LONDON, July 18, 2025 /PRNewswire/ -- Virax Biolabs Group Limited (NASDAQ: VRAX) ("Virax" or the "Company"), an innovative biotechnology company focused on the detection of immune responses and diagnosis of viral diseases, announced that it received a notice from The Nasdaq Stock Market LLC ("Nasdaq") dated July 14, 2025, notifying the Company that it is not in compliance with the minimum bid price requirement as set forth under NASDAQ Listing Rule 5550(a)(2)(the "Minimum Bid Price Rule") for continued list ...

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]

Core Insights - Virax Biolabs Group Limited will present at the 19th World Immune Regulation Meeting (WIRM) in Davos, Switzerland from March 12-15, 2025 [1] - The presentation will focus on T cell dysfunction in post-acute infection syndromes, led by Dr. Nigel McCracken, the Chief Operating Officer [2] - The company will showcase its immune profiling products for research use at Booth 116 during the conference [2] Company Overview - Virax Biolabs is a biotechnology company specializing in 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, particularly for diagnosing post-viral syndromes like Long COVID [4] Event Details - WIRM 2025 will host around 600 scientists and clinicians globally, featuring scientific lectures, networking opportunities, and a poster exhibition [3]

Core Viewpoint - Virax Biolabs Group Limited is committed to enhancing vaccine efficacy transparency and empowering public health decisions through innovative technology and immune profiling solutions [1][2][4]. Group 1: Company Commitment and Technology - The company recognizes the essential role of vaccines in public health and emphasizes the importance of transparency regarding vaccine effectiveness and individual immune profiles [2][3]. - Virax Biolabs is positioned to advance vaccine transparency by collaborating with vaccine developers, utilizing cutting-edge technology to measure vaccine efficacy and monitor long-term immune protection [3][4]. - The company is developing T-Cell-based test technologies aimed at providing an immunology profiling platform, which can be particularly effective in diagnosing post-viral syndromes like Long COVID [4]. Group 2: Alignment with Public Health Initiatives - Virax Biolabs aligns with the U.S. Department of Health and Human Services' commitment to vaccine efficacy transparency, which is crucial for informed public health decisions [1][4]. - The CEO of Virax Biolabs stated that the company is well-positioned to provide critical, data-driven insights on vaccine efficacy to support both existing and future vaccine development [4].

Core Viewpoint - Virax Biolabs Group Limited is focused on advancing its innovative T-cell diagnostics and immune profiling solutions, with strategic goals set for 2025 to enhance its market presence and address chronic inflammation and immune dysfunction [2][3][4]. Company Developments - In 2024, Virax launched ImmuneSelect, a research-use-only version of its ViraxImmune™ platform, aimed at researchers and clinicians [3][9]. - The company initiated a clinical study in the UK to assess the performance of the ViraxImmune™ platform in detecting T-cell dysfunction in post-acute infection syndrome patients, with an enrollment of up to 160 participants [6]. - Discussions have begun with U.S. clinical institutions to support IVD development, and a request for a formal meeting with the FDA is planned for Q2 2025 [7][8]. Financial Highlights - Research and development expenses increased by approximately 33% year-over-year as of September 30, 2024, with capital expenditures also rising [15]. - The company reported a cash balance of approximately $7.3 million and working capital of approximately $6.6 million as of September 30, 2024, with no long-term debt obligations [16]. Strategic Goals for 2025 - Key priorities include advancing clinical validation studies in the UK and U.S., progressing U.S. regulatory interactions, expanding distribution channels for ImmuneSelect, and initiating a clinical performance study for protective immunity [13][14]. Distribution Agreements - Virax has established distribution agreements for its ImmuneSelect products across the EU, UK, Norway, and Switzerland, and aims to secure U.S. distribution partners by Q1 2025 [10][11]. - The company expanded its ViraxClear distribution channels, including agreements to supply Mpox Virus Real-Time PCR Detection Kits to multiple regions [12].

Financial Performance - Revenue for the six months ended September 30, 2024, was $4,953, a decrease of 93.5% compared to $76,500 for the same period in 2023[5] - Net loss for the six months ended September 30, 2024, was $2,756,564, compared to a net loss of $2,914,204 for the same period in 2023, reflecting a 5.4% improvement[5] - Operating expenses for the six months ended September 30, 2024, totaled $2,872,417, an increase of 5.7% from $2,716,741 in the same period of 2023[5] - The company reported a gross loss of $6,474 for the six months ended September 30, 2024, compared to a gross profit of $10,518 for the same period in 2023[5] - Total revenue for the six months ended September 30, 2024, was $4,953, a significant decrease from $76,500 in the same period of 2023, indicating a decline in focus on the ViraxClear and ViraxVet platforms[74] - For the six months ended September 30, 2024, the company reported a loss of $2,756,427, resulting in a basic and diluted loss per share of $(0.89), compared to a loss of $2,909,652 and a loss per share of $(1.64) for the same period in 2023[78] Assets and Equity - Total assets increased to $9,442,944 as of September 30, 2024, up from $5,483,969 on March 31, 2024, representing a growth of 72%[3] - Total stockholders' equity rose to $8,416,877 as of September 30, 2024, compared to $5,138,775 on March 31, 2024, indicating a growth of 63.5%[3] - The accumulated deficit increased to $21,284,424 as of September 30, 2024, from $18,527,997 on March 31, 2024[3] Cash Flow and Liquidity - Cash at the end of the period increased to $7,285,991, up from $3,589,244 at the beginning of the period, marking a 103.5% increase[8] - Cash flows from operating activities showed a net cash used of $1,918,624 for the six months ended September 30, 2024, compared to $3,593,961 for the same period in 2023, indicating a reduction in cash outflow[8] - As of September 30, 2024, the company had a cash balance of $7,285,991 and current liabilities of $693,969, resulting in a net increase in cash of $3,696,747 for the six months ended September 30, 2024[14] Research and Development - The company expects to continue generating operating losses in the foreseeable future due to ongoing research and development activities, corporate overhead, and costs associated with being a public company[15] - The company is developing the ViraxImmune platform, which aims to provide immunology profiling to assess individual immune risk against major viral diseases and assist in early diagnosis of post-viral syndromes[11] - The company plans to apply for regulatory agency approval for its T cell Test under the ViraxImmune brand, focusing initially on diseases associated with post-viral syndromes, including SARS-CoV-2 and HPV[11] Shareholder Information - The company issued 1,499,909 shares for cash, raising $5,128,186 during the period[6] - The Company completed a Share Consolidation on December 18, 2023, consolidating every ten shares into one, enabling compliance with Nasdaq Marketplace Rule 5550(a)(2) and maintaining its listing[98] - As of September 30, 2024, the Company had 4,341,956 ordinary shares issued and outstanding[102] - The Company raised gross proceeds of $4,990,014 from a registered direct offering of 1,108,892 ordinary shares at $4.50 per share on August 21, 2024, with total net proceeds of $4,389,863 after offering costs[101] Taxation and Compliance - The Company expects to be subject to income and other taxes in various jurisdictions in the future, despite being organized as a Cayman Islands corporation[43] - Deferred tax assets are recognized only if it is probable that future taxable profit will be available to utilize those temporary differences and losses[45] Accounting Policies - The company’s financial statements are prepared in accordance with IFRS, ensuring consistency in accounting policies across all periods presented[17] - The company’s revenue recognition policy reflects the transfer of control of products to customers, with revenues recognized net of any taxes collected[31] - The Company accounts for leases under IFRS 16, recognizing a right-of-use asset and a lease liability for all leases with a term of more than twelve months[50] Inventory and Expenses - Inventories as of September 30, 2024, totaled $125,255, consisting of raw materials, work-in-progress, and finished goods, compared to $60,383 as of March 31, 2024[81] - The company reported depreciation expense of $117,220 for the six months ended September 30, 2024, significantly higher than $4,750 for the same period in 2023[84] - Accounts payable and accrued liabilities increased to $422,865 as of September 30, 2024, from $120,894 as of March 31, 2024[85] Loans and Liabilities - The company entered into a loan payable of $315,000 on July 1, 2024, with a balance of $222,728 as of September 30, 2024, and incurred interest expense of $5,794 during the period[86] - Lease liabilities totaled $380,474 as of September 30, 2024, with total lease payments amounting to $537,704[95] Capital Management - The Company aims to manage its capital resources to ensure financial strength and maximize financial flexibility, primarily through the sale of ordinary shares[119]

Core Insights - Virax Biolabs Group Limited has entered into a distribution agreement with Europa Biosite to commercialize its ImmuneSelect Research Use portfolio in the UK and Ireland [1] - The partnership aims to enhance the accessibility of ImmuneSelect products for researchers and pharmaceutical companies focusing on T cell response and immune status [1] Company Overview - Virax Biolabs is a biotechnology company specializing in the detection of immune responses and diagnosis of viral diseases, currently developing T-Cell-based test technologies [4] - The company’s focus includes providing an immunology profiling platform, particularly for diagnosing post-viral syndromes like Long COVID [4] Product Details - ImmuneSelect is a portfolio of research products aimed at investigating adaptive immunity, including peptide pools for various pathogens such as SARS-CoV-2, Lyme Disease, and Epstein-Barr Virus [2] - The products are designed for research and investigational use only and are compatible with standard laboratory equipment [2] Distribution Partner - Europa Biosite is a European supplier of life science products, comprising six leading distribution companies and offering over 5 million products across 16 European countries [3] - The partnership with Virax Biolabs is expected to leverage Europa Biosite's commercial infrastructure to provide local technical support and enhance product availability [1][3]