Slide 1: New Horizons in Bladder Cancer: Insights from Top-Line Data of ATLAS & ENVISION
Exhibit 99.2 New Horizons in Bladder Cancer: Insights from Top-Line Data of ATLAS & ENVISION Studies July 27, 2023 NASDAQ: URGN 1
Slide 2: Forward-looking Statements
Forward-looking Statements 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 potential of JELMYTO® to change the treatment paradigm in LG-UTUC; the potential of UGN-102 to
Slide 3: Agenda
UroGen…Uniquely Positioned Liz Barrett, President and CEO, UroGen The Burden of LG-IR-NMIBC Karim Chamie, M.D., MSHS, Associate Professor of Urology, UCLA Top-Line Data Results: ATLAS and ENVISION Sandip Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology, Morristown Hospital/Atlantic
Slide 4: UroGen… Uniquely Positioned
UROGEN… UNIQUELY POSITIONED LIZ BARRETT 4
Slide 5: We Aspire to Change the Treatment Paradigm
WE ASPIRE TO CHANGE THE Because Patients Deserve Better TREATMENT PARADIGM SURGICAL CARE MINIMALLY INVASIVE, ORGAN-SPARING THERAPEUTIC OPTIONS JELMYTO UGN-102 UGN-301 (UGN-101) Changing the Potential to Transform Expanding to Treatment the Treatment Immuno-Oncology Paradigm for Paradigm in for LG-UT
Slide 6: RTGel Proprietary Reverse-Thermal Hydrogel Technology
® RTGel Proprietary Reverse-Thermal Hydrogel Technology Uniquely Designed to Allow for Local Delivery of Medicines Increases dwell time and exposure of active drugs Potentially improves the ® RTGel exists as a therapeutic effects of liquid at lower existing products temperatures and converts to gel
Slide 7: Bladder Cancer Affects Patients and Families Across the U.S.
Bladder Cancer Affect s Pat ient s and Families Across t he U.S. One of the ~726,000 people in 1 the U.S. living with bladder cancer most recurrent 2 of ALL cancers 1. Cancer Stat Facts: Bladder Cancer. National Cancer Institute: Surveillance, Epidemiology, and End Results Program. Accessed July 10,
Slide 8: NMIBC Patients Can Find Themselves in a Frustrating Cycle of Treatment
NMIBC Pat ient s Can Find Themselves in a Frust rat ing Cycle of Treat ment ~82,000 ~23% ~68% of recurrent patients of recurrent addressable LG-IR- have 2 or more 2-5 patients have 5 or NMIBC patients 1 1 recurrences more recurrences 1. Babjuk et al. European Urology (2019), Simon (2019), UroGen pro
Slide 9: UGN-102: Leveraging Similarities
UGN-102: Leveraging Similarit ies ® JELMYTO & UGN-102 UGN-102 ® • RTGel method of • 10x larger potential delivery patient population ® • Mitomycin RTGel • Simpler administration combinations UGN-102 to bladder than to upper tract • Similar diseases at a genetic & mutational JELMYTO • Routine procedu
Slide 10: UGN-102: With Distinct Advantages
UGN-102: W ith Distinct Advantages ® JELMYTO & UGN-102 UGN-102 ® • RTGel method of • 10x larger potential delivery patient population ® • Mitomycin RTGel • Simpler administration combinations UGN-102 to bladder than to upper tract • Similar diseases at a genetic & mutational JELMYTO • Routine proced
Slide 11: Potential to Unlock a Significant Market Opportunity
Pot ent ial t o Unlock a Significant Market Opport unit y in a Very Underserved Pat ient Populat ion UGN-102 UGN-301 Phase 3 Phase 1 ~82,000 ~18,700 addressable U.S. population 1 addressable U.S. population $3B+ Market $5B+ $2B+ Market combined TAM Low-Grade Intermediate Risk Immunotherapy Targeting
Slide 12: UroGen is Poised to Transform the Way Bladder Cancer is Treated
UroGen is Poised to Transform the Way Bladder Cancer is #1 95% Treated UGN-102 may become shared prescriber base the first medicine to ® with JELMYTO treat LG-IR-NMIBC $3B+TAM $120M Compelling clinical private placement LG-IR-NMIBC market data package from 3 with experienced ripe for innovation tria
Slide 13: The Burden of LG-IR-NMIBC
THE BURDEN OF LG-IR-NMIBC KARIM CHAMIE, M.D. 13
Slide 14: Bladder Cancer is a Highly Heterogeneous Condition
Bladder Cancer is a HIGHLY Het erogeneous Condit ion NMIBC MIBC Risk Tis Ta T1 T2 T3 T4 non-invasive non-invasive tumor invades inner lining tumor invades tumor invades perivesical tumor spreads Low Risk and connective tissue muscle fat and lymph nodes to lymph nodes and other organs Intermediate Ri
Slide 15: AUA Risk Stratification for Non-Muscle Invasive Bladder Cancer
AUA Risk Stratification for Non-Muscle Invasive Bladder Cancer Low Risk Intermediate Risk High Risk a LG solitary Ta ≤ 3cm Recurrence within 1 yr, LG Ta HG T1 b PUNLMP Solitary LG Ta > 3cm Any recurrent, HG Ta LG Ta, multifocal HG Ta, > 3 cm (or multifocal) c d HG Ta, ≤ 3cm Any CIS LG T1 Any BCG fai
Slide 16: UGN-102 Could Become the First Approved Non-Surgical Treatment for LG-IR-NMIBC
UGN-102 Could Become t he First Approved Non-Surgical Treat ment for LG-IR-NMIBC NMIBC MIBC Risk Tis Ta T1 T2 T3 T4 non-invasive non-invasive tumor invades inner lining tumor invades tumor invades perivesical tumor spreads Low Risk and connective tissue muscle fat and lymph nodes to lymph nodes and
Slide 17: Repeat Surgery Comes with Risks for this Patient Population
Repeat Surgery Comes wit h Risks for t his Pat ient Populat ion Patients with LG-IR-NMIBC LG-IR-NMIBC patients who had who have multiple 2–4 procedures had a ~33% recurrences carry a of patients will experience an 14% adverse event 10-20% within 90 days of greater risk of death 1 2 undergoing a TURB
Slide 18: OPTIMA II Phase 2b Trial Showed Significant Tumor Response
OPTIMA II Phase 2b Trial Showed Significant Tumor Response and Long-Term Treatment Benefit UGN-102 Phase 2b OPTIMA OPTIMA II Rollover Study 1 Study (LG-IR-NMIBC) Long-Term Follow-Up a Initial Results These data suggest continued durability in patients who 2 24.4 65% CR 72.5% 47% received UGN-102 mon
Slide 19: Challenging the Future Standard of Care for LG-IR-NMIBC
Challenging t he Fut ure St andard of Care for LG-IR-NMIBC TURBT as the current standard of care Key Unmet Needs for Patients and HCPs Requires anesthesia Additional treatment options Associated with risk of complications Reduction of recurrence Requires lifelong surveillance and recurrent treatment
Slide 20: Top-Line Data Results: ATLAS and ENVISION
TOP-LINE DATA RESULTS: ATLAS AND ENVISION SANDIP PRASAD, M.D., M.PHIL. 20
Slide 21: Overview of UGN-102 Program
Overview of UGN-102 Program ATLAS TRIAL ENVISION TRIAL JULY 2023 LAUNCHED FEB 2021 LAUNCHED MARCH 2022 TOP-LINE RESULTS SHARED FOR BOTH ATLAS AND ENVISION PHASE 3 TRIALS 282 240 Enrolled Patients Enrolled Patients 2022 2018 2021 2023 2024 OPTIMA 2B TRIAL JANUARY 2022 LAUNCHED OCT 2018 RESULTS PUBLIS
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Slide 23: ATLAS Study Endpoints
ATLAS Study Endpoints Primary Endpoint (ITT): • Disease-free survival (DFS), defined as the time from randomization until the earliest date of any of the following events: üResidual disease at the 3-month assessment üRecurrence üProgression üDeath Key Secondary Endpoints: • Complete response rate (C
Slide 24: ATLAS Trial Design
ATLAS Trial Design Screening* Date of CR recurrence, UGN-102 DFS progression NCR • Suspected • Cystoscopy or death bladder • Cold cup biopsy cancer TURBT • Urine cytology 1:1 • Recurrence • CT urogram, retrograde Date of pyelogram, or CR recurrence, MRI TURBT DFS progression NCR or death TURBT -1 to
Slide 25: ATLAS Demographics and Safety Profile
ATLAS Demographics and Safet y Profile • Treatment-emergent AEs were generally mild to moderate Demographics and baseline characteristics were well balanced • Similar safety profile to other between treatment arms studies of UGN-102 • Any treatment or procedure related serious TEAEs were comparable
Slide 26: Summary of Disease-Free Survival
Summary of Disease-Free Survival: Significantly More Total Recurrence and Progression in TURBT Alone Arm UGN-102 +/- TURBT TURBT Alone (N = 140) / n (%) (N = 142) / n (%) Patients with Events, n (%) 37 (26.1) 55 (39.3) Recurrence of LG Disease 20 (14.1) 39 (27.9) Progression to HG Disease 17 (12.0)
Slide 27: DFS - 55% Reduction of Risk for Recurrence, Progression, or Death
DFS - 55% Reduction of Risk for Recurrence, Progression, or Death in the Intent to Treat Population H HR R: 0 : 0.4 .46 5 ( (0.2 0.29 4, 0.6 , 0.88 6) ) UroGen Data on File 27 Source: Table 14.2.1.1a Kaplan-Meier Plot of Disease-Free Survival
Slide 28: Three-Month Complete Response Rates Were Similar Between Treatment Arms
Three-Month Complete Response Rates Were Similar Between Treatment Arms UGN-102 Alone TURBT Alone (N = 142) (N = 140) CRR CRR Response n (%) n (%) (95%CI) (95% CI) Complete Response 92 (64.8) 64.8% (56.3, 72.6) 89 (63.6) 63.6% (55.0, 71.5) Non-complete Response 50 (35.2) 51 (36.4) Residual Disease 2
Slide 29: Summary of Duration of Response in Complete Responders
Summary of Duration of Response in Complete Responders: Longer DOR with UGN-102 Alone UGN-102 Alone TURBT Alone (N = 92) / n (%) (N = 89) / n (%) Patients with Events, n (%) 18 (19.6) 24 (27.0) Recurrence of LG Disease 15 (16.3) 17 (19.1) Progression to HG Disease 3 ( 3.3) 6 ( 6.7) Death 0 1 ( 1.1)
Slide 30: DOR - 54% Reduction of Risk in Patients Who Had a 3-Month CR
DOR - 54% Reduction of Risk for Recurrence, Progression, or Death in Patients Who had a 3-Month CR * HR: 0.46 (0.24, 0.86) *UGN Alone Subgroup of the UGN 102 +/- TURBT arm in ATLAS UroGen Data on File 30 Source: Table 14.2.1.1a Kaplan-Meier Plot of Duration of Response in Complete Responders
Slide 31: Co KM 7] W ‘i EX ( N WA
Co KM 7] W ‘i EX ( N WA
Slide 32: ENVISION Single-Arm Study Description
ENVISION Single-Arm Study Description Primary endpoint: • Complete response rate (CRR) at 3-month visit Key Secondary endpoint: • Duration of Response (DOR), defined as time from first documented CR until the earliest date of: üRecurrence of low-grade disease at the 3-month assessment üProgression ü
Slide 33: ENVISION Demographics and Safety Profile
ENVISION Demographics and Safet y Profile Demographics and baseline characteristics were reflective of • Treatment-emergent AEs were typical LG-IR-NMIBC patient generally mild to moderate population • Similar safety profile to other studies of UGN-102 UroGen Data on File Overall summary of Demograph
Slide 34: Summary of Response Rate at 3-Month Disease Assessment: CRR of 79.2%
Summary of Response Rat e At 3-Mont h Disease Assessment : CRR of 79.2% UGN-102 (N = 240) n (%) CRR (95% CI) Complete Response Rate Complete Response 190 (79.2) 79.2 (73.5, 84.1) Non-Complete Response 50 (20.8) 79.2% Residual Disease 35 (14.6) Progression to HG Disease 6 (2.5) Indeterminate 4 (1.7)
Slide 35: Next for ENVISION
Next for ENVISION DOR data expected in Planned NDA Submission 1H, 2024 2024 35
Slide 36: Impact on Clinical Practice Panel Discussion
IMPACT ON CLINICAL PRACTICE PANEL DISCUSSION 36
Slide 37: Panelists
Dr. Trinity Bivalacqua Dr. Karim Chamie Dr. Katie Murray Dr. Mark Schoenberg Dr. Sandip Prasad M.D., Ph.D., Director of DO, Associate Professor Moderator M.D., MSHS, Associate M.D., M.Phil., Director of Urologic Oncology and of Urology, New York Professor of Urology at Genitourinary Surgical Co-Dire
Slide 38: What's your initial reaction to the data presented?
TOPIC 1 What 's your initial reaction to the data presented? 38
Slide 39: Discussing the CR rate across OPTIMA II, ATLAS and ENVISION
TOPIC 2 Discussing the CR rate across the OPTIMA II, ATLAS and ENVISION trials. 39
Slide 40: Complete Response Rate for Recurrent Patients Within the UGN-102 Trials
Complet e Response Rat e for Recurrent Pat ient s W it hin t he UGN-102 Trials OPTIMA II ATLAS ENVISION (N=49) (N=57) (N=232) 73.5% 73.7% 80.2% ( 60.3, 84.5 ) ( 58.9, 85.1 ) ( 74.5, 85.1 ) UroGen Data on File Total OPTIMA II population n=63, recurrent population n=49 40 Total ATLAS population n=282,
Slide 41: DOR - 66% Reduction of Risk in Recurrent Patients
DOR - 66% Reduction of Risk for Recurrence, Progression, or Death in Recurrent Patients Who Received UGN-102 Alone in the ATLAS Trial * HR: 0.34 (0.15, 0.75) *UGN Alone Subgroup of the UGN 102 +/- TURBT arm in ATLAS 41 UroGen Data on File Kaplan-Meier Plot of DOR in Complete Responders in the Recurr
Slide 42: UGN-102 Shows Substantial Reduction of Risk Across Multiple Patient Populations
UGN-102 Shows Substantial Reduction of Risk of Recurrence, Progression, or Death Across Multiple Patient Populations in ATLAS ITT – All Patients 0.45 (0.29, 0.68) DFS CR Duration – UGN-102 Alone 0.46 (0.24, 0.86) DOR Recurrent – UGN-102 Alone 0.34 (0.15, 0.75) DOR UroGen Data on File 42 Various ATLA
Slide 43: Impact of in-office APP administration on adoption
TOPIC 3 How does the fact that UGN-102, if approved, can be given by an APP in the office impact how you might view adoption? 43
Slide 44: Neoadjuvant therapy adoption for NMIBC
TOPIC 4 Given that urologists are familiar with neoadjuvant chemotherapy use in the context of treating MIBC, do you think it will be a big leap for them to adopt neoadjuvant therapy for NMIBC? 44
Slide 45: Closing Thoughts
CLOSING THOUGHTS 45
Slide 46: UGN-102 Shows Substantial Reduction of Risk Across Multiple Patient Populations
UGN-102 Shows Substantial Reduction of Risk of Recurrence, Progression, or Death Across Multiple Patient Populations in ATLAS ITT – All Patients 0.45 (0.29, 0.68) DFS CR Duration – UGN-102 Alone 0.46 (0.24, 0.86) DOR Recurrent – UGN-102 Alone 0.34 (0.15, 0.75) DOR UroGen Data on File 46 Various ATLA
Slide 47: Q&A
Q&A Moderated by LIZ BARRETT 47
Slide 48: UroGen is Poised to Transform the Way Bladder Cancer is Treated
UroGen is Poised to Transform the Way Bladder Cancer is UGN-102 shows Treated Compelling clinical substantial risk data package from 3 reduction across trials and 565 patients patient populations $120M #1 $3B+TAM UGN-102 may become private placement LG-IR-NMIBC market the first medicine to with expe
Slide 49: Thank You
THANK YOU 49
Slide 50: BTR OK N
BTR OK N | ae ko Lie
Slide 51: Demographics and Baseline Characteristics Were Well Balanced
Demographics and Baseline Characteristics Were Well Balanced Between Treatment Arms UGN-102 +/- TURBT TURBT Alone Characteristic (N = 142) / n (%) (N = 140) / n (%) Median age (range), years 68.0 (23, 85) 67.0 (29, 88) Age ≥ 65 years, n (%) 91 (64.1) 77 (55.0) Sex, n (%) Male 105 (73.9) 93 (66.4) Fe
Slide 52: Overall Summary of Adverse Events in ATLAS
Overall Summary of Adverse Events in ATLAS: Safety Profile Similar to Other Studies of UGN-102 UGN-102 ± TURBT TURBT Alone (N = 138) (N = 132) Events n (%) Events n (%) Any Adverse Events 442 108 (78.3) 249 81 (61.4) Any Serious Adverse Events 13 12 (8.7) 11 7 (5.3) Any TEAEs 402 104 (75.4) 166 63 (
Slide 53: Most Commonly Reported AEs and Serious TEAEs
Most Commonly Report ed AEs and Serious TEAEs Incidence of Treatment-Emergent Adverse Events Incidence of Serious TEAEs (≥ 5% in Either Group) (≥ 1% in Either Group) UGN-102 ± TURBT TURBT Alone UGN-102 ± TURBT TURBT Alone (N = 138) / n (%) (N = 132) / n (%) (N = 138) / n (%) (N = 132) / n (%) Patien
Slide 54: Summary of Disease-Free Survival
Summary of Disease-Free Survival: Significantly More Total Progressions and Recurrences in TURBT Alone Arm UGN-102 +/- TURBT TURBT Alone (N = 140) / n (%) (N = 142) / n (%) Patients with Events, n (%) 37 (26.1) 55 (39.3) Recurrence of LG Disease 20 (14.1) 39 (27.9) Progression to HG Disease 17 (12.0
Slide 55: Summary of Duration of Response in Complete Responders
Summary of Duration of Response in Complete Responders: Longer DOR with UGN-102 UGN-102 Alone TURBT Alone (N = 92) / n (%) (N = 89) / n (%) Patients with Events, n (%) 18 (19.6) 24 (27.0) Recurrence of LG Disease 15 (16.3) 17 (19.1) Progression to HG Disease 3 ( 3.3) 6 ( 6.7) Death 0 1 ( 1.1) Patien
Slide 56: ENVISION Trial Design
ENVISION Trial Design Informed Consent and Screening Visit to Determine Eligibility (LG-IR-NMIBC and no evidence of HG disease based on cystoscopy, biopsy, and cytology) UGN-102 once -weekly for 6 weeks (total of 6 intravesical instillations) 3-month Visit Complete Response Non-complete Response (Pr
Slide 57: Summary of Demographics and Baseline Characteristics
Summary of Demographics and Baseline Characteristics UGN-102 Characteristic Statistic (N = 240) / n (%) Age Median Age (Min, Max) 70.0 (30, 92) Age Group 2 (Years), n (%) >= 65 162 (67.5) Sex, n (%) Male 147 (61.3) Female 93 (38.8) Prior TURBT, n (%) Yes 231 (96.3) No 9 (3.8) Previous LG NMIBC Episo
Slide 58: Overall Summary of Adverse Events in ENVISION
Overall Summary of Adverse Event s in ENVISION: Safety Profile Similar to Other Studies of UGN-102 UGN-102 (N = 240) Events n (%) Any Adverse Events 563 129 (53.8) Any Serious Adverse Events 26 19 (7.9) Any TEAEs 523 127 (52.9) Any Treatment or Procedure Related TEAEs 283 96 (40.0) Any Treatment Rel
Slide 59: Treatment-Related AEs were Generally Mild to Moderate
Treatment-Relat ed AEs were Generally Mild t o Moderat e and in line wit h expect at ions in t he field Incidence of Treatment-emergent Adverse Events Incidence of Treatment Related (≥ 5%) Serious TEAEs UGN-102 UGN-102 (N = 240) / n (%) (N = 240) / n (%) Severe or Patients With Any Serious TEAEs 2 (
Slide 60: Clinical Results Propel Us Towards FDA Submission
Clinical Result s Propel Us Towards FDA Submission ATLAS OPTIMA II ENVISION CR: 65.1% CR: 64.8% CR: 79.2% 12-month DOR: 72.5% 12-month DOR: 79.7% Safety: AEs mostly mild to Safety: AEs mostly mild to Safety: AEs mostly mild to moderate moderate moderate 60 Both DOR as estimated by Kaplan Meier Metho
Slide 61: UroGen is Poised to Transform the Way Bladder Cancer is Treated
UroGen is Poised to Transform the Way Bladder Cancer is UGN-102 shows Treated Compelling clinical substantial risk data package from 3 reduction across trials and 565 patients patient populations $120M #1 $3B+TAM UGN-102 may become private placement LG-IR-NMIBC market the first medicine to with expe
Slide 62: ATLAS Summary of Response Rate at Scheduled Disease Assessments
ATLAS Summary of Response Rate at Scheduled Disease Assessments (3-month CR Analysis Set) UGN-102 ± TURBT TURBT Alone (N = 92) (N = 89) CRR CRR Visit Response n (%) n (%) (95% CI) (95% CI) Month 6 Complete Response 85 (92.4) 92.4 (84.9, 96.9) 64 (71.9) 71.9 (61.4, 80.9) Recurrence 5 ( 5.4) 14 (15.7)
Slide 63: Summary of Baseline Factors table
‘UesGen Pharma Led. ‘DGN-102/BL006 Table 14 Susmary of Baseline Bgeete Factors TTT Analysis Set WeHRi nat "size (em, 2 (8) Vase Endens LG = Low Grades MEE = Non-muscie Invasive Sladder Gances) TURET = Teansurevheal Resection of BlaGder = Snokez category includes bovh former and gurrene, smokers. Non
Slide 64: Summary of Baseline Prognostic Factors table
UeoGen Fharma Led. ‘Ueu-102 /8L006 Table 14.1.6.2 Summary of Eaveline Prognostic Factors HTP Anaiysie See Characteristic Feevicus is MNGEC Episcder ye shunber of Previous 25 MHEC Estaodes, Previous 16 MUEC Episodes, = (3) Yee x Frise TORET, n (3) ae septeng 2 Bistory, 2 (8 onsdes) snoke: Bg = body W
Slide 65: Summary of Prior NMIBC Episodes
Suman) Uoe-L02 = TORET TORBT_ Alone oiena2) Gie240) Patients vith Any Price MMIEC episode, = (4) ‘Yes 87 (40.0) Prior MMIBC Episode (s) (months) Go = tener Quareiler So = Standard Devise TORT = calculated as (start date of current episode ~ end date of previous Dave of data extraction: 17MAI2022.
Slide 66: Summary of Prior NMIBC Episodes and Prior TURBT
Le 14.1 sumary of Price HESS Epussdes and Peter TURET THT Analysis Set UGN-102 2 TORET aren42) Number of Prior TORET [2] Mean Median (tie, Max) Feioe TURET, 2 (3) Yes Re Number of Prior TURET Group, = (2) oar TORET jeer Quartile: 8D = Se: jer Quartile WMGEC = Wenpancie = cancer Tesnaurechesi Resecti
Slide 67: Summary of Prior NMIBC Episodes and Prior TURBT
Table 14.1.6.2 Suomary of Prion IMEEC Episodes TTT Analy: and Frior TURET Days since last TURET at S Time since last TURET at Mean (30) Median (Ql, 02) Max IREEC = Seecgagete, Hpvasiye GigGiee Causes) G1 = iever Quaveiles G9 = taser Quaseiles G0 = Geandard Deviations TURE = (zonthe) is calculaced as
Slide 68: ATLAS Summary Demographics/Baseline Data by TURBT Naïve vs Prior TURBT
ATLAS SUMMARY DEMOGRAPHICS/BASELINE DATA BY (TURBT NAÏVE VS. >=1 PRIOR TURBT) >=1 prior TURBT TURBT Naïve (N=164) (N=118) UGN-102 ± TURBT TURBT Alone UGN-102 ± TURBT TURBT Alone (N=87) (N=77) (N=55) (N=63) Median age (range), years 66 (23,85) 65 (29,83) 69 (35,85) 69 (47,88) Sex, n (%) Male 64(73.6)
Slide 69: ATLAS Summary Demographics/Baseline Data by TURBT Naïve vs Prior TURBT
ATLAS SUMMARY DEMOGRAPHICS/BASELINE DATA BY (TURBT NAÏVE VS. >=1 PRIOR TURBT) >=1 prior TURBT TURBT Naïve (N=164) (N=118) UGN-102 ± TURBT TURBT Alone UGN-102 ± TURBT TURBT Alone (N=87) (N=77) (N=55) (N=63) Tumor Size (cm), n (%) <=3 cm 30(34.5) 33(42.9) 39(70.9) 40(63.5) >3 cm 54(62.1) 42(54.5) 13(2
Slide 70: ATLAS Summary Demographics/Baseline Data by TURBT Naïve vs Prior TURBT
ATLAS SUMMARY DEMOGRAPHICS/BASELINE DATA BY (TURBT NAÏVE VS. >=1 PRIOR TURBT) >=1 prior TURBT TURBT Naïve (N=164) (N=118) UGN-102 ± TURBT TURBT Alone UGN-102 ± TURBT TURBT Alone (N=87) (N=77) (N=55) (N=63) Number of Previous LG NMIBC Episodes, n (%) Yes 2(2.3) 3(3.9) 52(94.5) 62(98.4) No 85(97.7) 74
Slide 71: ATLAS Summary of CRR by Subgroup
ATLAS SUMMARY OF COMPLETE RESPONSE RATE (CRR) BY SUBGROUP (NAÏVE TURBT VS. >1 TURBT) TURBT Naive >= 1 TURBT (N=164) (N=118) UGN-102 ± TURBT TURBT Alone UGN-102 ± TURBT TURBT Alone (N=87) (N=77) (N=55) (N=63) CRR CRR CRR CRR n(%) n(%) n(%) n(%) (95% CI) (95% CI) (95% CI) (95% CI) Complete Response 51
Slide 72: ATLAS Summary of CRR by Month by Subgroup
ATLAS SUMMARY OF CRR BY MONTH BY (TURBT NAÏVE VS. >=1 PRIOR TURBT) (3-MONTH CRR ANALYSIS SET) TURBT Naïve >=1 prior TURBT (N=105) (N=76) UGN-102 ± TURBT TURBT Alone UGN-102 ± TURBT TURBT Alone (N=51) (N=54) (N=41) (N=35) CRR CRR CRR CRR Visit Response n(%) (95% CI) n(%) (95% CI) n(%) (95% CI) n(%) (
Slide 73: ATLAS Summary of DFS by Subgroup
ATLAS SUMMARY OF DISEASE-FREE SURVIVAL (DFS) BY SUBGROUP (NAÏVE TURBT VS. >1 TURBT) Confidential
Slide 74: ATLAS Summary of DFS by Subgroup
ATLAS SUMMARY OF DISEASE-FREE SURVIVAL (DFS) BY SUBGROUP (NAÏVE TURBT VS. >1 TURBT) Confidential
Slide 75: ATLAS % Patients Who Received TURBT at Months
ATLAS % Patients who received TURBT at 3 months UGN-102 ± TURBT TURBT Alone (N=138) (N=132) At the 3-Month Assessment n (%) n (%) TURBT 24 (17.4%) 18 (13.6%) Reference: 14.2.2.4
Slide 76: ATLAS: Patients Who Received TURBT With History of >1 Prior TURBT
ATLAS: Summary of Patients who received TURBT at 3 months with a history of > 1 prior TURBT (ITT Analysis Set) UGN-102 ± TURBT TURBT Alone (N=55) (N=63) Follow-on treatment with TURBT at Month-3 Assessment Visit 8 (14.5) 17 (27.0)
Slide 77: ATLAS Censoring in Months 0-3
ATLAS CENSORING IN MONTHS 0-3 Number of patients by treatment arm who were censored prior to a DFS of 3.0 months: • UGN Arm: 11 patients • TURBT Arm: 20 patients Many censored observations (n=31) take place near time zero due to patients being randomized but without additional assessments (e.g. at m
Slide 78: ENVISION: Summary of Baseline Prognostic Factors
ENVISION: Summary of Baseline Prognostic Factors (ITT Analysis Set) UGN-102 (N=240) Characteristic n (%) Age Group (Years), n (%) < 65 78 (32.5) >= 65 162 (67.5) Age Group (Years), n (%) < 75 151 (62.9) >= 75 89 (37.1) 2 BMI (kg/m ) category, n (%) < 30 183 (76.3) >= 30 55 (22.9) Missing 2 (0.8) Sex
Slide 79: ENVISION: Summary of Baseline Prognostic Factors
ENVISION: Summary of Baseline Prognostic Factors (ITT Analysis Set) UGN-102 (N=240) Characteristic n (%) Tumor Size (cm), n (%) <= 3 164 (68.3) > 3 40 (16.7) Missing 36 (15.0) Tumor Count, n (%) Single 45 (18.8) Multiple 193 (80.4) Missing 2 (0.8) Previous LG NMIBC Episodes within 1 Year of the Curr
Slide 80: Incidence of Treatment Related Serious TEAEs (ENVISION)
Incidence of Treatment Related Serious TEAEs (ENVISION Safety Analysis Set) UGN-102 Preferred Term (N=240) n (%) Patients with Any Treatment Related Serious TEAE 2 (0.8) Urethral stenosis 1 (0.4) Urinary retention 1 (0.4)
Slide 81: Incidence of Deaths (ENVISION)
Incidence of Deaths (ENVISION Safety Analysis Set) UGN-102 (N=240) n (%) Total Deaths anytime after first installation 2 (0.8) Pneumonia 1 (0.4) Cardiac failure 1 (0.4) Notes: Reported deaths were unrelated to treatment
Slide 82: Incidence of Serious TEAEs (ENVISION)
Incidence of Serious TEAEs (ENVISION Safety Analysis Set) UGN-102 (N=240) Preferred Term n (%) Patients with Any Serious TEAE 18 (7.5) Acetabulum fracture 1 (0.4) Adenocarcinoma pancreas 1 (0.4) Atrioventricular block second degree 1 (0.4) Blood creatinine increased 1 (0.4) COVID-19 1 (0.4) Cardiac
Slide 83: Incidence of Serious TEAEs (ENVISION)
Incidence of Serious TEAEs (ENVISION Safety Analysis Set) UGN-102 (N=240) Preferred Term n (%) Headache 1 (0.4) Hyponatraemia 1 (0.4) Incarcerated inguinal hernia 1 (0.4) Jaundice 1 (0.4) Lung cancer metastatic 1 (0.4) Nausea 1 (0.4) Pneumonia 1 (0.4) Transient ischaemic attack 1 (0.4) Urethral sten
Slide 84: Summary of Study Discontinuation by Study and Arm
Summary of Study Discontinuation by Study and Arm Study Treatment 0-3 Months 3 -6 Months 6 - 9 Months >9 Months ATLAS UGN-102 +/- TURBT (N=142) 8 (5.6) 5 (3.5) 3 (2.1) 3 (2.1) TURBT alone (N=140) 16 (11.4) 6 (4.3) 7 (5.0) 5 (3.6) ENVISION UGN-102 (N=240) 2 (0.8) 2 (0.8) 1 (0.4) OLYMPUS II UGN-102 75