohort in order to optimize statistical powering; futility criteria for the cohort was not met. Additionally, Aligos announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to pevifoscorvir sodium, a potential best/first-in-class capsid assembly modulator (CAM-E) under investigation for the treatment of chronic hepatitis B virus (HBV) infection.

Interim Analysis

The study design for the Phase 2 B-SUPREME study includes pre-specified sample size re-estimations for both Parts 1a and 2a to ensure sufficient power to demonstrate a statistically significant treatment effect at the primary endpoint. The first pre-specified interim analysis of the Phase 2 B-SUPREME study was performed after approximately 60% of HBeAg- participants (N=34, Part 2a) reached Week 12 or later. In addition, safety data was reviewed for all participants enrolled in the study (N=174) at the time the interim analysis was performed.

Findings from the first interim analysis include:

• The DSMB recommended increasing the sample size of Part 2a from 74 currently enrolled to 100 participants. A futility analysis was performed; the prespecified futility criteria was not met, per the statistical analysis plan.

• The study drugs were well-tolerated with no clinically concerning laboratory, physical examination, vital sign, or ECG abnormalities. No viral breakthrough related to study drugs has been observed in the study to date.

Aligos remains blinded to participant-level data. Completion of enrollment in the HBeAg- cohort is expected in the second half of 2026. Currently, there are 74 participants enrolled in the HBeAg- cohort (Part 2a), with 103 participants enrolled in the HBeAg+ cohort (Part 1a). Topline data remains on track for 2027.

“We are encouraged by this recommendation from the DSMB to increase the sample size in order to increase the probability for success of the study’s primary endpoint,” stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “We believe we can enroll the necessary study participants in the coming months, with topline data on track for 2027.

1

Additionally, I am thrilled to share that pevifoscorvir sodium has been granted Fast Track Designation. Aligos’ mission since its founding has been to improve outcomes for patients with unmet needs in liver and viral diseases and being granted Fast Track Designation for pevifoscorvir sodium is the next step in our journey to make this a reality. As we progress the Phase 2 B-SUPREME study, we look forward to working with regulators to determine the appropriate path forward.”

Fast Track Designation

The FDA Fast Track Designation was supported by the 96-Week Phase 1 (NCT04536337) data evaluating pevifoscorvir sodium monotherapy in patients with chronic HBV infection, which were presented at The Liver Meeting^® 2025, along with the 8-Week nucleoside analog follow-up data. This study demonstrated that pevifoscorvir sodium was well tolerated by study participants and the data demonstrated potential best-in-class reductions across clinically relevant viral markers.

Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. It enables more frequent meetings and communication with the FDA to ensure alignment on development plans and the collection of clinical data needed to support approval. Furthermore, clinical programs with Fast Track Designation may be eligible for Rolling Review, Accelerated Approval and Priority Review if relevant criteria are met. For conditions where an available treatment exists, a drug candidate must show some advantage over available therapy, such as superior effectiveness, to be granted Fast Track Designation¹.

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 pevifoscorvir sodium 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. The second interim analysis is expected in the second half of 2026 and topline data is expected in 2027.

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 promising 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.

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About Chronic HBV Infection

Chronic hepatitis B virus (HBV) infection is a life-threatening viral infection that primarily affects the liver with 254 million patients worldwide and approximately 1.2 million individuals become newly infected every year despite the availability of a prophylactic vaccine. Complications include cirrhosis, end-stage liver disease, and hepatocellular carcinoma, which collectively resulted in approximately 1.08 million deaths in 2022, according to the European Association for the Study of the Liver’s 2025 clinical practice guidelines. Chronic HBV infection 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 with high unmet medical needs such as chronic hepatitis B virus (HBV) infection, metabolic dysfunction-associated steatohepatitis (MASH), obesity, 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’ mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases; the expected pace of enrollment in the B-SUPREME study, timing for enrollment completion, expectations for second interim analysis in the second half of 2026, and expectations for topline data in 2027; whether the planned increase in enrollment will lead to success in meeting the study’s primary endpoint; expectations regarding what the B-SUPREME study will evaluate in the future; and whether the granting of Fast Track Designation by the FDA for pevifoscorvir sodium will lead to improved outcomes for patients with unmet needs in liver and viral diseases. Such forward-looking statements are subject to substantial risks and uncertainties that could cause actual results 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 and the regulatory approval processes. 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’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 5, 2026 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.

1. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track (Accessed April 14, 2026)

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Aligos Therapeutics

Contact

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

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Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 20.5 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.1 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 17.6 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.0 KB