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].

Financial Performance - The company incurred net losses of $5,457,763 and $1,749,870 for the years ended March 31, 2023 and 2022, respectively, with an accumulated deficit of $11,794,460 as of March 31, 2023[24]. - The company expects to continue incurring significant losses as it conducts ongoing preclinical studies and clinical trials for its ViraxImmune products, which will require additional development time and resources[24]. - The company's success is partially dependent on the continued demand for COVID-19 diagnostic products, which may decline due to changing healthcare policies[46]. Product Development and Regulatory Approval - The company plans to submit its new T-Cell IVD/Immune response Test kit under the name ViraxImmune for regulatory approval in the second half of 2023[25]. - The company is developing a T-Cell IVD/Immune response Test kit for COVID-19, with intentions to adapt it for immunological profiling against multiple viral threats[34]. - The proprietary T-Cell IVD/Immune response Test requires successful completion of clinical and validation studies, which are expensive and time-consuming[47]. - The company is developing a T-Cell IVD/immune response test under the ViraxImmune brand, but has not yet submitted any tests for regulatory approval[54]. Market Challenges and Competition - The company faces significant challenges in successfully commercializing its products, particularly in new markets, and requires appropriate infrastructure for effective marketing and sales[39]. - The market acceptance of the company's products by hospitals, public health departments, and consumer groups is crucial for generating sufficient revenue to achieve profitability[42]. - The company acknowledges that developing new products and services is a speculative and risky endeavor, with potential failures at any stage of development[27]. - The potential for competition from similar products increases as patents expire, impacting future revenue[86]. Intellectual Property Risks - The company faces challenges in protecting its intellectual property, which is vital for maintaining competitive advantage[76]. - Patent protection is uncertain, and pending applications may not result in issued patents, affecting market potential[78]. - The America Invents Act (AIA) introduced a "first-to-file" system for patents, which may increase the risk of third parties obtaining patents for inventions made by the company before filing[87]. - Changes in the AIA allow third parties to challenge issued patents in the USPTO, potentially increasing costs and uncertainties in patent enforcement[88]. Regulatory Compliance and Risks - Regulatory compliance regarding data protection is complex and evolving, with potential fines of up to €20 million or 4% of total worldwide annual turnover for non-compliance with GDPR[59]. - The company is subject to ongoing regulatory requirements, and failure to comply could result in significant penalties, including fines and product withdrawals[109]. - The European Union's In-Vitro Diagnostic Regulation (IVDR) requires compliance by May 26, 2025, for high-risk products, with subsequent deadlines for other classifications[112]. - Noncompliance with FDA requirements can lead to severe consequences, including fines, recalls, and criminal prosecution[125]. Operational Risks - The company relies on a limited number of suppliers for laboratory equipment and materials, which poses risks of delays and quality issues[51]. - Supplier disruptions could adversely affect the company's business and results of operations, particularly if key supplier relationships are not maintained[50]. - The company relies on key senior management and personnel, and losing them could disrupt operations and strategic plans[66]. - Information technology systems are essential for operations, and failures could adversely affect product development and service delivery[68]. Market Expansion and Customer Concentration - The company plans to expand its sales force globally and establish additional distributor relationships to access international markets, including the EU, United States, and Canada[48]. - A significant customer concentration exists, with one customer and five customers accounting for approximately 100% of total sales for the years ended March 31, 2023, and 2022[53]. Economic and Geopolitical Risks - The uncertainty surrounding the United Kingdom's withdrawal from the European Union (Brexit) could lead to significant new costs and impair the company's ability to transact business in the EU[141]. - The company may face increased trade barriers post-Brexit, making business operations in the EU and EEA more difficult[145]. - Economic conditions in Hong Kong and China are sensitive to global economic conditions, which may negatively impact the company's business and financial condition[158]. Financial and Tax Risks - The company is exposed to unanticipated changes in tax laws and regulations, which could materially affect its financial condition and results of operations[146]. - The company is subject to a 10% PRC withholding tax on dividends paid to non-resident investors, which may significantly affect the value of investments in Ordinary Shares[201]. - The company has never paid dividends on Ordinary Shares and does not anticipate paying any cash dividends in the foreseeable future[207]. Corporate Governance and Reporting - The company qualifies as a foreign private issuer, allowing it to follow less stringent reporting requirements compared to U.S. domestic public companies[213]. - If the company loses its foreign private issuer status, it would face increased regulatory and compliance costs under U.S. securities laws[214]. - The company may adopt corporate governance practices that differ significantly from Nasdaq standards, potentially affording less protection to shareholders[215].

Financial Performance - Revenue for the six months ended September 30, 2022, was $5,760, compared to $0 in the same period of 2021[5] - The net loss for the six months ended September 30, 2022, was $1.45 million, compared to a net loss of $575,040 in the same period of 2021[5] - Total operating expenses for the six months ended September 30, 2022, were $1.44 million, a significant increase from $566,740 in the same period of 2021[5] - The company reported a basic and diluted net loss per share of $0.38 for the six months ended September 30, 2022, compared to $0.24 in the same period of 2021[5] - The net loss attributable to the company for the six months ended September 30, 2022, was $1,443,611, resulting in a basic and diluted loss per share of $(0.38), compared to a loss of $(552,416) and $(0.24) per share in 2021[64] Assets and Equity - As of September 30, 2022, total assets increased to $5.30 million from $48,706 as of March 31, 2022[3] - Cash and cash equivalents at the end of the period were $4.57 million, up from $21,756 at the beginning of the period[7] - Stockholders' equity increased to $4.39 million as of September 30, 2022, from a deficit of $974,578 as of March 31, 2022[3] - As of September 30, 2022, the company reported an accumulated deficit of $7,780,577 and a net loss of $1,453,786 for the six months ended September 30, 2022, compared to a net loss of $575,040 for the same period in 2021[19] Capital and Financing - The company raised $6.56 million from shares issued for cash during the six months ended September 30, 2022[7] - The company completed its initial public offering (IPO) in July 2022 and subsequently raised approximately $3,844,500 through a private placement in November 2022[19] - The company needs to raise additional capital in the near term to fund ongoing operations and business activities[17] Research and Development - Research and development expenses for the six months ended September 30, 2022, were $96,622, slightly down from $108,097 in the same period of 2021[5] - The company is focused on developing tests for predicting adaptive immunity to viral diseases and has operations in multiple countries including the UK, Hong Kong, and the US[8] Currency and Exchange Rates - The company has a significant reliance on foreign currency, with the Renminbi being the functional currency for its Chinese subsidiary, while all other entities operate in U.S. dollars[30] - The average exchange rate for the British Pound was 0.831 for the six months ended September 30, 2022, compared to 0.723 for the same period in 2021[32] Stock and Shareholder Information - The company adopted the 2022 Equity Incentive Plan, allowing for the grant of options and shares for up to 1,319,418 ordinary shares, with approximately 159,418 shares available for issuance as of September 30, 2022[79] - The expected volatility for stock option awards was between 85.52% and 353.14% as of September 30, 2022[80] - The Company issued 1,160,000 stock options during the six months ended September 30, 2022, at an average exercise price of $5.03, with a total fair value of $4,966,500[82] - As of September 30, 2022, the Company had 1,160,000 outstanding stock options, with an aggregate intrinsic value of $4,966,500 and a remaining term of 10 years[83] Lease and Liabilities - The Company has short-term operating leases with future minimum lease payments totaling $30,921, with $16,866 due in the fiscal year ending March 31, 2023[87] - Current accounts payable and accrued liabilities were $725,270 as of September 30, 2022, down from $1,115,473 as of March 31, 2022[68] - As of September 30, 2022, the total amount due to related parties was $23,486, down from $126,183 as of March 31, 2022[89] Miscellaneous - The impact of the COVID-19 pandemic on the company's financial condition and future operations remains uncertain[22] - The company’s financial statements are prepared in accordance with International Financial Reporting Standards (IFRS)[21] - The company has not paid dividends historically and has no foreseeable plans to do so[39] - An employee was issued 54,300 unregistered shares of stock in lieu of services on December 31, 2022[94]

Financial Performance and Losses - The company incurred net losses of $1,749,870 and $672,915 for the years ended March 31, 2022 and 2021, respectively, with an accumulated deficit of $6,336,966 as of March 31, 2022[22]. - The company expects to continue incurring significant losses for the foreseeable future, particularly as it conducts ongoing preclinical studies and clinical trials for its Virax Immune products[22]. - Revenue for the fiscal years ended March 31, 2021, and 2020 was $123.82 million and $99.88 million, respectively, indicating a growth of approximately 24%[74]. Product Development and Regulatory Approval - The company plans to submit its new T-Cell IVD test kit under the name Virax Immune for regulatory approval in the first half of 2023[23]. - The company is developing the Virax Immune product to detect T-Cell immune responses to SARS-CoV-2, which is intended to provide insights into protection against COVID-19[25]. - The company is developing a T-Cell IVD test for major viral threats, including COVID-19, but has not yet submitted any tests for regulatory approval[54]. - The success of the company's proprietary T-Cell testing technology depends on the completion of clinical and validation studies, which are expensive and time-consuming[46]. - The process of obtaining and complying with governmental regulatory approvals is costly, time-consuming, and uncertain, with no guarantee of approval[106]. - The company will need to conform with the UK IVD regime and apply for a UK Conformity Assessed mark before selling its T-Cell IVD Test in the UK post June 30, 2023[105]. - Approximately 50% of the company's products will require pre-approval under the new In-Vitro Diagnostic Regulation (IVDR) compared to 100% under the previous self-declaration classification[114]. Market and Sales Strategy - The company aims to establish its own sales and marketing capabilities to promote its product candidates in the UK, EU, and North America, while also expanding to other markets[38]. - The company faces significant challenges in commercializing its products, particularly in new markets, and may incur high costs in establishing a sales force[38]. - The market acceptance of the company's products by hospitals, governments, and public health departments is crucial for achieving profitability[42]. - The company is expanding its sales force globally and establishing distributor relationships to access international markets, but market opportunities may take substantial time to develop[47]. Intellectual Property and Legal Risks - The company faces challenges in enforcing its patent rights, as detecting infringement can be difficult, especially if competitors do not advertise their components[82]. - There is uncertainty regarding the validity and enforceability of the company's patents, which could lead to significant expenses in defending these rights[83]. - The company may incur substantial costs and liabilities from potential intellectual property litigation, which could affect its ability to commercialize products[100]. - The company may face claims regarding the inventorship or ownership of its intellectual property, which could disrupt its business operations[102]. Regulatory Compliance and Risks - The company may face significant civil, criminal, and administrative penalties if found in violation of applicable laws and regulations[107]. - Compliance with privacy regulations is complex and violations could result in significant fines and damage to the company's reputation[131]. - The company may face heightened regulatory scrutiny from PRC authorities in the future, which could lead to fines or other penalties if non-compliance occurs[63]. - The company may incur substantial costs to ensure compliance with new or amended laws and regulations as the regulatory framework evolves[105]. Operational Challenges and Risks - The company faces significant risks related to supply chain disruptions, as it does not have formal contracts with two key suppliers, which could adversely affect operations[48]. - The COVID-19 pandemic may disrupt research and development activities, affecting the company's clinical pipeline and revenue[52]. - The company faces risks related to natural disasters and health epidemics, which could disrupt operations and impact financial condition[71]. - The company is dependent on key members of senior management, and the loss of any could disrupt operations or strategic plans[66]. Market Conditions and Economic Factors - The socio-political environment in Singapore and other operational countries may adversely impact the company's business and financial condition[156]. - Economic conditions in Hong Kong and China are sensitive to global trends, and a prolonged slowdown could negatively impact the company's business[159]. - Disruptions in the international trading environment could decrease the company's international sales, affecting its financial results[157]. Shareholder and Market Considerations - The company does not intend to pay cash dividends on its Ordinary Shares in the foreseeable future, having never paid dividends historically[214]. - The market price of the Ordinary Shares may experience significant volatility due to various factors, including fluctuations in operating results and regulatory developments[211]. - The initial public offering price may not reflect the market price following the IPO, leading to potential volatility in share value[204]. - The company is classified as a foreign private issuer, resulting in less frequent and less detailed reporting obligations compared to U.S. domestic public companies[217].