VRAX News & Events

Virax Biolabs files to sell 25.875M ordinary shares for holders

Virax Biolabs Group announced that it has successfully completed patient recruitment for its United Kingdom-based, multi-centre clinical study evaluating the performance of the ViraxImmune assay in detecting T cell dysfunction in Post-Acute Infection Syndromes,or PAIS, including Long COVID, post-treatment Lyme disease, or PTLD, and Myalgic Encephalomyelitis / Chronic Fatigue Syndrome, or ME/CFS. The study, conducted in collaboration with the UK's National Health Service, has achieved full enrolment ahead of schedule, reaching its target of 160 participants. It was randomised in a 3:1 ratio between symptomatic and non-symptomatic participants, with 40 patients recruited for each of the three symptomatic cohorts representing Long COVID, PTLD, and ME/CFS. The trial is designed to evaluate T cell dysfunction and immune dysregulation underlying the major symptoms observed in PAIS. The collected clinical samples will now undergo immunological analysis to evaluate the performance of the ViraxImmune assay in detecting T cell dysfunction as an aid in diagnosing PAIS in patients experiencing persistent and debilitating fatigue. The results from this analysis are intended to support regulatory submissions in the United Kingdom, including filings with the Medicines and Healthcare products Regulatory Agency, and may also inform subsequent U.S. submissions. In parallel, Virax announced that it received final minutes from its productive pre-submission meeting with the FDA on September 10 to discuss the proposed regulatory pathway for its ViraxImmune T cell assay. The meeting provided constructive feedback on the Company's continued development of the assay for use in patients with post-acute COVID-19 infection. Virax is incorporating the Agency's recommendations into its ongoing clinical and analytical development programs to support progress toward a future submission in the United States. The Company anticipates commencing its U.S.-based clinical study in 2026 in partnership with Emory University. Initial read-outs from this longitudinal study are expected in Q2 2026.

Virax Biolabs has signed a Research Services Agreement with Emory University's Center for the Advancement of Diagnostics for a Just Society to conduct clinical studies of ViraxImmune. These studies will focus on immune profiling in individuals with post-viral syndromes, beginning with post-acute sequelae of SARS-CoV-2, or PASC, commonly known as long COVID. Under the agreement, the Emory Laboratory for Innovative Assay Development will conduct patient recruitment, testing, and analysis to generate clinical data. This data is intended to support Virax's planned regulatory submissions and potential future commercial rollout. This collaboration aligns with Virax's preparations for a pre-submission meeting with the FDA in early September. The meeting will seek the FDA's feedback on the proposed intended use and regulatory pathway for ViraxImmune in PASC. The outcome will provide formal input on the pivotal U.S. clinical trial design and inform the company's regulatory and commercialisation strategy. ViraxImmune is a proprietary T cell testing technology designed to evaluate a patient's immune response profile.