Urogen Pharma Ltd. · NASDAQ:URGN
Urogen Pharma — Investor Presentation (August 2026)
30 slides from Urogen Pharma's investor presentation, August 2026
Slide 1: Transforming Urothelial Cancer Care Through Innovation
Transforming Urothelial Cancer Care Through Innovation August 2026
Slide 2: Disclaimers
Disclaimers This investor presentation contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation: the estimated addressable patient population and market and revenue opportunity for JELMYTO® and UGN-104 in LG-UT
Slide 3: Revenue Generating Company Pioneering New Therapies for Patients Living with Urothelial & Specialty Cancers
Revenue Generating Company Pioneering New Therapies for Patients Living with Urothelial & Specialty Cancers PROPRIETARY PROVEN AND NOVEL MEDICINES UNPRECEDENTED TECHNOLOGY (SMALL & LARGE MOLECULES) DATA Commercial Products Next-Generation Pipeline Strong Balance Sheet1 • UGN-103 & UGN-104: $108.0 mi
Slide 4: Novel, Sustained Release Therapeutic Delivery: RTGel
Novel, Sustained Release Therapeutic Delivery: RTGel® Proprietary reverse-thermal hydrogel technology designed to improve local medicine delivery Increases dwell time (6-24 hours) and exposure to active drugs* Improves the therapeutic effects of mitomycin Liquid at lower in LG-UTUC & LG-IR-NMIBC tem
Slide 5: LG-IR-NMIBC vs. HG-NMIBC Market
LG-IR-NMIBC vs. HG-NMIBC Market Low-Grade IR-NMIBC VS High-Grade NMIBC Chronic recurrence; rarely ISSUES Progression, metastasis & death progresses to high-grade disease TURBT, BCG, radical cystectomy, Repetitive TURBT SOC clinical trials Newly diagnosed Recurrent: Incidence: BCG-refractory: ~23K/ye
Slide 6: Patients Living with Urothelial Cancers Have Unique Needs
Patients Living with Urothelial Cancers Have Unique Needs Low-Grade Urinary tract is an elimination ~59K ~6-7K Upper Tract system resulting in challenging-to- addressable U.S. Urothelial Carcinoma Addressable recurrent population1,2 treat cancers: (LG-UTUC) U.S. population3,4,5 Low-Grade Intermediat
Slide 7: ZUSDURI (formerly UGN-102) Approved by FDA!
ZUSDURI® (formerly UGN-102) Approved by FDA! ZUSDURI is the first and only FDA-approved medication for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer 7 To see ZUSDURI’s full Prescribing Information and Important Safety Information visit Zusduri.com and https://www.urogen.co
Slide 8: Clear Patient Need with Frustrating Cycle of Treatment for Recurrent LG-IR-NMIBC
Clear Patient Need with Frustrating Cycle of Treatment for Recurrent LG-IR-NMIBC of recurrent patients have ~68% 2 or more recurrences4 $5B+ Potential 59,000 ~23% of recurrent patients have Recurrent 5 or more recurrences4 U.S. Patients1,2,3 Market1,2,3 greater risk of death for patients 23,000 ~14%
Slide 9: ZUSDURI: First and Only FDA-Approved Medicine For Patients with Recurrent LG-IR-NMIBC
ZUSDURI®: First and Only FDA-Approved Medicine For Patients with Recurrent LG-IR-NMIBC1,2 ZUSDURI® represents a new approach specifically for recurrent LG-IR-NMIBC, with strong efficacy and safety data in the ENVISION Phase 3 trial1 Innovative reverse-thermal Can be administered hydrogel containing
Slide 10: Sustained CR Ongoing at Months by Kaplan-Meier Estimate
Sustained CR Ongoing at 36 Months by Kaplan-Meier Estimate1 1.0 12mo 82.3% Probability of Remaining Event-Free 0.8 (75.9, 87.1) 24mo 72.2% 36mo (64.1, 78.8) 64.5% 0.6 (54.6, 72.8) 0.4 0.2 ZUSDURI® 0.0 Median DOR has not been reached 0 3 6 9 12 15 18 21 24 30 36 Time from 3-month CR (months) Number a
Slide 11: Adverse Events Mainly Related To Lower Urinary Tract Symptoms
Adverse Events Mainly Related To Lower Urinary Tract Symptoms1 ZUSDURI (N=240) n (% incidence) Any Adverse Events 140 (58.3) TEAEs were generally mild to Any Serious Adverse Events 30 (12.5) moderate in severity leading to Any TEAEs 137 (57.1) minimal treatment discontinuation Any Grade >=3 TEAEs 33
Slide 12: Surveyed ENVISION Patients Preferred ZUSDURI and Physicians Said They Will Use It
Surveyed ENVISION Patients Preferred ZUSDURI® and Physicians Said They Will Use It ENVISION Patient Perspectives on ZUSDURI® vs. TURBT1 92 % of surveyed Less impact on Patients would activities/ Less bleeding, recommend because UROLOGISTS responsibilities ZUSDURI® was stated they would use catheter
Slide 13: Delivering Industry-Leading Clinical Education and Operational Support
Delivering Industry-Leading Clinical Education and Operational Support Expanded field team is fully scaled and actively supporting the ZUSDURI launch • Regional Business Director (RBD) Sales Force • Territory Business Manager (TBM) ~8,500 Field Support • • Clinical Nurse Educator (CNE) Regional Oper
Slide 14: ZUSDURI Strong Revenue Momentum Since Launch
ZUSDURI Strong Revenue Momentum Since Launch Achieved $95M in Cumulative ZUSDURI Revenue Quarterly ZUSDURI $50.4M Revenues ($MM) Since +$21.2M Net Revenue Drivers (73%) Launch Strong sequential quarterly growth since FDA approval in June 2025 $29.2 +$15.2M (109%) Unique J-Code effective January 1, 2
Slide 15: NMIBC Landscape: Opportunity in LG-IR-NMIBC
NMIBC Landscape: Opportunity in LG-IR-NMIBC1,2 Marketed 2025 2026 2027 2028 2029 2030+ Phase 3 Topline Potential Approval Phase 2 data Potential Approval Phase 3b data Results of UGN-103 Phase 3 Initiation Phase 1/2 data Approved Phase 2 data 1. Data pulled from company websites as of April 15, 2026
Slide 16: JELMYTO
JELMYTO® First and Only FDA-Approved Non-Surgical Treatment for Patients with LG-UTUC
Slide 17: LG-UTUC: Rare Disease with High Recurrence
LG-UTUC: Rare Disease with High Recurrence Radical nephroureterectomy (RNU) and costly treatment drive need for innovation Substantial cost to 2,800 – 3,200 3,000 – 4,000 Newly Diagnosed1 Recurrent Patients2 the U.S. healthcare system associated $ Treatment Options 6,000 – 7,000 Treatment with manag
Slide 18: JELMYTO First and Only FDA-Approved Non-Surgical Treatment for Patients with LG-UTUC
JELMYTO® First and Only FDA-Approved Non-Surgical Treatment for Patients with LG-UTUC Clinically Meaningful OLYMPUS Phase 3 Data1 58% Complete Response Rate at 3 months 2 82% Durability of Response at 12 months by Kaplan-Meier estimate 2 47.8 Median Duration of Response (95%CI: 13.1, 57.5; n=41) dat
Slide 19: Growing Body of Real-World Evidence Supports JELMYTO
Growing Body of Real-World Evidence Supports JELMYTO®* Independent multicenter reviews support JELMYTO® real-world effectiveness** Favorable Recurrence Free Survival (RFS) rates Additional 69 CR1 % 23 % for patients with LG-UTUC who respond to initial induction2 Insights No differences in RFS Ureter
Slide 20: JELMYTO Revenue Trend Reflects Continued Growth
JELMYTO® Revenue Trend Reflects Continued Growth Achieved $43.7 million in June YTD 2026 revenue +4% $97-$101 Annual JELMYTO® WW Revenues ($MM) full-year revenue +9% $94.0 guidance $100 +28% $90.4 $82.7 $80 +34% $64.5 $60 $48.1 $40 $20 $11.9 $- 2020 2021 2022 2023 2024 2025 2026 Underlying demand re
Slide 21: Advancing our Mission to Transform Cancer Care
Advancing our Mission to Transform Cancer Care
Slide 22: Leadership Growth Strategy
Leadership Growth Strategy Leverage leadership in Establish Leadership in urothelial cancer and drug Specialty Oncology delivery to advance care for Expand into • Evaluate UGN-501 in other tumor types specialty oncology patients Other Specialty • Consider next best tumor for RTGel® Cancers and deliv
Slide 23: Diverse Pipeline Driving Innovation
Diverse Pipeline Driving Innovation Nonclinical Phase 1 Phase 2 Phase 3 NDA NEXT-GEN Recurrent low-grade FORMULATIONS intermediate risk non-muscle UGN-103 invasive bladder cancer Plan to submit (LG-IR-NMIBC) 3Q 2026 High-grade non-muscle UGN-103 invasive bladder cancer Expected start (HG-NMIBC) 2H 2
Slide 24: UGN-103 & UGN-104: Next-Generation Novel Mitomycin-Based Formulation
UGN-103 & UGN-104: Next-Generation Novel Mitomycin-Based Formulation New U.S. patent allowance covering non-surgical treatment of recurrent LG-IR NMIBC with ZUSDURI and UGN-103, expected to provide protection into July 2044 Potential Advantages Manufacturing efficiencies Phase 3 UTOPIA trial of UGN-
Slide 25: UGN-103: Advancing a Next-Generation Formulation for Patients with Recurrent LG-IR-NMIBC
UGN-103: Advancing a Next-Generation Formulation for Patients with Recurrent LG-IR-NMIBC Results to date from Phase 3 UTOPIA trial are consistent with Phase 3 ENVISION trial2,3,4 6-Month Duration of 3-Month CR Rate Response (DOR)5 UGN-103 Regulatory Pathway ▪ Built on RTGel® technology ▪ FDA alignme
Slide 26: UGN-501: A Next-gen Investigational Oncolytic Virus With Pipeline-in-a-Product Potential
UGN-501: A Next-gen Investigational Oncolytic Virus (OV) With Pipeline-in-a-Product Potential1 Potential Benefits 1 Tropism: Broad cell entry 1 • Specialized chimeric fiber for pan-tumor tropism • Enables the virus to enter cells expressing specialized receptor 2 2 Selectivity: Tumor dependent repli
Slide 27: UGN-501 IND-Enabling Studies Suggest the OV's Rapid Replication Improves Cancer Cell Death
UGN-501 IND-Enabling Studies Suggest the OV’s Rapid Replication Improves Cancer Cell Death WT Ad5 Investigational OV 1 Investigational OV 2 UGN-501 x Selectivity Tropism ~ Potency Selectivity x Tropism x Potency Selectivity Tropism x Potency Selectivity Tropism Potency Modest No Visible Limited Rapi
Slide 28: Strong Financial Position
Strong Financial Position $108.0M $72.5M $200M 50.5M Cash, cash Q2 2026 Refinanced term Shares equivalents, Total Revenue2 loan with outstanding as and marketable Pharmakon3 of June 30, 20264 securities1 1. Cash, cash equivalents, and marketable securities as of June 30, 2026. Excludes restricted ca
Slide 29: Poised to Transform Urothelial Cancer Care Through Innovation
Poised to Transform Urothelial Cancer Care Through Innovation ZUSDURI® first and only FDA-approved medicine in recurrent LG-IR- NMIBC; focus on commercial launch activities; unique J-Code became effective January 1, 2026; field team scaled to support launch Increasing adoption of JELMYTO®, recent du
Slide 30: Thank You
Thank You