UroGen Pharma Ltd.

After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I'd now like to go ahead and hand the conference over to your first speaker today, Vincent Perrone, Investor Relations. Vincent, you have the floor.

Thank you, Operator. Good morning, everyone, and welcome to Eurogen Pharma's second quarter 2025 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 June 30th, 2025. 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, David Lin, Chief Commercial Officer, and Chris Degnan, 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 and Zyzduri, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as anticipated data, regulatory filings and decisions, so STERI being the primary growth driver for Eurogen, the potential benefits of our products and product candidates, future R&D development efforts, our corporate goals, and 2025 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 URGEN disclaims any obligation to update these statements. I'll now turn the call over to Liz.

Thank you, Vincent. On June 12th, we achieved a defining milestone for URGEN with the FDA approval of Zesturi. for adults with recurrent, low-grade, intermediate-risk, non-muscle-invasive bladder cancer. This was truly a landmark moment for our company, and importantly, for the 59,000 annual patients in the U.S. who face recurrence and repeat surgeries year after year with no approved alternative. So, STERI is the first and only FDA-approved pharmacologic treatment for adults with this disease and has the potential to fundamentally change the treatment paradigm and offer patients durable, long-term recurrence and treatment-free living. We are proud to be leading that shift. Zysturi is Urigin's second commercial product and marks our transition from a rare disease-focused company to a scaled, multi-product organization. Five years ago, we launched Jalmito for the treatment of low-grade upper tracheothelial cancer. That experience laid the foundation for everything we're doing today. With Sysduri, we are entering a larger but less complex market. The total available market exceeds $5 billion annually, and we are well positioned to penetrate the opportunity with our expanded sales team of 82 territories as of August 1st, up from 50 previously. We have an experienced team with strong knowledge and relationships that will allow us to accelerate and guide the launch of this jury. Our commercial organization has a deep understanding of how care is delivered in neurology, from academic centers to high volume community practices. Their established relationships and field insights position us well for a strong and disciplined launch. Regarding the commercial launch of this jury, The initial focus is on setting up sites of care and driving clinical conviction. The team is focused on driving early adoption among urologists who previously prescribed John Mito and those willing to initiate treatment before a permanent J-code is assigned. This is a disciplined strategic launch built on learning from our first product. As we move to 2026 with broader reimbursement anticipated, we expect our reach to expand significantly. David will provide more details on the launch in a few minutes. Turning to Gelmito, I'm pleased to report a strong second quarter with net product revenues of $24.2 million, representing an 11% increase over the same period in 2024. Gelmito continues to grow with strong underlying demand in the second quarter, demonstrating continued adoption and usage of this important therapy for patients. The value proposition of Gemmita remains clear, durable responses backed by long-term data and real-world use. We are pleased with the results and acceptance received by urologists. Urigin's long-term goal is to develop and commercialize a differentiated portfolio of treatments that address meaningful unmet needs across urothelial and specialty cancers. UGN301, our anti-CTLA-4 monoclonal antibody, continues to progress in both monotherapy and combination studies for high-grade non-Muslim-based bladder cancer. Meanwhile, our next-generation pipeline is advancing. The Phase III utopia trial of UGM103 for recurrent low-grade intermediate-risk non-Muslim-based bladder cancer is now fully enrolled, and we expect initial complete response data by the end of 2025. We will share this data with the FDA and gain agreement on the path forward to approval. If the trial is successful, we expect to file an NDA for this product in 2026. We've also initiated a phase three trial in June of 2025 for UGM-104, our next generation mitomycin-based formulation for low-grade UTUC. Our balance sheet remains strong. With $161.6 million in cash, cash equivalents, and marketable securities as of June 30th. We believe we have the necessary capital to fund this historic launch while supporting the advancement of our pipeline and other strategic priorities. We will be thoughtful about potential opportunities to expand our portfolio for the long term while driving commercial success and profitability goals. The team at URGEN has demonstrated their dedication and resilience while striving to make a meaningful impact for patients. To the urology community, particularly those participating in research, as well as those publicly advocating support for our medicines, we could not do it without you. With two commercial products, an advancing pipeline, and a commercial infrastructure to scale, Urigin is well positioned for sustainable growth. We are executing with discipline and purpose, and we remain deeply committed to delivering meaningful innovation for patients and generating value for our shareholders. I will now turn the call over to Mark Schomburg. Mark.