UroGen Pharma Ltd.

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to EuroGen Pharma's third quarter 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 for EuroGen Pharma. Please go ahead.

Thank you, Jonathan. Good morning, everyone, and welcome to EuroGen Pharma's third quarter 2020 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 September 30, 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 Lova, 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. On today's call, Liz will provide a summary of our recent corporate developments. Mark will share clinical development and regulatory updates, and Jeff will discuss our recent launch of Gelmito and commercial updates. Molly will then provide an overview of our financial highlights for the third quarter before we open the call for questions. As a reminder, during today's call, we'll be making certain forward-looking statements. Various remarks that we make during this call about the company's future expectations, plans, and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. 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 factor section of Urogen Pharma's quarterly report on Form 10-Q filed with the SEC this morning, and other filings that Urogen Pharma makes with the SEC from time to time, as well as any negative effects on Urogen's business and 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 quarterly report on Form 10-Q 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. And with that, I'll now turn the call over to Liz.

Thank you, Sarah, and thank you all for joining us on our third quarter conference call. Since our last earnings call, Urogen has gained important traction in bringing Jalmido to patients in need and has continued to execute on our near-term business objectives and growth strategies for the long term. We are encouraged by the positive progress we've made to date in our commercial launch of Gemido, which was officially launched on June 1st, bringing the first-of-its-kind therapy to patients with low-grade upper-track ulcerative carcinoma. In our first full quarter of launch, we have exceeded our internal expectations and reported $3.5 million in net product sales. I think this is a testament to the efforts of our commercial team, as well as a positive reception we've received from physicians, despite the unprecedented environment we are continuing to operate in. Jeff will provide a more detailed update on our progress shortly, but we are excited about where we are and the outlook for this important medicine. As we previously communicated, we submitted a label update with the final results from the pivotal Phase III Olympus trial of gel mito. and we believe the FDA will approve the updated label for Gemido in early 2021. We expect the updated label to be similar to the current label, given the final results are consistent with previously shared results, and we anticipate presenting the final Olympus data at a medical meeting by the end of this year. We also continue to progress our uro-oncology pipeline. Our most advanced pipeline program is UGN-102. for the treatment of patients with low-grade intermediate-risk non-muscle-invasive bladder cancer. We see important synergies in the way in which low-grade upper tracheothalial carcinoma and low-grade intermediate-risk non-muscle-invasive bladder cancer present, as well as the way in which our novel technology may provide a solution and a new way of treating these diseases in vulnerable populations. The type of bladder cancer we're focusing on with UGN102 is very difficult to treat, and there are no drugs currently approved by the FDA for this indication. It is characterized by high rates of recurrence and the need for repetitive surgical intervention. The addressable patient population is approximately 80,000 patients annually in the U.S. alone. This includes newly diagnosed patients and patients who have a recurrence after surgery. We believe UGN-102 has the potential to provide a durable non-surgical treatment alternative to this patient population. On our last call, we provided update durability estimates from our Phase 2b Optima 2 trial of UGN-102, and we remain on track to share final data by year end. We also remain committed to initiating our pivotal Phase 3 clinical study by the end of this year. It's exciting for us to be able to demonstrate the potential of our novel technology in upper tracheothelial carcinoma with gelmido and in low-grade intermediate-risk non-muscle-invasive bladder cancer expected with 102. As we look beyond low-grade disease, we have an exciting earlier stage pipeline program, UGN302, a combination of UGN201, our TLR78 agonist, and UGN301, the anti-CTLA-4 antibody that we licensed from a genus to be combined with our gel technology. We are initially studying UGN302 in high-grade non-muscle-invasive bladder cancer and believe it has the potential to change the treatment paradigm for this hard-to-treat disease. Phase 1 studies are expected to start in the first half of 2021. I want to now take a moment to introduce three new members of our executive team, that joined us this past quarter. Molly Henderson, our new Chief Financial Officer, who you will be hearing from in a few minutes, has over 15 years of experience as a public company life science CFO, and joins us from Edvaxis, a clinical stage biotechnology company focused on the development and commercialization of immunotherapy products, where she served as Executive Vice President and Chief Financial Officer. Jason Smith has been named General Counsel and Chief Compliance Officer and joins us from Pfizer where he spent the last 11 years. Jason joined Pfizer as Chief Counsel for Vaccines and was most recently Chief Counsel Oncology. And last but not least, Polly Murphy has been named Chief Business Officer and joins us from Pfizer where she most recently served as the Vice President of Early Commercial Development in the Oncology Business Unit. These three executives bring a breadth of experience, which will support the acceleration of our pipeline development, our RTGL platform expansion, and access to external innovation, as well as great financial performance. Although the Botox study did not meet the primary endpoint, we learned a great deal regarding our proprietary RTGL technology that helps inform how we can best develop important new medicines through the use of this technology. We continue to actively explore business development opportunities with and without the use of RT-Gel, and we are building academic collaborations that fit within our mission of improving the lives of patients with urologic diseases and specialty cancers. In addition to platform expansion, we continue to investigate the potential geographic expansion of Gemido and our pipeline. Reflecting on the progress we've made, I believe the company is uniquely positioned with a strong management team, our first approved therapy, and a pipeline that could potentially change the way these cancers are treated. We remain unwavering in our commitment to develop new approaches and treatment options for patients as we build a long-term sustainable growth business. We are confident that our current portfolio will provide us with a strong foundation on which to grow our organization and build a leading uro-oncology company. With that, I'll turn the call over to Mark to discuss our recent clinical updates. Mark?