Accessibility StatementSkip Navigation Extends cash runway into first half of 2028, beyond planned completion of ViraxImmuneâ"¢Â US based regulatory study in post-acute sequelae of COVID-19 ("PASC", or long COVID) and submission to the FDA, completion of UK based regulatory study in post-acute infection syndrome (PAIS) and submission to MHRA along with expansion of our immune-profiling platform and partnerships. LONDON, Dec. 4, 2025 /PRNewswire/ -- Virax Biolabs Group Limited ("Virax" or the "Company") (Nas ...

Core Viewpoint - Virax Biolabs Group Limited has announced a private placement for the purchase and sale of 12,500,000 ordinary shares at a price of $0.40 per share, aiming to raise gross proceeds of $5 million for working capital and corporate purposes [1] Group 1: Private Placement Details - The private placement includes ordinary shares and preferred investment options to purchase an additional 12,500,000 ordinary shares [1] - The exercise price for the preferred investment options is set at $0.40 per ordinary share, exercisable immediately for five years [1] - H.C. Wainwright & Co. is the exclusive placement agent for this offering [1] Group 2: Financial Implications - The expected gross proceeds from the private placement are $5 million, before deducting fees and expenses [1] - The company plans to use the net proceeds for working capital and other general corporate purposes [1] Group 3: Regulatory and Compliance Aspects - The securities involved in this transaction are not registered under the Securities Act of 1933 and cannot be reoffered or resold in the U.S. without proper registration or exemption [1] - Virax has agreed to file an initial registration statement with the SEC for the resale of the ordinary shares issued to investors [1] Group 4: Company Overview - Virax Biolabs Group Limited focuses on immunology research and diagnostics, particularly in the detection of immune responses to viral diseases [1] - The company is developing T cell-based test technologies aimed at diagnosing conditions like Long COVID and other chronic immune-related issues [1]

Core Viewpoint - Virax Biolabs is positioned for significant advancements in its proprietary diagnostic technology for post-acute infection syndromes (PAIS), including Long COVID, with a focus on achieving key clinical and operational milestones in 2026 [1][2] Company Developments - The company completed recruitment for its first UK clinical study (VRX-002) ahead of schedule, with initial data expected in Q2 2026 [1] - A second UK trial (VRX-003) in PAIS has been fully enrolled [1] - A clinical collaboration with Emory University has been established to support U.S. regulatory and commercial plans for Long COVID [1] - The ImmuneSelect research-use-only (RUO) portfolio is being developed to generate near-term revenue [1] Financial Position - As of September 30, 2025, the company held approximately $3.3 million in cash, with total assets of $5.7 million and no long-term debt, resulting in shareholders' equity of roughly $5.1 million [2] - The market capitalization is approximately $1.7 million, indicating that the market currently assigns limited value to the company's clinical programs and intellectual property [2] Strategic Priorities for 2026 - The primary focus is to deliver high-quality clinical data from the UK PAIS study and initiate U.S. clinical work with Emory University [2] - The company aims to expand its ImmuneSelect RUO portfolio and explore collaborations in vaccine response and oncology [2] - Continued engagement with regulatory bodies in both the UK and U.S. is planned to support the development of ViraxImmune™ [2]

Core Insights - Virax Biolabs Group Limited has signed a Research Services Agreement with Emory University's ADJUST Center to conduct clinical studies on ViraxImmune™, focusing on immune profiling in individuals with post-viral syndromes, particularly long COVID [1][2][3] - The collaboration aims to generate clinical data that will support regulatory submissions and potential commercial rollout of ViraxImmune™ [2][3] - The partnership is part of Virax's strategy to prepare for a pre-submission meeting with the FDA to discuss the regulatory pathway for ViraxImmune™ in PASC [3][4] Company Overview - Virax Biolabs is an innovative biotechnology company focused on immune response detection and diagnostics, particularly in viral diseases [5] - The company is developing T cell-based test technologies aimed at providing an immunology profiling platform, which is crucial for diagnosing post-viral syndromes like long COVID [5] Collaboration Significance - Partnering with Emory University, a leading institution in immunology and clinical research, is seen as a critical step in validating ViraxImmune™ in real-world patient populations [4][7] - The collaboration is expected to advance Virax's U.S. market entry strategy and create long-term value for shareholders [4]

Core Viewpoint - Virax Biolabs Group Limited has appointed Dr. Iain Miller as an Independent Director to its Board, effective July 29, 2025, succeeding Yair Erez, who is stepping down to pursue other professional opportunities [1][2]. Group 1: Appointment Details - Dr. Miller brings over 30 years of leadership experience in the diagnostics and MedTech sectors, having held senior positions at GE Healthcare, bioMérieux, and Massachusetts General Hospital [3]. - He has founded and led four MedTech companies, including Presymptom Health, where he developed InfectiClear®, a novel diagnostic for infectious diseases [3][4]. - Dr. Miller holds a PhD in BioEngineering, an MBA, and a BSc in Physics & Electronics, and has published extensively on diagnostic innovation [4]. Group 2: Strategic Importance - The CEO of Virax, James Foster, emphasized that Dr. Miller's leadership and expertise will be crucial as the company advances its immune profiling platform and progresses towards IVD development and market entry [5]. - Dr. Miller expressed excitement about joining Virax at a time of strategic focus, highlighting the potential of the immune profiling platform to enhance monitoring of chronic and post-viral conditions [5]. Group 3: Company Focus - Virax Biolabs is focused on the detection of immune responses and diagnosis of viral diseases, currently developing T-Cell-based test technologies aimed at providing an immunology profiling platform [6]. - The company’s T-Cell testing is particularly relevant for diagnosing post-viral syndromes such as Long COVID and other chronic conditions linked to immune dysregulation [6].

Core Points - Virax Biolabs Group Limited has received a notice from Nasdaq indicating non-compliance with the minimum bid price requirement of $1.00 per share [1][2] - The company has a compliance period of 180 calendar days, until January 12, 2026, to regain compliance [3] - If the closing bid price reaches at least $1.00 for 10 consecutive business days during this period, Nasdaq will confirm compliance [3] - The notification does not lead to immediate delisting, and shares will continue to trade under the symbol "VRAX" [4] Company Overview - Virax Biolabs Group Limited is focused on the detection of immune responses and diagnosis of viral diseases [4] - The company is developing T-Cell-based test technologies aimed at providing an immunology profiling platform [4] - T-Cell testing is particularly effective for diagnosing post-viral syndromes such as Long COVID and other chronic conditions linked to immune dysregulation [4]

Financial Performance - The company incurred net losses of $6,067,232, $6,739,120, and $5,457,763 for the years ended March 31, 2025, 2024, and 2023, respectively, with an accumulated deficit of $24,589,244 as of March 31, 2025[26]. - The company expects to continue incurring significant losses for the foreseeable future as it conducts ongoing research and development of its ViraxImmune products[26]. - Revenues from the ViraxClear and ViraxVet brands were immaterial and accounted for 100% of total revenues for the fiscal year ended March 31, 2025[192]. - Research and development expenses for the years ended March 31, 2025, 2024, and 2023 were $1,779,802, $1,561,965, and $2,179,341 respectively, indicating a strategic investment in innovation[210]. Product Development and Commercialization - The strategic focus is on developing and commercializing immune profiling in-vitro diagnostics (IVDs) related to chronic inflammation and T cell exhaustion, including post-viral syndromes and other infectious diseases[28]. - The company aims to leverage the ViraxImmune platform to address a wide range of research, diagnostic, and health needs, but faces risks in generating compelling evidence for its T cell test results[31]. - The development of new products and services is a speculative endeavor, with potential failures at any stage of development or commercialization[29]. - The company is developing a comprehensive set of T cell diagnostics and immune profiling solutions, with a focus on obtaining FDA clearance for its IVD products[36]. - The company anticipates that product development will require substantial time and resources, with uncertain outcomes[29]. - The company is developing the ViraxImmune platform to assess individual immune risk profiles against major global viral diseases, with a Q-submission meeting anticipated in Q3 2025[187]. - The company plans to launch T cell immune profiling assays as research-use-only (RUO) before transitioning to in-vitro diagnostics (IVDs) for chronic inflammation and T cell exhaustion[200]. Regulatory and Compliance Challenges - Regulatory approvals are critical for the commercialization of ViraxImmune products, and failure to obtain these approvals could impair the company's strategic objectives[35]. - The company may face significant delays in obtaining regulatory approvals due to a shortage of capacity among Notified Bodies under the IVDR[102]. - Noncompliance with FDA requirements can result in severe penalties, including fines, recalls, and criminal prosecution[112]. - The regulatory environment for IVD may change, potentially impacting the company's ability to enter various markets[91]. - The company is subject to extensive government regulations related to development, testing, manufacturing, and commercialization in Europe and the United States[93]. Intellectual Property Risks - The absence of patents may expose the company to risks, including the inability to prevent competitors from replicating technologies, potentially eroding market share and revenue[71]. - The company relies on trade secrets and contractual protections to safeguard intellectual property, but these may be less effective than patents[72]. - Future patent applications may not be successful, and failure to secure patents could limit the company's competitive edge and lead to costly litigation[73]. - Unauthorized disclosure or misappropriation of trade secrets could harm the company's competitive position and business[87]. - The company’s ability to commercialize products may be hindered if it cannot adequately protect its intellectual property rights[81]. Market and Operational Risks - The company faces significant challenges in successfully commercializing its products, particularly in new markets, requiring appropriate infrastructure such as IT and enterprise resource planning[41]. - Establishing sales and marketing capabilities in targeted expansion regions is crucial; failure to do so may adversely affect the company's financial condition and results of operations[43]. - The success of the company's products depends on market acceptance by Contract Research Organizations, hospitals, and public health departments, as well as the growing interest in personal health management[46]. - The in-vitro diagnostics industry is subject to rapid change, and the company must keep pace with technological advancements to avoid obsolescence of its products and services[64]. - The company may face regulatory scrutiny regarding the collection and use of personal data, which could lead to fines and penalties affecting its business operations[61]. Management and Corporate Structure - The company has a limited operating history, having commenced operations in 2013, and has focused on organizing, staffing, and raising capital[25]. - The loss of key management personnel could disrupt operations and strategic plans, impacting the company's financial condition[65]. - The company operates as a holding company with no material operations of its own, conducting the majority of its operations through subsidiaries in the UK, US, and China[185]. - The company qualifies as a foreign private issuer, allowing it to follow less stringent reporting requirements compared to U.S. domestic public companies[153]. Financial and Market Position - The company incurs significant costs associated with being a public company, which may adversely affect its financial condition and results of operations[164]. - The market price of the company's shares may be volatile, influenced by various factors including potential class action litigation[145]. - The company does not intend to pay cash dividends on its ordinary shares in the foreseeable future, having never paid dividends previously[149]. - The company may experience reduced liquidity for its ordinary shares, which could affect trading activity in the secondary market[154]. Cybersecurity and Compliance - Cybersecurity threats pose risks to financial performance, with potential costs arising from system disruptions and regulatory compliance[125]. - The company has not experienced material cybersecurity breaches to date, but remains vulnerable to unauthorized access and data disclosure[126]. - The company faces risks related to compliance with anti-corruption and anti-money laundering laws, which could result in severe penalties and impact its reputation[163]. Market Opportunities - The primary markets of interest include the United Kingdom and North America, driven by rising healthcare expenditures and government support for research and development[199]. - The global IVD market is expected to grow due to factors such as an aging population and increased awareness of complex infectious diseases, despite challenges in developing nations[202]. - The company aims to develop lab-agnostic diagnostic devices to facilitate broader geographic distribution and rapid market capture[207].

Core Insights - H.C. Wainwright has initiated coverage on Virax Biolabs Group Limited, a U.K.-based company focused on immune response detection and viral disease diagnosis [1] - The company is developing T cell-based test technologies aimed at providing an immunology profiling platform, particularly effective for diagnosing post-viral syndromes like Long COVID [1][2] Company Overview - Virax Biolabs is working on the ViraxImmune platform, which will initially be available for research use only before seeking in vitro diagnostics (IVD) approval [3] - The platform utilizes peptide pools to activate memory T cells and measure specific cytokine profiles, addressing various diseases and research needs [2] Market Opportunity - Analyst Yi Chen estimates that between 254,000 and 301,000 patients annually could benefit from Virax's T cell exhaustion-based IVD [4] - The diagnostics market for long COVID cases alone could be worth hundreds of millions of dollars, with no reliable tests currently available for conditions linked to post-acute infection syndrome (PAIS) [4] Clinical Development - Virax Biolabs has begun enrolling patients in a multi-center clinical study in the U.K. to assess the performance of the ViraxImmune FluoroSpot T cell assay in detecting T cell dysfunction in post-acute infection syndrome patients [5] - The study aims to enroll up to 200 participants, with initial data expected in Q2 2026 [5] Analyst Rating - H.C. Wainwright has given Virax a Buy rating with a price target of $3 [4] - The stock is currently trading flat at $1.16 [6]

Core Insights - Virax Biolabs Group Limited has initiated patient enrollment for a multi-center clinical study in the UK to assess the performance of its ViraxImmune™ FluoroSpot T cell assay in detecting T cell dysfunction in patients with post-acute infection syndromes, including long COVID and other related conditions [1][2][3] Group 1: Clinical Study Details - The clinical study, registered as NCT06731179, is conducted in collaboration with the UK's National Health Service and aims to enroll up to 200 participants [2] - Initial data from this longitudinal assessment is expected to be available in Q2 2026 [2] Group 2: Company Objectives and Potential - The CEO of Virax Biolabs emphasized the lack of reliable diagnostics for conditions associated with post-acute infection syndromes, stating that the study's data will enhance understanding of immune dysregulation and improve diagnostics and patient care [3] - The ViraxImmune™ assay is positioned to potentially improve immune health assessment, leading to earlier treatment interventions and better patient outcomes [3] Group 3: Company Overview - Virax Biolabs is focused on developing T cell-based test technologies aimed at providing an immunology profiling platform, particularly effective for diagnosing post-viral syndromes like Long COVID and chronic conditions linked to immune dysregulation [4]

Core Insights - Virax Biolabs Group Limited presented data on T-Cell dysfunction in post-acute infection syndromes (PAIS) at the World Immune Regulation Meeting in Davos, Switzerland [1] - The data indicates that chronic infections can lead to T-Cell exhaustion, which is associated with reduced immune functionality and impaired cytokine production [2][3] - The company is conducting clinical validation studies to assess the link between T-Cell dysfunction and symptoms such as chronic fatigue and cognitive impairment [3] Company Overview - Virax Biolabs is focused on the detection of immune responses and diagnosis of viral diseases, developing T-Cell-based test technologies for immunology profiling [4] - The company aims to address post-viral syndromes like Long COVID and other chronic conditions linked to immune dysregulation through its diagnostic technologies [4]