Virax Biolabs Group Limited
Climate Impact & Sustainability Data (2020-03-31 to 2021-03-31, 2023, 2024, August 2024)
Reporting Period: 2020-03-31 to 2021-03-31
Environmental Metrics
Climate Goals & Targets
Environmental Challenges
- Obtaining regulatory approvals for Virax Immune products.
- Navigating the dynamic regulatory environment for IVD.
- Leveraging the Virax Immune platform to discover, develop, and commercialize additional products and services.
- Developing the T-Cell IVD Test under the Virax Immune brand successfully.
- Proceeding through clinical and validation studies successfully.
- Discovering and continuously developing products and services related to major viral threats and COVID-19 under the Virax Immune brand.
- Successfully commercializing products, particularly in new markets.
- Gaining market acceptance for products.
- Continued demand for diagnostic and products linked to COVID-19 and other major viral diseases.
- Successfully completing clinical and validation studies for the T-Cell IVD test.
- Developing new market opportunities quickly enough.
- Maintaining relationships with key suppliers and securing additional supply sources.
- Maintaining a limited number of suppliers for laboratory equipment and materials.
- Managing significant customer concentration.
- Keeping pace with rapid changes in the in-vitro diagnostics industry.
- Attracting and retaining key personnel.
- Protecting proprietary intellectual property and information.
- Complying with extensive regulations of domestic and international regulatory authorities.
- Complying with ongoing regulatory requirements and managing unanticipated problems with products.
- Managing potential product liability claims.
- Managing risks related to the UK's withdrawal from the European Union.
- Managing exposure to unanticipated changes in tax laws and regulations.
- Managing risks related to natural disasters, health epidemics, and outbreaks.
- Managing reliance on dividends and other distributions from subsidiaries.
- Managing broad discretion in the use of proceeds from the offering.
- Managing risks associated with being an emerging growth company and a foreign private issuer.
- Managing risks related to doing business in China and Hong Kong.
- Managing potential difficulties in protecting investor interests and enforcing rights through U.S. courts.
- Managing the lack of a prior public market for Ordinary Shares.
- Managing potential differences in offering prices between the primary and resale offerings.
- Managing potential decline in market price of Ordinary Shares due to resale by selling shareholders.
- Managing potential classification as a penny stock.
- Managing potential loss of foreign private issuer status.
- Managing potential prohibition of trading on a national exchange under the Holding Foreign Companies Accountable Act.
- Managing potential increased costs associated with being a public company.
- Managing potential lack of favorable research or reports from securities analysts.
- Managing potential impact of recently introduced economic substance legislation in the Cayman Islands.
Mitigation Strategies
- Intending to use net proceeds from the offering for research and development, obtaining product certification approvals, establishing distribution networks, expanding staff, marketing, working capital, operating expenses, inventory purchases, and regulatory and compliance work.
- Establishing sales and marketing capabilities and promoting product candidates.
- Developing technology to focus on other major viral threats beyond COVID-19.
- Testing multiple sources of reagents and test components.
- Expanding sales force globally and establishing additional distributor relationships.
- Developing specific production processes for new products.
- Obtaining product liability insurance.
- Implementing policies and practices to comply with privacy regulations.
- Maintaining information technology systems with safeguard protection against cyber-attacks.
- Implementing policies and practices to comply with anti-corruption and anti-money laundering laws.
- Intending to comply with Nasdaq corporate governance rules applicable to foreign private issuers.
Supply Chain Management
Climate-Related Risks & Opportunities
Reporting Period: 2023
Environmental Metrics
Climate Goals & Targets
Medium-term Goals:
- Expand sales force globally and establish additional distributor relationships.
- Penetrate new markets such as North America.
Short-term Goals:
- Submit new T-Cell IVD/Immune response Test kit for regulatory approval in the second half of 2023.
Environmental Challenges
- Limited operating history and incurred operating losses.
- Risks associated with biotechnology product development.
- Challenges in commercializing products, particularly in new markets.
- Market acceptance of products.
- Supply chain disruptions.
- Customer concentration.
- Risks related to intellectual property protection.
- Rapid changes in the in-vitro diagnostics industry.
- Dependence on key personnel.
- Risks related to information technology systems.
- Risks related to natural disasters and health epidemics.
- Risks related to regulatory and legal issues.
- Risks related to doing business in China and Hong Kong.
- Risks related to our corporate structure.
- Risks related to our securities.
- Recently introduced economic substance legislation of the Cayman Islands.
Mitigation Strategies
- Developing a pipeline of T-Cell testing IVD kits, applications, and medical devices.
- Growing sales and marketing capabilities and promoting product candidates.
- Establishing appropriate infrastructure for commercialization.
- Developing technology to focus on other major viral threats.
- Testing multiple sources of reagents and test complaints.
- Pursuing strategic partnerships, investments, or acquisitions.
- Expanding sales team.
- Developing robust product safety and quality programs.
- Actively monitoring contract manufacturers’ operations.
- Conducting reviews of all aspects of the supply chain.
- Implementing safeguard protection against cyber-attacks.
- Engaging BSI and restructuring quality management systems to align with the IVDR.
- Complying with new or amended laws and regulations.
- Seeking to issue debt or equity securities or obtain additional credit facilities.
Supply Chain Management
Responsible Procurement
- Quality control standard operating procedures in place for all third-party manufacturing facilities.
Climate-Related Risks & Opportunities
Reporting Period: 2024
Environmental Metrics
Climate Goals & Targets
Short-term Goals:
- Launch ViraxImmune suite of IVD T cell test kits.
- Expand sales and marketing efforts.
Environmental Challenges
- Limited operating history and significant losses.
- Risks associated with biotechnology product development.
- Challenges in commercializing products, particularly in new markets.
- Market acceptance and demand for products.
- Risks related to intellectual property protection.
- Rapid changes in the in-vitro diagnostics industry.
- Dependence on key personnel.
- Risks related to information technology systems.
- Risks related to natural disasters and health epidemics.
- Risks related to regulatory and legal issues.
- Risks related to doing business in China and Hong Kong.
- Share price volatility.
- Compliance with extensive regulations.
- Potential product liability claims.
- Risks related to cybersecurity.
- Compliance with anti-corruption and anti-money laundering laws.
- Significant costs associated with being a public company.
- Potential difficulties in protecting investor interests due to Cayman Islands incorporation.
Mitigation Strategies
- Developing a comprehensive set of T cell diagnostics and immune profiling solutions.
- Building sales and marketing capabilities.
- Collaborating with international industry leaders and governments.
- Investing in research and development.
- Protecting intellectual property rights.
- Keeping pace with industry changes.
- Implementing cybersecurity measures.
- Maintaining compliance programs.
- Obtaining product liability insurance.
- Establishing an U.S. office to receive service of process.
Supply Chain Management
Climate-Related Risks & Opportunities
Reporting Standards
Frameworks Used: IFRS
Sustainable Products & Innovation
- ViraxImmune T cell IVD/Immune response Test kit