Risk Factors Update Summary

• Competitors may file claims to impede marketability of products, regardless of merit, increasing legal risks.
• Shelf life of products limited to six months until FDA approves longer shelf life.
• Stock price volatility: Stock varied from high of $4.05 to low of $1.21 in 12 months.
• Inability to transfer personal data may result in operational interruptions and increased costs.
• Analyst impact: Market price influenced by analyst valuations and recommendations, affecting stock performance.
• Uncertainty in obtaining CE Certificate of Conformity may substantially delay decisions indefinitely.
• Platelet dose requirements vary greatly between regulatory agencies. Loss of platelets may result in lower yield, impacting revenue.
• Revenue from DoD is tied to achieving milestones, with repayment contingent on meeting agreement terms.
• Failure to comply with regulatory requirements may impact ability to perform under contracts.
• Delays in studies have occurred due to the pandemic. Further delays may compromise data generation.
• CE Certificates of Conformity under MDR are crucial for affixing the CE Mark, expiring in May 2024.
• Exclusive forum provisions: Bylaws limit stockholders' ability to choose judicial forum, potentially discouraging lawsuits.
• Additional post-approval studies may be required by the FDA, impacting product introduction.
• FDA approval received for the premarket approval trial, with top-line data expected in Q1 2024.
• CE Certificates of Conformity under MDR received for INTERCEPT platelet and plasma systems.
• Renewed manufacturing and supply agreement with Porex until December 31, 2025, with annual cap.
• Enhanced DE&I efforts with new webpage showcasing diversity, and added training program for awareness.