UroGen Pharma Ltd.

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to Eurogen Pharma's third quarter 2021 financial results and business update conference call. It is now my pleasure to turn the call over to Lee Roth, investor relations for Eurogen Pharma. Please go ahead.

Thank you, Jonathan. Good morning, everyone, and once again, welcome to the Eurogen Pharma third quarter 2021 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and the financial results for the quarter ended September 30th, 2021. A copy of this press release can be accessed on the investor section 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 Molly Henderson, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These may include statements regarding the success and timing of our ongoing commercialization of gel mito, planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, and 2021 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 as well as our latest SEC disclosure documents. Your cautions must place under reliance on these forward-looking statements, and Urigin disclaims any obligation to update such statements. With that, it's now my pleasure to turn the call over to Urigin's President and CEO, Liz Barrett. Liz?

Thank you, Lee, and thank you to everyone joining us today. Many of you joined us for our spotlight day last week, and we're pleased you're here with us today where we'll discuss our third quarter earnings and highlight recent development. During the third quarter, we made further progress in both the commercial and clinical development areas of our business. Our commercial team continued to execute on the rollout of Gemido in the face of ongoing impacts of the pandemic in the third quarter, especially in certain regions in the U.S., and our development and regulatory teams have made significant progress and our discussions with the FDA regarding UGN-102 as highlighted at last week's event. Jeff will provide more detail on the Jelmida commercialization, but at a high level, as the Delta variant increased to new COVID cases, patient visits and access declined, causing Q3 patient starts to also decline, which is reflected in the revenue results. As previously reported, we had a strong Q2 that included a small bullish from delayed patients in Q1. Even given the revenue results, we saw a quarter-over-quarter increase in patient enrollment forms in Q3 versus Q2. Importantly, we have experienced accelerated momentum in September and October, marking our two highest-ever months for both new patient starts and patient enrollment forms. Although the $11.4 million in revenue we achieved for the third quarter was shy of our initial expectations, we remained confident in our ability to finish the year strong. In addition to making progress on driving awareness of gelmito in the U.S., we also made progress internationally. We recently launched a named patient program for gelmito in five European countries, France, Germany, Switzerland, Austria, and the U.K., This is a pilot program with the potential to be expanded into other European countries and will provide physicians access to and experience with gel mito as an initial step to determine commercial feasibility in Europe. The program will be managed by Tanner GAP Inc., a division of Tanner Pharma Group, which is a global provider of specialty access solutions. Turning to UGN-102, we were excited to announce last week that after several rounds of discussions with the FDA, we will be initiating a new phase three study of UGN-102 and low-grade intermediate risk non-muscle invasive bladder cancer. This new trial will be a multinational single-arm study and replace the current phase three ATLAS trial. We believe the new study design is more appropriate for demonstrating safety and efficacy for UGN-102 and patients with low-grade non-muscle invasive bladder cancer who are at intermediate risk for recurrence. We also believe the new design increases the probability of success, and Mark will provide more details. In addition to these important updates, we and AbbVie recently made the decision to terminate our collaboration agreement. As we announced last year, a Phase II trial of RT gel in combination with Botox for intravascular installation for overactive bladder and urinary incontinence did not meet its primary endpoint, and we believe this was due to the inability of Botox to effectively permeate the urothelium. As we evaluated the potential to leverage RT-gel with the AbbVie portfolio, there was nothing compelling to continue our agreement, and therefore we believed terminating this relationship was the most prudent path forward to allow for maximum flexibility for our RT-gel intellectual property. Turning lastly to UGN301, Mark will share our progress in advancing UGN 301 for high-grade non-Muslim-based bladder cancer into patients. We hope you were able to watch our spotlight event last week and hear from notable key opinion leaders on the opportunity for Urogen to provide patients with new treatments in this high unmet need disease. At Urogen, one of our primary goals is to transform the treatment paradigm in uro and specialty oncology away from repeated surgical procedures and to non-invasive therapeutic ablation of tumors, as well as locally administered immunotherapy approaches. I'm extremely proud of the progress we continue to make toward this goal. With that, I'll turn the call over to Mark to discuss our recent clinical and development update. Mark?