UroGen Pharma Ltd.

Good morning, ladies and gentlemen. Thank you for standing by. And welcome to the Eurogen Pharma Q1 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 Perrone, Head Investor Relations. You may begin.

Thank you, operator. Good morning, everyone. And welcome to Eurogen Pharma's first 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 financial results for the quarter ended March 31st, 2023. The press release can be accessed on the investors portion of our website at investors.eurogen.com. Joining me on the call 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 gel mito, anticipated seasonality for gel mito in 2023, our ongoing and planned clinical trials, commercial and clinical milestones in the year ahead, the potential of Eurogen's product and product candidates to transform the treatment paradigm of urothelial and specialty cancers, market opportunities, potential future commercialization activities for UGN 102 if approved, data presentations, regulatory filings, future R&D development efforts, our corporate goals, our optimism regarding multiple avenues available to us to further strengthen our balance sheet 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. You are cautioned not to place undue reliance on these forward-looking statements, and your agenda explains any obligation to update these statements. I will now turn the call over to Liz. Liz?

Thank you, Vincent, and thank you to everyone joining us today. Urigin remains focused on developing novel therapies for urothelial and specialty cancers with the goal of fundamentally transforming the treatment paradigm for what we believe is a largely underserved patient population. With the launch of Gemido, we took an important first step in bringing to market an innovative non-surgical therapy designed to improve the standard of care for treating low-grade upper tract urothelial cancer. In achieving this goal, we have demonstrated the viability of intravascular delivery of chemotherapy and our proprietary RT gel to treat urinary cancer, setting the stage for our lead development program, UGN 102, which aims to address a major unmet need in low-grade intermediate risk non-muscle invasive bladder cancer, an indication impacting approximately 80,000 patients in the United States each year. Turning to the quarter, I'm pleased to announce that first quarter gel mito net revenues were $17.2 million, our second best quarter ever since launch, and a 27% increase from the same quarter one year prior. While continued growth in gel mito adoption is encouraging, we are further assured to see our guidance model consistent with actual results, indicating that the seasonality we've previously observed may be reliably predictable. As the utility and benefits of gel mito are increasingly recognized in the real world, it has also come to be acknowledged by the urology community, as we recently saw at the 2023 American Urology Association meeting in April. Mark and Jack will provide highlights from the conference, but at a high level, two additional studies reinforcing the utility and efficacy of gel mito were presented, further strengthening the growing body of real-world outcomes data supporting its broad use. Meanwhile, as we look ahead, the focus of our development strategy is very much on UGM-102 and its several near-term catalysts. Specifically, we remain on track to provide top-line data from our Phase III studies of UGM-102 this summer. For Envision, we anticipate providing the primary endpoint of complete response rate for approximately 240 patients who completed this study, while for ATLAS, the predecessor to Envision, We will provide complete response, durability, and safety data from approximately 280 patients that completed the study. Assuming positive results, the envisioned trial will form the basis of our FDA submission once durability can be appropriately measured. In anticipation of prospective favorable results, we expect to submit an NDA with the FDA in 2024. The goal would be to target priority review, which if granted, may potentially result in approval at the end of 2024 or early 2025. Our optimism in the potential outcome of Envision stems from a similarity to the Phase II Optima II trial of UGM-102, which demonstrated a 65 percent complete response rate and duration of response at 12 months of 72.5 percent using Kaplan-Meier analysis. We believe UGM-102 can be a transformational product and represent a significant opportunity to address a much larger patient population. Unlike Jalmido, administration is much simpler without the need for fluoroscopy. Therefore, if approved, we anticipate UGM-102 will be a significant driver of future growth as it will be the only primary non-surgical therapy addressing the nearly 80,000 new patients in the U.S. alone. who will undergo repetitive endoscopic resection and are burdened with the risk of surgery and anesthesia as the only recourse for disease control. Before turning the call over to my colleagues, I would like to quickly address our balance sheet. We continue to emphasize rigorous fiscal prudence and prioritize our cash spend on advancing our core value drivers, gel mito cells and UGM-102 development. Given what we believe is a significant market potential for UGM-102, we are optimistic that we can take advantage of a number of potential viable opportunities to further strengthen our balance sheet when appropriate. With that, I'll pass the call over to Mark. Mark?