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Radical Innovation Over Radical Intervention: Transforming LocalTherapies in Uro-Oncology

Corporate PresentationNovember 2018

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This presentation and the accompanying oral presentation by UroGen Pharma Ltd. (“UroGen”) contains forward-looking statements. Allstatements contained herein other than statements of historical fact constitute forward-looking statements, including statements regardingUroGen’s anticipated results of operations and financial position, business strategy and operating plans and UroGen’s expectations for futureoperations.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing andsuccess of preclinical studies and clinical trials conducted by or on behalf of UroGen, including with respect to the efficacy and safety of UroGen’sproduct candidates; UroGen’s ability to obtain and maintain regulatory approval of its product candidates, and the labeling for any approvedproducts; the scope, progress, expansion and costs of developing and commercializing UroGen’s product candidates; UroGen’s ability to obtainand maintain intellectual property protection for its product candidates; UroGen’s anticipated growth strategies; UroGen’s expectations regardingcompetition; the anticipated trends and challenges in UroGen’s business and the markets in which it operates; UroGen’s ability to attract orretain key management and personnel; the size and growth of the potential markets for UroGen’s product candidates and its ability to servethose markets; the rate and degree of market acceptance of UroGen’s product candidates vis-à-vis alternative or existing therapies; UroGen’sexpectations regarding regulatory requirements; developments in applicable regulatory regimes; and the manner in which UroGen intends to useits cash resources and the sufficiency thereof. Moreover, UroGen operates in a very competitive and rapidly changing environment in which newrisks emerge from time to time. It is not possible for UroGen’s management to predict all risks, nor can UroGen assess the impact of all factors onits business or the extent to which any such factor or combination of factors may cause actual results to differ materially from those containedherein. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur, andUroGen’s actual results could differ materially and adversely from those anticipated or implied by the forward-looking statements containedherein. Except at required by law, UroGen undertakes no obligation to update any such forward-looking statements after the date hereof toconform to actual results or changes in UroGen’s expectations.

Forward-Looking Statements

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• Developed RTGel™, a sustained release, hydrogel-based platform technology with the potential for use in a range of body cavities where increased dwell time may improve therapeutic profiles of existing drugs

• Lead investigational therapies:

UroGen Addressing Unmet Needs in Urology

UGN-101 (mitomycin gel) for

instillation

: Phase 3 enrollment completedo Initiation of Q4 2018 Rolling

NDA Submission planned for Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC)

o Potential to be the first drug ever approved in UTUC

UGN-102(mitomycin gel) for

intravesical instillation

: Phase 2b

o Potential to be the first drug ever approved as first-line chemoablative treatment for non-muscle invasive bladder cancer (NMIBC)

o Initial data from the trial expected in 1H 2019

UGN-201

: Pre-Clinical

o TLR 7 agonist intravesical instillation for the treatment of carcinoma in situ (CIS bladder cancer)

o Preliminary efficacy signal in Phase 1b in bladder CIS

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Deep Oncology Development & Business Efficiency Experience

Arie Belldegrun, MD, FACS

Chairman

Ron Bentsur

Chief Executive Officer

Peter P. Pfreundschuh

Chief Financial Officer

Mark Schoenberg, MD

Chief Medical Officer

Stephen Mullennix

Chief Operating Officer

Woody Bryan, Ph.D.

SVP, Business Development

Elyse Seltzer, MD

SVP, Clinical Development

Jeffrey Bova

SVP, Commercial

James Ottinger, R.PH

SVP, Regulatory Affairs

Marina Konorty, Ph.D.

VP, R&D and Head of Israel Operations

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Current Standard of Care for UTUC & NMIBC

Repeated Cycle of Surgical Therapy in Urology

UTUCUpper Tract UrothelialCarcinoma

Resection of visible & accessible tumors only

Kidney & upper tract removal

Multifocal & inaccessibletumors

High rates of recurrences

LG NMIBCLow Grade Non-Muscle-Invasive Bladder Cancer

Resection of visible tumors

Adjuvant chemo

follow up

High rates of recurrences

• Bladder cancer is one of the top 10 most common cancers in the world• Lack of FDA-approved drugs for the treatment of urinary tract diseases

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Limitations of Current Treatment Options & Procedures

Upper Tract = ~ 5 Minutes

Bladder = ~ 30 Minutes

• Constant urine creation

• Bladder and upper tract movement

• Voiding

• Drug washes out before it has a chance to work properly

UT Physiology Limits Drug Exposure

Upper Tract = Intricate Structures

Bladder = Hard to See All Tumors

• Renal pelvis anatomy makes it hard to see and reach all tumors (tough angles and poor visualization)

• Not all bladder tumors are easily seen, making complete tumor resection difficult

UT Anatomy Limits Surgical Therapy

30seconds

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Radical Surgery is Common for Low Stage Disease

• 15,902 cases of UTUC cases were identified from 2000–2008 from NCDB

• Stage 0 and Stage I accounted for 59% of cases

• Nephroureterectomy performed 78%

Stage IStage 0

Kohut and Zhu (2012) JUrol

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How Our Innovative RTGel Technology Platform Works

(1) RTGel: Reverse Thermal Gelation Hydrogel.

RTGel(1): Liquid at low temperature (LT) and converts into gel form at body temperature (BT) following intravesical instillation

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CATEGORY PROGRAM PRE-CLINICAL

PHASE 1 PHASE 2 PHASE 3 NEXT MILESTONE

Uro-oncology

UGN-101 (Orphan)Low-Grade Upper Tract Urothelial Carcinoma (UTUC)

•NDA Rolling Submission Q4 2018•Topline Data = January 2019• Potential Approval 2019

UGN-102 Low-Grade Non-Muscle Invasive Bladder Cancer (NMIBC)

• Ph 2b Interim Topline Data 1H 2019

Immuno-Uro-oncology

UGN-201 (TLR7 Agonist + checkpoint inhibitors)(Orphan)Carcinoma in Situ (CIS) Bladder Cancer

NeuromodulationBotuGel1

Overactive Bladder• Ph 2 Initiated by Allergan in November 2017

Advancing Our Innovative Pipeline

1 Licensed to Allergan

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• Novel sustained-release mitomycin formulation

• Potential to become first drug ever approved as a first-line chemoablation treatment of low-grade UTUC

• FDA Orphan Drug Designation

• FDA Breakthrough Therapy Designation

• FDA Fast Track Designation

• Initiation of Rolling NDA Submission Planned for Q4 2018

Phase 3 Enrollment Completed

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UGN-101For Low-Grade UTUC

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PATIENT FLOW EPIDEMIOLOGY

*LG UTUC Prevalent population is modeled assuming 10-year lifespan of incident patients, 70% lifetime / 40% annual recurrence following endoscopic resection, adjusted for rates of kidney removal.

Approximately 6,000 - 8,000 patients present with LG UTUC every year the US

Repeated ureteroscopicmanagement

Follow up every 3 months until recurrence: Retreat

with ureteroscopy or RNU

Radical nephroureterectomy

(RNU)

UTUC diagnosis and biopsy

Low GradeHigh Grade

331M US population

7,000Annual incidence: 2.06 per

100,000Ramon, 2010

3,000 –4,000

40% - 60% of UTUCMargulis, 2009

Primary Market Research

Total population at launch

New UTUC

Patients

New Low Grade NMI UTUC Patients*

3,000 –4,000

Cutress, 2012Primary Market Research

Annual Recurrent LG NMI UTUC Patients

= ~6,000 – 8,000 Patients

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Design:• Single pivotal, open-label, single-arm,

Phase 3 trialPatient Group:• Patients with low-grade UTUC Number of Patients: • ~70 patientsTreatment Regimen:• Six weekly instillations of UGN-101

UGN-101: OLYMPUS Pivotal Trial Design & Expected Timing

Recruiting and Treating Patients

Interim Analysis

Trial Starts

End Recruitment, PrimaryEndpoint

Planned Initiation of RollingNDA Submission

Top-Line Data January 2019

*CR: Complete Response

Primary Efficacy Endpoint:• CR* at ~four weeks after last instillation• Patients with CR will be:

– Followed for durability– Treated with UGN-101 monthly for up to 12

months of maintenance therapy Regulatory Pathway:• 505(b)(2)

2017 2018 2019

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PotentialApproval and

Launch

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Interim Analysis: CR Rate Exceeds Expectations & Provides Validation of Potential of the RTGel Platform

COMPASSIONATE USE PROGRAM

(n=18*)

CR (%) PR (%)

44 28

• Of 8 original patients who achieved CR, 4 remain in CR.

• Of these 4, 3 have remained in CR for 18+ months.

UGN-101 INTERIM ANALYSIS

(n= 34*)

CR (%) PR (%)

59 15

• Of the 20 patients who achieved CR:• 13 have reached 3 mo

• 4 reached 6 mo• 1 has reached 9 mo

• All remain in CR

CLINICALLY MEANINGFUL OUTCOME

CR (%)

~20%**

*Intent to Treat Analysis (ITT)

**Based on discussions with KOLs

Follow-Up Ongoing

• P3 Topline Results: Expected January 2019 • Initiation of Rolling NDA Submission: Planned for Q4 2018

Du

rab

ility

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Treatment Emergent AEs (>5%)

Adverse Event N=42 (%)

Flank pain 17 (40.5%)

Ureteral events 16 (38.1%)

Nausea/Vomiting 15 (35.7%)

LUTS 15 (35.7%)

Renal events 13 (31.0%)

Immune reactions 13 (31.0%)

Weakness/Fatigue 12 (28.6%)

Hematuria 12 (28.6%)

UTI/Urosepsis 10 (23.8%)

• Majority reported as mild or moderate and resolved

• Most were transient

• AEs were in line with MMC/endoscopic therapies

UGN-101: Appears Safe and Well-Tolerated

Safety profile is in line with published literature on endoscopic tumor ablation and kidney stone removal.

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• RTGel / high dose mitomycin sustained-release formulation

• Potential alternative to TURBT

• Potential first-line chemoablation treatment of low-grade NMIBC

• Phase 2b single-arm, open-label, multi-center trial of UGN-102 enrolling patients

• Initial Ph 2b Interim Topline Data 1H 2019

Phase 2b

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UGN-102For Low-Grade NMIBC

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UGN-102 is a Potential Alternative for Up to 85,000 Patients Where Current Standard of Care (TURBT) is No Longer Effective

Sources: Holmang, 1995; Neilsen, 2014; Babjuk, 2015; Herr, 2007; Cutress, 2012; NIH SEER Stat; UroGen Market Research

PATIENT FLOW EPIDEMIOLOGY

Bladder Cancer Diagnosis

TURB-T; Biopsy resected tissue

81,190 SEER STAT

29,600NMIBC 75%;

70% Ta; 70% LG

Bladder Cancer Incidence

New LG Ta

Patients

Recurrent LG Ta NMIBC Patients

100,000 –140,000

Stage: • NMIBC: Ta, CIS, T1,• MIBC: T2, T3, T4 Grade:• Ta and T1 can be low or high grade• CIS is always high grade

LG Ta(Watch and wait for recurrence)

CIS(BCG)

HG Ta, T1(TURB-T;

Adjuvant BCG)

MIBC(Radical

cystectomy)

Low risk for recurrence

Intermediate risk for recurrence

High risk for recurrence

1 or 2 criteria: • Multiple tumors• Tumors >3cm• Early recurrence

Repeated TURB-Ts with each recurrence

Intermediate risk

at recurrence

Up to ~ 60% of recurrent patients

• Primary market research

Up to85,000

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45%

86%83%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

UGN-102 0.06% (40mg) n=20 pts

UGN-102 0.12% (80mg)n=22 pts

UGN-102 0.2% (120mg)n=12 pts

Phase 2a Dose Escalation (DE)

CR

%

20 22 12

UGN-102: Dose Response Study

• 86% complete response with UGN-102 0.12% (80mg)

• Using higher doses may not increase efficacy

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UGN-102: Durable CRs in Clinical Program

% of patients treated with UGN-102 with CR over 12 months

~80% durability at 12 months No additional treatments were given during this period

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20

Du

rab

le C

R %

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0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

PDE 3m 6m 9m 12m

28 28 25 2224

100% 100%

89.3% 85.7%78.6%

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• Novel Imiquimod formulation for bladderinstillation

• Orphan Drug Designation for CIS bladder cancer

• Potential local immunotherapy for the treatment of CIS bladder cancer

• Conducting pre-clinical research to evaluate UGN-201 either as a single-agent or in combination for high-grade disease

• Phase 1b suggests preliminary efficacy signal in bladder CIS

Pre-Clinical

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UGN-201

For CIS Bladder Cancer

CIS = Carcinoma in Situ

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• Exclusive license agreement with Allergan

• Potential to evolve from multiple injections of BOTOX into the bladder to a single instillation into the bladder

• Up to $225 million ($25 million already received and $200 million in pending milestones) and tiered royalties on net sales

• Phase 2 trial initiated by Allergan in November 2017

Phase 2

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BotuGel™

For Overactive Bladder

Validates the RTGel Platform Beyond Oncology

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Broad Potential for RTGel Technology Platform

• Phase 3 in U.S. for UTUC• Phase 2 in U.S. for BC• Potential First Line Therapies• RTGel with MMC

• License with Allergan• Instillation therapy for OAB• RTGel with botulinum toxin

• RTGel as Gastro-Retentive Drug Delivery System (GRDDS)

• Local treatment of GI Tract with reduced systemic effect

• Local treatment of affected lining of uterus or fallopian tubes

• Liquid functional food for oral delivery comprising an in situ gelling agent for use in reducing weight

• Liquid composition for oral or enteral administration

UTUC / Bladder Cancer

Overactive Bladder

Gastroenterology

Women’s Health

Weight loss; Enteral Feeding

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UroGen: Emerging Leader in the Treatment of Urothelial Cancers and Other Urological Indications

Potential for first ever FDA drug approval for the treatment of UTUC

Management team with experience in drug development, oncology/urology and business efficiencies

Strong cash position of approximately $109.5 million as of September 30th, 2018

Innovative technology platform with potential for use beyond oncology to improve therapeutic profiles of existing drugs in a wide range of body cavities

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Thank You