ExpreS2ion Biotech Holding AB
Climate Impact & Sustainability Data (2023)
Reporting Period: 2023
Environmental Metrics
ESG Focus Areas
- Animal welfare
- Biodiversity
- Business ethics
- Employee well-being
- Employee development
- Environmental impact
Environmental Achievements
- Autoclaving and pyrolysing all glassware, reducing the need for disposable plastics in the R&D phase.
- Diminished use of single-use plastics in cell line development by shifting towards plate-based processes.
Social Achievements
- Adherence to guidelines set by Arbejdstilsynet (Danish Working Environment Authority) for employee well-being, including safety inspections, hazard handling training, and open communication.
- Prioritising comprehensive employee development through funded training opportunities and a flat organizational structure promoting early responsibility and mentorship.
Governance Achievements
- Adherence to corporate governance requirements as a publicly traded company on Nasdaq First North, including compliance with listing requirements, K3 accounting standards, and annual audits.
- Implementation of comprehensive governance policies covering Board procedures, CEO instructions, information and communications, confidentiality, Board minutes, and registration of insider transactions.
Climate Goals & Targets
Medium-term Goals:
- Develop a novel CMV lead vaccine candidate before the end of 2025.
Short-term Goals:
- Complete manufacturing process for ES2B-C001, prepare Phase I clinical trial plan, submit clinical trial application.
Environmental Challenges
- Persistent losses affecting valuation and share price.
- Resource constraints limiting large-scale activities.
- Costly development programs.
- Risk of unsuccessful clinical trials and regulatory approvals.
- Competition from larger players.
- Partner failures in obtaining approvals or commercialisation.
- High risk of failure in new biopharmaceutical product development.
- Dependence on key employees.
- Partner dependency.
- Technology dependency (reliance on AdaptVac’s cVLP technology).
- Funding shortfall.
- Increasing burn rate.
- Equity dependency.
- Grant funding uncertainty.
- Limited cVLP platform control.
- Risk of data breaches.
- Freedom to operate (FTO) risks.
- Risk of unwanted side effects or harm to patients during clinical trials.
- Inactive and illiquid share trading and volatile share price.
- Currency risk due to operations in multiple currencies.
- Inflation impacting material and labor costs.
Mitigation Strategies
- Diversifying the development pipeline, prioritizing cost-effective R&D, optimizing resource allocation, strategic collaborations.
- Efficiently managing development costs, exploring funding options and grants, diversifying the product portfolio.
- Robust trial design, collaboration with regulatory agencies, diversifying the candidate portfolio, post-trial data analysis, transparent communication.
- Leveraging unique technology platform, fostering strong relationships with Key Opinion Leaders, continuously monitoring competitor activities.
- Staying informed about the regulatory landscape, planning contingencies for potential setbacks, close collaboration with agencies and authorities.
- Rigorous pre-clinical evaluation and clinical trials, diversifying the product pipeline, collaborating with research partners.
- Offering retention incentives, implementing mentoring and cross-training programs.
- Fostering strong relationships with partners, clearly defining terms in out-licensing agreements, closely monitoring development progress.
- Robust technology transfer processes, investing in internal R&D capabilities, exploring partnerships for technology diversification.
- Diversifying funding sources, optimizing operations to reduce expenses, closely monitoring costs, preparing contingency plans.
- Exploring multiple funding sources beyond grants.
- Close collaboration with AdaptVac, exploring alternative platforms.
- Robust encryption, access controls, regular security audits, staff education on data protection.
- Thorough IP searches, patent landscape analysis, early FTO risk assessment, seeking legal advice.
- Accurate risk assessment during product development, comprehensive clinical trial insurance.
- Enhancing market visibility, actively engaging with investors, regularly communicating company updates, implementing liquidity management strategies, risk communication, insurance coverage, geopolitical risk assessment.
- Majority of cash and equivalents in DKK, contract terms denominated in SEK, evaluating currency risk in new contracts.
- Monitoring price and wage levels, forecasting accurately, inflation clauses in contracts, evaluating alternative suppliers.
Supply Chain Management
Responsible Procurement
- Selecting vendors for animal testing adhering to Global Animal Welfare (GAW), AAALAC, and French Ministry of Agriculture standards.
Climate-Related Risks & Opportunities
Reporting Standards
Frameworks Used: K3
Third-party Assurance: Ernst & Young AB
UN Sustainable Development Goals
- SDG 3: Good Health and Well-being
Developing and deploying effective, safe, cost-efficient, and scalable vaccines to combat a wide range of disorders, from various types of cancer to infectious diseases.