UroGen Pharma (URGN) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Company overview and technology

• Focuses on delivering medicines to the urinary tract using a reverse thermal gel platform that transitions from liquid to gel at body temperature, enabling prolonged drug delivery for urothelial cancers.

• The core technology can be combined with various drugs and is currently used to treat urothelial cancer, with a clinical focus on non-muscle invasive bladder cancer.

UGN-102 clinical program and data

• UGN-102 targets intermediate-risk, non-muscle invasive bladder cancer, offering a non-surgical alternative to traditional surgery, especially for elderly patients.

• ENVISION trial showed an 80% complete response rate at three months, with 80% of responders disease-free at one year, outperforming surgery, which has a 50% relapse rate at one year.

• NDA has been filed for UGN-102, with a potential launch expected in early to late spring 2025, depending on priority review status.

Commercialization and market strategy

• Existing sales force will be expanded for UGN-102, leveraging overlap with the Jelmyto product’s target physicians.

• J-code for reimbursement is expected about six months post-approval, with initial focus on practices comfortable with a miscellaneous code.

• Jelmyto, for upper tract urothelial cancer, has seen slow but steady uptake, aided by technical advances in administration.