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EX - 99.1 2 d243248dex991.htm EX - 99.1 • Exhibit 99.1 UroGen Pharma UroGen Pharma Reports Third Quarter 2021 Financial Results and Recent Corporate Developments Shift to single - arm Phase 3 study for UGN - 102 in bladder cancer streamlines pivotal study to form basis of FDA submission JelmytoⓇ net product revenue of $ 11.4 million for the third quarter of 2021 ; New patient starts in September and October outpace July and August by nearly 60 % Conference call and webcast to be held today at 10:00 AM ET PRINCETON , N.J. , November 15 , 2021 - UroGen Pharma Ltd. ( Nasdaq : URGN ) , a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers , today announced financial results for the third quarter ended September 30 , 2021 , and provided an overview of the Company's recent developments . “ The third quarter of 2021 was one of continued progress at UroGen , both clinically and commercially , ” said Liz Barrett , President and Chief Executive Officer of UroGen . " As we highlighted at our Spotlight Event last week , we will initiate a new single - arm Phase 3 study of UGN - 102 in low - grade , intermediate - risk , non - muscle invasive bladder cancer . We believe this new design affords a higher probability of regulatory success for UGN - 102 in patients with low - grade IR - NMIBC , while allowing us to remain on - track for a planned NDA submission in 2024. " She added , “ Additionally , as we approach the close of 2021 , we are pleased with the strong demand we're seeing for Jelmyto . September and October marked our highest months ever for both new patient starts and patient enrollment forms . We look forward to a strong start to 2022 , as we advance and grow our pipeline while furthering the adoption of Jelmyto with the goal of it becoming the standard of care for patients with low - grade UTUC . " Business Highlights : Jelmyto ( mitomycin ) for pyelocalyceal solution : • Achieved highest - ever Patient Enrollment Forms and New Patient Starts in September and October 2021 . UroGen generated net product revenue of $ 11.4 million for the third quarter of 2021 , representing over 200 % growth over the third quarter of 2020 ( first full quarter of launch ) , this compares to $ 13.0 million in the second quarter of 2021 . As of November 1 , 2021 , 706 sites have been activated , which means they have completed their internal processes and have treated or are ready to treat patients . This represents a 73 % increase since August 1 , 2021 . Sites that have treated more than one patient as of November 1 , 2021 , increased to 86 , compared to 63 as of August 1 , 2021 : an increase of approximately 37 % . UGN - 102 ( mitomycin ) for intravesical solution : • Following discussions with the U.S. Food & Drug Administration ( FDA ) , the Company announced plans to conduct a new single - arm Phase 3 study of UGN - 102 for the treatment of low - grade , intermediate risk non - muscle invasive bladder cancer ( LG - IR - NMIBC ) . The trial , which is expected to initiate in early 2022 , will be similar in design to the Company's previous OPTIMA II study . Based on the results of the OPTIMA II study , the Company believes this new trial carries a high probability of demonstrating a significant benefit for patients .