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]

Company Overview - Virax Biolabs Group Limited is an innovative biotechnology company 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, particularly effective for diagnosing post-viral syndromes like Long COVID and other chronic conditions linked to immune dysregulation [4] Event Participation - The company will host a booth at the 7th European Congress of Immunology (ECI) from September 1 - 4, 2024, in Dublin, Ireland [1] - Virax will showcase its portfolio of immune profiling products for research use at Booth C13, with management available for discussions with research organizations and potential customers [2] Industry Context - The European Congress of Immunology is a triennial joint meeting of all European Federation of Immunological Societies (EFIS), regarded as one of the most prestigious international conferences in basic and clinical immunology, attracting over 3,000 delegates [3] - The theme for this year's congress is 'Conquering challenges with Immunology' [3]

Group 1 - Virax Biolabs Group Limited has entered into a distribution agreement to commercialize RT PCR Mpox virus detection kits in 13 European countries and GCC nations [1][3] - The RT PCR Mpox virus detection kits are CE-marked for sale in Europe and authorized by the UK's Medicines and Healthcare products Regulatory Agency, with a sensitivity of 96.7% and specificity of 93.72%, delivering results in under 70 minutes [2] - The partnership aims to equip healthcare professionals with tools to diagnose and mitigate the spread of the Mpox virus, reaching at-risk communities across major geographies [3] Group 2 - Virax Biolabs is focused on the detection of immune responses and diagnosis of viral diseases, currently developing T-Cell-based test technologies for immunology profiling [5]

Core Viewpoint - Virax Biolabs Group Limited has successfully closed a registered direct offering, raising approximately $5 million through the sale of 1,108,892 ordinary shares at a price of $4.50 per share [1][2]. Company Overview - Virax Biolabs Group Limited is a biotechnology company focused on detecting immune responses and diagnosing viral diseases [5]. - The company is developing T-Cell-based test technologies aimed at providing an immunology profiling platform, which is particularly effective for diagnosing post-viral syndromes like Long COVID and other chronic conditions related to immune dysregulation [5]. Offering Details - The offering was facilitated by H.C. Wainwright & Co. as the exclusive placement agent [1]. - The gross proceeds from the offering were approximately $5 million before deducting fees and expenses [2]. - The shares were sold under a "shelf" registration statement filed with the SEC, which was declared effective in December 2023 [3].