Risk Factors Update Summary

• Introduction of conditional marketing authorization process with specific obligations and annual reviews.
• Shelf registration statement allows us to offer various securities, diluting investors by subsequent sales.
• Accumulated deficit increased from $436 million to $457 million.
• Addition of the European Commission as a regulatory authority may impact approval processes.
• Risks related to the use of net operating loss carryforwards and tax attributes.
• Stock price fluctuated from $2.83 to $17.01 per share in the last 12 months.
• Deprioritized omburtamab program, received 18-month BLA extension until May 30, 2025.
• Inclusion of the European Commission in the approval process for companion diagnostics.
• Potential dilution due to future sales of common stock, with 6,900,000 shares outstanding.
• Class action lawsuit filed against the company alleging violations, potentially impacting financials.
• Received FDA clearance for CD38-SADA construct, expect to dose first patient in 2024.
• Changes in management, including the appointment of a new CEO, may impact operations.
• Deprioritized omburtamab program for all indications and product candidates.
• Transitioned to Self-Assembly DisAssembly Pretargeted (SADA PRIT) technology platform.
• Deprioritized omburtamab program, considering future development, no assurance of FDA approval.
• Scrapped batches of DANYELZA, resulting in charges to write off inventory of $0.8 million in 2023.