Virax Biolabs' proprietary in-development diagnostic technology for post-acute infection syndromes ("PAIS"), such as Long COVID, positions the Company for an important data year ahead, following a series of recent clinical and operational milestones over the past 12 months.
LONDON, Dec. 3, 2025 /PRNewswire/ -- Virax Biolabs Group Limited (NASDAQ: VRAX) ("Virax" or the "Company"), an innovative biotechnology company dedicated to the advancement of immunology research and diagnostics, today highlighted key milestones, achievements and clinical progress while outlining its strategic priorities for 2026 in a letter to shareholders and investors.
Post-acute infection syndromes ("PAIS") – including Long COVID, myalgic encephalomyelitis / chronic fatigue syndrome ("ME/CFS") and post-treatment Lyme disease ("PTLD") – present a major healthcare challenge globally. In his letter to stakeholders and investors, Virax CEO James Foster outlines the Company's significant clinical progress in PAIS diagnostic development, alongside its financial position. Management believes this reflects a strong platform and tangible product potential for the ViraxImmune™ programme.
The letter looks back on the past year and sets out goals for 2026. It describes Virax Biolabs' transition from planning to execution across its core strategic programmes, the deepening of its scientific data package, and the advancement of U.S. and UK regulatory pathways. Key clinical and operational milestones highlighted in the letter include:
- UK Clinical Study Recruitment Completion: Full recruitment into its first UK clinical study (VRX-002) was completed ahead of schedule, with initial data expected in Q2 2026.
- New UK Trial Initiation: Initiation of a second UK-based trial (VRX-003) in PAIS, which is now fully enrolled.
- U.S. Research Collaboration: Establishment of a clinical collaboration with Emory University (ADJUST Center and ELIAD) to support U.S. regulatory and potential commercial plans in post-acute sequelae of COVID-19 (PASC, or Long COVID).
- ImmuneSelect RUO expansion: Continued development of the ImmuneSelect research-use-only ("RUO") portfolio of immune-profiling reagents, which can be commercialised for research use without waiting for diagnostic approvals and has the potential to contribute to near-term revenue as adoption builds among research and biopharmaceutical customers.
- Solid Balance Sheet: A debt-free balance sheet with sufficient cash on hand to execute near-term commercial and scientific priorities.
"The past year has been about execution – moving from plans on paper to recruited patients, generated data, regulatory engagement and strengthened institutional partnerships," said James Foster, Chairman and Chief Executive Officer of Virax Biolabs.
Virax Biolabs' progress and partnerships demonstrate the Company's commitment to advancing immunology research, developing what we believe to be a first-of-its-kind PAIS diagnostic, and building value for its stakeholders throughout 2026.
The full text of Mr Foster's 2025 Annual Letter to Shareholders is reproduced below.
Dear Fellow Shareholders,
As we close out 2025 and look ahead to the next phase of Virax Biolabs' journey, I am pleased to share an update on our progress and our priorities for the coming years. Over the past twelve months, we have moved from plans to execution across our core programmes – completing recruitment for our first UK clinical study, deepening our scientific data package, strengthening our U.S. and UK regulatory pathways, and reinforcing the balance sheet to support these activities.
Our strategic goal remains unchanged: to build a leading immune-profiling platform focused on T cell diagnostics and functional immune monitoring in post-acute infection syndromes, protective immunity and related areas of chronic immune dysfunction.
In 2026, our focus is on three core catalysts: delivering initial data from our UK PAIS study to support our planned UK regulatory submission; initiating the U.S. clinical study with Emory University in post-acute sequelae of COVID-19 ("PASC", also known as long COVID); and expanding commercial uptake of our ImmuneSelect research-use-only ("RUO") products as a potential nearer-term revenue driver and as a tool to improve understanding of immune system health globally.
Major Developments in 2025
Over the year, we announced the initiation of our first UK clinical validation study (VRX-002), the presentation of new T cell dysfunction data at WIRM in Davos, the launch of a long COVID collaboration with Emory University in the U.S., and continued strengthening of our scientific and clinical infrastructure. In addition, we initiated a second UK-based clinical study (VRX-003) in PAIS to support our planned regulatory submissions.
- Advancing the ViraxImmune™ clinical programme and ImmuneSelect research portfolio
In March, we announced that we had enrolled the first patients into our UK multicentre clinical study ( https://clinicaltrials.gov/study/NCT06731179 ), involving 160 subjects and evaluating the ViraxImmune™ T cell assay in PAIS, including long COVID, post-treatment Lyme disease ("PTLD"), and ME/CFS. This multi-site study, involving five clinical centres and run in collaboration with the National Health Service ("NHS"), is designed to generate the clinical data required to support planned regulatory submissions and ultimately to help inform patient care over time. Additionally, in April we initiated our second UK-based clinical study in PAIS, involving 100 subjects and run by Eurofins, which is now fully enrolled.
Shortly thereafter, we presented mechanistic data on T cell exhaustion and dysfunction in PAIS at the 19th World Immune Regulation Meeting ("WIRM") in Davos, Switzerland. These data showed progressive up-regulation of multiple exhaustion markers (PD-1, LAG-3, TIGIT, TIM-3, CD39) with repeated antigen stimulation, alongside changes in cytokine profiles in PAIS patients versus healthy controls. In simple terms, the findings suggest that many PAIS patients show clear signs of ongoing T cell dysfunction, which is consistent with the type of immune dysfunction that ViraxImmune™ is designed to characterise. We had previously announced our participation at WIRM as an important opportunity to showcase our immune-profiling portfolio to the scientific community.
In November, we reported a key operational milestone: completion of patient recruitment for the UK clinical study ahead of schedule, reaching the full target of 160 participants across long COVID, PTLD and ME/CFS cohorts. The collected samples are now undergoing detailed immunological analysis. We expect initial read-outs from this longitudinal study in the second quarter of 2026. These results are intended to support our planned submissions to the UK Medicines and Healthcare products Regulatory Agency ("MHRA") and to inform subsequent regulatory pathways.
Taken together, the progress in 2025 has significantly reduced the clinical execution risk for ViraxImmune™ and positioned us for an important data year ahead.
Alongside ViraxImmune™, we have continued to develop our ImmuneSelect RUO portfolio of peptide pools, ELISpot plates and related reagents. While still at an early stage, this offering already supports revenue-generating opportunities with laboratories and researchers working on chronic infection, inflammation and immune dysfunction. Because these are RUO reagents rather than diagnostic tests, they are for research use only and can be commercialised without waiting for diagnostic approvals, offering the potential to contribute to revenue in the near term as we build adoption among research and biopharmaceutical customers. We see ImmuneSelect as both a standalone commercial opportunity in the research and biopharmaceutical markets and a complementary channel for expanding awareness and adoption of the ViraxImmune™ platform over time. - Building a transatlantic regulatory and clinical footprint
In parallel with our UK work, we have made meaningful advances in the United States. In August, we announced a Research Services Agreement with Emory University's ADJUST Center and the Emory Laboratory for Innovative Assay Development ("ELIAD"). Under this agreement, Emory will conduct clinical studies of ViraxImmune™ focusing initially on post-acute sequelae of COVID-19 ("PASC", or long COVID), generating data to help inform our U.S. regulatory strategy and potential future commercial plans.
This collaboration is closely linked to our engagement with the U.S. Food and Drug Administration ("FDA"). We used 2025 to prepare for and then hold an in-person pre-submission meeting ("Q-sub") with the FDA to discuss the proposed intended use and regulatory pathway for ViraxImmune™ in PASC, also known as long COVID. The final minutes from this meeting, received in the autumn, provided constructive feedback on our clinical and analytical development plans. We are incorporating this guidance as we design our planned U.S. clinical study with Emory University, which we anticipate initiating in 2026.
Financial Position and Valuation
Our balance sheet remains a core strength of the Company.
As of 30 September 2025, we held approximately $3.3 million in cash and cash equivalents, with total assets of $5.7 million and total liabilities of $0.6 million, resulting in shareholders' equity of roughly $5.1 million and no long-term debt.
At the time of writing, Virax's market capitalisation is approximately $1.7 million. Based on these figures, the Company is trading below its cash balance and at a negative implied enterprise value (market capitalisation plus debt minus cash), which in our view implies that the market is currently ascribing limited value to our clinical programmes, intellectual property, laboratory infrastructure and longer-term commercial potential. While we cannot and do not make predictions about near-term share price movements, we believe this disconnect does not reflect what we see as the intrinsic value of our assets, the underlying progress of the business, or the scale of the opportunity we are pursuing. Our focus remains on disciplined capital allocation and execution of our strategy, confident that sustained delivery over time is the most effective way to create long-term shareholder value.
With a healthy cash position, a modest liability profile and no term debt to service, we believe we are appropriately capitalised to deliver our near-term clinical and regulatory milestones.
Strategic Priorities for 2026 and Beyond
Looking ahead, our first priority is to deliver high-quality clinical data from the UK PAIS study. With recruitment now complete, we are focused on finalising the immunological analyses and currently expect to share initial data in Q2 2026, including at scientific meetings and, where appropriate, in peer-reviewed publications. In parallel, we plan to initiate U.S. clinical work with Emory University by finalising a protocol that reflects recent FDA feedback and beginning enrolment into a long COVID–focused study in 2026. Together, these programmes are intended to help establish a robust transatlantic evidence base for ViraxImmune™. In addition, we are evaluating potential U.S. laboratory-based testing service offerings for ViraxImmune™, through appropriate laboratories and subject to applicable regulatory requirements, as a way to begin building early clinical experience and market familiarity with the assay, if pursued.
We will continue to progress our regulatory pathways in both the UK and the U.S., and emerging clinical and analytical data from these programmes will be used to prepare for interactions with the MHRA and subsequent submission steps. At the same time, we will maintain an active dialogue with the FDA as our data package matures, with the aim of helping to define a potential path for ViraxImmune™ in long COVID and related indications.
We also intend to expand our immune-profiling platform and partnerships. This includes growing the ImmuneSelect RUO portfolio and its distribution network, with the goal of building a recurring, diversified RUO revenue base over time, and exploring collaborations that apply ViraxImmune™ and ImmuneSelect to vaccine response, protective immunity and oncology. Across all of this, we remain disciplined in how we deploy capital—prioritising spending on activities that move us toward clear clinical, regulatory and commercial milestones, and seeking non-dilutive funding and strategic partnerships wherever possible to support the platform while protecting shareholder value.
Closing Thoughts
The past year has been about execution – moving from plans on paper to enrolled patients, generated data, regulatory engagement and strengthened institutional partnerships. We now enter 2026 with what we believe is a clearer clinical path, a stronger scientific story and the resources to pursue our next set of milestones.
On behalf of the Board and the entire Virax team, I would like to thank you for your continued support and patience during what we recognise has been a challenging market environment for small-cap biotech. We remain firmly committed to our mission of developing meaningful immune-profiling diagnostics for patients suffering from post-acute infection syndromes and related immune-mediated conditions, and to building long-term value for all our stakeholders.
Sincerely,
James Foster
Chairman and Chief Executive Officer
Virax Biolabs Group Limited
Virax Biolabs Group Limited is an innovative biotechnology company focused on the detection of immune responses to and diagnosis of viral diseases. Virax Biolabs Group Limited is developing T cell-based test technologies with the intention of providing an immunology profiling platform. T cell testing can be particularly effective in the diagnosis and therapeutics of post-acute infection syndromes such as 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 change the direction of the Company; our ability to keep pace with new technology and changing market needs; 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, the forward-looking events discussed in this press release and other statements made from time to time by us or our representatives might not occur.
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