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EX - 99.1 2 d133802dex991.htm EX - 99.1 Exhibit 99.1 UroGen Pharma UroGen Pharma Reports First Quarter 2021 Financial Results and Recent Corporate Developments JelmytoⓇ net product revenue of $ 7.5 million for the first quarter of 2021 New patient starts in March and April of 2021 increased 100 % and 165 % , respectively , compared to new patient starts in January 2021 Phase 3 ATLAS trial enrollment ongoing with new sites activated in Europe Active platform expansion in immuno - oncology with commencement of strategic collaborations with leading academic institutions Conference call and webcast to be held today at 8:30 AM ET PRINCETON , N.J. , May 13 , 2021 - UroGen Pharma Ltd. ( Nasdaq : URGN ) , a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases , today announced financial results for the first quarter ended March 31 , 2021 and provided an overview of the Company's recent developments . " We are pleased with the progress we have made across our expanded pipeline and the momentum we've seen since we reported fourth quarter 2020 earnings in March . The number of patient enrollments , patient starts and doses shipped in April were each up more than 100 % compared to January . We believe this signifies broader awareness of Jelmyto and increasing physician support , ” said Liz Barrett , President and Chief Executive Officer of UroGen . " As we look to the remainder of 2021 with increased vaccination rates and eased COVID - 19 restrictions across the United States , we feel confident that this momentum will continue as we advance our mission to bring novel solutions to patients with specialty cancers and urologic diseases . " Business Highlights and Upcoming Milestones : Jelmyto ( mitomycin ) for pyelocalyceal solution : • UroGen achieved net product revenue of $ 7.5 million for the first quarter of 2021 . As of May 1 , 2021 , 316 sites have been activated , which means they have completed their internal processes and have treated or are ready to treat patients . This represents a 26 % increase since March 1 , 2021 . Sites that have treated more than one patient as of May 1 , 2021 increased to 40 , compared to 31 as of March 1 , 2021 : an increase of approximately 30 % . UGN - 102 ( mitomycin ) for intravesical solution : ATLAS , the Phase 3 trial of UGN - 102 , continues to enroll patients with low - grade intermediate risk non - muscle invasive bladder cancer ( LG - IR - NMIBC ) . The ATLAS trial is expected to enroll approximately 630 patients and is evaluating UGN - 102 as a primary non - surgical treatment compared to standard of care - transurethral resection of bladder tumor ( TURBT ) – in patients diagnosed with LG - IR - NMIBC . Platform expansion : - Expanded immuno - oncology pipeline with the announcement of two strategic research collaborations during the first quarter of 2021 . As part of the Company's strategic three - year collaboration agreement with The University of Texas MD Anderson Cancer Center , UroGen and MD Anderson expect to advance the UGN - 302 program [ UGN - 201 ( imiquimod ) TLR 7/8 + UGN - 301