UroGen Pharma Ltd.

Ladies and gentlemen, thank you for standing by and welcome to the EuroGen Pharma first quarter 2020 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 1 on your telephone. As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Kate Bechtold, Senior Director of Investor Relations. Please go ahead.

Thank you, operator. Good morning, everyone, and welcome to Urigin Pharma's first quarter 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 ended March 31st, 2020. The press release can be accessed on the investors portion of our website at investors.urigin.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 Peter Freundschuh, Chief Financial Officer. Please note that we are conducting our call today 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 developments. Mark will share clinical development and regulatory updates. and Jeff will discuss our commercial strategy and updates. Peter will then provide an overview of our financial highlights for the first quarter before we open up the call for questions. As a reminder, during today's call, we will 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 URGEN PhRMA's quarterly report on Form 10-Q filed with the SEC this morning and other filings that URGEN PhRMA makes with the SEC from time to time, as well as any negative effects on URGEN'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 quarterly report on Form 10-Q and the company's other SEC filings. These documents are available under the SEC filing 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, Kate. Good morning, everyone, and thank you for joining us today. I'm very pleased to be speaking with you so quickly following the FDA approval of our lead product, Gemido, for the treatment of adult patients with low-grade upper tract urothelial cancer, or low-grade UTUC. The events of the first quarter and flawless execution of our team set the stage for this new chapter in Urigin. We are now officially a commercial stage company, and we could not be more excited about the opportunity to bring Gemido to patients and physicians. We have received a very positive response from physicians quickly following our approval, demonstrating the high unmet need in this area. As we look forward to the remainder of 2020, we will maintain the momentum from this landmark event and deliver on our commitments to all stakeholders, particularly to our patients. Our top priorities include the flawless execution of our gel mito launch and the continued advancement of our portfolio of innovative medicines. While we continue to navigate through the global COVID-19 pandemic, our team remains focused on bringing Gelmito to patients as quickly as possible. Jeff will provide more detail on commercial activities, but I'm pleased to say that as soon as we received approval, we were contacted by physicians with identified patients in need of our therapy. As mentioned on our recent call, our commercial team quickly pivoted their strategy to adapt to the current environment to ensure a successful launch. The creative solutions they have developed, including a virtual platform, have already provided for effective engagement with our healthcare professionals and key stakeholders, and the team remains on track for launch on June 1st. Underscoring this momentum was the publication of the results from the pivotal Phase III Olympus trial in the Lancet Oncology just last week. reporting a 59% complete response in patients with low-grade UTUC and 12-month durability based on interim data estimated at 84% for the Kaplan-Meier analysis. Mark will elaborate on this data and product labeling in a moment, but the results supported the approval of gel mito for treatment of patients with this difficult-to-treat cancer. With the approval secured, we are now accelerating research to further identify opportunities to bring Gemmido to patients in other parts of the world, and we look forward to updating you on these plans as we progress. Beyond Drought Gemmido, our pipeline continues to advance as we look ahead to other medicines in areas of unmet need that could benefit from our proprietary technology or can leverage our core expertise in urologic and specialty cancers. Our latest stage product in development is UGN-102 for the treatment of patients with low-grade intermediate-risk non-muscle-invasive bladder cancer. Patients with this type of bladder cancer remain a very challenging population, characterized by high rates of recurrence within 12 months and the need for repetitive surgical intervention. There are currently no drugs approved by the FDA for first-line treatment of this disease. And the annual treatable population of patients with low-grade intermediate-risk non-muscle-invasive bladder cancer is approximately 80,000 patients in the U.S. alone. Updated complete response and durability data from the Phase IIb Optima II trial of UGN102 in this patient population was recently included as part of a late-breaking abstract published in the April supplement to the Journal of Urology. We are very encouraged by the positive data, which Mark will discuss in more detail. These data, combined with the data from the Olympus for low-grade UTUC, give us confidence in the potential of UGN102 to have a profound impact and offer patients a better option for the treatment of this large and important patient population. We are on track to finalize our pivotal study with the FDA and initiate later this year. Our approval of our first medicine and the positive Phase II data provide strong evidence of the applicability of our innovative delivery technology, RT-Gel, and we continue to support activities to develop novel medicines within URGEN and through external partnerships. Beyond low-grade disease, we continue to advance UGN 302. A combination of UGN201, our TLR78 agonist, azalafrilumab, an anti-CTLA-4 antibody we licensed from a genus for high-grade non-muscle-invasive bladder cancer. While no one can fully predict the potential impact to our business and timeline based on the COVID-19 pandemic, our team remains dedicated to pioneering new approaches and treatment options for patients as we build a long-term sustainable growth company. The company is well capitalized, and we remain confident we can achieve peak revenue potential of greater than $1 billion from our Gelmito and UGN 102 programs alone, providing a strong foundation to build upon. With that, I'll turn the call over to Mark to discuss our recent clinical updates. Mark?