UroGen Pharma (URGN) H.C. Wainwright 4th Annual BioConnect Investor Conference summary

Technology and product overview

• Two commercial-stage products utilize a proprietary RTGel platform enabling depot drug delivery for urothelial cancers.

• RTGel forms a liquid at cool temperatures and a soft gel at body temperature, allowing sustained drug release in the urinary tract.

• ZUSDURI targets low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC), a disease characterized by frequent recurrences but low mortality.

• JELMYTO is indicated for low-grade upper tract urothelial carcinoma, requiring more complex administration.

Market opportunity and patient population

• Approximately 800,000 people in the U.S. live with NMIBC, with 400,000 in the recurrent pool and 20,000 newly diagnosed low-grade IR cases annually.

• ZUSDURI addresses a significant unmet need by reducing the need for repeated surgical procedures (TURBT) in a large patient population.

• JELMYTO serves a smaller market of about 6,000 upper tract patients in the U.S.

Clinical data and therapeutic impact

• ENVISION study 36-month data show 64% of initial complete responders to ZUSDURI remain in remission at 36 months, with median duration not yet reached.

• ZUSDURI's six-week treatment regimen offers a non-surgical alternative, potentially sparing patients multiple TURBT procedures over their lifetime.

• Retreatment data are being generated, with expectations for further durability and flexibility in patient management.