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].

Core Viewpoint - Virax Biolabs Group Limited has announced a definitive agreement for the issuance and sale of 1,108,892 ordinary shares at a price of $4.50 per share, aiming to raise approximately $5 million in gross proceeds for working capital and general corporate purposes [1][2]. Group 1 - The closing of the offering is expected to occur on or about August 23, 2024, pending customary closing conditions [1]. - H.C. Wainwright & Co. is acting as the exclusive placement agent for this offering [2]. - The net proceeds from the offering will be utilized for working capital and general corporate purposes [2]. Group 2 - The securities are being offered under a "shelf" registration statement on Form F-3, previously filed with the SEC [3]. - A final prospectus supplement and accompanying base prospectus will be filed with the SEC and made available on their website [3]. - The offering is conducted in compliance with securities laws, and no unlawful offers or sales will occur [4]. Group 3 - Virax Biolabs Group Limited focuses on the detection of immune responses and diagnosis of viral diseases, developing T-Cell-based test technologies [5]. - The company aims to provide an immunology profiling platform, particularly effective for diagnosing post-viral syndromes like Long COVID [5].

Financial Performance - Revenues for the year ended March 31, 2024, were $156,419, a significant increase from $8,561 for the year ended March 31, 2023, representing a growth of approximately 1,730%[269]. - Cost of revenues for the year ended March 31, 2024, was $105,829, compared to $9,926 for the year ended March 31, 2023, indicating a substantial increase in costs associated with test kit supply[270]. - Operating expenses increased by approximately 14%, totaling $6,547,063 for the year ended March 31, 2024, compared to $5,731,396 for the year ended March 31, 2023[271]. - The net loss for the year ended March 31, 2024, was $6,739,120, compared to a net loss of $5,457,763 for the year ended March 31, 2023, reflecting an increase in losses[276]. - Cash used in operating activities was $6,247,016 for the year ended March 31, 2024, up from $4,179,767 for the year ended March 31, 2023, primarily due to increased operational costs[279]. - Cash used in investing activities was $1,164,449 for the year ended March 31, 2024, compared to $178,403 for the year ended March 31, 2023, indicating increased investment in intangible assets[280]. - The Company has an accumulated deficit of $18,527,997 as of March 31, 2024, and a cash balance of $3,589,244[287]. - Net cash provided by financing activities was $1,648,171 for the year ended March 31, 2024, primarily from the exercise of warrants[286]. - The Company plans to use its current cash balance for research and development, product certification approvals, and establishing distribution networks[288]. - The Company has not generated significant revenue from existing operations and relies on its cash balance and financing to fund its business plans[288]. - The Company may seek additional capital through government grants, debt or equity securities, or credit facilities if future cash is insufficient[289]. - The Company has not generated consistent cash flows to fund operations and may require additional capital for future expenditures[287]. Capital Expenditures and Investments - For the fiscal year ended March 31, 2024, capital expenditures were $1,164,449, compared to $178,403 for the previous year, reflecting a significant increase in investment[194]. - The Company raised approximately $4,000,000 through a private placement offering on March 8, 2023, to support its operations and development efforts[283]. - The Company entered into an inducement offer agreement to exercise 734,073 existing warrants at a reduced price of $2.934 per share, generating approximately $1.9 million in net proceeds[285]. - The Company issued new warrants to purchase up to 1,468,145 ordinary shares at an exercise price of $2.924[285]. Research and Development - Research and development expenses for the years ended March 31, 2024, and 2023 were $1,561,965 and $2,179,341, respectively, indicating a decrease of approximately 28.3%[222]. - The company is developing the ViraxImmune platform, which aims to provide immunology profiling for major viral diseases and assist in early diagnosis of post-viral syndromes[264]. - The company is focused on developing a comprehensive set of immune profiling IVDs to enable early diagnosis for post-viral syndromes[229]. - The company intends to launch T cell immune profiling assays as research-use-only (RUO) before releasing fully approved IVDs[212]. - The company is collaborating on the UK ImRESP trial to generate longitudinal samples for the development of IVD diagnostics[230]. Market and Product Development - ViraxImmune, the company's primary focus, aims to develop T cell diagnostics and immune profiling solutions for chronic inflammation and T cell exhaustion[205]. - The potential market for ViraxImmune includes the UK and North America, driven by rising healthcare expenditures and a large patient population[210]. - The IVD market is expected to grow due to factors such as an aging population and increased awareness of infectious diseases[214]. - The ViraxImmune platform will initially focus on measuring chronic inflammation associated with T cell exhaustion in areas such as SARS-CoV-2 effects and post-viral syndromes[218]. - The company aims to capture a broader market share by designing the ViraxImmune T cell IVD test kit to be lab agnostic and easy to use[219]. - The primary markets of interest for the company are the United Kingdom and North America, driven by rising healthcare expenditures and a large patient population[220]. Corporate Structure and Governance - Virax Biolabs qualifies as an "emerging growth company" with less than $1.235 billion in revenue for the last fiscal year, allowing it to take advantage of reduced reporting requirements[196]. - The company operates through subsidiaries in the UK, the US, and China, focusing on the prevention and diagnosis of viral diseases[200]. - The company has a corporate structure consisting of multiple wholly owned subsidiaries, including Virax Biolabs Group Limited and Virax Biolabs (UK) Limited, which focus on research and development activities[254]. - The company has established an audit committee consisting of three independent directors to oversee financial reporting and audits[317]. - The compensation committee, composed of three independent directors, is responsible for reviewing and approving the compensation structure for executive officers[318]. - The board of directors consists of five members, with a majority being independent directors as per Nasdaq rules[315]. Regulatory Compliance - The FDA requires a 510(k) premarket notification for Class II devices, which must demonstrate substantial equivalence to a predicate device[241]. - The FDA has a performance goal review time of 180 days for a PMA submission, although actual review times may be longer due to additional data requests[244]. - Emergency Use Authorizations (EUAs) were issued by the FDA during the SARS-CoV-2 pandemic to expedite access to critical medical products[246]. - The company is subject to ongoing FDA regulations, including record-keeping and reporting of adverse experiences related to its medical devices[245]. - The company may face civil penalties or product recalls if found in material violation of FDA regulations[248]. Employee Compensation and Structure - James Foster's total compensation for 2024 is $650,800, a decrease of 62.5% from $1,738,975 in 2023[302]. - Cameron Shaw's total compensation for 2024 is $243,462, down from $1,697,675 in 2023, reflecting a 85.6% decrease[302]. - Jason Davis, Chief Financial Officer, received a total compensation of $625,118 in 2024, compared to $1,028,500 in 2023, a decline of 39.2%[302]. - As of March 31, 2024, the company had 17 full-time employees, with 11 in the United Kingdom, 1 in the United States, and 5 in China[325]. Shareholder Information - The authorized share capital is US$50,000, divided into 50,000,000 ordinary shares with a par value of $0.001 each[333]. - The beneficial ownership of ordinary shares includes James Foster with 287,987 shares, representing 11.2% of the total[329]. - The company’s ordinary shares have been trading on Nasdaq under the symbol "VRAX" since July 21, 2022[332]. - There are no limitations on non-residents or foreign shareholders regarding voting rights on ordinary shares[339]. - The board of directors has the authority to issue additional ordinary shares, which may dilute existing shareholders' voting power[345]. Taxation and Legal Considerations - The company is classified as an exempted company under the Cayman Companies Act, allowing it to conduct business mainly outside the Cayman Islands[347]. - The company does not currently expect to be classified as a Passive Foreign Investment Company (PFIC) for the current taxable year or the foreseeable future[354]. - If the company is classified as a PFIC, U.S. Holders could be liable for additional taxes and interest charges under the PFIC excess distribution regime[356]. - U.S. Holders are strongly urged to consult their tax advisors regarding the implications of PFIC status on their investments in the company's ordinary shares[364].