UroGen Pharma Ltd.

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the EuroGen Pharma's second quarter 2023 earnings call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Vincent Perron, head of investor relations. You may begin.

Thank you. Good morning, everyone, and welcome to EuroGen Pharma's second quarter 2023 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and preliminary financial results for the quarter ended June 30, 2023. The press release can be accessed on the investors portion of our website at investors.eurogen.com. Joining me today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, Jeff Bova, Chief Commercial Officer, and Don Kim, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to Gelmito, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as potential future commercialization activities for UGN 102, if approved, anticipated data, regulatory filings, and decisions including UGN 102 potentially receiving priority review, UGN 102 being the primary growth driver for URGENT if approved, future research and development efforts, our corporate goals, and 2023 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. who are cautioned not to place undue reliance on these forward-looking statements, and Urogen disclaims any obligation to update these statements. I'll now turn the call over to Liz. Liz?

Thank you, Vincent, and thank you to everyone joining us today. I'm excited to speak to you during what I can only describe as a transformative time for Urogen. Urogen is committed to revolutionizing patient care by developing and commercializing novel therapies targeting urothelial and specialty cancers, for patients that deserve better. We recently announced unprecedented results from two phase three clinical trials investigating the use of UGN-102 to treat patients with low-grade intermediate risk non-muscle invasive bladder cancer. Both the ATLAS and Envision trials met their primary endpoints, demonstrating meaningful and consistent results overall and relative to TURBT. In the ATLAS trial, UGM-102 met its primary endpoint of disease-free survival, reducing risk of recurrence, progression, or death by 55%. Disease-free survival 15 months after randomization was estimated to be 72% for patients in the UGN plus or minus TURBT arm compared to 50% for patients in the TURBT arm by Kaplan-Meier analysis. UGM-102 also showed a 65% complete response rate at three months for patients who only received UGM-102, compared to a 64% complete response rate at three months for patients who only received a TURBT. The Envision trial also met its primary endpoint by demonstrating that patients treated with UGM-102 had a 79.2% rate of complete response at three months following the initiation of treatment. UTN 102 has now demonstrated a consistent and what we believe compelling therapeutic and safety profile across multiple clinical trials while showcasing the limitations of TURBT in this patient population. Looking ahead, data evaluating the secondary endpoint of duration of response is expected in the first half of 2024. Assuming positive findings, we anticipate submitting an NDA to the FDA in 2024 The goal would be to receive priority review, which, if granted, may potentially result in approval as early as the end of 2024 or early 2025. If approved, we anticipate UGM-102 to be the primary growth driver for urogen as the first ever non-surgical treatment option for disease afflicting approximately 82,000 new patients in the U.S. each year, with an annual total market opportunity of more than $3 billion. The shift away from traditional surgical care has the potential to improve the quality of life of tens of thousands of individuals battling this highly recurrent disease. This patient-centric focus underscores URGEN's dedication to having a meaningful impact on patient care. Turning to Gemido, second quarter net revenues were a record $21.1 million, a 27% increase from the same quarter one year prior. We're pleased to see the continued and consistent growth and adoption as additional recent real-world data strengthens the case for Gelmito's therapeutic value and safety across different practice patterns. We will leverage Gelmito's recent success as we shape UGM-102's prospective precursor commercialization strategy. In parallel, strategic steps were taken to strengthen our financial position. The recent $120 million private placement of ordinary shares provides us with the resources to support our business, including our anticipated pre-commercialization and launch strategy for UGM-102. We are proud to partner with a group of high-quality biotech investors who believe in the opportunity of Urogen's portfolio to address significant unmet needs in urothelial and specialty cancers. I am thrilled for the progress we've made in 2023 and for the road ahead as we plan for an FDA submission of UGM-102 next year. We believe UGM-102 and Gelmito together represent over a billion-dollar revenue opportunity. Urigin is positioned to pioneer a new era in urologic and specialty cancer care while creating significant value for our patients and shareholders. With that, I'll pass the call over to Mark. Mark?