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UroGen Pharma Ltd. (NASDAQ:URGN)
Q2 2018 Earnings Conference Call
Aug. 14, 2018, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to UroGen Pharma's Second Quarter 2018 Financial Results and Business Update Conference Call. It is now my pleasure to turn the call over to Kate Bechtold, Director of Corporate Communications and Investor Relations for UroGen Pharma. Please go ahead.

Kate Bechtold -- Director of Corporate Communications and Investor Relations

Thank you, operator. Good morning everyone and welcome to UroGen Pharma's Second Quarter 2018 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, 2018. The press release can be accessed on the Investors portion of our website at investors.urogen.com.

Joining me on the call today are Ron Bentsur, Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer, and Stephen Mullennix, our Chief Operating Officer. Ron will provide a summary of our recent corporate developments, and Mark will share clinical development and regulatory updates. Stephen will then provide an overview of our financial highlights for the second quarter of 2018 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 Factors section of UroGen Pharma's annual report on Form 20-F filed with the SEC on March 15th, 2018, and other filings that UroGen Pharma makes with the SEC from time to time. We encourage all investors to read the company's annual report on Form 20-F and the company's other SEC filings. These documents are available under the SEC Filings section of the Investors page of UroGen's website at investors.urogen.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 Ron.

Ron Bentsur -- Chief Executive Officer

Thank you, Kate. Good morning, everyone, and thank you for joining us on our conference call today. The second quarter of 2018 was a period of dynamic clinical and operational execution for UroGen. We continue to make progress toward our goal of establishing a leadership position in the field of uro-oncology as we advance our two lead programs, UGN-101 and UGN-102, that we believe have the potential to become the first front-line non-surgical therapies for patients in their respective indications.

The update on our lead product, UGN-101, formerly referred to as MitoGel, is no doubt of greatest interest. The ongoing Phase 3 is an open-label, single-arm trial. In May, we presented positive findings from an interim analysis of 34 patients in the OLYMPUS Phase 3 trial at the American Urological Association or AUA annual meeting. The results were extremely encouraging with 59% achieving a complete response or CR. In addition, five of 34 patients or 15%, achieved a partial response. At the time of the interim analysis, durability also appeared favorable.

Of the 20 patients who achieved the CR, 13 patients had reached the three-month follow-up time point and all remained in CR. Of those 13 patients, four had reached the six-month follow-up time point and one had reached the nine-month follow-up time point, and all remained in CR. The data following the interim analysis reported three months ago at the AUA continues to be very compelling, and we look forward to presenting top line results from the study later this year.

Importantly, we recently received formal guidance from the FDA that the UGN-101 program is eligible for a rolling NDA submission. And as such, we now plan to initiate a rolling NDA submission for UGN-101 in the fourth quarter of 2018. This is ahead of our initial submission projection of Q1 2019. This will bring us one step closer to potentially having the first drug ever approved as a first-line chemoablation treatment in low-grade UTUC and potentially transforming the treatment paradigm. I will let Mark discuss our progress on the clinical front in more detail, but I will briefly review a few additional accomplishments from recent months.

While we continue to move forward with our lead program UGN-101, we are also happy to report significant progress with our other pipeline drug candidates. At the end of the second quarter, we submitted an Investigational New Drug or IND application to the FDA for UGN-102, formerly referred to as VesiGel, UroGen's mitomycin gel for intravesical instillation for the treatment of patients with low-grade non-muscle invasive bladder cancer or NMIBC.

UGN-102 represents the next big opportunity of our RTGel platform with a potential to address approximately 400,000 patients diagnosed with low-grade NMIBC. I'm pleased to announce that following our IND submission at the end of June, we have now initiated our Phase 2b single-arm, open-label, multicenter trial to assess the efficacy and safety of UGN-102 as a potential first-line chemoablation agent in the treatment of patients with low-grade NMIBC who are at high risk for recurrence. These patients are commonly referred to as the tough-to-treat patients. The design of the study should also allow us to provide data updates periodically, and we anticipate that the first such update could come as early as Q1 2019.

Over the last several months, we have been conducting extensive pre-clinical work for UGN-201 or VesiMune, our toll-like receptor 7 agonist immunotherapy-based drug candidate, to potentially address high-grade tumors. Specifically, we have been testing VesiMune pre-clinically as a single agent and in combination with checkpoint inhibitors for the treatment of high-grade tumors. Mark will elaborate further on this program.

While our pipeline continues to advance, we believe that we're in the nascent stages of the true potential of our RTGel platform. We strongly believe that UTUC and bladder cancer could be just the beginning. They demonstrate the opportunity to realize the full potential of proven therapies through longer dwell time in a body cavity.

The first example beyond our uro-oncology pipeline is the agreement that we have with Allergan to advance their research, which combines BOTOX with our RTGel platform. We believe other critical areas of exploration will likely be GI and women's health. In the immediate term, we continue to focus on assembling the best talent to lead our transition from clinical stage to commercialization. In July, we announced that Shawn Tomasello joined our Board of Directors. Shawn is a renowned industry expert with a history of commercializing revolutionary multi-billion dollar products in hematology oncology. Her expertise in successfully defining a market and launching disruptive and innovative therapies in areas of high unmet medical need has been clearly on display in her role at Pharmacyclics with one of the most successful oncology drug launches in history with IMBRUVICA, and at her most recent role as Chief Commercial Officer of Kite Pharma, now Kite, a Gilead company, where she led the commercialization of Yescarta, the first ever approved CAR T therapy. We are thrilled that Shawn has joined our Board as we prepare for the potential approval and commercialization of UGN-101.

In addition, we couldn't be more pleased to announce last week that Peter Pfreundschuh will be joining UroGen as Chief Financial Officer effective August 20th. Peter brings more than two decades of executive leadership experience in life sciences, mostly recently serving as CFO of Sucampo Pharmaceuticals where he played a critical role in its recent acquisition by Mallinckrodt for $1.2 billion. Stephen Mullennix will continue in his role as Chief Operating Officer, and we believe that his operational excellence, combined with Peter's successful track record as CFO, will create an excellent partnership. We look forward to formally introducing Peter to all of you over the next few weeks. This quarter was marked by continued execution across multiple fronts, and we're excited to build on that progress.

I will now turn it over to Mark, who will discuss our clinical programs in more detail. Mark, please go ahead.

Mark Schoenberg -- Chief Medical Officer

Thanks, Ron. As a practicing urologist, I'd first like to say how proud I am of what our team has accomplished and what this could ultimately mean for patients. We are certainly excited about the data we've seen to date from our UGN-101 trial. To add to Ron's previous remarks, our OLYMPUS trial is being conducted at clinical sites across the United States and Israel. Patients in the trial undergo six weekly catheter installation treatments of UGN-101.

The primary efficacy endpoint is complete response or CR, assessed at approximately 10 weeks from the start of treatment or approximately four weeks following the six weekly installation of the therapy. Patients who achieve a complete response at primary disease evaluation or PDE, are then followed up for durability of disease control for up to one year, and are eligible to receive up to a year of monthly maintenance therapy of UGN-101.

PDE consists of ureteroscopy and wash cytology, a standard microscopic test of cells obtained from the urine of the upper tract four to six weeks after the completion of treatment. The CR rate of 59%, as we reported in our interim analysis three months ago at the AUA, combined with the fact that UGN-101 was well tolerated, is remarkably compelling. It is also important to mention that in the study, more than a third of the patients presented with unresectable tumors. Such patients in a real-life setting would be candidates for kidney removal.

Our optimism about the 59% CR rate from the interim analysis is further fueled by comparison to the CR rate of 44% observed in the UGN-101 Compassionate Use program, as well as the 20% CR rate that has been deemed clinically meaningful by key opinion leaders in the field. In addition to the 59% of the intent to treat population who achieved a CR at the time of the interim analysis, 15% or five of the 34 patients achieved a partial response. While only the CR will be considered for regulatory purposes in evaluating the OLYMPUS trial, we believe that partial response rates will also be meaningful to practicing physicians in the real world.

Let me put all of this in context with typical outcomes for these patients. The thousands of patients currently living with UTUC do not have many therapeutic options to manage their disease. By potentially enabling the treatment of these tumors by non-surgical means, we are sparing patients from the well-known risks and complications associated with repetitive surgical procedures and potential kidney removal. We believe that UGN-101 will be particularly useful for those patients with rapidly and chronically recurrent cancer, and for those whose disease cannot be visualized or resected using contemporary endoscopic technology.

Because surgical therapy has limitations, low-grade UTUC remains a chronic relapsing problem among elderly patients who have relatively few effective treatment options. And those are the fortunate patients that present with resectable tumors. For those who present with unresectable tumors unfortunately, the only current alternative is kidney removal.

There was clear consensus among an expert panel discussing the interim data of UGN-101 at an event during the 2018 AUA that UGN-101 offers an opportunity to avoid major quality of life-altering surgery and associated complications. Experts further noted that this may be a viable alternative for patients whose health may suffer as a result of major surgery or further renal functional loss. With the planned completion of the UGN-101 trial in the second half of this year, and the initiation of the rolling submission of the UGN-101 NDA planned for the fourth quarter, we are getting closer to delivering a technology that has the potential to change the outlook for patients with low-grade UTUC. We are now three months past the interim analysis presentation at the AUA and continue to be encouraged by the results observed in the trial.

We look forward to leveraging the experience we've gained from the UGN-101 clinical studies as we embark on our next product candidate, UGN-102. This month, we initiated our Phase 2b single-arm, open-label, multicenter trial designed to assess the efficacy and safety of UGN-102 as a potential first-line chemoablation agent in the treatment of patients with low-grade non-muscle invasive bladder cancer or NMIBC who are at risk for recurrence.

Like UTUC, there are currently no drugs approved by the FDA as first-line treatment for NMIBC, and only three drugs have been approved by the FDA, all as adjuvant treatments following TURBT or transurethral resection of bladder tumor. TURBT is performed under anesthesia and is associated with the standard risks of anesthesia as well as injury to the bladder and postoperative bleeding. Relapse of disease is common after TURBT with approximately 40% of patients recurring at one year. It is not unusual for patients to require multiple repetitive surgical procedures to control NMIBC, making bladder cancer the costliest cancer to treat in the United States.

The annual incidence of urothelial bladder cancer is approximately 80,000 in the United States with a prevalence of 700,000. NMIBC accounts for approximately 80% of all new cases of bladder cancer diagnosed in the United States each year. This means there is potentially a large patient population that may benefit from UGN-102.

The Phase 2b OPTIMA II trial is an open-label, single-arm study and is anticipated to enroll approximately 60 patients primarily in clinical sites in the US. As we move forward with this study, we are encouraged by the results of our Phase 2a study of UGN-102, in which an 86% CR rate was achieved. We look forward to initial data from the OPTIMA II trial anticipated in early 2019.

We continue to advance research for UGN-201 known as Vesimune, our novel imiquimod formulation for bladder instillation as a single agent and in combination with immune checkpoint inhibitors for the treatment of high-grade urothelial cancer. Pre-clinical models have demonstrated antitumor effects of UGN-201 as a single agent as well as in combination with novel immunomodulatory molecules via intravesical instillation in urothelial cancer. We are particularly encouraged by the single agent approach and look forward to updating you on these pre-clinical experiments later this year.

We are also working on formulating VesiMune with our RTGel because we believe that dwell time is a critical parameter for the ultimate use of this agent as well. We have made significant strides toward achieving this formulation. We look forward to updating you on the specifics of a clinical trial design for UGN-201 later this year.

With that, I would now like to turn the call over to Stephen to briefly review our financials.

Stephen Mullennix -- Chief Operating Officer

Thank you, Mark, and good morning to all of you on today's call. UroGen is well capitalized to further advance our clinical development programs and support our commercial planning efforts in preparation for potential US approval of UGN-101 in 2019. We closed the second quarter of 2018 with $119.1 million in cash and cash equivalents. We believe our quarter-end cash position will be sufficient to fund the planned operations for well beyond the next 12 months.

For the second quarter and six months ended June 30th, 2018, we reported a net loss of $18 million or $1.14 per share, and $31.4 million or $2.02 per share respectively. This compares to net losses of approximately $6.2 million or $0.70 per share, and $9.6 million or $1.81 per share for the same periods in 2017. The net losses for the second quarter and six months ended June 30th, 2018 include $7.7 million and $12.3 million respectively in non-cash share-based compensation expense.

Research and development expenses for the second quarter and six months ended June 30th, 2018 were $8.3 million and $15.9 million respectively, compared to $3.7 million and $6.3 million for the same periods ended June 30th, 2017, and include $2.8 million and $5.3 million in non-cash share-based compensation expenses respectively. The increase from 2017 to 2018 reflects an increase in direct costs associated with our UGN-101 Phase 3 OLYMPUS trial, an increase in personnel costs and an increase in share-based compensation.

General and administrative expenses for the second quarter and six months ended June 30th, 2018 were $10.2 million and $16.3 million respectively, as compared to $2.3 million and $3.2 million for the same periods in 2017, and include $4.9 million and $7.0 million in non-cash share-based compensation expenses respectively. As of June 30th, 2018, we had approximately 15.9 million ordinary shares outstanding.

With that, operator, I would now like to turn the call over for questions.

Questions and Answers:

Operator

Thank you. We will now begin the question-and-answer session. (Operator Instructions) And our first question is from Boris Peaker from Cowen.

Boris Peaker -- Cowen -- Analyst

Good morning.

Ron Bentsur -- Chief Executive Officer

Good morning, Boris.

Stephen Mullennix -- Chief Operating Officer

Hey, Boris.

Boris Peaker -- Cowen -- Analyst

My first question, maybe just on the definition of disease. Could you just elaborate on what's the difference between low-grade non-muscle invasive bladder cancer with or without a high risk of recurrence, and what fraction of low-grade patients fall within the low-grade -- low risk versus high risk of recurrence?

Mark Schoenberg -- Chief Medical Officer

Hey, Boris. It's Mark. Great question, an important one for this trial. Low-grade non-muscle invasive bladder cancer is actually the big group in non-muscle invasive bladder cancer. Somewhere around 60% of the patients who have non-muscle invasive disease fall into this group. The high recurring fraction in this population, which is a problem for urologists, because these are people who effectively fail surgical therapy and recur multiple times both within the year and also throughout life, are tough to treat and are defined both by us and in our conversations with the agency as tough to treat.

So this group probably represents, we estimate, somewhere between 10% and 15%, excuse me, of the total population, but we're choosing to focus on them because they represent a real unmet need in our conversation with physicians, and frankly, across the spectrum of urologists with whom we've discussed this application. Remember the group of patients we're drawing this subset from is 400,000 prevalence in the United States. So this provides us with, we think, a window into a very big population of patients who would be served by a non-surgical alternative, particularly for those who don't respond to surgical therapy by recurring multiple times during life.

Boris Peaker -- Cowen -- Analyst

Got you. Mark, let me just clarify. When you said 10% to 15%, that's of the entire NMIBC or only of the low-grade NMIBC?

Mark Schoenberg -- Chief Medical Officer

That's of the low-grade group.

Boris Peaker -- Cowen -- Analyst

Got you. And so my question for the -- the second question is, for UGN-102 OPTIMA trial, you mentioned you're going to provide interim updates since it's a single-arm study. I'm just curious, how many updates are you anticipating? Is it just a single update or you think you could squeeze in multiple ones?

Ron Bentsur -- Chief Executive Officer

Hey, Boris, it's Ron. Probably multiple ones. Every time we'll have a critical mass of data accumulated, we will look for an important venue to report the data, whether it's a medical conference or something along those lines, but we anticipate that over the course of the study, which will probably take roughly 15 to 18 months from start to finish, we will have several opportunities to report data.

Boris Peaker -- Cowen -- Analyst

Great. Thank you very much for taking my questions.

Ron Bentsur -- Chief Executive Officer

Thank you.

Operator

Our next question is from Matthew Andrews from Jefferies.

Matthew Andrews -- Jefferies -- Analyst

Hey, good morning. Ron and Mark, just curious what change relative to MitoGel and the timing, and how did this meeting come about with the agency? Have you shared data with them on the OLYMPUS study at this point in time? Just curious how that all came about.

Ron Bentsur -- Chief Executive Officer

Are you referring to the rolling submission or --

Matthew Andrews -- Jefferies -- Analyst

Yes, that's correct. That's correct. I apologize. You moved it up a quarter. So just curious, was there something in the data that you shared with them that they felt warranted giving you this guidance to accelerate the timing a little bit?

Ron Bentsur -- Chief Executive Officer

Keep in mind that when we presented the data at the AUA, before we did that we reached out to the agency to basically ask for permission to do that because we felt that the AUA was a very important venue to get the word out and to obviously increase the awareness because of the size and the attendance of a venue such as the AUA. So in doing so, we shared the data with them. It was roughly the same dataset that was presented at the AUA. And there was a little bit of follow-up dialog after that and we received formal guidance from them that we are eligible for a rolling submission about a month or a month and a half ago, something like that.

And we kind of caucused internally to figure out what -- how we want to approach that and how quickly we can get that started, and we came to the conclusion internally that we in fact could be in a position or should be in a position to start the rolling submission in the fourth quarter as opposed to the first quarter of 2019. So that puts us slightly ahead of schedule. So obviously that's very good news, first of all the fact that the FDA has given us this ability in a formal fashion, they basically are allowing for rolling submission. And as you know, rolling submission does give you an opportunity to expedite things because modules that don't necessarily have to wait for final data can get prepared and can get submitted, and that also helps out the review process overall. So that's really the intent of the whole thing. So we're very pleased by that obviously. And I can't speak on behalf of the FDA, but obviously one would want to believe or one would expect that a lot of it was driven by the strength of the data that was presented to them when we reached out to them to ask for the AUA presentation.

Matthew Andrews -- Jefferies -- Analyst

Got you. And then, excuse me, presumably you would need data in all said, roughly 74 to include into the clinical section when you file or do you believe you just have to be close to that 74-ish to submit the package?

Ron Bentsur -- Chief Executive Officer

Yes. So we would need the top line data, so -- in order to finish the clinical module, but keep in mind that the clinical module is just one of five modules. There are other modules that we can start working on, and in fact, we believe we can complete by the fourth quarter, so we could start that submission. And also keep in mind that at the time of the submission of the clinical module, we will not have all the durability information yet because we'll still have patients that need to be followed up for that 12-month period. The FDA is fully aware of that. That's been agreed to. So during the review process, we will provide them with the durability and safety updates from the patients that are being followed up.

Matthew Andrews -- Jefferies -- Analyst

And then just a follow-up on Boris' question. From a clinical or regulatory standpoint, is there any sort of controversy in and around defining this patient population that's at risk for recurrence with the low-grade non-muscle? Do you have agreement with the FDA for this study, what the exact population is that you're going to study?

Ron Bentsur -- Chief Executive Officer

Yeah, Matt, so I'll answer top level and then I'll ask Mark to provide a little bit more detail, but we have discussed this population preliminarily with the FDA. We believe that the FDA understand that a population like that does exist. These are patients that are essentially surgery failures. They just recur very frequently, which in essence means that the surgery doesn't do a very good job on these patients and it could be for a variety of reasons. And we believe that there is a meeting of the minds insofar as the fact that a sub-population like that clearly exists, and it just becomes futile to essentially take these patients and put them in this -- into this vicious cycle over and over and over again very frequently.

Now, obviously this is a Phase 2b study. This is not a pivotal study. So at the end of the day, the data is going to determine what the next undertaking is going to be, whether this study could potentially qualify or whether this study enhanced, meaning more patients, could become a pivotal study, or possibly another Phase 3 study would be needed. Again, it's a little premature to be able to ascertain that, but I think that there is clearly an understanding from the FDA that a population like this does exist. But again, just to be cautious, this is a Phase 2b study. This is not a pivotal study. Go ahead, Mark.

Mark Schoenberg -- Chief Medical Officer

Just to add on to that, Matt. There is a very clear message from the urologic community that this population is a problem. And anybody in practice who takes care of these patients knows that there is a segment of the population of patients with low-grade disease who recur so often that they cannot be considered anything other than essentially not responsive to contemporary therapy. So there is an unmet need, and we believe that by focusing on that group, we're really addressing a tangible, verifiable medical problem, and we have corroboration from our KOLs and from discussion with urologists in the community. So we feel confident that we can identify this group.

Matthew Andrews -- Jefferies -- Analyst

Okay. Great. Thank you.

Ron Bentsur -- Chief Executive Officer

Thank you.

Operator

Our next question is from Leland Gershell from Oppenheimer.

Leland Gershell -- Oppenheimer -- Analyst

Hey, good morning.

Ron Bentsur -- Chief Executive Officer

Good morning.

Leland Gershell -- Oppenheimer -- Analyst

Good morning. On the UGN-102 OPTIMA trial, the design of that trial should be the same effectively as for OLYMPUS in terms of weekly infusion, six weekly, and then will patients be eligible who get a response for maintenance therapy? How should we think about the design?

Mark Schoenberg -- Chief Medical Officer

Yeah. So Leland, it's Mark. Exactly the same type of design in the sense that patients will have biopsy confirmation disease, they'll receive six weekly installations of 102, and then after a resting period, which is traditional in urology of four to six weeks, a primary disease evaluation completely analogous to what's seen in the 101 trial, and then these patients will be followed. At this point, we are not planning on providing maintenance therapy for these patients, but that's the current design.

Leland Gershell -- Oppenheimer -- Analyst

Okay, great. And then as we look toward the final data from OLYMPUS later this year, will we also be seeing data from the maintenance setting of the Compassionate Use in terms of longer-term therapy with UGN-101?

Ron Bentsur -- Chief Executive Officer

So hopefully, we continue to follow these patients out and keep in mind that we're seeing some very extended durabilities from the Compassionate Use program. In fact, one patient is out two years, and we know of another patient that's out north of a year and a half, well north of a year and a half. So we know that we're seeing some very nice robust durability results from the study. So obviously we're very keen to continue to follow these patients out. Sometimes it's difficult because it's three years from the start of treatment, so some patients move and some patients getting lost to follow up and so on. But the bottom line is that overall when you look at the durability picture that has emerged from the Compassionate Use program, we're very encouraged by that, the median durability is north of 12 months, and again it's a small N. It's only eight patients that were followed out. But if it's any indication of what's to come from the OLYMPUS study, then obviously we've got a very good reason to be optimistic.

Leland Gershell -- Oppenheimer -- Analyst

Okay, great. And then my last question is on the financial side. As we look at the R&D and G&A, which are bumping up a little bit, how should we think about those expenses through rest of this year as the OPTIMA trial gets going and pre-commercial plans are made for UGN-101 with the rolling NDA also going on?

Stephen Mullennix -- Chief Operating Officer

Hi, thanks. Yeah, this is Stephen. The levels that you're seeing through the last quarter will be what we predict through the bulk of the end of the year. There may be a slight uptick as we bring on sites and patients into the 102 study, but I don't expect a dramatic increase there.

Leland Gershell -- Oppenheimer -- Analyst

Okay. Great. That's very helpful. Thanks very much.

Ron Bentsur -- Chief Executive Officer

Thank you.

Operator

Our next question is from Ren Benjamin from Raymond James.

Reni Benjamin -- Raymond James -- Analyst

Hey, good morning guys. Thanks for taking the question.

Ron Bentsur -- Chief Executive Officer

Good morning.

Reni Benjamin -- Raymond James -- Analyst

Good morning. And I guess just to start off, you guys mentioned the five of 34 patients who achieved a partial response. Do these patients with PRs, do they -- any of them convert to a CR with later treatments or maintenance treatment? And how in the landscape or with physicians right now, how are PRs typically viewed for an indication like this?

Mark Schoenberg -- Chief Medical Officer

Hi, Ren, it's Mark. So a great question. In the trial, once you have not had a CR, you're considered a non-responder. So for the purposes of regulatory submission, they don't count. However importantly, if you talk to doctors in the real world, partial response is also very meaningful because what this means is the patients who had potentially disease that could not be managed endoscopically, patients that would end up having to have their kidneys removed, can now be converted to patients who can have a minor surgical procedure and be rendered disease free. So we saw this in the Compassionate Use program where several patients had disease that was considerably downsized from what would have been deemed unresectable to manageable. So we know as a practical matter that this will very likely be a use in the real world of 101 once -- hopefully when it's available for the treatment of patients in general practice.

Ron Bentsur -- Chief Executive Officer

And Ren, in fact, we had one patient in the Compassionate Use who was a partial responder and then that patient was actually retreated with UGN-101 and achieved a complete response. So that may happen in the real world as well, retreatment to try to achieve a complete response.

Reni Benjamin -- Raymond James -- Analyst

Got it. And then how many patients are -- or do you have a sense of how many patients are opting to continue to take the monthly, and I call it a booster but treatment after the initial six weeks of infusions?

Ron Bentsur -- Chief Executive Officer

Yeah. So it's -- so only the patients who achieve a complete response obviously are eligible to receive the monthly maintenance. And right now about two-thirds of the patients are opting to do that. And quite frankly, the other third that's not doing it, is opting out mostly due to convenience reasons. Keep in mind, this is an elderly patient population. It's not easy for them to come in, to drive into a clinic monthly. So they do it for the initial treatment because it's very important, but sometimes it's just too taxing on them just from a logistical perspective, but still the lion's share of the patients are opting into the maintenance program.

Reni Benjamin -- Raymond James -- Analyst

Got it. And then -- I know the top line results are expected at the end of this year. Is it fair to assume that the top line results will be press released and then more detailed results at a conference next year, or is there a conference this year that I'm forgetting about?

Ron Bentsur -- Chief Executive Officer

We don't know yet. We don't know. Well, obviously once we can fine-tune the resolution, we'll provide updates on that.

Reni Benjamin -- Raymond James -- Analyst

Okay. Can you talk a little bit --

Ron Bentsur -- Chief Executive Officer

We would --

Reni Benjamin -- Raymond James -- Analyst

Oh, sorry, go ahead, Ron.

Ron Bentsur -- Chief Executive Officer

No, no. We -- obviously we're on track to reporting top line by -- in the second half. I don't know exactly what the conference venue is going to be where we'll provide the full detail.

Reni Benjamin -- Raymond James -- Analyst

Got it. And can you talk a little bit about your ex-US regulatory strategy and how that might unfold?

Ron Bentsur -- Chief Executive Officer

Yeah. So we plan to have a formal meeting with the EMA this year, and obviously it's too early to tell, but we're certainly hopeful that they will recognize the program that is being undertaken here in the US as a program that will be sufficient for approval in Europe for upper tract. That's certainly the goal. And we'll find out within a few months and look worst-case, if they demand another study, we'll probably end up running another study to get that European approval, but we're certainly hoping and we'll certainly try to negotiate hard to get this current program to qualify as the approval study or the OLYMPUS study to qualify as the pivotal study for Europe as well.

Reni Benjamin -- Raymond James -- Analyst

Got it. Thanks for taking the questions and congrats on the progress.

Ron Bentsur -- Chief Executive Officer

Thank you very much.

Mark Schoenberg -- Chief Medical Officer

Thank you.

Operator

Our next question is from Matt Kaplan from Ladenburg Thalmann.

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

Hi, good morning, guys.

Ron Bentsur -- Chief Executive Officer

Good morning.

Mark Schoenberg -- Chief Medical Officer

Hey, good morning.

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

I guess a question for Mark. Just wanted to follow up and get a little bit more details on that UGN-102. What should we be looking for in the Phase 2b study, given the patient population you're enrolling there in the context of the prior results from Phase 2 that we saw, very high CR rate?

Mark Schoenberg -- Chief Medical Officer

Yeah. So this population -- I think it's probably obvious from what we've been talking about, this population is an even more adversely affected population than was studied in the OPTIMA I program. So you remember that the OPTIMA I program had an 86% complete response and very encouraging durability. So now we're moving to an even more adversely affected group of people who have even higher rates of recurrence. And the reason we're doing that is because we think there is an unmet medical need that we're pretty clear on based on our conversations with our doctors. And it also sort of falls in line with the data we have available from OPTIMA I, showing that the approach works better in people with multifocal tumors, with larger tumors. That's the target we're after. We're trying to look at people who would otherwise have to have surgery, we're sparing them the risk of anesthesia et cetera as opposed to people who could be very easily taken care of in the office, who have tiny tumors that could be fulgurated. So what we're looking for is a CR rate in this adversely affected population as well as durability, but obviously it's a worse group. So the numbers we're looking at would be probably lower than what we saw in OPTIMA I. Remains to be seen from the trial.

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

Great. That's helpful. And then for 101, as you're kind of nearing the start of your rolling submission of the NDA, is there potential for a priority review status there?

Ron Bentsur -- Chief Executive Officer

Yeah, there certainly is potential for priority review, we believe that we should be eligible and hopefully will hear soon, but again until we have it in writing and confirmed, we just need to wait and to see if we get it. Obviously we're very keen on getting it because it will mean an expedited review of typically six months as opposed to 10 or 12 months. So obviously that would be very beneficial. And given the fact that we have Fast Track and Orphan Drug designations, particularly Fast Track, we should be eligible, but again we need formal certification for that.

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

Okay. Thanks, Ron. And then just shifting gears, you mentioned the kind of -- their base technology, the gel technology and potentially applications outside of urology in GI and women's health. When should we expect to hear some of the details around what you're going to pursue there from a pipeline point of view?

Ron Bentsur -- Chief Executive Officer

Yeah. So we're starting to look into that. The R&D group is putting pen to paper to start working on those two potential avenues. So over the next few months, we will be probably elucidating path forward, including the possibility of already generating some pre-clinical data in those areas. So definitely people should be on the lookout for some -- at least some pre-clinical data within the next, call it, six to nine months for those two potential avenues.

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

Well, congrats on the progress guys, and thanks for taking the questions.

Ron Bentsur -- Chief Executive Officer

(inaudible).

Mark Schoenberg -- Chief Medical Officer

Thanks, Matt.

Stephen Mullennix -- Chief Operating Officer

Thanks.

Operator

I'm showing no further questions at this time. I will now turn the call back over to UroGen's CEO, Ron Bentsur, for closing remarks.

Ron Bentsur -- Chief Executive Officer

Thank you, operator. I want to thank you all for your time today. We remain very pleased with the progress we've made this quarter, and look forward to updating you on key milestones in the months ahead. Operator, you may now disconnect.

Operator

Thank you. Ladies and gentlemen, this concludes today's conference. Thank you for participating, and you may now disconnect.

Duration: 44 minutes

Call participants:

Kate Bechtold -- Director of Corporate Communications and Investor Relations

Ron Bentsur -- Chief Executive Officer

Mark Schoenberg -- Chief Medical Officer

Stephen Mullennix -- Chief Operating Officer

Boris Peaker -- Cowen -- Analyst

Matthew Andrews -- Jefferies -- Analyst

Leland Gershell -- Oppenheimer -- Analyst

Reni Benjamin -- Raymond James -- Analyst

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

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