UroGen Pharma Ltd.

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the EuroGen Pharma's fourth quarter and full year 2020 financial results and business update conference call. It is now my pleasure to turn the call over to Sarah Sherman, Head of Investor Relations at EuroGen Pharma. Please go ahead.

Thank you, Jonathan. Good morning, everyone, and welcome to EuroGen Pharma's fourth quarter and full year 2020 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 and year ended, December 31, 2020. 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 Molly Henderson, Chief Financial Officer. Please note that we continue to conduct our calls from different locations, so we appreciate your patience and understanding should we have any technical difficulties. Liz will provide a summary of our recent corporate development, Mark will share clinical development updates, and Jeff will provide a commercial update. Molly will then provide an overview of our financial highlights for the fourth quarter and full year before we open the call for questions. During today's call, we will be making certain forward-looking statements. These may include statements regarding the timing of our ongoing and planned clinical trials, gel mito commercialization, data presentations, potential regulatory filings, future research and clinical development efforts, our ability to change treatment paradigms, manufacturing capabilities, future expectations, plans, and prospects, and 2021 financial guidance, among other things. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of Eurogen Pharma's annual report on Form 10-K filed with the SEC this morning and other filings that Eurogen Pharma makes with the SEC from time to time, as well as any negative effects on Eurogen's business, as well as commercialization and product development plans caused by or associated with the COVID-19 pandemic to the extent not disclosed previously. We encourage all investors to read the company's annual report on Form 10-K and and the company's other SEC filings. These documents are available under the SEC filings section of the Investors page of URGEN's website at investors.URGEN.com. In addition, all information we provide on this conference call represents our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we undertake no obligation to update any forward-looking statements we may make on this call on account of new information, future events, or otherwise. I will now turn the call over to Liz.

Thank you, Sarah, and thank you to everyone joining us today. It's not an understatement to say that 2020 was memorable for everyone. Despite the challenges we face collectively, it's been inspiring to see how innovation in the pharma and biotech industries have persevered to the benefit of society. Although this is what our industry does day in and day out, I am grateful to see the heroic efforts being universally applauded. While that work has rightfully been on the forefront, many diseases don't become front-page news, but they do take center stage for the individuals who have been diagnosed. Urogen is focused on developing treatments focused on urologic and specialty cancers. Last year, our first approved therapy, Gelmito, became the first and only FDA-approved non-surgical treatment option for adult patients with low-grade upper tracheothelial cancer. Although launching Gelmito in the midst of the COVID-19 pandemic certainly presented challenges, we are incredibly pleased with the way our team has responded to those challenges in the first two full quarters of launch. We recorded $8 million in net product sales for the fourth quarter of 2020 and $11.8 million since the June 1, 2020 launch. We continue to be mindful of the environment we're operating in, including the vaccine rollout and its impact on the healthcare system and the patient populations we serve. We have seen these trends have an impact on patient procedures, including gel mito uptake, in the first two months of 2021. We continue to closely monitor, and Jeff and Molly will provide more details on our progress shortly, but we remain confident in the outlook for continued and accelerated adoption as the year progresses. And the demonstration of what's possible makes us even more enthusiastic for what's to come. We've made important progress in advancing our pipeline and executing on our near and long-term growth strategy. Most recently, we initiated the ATLAS trial, our Phase III clinical study of our lead product candidate, UGN102, for patients diagnosed with low-grade intermediate-risk non-muscle-invasive bladder cancer. We're very excited about the UGN-102 program for many reasons, but mainly for the significant unmet need in this patient population with no FDA-approved primary treatment options. We believe that there are important similarities across the therapeutic indications for both gelmito and UGN-102, and we hope to leverage our learnings and experience from gelmito and apply those to UGN-102 and its potential for these approximately 80,000 patients annually in the U.S. alone. The low-grade intermediate risk patient is a unique patient population identified as at high risk for recurrence, and current standard is just not good enough. In our Phase IIb study, 57% of patients had received three or more TURBT surgeries prior to enrolling in the trials. These patients deserve better options, and if UGN-102 is approved, these patients may benefit from the first primary non-surgical treatment option. We were very encouraged by the data we shared from the Optima 2 trial, showing a strong, complete, and importantly, durable response, and believe it supports UGN-102's potential as an outpatient treatment option for these patients. We intend to present these data at an upcoming medical meeting and publish in a peer-reviewed journal. Our work extends beyond low-grade disease to high-grade disease. Our early-stage programs, most notably UGN302, is initially being studied in high-grade non-muscle-invasive bladder cancer, a life-threatening disease with risk of progression. We believe that UGN302, which is a combination of UGN201, our TLR7-8 agonist, and UGN301, the anti-CTLA-4 antibody that we license from a genus, combined with our gel technology, has the potential to transform this disease and provide an advance to currently available treatment options. The recently announced three-year research collaboration with the University of Texas MD Anderson Cancer Center is aimed at advancing this combinatorial intravascular immunotherapy for the treatment of high-grade non-muscle-invasive bladder cancer, with an initial focus on UGN302. We're particularly excited to leverage a collective experience of Dr. James Allison and Dr. Pam Sharma, who have both been instrumental in developing breakthrough therapies with MEO oncology. We continue to expand our focus in MEO therapy research, utilizing our proprietary technology with checkpoint inhibitors, as reflected in this week's announcement of a non-clinical sponsored research agreement the Johns Hopkins University, to explore this combination in glioblastoma multiforme, or GBM, an aggressive and difficult-to-treat brain cancer. These two important programs with world-renowned academic institutions are part of our ongoing efforts to expand our pipeline and realize the full potential of our proprietary RTGL platform. As we look ahead, we are pleased to announce that we completed a strategic transaction with RTW providing funding of $75 million. We believe this will serve to fuel our mission to advance and bring life-altering therapies to patients. Molly will provide additional detail on this important transaction shortly, but this funding ensures a solid financial outlook for our company. As we look ahead, we are building a company to transform how we treat specialty cancers and urologic diseases. We have and continue to deliver on all of our commitments, and I am proud of the work we are doing. We face challenges every day, and our colleagues rise to overcome barriers because we share a vision to have an impact on patients that need our medicines. We have a strong foundation to ensure a long-term growth business and realize leadership by delivering new approaches to patients that have been left behind. With that, I'll turn the call over to Mark to discuss our recent clinical updates. Mark?