UroGen Pharma Announces Three Data Presentations Related to its Clinical Stage Uro-Oncology Candidates at the American Urology Association’s 2016 Annual Meeting

New York, NY and Ra’anana, Israel, May 5th, 2016: UroGen Pharma, a clinical-stage biopharmaceutical company developing novel, locally-administered pharmaceutical solutions for urological pathologies with a focus on uro-oncology, announced today that the Company has been selected to present two oral/podium presentations and one poster presentation at the American Urology Association 2016 Annual Meeting in San Diego, California, on May 7-11, 2016.

“We are excited that findings from three studies highlighting our novel therapies designed to potentially change the standard of care for urological pathologies will be presented at the AUA annual meeting. We are developing non-surgical, local solutions – MitoGel, VesiGel and Vesimune – for several forms of bladder cancer and upper tract urothelial carcinoma” said Ron Bentsur, Chief Executive Officer.

The abstracts related to UroGen Pharma’s clinical stage uro-oncology candidates will be presented at the American Urology Association 2016 Annual Meeting are detailed below:

Title: The Chemoablative Effect of VesiGel Instillation in Patients with NMIBC – Preliminary Results
Presenting Author: Ilan Leibovitch, M.D., Department of Urology, Meir Medical Center, Tel Aviv, Israel
Session: Bladder Cancer: Non-Invasive II on Saturday, May, 7 from 8:00 am – 10:00 am PST

Title: Preclinical trial of serial MitoGel® instillations into the pelvicalyceal system of the Yorkshire swine
Presenting Author: Nicholas Donin, M.D., Department of Urology, UCLA, Los Angeles, CA
Session: Bladder Cancer: Upper Tract Transitional Cell Carcinoma I on Saturday, May 7 from 8:00 am to 10:00 am PST

Title: A Phase 2 Study of Vesimune®, intravesical imiquimod, for the Treatment of Carcinoma in Situ Bladder Cancer
Presenting Author: Nicholas Donin, M.D., Department of Urology, UCLA, Los Angeles, CA
Session: Late-Breaking Science & Technology Poster, Saturday, May 7 from 10:30 am to 11:30 am PST

About UroGen Pharma

UroGen Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies designed to change the standard of care for urological pathologies with a focus on uro-oncology. The lead product candidates, MitoGel and VesiGel, are designed to potentially remove tumors by non-surgical means, to treat several forms of non-muscle invasive urothelial cancer, including low-grade bladder cancer and upper tract urothelial carcinoma, or UTUC.  In addition, UroGen is developing a clinical-stage product candidate for the treatment of overactive bladder and interstitial cystitis and a clinical-stage product candidate for the treatment of high-grade non-muscle invasive bladder cancer.

Company Contact Information:

Gary Titus, Chief Financial Officer
garyt@urogen.com

Investors:

Stephanie Carrington, ICR, Inc.
stephanie.carrington@icrinc.com
646-277-1282

Forward Looking Statements

This press release contains forward-looking statements.  All statements contained herein other than statements of historical fact constitute forward-looking statements, including statements regarding UroGen Pharma’s anticipated results of the operations and financial position, business strategy and operating plans. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing and success of preclinical studies and clinical trials conducted by or on behalf of UroGen Pharma, including with respect to the efficacy and safety of its product candidates; UroGen Pharma’s ability to obtain and maintain regulatory approval of its product candidates, and the labeling for any approved products; the scope, progress, expansion and costs of developing and commercializing UroGen Pharma’s product candidates; UroGen Pharma’s ability to obtain and maintain intellectual property protection for its product candidates; UroGen Pharma’s anticipated growth strategies; UroGen Pharma’s expectations regarding competition; the anticipated trends and challenges in UroGen Pharma’s business and the markets in which it operates; UroGen Pharma’s ability to attract or retain key management and personnel; the size and growth of the potential markets for UroGen Pharma’s product candidates and its ability to serve those markets; the rate and degree of market acceptance of UroGen Pharma’s product candidates vis-à-vis alternative therapies; UroGen Pharma’s expectations regarding regulatory requirements; developments in applicable regulatory regimes; and the manner in which UroGen Pharma intends to use its cash resources and the sufficiency thereof. Moreover, UroGen Pharma operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. It is not possible for UroGen Pharma’s management to predict all risks, nor can they assess the impact of all factors on its business or the extent to which any such factor or combination of factors may cause actual results to differ materially from those contained herein.  In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur, and UroGen Pharma’s actual results could differ materially and adversely from those anticipated or implied by the forward-looking statements contained herein. UroGen Pharma undertakes no obligation to update any such forward-looking statements after the date hereof to conform to actual results or changes in expectations.

 

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