Risk Factors Update Summary

• FDA requested a new clinical trial for DCCR after preliminary comments from the FDA. This may delay NDA submission.
• Regulatory approval process uncertainties may lead to failure to obtain approvals for planned products, impacting business operations.
• Fast track designation may not lead to faster review process, delaying potential sales revenue.
• Net loss increased from $24 million to $39 million in 2023, with an accumulated deficit of $237 million to $276 million.
• Risks related to patent infringement and intellectual property litigation increased, with potential impacts on commercialization.
• FDA may withdraw fast track designation if filing lacks evidence of safety and benefits.
• Cash and cash equivalents decreased from $14 million to $6 million, with working capital decreasing from $8 million to $3 million.
• Potential changes in U.S. trade policies, tariffs, and taxes could negatively impact cross-border operations.
• Recent legislation allows federal negotiation of maximum fair price for certain high-priced drugs.
• Operating activities used $20 million in 2022, increasing to $24 million in 2023, with continued losses expected.