Climate Change Data

Environmental Metrics

Climate Goals & Targets

Supply Chain Management

Climate-Related Risks & Opportunities

Environmental Metrics

Social Achievements

• Women represent approximately 54% of our workforce and men represent approximately 46%.

Climate Goals & Targets

Environmental Challenges

• Material weaknesses in internal control over financial reporting.
• Limited operating history.
• Significant losses since inception.
• Dependence on third-party manufacturers and collaborators.
• Competition from other biotechnology and pharmaceutical companies.
• Small target patient populations for DANYELZA and product candidates.
• Potential for serious adverse events with DANYELZA and product candidates.
• Uncertainties in clinical trial outcomes and regulatory approval.
• Complexity and cost of manufacturing biologics.
• Risks associated with strategic collaborations.
• Uncertainty in coverage and reimbursement decisions by third-party payors.
• Extensive government regulation of drug products.
• Impact of the COVID-19 pandemic.

Mitigation Strategies

• Hiring additional finance and accounting professionals.
• Implementing controls to remediate material weaknesses.
• Building a focused, specialized sales and marketing organization.
• Exploring commercialization partnerships.
• Developing commercially viable manufacturing processes.
• Managing relationships with third-party manufacturers and collaborators.
• Monitoring and mitigating the impacts of the COVID-19 pandemic.

Supply Chain Management

Climate-Related Risks & Opportunities

Environmental Metrics

Social Achievements

• Women represented approximately 60% of our workforce and men represented approximately 40%.

Climate Goals & Targets

Environmental Challenges

• Russia’s invasion of Ukraine and ancillary developments have had and may continue to have an adverse effect on our business.
• The COVID-19 pandemic or similar health crises, macroeconomic conditions, such as rising inflation, uncertain global financial markets, supply chain disruptions, and by geopolitical events, including the recent global conflict resulting from the invasion of Ukraine by Russia, and sanctions related thereto, which resulted in the suspension of our clinical trial and regulatory activities in Russia

Mitigation Strategies

• In January 2023, we announced a restructuring plan and implemented a workforce reduction. The objective of these initiatives is to focus the organization and its resources on key near and long-term potential growth drivers, namely the DANYELZA franchise and development of our SADA platform.

Supply Chain Management

Climate-Related Risks & Opportunities

Environmental Metrics

Social Achievements

• Approximately 35% reduction in workforce in May 2023 as part of a strategic restructuring plan.

Climate Goals & Targets

Environmental Challenges

• Supply chain disruptions due to geopolitical events (Russia's invasion of Ukraine, Israel-Hamas conflict).
• Competition in the biotechnology and pharmaceutical industries.
• Limited operating history and significant losses since inception.
• Dependence on third-party manufacturers and collaborators.
• Challenges in patient enrollment for clinical trials.
• Potential for serious adverse events with product candidates.
• Uncertainty in regulatory approval processes.
• Limited experience operating as a commercial company.
• Dependence on a limited number of customers for a high percentage of revenue.

Mitigation Strategies

• Strategic restructuring plan to extend cash resources and prioritize resources.
• Commercialization partnerships to maximize value in select territories.
• Efforts to expand sales and marketing capabilities.
• Ongoing efforts to secure additional funding.
• Development of the SADA PRIT technology platform.
• Education and training of medical personnel on product side effects.
• Close collaboration with regulatory authorities.
• Diversification of manufacturing and supply chains (where possible).

Supply Chain Management

Climate-Related Risks & Opportunities