UroGen Pharma Strengthens Leadership Team and Expands Uro-Oncology Clinical Pipeline With Addition of TLR-7 Agonist Phase 2 Asset

NEW YORK and RA'ANANA, Israel, Jan. 13, 2016 (GLOBE NEWSWIRE) -- UroGen Pharma, Ltd. (formerly known as TheraCoat), a clinical-stage biopharmaceutical company developing novel, locally-administered pharmaceutical solutions for urological pathologies with a focus on uro-oncology, announced today the appointment of two key executive officers: Ron Bentsur has joined the company as Chief Executive Officer and Gary Titus has joined the company as Chief Financial Officer. In addition, Gil Hakim has been appointed President of Israeli Operations.

In the fourth quarter of 2015, UroGen completed the acquisition of Vesimune, a TLR-7 agonist immunotherapy drug candidate in a novel, liquid formulation for the treatment of high grade non-muscle invasive bladder cancer, including carcinoma in situ (CIS) bladder cancer, from Telormedix SA. This purchase expands UroGen's clinical-stage uro-oncology drug candidate pipeline and supports the company’s multi-modality approach for the potential treatment of low and high-grade bladder cancers.

The company is focused on the development of therapeutic candidates to address medical needs across a number of urologic indications, including uro-oncology. UroGen’s uro-oncology drug candidate pipeline is comprised of MitoGel™, a novel chemoablation, non-surgical treatment for low-grade Upper Tract Urothelial Carcinoma (UTUC); VesiGelTM, novel chemoablation, non-surgical treatment for low-grade bladder cancer; and Vesimune™, a local immunomodulation approach for the treatment of high-grade bladder cancer, including CIS. UroGen has obtained Orphan Drug Designations for MitoGel™ and Vesimune™ from the U.S. Food and Drug Administration (FDA). UroGen expects to commence a pivotal trial of MitoGel in low-grade UTUC in the second half of 2016.

Arie Belldegrun, M.D., Chairman of UroGen’s Board of Directors, commented, “On behalf of the Board of Directors, I welcome Ron and Gary to UroGen. Ron brings two decades of biopharmaceutical experience to UroGen and a track record of taking clinical stage drug candidates through the FDA approval process. Gary is a seasoned biotech CFO with expertise in private and public companies, as well as commercial and clinical-stage companies."

Dr. Belldegrun added, "I believe that UroGen is well positioned to advance the clinical development of its exciting pipeline of urology-focused therapeutic candidates, which have the potential to be best-in-class. The prospect of treating a variety of urological cancers locally and without the use of surgery represents a potential shift in the treatment paradigm."

Mr. Bentsur commented, “I am excited to be joining UroGen as CEO at this dynamic time for the company. With no new drugs approved for bladder or upper tract cancers in close to 20 years, this patient population remains dramatically underserved. We have a robust pipeline of clinical-stage drug candidates for uro-oncology and other urologic pathologies, which provides us with an opportunity to offer meaningful improvements over current standards of care.”

Mr. Bentsur is an experienced biopharmaceutical CEO and joins UroGen from Keryx Biopharmaceuticals, where he spent six years as Chief Executive Officer. Mr. Bentsur led Keryx through its transition from an early clinical-stage to a fully-integrated commercial biopharmaceutical company following the September 2014 FDA approval and launch of Auryxia™ for the treatment hyperphosphatemia in dialysis patients. Prior to his tenure at Keryx, Mr. Bentsur served as CEO of XTL Biopharmaceuticals. Mr. Bentsur serves as a Director of Stemline Therapeutics, Inc. and Chairman of Advanced Inhalation Technologies, Ltd.

Mr. Titus is an experienced financial professional with more than 20 years of experience in the healthcare and life sciences arena. Most recently, Mr. Titus served as the Chief Financial Officer of BioCardia, a private, cell-based regenerative medicine company. Prior to that, he served as Chief Financial Officer of SciClone Pharmaceuticals, a commercial-stage biotechnology company. Mr. Titus was previously Chief Financial Officer of Kosan Biosciences until it was acquired by Bristol Myers Squibb. Mr. Titus serves as Chairman of ImmunoCellular Therapeutics Ltd.

About Bladder Cancer and Upper Tract Urothelial Carcinoma (UTUC)

Bladder cancer is the fourth most common cancer in men and ninth in women. In 2015, an estimated 74,000 adults were diagnosed with bladder cancer in the United States. In 2012, there were an estimated 577,403 people living with bladder cancer in the United States. First line treatment of bladder cancer comprises the surgical removal of the tumor, a procedure known as Trans-Urethral Resection of a Bladder Tumor, or TURBT, followed by periodic adjuvant chemotherapy instillations. Bladder cancer is one of the most expensive cancers per patient to treat due to high recurrence rates, intensive surveillance strategies, and expensive treatment costs. The lifetime management of bladder cancer may cost as much as $187,000 per patient, or an aggregate of $3.98 billion annually, in the United States alone. UTUC comprises approximately 10% of renal neoplasms and approximately 5% of urothelial carcinomas. Minimally invasive organ-sparing endoscopic procedures have shown favorable survival data in select patients with small, low grade tumors. However, recurrence rates can reach as high as 90%. Radical nephrectomy (kidney removal) with excision of an ipsilateral bladder cuff remains the standard of care for the treatment of UTUC.

About UroGen Pharma

UroGen Pharma is a clinical stage biopharmaceutical company formerly known as TheraCoat that is focused on the development of novel, locally administered pharmaceutical solutions for urological pathologies, including product candidates in uro-oncology that utilize novel chemoablation and immunomodulation approaches. UroGen has three uro-oncology drug candidates in various stages of clinical development, as well as a number of drug candidates in preclinical development. In addition, UroGen is developing a clinical-stage drug candidate for the treatment of overactive bladder and interstitial cystitis and has recently established a preclinical collaboration with a strategic partner for the development of this compound for the treatment of overactive bladder. Please click on the following link to learn more: www.urogen.com

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.

Company Contact Information: Gary Titus Chief Financial Officer garyt@urogen.com Investors: Stephanie Carrington ICR, Inc. stephanie.carrington@icrinc.com 646-277-1282

Source: UroGen Pharma