UroGen Pharma Ltd.

Good morning, ladies and gentlemen. Thank you for standing by. And welcome to the Eurogen Pharma second quarter, 2022 . And then my pleasure to turn the call over to Vincent Perrone, Senior Director of Investor Relations for Eurogen Pharma. Please go ahead.

Thank you, operator. Good morning, everyone, and welcome to EuroGen Pharma's second quarter 2022 financial results and business update conference call. Earlier today, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended June 30th, 2022. 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 CEO, 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 Gelmido, our ongoing and planned research efforts and clinical trials, the potential benefits of Gelmido and our product candidates, data presentations, regulatory filings, future revenue opportunities, potentially reaching cash flow breakeven by 2025, the availability of the second tranche of our term loan facility, 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 June 30th, 2022, filed today. who 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. Liz?

Thank you, Vincent, and thank you to everyone joining us today. As summarized in this morning's press release, our progress through the second quarter of 2022 can primarily be viewed along three lines. First is the continued growth of our gel mito revenue. Second is the on-pace enrollment of our clinical programs And the third is further strengthening of the body of evidence, underscoring the benefit of John Mito in a real-world setting. The common thread between each of these areas is disciplined execution and determined commitment from our entire team to deliver benefit to patients and value to shareholders, which I am pleased to discuss in more detail with you today. Our overarching goal remains to fundamentally transform the treatment paradigm for patients suffering from urothelial or specialty cancers. reflecting a largely underserved patient population with a crucial need for novel therapies. Our currently approved medicine, Gelmito, is a prime example of filling a need with a kidney-sparing option for patients suffering from low-grade upper tract ulcerative carcinoma. And I'm pleased to report that we continue to see increased adoption with net revenue of $16.6 million, a year-over-year growth of 28%, and 22% growth over Q1. Jeff will describe our commercial results in more detail, including a review of real-world gel mito outcomes data recently presented at AUA. But we remain confident in our original guidance and expect growth and acceleration of gel mito adoption throughout the remainder of 2022. Beyond gel mito, our two ongoing clinical trials are actively underway and enrolling at expected rates. Most importantly, our Envision Phase III Pivotal Study of UGN-102, a novel medicine in development to treat patients with low-grade, intermediate-risk, non-muscle-invasive bladder cancer, remains on track for full enrollment by year-end. Assuming positive data, we anticipate filing an NDA with the FDA in 2024 and would target a priority review, which may allow for approval by the end of 2024. If approved, UGM-102 will be the first non-surgical primary therapeutic to treat these patients. Post-approval, we anticipate a streamlined launch given we are able to leverage our established commercial framework with a common prescriber base and similar product features with Jalmido. Based on market research, we believe UGM-102 addresses a large patient population of 80,000 patients in the U.S. alone, and foresee a potential combined revenue of over a billion dollars for UGM-102 and Jalmito by 2027. Concurrently, our first in human study to evaluate the safety and tolerability of UGN-301 is ongoing and provides an opportunity to broaden our technology application with expansion into immuno-oncology and inclusion of locally delivered immunotherapies targeting high-grade urologic cancers. Mark will provide a further update on our clinical portfolio shortly. Based on our current revenue projections and financial models, we believe we have the tools to reach cash flow breakeven by 2025. This is based on our confidence in our ability to achieve our guided full-year 2022 Gemida product revenues in the range of $70 to $80 million, as well as access to an additional $25 million from the up to $100 million term loan facility with funds managed by Formicon advisors. We recognize that the capital markets are challenging for many companies in need of capital right now. However, we do not foresee a near-term need to raise additional cash. Don will share our updated operating expense projections, reflecting a slight decrease in our full-year guidance from last quarter's projections. While there are additional studies and business development opportunities we are considering, We continue to weigh these opportunities against our goal of reaching profitability. With that, I'll turn the call over to Mark to discuss our recent clinical development update. Mark?