Virax Biolabs (VRAX)
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Virax Biolabs (VRAX) - 2023 Q4 - Annual Report
2023-06-14 20:31
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].
Virax Biolabs (VRAX) - 2023 Q4 - Annual Report
2023-02-02 21:30
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]
Virax Biolabs (VRAX) - 2022 Q4 - Annual Report
2022-08-12 20:20
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].