Risk Factors Update Summary

• Enrollment for MB-117 and MB-217 gene therapy programs anticipated in 2024 following modified LV vector availability.
• 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 could impact commercial sale.
• Mustang announced initial data for MB-106 with a 100% overall response rate for patients with follicular lymphoma.
• The company reduced the number of marketed products from four to three, impacting revenue streams.
• Introduction of Section 505(b)(2) regulatory pathway implications on product approval timelines and costs.
• Decrease in outstanding debt from $91 million to $60 million and under the Oaktree Agreement from $188.5 million to $142.3 million.
• Avenue reported preclinical data for BAER-101 showing full seizure suppression at 0.3 mg/kg dose.
• Cyprium assigned the NDA and certain assets for CUTX-101 to Sentynl, receiving $805 million upfront.
• AstraZeneca acquired Caelum for approximately $212 million, netting $31.8 million upon BLA approval.
• Cyprium announced a $4.1 million grant from NINDS for preclinical studies and IND application preparation.
• Avenue announced final agreement with the FDA for IV Tramadol, aiming to address previous CRLs.
• Accumulated deficit increased from approximately $634 million to $694 million as of December 31, 2023.
• Change from "FDA" to "32FDA" in the risk disclosures section.
• Research and development expenses decreased from approximately $134.2 million to $101.7 million in 2023.
• Journey filed an NDA for DFD-29, with FDA acceptance and a PDUFA goal date of November 4, 2024.
• Change from "Common Stock and/or debt securities" to "Securities" in various sections.