Virax Biolabs posts early ViraxImmune pilot data

Virax Biolabs Group Limited reported early pilot performance data for ViraxImmune™, a blood-based test in development for Long COVID, ME/CFS and related post-acute infection syndromes.

Rhea-AI Filing Summary

Virax Biolabs Group Limited reported early pilot performance data for ViraxImmune™, a blood-based test in development for Long COVID, ME/CFS and related post-acute infection syndromes. In the pilot dataset, the test showed measurable separation between PAIS patients and healthy controls, with 88% specificity and 92% positive predictive value.

ViraxImmune™ has been evaluated in more than 120 subjects in an ongoing UK clinical study. Virax plans a larger clinical validation using samples from 300 additional participants, with analysis expected to begin in Q4 2026 and results expected in Q1 2027, supporting a planned U.S. market-entry via a PAIS-focused Laboratory Developed Test followed by broader in vitro diagnostic development. Virax estimates up to 21 million U.S. adults may be living with Long COVID and related PAIS conditions, with about 2.5 million new cases each year.

Insights

Biotech & clinical development analyst

Early ViraxImmune™ pilot data look encouraging but remain preliminary.

Virax Biolabs released pilot performance data for its ViraxImmune™ immune-profiling test in Long COVID and related syndromes, reporting 88% specificity and 92% positive predictive value. The assay has been run in more than 120 subjects in an ongoing UK study.

The company outlines a next step of analyzing samples from 300 additional participants, with work starting in Q4 2026 and results in Q1 2027. These numbers come from an internal pilot dataset and are described as preliminary, with ViraxImmune™ not yet approved for diagnostic use.

If future validation supports the pilot findings, Virax plans a U.S. Laboratory Developed Test route first, followed by broader in vitro diagnostic development. Actual commercial impact will depend on outcomes of the larger validation, regulatory interactions and how the sizable estimated PAIS population is addressed.

Key Figures

ViraxImmune specificity: 88% specificity ViraxImmune PPV: 92% positive predictive value Subjects studied: More than 120 subjects +5 more

8 metrics

ViraxImmune specificity 88% specificity Pilot dataset in PAIS patients vs healthy controls

ViraxImmune PPV 92% positive predictive value Pilot dataset performance metric

Subjects studied More than 120 subjects Ongoing UK clinical study for ViraxImmune

Planned validation cohort 300 participants Larger clinical validation analysis planned

Estimated U.S. PAIS population Up to 21 million adults Long COVID and related PAIS conditions in U.S.

Estimated new U.S. PAIS cases 2.5 million new cases per year Long COVID and related PAIS conditions

Validation analysis start Q4 2026 Planned start of larger clinical validation

Validation results timing Q1 2027 Expected results from 300-participant analysis

Key Terms

post-acute infection syndromes, positive predictive value, Laboratory Developed Test, in vitro diagnostic, +2 more

6 terms

post-acute infection syndromes medical

"its blood-based test in development for Long COVID, ME/CFS and related post-acute infection syndromes"

Post-acute infection syndromes are conditions where people continue to experience symptoms or develop new health problems weeks or months after an initial infection has cleared. Like an echo after a loud noise, these lingering effects can include fatigue, cognitive problems, and organ-specific issues, and they matter to investors because they can drive long-term demand for medical care, therapies, diagnostics, disability claims and workforce impacts that affect company costs and market opportunities.

positive predictive value medical

"achieving 88% specificity and 92% positive predictive value (“PPV”)"

Positive predictive value is a measure of how likely it is that a positive result actually indicates a true positive. For investors, it helps assess how reliable a signal or indicator is in predicting real opportunities or risks, similar to how knowing that a weather forecast predicts rain accurately helps you decide whether to carry an umbrella. A higher positive predictive value means greater confidence that a positive signal truly reflects a meaningful event.

Laboratory Developed Test regulatory

"an initial PAIS-focused U.S. Laboratory Developed Test (“LDT”) route"

A laboratory developed test is a medical diagnostic created, validated and performed within a single clinical laboratory rather than sold as a boxed product to other labs or clinics. For investors, LDTs can offer faster product rollout and niche revenue streams like a custom service, but they also carry regulatory and reimbursement uncertainty and competitive risk—think of them as a handmade tool that can be quickly offered to customers but may face shifting rules or market limits.

in vitro diagnostic regulatory

"with broader in vitro diagnostic (“IVD”) development planned over time"

In vitro diagnostics are tests, instruments and kits used to analyze samples taken from the body—such as blood, urine or swabs—outside the body (in a lab or cartridge) to detect disease, infections, genetic traits or other biological signs. Investors care because these products generate sales, recurring revenue from consumable test kits, and value that hinges on test accuracy, regulatory approvals and reimbursement policies; like a home pregnancy test but for many medical conditions.

forward-looking statements regulatory

"This press release contains forward-looking statements."

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

immune profiling medical

"a potential objective immune-profiling test for Long COVID, ME/CFS"

A detailed examination of the cells, proteins and signals that make up an individual’s immune system, producing a snapshot or “fingerprint” of how that system is behaving. For investors, immune profiling matters because it helps predict which therapies are likely to work, guides patient selection and clinical trial design, and can reduce development risk or unlock higher commercial value for treatments that can be targeted to the right patients.

FAQ

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

What did Virax Biolabs (VRAX) report about ViraxImmune in this Form 6-K?

Virax Biolabs reported early pilot performance data for ViraxImmune™, its blood-based test for Long COVID, ME/CFS and related syndromes. The pilot dataset showed measurable separation between patients and healthy controls, with encouraging initial performance metrics supporting further clinical validation plans.

What are the key performance metrics for ViraxImmune reported by Virax Biolabs (VRAX)?

In the pilot dataset, ViraxImmune™ achieved 88% specificity and 92% positive predictive value. These early metrics indicate the test distinguished PAIS patients from healthy controls, and Virax views them as supportive of advancing ViraxImmune™ into larger clinical validation studies.

How many subjects have been studied so far in the ViraxImmune program at Virax Biolabs (VRAX)?

ViraxImmune™ has been evaluated in more than 120 subjects in an ongoing UK clinical study. These participants include individuals with Long COVID, ME/CFS and related post-acute infection syndromes, helping generate the pilot dataset described in the May 26, 2026 announcement.

What are the next clinical milestones for ViraxImmune according to Virax Biolabs (VRAX)?

Virax is planning a larger clinical validation analysis using previously collected samples from 300 additional participants. The company expects this analysis to begin in Q4 2026, with results anticipated in Q1 2027, to further assess ViraxImmune’s performance and refine its development path.

What U.S. market-entry strategy did Virax Biolabs (VRAX) outline for ViraxImmune?

Virax expects to pursue an initial U.S. Laboratory Developed Test (LDT) route focused on PAIS for ViraxImmune™. Over time, the company plans broader in vitro diagnostic (IVD) development, aiming to offer more widely deployable versions if future validation and regulatory steps are successful.

How large is the potential U.S. testing opportunity described by Virax Biolabs (VRAX)?

Virax estimates up to 21 million adults in the United States may be living with Long COVID and related PAIS conditions, with about 2.5 million new cases annually. The company believes this substantial population could represent a significant testing opportunity for objective immune-profiling approaches like ViraxImmune™.

Is ViraxImmune currently approved for diagnostic use according to Virax Biolabs (VRAX)?

Virax states that ViraxImmune™ is still in development and not approved for diagnostic use in any jurisdiction. The reported VRX003 pilot observations are preliminary and intended to guide ongoing assay development and future clinical validation rather than current clinical deployment.

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

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Accepted by SEC EDGAR 05/26/2026 - 07:33 AM Learn about SEC filing dates

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of May 2026

Commission File Number: 001-41440

Virax Biolabs Group Limited

(Registrant’s Name)

BioCity Glasgow

Bo'Ness Road Newhouse

Lanarkshire, ML1 SUH

United Kingdom

(Address of Principal Executive Offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

When used in this Form 6-K, unless otherwise indicated, the terms “the Company,” “Virax,” “we,” “us” and “our” refer to Virax Biolabs Group Limited. and its subsidiaries.

Information Contained in this Form 6-K Report

On May 26, 2026, Virax Biolabs Group Limited issued a press release today reporting positive early pilot performance data for ViraxImmune™, its blood-based test in development for Long COVID, myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”) and related post-acute infection syndromes (“PAIS”). In the pilot dataset, ViraxImmune™ demonstrated measurable separation between PAIS patients and healthy controls, achieving 88% specificity and 92% positive predictive value (“PPV”) — early performance metrics that Virax believes support continued development and advancement into larger clinical validation.

Based on estimates derived from CDC, the RECOVER Initiative and other peer-reviewed and public-health sources, Virax estimates that up to 21 million adults in the United States may currently be living with Long COVID and related PAIS conditions, with approximately 2.5 million new cases estimated each year. Virax believes this represents a significant potential U.S. testing opportunity in an area where many patients are often assessed through symptoms and exclusion, rather than objective immune biomarkers of the type ViraxImmune™ is being developed to assess.

Highlights:

•In the pilot dataset, ViraxImmune™ demonstrated measurable separation between PAIS patients and healthy controls and achieved 88% specificity and 92% positive predictive value (“PPV”).

•ViraxImmune™ has now been evaluated in more than 120 subjects in the Company’s ongoing UK clinical study in Long COVID, ME/CFS and related post-acute infection syndromes.

•Virax is preparing for its next major development milestone: a larger clinical validation analysis involving previously collected samples from 300 additional participants, with analysis expected to begin in Q4 2026 and results expected in Q1 2027.

•Findings support continued advancement toward Virax’s intended U.S. market-entry strategy: an initial PAIS-focused U.S. Laboratory Developed Test (“LDT”) route, with broader in vitro diagnostic (“IVD”) development planned over time.

A copy of the press release dated May 26, 2026 is included as Exhibit 99.1 to this report.

Exhibits

Exhibit No		Description
99.1		Press release dated May 26, 2026

SIGNATURES

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

			VIRAX BIOLABS GROUP LIMITED
Date:	May 26, 2026	By:	/s/ James Foster
			James Foster, Chief Executive Officer

Exhibit 99.1

Virax Biolabs Reports Positive Early Clinical Data for ViraxImmune™ in Long COVID and Related Post-Acute Infection Syndromes

LONDON, May 26, 2026 /PRNewswire/ - Virax Biolabs Group Limited (NASDAQ: VRAX) (“Virax” or the “Company”) today reported positive early pilot performance data for ViraxImmune™, its blood-based test in development for Long COVID, myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”) and related post-acute infection syndromes (“PAIS”). In the pilot dataset, ViraxImmune™ demonstrated measurable separation between PAIS patients and healthy controls, achieving 88% specificity and 92% positive predictive value (“PPV”) — early performance metrics that Virax believes support continued development and advancement into larger clinical validation.

Based on estimates derived from CDC, the RECOVER Initiative and other peer-reviewed and public-health sources, Virax estimates that up to 21 million adults in the United States may currently be living with Long COVID and related PAIS conditions, with approximately 2.5 million new cases estimated each year. Virax believes this represents a significant potential U.S. testing opportunity in an area where many patients are often assessed through symptoms and exclusion, rather than objective immune biomarkers of the type ViraxImmune™ is being developed to assess.

Highlights:

•In the pilot dataset, ViraxImmune™ demonstrated measurable separation between PAIS patients and healthy controls and achieved 88% specificity and 92% positive predictive value (“PPV”).

•ViraxImmune™ has now been evaluated in more than 120 subjects in the Company’s ongoing UK clinical study in Long COVID, ME/CFS and related post-acute infection syndromes.

•Virax is preparing for its next major development milestone: a larger clinical validation analysis involving previously collected samples from 300 additional participants, with analysis expected to begin in Q4 2026 and results expected in Q1 2027.

•Findings support continued advancement toward Virax’s intended U.S. market-entry strategy: an initial PAIS-focused U.S. Laboratory Developed Test (“LDT”) route, with broader in vitro diagnostic (“IVD”) development planned over time.

If validated in larger studies, ViraxImmune™ could become one of the first objective immune-profiling approaches developed specifically for Long COVID, ME/CFS and related post-acute infection syndromes. Virax believes this approach could support a differentiated diagnostic strategy in an area of significant unmet need, with potential applications in patient stratification, clinical decision-making, longitudinal monitoring and therapeutic development.

“These early pilot data mark an important step in the development of ViraxImmune™ as a potential objective immune-profiling test for Long COVID, ME/CFS and related post-acute infection syndromes,” said James Foster, Chairman and Chief Executive Officer of Virax Biolabs. “The observed separation between patients and healthy controls, together with encouraging early performance metrics, supports our confidence that ViraxImmune™ has the potential to address a major unmet diagnostic need as we advance toward our planned U.S. LDT-first route to market.”

“Patients with Long COVID, ME/CFS and related post-acute infection syndromes often face lengthy diagnostic journeys and limited objective testing options,” said Dr. Sean Knight, MD, PhD, Principal Investigator at the Lydia Becker Institute of Immunology and Inflammation, University of Manchester, and Consultant Respiratory Physician at Northern Care Alliance NHS Foundation Trust. “Objective immune profiling may help improve how these patients are assessed, stratified and monitored over time. These early pilot findings are encouraging and support further clinical validation of ViraxImmune™.”

Virax will host an investor webcast on May 26, 2026, at 4:15 p.m. ET to review the early ViraxImmune™ dataset, discuss the clinical and commercial implications of the findings, and outline the Company’s planned path toward larger clinical validation, assay finalization and U.S. market entry. Interested parties may register for the webcast at this link. A replay will be made available following the event.

ViraxImmune™ is in development and is not approved for diagnostic use in any jurisdiction. The VRX003 observations are preliminary and are intended to inform ongoing assay development and future clinical validation planning.

About Virax Biolabs Group Limited

Virax Biolabs Group Limited is a biotechnology company focused on the detection of immune responses to and diagnosis of viral diseases. The Company is developing T cell-based test technologies intended to support an immunology profiling platform. T cell testing may have applications in post-acute infection syndromes, including Long COVID, and other chronic conditions linked to immune dysregulation.

For more information, please visit www.viraxbiolabs.com

Caution Concerning Forward-Looking Statements

This press release contains forward-looking statements. In addition, from time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms.

In evaluating these forward-looking statements, you should consider various factors, including: our ability to keep pace with new technology and changing market needs; potential for clinical trials to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of preliminary, interim or top-line data to accurately reflect the complete results of a trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to continue to secure FDA and other regulators’ agreement on the regulatory path for ViraxImmune™ or other potential products; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us.

These forward-looking statements are based on information currently available to Virax and its current plans or expectations and are subject to a number of known and unknown uncertainties, risks and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the “Risk Factors” section of Virax’s Annual Report on Form 20-F for the year ended March 31, 2025. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions.

Company Contact:

Virax Biolabs Group Limited
Phone: +44 020 7788 7414
Email: info@viraxbiolabs.com

Investor Contact:

Dave Gentry, CEO
RedChip Companies, Inc.
Phone: 1-407-644-4256
Email: VRAX@redchip.com

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