UroGen Pharma (URGN) Corporate presentation summary

Innovation in urothelial cancer care

• Focus on transforming urothelial cancer treatment through proprietary RTGel® technology and novel drug formulations.

• Commercial portfolio includes ZUSDURI® for recurrent LG-IR-NMIBC and JELMYTO® for LG-UTUC, both first and only FDA-approved non-surgical treatments in their indications.

• Next-generation pipeline features UGN-103, UGN-104, and UGN-501, targeting additional urothelial and specialty cancers.

• Strong intellectual property position with new patents extending protection into the 2040s.

Market opportunity and patient need

• Addressable U.S. populations: ~59,000 recurrent LG-IR-NMIBC, ~6-7,000 LG-UTUC, and ~19,000 HG-NMIBC patients.

• Significant unmet need due to high recurrence rates, limited non-surgical options, and risks associated with repeated TURBT procedures.

• ZUSDURI® is the only FDA-approved non-surgical chemoablative treatment for recurrent LG-IR-NMIBC.

Clinical data and product performance

• ZUSDURI® demonstrated a 79.6% complete response rate at 3 months and 82.3% durability at 12 months in Phase 3 ENVISION trial.

• 36-month durability of response for ZUSDURI® is 64.5% by Kaplan-Meier analysis.

• JELMYTO® showed a 58% complete response at 3 months and 82% durability at 12 months in OLYMPUS Phase 3 trial, with median duration of response of 47.8 months.

• Real-world evidence supports JELMYTO® effectiveness, with up to 69% CR in multicenter reviews.

• Adverse events for ZUSDURI® are mainly mild to moderate lower urinary tract symptoms, with minimal discontinuation.