UroGen Pharma Ltd.

Good morning, ladies and gentlemen. Thank you for standing by and welcome to EuroGen Pharma's first quarter 2022 financial results and business update conference call. It is now my pleasure to turn the call over to Vincent Peron, Senior Director of Investor Relations for EuroGen Pharma. Please go ahead.

Thank you, Operator. Good morning, everyone, and welcome to EuroGen Pharma's first quarter 2022 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, 2022. 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 relating to gel mito, ongoing and planned clinical trials, commercial and clinical milestones in the year ahead, the potential of UGN-102 to transform the treatment paradigm as the first viable non-surgical alternative for low-grade intermediate-risk NMIBC, potential future commercialization activities for UGN 102, if approved, data presentations, regulatory filings, future research and development efforts, our goals, potentially reaching cash flow break-even by 2025, and 2022 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, including under the risk factors heading of our quarterly report on Form 10-Q for the quarter ended March 31, 2022, filed today. You are cautioned not to place undue reliance on these forward-looking statements, and your agenda claims 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. Urogen 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. During the first quarter, we continue to make important progress toward achieving this goal while setting the stage for several meaningful commercial and clinical milestones in the year ahead. Growing patient access and awareness continue to drive adoption of gel mitomes. Total net sales in Q1 were $13.6 million in line with our expectations and representing an 81% increase over the first quarter of 2021. Jeff will provide more detail on our commercial efforts and will remain optimistic about our ability to accelerate growth during the remainder of 2022. In March, we held our first ever in-person national sales meeting. I'm pleased to say it was a great event, giving the commercial organization an opportunity to come together and exchange ideas and best practices, and take actionable learnings into the field with the common goal of ensuring that all appropriate patients have access to gel mito. Beyond gel mito, we made significant progress in the clinic, advancing our lead development program, UGN-102, and initiating a first-in-human study of UGN-301, expanding our clinical focus to include immunotherapies for the treatment of high-grade disease. turning first to UGM-102, which aims to address a major unmet need and low-grade intermediate risk non-multi-invasive bladder cancer, an indication impacting about 80,000 patients in the United States each year. During the first quarter, we began dosing patients in our single-arm, open-label, Phase III Envision pivotal trial of UGM-102. We believe Envision has a high probability of technical and regulatory success given its streamlined design and encouraging results from the previously completed Phase II Optima II study. We anticipate completing enrollment by the end of 2022 and following patients for durability and assuming positive findings, submit an NDA for approval in 2024. Importantly, UGM-102, if approved, which share a prescriber base with Gelmido, allowing for an efficient and expedient product launch within our established commercial organization. We continue to believe Gelmido and UGM-102 together represent well over a billion-dollar revenue opportunity for Urogen, and the initiation of our phase-through Envision Pivotal Study of UGM-102 moves us closer to realizing the full potential of this innovative investigational therapy. I'm pleased to announce that last month we initiated a novel multi-arm Phase I clinical trial intended to evaluate the safety and tolerability of UGN301 as monotherapy and in combination with other chemotherapies and immunomodulators as our first immunotherapy investigational candidate intended to treat patients with high-grade disease, which remains a high unmet need. Mark will provide additional details regarding our Phase I study that represents a unique approach to treating high-grade non-muscle invasive bladder cancer. With the closing of an up to $100 million term-long facility with funds managed by Pharmacon advisors earlier this year, we took important steps to significantly strengthen our balance sheet. This capital gives us the financial flexibility to continue expanding our commercial and development efforts. Based on our current financial projections, we believe we have the tools needed to reach cash flow break even by 2025. At Urogen, our mission is to build and commercialize a strong portfolio of innovative therapies with the potential to meaningfully advance the standard of care in urologic and specialty oncology. Away from repetitive surgeries and disease management to minimally invasive therapeutic ablation of tumors, and locally administered immunotherapy approaches. We expect 2022 to be a pivotal year for our company. As we aim to accelerate growth and create meaningful value for our patients and shareholders, we remain focused on several key deliverables, which we believe are critical to our success this year. We are on track to achieve our guided full-year revenue range of $70 to $80 million in total gemido net sales. We expect to fully enroll our ongoing Phase III Envision Pivotal trial, bringing us closer to an NDA submission in 2024. With the initiation of our novel multi-arm Phase I clinical trial of UGN301, our anti-CTLA-4 antibody, we expanded our clinical development focus to include immunotherapies for the treatment of high-grade disease. And perhaps most importantly, we believe we have the tools and sufficient capital to support our business through cash flow break-even. I'm extremely proud of the progress we continue to make toward our goal of bringing novel solutions to patients that deserve better. With that, I'll turn the call over to Mark to discuss our recent clinical and development updates. Mark?