UroGen Pharma Ltd.

Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: confidence in the long-term commercial opportunity of ZUSDURI; the development plans for UGN-103, including to expand into additional patient populations, including high-grade NMIBC and as an adjuvant therapy in newly diagnosed intermediate-risk NMIBC patients and the timing, design and expected enrollment of planned clinical trials related thereto; the timing and outcome of the FDA’s review of the UGN-103 NDA, including UroGen’s planned submission of DOR data from the UTOPIA trial to the FDA and the expected PDUFA date; the expected scope and duration of patent protection for ZUSDURI and UGN-103; UroGen’s ability to build a sustainable growth company and create meaningful long-term shareholder value; expected enrollment completion of the ongoing Phase 3 clinical trial evaluating UGN-104 in LG-UTUC; plans to evaluate UGN-501 in aqueous solution, as well as future development of UGN-501 formulated withRTGel technology; the opportunities for UroGen’s future growth, including the expansion of UGN-103 into high-grade NMIBC, advancement of UGN-501 and the strategic collaboration with IntraGel; the long-term revenue potential of UroGen’s bladder cancer portfolio; and UroGen’s expected 2026 revenue and operating expenses. Words such as “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: even though the NDA for UGN-103 has been accepted by the FDA, there is no guarantee that such NDA will be sufficient to support approval of UGN-103 on the timeframe expected, or at all; the PDUFA target action date of June 14, 2027 may be delayed due to various factors outside UroGen’s control; preliminary clinical results may not be indicative of results that may be observed in the future; potential safety and other complications related to UroGen’s products and product candidates, including potential delays or difficulties in initiating, enrolling, conducting or completing clinical trials and submitting planned data; UroGen may not realize any benefits from the IntraGel collaboration; risks related to our and our licensors’ ability to protect our respective patents and other intellectual property, including the fact that UroGen’s or its licensors’ pending patent applications may not be successful, and in such event, the duration of intellectual property protection would be more limited; the ability to maintain regulatory approval; complications associated with commercialization activities; labeling limitations; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s products and product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen’s ability to attract or retain key management, members of the board of directors and other personnel; UroGen’sRTGel technology and UroGen’s products and product candidates may not perform as expected; new data relating to ZUSDURI may result in changes to the product label and may adversely affect sales, or result in withdrawal of ZUSDURI from the market; the potential for payors to delay, limit or deny coverage for ZUSDURI; UroGen may not successfully develop and receive regulatory approval of any other product that incorporatesRTGeltechnology; UroGen’s ability to achieve its revenue and operating-expense guidance, which is based on estimates and assumptions that may prove inaccurate; and the impacts of general macroeconomic and geopolitical conditions on UroGen’s business and financial position. These and other risks and uncertainties are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2026, filed with the U.S. Securities and Exchange Commission on November 4, 2026. In light of these risks and uncertainties, the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.