Risk Factors Update Summary

• Mustang announced initial data for MB-106, showing an ORR of 95% in patients with relapsed or refractory B cell NHL or CLL.
• Checkpoint announced positive results for cosibelimab, with an ORR of 47.4% in metastatic cSCC.
• Addition of IV tramadol under DEA regulations as a Schedule IV substance. This may impact commercial sale.
• Enrollment completed in January 2024 for clinical trial NCT05517603, with topline data expected in Q2 2024.
• The company reduced the number of marketed products from four to three, impacting revenue streams.
• Decrease in outstanding debt from $91 million to $60 million and under the Oaktree Agreement from $60 million to $50 million.
• Avenue reported preclinical data for BAER-101 in August 2023, showing full seizure suppression at 0.3 mg/kg.
• Cyprium terminated collaborations with TG Therapeutics, with full rights reverting back to Cyprium.
• AstraZeneca acquired Caelum for approximately $212 million, netting $31.8 million upon BLA approval.
• Cyprium received a $4.1 million grant from NINDS in March 2024 for preclinical studies and IND preparation.
• Avenue resubmitted the NDA for IV Tramadol after receiving a second Complete Response Letter.
• Increase in accumulated deficit from approximately $634 million to $694 million as of December 31, 2023.
• Journey filed a New Drug Application for DFD-29, with FDA acceptance and a PDUFA goal date of November 4, 2024.
• Change in R&D expenses from approximately $134.2 million to $101.7 million for 2023.
• Addition of the Inflation Reduction Act of 2022 impacting drug pricing and reimbursement, potentially reducing profitability.
• Change in the number of marketed products with patent protection from four to three.
• Addition of the conflict between Russia and Ukraine impacting clinical trials and supply chain operations.