UroGen Pharma Ltd.

Hello, and welcome to your GenPharma first quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask the question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. I would now like to turn the conference over to Vincent Perrone. You may begin.

Thank you, operator. Good morning, everyone, and welcome to URGEN Pharma's first 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 March 31st, 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 pre-commercialization activities related to UGN 102, regulatory meetings and decisions, our commercialization strategy and expectations, as well as potential future commercialization activities for UGN 102, if approved, market and revenue opportunities, commercialization activities related to gel mito, our ongoing and planned clinical trials, commercial and clinical milestones, UGN 102 being the primary growth driver for Eurogen, future R&D efforts, and our goals in 2025 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. The 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 agendas claims any obligation to update these statements. I'll now turn the call over to Liz Barrett, Chief Executive Officer. Liz?

Thank you, Vincent, and thank you all for joining us this morning. The new drug application for our lead development stage candidate, UGN102, is now in the final stages of FDA review, with a PDUFA target date of June 13th. We designed the UGN102 as a novel and innovative treatment for patients with low-grade, intermediate-risk, non-muscle-invasive bladder cancer. We believe UGM-102 has the potential to change the treatment paradigm and meaningfully improve the standard of care in this patient population. If approved, UGM-102 will be the primary growth driver for our company and alongside John Mito could solidify our leadership in the urothelial cancer space, advancing our mission to bring innovative, patient-centered solutions to urologic cancers. We have been informed by the FDA that an Oncologic Drugs Advisory Committee, or ODAC, meeting has been scheduled for UGM-102 on May 21st. This is consistent with our expectations and we look forward to the opportunity to showcase the strength and consistency of our clinical data to the members of the panel and the public. We have been preparing for the ODAC meeting and believe we are well prepared to present a clear compelling, and scientifically robust case supporting the approval of UGM-102. In parallel, our regulatory team continues to engage regularly with the agency and has been responding to their information request. To date, we've encountered no resource or policy-related issues that concern us. The UGM-102 NDA is supported by a robust development program demonstrating meaningful complete response rate durable responses, and an acceptable safety profile across three late stage clinical trials. In March, we reported updated data from the Pivotal Envision Trial, demonstrating that 80.6% of patients who achieved ACR at three months remained in response at 18 months per Kaplan-Meier estimate. It's important to highlight that these robust results are with UGM-102 alone, and not following a transurethral resection of bladder tumor. Additionally, there are six weekly installations. Then patients are treatment-free until recurrence. As Mark will highlight, these results, along with the broader update on UGM-102 and gel mito, were shared with the urology community at this year's AUA meeting, underscoring our clinical leadership and commitment to advancing innovation in uro-oncology. With the PDUFA date goal approximately one month away, a commercial team has been actively preparing for the potential launch of UGM-102. This launch would mark a pivotal moment in URGEN's evolution from a rare disease-focused company to a scaled, multi-product team positioned to serve a significantly broader patient population. We're expanding our commercial footprint accordingly with plans to grow our sales force from approximately 50 reps today to over 80 at launch. Our medical affairs and market access teams are also deeply engaged in prelaunch planning. We are targeting commercial readiness by June, and we will be ready to promote immediately following approval with product availability in July. UGM-102 represents a transformative growth opportunity for urogen. We estimate an addressable population of approximately 60,000 patients annually, with recurrent low-grade intermediate risk non-muscle invasive bladder cancer, translating to a market opportunity of over $5 billion. This is nearly 10 times larger than the gel mito market. Critically, this market is highly accessible. Unlike the more fragmented UTUC setting, NMIBC patients are widely distributed and primarily managed by community urologists across the country. UGM-102 is well aligned with current clinical workflows. It's easy to administer, does not require specialized equipment, and can be delivered by a nurse with minimal additional training. We believe these advantages position UGM-102 to become a foundational therapy in the management of low-grade intermediate risk non-muscle invasive bladder cancer and a significant driver of long-term value creation for URGEN. Turning to gelmito, we reported $20.3 million in first quarter cells and 8% year-over-year growth compared to the first quarter of 2024, driven by underlying demand growth of 12%. We continue to advance our pipeline across multiple fronts, including our next-generation programs for gelmito and UGM-102, as well as our emerging immuno-oncology initiatives. In February, we acquired product candidate ICVB1042, a next-generation investigational oncolytic virus from Econovir, which we have assigned an internal code name of UGN501. This is an important step in expanding our presence in immune-based therapies for urologic cancers. In parallel, we also have multiple strategic research collaborations in place aimed at leveraging our proprietary RT-gel technology to enhance the delivery and effectiveness of various existing drugs. Urogen is executing with focus and discipline. We remain committed to transforming the treatment landscape in uro-oncology and are supported by a strong balance sheet with just over $200 million in cash, cash equivalents, and marketable securities as of March 31st. We are investing in innovation with purpose, driven by the opportunity to make a meaningful impact on patients while delivering value to our shareholders. I will turn the call over to Mark Schomburg, who will provide a clinical update. Mark.