Virax Biolabs Group Limited 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.
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.
For more information, please visit www.viraxbiolabs.com
