UroGen Pharma Ltd.

Thank you for standing by, and welcome to the EuroGen Farmer Second Quarter 2020 Financial Results and Business Update Conference Call. At this time, all participants are in the listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, to Peter Furenshue, CFO. Thank you. Please go ahead.

Thank you, operator. Good morning, everyone, and welcome to Urgent Pharma's second 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 June 30th, 2020. The press release can be accessed on the investors portion of our website at investors.urgen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, and Jeff Bova, Chief Commercial 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. In just a minute, I will turn things over to Liz, who will provide a summary of our recent corporate developments. Mark will then share a clinical development update And Jeff will discuss our commercial progress made since launching Gelmito in June. Following Jeff, I will provide an overview of our financial highlights for the second quarter before opening up the call for questions. As a reminder, during today's call, we will be making forward-looking statements. Various remarks that we make during this call about the company's future expectations and plans and prospects constitute forward-looking statements for the purpose of the safe harbor provision 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 the Urgent Pharma'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 any commercialization and product development plans caused by or associated with 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, Peter. Good morning, everyone, and thank you for joining us today. I'm delighted to be speaking with you representing a company that has successfully transitioned from a clinical to commercial stage biopharmaceutical company. Since the June 1 launch of Gemido, for patients with low-grade upper tract ulithelial cancer or low-grade UTUC, we have been extremely pleased with the response from both physicians and patients. We are very pleased that as of June 30th, 20 doses have been administered to patients, and thanks to the preparedness of our team, we've been able to meet every request for product and support. Jeff will provide more details on the launch, but interest has been significant, and we continue to see increased demand despite the challenging environment. I would like to recognize and thank Jeff and the entire commercial team as they have proven their commitment to bringing this breakthrough therapy to patients. Further supporting our launch efforts have been the publication of results from the pivotal Phase III Olympus trial of Gemido in the Lancet Oncology and in a supplement to the April 2020 issue of the Journal of Urology. This data was also the focus of a virtual presentation at the 2020 American Neurological Association annual meeting in mid-May. Additionally, Dr. Kareem Chamey from UCLA highlighted the benefits of gel mito as a kidney-sparing option for low-grade UTUC and reviewed the clinical profile and safety data as part of a theater during the AUA live meeting at the end of June. The publication and presentation of Olympus data continue to underscore why Gemido is important to patients as the first and only approved non-surgical chemoablative treatment for those with this rare and difficult to treat disease. The Olympus study has now completed, and we submitted an updated label to the FDA, including the final safety and efficacy data. While there's no mandated timeline for review, We believe the FDA will approve an updated label in the second half of 2020. It's important to note that the final data is consistent with our previous results, so we don't anticipate significant changes to our label. In addition to the approval and launch of our first therapy, we continue to advance key initiatives designed to build a long-term growth company. This includes the presentation of updated data from the Phase II Optima trial, of UGN-102 at the AUA Annual Meeting in May. No drugs are currently approved by the FDA as first-line treatment for low-grade, intermediate-risk, non-muscle-invasive bladder cancer. This is a sizable opportunity with over 80,000 addressable patients in the U.S. alone, and we believe UGN-102 has the potential to be the first FDA-approved therapy in this setting. and an important non-surgical treatment alternative for this difficult-to-treat patient population. Mark will share our latest update to the data as of July, but we remain very encouraged by the positive complete response and 12-month durability data. This data, combined with the data from Olympus for low-grade UTUC, supports the potential of UGN-102 to have a profound impact on patients who deserve better options. We remain on track to share the final CR and durability data from the Optima II trial by year end, and we will initiate the pivotal Phase III clinical study. Mark will share the details of the trial design, including patient numbers and timing, which are in line with our previous discussions and expectations. Additionally, our UGN 302 program has generated a lot of excitement internally and externally. and it has the potential to transform how high-grade, non-muscle-invasive bladder cancer is treated. UGN302 is a combination of UGN201, our TLR7-8 agonist, and Xalafrilamab, the anti-CTLA-4 antibody we licensed from a genus. There remains a significant unmet need in these patients, despite recent approvals, as the data supporting these approvals reflects only incremental improvements and the continued need for treatment post-BCG. Lastly, we have a strong balance sheet and are pleased with our financial outperformance in Q2. Peter will discuss in more detail, but our cash position allows for our current operations well into 2022, and we have no need for additional capital at this time. We continue to search for new medicines and partnerships to ensure sustainable growth but early successes demonstrate the potential of our medicines and strengthen our belief that we can achieve peak revenue of more than $1 billion annually from our current portfolio. With that, I'll turn the call over to Mark to discuss our recent clinical update. Mark?